Susan London

The immune checkpoint inhibitor pembrolizumab has good antitumor activity and a favorable safety profile when used to treat relapsed or refractory classic Hodgkin lymphoma, according to findings from the KEYNOTE-087 trial.

Pembrolizumab has garnered interest for this population because Hodgkin Reed-Sternberg cells have a chromosomal alteration leading to overexpression of both programmed death ligand 1 and programmed death ligand 2.

Neil Osterweil

The immune checkpoint inhibitor pembrolizumab has good antitumor activity and a favorable safety profile when used to treat relapsed or refractory classic Hodgkin lymphoma, according to findings from the KEYNOTE-087 trial.

Pembrolizumab has garnered interest for this population because Hodgkin Reed-Sternberg cells have a chromosomal alteration leading to overexpression of both programmed death ligand 1 and programmed death ligand 2.

Neil Osterweil

The immune checkpoint inhibitor pembrolizumab has good antitumor activity and a favorable safety profile when used to treat relapsed or refractory classic Hodgkin lymphoma, according to findings from the KEYNOTE-087 trial.

Pembrolizumab has garnered interest for this population because Hodgkin Reed-Sternberg cells have a chromosomal alteration leading to overexpression of both programmed death ligand 1 and programmed death ligand 2.

Neil Osterweil

With optimal approaches still evolving for the diagnosis and management of peripheral neuropathies associated with Waldenström macroglobulinemia and other IgM paraproteinemias, new consensus recommendations from a multidisciplinary panel were recently published in the British Journal of Haematology.

Up to half of patients with IgM monoclonal gammopathies develop peripheral neuropathy, according to the 11-member panel (Br J Haematol. 2017 Mar;176[5]:728-42). The panel began deliberations at the eighth International Workshop on Waldenström Macroglobulinemia in London and was led by Shirley D’Sa, MD, of the Waldenström Clinic, Cancer Division, University College London Hospitals NHS Foundation Trust.

• Diagnostic evaluation: “The indications for invasive investigations such as cerebrospinal fluid analysis, nerve conduction tests, and sensory nerve biopsies are unclear,” according to the panelists.

When clinical examination identifies a neuropathy, neurophysiologic testing can ascertain its nature and inform additional work-up. Cerebrospinal fluid examination is not mandatory in cases of demyelinating neuropathy, but it is indicated when clinical evaluation is inconclusive and malignancy or CNS invasion is suspected.

Nerve biopsy carries substantial risk and is rarely indicated. It may be warranted when a comprehensive systemic work-up has not identified a cause and clinicians still suspect amyloid, vasculitis, or direct cellular invasion; in atypical cases not responding to treatment; or when the neuropathy is progressive and debilitating.

When it comes to imaging, “MRI of the neuraxis should be performed prior to lumbar puncture to avoid false positive meningeal enhancement,” they advised. “Prior discussion of likely sites of involvement with an experienced neuroradiologist will ensure that the correct sequences of the correct anatomical area are performed with appropriate gadolinium enhancement.”

• Clinical phenotypes and their treatment: IgM-associated neuropathies vary with respect to specific antibodies present and the likelihood that they are causally associated with the neuropathy, Dr. D’Sa and her colleagues noted. They provided a decision tree to help guide the work-up to determine the specific etiology.

“The presence of a neuropathy alone is not a justification for treatment, but steady progression with accumulating disability should prompt action,” they maintained.

Patients with antibody-negative peripheral neuropathy associated with IgM monoclonal gammopathies of undetermined significance who have mild disease and no hematologic reason for treatment can be managed with surveillance, according to the panelists.

However, immunosuppressive or immunomodulatory treatment should be considered when there is substantial or progressive disability associated with demyelination.

Patients with anti-MAG (myelin-associated glycoprotein) demyelinating neuropathy may benefit from rituximab (Rituxan). In those with more advanced disease, clinicians should consider immunosuppressive or immunomodulatory treatment instead.

Surveillance is also an option for Waldenström macroglobulinemia–associated peripheral neuropathy that is progressing slowly. When used, treatment should be tailored to severity of both systemic and neurologic disease.
 

• Treatment response assessment: “The optimum way to measure clinical response to treatment unknown,” Dr. D’Sa and her fellow panelists noted. A variety of measures of muscle strength, sensory function, and disability are used.

“The I-RODS [Inflammatory Rasch-Built Overall Disability Scale] more often captures clinically meaningful changes over time, with a greater magnitude of change, compared with the INCAT-ONLS [Inflammatory Neuropathy Cause and Treatment–Overall Neuropathy Limitation Scale] disability scale and its use is therefore suggested in future trials involving patients with inflammatory neuropathies,” they wrote.

• Model of care: Management of patients with IgM-associated neuropathies requires multidisciplinary care with good collaboration to optimize patient outcomes, the consensus panel said.

“A suggested model of care is a combined neurological and hematological clinic, in which patients are seen jointly by a specialist neurologist and hematologist and a decision can be made about the sequence of investigations, interventions, and the formulation of a treatment plan,” they proposed. “Appropriate and timely referral to physical, occupational, and orthotic professionals is recommended in order to maximize safety and function.”

• Future perspectives: “There is much to be done to improve outcomes for patients with IgM and [Waldenström macroglobulinemia]-associated peripheral neuropathies,” the panelists concluded.

Key areas of focus are “early recognition of the problem, appropriate causal attribution achieved through sensitive diagnostics that are not overly invasive, timely therapeutic intervention with effective and nonneurotoxic therapies, achievement of an appropriate degree of clonal reduction for optimum clinical outcomes, and the use of reproducible and readily applicable tools to measure outcomes.”

Dr. D’Sa disclosed that she receives honoraria from Janssen.

With optimal approaches still evolving for the diagnosis and management of peripheral neuropathies associated with Waldenström macroglobulinemia and other IgM paraproteinemias, new consensus recommendations from a multidisciplinary panel were recently published in the British Journal of Haematology.

Up to half of patients with IgM monoclonal gammopathies develop peripheral neuropathy, according to the 11-member panel (Br J Haematol. 2017 Mar;176[5]:728-42). The panel began deliberations at the eighth International Workshop on Waldenström Macroglobulinemia in London and was led by Shirley D’Sa, MD, of the Waldenström Clinic, Cancer Division, University College London Hospitals NHS Foundation Trust.

• Diagnostic evaluation: “The indications for invasive investigations such as cerebrospinal fluid analysis, nerve conduction tests, and sensory nerve biopsies are unclear,” according to the panelists.

When clinical examination identifies a neuropathy, neurophysiologic testing can ascertain its nature and inform additional work-up. Cerebrospinal fluid examination is not mandatory in cases of demyelinating neuropathy, but it is indicated when clinical evaluation is inconclusive and malignancy or CNS invasion is suspected.

Nerve biopsy carries substantial risk and is rarely indicated. It may be warranted when a comprehensive systemic work-up has not identified a cause and clinicians still suspect amyloid, vasculitis, or direct cellular invasion; in atypical cases not responding to treatment; or when the neuropathy is progressive and debilitating.

When it comes to imaging, “MRI of the neuraxis should be performed prior to lumbar puncture to avoid false positive meningeal enhancement,” they advised. “Prior discussion of likely sites of involvement with an experienced neuroradiologist will ensure that the correct sequences of the correct anatomical area are performed with appropriate gadolinium enhancement.”

• Clinical phenotypes and their treatment: IgM-associated neuropathies vary with respect to specific antibodies present and the likelihood that they are causally associated with the neuropathy, Dr. D’Sa and her colleagues noted. They provided a decision tree to help guide the work-up to determine the specific etiology.

“The presence of a neuropathy alone is not a justification for treatment, but steady progression with accumulating disability should prompt action,” they maintained.

Patients with antibody-negative peripheral neuropathy associated with IgM monoclonal gammopathies of undetermined significance who have mild disease and no hematologic reason for treatment can be managed with surveillance, according to the panelists.

However, immunosuppressive or immunomodulatory treatment should be considered when there is substantial or progressive disability associated with demyelination.

Patients with anti-MAG (myelin-associated glycoprotein) demyelinating neuropathy may benefit from rituximab (Rituxan). In those with more advanced disease, clinicians should consider immunosuppressive or immunomodulatory treatment instead.

Surveillance is also an option for Waldenström macroglobulinemia–associated peripheral neuropathy that is progressing slowly. When used, treatment should be tailored to severity of both systemic and neurologic disease.
 

• Treatment response assessment: “The optimum way to measure clinical response to treatment unknown,” Dr. D’Sa and her fellow panelists noted. A variety of measures of muscle strength, sensory function, and disability are used.

“The I-RODS [Inflammatory Rasch-Built Overall Disability Scale] more often captures clinically meaningful changes over time, with a greater magnitude of change, compared with the INCAT-ONLS [Inflammatory Neuropathy Cause and Treatment–Overall Neuropathy Limitation Scale] disability scale and its use is therefore suggested in future trials involving patients with inflammatory neuropathies,” they wrote.

• Model of care: Management of patients with IgM-associated neuropathies requires multidisciplinary care with good collaboration to optimize patient outcomes, the consensus panel said.

“A suggested model of care is a combined neurological and hematological clinic, in which patients are seen jointly by a specialist neurologist and hematologist and a decision can be made about the sequence of investigations, interventions, and the formulation of a treatment plan,” they proposed. “Appropriate and timely referral to physical, occupational, and orthotic professionals is recommended in order to maximize safety and function.”

• Future perspectives: “There is much to be done to improve outcomes for patients with IgM and [Waldenström macroglobulinemia]-associated peripheral neuropathies,” the panelists concluded.

Key areas of focus are “early recognition of the problem, appropriate causal attribution achieved through sensitive diagnostics that are not overly invasive, timely therapeutic intervention with effective and nonneurotoxic therapies, achievement of an appropriate degree of clonal reduction for optimum clinical outcomes, and the use of reproducible and readily applicable tools to measure outcomes.”

Dr. D’Sa disclosed that she receives honoraria from Janssen.

With optimal approaches still evolving for the diagnosis and management of peripheral neuropathies associated with Waldenström macroglobulinemia and other IgM paraproteinemias, new consensus recommendations from a multidisciplinary panel were recently published in the British Journal of Haematology.

Up to half of patients with IgM monoclonal gammopathies develop peripheral neuropathy, according to the 11-member panel (Br J Haematol. 2017 Mar;176[5]:728-42). The panel began deliberations at the eighth International Workshop on Waldenström Macroglobulinemia in London and was led by Shirley D’Sa, MD, of the Waldenström Clinic, Cancer Division, University College London Hospitals NHS Foundation Trust.

• Diagnostic evaluation: “The indications for invasive investigations such as cerebrospinal fluid analysis, nerve conduction tests, and sensory nerve biopsies are unclear,” according to the panelists.

When clinical examination identifies a neuropathy, neurophysiologic testing can ascertain its nature and inform additional work-up. Cerebrospinal fluid examination is not mandatory in cases of demyelinating neuropathy, but it is indicated when clinical evaluation is inconclusive and malignancy or CNS invasion is suspected.

Nerve biopsy carries substantial risk and is rarely indicated. It may be warranted when a comprehensive systemic work-up has not identified a cause and clinicians still suspect amyloid, vasculitis, or direct cellular invasion; in atypical cases not responding to treatment; or when the neuropathy is progressive and debilitating.

When it comes to imaging, “MRI of the neuraxis should be performed prior to lumbar puncture to avoid false positive meningeal enhancement,” they advised. “Prior discussion of likely sites of involvement with an experienced neuroradiologist will ensure that the correct sequences of the correct anatomical area are performed with appropriate gadolinium enhancement.”

• Clinical phenotypes and their treatment: IgM-associated neuropathies vary with respect to specific antibodies present and the likelihood that they are causally associated with the neuropathy, Dr. D’Sa and her colleagues noted. They provided a decision tree to help guide the work-up to determine the specific etiology.

“The presence of a neuropathy alone is not a justification for treatment, but steady progression with accumulating disability should prompt action,” they maintained.

Patients with antibody-negative peripheral neuropathy associated with IgM monoclonal gammopathies of undetermined significance who have mild disease and no hematologic reason for treatment can be managed with surveillance, according to the panelists.

However, immunosuppressive or immunomodulatory treatment should be considered when there is substantial or progressive disability associated with demyelination.

Patients with anti-MAG (myelin-associated glycoprotein) demyelinating neuropathy may benefit from rituximab (Rituxan). In those with more advanced disease, clinicians should consider immunosuppressive or immunomodulatory treatment instead.

Surveillance is also an option for Waldenström macroglobulinemia–associated peripheral neuropathy that is progressing slowly. When used, treatment should be tailored to severity of both systemic and neurologic disease.
 

• Treatment response assessment: “The optimum way to measure clinical response to treatment unknown,” Dr. D’Sa and her fellow panelists noted. A variety of measures of muscle strength, sensory function, and disability are used.

“The I-RODS [Inflammatory Rasch-Built Overall Disability Scale] more often captures clinically meaningful changes over time, with a greater magnitude of change, compared with the INCAT-ONLS [Inflammatory Neuropathy Cause and Treatment–Overall Neuropathy Limitation Scale] disability scale and its use is therefore suggested in future trials involving patients with inflammatory neuropathies,” they wrote.

• Model of care: Management of patients with IgM-associated neuropathies requires multidisciplinary care with good collaboration to optimize patient outcomes, the consensus panel said.

“A suggested model of care is a combined neurological and hematological clinic, in which patients are seen jointly by a specialist neurologist and hematologist and a decision can be made about the sequence of investigations, interventions, and the formulation of a treatment plan,” they proposed. “Appropriate and timely referral to physical, occupational, and orthotic professionals is recommended in order to maximize safety and function.”

• Future perspectives: “There is much to be done to improve outcomes for patients with IgM and [Waldenström macroglobulinemia]-associated peripheral neuropathies,” the panelists concluded.

Key areas of focus are “early recognition of the problem, appropriate causal attribution achieved through sensitive diagnostics that are not overly invasive, timely therapeutic intervention with effective and nonneurotoxic therapies, achievement of an appropriate degree of clonal reduction for optimum clinical outcomes, and the use of reproducible and readily applicable tools to measure outcomes.”

Dr. D’Sa disclosed that she receives honoraria from Janssen.

ORLANDO – Accumulating experience is showing the benefits of various models of care for cancer survivors in terms of health care use and costs, while also suggesting that some provide higher-quality care than others, according to a pair of studies reported at a symposium on quality care sponsored by the American Society of Clinical Oncology.

Initiative for breast cancer survivors

“In 2011, Cancer Care Ontario did a quick environmental scan of our 14 regional cancer centers and found that the transition of breast cancer survivors from oncologists to primary care was very variable, and that centers often didn’t transition patients very frequently,” said Nicole Mittmann, PhD, first author on one of the studies, chief research officer for Cancer Care Ontario, and an investigator at Sunnybrook Research Institute, Toronto.

The advisory organization therefore implemented the Well Follow-Up Care Initiative to facilitate appropriate transition of breast cancer survivors. Each regional center was given a $100,000 incentive to roll out a model of the initiative.

Dr. Mittmann and her coinvestigators used provincial administrative databases to compare health care use and associated costs between 2,324 breast cancer survivors who were transitioned with the initiative and 2,324 propensity-matched control survivors who were not. The survivors were about 5 years out from their breast cancer diagnosis at baseline and had median follow-up of 2 years.

Study results reported at the symposium showed that the mean annual total cost of care per patient paid for by the provincial health ministry was $6,575 for the transitioned group and $10,832 for the nontransitioned group, a difference of $4,257 (39%). The main drivers were reduced costs of long-term care and cancer clinic visits.

Findings were similar for median annual costs, which amounted to $2,261 for the transitioned group and $2,903 for the control group, a difference of $638.

Compared with the nontransitioned group, the transitioned group had significantly fewer annual visits to medical oncologists (0.39 vs. 1.29) and radiation oncologists (0.16 vs. 0.36), while visits to general or family practitioners were statistically indistinguishable (7.35 and 7.91), Dr. Mittmann reported. There was also a trend toward fewer emergency department visits.

The transitioned group had fewer bone scans, CT and MRI scans, and radiographs annually, but differences were not significant.

Reassuringly, Dr. Mittmann said, survivors who were transitioned did not fare worse than their nontransitioned counterparts in overall survival; if anything, they tended to live longer. “We think that because the individual cancer centers enrolled patients that they thought were very well that this is a very well and highly selected and maybe a biased group,” Dr. Mittmann acknowledged. “But we certainly see that they are not doing worse than the control group.”

“About $1.4 million was distributed to the cancer centers” for the initiative, she noted. “That generated a savings for the health system of $1.5 million, if you are looking at median costs, to $9.9 million, if you are looking at mean costs.

“The transition of appropriate breast cancer survivors to the community appears to be safe and effective outside of a clinical trial, at least based on this particular retrospective analysis using databases,” she said. “The overall costs are not increased, and they may actually be decreased based on our data, and certainly these results will inform policy.”

The investigators plan several next steps, such as encouraging senior leadership at Cancer Care Ontario and the Ministry of Health to endorse the findings, according to Dr. Mittmann. In addition, “[we plan to] engage with both oncology and primary care leadership and think about how we can potentially roll out a program like this, and develop tools, whether those are letters or information packages, and education, to … appropriately transition individuals.”

Considerations in interpreting the study’s findings include the quality of the matching of survivors, according to invited discussant Monika K. Krzyzanowska, MD, a medical oncologist at Princess Margaret Cancer Centre, an associate professor at the University of Toronto, and a clinical lead of Quality Care and Access, Systemic Treatment Program, at Cancer Care Ontario. “The quality of that match depends on what’s in the model, so there could be potential for residual confounding, and administrative data may not have all of the elements that you would need to get a perfect match.”

Comparison of survivorship care models

Two-thirds of the large and growing population of cancer survivors are at least 5 years out from diagnosis, stimulating considerable discussion in the oncology community about how to best address their needs, according to Sarah Raskin, PhD, senior author on the second study and a research scientist at the Institute for Patient-Centered Initiatives and Health Equity at George Washington University Cancer Center, Washington.

“Yet, for a lack of cancer survivorship–specific guidelines from research or practice, cancer centers are increasingly developing survivorship care in a variety of ways, many of which are ad hoc or unproven as yet,” she said.

Dr. Raskin and her colleagues compared three emerging models of survivorship care: a specialized consultative model and a specialized longitudinal model – whereby patients have a single or multiple formalized survivorship visits, respectively, with care typically led by an oncology nurse-practitioner – and an oncology-embedded model – whereby survivorship is addressed as a part of ongoing oncology follow-up care, typically by the oncologist.

The investigators worked with survivors to develop the Patient-Prioritized Measure of High-Quality Survivorship Care, a 46-question scale assessing nine components of survivorship care that capture the health care priorities and needs that matter most to patients. Each component is rated on a scale from 0 (not at all met) to 1 (somewhat met) to 2 (definitely met).

Analyses were based on responses of 827 survivors of breast, colorectal, and prostate cancer who received care at 28 U.S. institutions using one of the above models and who were surveyed by telephone about the care received 1 week after their initial survivorship visit.

Results showed that survivors cared for under the three models differed significantly with respect to scores for seven of the nine components of quality of care, Dr. Raskin reported. The exceptions were practical life support, where the mean score was about 0.6-0.8 across the board, and having a medical home, where the mean score was about 1.8-1.9 across the board.

The specialized consult model of care had the highest scores for mental health and social support, information and resources, and supportive and prepared clinicians. The specialized longitudinal model of care had the highest scores for empowered and engaged patients, open patient-clinician communication, care coordination and transitions, and access to full spectrum of care. The oncology-embedded model had the lowest scores. Analysis of the tool’s 46 individual questions showed that patients cared for at institutions using the oncology-embedded model were significantly less likely than were counterparts cared for at institutions using the specialized models to report that the institution performed various activities such as offering a treatment summary, inquiring about the patient’s biggest worries or problems, and explaining the reasons why tests were needed (P less than .05 for each).

For some metrics, the overall proportion reporting that an activity was performed was low, regardless of the model being used. For example, only 48% of all patients reported being helped to set goals or make short-term plans to manage follow-up care and improve health, merely 24% reported being provided emotional and social support to deal with changes in relationships, and just 19% reported being referred to special providers for other medical problems.

“Overall, all three models are performing highly in terms of providing survivors with a medical home and communicating with patients. However, all three are performing quite low in terms of providing mental health and social support, as well as practical life support,” said Dr. Raskin.

“By model, we see that the embedded ongoing care model is significantly underperforming compared with both specialized models on seven of nine components, and we have some hypotheses from our early work with [Commission on Cancer]–accredited centers to explain this,” she added. “Embedded survivorship models have a lot of variability – many are high performers but others are low performers as compared with specialized programs. Embedded survivorship care models are typically led by the treating oncologist, who historically has focused on treating sick patients and less so on providing social supports for follow-up of well patients or ‘well-er’ patients. At the same time, specialized models focus predominantly on survivorship care and providing services and referrals for survivors, which may explain their high scores.

“We know that the higher quality of care measures presented here do not necessarily translate to better patient outcomes, and that’s actually going to be the next phase of our analysis,” she concluded.

The study sample may have had some selection bias, and it is unclear how well validated the tool was, according to Dr. Krzyzanowska, the discussant. Another issue was its assessment of quality of care at only a single time point.

Nonetheless, the findings show “that measuring quality of survivorship care from a patient perspective is feasible and valuable. We have already heard about [need for] survivorship plans in survivorship care, so certainly the work that was just presented is extremely important to help to fill some of these gaps,” she said.

“I’m not sure that we yet know what the optimal model of survivorship care is without the information of the other outcomes. Furthermore, there’s different survivor populations and different ways that health care is organized, so perhaps there isn’t really one optimal model, but the model has to fit with the context,” Dr. Krzyzanowska concluded. “That being said … the tool that they have created can be a great tool for existing survivorship care programs to assess and improve the quality of their care.”

Dr. Mittmann and Dr. Raskin had no disclosures to report.

ORLANDO – Accumulating experience is showing the benefits of various models of care for cancer survivors in terms of health care use and costs, while also suggesting that some provide higher-quality care than others, according to a pair of studies reported at a symposium on quality care sponsored by the American Society of Clinical Oncology.

Initiative for breast cancer survivors

“In 2011, Cancer Care Ontario did a quick environmental scan of our 14 regional cancer centers and found that the transition of breast cancer survivors from oncologists to primary care was very variable, and that centers often didn’t transition patients very frequently,” said Nicole Mittmann, PhD, first author on one of the studies, chief research officer for Cancer Care Ontario, and an investigator at Sunnybrook Research Institute, Toronto.

The advisory organization therefore implemented the Well Follow-Up Care Initiative to facilitate appropriate transition of breast cancer survivors. Each regional center was given a $100,000 incentive to roll out a model of the initiative.

Dr. Mittmann and her coinvestigators used provincial administrative databases to compare health care use and associated costs between 2,324 breast cancer survivors who were transitioned with the initiative and 2,324 propensity-matched control survivors who were not. The survivors were about 5 years out from their breast cancer diagnosis at baseline and had median follow-up of 2 years.

Study results reported at the symposium showed that the mean annual total cost of care per patient paid for by the provincial health ministry was $6,575 for the transitioned group and $10,832 for the nontransitioned group, a difference of $4,257 (39%). The main drivers were reduced costs of long-term care and cancer clinic visits.

Findings were similar for median annual costs, which amounted to $2,261 for the transitioned group and $2,903 for the control group, a difference of $638.

Compared with the nontransitioned group, the transitioned group had significantly fewer annual visits to medical oncologists (0.39 vs. 1.29) and radiation oncologists (0.16 vs. 0.36), while visits to general or family practitioners were statistically indistinguishable (7.35 and 7.91), Dr. Mittmann reported. There was also a trend toward fewer emergency department visits.

The transitioned group had fewer bone scans, CT and MRI scans, and radiographs annually, but differences were not significant.

Reassuringly, Dr. Mittmann said, survivors who were transitioned did not fare worse than their nontransitioned counterparts in overall survival; if anything, they tended to live longer. “We think that because the individual cancer centers enrolled patients that they thought were very well that this is a very well and highly selected and maybe a biased group,” Dr. Mittmann acknowledged. “But we certainly see that they are not doing worse than the control group.”

“About $1.4 million was distributed to the cancer centers” for the initiative, she noted. “That generated a savings for the health system of $1.5 million, if you are looking at median costs, to $9.9 million, if you are looking at mean costs.

“The transition of appropriate breast cancer survivors to the community appears to be safe and effective outside of a clinical trial, at least based on this particular retrospective analysis using databases,” she said. “The overall costs are not increased, and they may actually be decreased based on our data, and certainly these results will inform policy.”

The investigators plan several next steps, such as encouraging senior leadership at Cancer Care Ontario and the Ministry of Health to endorse the findings, according to Dr. Mittmann. In addition, “[we plan to] engage with both oncology and primary care leadership and think about how we can potentially roll out a program like this, and develop tools, whether those are letters or information packages, and education, to … appropriately transition individuals.”

Considerations in interpreting the study’s findings include the quality of the matching of survivors, according to invited discussant Monika K. Krzyzanowska, MD, a medical oncologist at Princess Margaret Cancer Centre, an associate professor at the University of Toronto, and a clinical lead of Quality Care and Access, Systemic Treatment Program, at Cancer Care Ontario. “The quality of that match depends on what’s in the model, so there could be potential for residual confounding, and administrative data may not have all of the elements that you would need to get a perfect match.”

Comparison of survivorship care models

Two-thirds of the large and growing population of cancer survivors are at least 5 years out from diagnosis, stimulating considerable discussion in the oncology community about how to best address their needs, according to Sarah Raskin, PhD, senior author on the second study and a research scientist at the Institute for Patient-Centered Initiatives and Health Equity at George Washington University Cancer Center, Washington.

“Yet, for a lack of cancer survivorship–specific guidelines from research or practice, cancer centers are increasingly developing survivorship care in a variety of ways, many of which are ad hoc or unproven as yet,” she said.

Dr. Raskin and her colleagues compared three emerging models of survivorship care: a specialized consultative model and a specialized longitudinal model – whereby patients have a single or multiple formalized survivorship visits, respectively, with care typically led by an oncology nurse-practitioner – and an oncology-embedded model – whereby survivorship is addressed as a part of ongoing oncology follow-up care, typically by the oncologist.

The investigators worked with survivors to develop the Patient-Prioritized Measure of High-Quality Survivorship Care, a 46-question scale assessing nine components of survivorship care that capture the health care priorities and needs that matter most to patients. Each component is rated on a scale from 0 (not at all met) to 1 (somewhat met) to 2 (definitely met).

Analyses were based on responses of 827 survivors of breast, colorectal, and prostate cancer who received care at 28 U.S. institutions using one of the above models and who were surveyed by telephone about the care received 1 week after their initial survivorship visit.

Results showed that survivors cared for under the three models differed significantly with respect to scores for seven of the nine components of quality of care, Dr. Raskin reported. The exceptions were practical life support, where the mean score was about 0.6-0.8 across the board, and having a medical home, where the mean score was about 1.8-1.9 across the board.

The specialized consult model of care had the highest scores for mental health and social support, information and resources, and supportive and prepared clinicians. The specialized longitudinal model of care had the highest scores for empowered and engaged patients, open patient-clinician communication, care coordination and transitions, and access to full spectrum of care. The oncology-embedded model had the lowest scores. Analysis of the tool’s 46 individual questions showed that patients cared for at institutions using the oncology-embedded model were significantly less likely than were counterparts cared for at institutions using the specialized models to report that the institution performed various activities such as offering a treatment summary, inquiring about the patient’s biggest worries or problems, and explaining the reasons why tests were needed (P less than .05 for each).

For some metrics, the overall proportion reporting that an activity was performed was low, regardless of the model being used. For example, only 48% of all patients reported being helped to set goals or make short-term plans to manage follow-up care and improve health, merely 24% reported being provided emotional and social support to deal with changes in relationships, and just 19% reported being referred to special providers for other medical problems.

“Overall, all three models are performing highly in terms of providing survivors with a medical home and communicating with patients. However, all three are performing quite low in terms of providing mental health and social support, as well as practical life support,” said Dr. Raskin.

“By model, we see that the embedded ongoing care model is significantly underperforming compared with both specialized models on seven of nine components, and we have some hypotheses from our early work with [Commission on Cancer]–accredited centers to explain this,” she added. “Embedded survivorship models have a lot of variability – many are high performers but others are low performers as compared with specialized programs. Embedded survivorship care models are typically led by the treating oncologist, who historically has focused on treating sick patients and less so on providing social supports for follow-up of well patients or ‘well-er’ patients. At the same time, specialized models focus predominantly on survivorship care and providing services and referrals for survivors, which may explain their high scores.

“We know that the higher quality of care measures presented here do not necessarily translate to better patient outcomes, and that’s actually going to be the next phase of our analysis,” she concluded.

The study sample may have had some selection bias, and it is unclear how well validated the tool was, according to Dr. Krzyzanowska, the discussant. Another issue was its assessment of quality of care at only a single time point.

Nonetheless, the findings show “that measuring quality of survivorship care from a patient perspective is feasible and valuable. We have already heard about [need for] survivorship plans in survivorship care, so certainly the work that was just presented is extremely important to help to fill some of these gaps,” she said.

“I’m not sure that we yet know what the optimal model of survivorship care is without the information of the other outcomes. Furthermore, there’s different survivor populations and different ways that health care is organized, so perhaps there isn’t really one optimal model, but the model has to fit with the context,” Dr. Krzyzanowska concluded. “That being said … the tool that they have created can be a great tool for existing survivorship care programs to assess and improve the quality of their care.”

Dr. Mittmann and Dr. Raskin had no disclosures to report.

ORLANDO – Accumulating experience is showing the benefits of various models of care for cancer survivors in terms of health care use and costs, while also suggesting that some provide higher-quality care than others, according to a pair of studies reported at a symposium on quality care sponsored by the American Society of Clinical Oncology.

Initiative for breast cancer survivors

“In 2011, Cancer Care Ontario did a quick environmental scan of our 14 regional cancer centers and found that the transition of breast cancer survivors from oncologists to primary care was very variable, and that centers often didn’t transition patients very frequently,” said Nicole Mittmann, PhD, first author on one of the studies, chief research officer for Cancer Care Ontario, and an investigator at Sunnybrook Research Institute, Toronto.

The advisory organization therefore implemented the Well Follow-Up Care Initiative to facilitate appropriate transition of breast cancer survivors. Each regional center was given a $100,000 incentive to roll out a model of the initiative.

Dr. Mittmann and her coinvestigators used provincial administrative databases to compare health care use and associated costs between 2,324 breast cancer survivors who were transitioned with the initiative and 2,324 propensity-matched control survivors who were not. The survivors were about 5 years out from their breast cancer diagnosis at baseline and had median follow-up of 2 years.

Study results reported at the symposium showed that the mean annual total cost of care per patient paid for by the provincial health ministry was $6,575 for the transitioned group and $10,832 for the nontransitioned group, a difference of $4,257 (39%). The main drivers were reduced costs of long-term care and cancer clinic visits.

Findings were similar for median annual costs, which amounted to $2,261 for the transitioned group and $2,903 for the control group, a difference of $638.

Compared with the nontransitioned group, the transitioned group had significantly fewer annual visits to medical oncologists (0.39 vs. 1.29) and radiation oncologists (0.16 vs. 0.36), while visits to general or family practitioners were statistically indistinguishable (7.35 and 7.91), Dr. Mittmann reported. There was also a trend toward fewer emergency department visits.

The transitioned group had fewer bone scans, CT and MRI scans, and radiographs annually, but differences were not significant.

Reassuringly, Dr. Mittmann said, survivors who were transitioned did not fare worse than their nontransitioned counterparts in overall survival; if anything, they tended to live longer. “We think that because the individual cancer centers enrolled patients that they thought were very well that this is a very well and highly selected and maybe a biased group,” Dr. Mittmann acknowledged. “But we certainly see that they are not doing worse than the control group.”

“About $1.4 million was distributed to the cancer centers” for the initiative, she noted. “That generated a savings for the health system of $1.5 million, if you are looking at median costs, to $9.9 million, if you are looking at mean costs.

“The transition of appropriate breast cancer survivors to the community appears to be safe and effective outside of a clinical trial, at least based on this particular retrospective analysis using databases,” she said. “The overall costs are not increased, and they may actually be decreased based on our data, and certainly these results will inform policy.”

The investigators plan several next steps, such as encouraging senior leadership at Cancer Care Ontario and the Ministry of Health to endorse the findings, according to Dr. Mittmann. In addition, “[we plan to] engage with both oncology and primary care leadership and think about how we can potentially roll out a program like this, and develop tools, whether those are letters or information packages, and education, to … appropriately transition individuals.”

Considerations in interpreting the study’s findings include the quality of the matching of survivors, according to invited discussant Monika K. Krzyzanowska, MD, a medical oncologist at Princess Margaret Cancer Centre, an associate professor at the University of Toronto, and a clinical lead of Quality Care and Access, Systemic Treatment Program, at Cancer Care Ontario. “The quality of that match depends on what’s in the model, so there could be potential for residual confounding, and administrative data may not have all of the elements that you would need to get a perfect match.”

Comparison of survivorship care models

Two-thirds of the large and growing population of cancer survivors are at least 5 years out from diagnosis, stimulating considerable discussion in the oncology community about how to best address their needs, according to Sarah Raskin, PhD, senior author on the second study and a research scientist at the Institute for Patient-Centered Initiatives and Health Equity at George Washington University Cancer Center, Washington.

“Yet, for a lack of cancer survivorship–specific guidelines from research or practice, cancer centers are increasingly developing survivorship care in a variety of ways, many of which are ad hoc or unproven as yet,” she said.

Dr. Raskin and her colleagues compared three emerging models of survivorship care: a specialized consultative model and a specialized longitudinal model – whereby patients have a single or multiple formalized survivorship visits, respectively, with care typically led by an oncology nurse-practitioner – and an oncology-embedded model – whereby survivorship is addressed as a part of ongoing oncology follow-up care, typically by the oncologist.

The investigators worked with survivors to develop the Patient-Prioritized Measure of High-Quality Survivorship Care, a 46-question scale assessing nine components of survivorship care that capture the health care priorities and needs that matter most to patients. Each component is rated on a scale from 0 (not at all met) to 1 (somewhat met) to 2 (definitely met).

Analyses were based on responses of 827 survivors of breast, colorectal, and prostate cancer who received care at 28 U.S. institutions using one of the above models and who were surveyed by telephone about the care received 1 week after their initial survivorship visit.

Results showed that survivors cared for under the three models differed significantly with respect to scores for seven of the nine components of quality of care, Dr. Raskin reported. The exceptions were practical life support, where the mean score was about 0.6-0.8 across the board, and having a medical home, where the mean score was about 1.8-1.9 across the board.

The specialized consult model of care had the highest scores for mental health and social support, information and resources, and supportive and prepared clinicians. The specialized longitudinal model of care had the highest scores for empowered and engaged patients, open patient-clinician communication, care coordination and transitions, and access to full spectrum of care. The oncology-embedded model had the lowest scores. Analysis of the tool’s 46 individual questions showed that patients cared for at institutions using the oncology-embedded model were significantly less likely than were counterparts cared for at institutions using the specialized models to report that the institution performed various activities such as offering a treatment summary, inquiring about the patient’s biggest worries or problems, and explaining the reasons why tests were needed (P less than .05 for each).

For some metrics, the overall proportion reporting that an activity was performed was low, regardless of the model being used. For example, only 48% of all patients reported being helped to set goals or make short-term plans to manage follow-up care and improve health, merely 24% reported being provided emotional and social support to deal with changes in relationships, and just 19% reported being referred to special providers for other medical problems.

“Overall, all three models are performing highly in terms of providing survivors with a medical home and communicating with patients. However, all three are performing quite low in terms of providing mental health and social support, as well as practical life support,” said Dr. Raskin.

“By model, we see that the embedded ongoing care model is significantly underperforming compared with both specialized models on seven of nine components, and we have some hypotheses from our early work with [Commission on Cancer]–accredited centers to explain this,” she added. “Embedded survivorship models have a lot of variability – many are high performers but others are low performers as compared with specialized programs. Embedded survivorship care models are typically led by the treating oncologist, who historically has focused on treating sick patients and less so on providing social supports for follow-up of well patients or ‘well-er’ patients. At the same time, specialized models focus predominantly on survivorship care and providing services and referrals for survivors, which may explain their high scores.

“We know that the higher quality of care measures presented here do not necessarily translate to better patient outcomes, and that’s actually going to be the next phase of our analysis,” she concluded.

The study sample may have had some selection bias, and it is unclear how well validated the tool was, according to Dr. Krzyzanowska, the discussant. Another issue was its assessment of quality of care at only a single time point.

Nonetheless, the findings show “that measuring quality of survivorship care from a patient perspective is feasible and valuable. We have already heard about [need for] survivorship plans in survivorship care, so certainly the work that was just presented is extremely important to help to fill some of these gaps,” she said.

“I’m not sure that we yet know what the optimal model of survivorship care is without the information of the other outcomes. Furthermore, there’s different survivor populations and different ways that health care is organized, so perhaps there isn’t really one optimal model, but the model has to fit with the context,” Dr. Krzyzanowska concluded. “That being said … the tool that they have created can be a great tool for existing survivorship care programs to assess and improve the quality of their care.”

Dr. Mittmann and Dr. Raskin had no disclosures to report.

ORLANDO – Women with breast cancer who look for well-rounded information about treatment on the websites of prominent U.S. cancer centers are likely to come up short, suggests a study presented at a symposium on quality care sponsored by the American Society of Clinical Oncology.

Research has shown that nearly all women with breast cancer search the Internet for information about its treatment, and two-thirds report that what they find has a strong influence on their decision-making process (J Cancer Educ. 2013;28[4]:662-8).

But the analysis of content on the websites of 63 National Cancer Institute–designated comprehensive cancer centers or clinical cancer centers found that, on average, they addressed only 21% of a set of key concepts that women need to understand to make informed decisions about surgery, radiation therapy, chemotherapy, hormone therapy, and breast reconstruction. This contrasted starkly with 85% for the National Cancer Institute’s own website (cancer.gov) and 88% for the Susan G. Komen Foundation’s website (komen.org).

Susan London/Frontline Medical News

Study details

For the study, the investigators developed a list of 33 decision-specific knowledge questions about breast cancer treatment by drawing on decision quality instruments that assess how informed a woman’s decision-making process is. The primary outcome was whether the website provided sufficient information to answer each question. The researchers assessed seven measures of accessibility as secondary outcomes.

Results showed that websites contained sufficient content to address only 21% of the decision-specific knowledge questions, Dr. Dulaney reported in a poster session. The value was 17% for questions pertaining to breast surgery and radiation therapy, 18% for those pertaining to chemotherapy and hormone therapy, and 21% for those pertaining to breast reconstruction.

In addition, “a lot of websites put the information in silos,” he noted. “You can read about mastectomy, you can read about lumpectomy, you can read about chemo. But you can’t really get the big picture, which is how do these compare to each other, and which treatment is best for me.”

Even the most commonly addressed single question – what type of reconstruction is most likely to require more than one surgery or procedure – was addressed by only 51% of sites. Proportions were similar for questions pertaining to the type of tumors against which hormone therapy works best (48%) and the schedule for radiation therapy after lumpectomy (47%).

At the other extreme, however, very small proportions of sites addressed questions pertaining to how many women with treated early breast cancer will die from the disease (7%), how many undergoing breast reconstruction will experience complications requiring hospitalization or an unplanned procedure (4%), how skipping chemotherapy and hormone therapy influences risk of death (2%), and whether waiting several weeks to decide about those therapies affects survival (2%). These topics are more negative, Dr. Dulaney observed, “but these are things women need to know.”

None of the websites provided sufficient information to answer all 33 knowledge questions. But perhaps more worrisome, 16% did not provide sufficient information to answer any of them, he said.

When it came to accessibility of information, 94% of sites clearly had a breast cancer–specific page, 87% had information about breast cancer–specific trials, and 86% showed members of the center’s breast cancer team. But only 59% were mobile device friendly as assessed with a Google tool, and merely 24% had obvious links to view information in Spanish.

“A lot of minorities and people of lower socioeconomic status exclusively access the Internet via mobile devices, so they may not have a computer or [other] access to the Internet. But they have a cell phone that is probably a smartphone, and they can get online and search for information that way,” Dr. Dulaney said.

Many oncologists may not have had any say regarding the content and accessibility features of their institution’s website, he acknowledged.

“So we should maybe, number one, try to have more involvement in what information goes on to the website, and two, take a look at our own websites to see what’s on there, because patients are going to look for you, and they are going to associate this information with you,” he said. “If you are at a big institution and you really can’t make a change on your website, you can use alternatives such as social media platforms, things like that, to try and get information out to people.”

From a larger perspective, oncologists have often simply counseled patients that they can’t rely on information they have found online, according to Dr. Dulaney.

“But in this day and age, that can’t really be an answer,” he concluded. “Information on the web is ubiquitous, and there is good information out there. We need to do a better job of speaking up in the conversation. We have the answers to a lot of these questions, we just need to make our voices heard and also direct patients to reliable sources of information.”

ORLANDO – Women with breast cancer who look for well-rounded information about treatment on the websites of prominent U.S. cancer centers are likely to come up short, suggests a study presented at a symposium on quality care sponsored by the American Society of Clinical Oncology.

Research has shown that nearly all women with breast cancer search the Internet for information about its treatment, and two-thirds report that what they find has a strong influence on their decision-making process (J Cancer Educ. 2013;28[4]:662-8).

But the analysis of content on the websites of 63 National Cancer Institute–designated comprehensive cancer centers or clinical cancer centers found that, on average, they addressed only 21% of a set of key concepts that women need to understand to make informed decisions about surgery, radiation therapy, chemotherapy, hormone therapy, and breast reconstruction. This contrasted starkly with 85% for the National Cancer Institute’s own website (cancer.gov) and 88% for the Susan G. Komen Foundation’s website (komen.org).

Susan London/Frontline Medical News

Study details

For the study, the investigators developed a list of 33 decision-specific knowledge questions about breast cancer treatment by drawing on decision quality instruments that assess how informed a woman’s decision-making process is. The primary outcome was whether the website provided sufficient information to answer each question. The researchers assessed seven measures of accessibility as secondary outcomes.

Results showed that websites contained sufficient content to address only 21% of the decision-specific knowledge questions, Dr. Dulaney reported in a poster session. The value was 17% for questions pertaining to breast surgery and radiation therapy, 18% for those pertaining to chemotherapy and hormone therapy, and 21% for those pertaining to breast reconstruction.

In addition, “a lot of websites put the information in silos,” he noted. “You can read about mastectomy, you can read about lumpectomy, you can read about chemo. But you can’t really get the big picture, which is how do these compare to each other, and which treatment is best for me.”

Even the most commonly addressed single question – what type of reconstruction is most likely to require more than one surgery or procedure – was addressed by only 51% of sites. Proportions were similar for questions pertaining to the type of tumors against which hormone therapy works best (48%) and the schedule for radiation therapy after lumpectomy (47%).

At the other extreme, however, very small proportions of sites addressed questions pertaining to how many women with treated early breast cancer will die from the disease (7%), how many undergoing breast reconstruction will experience complications requiring hospitalization or an unplanned procedure (4%), how skipping chemotherapy and hormone therapy influences risk of death (2%), and whether waiting several weeks to decide about those therapies affects survival (2%). These topics are more negative, Dr. Dulaney observed, “but these are things women need to know.”

None of the websites provided sufficient information to answer all 33 knowledge questions. But perhaps more worrisome, 16% did not provide sufficient information to answer any of them, he said.

When it came to accessibility of information, 94% of sites clearly had a breast cancer–specific page, 87% had information about breast cancer–specific trials, and 86% showed members of the center’s breast cancer team. But only 59% were mobile device friendly as assessed with a Google tool, and merely 24% had obvious links to view information in Spanish.

“A lot of minorities and people of lower socioeconomic status exclusively access the Internet via mobile devices, so they may not have a computer or [other] access to the Internet. But they have a cell phone that is probably a smartphone, and they can get online and search for information that way,” Dr. Dulaney said.

Many oncologists may not have had any say regarding the content and accessibility features of their institution’s website, he acknowledged.

“So we should maybe, number one, try to have more involvement in what information goes on to the website, and two, take a look at our own websites to see what’s on there, because patients are going to look for you, and they are going to associate this information with you,” he said. “If you are at a big institution and you really can’t make a change on your website, you can use alternatives such as social media platforms, things like that, to try and get information out to people.”

From a larger perspective, oncologists have often simply counseled patients that they can’t rely on information they have found online, according to Dr. Dulaney.

“But in this day and age, that can’t really be an answer,” he concluded. “Information on the web is ubiquitous, and there is good information out there. We need to do a better job of speaking up in the conversation. We have the answers to a lot of these questions, we just need to make our voices heard and also direct patients to reliable sources of information.”

ORLANDO – Women with breast cancer who look for well-rounded information about treatment on the websites of prominent U.S. cancer centers are likely to come up short, suggests a study presented at a symposium on quality care sponsored by the American Society of Clinical Oncology.

Research has shown that nearly all women with breast cancer search the Internet for information about its treatment, and two-thirds report that what they find has a strong influence on their decision-making process (J Cancer Educ. 2013;28[4]:662-8).

But the analysis of content on the websites of 63 National Cancer Institute–designated comprehensive cancer centers or clinical cancer centers found that, on average, they addressed only 21% of a set of key concepts that women need to understand to make informed decisions about surgery, radiation therapy, chemotherapy, hormone therapy, and breast reconstruction. This contrasted starkly with 85% for the National Cancer Institute’s own website (cancer.gov) and 88% for the Susan G. Komen Foundation’s website (komen.org).

Susan London/Frontline Medical News

Study details

For the study, the investigators developed a list of 33 decision-specific knowledge questions about breast cancer treatment by drawing on decision quality instruments that assess how informed a woman’s decision-making process is. The primary outcome was whether the website provided sufficient information to answer each question. The researchers assessed seven measures of accessibility as secondary outcomes.

Results showed that websites contained sufficient content to address only 21% of the decision-specific knowledge questions, Dr. Dulaney reported in a poster session. The value was 17% for questions pertaining to breast surgery and radiation therapy, 18% for those pertaining to chemotherapy and hormone therapy, and 21% for those pertaining to breast reconstruction.

In addition, “a lot of websites put the information in silos,” he noted. “You can read about mastectomy, you can read about lumpectomy, you can read about chemo. But you can’t really get the big picture, which is how do these compare to each other, and which treatment is best for me.”

Even the most commonly addressed single question – what type of reconstruction is most likely to require more than one surgery or procedure – was addressed by only 51% of sites. Proportions were similar for questions pertaining to the type of tumors against which hormone therapy works best (48%) and the schedule for radiation therapy after lumpectomy (47%).

At the other extreme, however, very small proportions of sites addressed questions pertaining to how many women with treated early breast cancer will die from the disease (7%), how many undergoing breast reconstruction will experience complications requiring hospitalization or an unplanned procedure (4%), how skipping chemotherapy and hormone therapy influences risk of death (2%), and whether waiting several weeks to decide about those therapies affects survival (2%). These topics are more negative, Dr. Dulaney observed, “but these are things women need to know.”

None of the websites provided sufficient information to answer all 33 knowledge questions. But perhaps more worrisome, 16% did not provide sufficient information to answer any of them, he said.

When it came to accessibility of information, 94% of sites clearly had a breast cancer–specific page, 87% had information about breast cancer–specific trials, and 86% showed members of the center’s breast cancer team. But only 59% were mobile device friendly as assessed with a Google tool, and merely 24% had obvious links to view information in Spanish.

“A lot of minorities and people of lower socioeconomic status exclusively access the Internet via mobile devices, so they may not have a computer or [other] access to the Internet. But they have a cell phone that is probably a smartphone, and they can get online and search for information that way,” Dr. Dulaney said.

Many oncologists may not have had any say regarding the content and accessibility features of their institution’s website, he acknowledged.

“So we should maybe, number one, try to have more involvement in what information goes on to the website, and two, take a look at our own websites to see what’s on there, because patients are going to look for you, and they are going to associate this information with you,” he said. “If you are at a big institution and you really can’t make a change on your website, you can use alternatives such as social media platforms, things like that, to try and get information out to people.”

From a larger perspective, oncologists have often simply counseled patients that they can’t rely on information they have found online, according to Dr. Dulaney.

“But in this day and age, that can’t really be an answer,” he concluded. “Information on the web is ubiquitous, and there is good information out there. We need to do a better job of speaking up in the conversation. We have the answers to a lot of these questions, we just need to make our voices heard and also direct patients to reliable sources of information.”

ORLANDO – A large proportion of patients with advanced non–small cell lung cancer (NSCLC) are not being tested for tumor associated–epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) alterations according to national guidelines. This situation may be leading to suboptimal treatment, a large retrospective cohort study suggests.

Guidelines from the American Society of Clinical Oncology and the National Comprehensive Cancer Network recommend testing before first-line therapy for all treatment-eligible patients with nonsquamous histology and for those patients with squamous histology who are nonsmokers or who have mixed cell types or small tumor samples. Additionally, the guidelines recommend that results be made available within 2 weeks of the lab’s receipt of the sample so that they can be used to inform treatment decisions.

Study details

For the study, the investigators identified 16,316 patients with advanced NSCLC from 206 community clinics across the United States participating in the Flatiron Network. All patients were treated between 2014 and 2016.

Cross-checking of the total Flatiron population against the National Program of Cancer Registries and Surveillance, Epidemiology, and End Results databases suggested that it is a good national representation, according to Mr. Rughani.

A record review showed that the rate of EGFR and ALK testing among study patients ranged widely across clinics, from 0% to 100% for both the nonsquamous cases and the squamous cases, according to results reported in a poster session. The median was 79% for the former and 16% for the latter.

Overall, 22% of the nonsquamous cohort and 79% of the squamous cohort did not have any evidence of testing in their records. For the latter, a sampling of records was unable to verify whether testing was appropriately matched to eligibility criteria.

When testing was performed, 35% of EGFR test results and 37% of ALK test results were not available to the treating clinician until more than 4 weeks after the date of the advanced cancer diagnosis.

“The delays were mostly attributed to nonlab factors. When we isolated the time that the lab took to turn it around, it was under 2 weeks for the vast majority of patients,” Mr. Rughani reported. Possible nonlab culprit factors include clinic work flows, insurance-related issues, and families’ and patients’ hesitancy to be tested, he said.

Delays in receipt of positive test results appeared to influence choice of first-line therapy. Among patients in whom these results were available before first-line therapy, 80% of those found to have an EGFR-mutated tumor received an EGFR–tyrosine kinase inhibitor, and 77% of those found to have ALK-rearranged tumors received an ALK inhibitor.

In sharp contrast, among patients in whom positive test results did not become available until after the start of first-line therapy, respective values were just 43% and 42%.

“Anecdotally, we saw that some patients would go on to Avastin [bevacizumab] in the front line when the results were delayed, and then, ultimately, they would have the opportunity to receive an EGFR[–tyrosine kinase inhibitor] or something like that in later lines,” commented Mr. Rughani. “So, that impacted treatment decisions there.”

Mr. Rughani disclosed stock and other ownership interests in Flatiron Health.

[email protected]

ORLANDO – A large proportion of patients with advanced non–small cell lung cancer (NSCLC) are not being tested for tumor associated–epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) alterations according to national guidelines. This situation may be leading to suboptimal treatment, a large retrospective cohort study suggests.

Guidelines from the American Society of Clinical Oncology and the National Comprehensive Cancer Network recommend testing before first-line therapy for all treatment-eligible patients with nonsquamous histology and for those patients with squamous histology who are nonsmokers or who have mixed cell types or small tumor samples. Additionally, the guidelines recommend that results be made available within 2 weeks of the lab’s receipt of the sample so that they can be used to inform treatment decisions.

Study details

For the study, the investigators identified 16,316 patients with advanced NSCLC from 206 community clinics across the United States participating in the Flatiron Network. All patients were treated between 2014 and 2016.

Cross-checking of the total Flatiron population against the National Program of Cancer Registries and Surveillance, Epidemiology, and End Results databases suggested that it is a good national representation, according to Mr. Rughani.

A record review showed that the rate of EGFR and ALK testing among study patients ranged widely across clinics, from 0% to 100% for both the nonsquamous cases and the squamous cases, according to results reported in a poster session. The median was 79% for the former and 16% for the latter.

Overall, 22% of the nonsquamous cohort and 79% of the squamous cohort did not have any evidence of testing in their records. For the latter, a sampling of records was unable to verify whether testing was appropriately matched to eligibility criteria.

When testing was performed, 35% of EGFR test results and 37% of ALK test results were not available to the treating clinician until more than 4 weeks after the date of the advanced cancer diagnosis.

“The delays were mostly attributed to nonlab factors. When we isolated the time that the lab took to turn it around, it was under 2 weeks for the vast majority of patients,” Mr. Rughani reported. Possible nonlab culprit factors include clinic work flows, insurance-related issues, and families’ and patients’ hesitancy to be tested, he said.

Delays in receipt of positive test results appeared to influence choice of first-line therapy. Among patients in whom these results were available before first-line therapy, 80% of those found to have an EGFR-mutated tumor received an EGFR–tyrosine kinase inhibitor, and 77% of those found to have ALK-rearranged tumors received an ALK inhibitor.

In sharp contrast, among patients in whom positive test results did not become available until after the start of first-line therapy, respective values were just 43% and 42%.

“Anecdotally, we saw that some patients would go on to Avastin [bevacizumab] in the front line when the results were delayed, and then, ultimately, they would have the opportunity to receive an EGFR[–tyrosine kinase inhibitor] or something like that in later lines,” commented Mr. Rughani. “So, that impacted treatment decisions there.”

Mr. Rughani disclosed stock and other ownership interests in Flatiron Health.

[email protected]

ORLANDO – A large proportion of patients with advanced non–small cell lung cancer (NSCLC) are not being tested for tumor associated–epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) alterations according to national guidelines. This situation may be leading to suboptimal treatment, a large retrospective cohort study suggests.

Guidelines from the American Society of Clinical Oncology and the National Comprehensive Cancer Network recommend testing before first-line therapy for all treatment-eligible patients with nonsquamous histology and for those patients with squamous histology who are nonsmokers or who have mixed cell types or small tumor samples. Additionally, the guidelines recommend that results be made available within 2 weeks of the lab’s receipt of the sample so that they can be used to inform treatment decisions.

Study details

For the study, the investigators identified 16,316 patients with advanced NSCLC from 206 community clinics across the United States participating in the Flatiron Network. All patients were treated between 2014 and 2016.

Cross-checking of the total Flatiron population against the National Program of Cancer Registries and Surveillance, Epidemiology, and End Results databases suggested that it is a good national representation, according to Mr. Rughani.

A record review showed that the rate of EGFR and ALK testing among study patients ranged widely across clinics, from 0% to 100% for both the nonsquamous cases and the squamous cases, according to results reported in a poster session. The median was 79% for the former and 16% for the latter.

Overall, 22% of the nonsquamous cohort and 79% of the squamous cohort did not have any evidence of testing in their records. For the latter, a sampling of records was unable to verify whether testing was appropriately matched to eligibility criteria.

When testing was performed, 35% of EGFR test results and 37% of ALK test results were not available to the treating clinician until more than 4 weeks after the date of the advanced cancer diagnosis.

“The delays were mostly attributed to nonlab factors. When we isolated the time that the lab took to turn it around, it was under 2 weeks for the vast majority of patients,” Mr. Rughani reported. Possible nonlab culprit factors include clinic work flows, insurance-related issues, and families’ and patients’ hesitancy to be tested, he said.

Delays in receipt of positive test results appeared to influence choice of first-line therapy. Among patients in whom these results were available before first-line therapy, 80% of those found to have an EGFR-mutated tumor received an EGFR–tyrosine kinase inhibitor, and 77% of those found to have ALK-rearranged tumors received an ALK inhibitor.

In sharp contrast, among patients in whom positive test results did not become available until after the start of first-line therapy, respective values were just 43% and 42%.

“Anecdotally, we saw that some patients would go on to Avastin [bevacizumab] in the front line when the results were delayed, and then, ultimately, they would have the opportunity to receive an EGFR[–tyrosine kinase inhibitor] or something like that in later lines,” commented Mr. Rughani. “So, that impacted treatment decisions there.”

Mr. Rughani disclosed stock and other ownership interests in Flatiron Health.

[email protected]

ORLANDO – A multifaceted portfolio of physician-led measures with feedback and financial incentives can dramatically improve the quality of care provided at cancer centers, suggests the experience of Stanford (Calif.) Health Care.

Physician leaders of 13 disease-specific cancer care programs (CCPs) identified measures of care that were meaningful to their team and patients, spanning the spectrum from new diagnosis through end of life and survivorship care. Quality and analytics teams developed 16 corresponding metrics and performance reports used for feedback. Programs were also given a financial incentive to meet jointly set targets.

After a year, the CCPs had improved on 12 of the metrics and maintained high baseline levels of performance on the other 4 metrics, investigators reported at a symposium on quality care sponsored by the American Society of Clinical Oncology. For example, they got better at entering staging information in a dedicated field in the electronic health record (+50% absolute increase), recording hand and foot pain (+34%), performing hepatitis B testing before rituximab use (+17%), and referring patients with ovarian cancer for genetic counseling (+43%).

Susan London/Frontline Medical News

Susan London/Frontline Medical News

Study details

“In the summer of 2015, we were starting to feel a lot of pressure to prepare for evolving reimbursement models,” Ms. Porter said, explaining the initiative’s genesis. “Mainly, how do we define our value, and how can we measure and improve on that value of the care we deliver? One answer, of course, is to measure and reduce unnecessary variation. And we knew, to be successful, we had to increase our physician engagement and leadership in the selection and improvement of our metrics.”

Physician leaders of the CCPs were asked to choose quality measures that met three criteria: they were meaningful and important to both the care team and patients, they had pertinent data elements already available in existing databases (to reduce documentation burden), and they were multidisciplinary in nature, reflecting the care provided by the whole program. The measures ultimately selected included a variety of those put forth by American Society of Clinical Oncology’s Quality Oncology Practice Initiative and the American Society for Radiation Oncology. CCPs were offered a financial incentive for meeting targets ranging from $75,000 to $125,000 that was based on number of providers and patient volume, rather than on the impact of improved metric. “This was really meant for reinvestment back into their quality programs,” Ms. Porter said. “I would argue this was really a culture-building year for us, and we hope that next year there might be a little bit more tangible value with the metrics.”

The quality team gave CCPs monthly or quarterly performance reports with unblinded physician- and patient-level details that were ultimately disseminated to all the other CCPs. They also investigated any missing data for individual metrics.

Study results showed that half of the 16 measures the physician leaders chose pertained to the diagnosis and treatment planning phase of care, according to Ms. Porter. “It was important to many of our CCPs to ensure that specific testing was done, which would then, in turn, drive treatment planning decisions,” she commented.

At the end of the year, each metric was assessed among 13 to 2,406 patients. “All CCPs met their predetermined target and earned their financial incentive award for the year,” Ms. Porter reported.

Improvement was most marked, with a 50% absolute increase, for the metric of completing a staging module, which required conversion of staging information (historically embedded in progress notes) into a structured format in a dedicated field in the electronic health record within 45 days of a patient’s first cancer treatment. This practice enables ready identification of stage cohorts in which value of care can be assessed, she noted.

There were also sizable absolute increases in relevant CCPs in the proportion of blood and marrow transplant recipients referred to survivorship care by day 100 (+20%) and visiting that service by day 180 (+13%), recording of hand and foot pain (+34%) and radiation dermatitis (+21%), mismatch repair testing in patients with newly diagnosed colorectal cancer (+10%), referral of patients with newly diagnosed ovarian cancer for genetic counseling (+43%), cytogenetic testing in patients with newly diagnosed hematologic malignancies (+17%), hepatitis B testing before rituximab administration (+17%), and allowance of at least 2 nights for treatment plan physics–quality assurance before the start of a nonemergent radiation oncology treatment (+14%).

Meanwhile, there were decreases, considered favorable changes, in chemotherapy use in the last 2 weeks of life among neuro-oncology patients (–9%) and in patients’ receipt of more than 10 fractions of radiation therapy for palliation of bone metastases (–9%).

Finally, there was no change in several metrics of quality that were already at very high or low levels, as appropriate, at baseline: molecular testing in patients with newly diagnosed acute myeloid leukemia (stable at 95%), hospice enrollment at the time of death for neuro-oncology patients (stable at 100%), chemotherapy in the last 2 weeks of life for patients with sarcoma (stable at 0%), and epidermal growth factor receptor testing in patients with newly diagnosed lung adenocarcinoma (stable at 98%).
 

ORLANDO – A multifaceted portfolio of physician-led measures with feedback and financial incentives can dramatically improve the quality of care provided at cancer centers, suggests the experience of Stanford (Calif.) Health Care.

Physician leaders of 13 disease-specific cancer care programs (CCPs) identified measures of care that were meaningful to their team and patients, spanning the spectrum from new diagnosis through end of life and survivorship care. Quality and analytics teams developed 16 corresponding metrics and performance reports used for feedback. Programs were also given a financial incentive to meet jointly set targets.

After a year, the CCPs had improved on 12 of the metrics and maintained high baseline levels of performance on the other 4 metrics, investigators reported at a symposium on quality care sponsored by the American Society of Clinical Oncology. For example, they got better at entering staging information in a dedicated field in the electronic health record (+50% absolute increase), recording hand and foot pain (+34%), performing hepatitis B testing before rituximab use (+17%), and referring patients with ovarian cancer for genetic counseling (+43%).

Susan London/Frontline Medical News

Susan London/Frontline Medical News

Study details

“In the summer of 2015, we were starting to feel a lot of pressure to prepare for evolving reimbursement models,” Ms. Porter said, explaining the initiative’s genesis. “Mainly, how do we define our value, and how can we measure and improve on that value of the care we deliver? One answer, of course, is to measure and reduce unnecessary variation. And we knew, to be successful, we had to increase our physician engagement and leadership in the selection and improvement of our metrics.”

Physician leaders of the CCPs were asked to choose quality measures that met three criteria: they were meaningful and important to both the care team and patients, they had pertinent data elements already available in existing databases (to reduce documentation burden), and they were multidisciplinary in nature, reflecting the care provided by the whole program. The measures ultimately selected included a variety of those put forth by American Society of Clinical Oncology’s Quality Oncology Practice Initiative and the American Society for Radiation Oncology. CCPs were offered a financial incentive for meeting targets ranging from $75,000 to $125,000 that was based on number of providers and patient volume, rather than on the impact of improved metric. “This was really meant for reinvestment back into their quality programs,” Ms. Porter said. “I would argue this was really a culture-building year for us, and we hope that next year there might be a little bit more tangible value with the metrics.”

The quality team gave CCPs monthly or quarterly performance reports with unblinded physician- and patient-level details that were ultimately disseminated to all the other CCPs. They also investigated any missing data for individual metrics.

Study results showed that half of the 16 measures the physician leaders chose pertained to the diagnosis and treatment planning phase of care, according to Ms. Porter. “It was important to many of our CCPs to ensure that specific testing was done, which would then, in turn, drive treatment planning decisions,” she commented.

At the end of the year, each metric was assessed among 13 to 2,406 patients. “All CCPs met their predetermined target and earned their financial incentive award for the year,” Ms. Porter reported.

Improvement was most marked, with a 50% absolute increase, for the metric of completing a staging module, which required conversion of staging information (historically embedded in progress notes) into a structured format in a dedicated field in the electronic health record within 45 days of a patient’s first cancer treatment. This practice enables ready identification of stage cohorts in which value of care can be assessed, she noted.

There were also sizable absolute increases in relevant CCPs in the proportion of blood and marrow transplant recipients referred to survivorship care by day 100 (+20%) and visiting that service by day 180 (+13%), recording of hand and foot pain (+34%) and radiation dermatitis (+21%), mismatch repair testing in patients with newly diagnosed colorectal cancer (+10%), referral of patients with newly diagnosed ovarian cancer for genetic counseling (+43%), cytogenetic testing in patients with newly diagnosed hematologic malignancies (+17%), hepatitis B testing before rituximab administration (+17%), and allowance of at least 2 nights for treatment plan physics–quality assurance before the start of a nonemergent radiation oncology treatment (+14%).

Meanwhile, there were decreases, considered favorable changes, in chemotherapy use in the last 2 weeks of life among neuro-oncology patients (–9%) and in patients’ receipt of more than 10 fractions of radiation therapy for palliation of bone metastases (–9%).

Finally, there was no change in several metrics of quality that were already at very high or low levels, as appropriate, at baseline: molecular testing in patients with newly diagnosed acute myeloid leukemia (stable at 95%), hospice enrollment at the time of death for neuro-oncology patients (stable at 100%), chemotherapy in the last 2 weeks of life for patients with sarcoma (stable at 0%), and epidermal growth factor receptor testing in patients with newly diagnosed lung adenocarcinoma (stable at 98%).
 

ORLANDO – A multifaceted portfolio of physician-led measures with feedback and financial incentives can dramatically improve the quality of care provided at cancer centers, suggests the experience of Stanford (Calif.) Health Care.

Physician leaders of 13 disease-specific cancer care programs (CCPs) identified measures of care that were meaningful to their team and patients, spanning the spectrum from new diagnosis through end of life and survivorship care. Quality and analytics teams developed 16 corresponding metrics and performance reports used for feedback. Programs were also given a financial incentive to meet jointly set targets.

After a year, the CCPs had improved on 12 of the metrics and maintained high baseline levels of performance on the other 4 metrics, investigators reported at a symposium on quality care sponsored by the American Society of Clinical Oncology. For example, they got better at entering staging information in a dedicated field in the electronic health record (+50% absolute increase), recording hand and foot pain (+34%), performing hepatitis B testing before rituximab use (+17%), and referring patients with ovarian cancer for genetic counseling (+43%).

Susan London/Frontline Medical News

Susan London/Frontline Medical News

Study details

“In the summer of 2015, we were starting to feel a lot of pressure to prepare for evolving reimbursement models,” Ms. Porter said, explaining the initiative’s genesis. “Mainly, how do we define our value, and how can we measure and improve on that value of the care we deliver? One answer, of course, is to measure and reduce unnecessary variation. And we knew, to be successful, we had to increase our physician engagement and leadership in the selection and improvement of our metrics.”

Physician leaders of the CCPs were asked to choose quality measures that met three criteria: they were meaningful and important to both the care team and patients, they had pertinent data elements already available in existing databases (to reduce documentation burden), and they were multidisciplinary in nature, reflecting the care provided by the whole program. The measures ultimately selected included a variety of those put forth by American Society of Clinical Oncology’s Quality Oncology Practice Initiative and the American Society for Radiation Oncology. CCPs were offered a financial incentive for meeting targets ranging from $75,000 to $125,000 that was based on number of providers and patient volume, rather than on the impact of improved metric. “This was really meant for reinvestment back into their quality programs,” Ms. Porter said. “I would argue this was really a culture-building year for us, and we hope that next year there might be a little bit more tangible value with the metrics.”

The quality team gave CCPs monthly or quarterly performance reports with unblinded physician- and patient-level details that were ultimately disseminated to all the other CCPs. They also investigated any missing data for individual metrics.

Study results showed that half of the 16 measures the physician leaders chose pertained to the diagnosis and treatment planning phase of care, according to Ms. Porter. “It was important to many of our CCPs to ensure that specific testing was done, which would then, in turn, drive treatment planning decisions,” she commented.

At the end of the year, each metric was assessed among 13 to 2,406 patients. “All CCPs met their predetermined target and earned their financial incentive award for the year,” Ms. Porter reported.

Improvement was most marked, with a 50% absolute increase, for the metric of completing a staging module, which required conversion of staging information (historically embedded in progress notes) into a structured format in a dedicated field in the electronic health record within 45 days of a patient’s first cancer treatment. This practice enables ready identification of stage cohorts in which value of care can be assessed, she noted.

There were also sizable absolute increases in relevant CCPs in the proportion of blood and marrow transplant recipients referred to survivorship care by day 100 (+20%) and visiting that service by day 180 (+13%), recording of hand and foot pain (+34%) and radiation dermatitis (+21%), mismatch repair testing in patients with newly diagnosed colorectal cancer (+10%), referral of patients with newly diagnosed ovarian cancer for genetic counseling (+43%), cytogenetic testing in patients with newly diagnosed hematologic malignancies (+17%), hepatitis B testing before rituximab administration (+17%), and allowance of at least 2 nights for treatment plan physics–quality assurance before the start of a nonemergent radiation oncology treatment (+14%).

Meanwhile, there were decreases, considered favorable changes, in chemotherapy use in the last 2 weeks of life among neuro-oncology patients (–9%) and in patients’ receipt of more than 10 fractions of radiation therapy for palliation of bone metastases (–9%).

Finally, there was no change in several metrics of quality that were already at very high or low levels, as appropriate, at baseline: molecular testing in patients with newly diagnosed acute myeloid leukemia (stable at 95%), hospice enrollment at the time of death for neuro-oncology patients (stable at 100%), chemotherapy in the last 2 weeks of life for patients with sarcoma (stable at 0%), and epidermal growth factor receptor testing in patients with newly diagnosed lung adenocarcinoma (stable at 98%).
 

ORLANDO – A decision support tool safely reduces use of colony-stimulating factors (CSFs) in patients undergoing chemotherapy for lung cancer, suggests a retrospective claims-based cohort study of nearly 3,500 patients across the country.

The rate of CSF use fell among patients treated in the nine states that implemented the tool – a library of chemotherapy regimens and their expected FN risk that uses preauthorization and an algorithm to promote risk-appropriate, guideline-adherent use – but it remained unchanged in the 39 states and the District of Columbia, where usual practice continued, investigators reported at a symposium on quality care sponsored by the American Society of Clinical Oncology and simultaneously published (J Oncol Pract. 2017 March 4. doi: 10.1200/JOP.2017.020867). The adjusted difference was nearly 9%.

Parsing the findings

Although the United States makes up just 4% of the world’s population, it uses nearly 80% of CSFs sold by a leading manufacturer, according to invited discussant Thomas J. Smith, MD, a professor of oncology and palliative medicine at Johns Hopkins University in Baltimore.

“When we rewrote the ASCO [American Society of Clinical Oncology] guidelines on CSF use in 2015, there were some specific indications: dose-intense chemo for adjuvant breast cancer and uroepithelial cancer and ... when the risk of febrile neutropenia is about 20% and dose reduction is not an appropriate strategy. We were quick to point out that most regimens have a risk of febrile neutropenia much less than that,” he noted.

Dr. Agiro and his colleagues’ findings are valid, real, and reproducible, Dr. Smith maintained. However, it is unclear to what extent the observed levels of CSF use represented overuse.

“In lung cancer, there are very few regimens that have a febrile neutropenia rate close to 20%,” he elaborated. “What we don’t know is how much of this [use] was actually justified. I would suspect it is 10% or 15%, rather than 40%.”

CSF use, as guided by the new tool, “might not support increased dose density [of chemotherapy], but I would challenge anybody in the audience to show me data in normal solid tumor patients that [show that] dose density maintained by CSFs makes a difference in overall survival,” he said.

Questions yet to be addressed include the difficulty and cost of using the decision support tool and the possible negative impact on practices’ finances, according to Dr. Smith.

“When ESAs [erythropoiesis-stimulating agents] came off being used so much, some of my friends’ practices took a 15% to 20% drop in their revenue, and this is an important source of revenue for a lot of practices,” he explained. “So, I hope that when we take this revenue away, that we are cognizant of that and realize that it’s just another stress on practices, many of which are under significant stress already.”
 

Study details

An estimated 26% of uses of CSFs in patients with lung cancer are not in accordance with the ASCO practice guidelines, according to Dr. Agiro. “Such variations from recommendations are sometimes the reason why different stakeholders take actions” to improve care, such as ASCO’s Quality Oncology Practice Initiative (QOPI) and the American Board of Internal Medicine’s Choosing Wisely initiative (J Oncol Pract. 2015;11:338-43).

The decision support tool evaluated in the study uses preauthorization before delivery of care and, therefore, differs from point-of-care interventions, he noted.

“The tool allows access to a library of chemotherapy regimens and their associated, expected febrile neutropenia risk based on the myelotoxicity of the planned regimens as indicated in published trials. The tool is accessible online and provides real-time recommendations that are tailored based on disease- and patient-specific factors for either the use of CSF or not,” he elaborated.

According to the tool’s algorithm, use is recommended for patients who are given a regimen with a high risk of febrile neutropenia (greater than 20%) and is not recommended for those given a low-risk regimen (less than 10%). It is tailored according to the presence of additional risk factors for the intermediate-risk group.

Oncologists use the tool only for patients starting a new chemotherapy and only in the first cycle, when the risk of febrile neutropenia is highest, according to Dr. Agiro. “Once the approval is given in the first cycle, it remains in effect for the next 6 months, so they don’t have to use it again and again in additional cycles,” he explained.

The decision support tool was implemented in nine states starting in July 2014. In the study, which was funded by Anthem, the investigators analyzed administrative claims data from commercially insured adult patients starting chemotherapy for lung cancer, assessing changes in outcomes between a preimplementation period (April 2013 to Dec. 2013) and a postimplementation period (July 2014 to March 2015).

Analyses were based on 1,857 patients in the states that implemented the tool and 1,610 patients in the states that did not.

The percentage of patients receiving CSFs in the 6 months after starting chemotherapy fell in states that implemented the decision support tool (from 48.4% to 35.6%) but remained stable in states that did not (43.2% and 44.4%), Dr. Agiro reported. The adjusted difference in differences was –8.7% (P less than .001).

Meanwhile, the percentage of patients admitted for febrile neutropenia or experiencing this outcome while hospitalized increased in both states implementing the tool (from 2.8% to 4.3%) and those not implementing it (from 3.1% to 5.1%). Although the magnitude of increase was smaller in the former (+1.5% vs. +2.0%), the difference was not significant. Findings were essentially the same among the subset of patients aged 65 years and older.

“It’s important to study both intended and unintended consequences of such interventions,” Dr. Agiro noted. “Our study goes beyond financial considerations by looking at unintended outcomes: in this case, focusing on the incidence of febrile neutropenia, an outcome that is of prime interest to patients and oncologists and payers alike.”

The study may have missed some cases of febrile neutropenia, he acknowledged. “Also, there are other important outcomes of concern. For example, were there any delays in chemotherapy administration or immune recovery that could have been triggered by the implementation of the decision support program?”

The impact, both intended and unintended, on practices warrants evaluation as well, he further noted. “An important question could be, ‘Does it take less time to use this decision support tool compared to the time taken with normal care processes?’ ”

Dr. Agiro disclosed that he is employed by, has stock or other ownership interests in, and receives research funding from Anthem.
 

ORLANDO – A decision support tool safely reduces use of colony-stimulating factors (CSFs) in patients undergoing chemotherapy for lung cancer, suggests a retrospective claims-based cohort study of nearly 3,500 patients across the country.

The rate of CSF use fell among patients treated in the nine states that implemented the tool – a library of chemotherapy regimens and their expected FN risk that uses preauthorization and an algorithm to promote risk-appropriate, guideline-adherent use – but it remained unchanged in the 39 states and the District of Columbia, where usual practice continued, investigators reported at a symposium on quality care sponsored by the American Society of Clinical Oncology and simultaneously published (J Oncol Pract. 2017 March 4. doi: 10.1200/JOP.2017.020867). The adjusted difference was nearly 9%.

Parsing the findings

Although the United States makes up just 4% of the world’s population, it uses nearly 80% of CSFs sold by a leading manufacturer, according to invited discussant Thomas J. Smith, MD, a professor of oncology and palliative medicine at Johns Hopkins University in Baltimore.

“When we rewrote the ASCO [American Society of Clinical Oncology] guidelines on CSF use in 2015, there were some specific indications: dose-intense chemo for adjuvant breast cancer and uroepithelial cancer and ... when the risk of febrile neutropenia is about 20% and dose reduction is not an appropriate strategy. We were quick to point out that most regimens have a risk of febrile neutropenia much less than that,” he noted.

Dr. Agiro and his colleagues’ findings are valid, real, and reproducible, Dr. Smith maintained. However, it is unclear to what extent the observed levels of CSF use represented overuse.

“In lung cancer, there are very few regimens that have a febrile neutropenia rate close to 20%,” he elaborated. “What we don’t know is how much of this [use] was actually justified. I would suspect it is 10% or 15%, rather than 40%.”

CSF use, as guided by the new tool, “might not support increased dose density [of chemotherapy], but I would challenge anybody in the audience to show me data in normal solid tumor patients that [show that] dose density maintained by CSFs makes a difference in overall survival,” he said.

Questions yet to be addressed include the difficulty and cost of using the decision support tool and the possible negative impact on practices’ finances, according to Dr. Smith.

“When ESAs [erythropoiesis-stimulating agents] came off being used so much, some of my friends’ practices took a 15% to 20% drop in their revenue, and this is an important source of revenue for a lot of practices,” he explained. “So, I hope that when we take this revenue away, that we are cognizant of that and realize that it’s just another stress on practices, many of which are under significant stress already.”
 

Study details

An estimated 26% of uses of CSFs in patients with lung cancer are not in accordance with the ASCO practice guidelines, according to Dr. Agiro. “Such variations from recommendations are sometimes the reason why different stakeholders take actions” to improve care, such as ASCO’s Quality Oncology Practice Initiative (QOPI) and the American Board of Internal Medicine’s Choosing Wisely initiative (J Oncol Pract. 2015;11:338-43).

The decision support tool evaluated in the study uses preauthorization before delivery of care and, therefore, differs from point-of-care interventions, he noted.

“The tool allows access to a library of chemotherapy regimens and their associated, expected febrile neutropenia risk based on the myelotoxicity of the planned regimens as indicated in published trials. The tool is accessible online and provides real-time recommendations that are tailored based on disease- and patient-specific factors for either the use of CSF or not,” he elaborated.

According to the tool’s algorithm, use is recommended for patients who are given a regimen with a high risk of febrile neutropenia (greater than 20%) and is not recommended for those given a low-risk regimen (less than 10%). It is tailored according to the presence of additional risk factors for the intermediate-risk group.

Oncologists use the tool only for patients starting a new chemotherapy and only in the first cycle, when the risk of febrile neutropenia is highest, according to Dr. Agiro. “Once the approval is given in the first cycle, it remains in effect for the next 6 months, so they don’t have to use it again and again in additional cycles,” he explained.

The decision support tool was implemented in nine states starting in July 2014. In the study, which was funded by Anthem, the investigators analyzed administrative claims data from commercially insured adult patients starting chemotherapy for lung cancer, assessing changes in outcomes between a preimplementation period (April 2013 to Dec. 2013) and a postimplementation period (July 2014 to March 2015).

Analyses were based on 1,857 patients in the states that implemented the tool and 1,610 patients in the states that did not.

The percentage of patients receiving CSFs in the 6 months after starting chemotherapy fell in states that implemented the decision support tool (from 48.4% to 35.6%) but remained stable in states that did not (43.2% and 44.4%), Dr. Agiro reported. The adjusted difference in differences was –8.7% (P less than .001).

Meanwhile, the percentage of patients admitted for febrile neutropenia or experiencing this outcome while hospitalized increased in both states implementing the tool (from 2.8% to 4.3%) and those not implementing it (from 3.1% to 5.1%). Although the magnitude of increase was smaller in the former (+1.5% vs. +2.0%), the difference was not significant. Findings were essentially the same among the subset of patients aged 65 years and older.

“It’s important to study both intended and unintended consequences of such interventions,” Dr. Agiro noted. “Our study goes beyond financial considerations by looking at unintended outcomes: in this case, focusing on the incidence of febrile neutropenia, an outcome that is of prime interest to patients and oncologists and payers alike.”

The study may have missed some cases of febrile neutropenia, he acknowledged. “Also, there are other important outcomes of concern. For example, were there any delays in chemotherapy administration or immune recovery that could have been triggered by the implementation of the decision support program?”

The impact, both intended and unintended, on practices warrants evaluation as well, he further noted. “An important question could be, ‘Does it take less time to use this decision support tool compared to the time taken with normal care processes?’ ”

Dr. Agiro disclosed that he is employed by, has stock or other ownership interests in, and receives research funding from Anthem.
 

ORLANDO – A decision support tool safely reduces use of colony-stimulating factors (CSFs) in patients undergoing chemotherapy for lung cancer, suggests a retrospective claims-based cohort study of nearly 3,500 patients across the country.

The rate of CSF use fell among patients treated in the nine states that implemented the tool – a library of chemotherapy regimens and their expected FN risk that uses preauthorization and an algorithm to promote risk-appropriate, guideline-adherent use – but it remained unchanged in the 39 states and the District of Columbia, where usual practice continued, investigators reported at a symposium on quality care sponsored by the American Society of Clinical Oncology and simultaneously published (J Oncol Pract. 2017 March 4. doi: 10.1200/JOP.2017.020867). The adjusted difference was nearly 9%.

Parsing the findings

Although the United States makes up just 4% of the world’s population, it uses nearly 80% of CSFs sold by a leading manufacturer, according to invited discussant Thomas J. Smith, MD, a professor of oncology and palliative medicine at Johns Hopkins University in Baltimore.

“When we rewrote the ASCO [American Society of Clinical Oncology] guidelines on CSF use in 2015, there were some specific indications: dose-intense chemo for adjuvant breast cancer and uroepithelial cancer and ... when the risk of febrile neutropenia is about 20% and dose reduction is not an appropriate strategy. We were quick to point out that most regimens have a risk of febrile neutropenia much less than that,” he noted.

Dr. Agiro and his colleagues’ findings are valid, real, and reproducible, Dr. Smith maintained. However, it is unclear to what extent the observed levels of CSF use represented overuse.

“In lung cancer, there are very few regimens that have a febrile neutropenia rate close to 20%,” he elaborated. “What we don’t know is how much of this [use] was actually justified. I would suspect it is 10% or 15%, rather than 40%.”

CSF use, as guided by the new tool, “might not support increased dose density [of chemotherapy], but I would challenge anybody in the audience to show me data in normal solid tumor patients that [show that] dose density maintained by CSFs makes a difference in overall survival,” he said.

Questions yet to be addressed include the difficulty and cost of using the decision support tool and the possible negative impact on practices’ finances, according to Dr. Smith.

“When ESAs [erythropoiesis-stimulating agents] came off being used so much, some of my friends’ practices took a 15% to 20% drop in their revenue, and this is an important source of revenue for a lot of practices,” he explained. “So, I hope that when we take this revenue away, that we are cognizant of that and realize that it’s just another stress on practices, many of which are under significant stress already.”
 

Study details

An estimated 26% of uses of CSFs in patients with lung cancer are not in accordance with the ASCO practice guidelines, according to Dr. Agiro. “Such variations from recommendations are sometimes the reason why different stakeholders take actions” to improve care, such as ASCO’s Quality Oncology Practice Initiative (QOPI) and the American Board of Internal Medicine’s Choosing Wisely initiative (J Oncol Pract. 2015;11:338-43).

The decision support tool evaluated in the study uses preauthorization before delivery of care and, therefore, differs from point-of-care interventions, he noted.

“The tool allows access to a library of chemotherapy regimens and their associated, expected febrile neutropenia risk based on the myelotoxicity of the planned regimens as indicated in published trials. The tool is accessible online and provides real-time recommendations that are tailored based on disease- and patient-specific factors for either the use of CSF or not,” he elaborated.

According to the tool’s algorithm, use is recommended for patients who are given a regimen with a high risk of febrile neutropenia (greater than 20%) and is not recommended for those given a low-risk regimen (less than 10%). It is tailored according to the presence of additional risk factors for the intermediate-risk group.

Oncologists use the tool only for patients starting a new chemotherapy and only in the first cycle, when the risk of febrile neutropenia is highest, according to Dr. Agiro. “Once the approval is given in the first cycle, it remains in effect for the next 6 months, so they don’t have to use it again and again in additional cycles,” he explained.

The decision support tool was implemented in nine states starting in July 2014. In the study, which was funded by Anthem, the investigators analyzed administrative claims data from commercially insured adult patients starting chemotherapy for lung cancer, assessing changes in outcomes between a preimplementation period (April 2013 to Dec. 2013) and a postimplementation period (July 2014 to March 2015).

Analyses were based on 1,857 patients in the states that implemented the tool and 1,610 patients in the states that did not.

The percentage of patients receiving CSFs in the 6 months after starting chemotherapy fell in states that implemented the decision support tool (from 48.4% to 35.6%) but remained stable in states that did not (43.2% and 44.4%), Dr. Agiro reported. The adjusted difference in differences was –8.7% (P less than .001).

Meanwhile, the percentage of patients admitted for febrile neutropenia or experiencing this outcome while hospitalized increased in both states implementing the tool (from 2.8% to 4.3%) and those not implementing it (from 3.1% to 5.1%). Although the magnitude of increase was smaller in the former (+1.5% vs. +2.0%), the difference was not significant. Findings were essentially the same among the subset of patients aged 65 years and older.

“It’s important to study both intended and unintended consequences of such interventions,” Dr. Agiro noted. “Our study goes beyond financial considerations by looking at unintended outcomes: in this case, focusing on the incidence of febrile neutropenia, an outcome that is of prime interest to patients and oncologists and payers alike.”

The study may have missed some cases of febrile neutropenia, he acknowledged. “Also, there are other important outcomes of concern. For example, were there any delays in chemotherapy administration or immune recovery that could have been triggered by the implementation of the decision support program?”

The impact, both intended and unintended, on practices warrants evaluation as well, he further noted. “An important question could be, ‘Does it take less time to use this decision support tool compared to the time taken with normal care processes?’ ”

Dr. Agiro disclosed that he is employed by, has stock or other ownership interests in, and receives research funding from Anthem.
 

ORLANDO – Implementation of clinical pathways aimed at improving appropriate, evidence-based care for patients with metastatic non–small-cell lung cancer (NSCLC) reduces costs without negatively affecting survival, the Dana-Farber Cancer Institute’s experience suggests.

“At Dana-Farber ... we have looked toward pathways as a potential tool to help manage complexity and resource utilization,” senior author David M. Jackman, MD, explained at a symposium on quality care sponsored by the American Society of Clinical Oncology. “We see pathways as a patient-centered platform that provides real-time decision-making support across the continuum of cancer care. We think that these should be based on preemptive decision making, reflect current standards of care, incorporate feedback from which we can learn from our practice patterns, and support clinical research.”

Susan London/Frontline Medical News

More evidence of benefit

The Dana-Farber study adds to others showing that the benefits of pathways are real and reproducible, according to invited discussant Thomas J. Smith, MD, professor of oncology and palliative medicine at Johns Hopkins Medicine in Baltimore.

Susan London/Frontline Medical News

Pathways development

In developing the pathways, Dana-Farber began with lung cancer in part because the center sees a high volume of patients with the disease. In addition, decision making for this malignancy is complex, and there was considerable variation in oncologists’ practices.

“Our platform exists as an independent web-based system that currently lives outside of our EMR. Physicians can access this in real time, in the clinic room with the patient if they so choose,” Dr. Jackman explained. “From our EMR, we are flagged every time a provider orders a new start [of therapy], whether it’s IV chemo, oral chemo, or hormonal therapy. From our vendor, we receive granular treatment decision information made within the pathways system – information about the provider and site, information about the patients, their disease, and the line of therapy, as well as other important factors that drive decision making. Finally, from our clinical trials system interface, we can confirm trial enrollment data.”

Oncologists are free to leave the suggested pathway if their clinical judgment favors an alternate course, according to Dr. Jackman.

“We always want our physicians to feel comfortable treating the patients in front of them however they see best fit. If that means an off-pathway therapy, we want them to have the freedom to do that,” he said. “But we think one of the major tools of the pathways is to help capture the reasons why. So if they think it’s warranted and appropriate, go ahead, go off pathway, but tell us why you are doing it so we can learn from it.”

Using Pathways has not proved burdensome, according to Dr. Jackman. Navigating through the system requires about a minute or two, and use is required only when a patient is starting a new therapy, which typically occurs less than once per half-day clinic session.

Study details

In the study, he and colleagues compared costs of care in the first year after diagnosis of stage IV NSCLC between 160 patients treated at Dana-Farber in 2012 (before Pathways implementation) and 210 patients treated there in 2014 (after Pathways implementation).

“It should be noted that because we are a free-standing outpatient cancer center, all of the costs that we were able to gather are intramural and therefore related only to outpatient activities,” he pointed out.

The total annual costs of care per patient, adjusted for potential confounders (age, sex, race, distance to the institute, clinical trial enrollment, and EGFR and ALK status) fell by $17,085 after implementation of Pathways, from $69,122 to $52,037 (P = .01), he reported.

The largest source of cost savings by far, accounting for 73% of the total, was reduced use of antineoplastic agents (chemotherapy, biologics, and other anticancer agents). Cost for this component fell from $44,237 per patient to $31,846 (P less than .01).

“The majority of this savings came through a reduction in the use of what we considered unwarranted use of combination chemotherapy,” Dr. Jackman said. “In the first-line setting, we specifically went after the regimen of carboplatin, pemetrexed, and bevacizumab; based on our interpretation of the PointBreak study, we felt that that regimen did not bring additional efficacy but did essentially double drug costs. In going after that, we reduced not only use of that but also the subsequent use of pemetrexed plus bevacizumab maintenance. In the second-line setting, with the implementation of Pathways, we saw a decrease in the use of inappropriate platinum-based doublet therapy in those patients who had previously progressed on a platinum-based doublet.”

Median overall survival did not decrease and in fact increased slightly, from 10.7 months before Pathways implementation to 11.2 months afterward (P = .08). Corresponding 1-year rates of survival were 52% and 64%.

“We stand on the shoulders of those who came before us, who have also shown savings associated with implementation of pathways,” concluded Dr. Jackman. “But we hope that we add our voice and our data to this argument that pathways, I think, are a reasonable tool as we try to manage complexity and resource utilization. In addition, we do so without impinging upon clinical outcomes.”

The study was limited by its inclusion of only outpatient costs at Dana-Farber, he acknowledged. “You and we would be very interested in being able to know whether our Pathways implementation affected ED [emergency department] visits or hospitalizations. To that end, we are working with some of our regional payers to try to transparently share data around outcomes, costs, and usage, so that we can learn more in this regard.”

Dr. Jackman disclosed that he is an adviser or consultant to Bayer, Celgene, CVS Caremark, Genentech, and Lilly.

ORLANDO – Implementation of clinical pathways aimed at improving appropriate, evidence-based care for patients with metastatic non–small-cell lung cancer (NSCLC) reduces costs without negatively affecting survival, the Dana-Farber Cancer Institute’s experience suggests.

“At Dana-Farber ... we have looked toward pathways as a potential tool to help manage complexity and resource utilization,” senior author David M. Jackman, MD, explained at a symposium on quality care sponsored by the American Society of Clinical Oncology. “We see pathways as a patient-centered platform that provides real-time decision-making support across the continuum of cancer care. We think that these should be based on preemptive decision making, reflect current standards of care, incorporate feedback from which we can learn from our practice patterns, and support clinical research.”

Susan London/Frontline Medical News

More evidence of benefit

The Dana-Farber study adds to others showing that the benefits of pathways are real and reproducible, according to invited discussant Thomas J. Smith, MD, professor of oncology and palliative medicine at Johns Hopkins Medicine in Baltimore.

Susan London/Frontline Medical News

Pathways development

In developing the pathways, Dana-Farber began with lung cancer in part because the center sees a high volume of patients with the disease. In addition, decision making for this malignancy is complex, and there was considerable variation in oncologists’ practices.

“Our platform exists as an independent web-based system that currently lives outside of our EMR. Physicians can access this in real time, in the clinic room with the patient if they so choose,” Dr. Jackman explained. “From our EMR, we are flagged every time a provider orders a new start [of therapy], whether it’s IV chemo, oral chemo, or hormonal therapy. From our vendor, we receive granular treatment decision information made within the pathways system – information about the provider and site, information about the patients, their disease, and the line of therapy, as well as other important factors that drive decision making. Finally, from our clinical trials system interface, we can confirm trial enrollment data.”

Oncologists are free to leave the suggested pathway if their clinical judgment favors an alternate course, according to Dr. Jackman.

“We always want our physicians to feel comfortable treating the patients in front of them however they see best fit. If that means an off-pathway therapy, we want them to have the freedom to do that,” he said. “But we think one of the major tools of the pathways is to help capture the reasons why. So if they think it’s warranted and appropriate, go ahead, go off pathway, but tell us why you are doing it so we can learn from it.”

Using Pathways has not proved burdensome, according to Dr. Jackman. Navigating through the system requires about a minute or two, and use is required only when a patient is starting a new therapy, which typically occurs less than once per half-day clinic session.

Study details

In the study, he and colleagues compared costs of care in the first year after diagnosis of stage IV NSCLC between 160 patients treated at Dana-Farber in 2012 (before Pathways implementation) and 210 patients treated there in 2014 (after Pathways implementation).

“It should be noted that because we are a free-standing outpatient cancer center, all of the costs that we were able to gather are intramural and therefore related only to outpatient activities,” he pointed out.

The total annual costs of care per patient, adjusted for potential confounders (age, sex, race, distance to the institute, clinical trial enrollment, and EGFR and ALK status) fell by $17,085 after implementation of Pathways, from $69,122 to $52,037 (P = .01), he reported.

The largest source of cost savings by far, accounting for 73% of the total, was reduced use of antineoplastic agents (chemotherapy, biologics, and other anticancer agents). Cost for this component fell from $44,237 per patient to $31,846 (P less than .01).

“The majority of this savings came through a reduction in the use of what we considered unwarranted use of combination chemotherapy,” Dr. Jackman said. “In the first-line setting, we specifically went after the regimen of carboplatin, pemetrexed, and bevacizumab; based on our interpretation of the PointBreak study, we felt that that regimen did not bring additional efficacy but did essentially double drug costs. In going after that, we reduced not only use of that but also the subsequent use of pemetrexed plus bevacizumab maintenance. In the second-line setting, with the implementation of Pathways, we saw a decrease in the use of inappropriate platinum-based doublet therapy in those patients who had previously progressed on a platinum-based doublet.”

Median overall survival did not decrease and in fact increased slightly, from 10.7 months before Pathways implementation to 11.2 months afterward (P = .08). Corresponding 1-year rates of survival were 52% and 64%.

“We stand on the shoulders of those who came before us, who have also shown savings associated with implementation of pathways,” concluded Dr. Jackman. “But we hope that we add our voice and our data to this argument that pathways, I think, are a reasonable tool as we try to manage complexity and resource utilization. In addition, we do so without impinging upon clinical outcomes.”

The study was limited by its inclusion of only outpatient costs at Dana-Farber, he acknowledged. “You and we would be very interested in being able to know whether our Pathways implementation affected ED [emergency department] visits or hospitalizations. To that end, we are working with some of our regional payers to try to transparently share data around outcomes, costs, and usage, so that we can learn more in this regard.”

Dr. Jackman disclosed that he is an adviser or consultant to Bayer, Celgene, CVS Caremark, Genentech, and Lilly.

ORLANDO – Implementation of clinical pathways aimed at improving appropriate, evidence-based care for patients with metastatic non–small-cell lung cancer (NSCLC) reduces costs without negatively affecting survival, the Dana-Farber Cancer Institute’s experience suggests.

“At Dana-Farber ... we have looked toward pathways as a potential tool to help manage complexity and resource utilization,” senior author David M. Jackman, MD, explained at a symposium on quality care sponsored by the American Society of Clinical Oncology. “We see pathways as a patient-centered platform that provides real-time decision-making support across the continuum of cancer care. We think that these should be based on preemptive decision making, reflect current standards of care, incorporate feedback from which we can learn from our practice patterns, and support clinical research.”

Susan London/Frontline Medical News

More evidence of benefit

The Dana-Farber study adds to others showing that the benefits of pathways are real and reproducible, according to invited discussant Thomas J. Smith, MD, professor of oncology and palliative medicine at Johns Hopkins Medicine in Baltimore.

Susan London/Frontline Medical News

Pathways development

In developing the pathways, Dana-Farber began with lung cancer in part because the center sees a high volume of patients with the disease. In addition, decision making for this malignancy is complex, and there was considerable variation in oncologists’ practices.

“Our platform exists as an independent web-based system that currently lives outside of our EMR. Physicians can access this in real time, in the clinic room with the patient if they so choose,” Dr. Jackman explained. “From our EMR, we are flagged every time a provider orders a new start [of therapy], whether it’s IV chemo, oral chemo, or hormonal therapy. From our vendor, we receive granular treatment decision information made within the pathways system – information about the provider and site, information about the patients, their disease, and the line of therapy, as well as other important factors that drive decision making. Finally, from our clinical trials system interface, we can confirm trial enrollment data.”

Oncologists are free to leave the suggested pathway if their clinical judgment favors an alternate course, according to Dr. Jackman.

“We always want our physicians to feel comfortable treating the patients in front of them however they see best fit. If that means an off-pathway therapy, we want them to have the freedom to do that,” he said. “But we think one of the major tools of the pathways is to help capture the reasons why. So if they think it’s warranted and appropriate, go ahead, go off pathway, but tell us why you are doing it so we can learn from it.”

Using Pathways has not proved burdensome, according to Dr. Jackman. Navigating through the system requires about a minute or two, and use is required only when a patient is starting a new therapy, which typically occurs less than once per half-day clinic session.

Study details

In the study, he and colleagues compared costs of care in the first year after diagnosis of stage IV NSCLC between 160 patients treated at Dana-Farber in 2012 (before Pathways implementation) and 210 patients treated there in 2014 (after Pathways implementation).

“It should be noted that because we are a free-standing outpatient cancer center, all of the costs that we were able to gather are intramural and therefore related only to outpatient activities,” he pointed out.

The total annual costs of care per patient, adjusted for potential confounders (age, sex, race, distance to the institute, clinical trial enrollment, and EGFR and ALK status) fell by $17,085 after implementation of Pathways, from $69,122 to $52,037 (P = .01), he reported.

The largest source of cost savings by far, accounting for 73% of the total, was reduced use of antineoplastic agents (chemotherapy, biologics, and other anticancer agents). Cost for this component fell from $44,237 per patient to $31,846 (P less than .01).

“The majority of this savings came through a reduction in the use of what we considered unwarranted use of combination chemotherapy,” Dr. Jackman said. “In the first-line setting, we specifically went after the regimen of carboplatin, pemetrexed, and bevacizumab; based on our interpretation of the PointBreak study, we felt that that regimen did not bring additional efficacy but did essentially double drug costs. In going after that, we reduced not only use of that but also the subsequent use of pemetrexed plus bevacizumab maintenance. In the second-line setting, with the implementation of Pathways, we saw a decrease in the use of inappropriate platinum-based doublet therapy in those patients who had previously progressed on a platinum-based doublet.”

Median overall survival did not decrease and in fact increased slightly, from 10.7 months before Pathways implementation to 11.2 months afterward (P = .08). Corresponding 1-year rates of survival were 52% and 64%.

“We stand on the shoulders of those who came before us, who have also shown savings associated with implementation of pathways,” concluded Dr. Jackman. “But we hope that we add our voice and our data to this argument that pathways, I think, are a reasonable tool as we try to manage complexity and resource utilization. In addition, we do so without impinging upon clinical outcomes.”

The study was limited by its inclusion of only outpatient costs at Dana-Farber, he acknowledged. “You and we would be very interested in being able to know whether our Pathways implementation affected ED [emergency department] visits or hospitalizations. To that end, we are working with some of our regional payers to try to transparently share data around outcomes, costs, and usage, so that we can learn more in this regard.”

Dr. Jackman disclosed that he is an adviser or consultant to Bayer, Celgene, CVS Caremark, Genentech, and Lilly.

The investigational anti-CD20 monoclonal antibody ublituximab is safe and has good antitumor activity in patients with B-cell non-Hodgkin lymphoma (B-NHL) or chronic lymphocytic leukemia (CLL) who have previously received the anti-CD20 antibody rituximab, results from a phase I/II trial suggest.

Ublituximab is engineered to have a low fucose content. This feature gives it enhanced antibody-dependent cellular cytotoxicity relative to other anti-CD20 antibodies, especially against tumors having low expression of that protein, as may occur in the development of rituximab resistance.

In the trial, nearly half of the 35 patients studied had a complete or partial response to ublituximab, including nearly one-third of those whose disease was refractory to rituximab (Rituxan) (Br J Haematol. 2017 Apr;177[2]:243-53). The main adverse events were infusion-related reactions, fatigue, pyrexia, and diarrhea, but almost all were lower grade.

“Ublituximab was well tolerated and efficacious in a heterogeneous and highly rituximab–pretreated patient population,” said the investigators, who were led by Ahmed Sawas, MD, at the Center for Lymphoid Malignancies, Columbia University Medical Center, N.Y.

The observed response rate is much the same as those seen with two other anti-CD20 antibodies – obinutuzumab (Gazyva)and ofatumumab (Arzerra)– in similar patient populations, and ublituximab may have advantages in terms of fewer higher-grade infusion-related reactions and shorter infusion time.

“Enhanced anti-CD20 [monoclonal antibodies] that are well tolerated and active in rituximab-resistant disease can provide meaningful clinical benefit to patients with limited treatment options,” the investigators noted.

The trial enrolled 27 patients with B-NHL and 8 patients with CLL (or small lymphocytic lymphoma) who had rituximab-refractory disease (defined by progression on or within 6 months of receiving that agent) or rituximab-relapsed disease (defined by progression more than 6 months after receiving it). They had received a median of three prior therapies.

The patients were treated on an open-label basis with ublituximab at various doses as induction therapy (3-4 weekly infusions during cycles 1 and 2) and then as maintenance therapy (monthly during cycles 3-5, then once every 3 months for up to 2 years). All patients received an oral antihistamine and steroids before infusions.

By the end of the trial, 60% of patients had discontinued treatment because of progression; 23% had discontinued because of adverse events, physician decision, or other reasons; and the remaining 17% had received all planned treatment, Dr. Sawas and his coinvestigators reported.

None of the patients experienced dose-limiting toxicities or unexpected adverse events. The rate of any-grade adverse events was 100%, and the rate specifically of grade 3/4 adverse events was 49%. The rate of serious adverse events (most commonly pneumonia) was 37%.

The leading nonhematologic adverse events were infusion-related reactions (40%; grade 3/4, 0%), fatigue (37%; grade 3/4, 3%), pyrexia (29%; grade 3/4, 0%), and diarrhea (26%; grade 3/4, 0%).

The leading hematologic adverse events were neutropenia (14%; grade 3/4, 14%), with no associated infections; anemia (11%; grade 3/4, 6%); and thrombocytopenia (6%; grade 3/4, 6%), with no associated bleeding.

The overall response rate was 45% (44% in the B-NHL cohort and 50% in the CLL cohort); the majority of responses were partial responses. Notably, the rate was 31% among the subset of patients who had rituximab-refractory disease.

The median duration of response to ublituximab was 9.2 months, and the median progression-free survival was 7.7 months.

“Anti-CD20 therapy has demonstrated the greatest benefit in combination, traditionally with multidrug chemotherapy–based regimens,” the investigators noted. “While the introduction of novel targeted therapies has shifted the treatment paradigm of CLL and indolent lymphoma, the activity of these agents is likely to be potentiated by the addition of an anti-CD20 [monoclonal antibody], given their different mechanisms of action.”

In fact, several multidrug, non–chemotherapy-based regimens are showing promising efficacy and milder toxicity in early trials, they pointed out. “In similar fashion, ublituximab is being evaluated for the treatment of NHL or CLL in combination with other agents,” such as the immunomodulator lenalidomide (Revlimid) and the Bruton tyrosine kinase inhibitor ibrutinib (Imbruvica).

TG Therapeutics funded the trial. Dr. Sawas disclosed that he receives research funds from TG Therapeutics.

[email protected]

The investigational anti-CD20 monoclonal antibody ublituximab is safe and has good antitumor activity in patients with B-cell non-Hodgkin lymphoma (B-NHL) or chronic lymphocytic leukemia (CLL) who have previously received the anti-CD20 antibody rituximab, results from a phase I/II trial suggest.

Ublituximab is engineered to have a low fucose content. This feature gives it enhanced antibody-dependent cellular cytotoxicity relative to other anti-CD20 antibodies, especially against tumors having low expression of that protein, as may occur in the development of rituximab resistance.

In the trial, nearly half of the 35 patients studied had a complete or partial response to ublituximab, including nearly one-third of those whose disease was refractory to rituximab (Rituxan) (Br J Haematol. 2017 Apr;177[2]:243-53). The main adverse events were infusion-related reactions, fatigue, pyrexia, and diarrhea, but almost all were lower grade.

“Ublituximab was well tolerated and efficacious in a heterogeneous and highly rituximab–pretreated patient population,” said the investigators, who were led by Ahmed Sawas, MD, at the Center for Lymphoid Malignancies, Columbia University Medical Center, N.Y.

The observed response rate is much the same as those seen with two other anti-CD20 antibodies – obinutuzumab (Gazyva)and ofatumumab (Arzerra)– in similar patient populations, and ublituximab may have advantages in terms of fewer higher-grade infusion-related reactions and shorter infusion time.

“Enhanced anti-CD20 [monoclonal antibodies] that are well tolerated and active in rituximab-resistant disease can provide meaningful clinical benefit to patients with limited treatment options,” the investigators noted.

The trial enrolled 27 patients with B-NHL and 8 patients with CLL (or small lymphocytic lymphoma) who had rituximab-refractory disease (defined by progression on or within 6 months of receiving that agent) or rituximab-relapsed disease (defined by progression more than 6 months after receiving it). They had received a median of three prior therapies.

The patients were treated on an open-label basis with ublituximab at various doses as induction therapy (3-4 weekly infusions during cycles 1 and 2) and then as maintenance therapy (monthly during cycles 3-5, then once every 3 months for up to 2 years). All patients received an oral antihistamine and steroids before infusions.

By the end of the trial, 60% of patients had discontinued treatment because of progression; 23% had discontinued because of adverse events, physician decision, or other reasons; and the remaining 17% had received all planned treatment, Dr. Sawas and his coinvestigators reported.

None of the patients experienced dose-limiting toxicities or unexpected adverse events. The rate of any-grade adverse events was 100%, and the rate specifically of grade 3/4 adverse events was 49%. The rate of serious adverse events (most commonly pneumonia) was 37%.

The leading nonhematologic adverse events were infusion-related reactions (40%; grade 3/4, 0%), fatigue (37%; grade 3/4, 3%), pyrexia (29%; grade 3/4, 0%), and diarrhea (26%; grade 3/4, 0%).

The leading hematologic adverse events were neutropenia (14%; grade 3/4, 14%), with no associated infections; anemia (11%; grade 3/4, 6%); and thrombocytopenia (6%; grade 3/4, 6%), with no associated bleeding.

The overall response rate was 45% (44% in the B-NHL cohort and 50% in the CLL cohort); the majority of responses were partial responses. Notably, the rate was 31% among the subset of patients who had rituximab-refractory disease.

The median duration of response to ublituximab was 9.2 months, and the median progression-free survival was 7.7 months.

“Anti-CD20 therapy has demonstrated the greatest benefit in combination, traditionally with multidrug chemotherapy–based regimens,” the investigators noted. “While the introduction of novel targeted therapies has shifted the treatment paradigm of CLL and indolent lymphoma, the activity of these agents is likely to be potentiated by the addition of an anti-CD20 [monoclonal antibody], given their different mechanisms of action.”

In fact, several multidrug, non–chemotherapy-based regimens are showing promising efficacy and milder toxicity in early trials, they pointed out. “In similar fashion, ublituximab is being evaluated for the treatment of NHL or CLL in combination with other agents,” such as the immunomodulator lenalidomide (Revlimid) and the Bruton tyrosine kinase inhibitor ibrutinib (Imbruvica).

TG Therapeutics funded the trial. Dr. Sawas disclosed that he receives research funds from TG Therapeutics.

[email protected]

The investigational anti-CD20 monoclonal antibody ublituximab is safe and has good antitumor activity in patients with B-cell non-Hodgkin lymphoma (B-NHL) or chronic lymphocytic leukemia (CLL) who have previously received the anti-CD20 antibody rituximab, results from a phase I/II trial suggest.

Ublituximab is engineered to have a low fucose content. This feature gives it enhanced antibody-dependent cellular cytotoxicity relative to other anti-CD20 antibodies, especially against tumors having low expression of that protein, as may occur in the development of rituximab resistance.

In the trial, nearly half of the 35 patients studied had a complete or partial response to ublituximab, including nearly one-third of those whose disease was refractory to rituximab (Rituxan) (Br J Haematol. 2017 Apr;177[2]:243-53). The main adverse events were infusion-related reactions, fatigue, pyrexia, and diarrhea, but almost all were lower grade.

“Ublituximab was well tolerated and efficacious in a heterogeneous and highly rituximab–pretreated patient population,” said the investigators, who were led by Ahmed Sawas, MD, at the Center for Lymphoid Malignancies, Columbia University Medical Center, N.Y.

The observed response rate is much the same as those seen with two other anti-CD20 antibodies – obinutuzumab (Gazyva)and ofatumumab (Arzerra)– in similar patient populations, and ublituximab may have advantages in terms of fewer higher-grade infusion-related reactions and shorter infusion time.

“Enhanced anti-CD20 [monoclonal antibodies] that are well tolerated and active in rituximab-resistant disease can provide meaningful clinical benefit to patients with limited treatment options,” the investigators noted.

The trial enrolled 27 patients with B-NHL and 8 patients with CLL (or small lymphocytic lymphoma) who had rituximab-refractory disease (defined by progression on or within 6 months of receiving that agent) or rituximab-relapsed disease (defined by progression more than 6 months after receiving it). They had received a median of three prior therapies.

The patients were treated on an open-label basis with ublituximab at various doses as induction therapy (3-4 weekly infusions during cycles 1 and 2) and then as maintenance therapy (monthly during cycles 3-5, then once every 3 months for up to 2 years). All patients received an oral antihistamine and steroids before infusions.

By the end of the trial, 60% of patients had discontinued treatment because of progression; 23% had discontinued because of adverse events, physician decision, or other reasons; and the remaining 17% had received all planned treatment, Dr. Sawas and his coinvestigators reported.

None of the patients experienced dose-limiting toxicities or unexpected adverse events. The rate of any-grade adverse events was 100%, and the rate specifically of grade 3/4 adverse events was 49%. The rate of serious adverse events (most commonly pneumonia) was 37%.

The leading nonhematologic adverse events were infusion-related reactions (40%; grade 3/4, 0%), fatigue (37%; grade 3/4, 3%), pyrexia (29%; grade 3/4, 0%), and diarrhea (26%; grade 3/4, 0%).

The leading hematologic adverse events were neutropenia (14%; grade 3/4, 14%), with no associated infections; anemia (11%; grade 3/4, 6%); and thrombocytopenia (6%; grade 3/4, 6%), with no associated bleeding.

The overall response rate was 45% (44% in the B-NHL cohort and 50% in the CLL cohort); the majority of responses were partial responses. Notably, the rate was 31% among the subset of patients who had rituximab-refractory disease.

The median duration of response to ublituximab was 9.2 months, and the median progression-free survival was 7.7 months.

“Anti-CD20 therapy has demonstrated the greatest benefit in combination, traditionally with multidrug chemotherapy–based regimens,” the investigators noted. “While the introduction of novel targeted therapies has shifted the treatment paradigm of CLL and indolent lymphoma, the activity of these agents is likely to be potentiated by the addition of an anti-CD20 [monoclonal antibody], given their different mechanisms of action.”

In fact, several multidrug, non–chemotherapy-based regimens are showing promising efficacy and milder toxicity in early trials, they pointed out. “In similar fashion, ublituximab is being evaluated for the treatment of NHL or CLL in combination with other agents,” such as the immunomodulator lenalidomide (Revlimid) and the Bruton tyrosine kinase inhibitor ibrutinib (Imbruvica).

TG Therapeutics funded the trial. Dr. Sawas disclosed that he receives research funds from TG Therapeutics.

[email protected]

The large majority of women who start using a long-acting reversible contraceptive (LARC) find it acceptable and cost effective enough to continue using the method for at least 2 years, findings from a retrospective cohort study suggest.

Investigators performed a chart review to assess continuation rates in a real-world, mixed-payer setting among 8,603 women aged 15-44 years who had a device inserted between 2004 and 2012 at the University of Utah Healthcare System.

flocu/ThinkStock

The large majority of women who start using a long-acting reversible contraceptive (LARC) find it acceptable and cost effective enough to continue using the method for at least 2 years, findings from a retrospective cohort study suggest.

Investigators performed a chart review to assess continuation rates in a real-world, mixed-payer setting among 8,603 women aged 15-44 years who had a device inserted between 2004 and 2012 at the University of Utah Healthcare System.

flocu/ThinkStock

The large majority of women who start using a long-acting reversible contraceptive (LARC) find it acceptable and cost effective enough to continue using the method for at least 2 years, findings from a retrospective cohort study suggest.

Investigators performed a chart review to assess continuation rates in a real-world, mixed-payer setting among 8,603 women aged 15-44 years who had a device inserted between 2004 and 2012 at the University of Utah Healthcare System.

flocu/ThinkStock