FDA approves ibrutinib-rituximab combo for newly diagnosed CLL, SLL in adults

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The Food and Drug Administration has expanded the indication for ibrutinib (Imbruvica) to allow its combination with rituximab for frontline treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults.

The approval, announced April 21, was based on findings from the randomized, controlled, open-label, phase 3 E1912 trial of 529 patients, which demonstrated significantly improved progression-free survival (PFS) among those who received ibrutinib plus rituximab, compared with those who received fludarabine, cyclophosphamide, and rituximab (FCR) (87% vs. 75%; hazard ratio, 0.34). Median PFS was not reached in either arm after a median follow-up of 37 months.

E1912 was the first study to show superiority of a chemotherapy-free regimen over FCR chemoimmunotherapy, considered the gold standard for newly diagnosed CLL and SLL for the past 2 decades.

The recommended dosage for the newly approved combination is a once-daily 420-mg dose of ibrutinib taken with a glass of water, with rituximab initiation in the second cycle at doses of 50 mg/m2 on day 1, 325 mg/m2 on day 2, and 500 mg/m2 on days 1-5 of subsequent cycles for a total of six cycles.

This approval marks the 11th for ibrutinib across six disease areas, and its 6th in CLL.

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The Food and Drug Administration has expanded the indication for ibrutinib (Imbruvica) to allow its combination with rituximab for frontline treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults.

The approval, announced April 21, was based on findings from the randomized, controlled, open-label, phase 3 E1912 trial of 529 patients, which demonstrated significantly improved progression-free survival (PFS) among those who received ibrutinib plus rituximab, compared with those who received fludarabine, cyclophosphamide, and rituximab (FCR) (87% vs. 75%; hazard ratio, 0.34). Median PFS was not reached in either arm after a median follow-up of 37 months.

E1912 was the first study to show superiority of a chemotherapy-free regimen over FCR chemoimmunotherapy, considered the gold standard for newly diagnosed CLL and SLL for the past 2 decades.

The recommended dosage for the newly approved combination is a once-daily 420-mg dose of ibrutinib taken with a glass of water, with rituximab initiation in the second cycle at doses of 50 mg/m2 on day 1, 325 mg/m2 on day 2, and 500 mg/m2 on days 1-5 of subsequent cycles for a total of six cycles.

This approval marks the 11th for ibrutinib across six disease areas, and its 6th in CLL.

The Food and Drug Administration has expanded the indication for ibrutinib (Imbruvica) to allow its combination with rituximab for frontline treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults.

The approval, announced April 21, was based on findings from the randomized, controlled, open-label, phase 3 E1912 trial of 529 patients, which demonstrated significantly improved progression-free survival (PFS) among those who received ibrutinib plus rituximab, compared with those who received fludarabine, cyclophosphamide, and rituximab (FCR) (87% vs. 75%; hazard ratio, 0.34). Median PFS was not reached in either arm after a median follow-up of 37 months.

E1912 was the first study to show superiority of a chemotherapy-free regimen over FCR chemoimmunotherapy, considered the gold standard for newly diagnosed CLL and SLL for the past 2 decades.

The recommended dosage for the newly approved combination is a once-daily 420-mg dose of ibrutinib taken with a glass of water, with rituximab initiation in the second cycle at doses of 50 mg/m2 on day 1, 325 mg/m2 on day 2, and 500 mg/m2 on days 1-5 of subsequent cycles for a total of six cycles.

This approval marks the 11th for ibrutinib across six disease areas, and its 6th in CLL.

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REACH2: Ruxolitinib outperformed control treatment for refractory acute GVHD

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Wed, 04/22/2020 - 18:15

Ruxolitinib produced significantly better efficacy outcomes in patients with glucocorticoid-refractory acute graft-versus-host disease (GVHD), compared with investigator’s choice of control therapy, in the phase 3 REACH2 trial.

However, there was a higher incidence of thrombocytopenia with ruxolitinib than with control treatment, according to a report by Robert Zeiser, MD, of University of Freiburg (Germany) and colleagues on behalf of the REACH2 research group. The report was published in the New England Journal of Medicine.

The REACH2 trial (NCT02913261) is a randomized, open-label, phase 3 trial comparing the efficacy and safety of oral ruxolitinib (10 mg twice daily) with investigator’s choice of therapy for control treatment using a list of nine commonly used options.

Patients were 12 years of age or older with glucocorticoid-refractory acute GVHD after allogeneic stem cell transplant. A total of 154 patients were assigned to the ruxolitinib group, and 155 patients were in the control group.

Most patients – 152 in the ruxolitinib group and 150 in the control group – received at least one dose of trial treatment.

Treatment discontinuation occurred in 72% (111/154) of patients in the ruxolitinib group and in 85% (132/155) of those in the control group. The most common reason for discontinuation was lack of efficacy (in 21% and 44%, respectively).
 

Outcomes

The overall response at day 28 (the primary endpoint) was significantly higher in the ruxolitinib group than in the control group (62% vs. 39%; odds ratio, 2.64; P < .001). The durable overall response at day 56 was also significantly higher in the ruxolitinib group than in the control group (40% vs. 22%; OR, 2.38; P < .001).

The estimated cumulative incidence of loss of response at 6 months was 10% in the ruxolitinib group compared with 39% in the control group.

The median failure-free survival was considerably longer with ruxolitinib than with control treatment (5.0 months vs. 1.0 month; hazard ratio for relapse or progression of hematologic disease, non–relapse-related death, or the use of new systemic therapy for acute GVHD, 0.46).

The median overall survival was 11.1 months in the ruxolitinib group and 6.5 months in the control group (HR, 0.83).

Overall, 72 patients (47%) in the ruxolitinib group and 77 (51%) in the control group died by the data cutoff date. Most deaths were attributed to acute GVHD (22% in the ruxolitinib group and 25% in the control group).

The most common adverse events at day 28 (in the ruxolitinib and control arms, respectively) were thrombocytopenia (33% and 18%), anemia (30% and 28%), and cytomegalovirus infection (26% and 21%).
 

Praise for ‘successful’ randomized trial in GVHD

“The authors are to be congratulated for completing this successful randomized trial, which showed convincingly that ruxolitinib was more effective than the investigator’s choice of therapy ... in patients in whom glucocorticoid therapy had failed,” wrote Nelson Chao, MD, of Duke University in Durham, N.C., in his invited editorial.

He went on to speculate on the possible mechanism for ruxolitinib in these patients, discussing the possible role of the STAT3 and STAT1 signaling pathways.

Dr. Chao also found it “interesting that the incidence of infectious complications or relapse was apparently not greater with ruxolitinib than with control therapy,” but he noted that the total follow-up time was short.

“As with all good research, these observations raise important questions and set the stage for further work in this area,” he concluded.

The REACH2 trial was funded by Novartis. The study authors disclosed relationships with a variety of pharmaceutical companies, including Novartis. Dr. Chao reported having no relevant disclosures.

SOURCE: Zeiser R et al. N Engl J Med. 2020. doi: 10.1056/NEJMoa1917635.

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Ruxolitinib produced significantly better efficacy outcomes in patients with glucocorticoid-refractory acute graft-versus-host disease (GVHD), compared with investigator’s choice of control therapy, in the phase 3 REACH2 trial.

However, there was a higher incidence of thrombocytopenia with ruxolitinib than with control treatment, according to a report by Robert Zeiser, MD, of University of Freiburg (Germany) and colleagues on behalf of the REACH2 research group. The report was published in the New England Journal of Medicine.

The REACH2 trial (NCT02913261) is a randomized, open-label, phase 3 trial comparing the efficacy and safety of oral ruxolitinib (10 mg twice daily) with investigator’s choice of therapy for control treatment using a list of nine commonly used options.

Patients were 12 years of age or older with glucocorticoid-refractory acute GVHD after allogeneic stem cell transplant. A total of 154 patients were assigned to the ruxolitinib group, and 155 patients were in the control group.

Most patients – 152 in the ruxolitinib group and 150 in the control group – received at least one dose of trial treatment.

Treatment discontinuation occurred in 72% (111/154) of patients in the ruxolitinib group and in 85% (132/155) of those in the control group. The most common reason for discontinuation was lack of efficacy (in 21% and 44%, respectively).
 

Outcomes

The overall response at day 28 (the primary endpoint) was significantly higher in the ruxolitinib group than in the control group (62% vs. 39%; odds ratio, 2.64; P < .001). The durable overall response at day 56 was also significantly higher in the ruxolitinib group than in the control group (40% vs. 22%; OR, 2.38; P < .001).

The estimated cumulative incidence of loss of response at 6 months was 10% in the ruxolitinib group compared with 39% in the control group.

The median failure-free survival was considerably longer with ruxolitinib than with control treatment (5.0 months vs. 1.0 month; hazard ratio for relapse or progression of hematologic disease, non–relapse-related death, or the use of new systemic therapy for acute GVHD, 0.46).

The median overall survival was 11.1 months in the ruxolitinib group and 6.5 months in the control group (HR, 0.83).

Overall, 72 patients (47%) in the ruxolitinib group and 77 (51%) in the control group died by the data cutoff date. Most deaths were attributed to acute GVHD (22% in the ruxolitinib group and 25% in the control group).

The most common adverse events at day 28 (in the ruxolitinib and control arms, respectively) were thrombocytopenia (33% and 18%), anemia (30% and 28%), and cytomegalovirus infection (26% and 21%).
 

Praise for ‘successful’ randomized trial in GVHD

“The authors are to be congratulated for completing this successful randomized trial, which showed convincingly that ruxolitinib was more effective than the investigator’s choice of therapy ... in patients in whom glucocorticoid therapy had failed,” wrote Nelson Chao, MD, of Duke University in Durham, N.C., in his invited editorial.

He went on to speculate on the possible mechanism for ruxolitinib in these patients, discussing the possible role of the STAT3 and STAT1 signaling pathways.

Dr. Chao also found it “interesting that the incidence of infectious complications or relapse was apparently not greater with ruxolitinib than with control therapy,” but he noted that the total follow-up time was short.

“As with all good research, these observations raise important questions and set the stage for further work in this area,” he concluded.

The REACH2 trial was funded by Novartis. The study authors disclosed relationships with a variety of pharmaceutical companies, including Novartis. Dr. Chao reported having no relevant disclosures.

SOURCE: Zeiser R et al. N Engl J Med. 2020. doi: 10.1056/NEJMoa1917635.

Ruxolitinib produced significantly better efficacy outcomes in patients with glucocorticoid-refractory acute graft-versus-host disease (GVHD), compared with investigator’s choice of control therapy, in the phase 3 REACH2 trial.

However, there was a higher incidence of thrombocytopenia with ruxolitinib than with control treatment, according to a report by Robert Zeiser, MD, of University of Freiburg (Germany) and colleagues on behalf of the REACH2 research group. The report was published in the New England Journal of Medicine.

The REACH2 trial (NCT02913261) is a randomized, open-label, phase 3 trial comparing the efficacy and safety of oral ruxolitinib (10 mg twice daily) with investigator’s choice of therapy for control treatment using a list of nine commonly used options.

Patients were 12 years of age or older with glucocorticoid-refractory acute GVHD after allogeneic stem cell transplant. A total of 154 patients were assigned to the ruxolitinib group, and 155 patients were in the control group.

Most patients – 152 in the ruxolitinib group and 150 in the control group – received at least one dose of trial treatment.

Treatment discontinuation occurred in 72% (111/154) of patients in the ruxolitinib group and in 85% (132/155) of those in the control group. The most common reason for discontinuation was lack of efficacy (in 21% and 44%, respectively).
 

Outcomes

The overall response at day 28 (the primary endpoint) was significantly higher in the ruxolitinib group than in the control group (62% vs. 39%; odds ratio, 2.64; P < .001). The durable overall response at day 56 was also significantly higher in the ruxolitinib group than in the control group (40% vs. 22%; OR, 2.38; P < .001).

The estimated cumulative incidence of loss of response at 6 months was 10% in the ruxolitinib group compared with 39% in the control group.

The median failure-free survival was considerably longer with ruxolitinib than with control treatment (5.0 months vs. 1.0 month; hazard ratio for relapse or progression of hematologic disease, non–relapse-related death, or the use of new systemic therapy for acute GVHD, 0.46).

The median overall survival was 11.1 months in the ruxolitinib group and 6.5 months in the control group (HR, 0.83).

Overall, 72 patients (47%) in the ruxolitinib group and 77 (51%) in the control group died by the data cutoff date. Most deaths were attributed to acute GVHD (22% in the ruxolitinib group and 25% in the control group).

The most common adverse events at day 28 (in the ruxolitinib and control arms, respectively) were thrombocytopenia (33% and 18%), anemia (30% and 28%), and cytomegalovirus infection (26% and 21%).
 

Praise for ‘successful’ randomized trial in GVHD

“The authors are to be congratulated for completing this successful randomized trial, which showed convincingly that ruxolitinib was more effective than the investigator’s choice of therapy ... in patients in whom glucocorticoid therapy had failed,” wrote Nelson Chao, MD, of Duke University in Durham, N.C., in his invited editorial.

He went on to speculate on the possible mechanism for ruxolitinib in these patients, discussing the possible role of the STAT3 and STAT1 signaling pathways.

Dr. Chao also found it “interesting that the incidence of infectious complications or relapse was apparently not greater with ruxolitinib than with control therapy,” but he noted that the total follow-up time was short.

“As with all good research, these observations raise important questions and set the stage for further work in this area,” he concluded.

The REACH2 trial was funded by Novartis. The study authors disclosed relationships with a variety of pharmaceutical companies, including Novartis. Dr. Chao reported having no relevant disclosures.

SOURCE: Zeiser R et al. N Engl J Med. 2020. doi: 10.1056/NEJMoa1917635.

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Key clinical point: Ruxolitinib was significantly more effective against acute graft-versus-host disease than was control treatment.

Major finding: The overall response at day 28 was significantly higher in the ruxolitinib group than in the control group (62% vs. 39%; P < .001).

Study details: Phase 3 trial of 154 patients randomized to ruxolitinib and 155 patients randomized to investigator’s choice of control therapy.

Disclosures: The trial was funded by Novartis. Authors disclosed relationships with a variety of pharmaceutical companies, including Novartis.

Source: Zeiser R et al. N Engl J Med. 2020. doi: 10.1056/NEJMoa1917635.

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Five prognostic indexes come up short for planning early CLL treatment

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Fri, 12/16/2022 - 11:32

 

Prognostic indexes have been developed recently to assess time to first treatment in early-stage chronic lymphocytic leukemia (CLL) patients. However, none of five indexes evaluated in a study showed more than a moderate prognostic value or were precise enough to permit clinical decisions to be made, according to a report by Spanish researchers.

Their study, published in Clinical Lymphoma, Myeloma and Leukemia, examined the comparative prognostic value of five prognostic indexes – the CLL-IPI, the Barcelona-Brno, the IPS-A, the CLL-01, and the Tailored approach – on evaluating 428 Binet A CLL patients from a multicenter Spanish database which contained the relevant necessary clinical and biological information. The predictive value of the scores was assessed with Harrell´s C index and receiver operating characteristic curve (area under the curve, AUC).

The researchers found a significant association between time to first treatment and risk subgroups for all the indexes used. The most accurate index was the IPS-A (Harrell´s C, 0.72; AUC, 0.76), followed by the CLL-01 (Harrell´s C, 0.69; AUC, 0.70), the CLL-IPI (Harrell´s C, .69; AUC, 0.69), the Barcelona-Brno (Harrell´s C: 0.67, AUC, 0.69) and the Tailored approach (Harrell´s C, 0.61 and 0.58, AUCs, 0.58 and 0.54).

However, the concordance between four of the five indexes (the Tailored approach was not included for technical reasons) compared was low (44%): 146 cases were classified as low risk with all four indexes tested, 36 as intermediate risk, and 4 as high risk. In the remaining 242 patients (56%) at least one discrepancy was detected in the allocation among prognostic subgroups between the indexes. However, only 12 patients (3%) were allocated as low and high risk at the same time with different indexes, showing the extremes of the discordance.

These data suggest that, although all of these indexes “significantly improve clinical staging and help physicians in routine clinical practice, it is necessary to harmonize larger cohorts of patients in order to define the best index for treatment decision making in the real world,” the authors stated.

“All the models had a moderate prognostic value to predict time to first therapy. ... None of them was precise enough to allow clinical decisions based exclusively on it,” the authors concluded.

The study was supported by grants from the Spanish government and a variety of nonprofit institutions. The authors reported no commercial disclosures.

SOURCE: Gascon y Marín IG et al. Clin Lymphoma Myeloma Leuk. 2020 Apr 13. doi: 10.1016/j.clml.2020.03.003.

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Prognostic indexes have been developed recently to assess time to first treatment in early-stage chronic lymphocytic leukemia (CLL) patients. However, none of five indexes evaluated in a study showed more than a moderate prognostic value or were precise enough to permit clinical decisions to be made, according to a report by Spanish researchers.

Their study, published in Clinical Lymphoma, Myeloma and Leukemia, examined the comparative prognostic value of five prognostic indexes – the CLL-IPI, the Barcelona-Brno, the IPS-A, the CLL-01, and the Tailored approach – on evaluating 428 Binet A CLL patients from a multicenter Spanish database which contained the relevant necessary clinical and biological information. The predictive value of the scores was assessed with Harrell´s C index and receiver operating characteristic curve (area under the curve, AUC).

The researchers found a significant association between time to first treatment and risk subgroups for all the indexes used. The most accurate index was the IPS-A (Harrell´s C, 0.72; AUC, 0.76), followed by the CLL-01 (Harrell´s C, 0.69; AUC, 0.70), the CLL-IPI (Harrell´s C, .69; AUC, 0.69), the Barcelona-Brno (Harrell´s C: 0.67, AUC, 0.69) and the Tailored approach (Harrell´s C, 0.61 and 0.58, AUCs, 0.58 and 0.54).

However, the concordance between four of the five indexes (the Tailored approach was not included for technical reasons) compared was low (44%): 146 cases were classified as low risk with all four indexes tested, 36 as intermediate risk, and 4 as high risk. In the remaining 242 patients (56%) at least one discrepancy was detected in the allocation among prognostic subgroups between the indexes. However, only 12 patients (3%) were allocated as low and high risk at the same time with different indexes, showing the extremes of the discordance.

These data suggest that, although all of these indexes “significantly improve clinical staging and help physicians in routine clinical practice, it is necessary to harmonize larger cohorts of patients in order to define the best index for treatment decision making in the real world,” the authors stated.

“All the models had a moderate prognostic value to predict time to first therapy. ... None of them was precise enough to allow clinical decisions based exclusively on it,” the authors concluded.

The study was supported by grants from the Spanish government and a variety of nonprofit institutions. The authors reported no commercial disclosures.

SOURCE: Gascon y Marín IG et al. Clin Lymphoma Myeloma Leuk. 2020 Apr 13. doi: 10.1016/j.clml.2020.03.003.

 

Prognostic indexes have been developed recently to assess time to first treatment in early-stage chronic lymphocytic leukemia (CLL) patients. However, none of five indexes evaluated in a study showed more than a moderate prognostic value or were precise enough to permit clinical decisions to be made, according to a report by Spanish researchers.

Their study, published in Clinical Lymphoma, Myeloma and Leukemia, examined the comparative prognostic value of five prognostic indexes – the CLL-IPI, the Barcelona-Brno, the IPS-A, the CLL-01, and the Tailored approach – on evaluating 428 Binet A CLL patients from a multicenter Spanish database which contained the relevant necessary clinical and biological information. The predictive value of the scores was assessed with Harrell´s C index and receiver operating characteristic curve (area under the curve, AUC).

The researchers found a significant association between time to first treatment and risk subgroups for all the indexes used. The most accurate index was the IPS-A (Harrell´s C, 0.72; AUC, 0.76), followed by the CLL-01 (Harrell´s C, 0.69; AUC, 0.70), the CLL-IPI (Harrell´s C, .69; AUC, 0.69), the Barcelona-Brno (Harrell´s C: 0.67, AUC, 0.69) and the Tailored approach (Harrell´s C, 0.61 and 0.58, AUCs, 0.58 and 0.54).

However, the concordance between four of the five indexes (the Tailored approach was not included for technical reasons) compared was low (44%): 146 cases were classified as low risk with all four indexes tested, 36 as intermediate risk, and 4 as high risk. In the remaining 242 patients (56%) at least one discrepancy was detected in the allocation among prognostic subgroups between the indexes. However, only 12 patients (3%) were allocated as low and high risk at the same time with different indexes, showing the extremes of the discordance.

These data suggest that, although all of these indexes “significantly improve clinical staging and help physicians in routine clinical practice, it is necessary to harmonize larger cohorts of patients in order to define the best index for treatment decision making in the real world,” the authors stated.

“All the models had a moderate prognostic value to predict time to first therapy. ... None of them was precise enough to allow clinical decisions based exclusively on it,” the authors concluded.

The study was supported by grants from the Spanish government and a variety of nonprofit institutions. The authors reported no commercial disclosures.

SOURCE: Gascon y Marín IG et al. Clin Lymphoma Myeloma Leuk. 2020 Apr 13. doi: 10.1016/j.clml.2020.03.003.

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European cancer centers restructure care in the era of COVID-19

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Thu, 12/15/2022 - 17:37

Delivering cancer care during the COVID-19 pandemic has proved particularly challenging, as minimizing the risk of infection must be balanced with maintaining optimal outcomes.

Healthcare systems and oncologists have had to reorganize standard oncologic care in order to protect vulnerable patients from exposure to COVID-19 as well as deal with pandemic-related issues of equipment and staffing shortages.

A new article now describes how seven cancer centers in Europe rapidly reorganized their oncologic services and are tackling this crisis, as well as offering guidance to other institutions.

This was a major undertaking, to work out a system where patients can still get care but in a safer manner, explained coauthor Emile Voest, MD, medical director of the Netherlands Cancer Institute in Amsterdam.

“Decisions needed to be taken based on availability of personnel, protective materials, and urgencies,” he told Medscape Medical News. “Because every country had its own speed of development of the COVID pandemic, there were different scenarios in all institutions, but all with a common factor of key expertise on how to de-escalate in a safe manner.”

The article was published April 16 in Nature Medicine.

The Netherlands Cancer Institute (the Netherlands), Karolinska Institute (Sweden), Institute Gustave Roussy (France), Cambridge Cancer Center (United Kingdom), Istituto Nazionale dei Tumori di Milano (Italy), German Cancer Research Center (Germany), and Vall d’Hebron Institute of Oncology (Spain) have been working closely together in a legal entity since 2014, and have created ‘Cancer Core Europe’ (CCE). The goal is to “maximize coherence and critical mass in cancer research,” the authors note.

The consortium represents roughly 60,000 patients with newly diagnosed cancer, delivers approximately 300,000 treatment courses, and conducts about 1.2 million consultations annually, with more than 1,500 ongoing clinical trials. In a joint effort, the centers collected, translated, and compared the guidelines that had been put in place to treat patients with cancer during the COVID-19 pandemic.

Cancer treatment is multidisciplinary and involves many specialties including surgery, radiology, pathology, radiation oncology, and medical oncology. Coordinating care among disciplines is a very complex process, Voest noted.

“Changing treatment also means that you need to reconsider capacities and requirements,” he said. “Hospitals have installed crisis teams that were very good at coordinating these efforts.”
 

Restructuring care

Cancer care had to be reorganized on multiple levels, and the CCE centers looked at several aspects that needed to be accounted for, to ensure continuity in cancer care.

“The biggest challenge for the NHS and other healthcare systems is the surge of patients requiring oxygen and/or intensive care, and the nature and infectiousness of the virus,” said coauthor Carlos Caldas, MD, FMedSci, professor of cancer medicine at the University of Cambridge, United Kingdom. “In hospitals that are mostly run close to capacity, and where all kinds of patients are treated, this has created major resource and logistical problems.”

For regular clinical activities, the institutions with dedicated cancer centers (German Cancer Research Center, Institute Gustave Roussy, Istituto Nazionale dei Tumori di Milano, and Netherlands Cancer Institute) have attempted to stay COVID-19 free. This policy would in turn help ensure that sufficient clinical and intensive-care capacity could be reserved for critical cancer surgeries or management of treatment-related side effects, and allow hospitals outside of the CCE to transfer patients with cancer to these centers. The general hospitals can then focus on caring for patients with COVID-19, as well as other illnesses/injuries that require inpatient care.

As the CCE centers located within general hospitals (Cambridge Cancer Center, Vall d’Hebron Institute of Oncology and Karolinska Institute) have to admit patients with suspected and positive cases of COVID-19, being “COVID-19 free” was never a realistic or pursued goal.

The authors note that it is the responsibility of all healthcare professionals to ensure patients are not exposed to COVID-19, and this has meant minimizing hospital visits and person-to-person contact. For example, whenever possible, consultations take place via telephone calls or over the Internet, and nonurgent appointments that would require a patient’s physical presence at the clinic have been postponed. Visitors are also not permitted to accompany patients when admitted to the hospital or during procedures.

Standard-of-care treatment regimens have been adapted across all centers to minimize the number of hospital visits and hospitalizations and prevent “anticancer treatment-induced” complications of COVID-19.

To minimize visits and hospitalizations, strategies include converting intravenous treatments to oral or subcutaneous regimens when possible; switching from cytotoxic chemotherapy to a less-toxic approach to minimize the risk of complications requiring hospitalization; or to pause therapies when possible (stable disease reached or better). In addition, nonemergency surgeries have been postponed or replaced by radiotherapy.

To prevent anticancer treatment-induced complications of COVID-19, most centers use the paradigm that the added benefit for tumor control should be weighed against the potential risk for COVID-19–related morbidity and mortality. To prevent or reduce the risk of neutropenia and lymphopenia, for example, all centers have suggested a de-escalation of cytotoxic chemotherapy or targeted treatment strategies, or to forgo second or subsequent lines of palliative treatments if response rates from up-front therapy are low.

Some of these changes may be here to stay, noted Caldas. “One of the positive messages that comes out of this is that, clearly, care can be delivered in a safe and compassionate manner without requiring as many hospital visits as in the pre-COVID-19 era,” he said. “In the future, we will take heed of the COVID-19 experience to improve delivery of cancer care.”
 

 

 

Capacity of facilities

Many healthcare systems have become overwhelmed as the pandemic has intensified, thus making it necessary to prioritize. To prepare for this possibility, CCE centers have established protocols to categorize and prioritize patients for systemic treatment or surgery. While the protocols vary by center, they are comparable with one another as they prioritize on the basis of anticipated treatment outcome, the authors note.

The guidelines in CCE centers unanimously recommend that neoadjuvant therapies and curative surgeries be the top priority, for the times when operating room and/or ICU capacity is limited. As an alternative, neoadjuvant systemic treatments may be initiated or extended to postpone surgery, and other nonsurgical interventions can be considered.

In addition, some centers agree that certain elective surgeries can be safely delayed if backed by scientific evidence. As an example, an 11-week deferment of surgery may be acceptable for patients with rectal cancer after downstaging.

Cancer centers may also need to upscale and downscale quickly, depending on how the pandemic evolves, and many have already outlined scenarios to prepare for increasing or decreasing their capacity using phased approaches.

The Netherlands Cancer Institute, for example, has defined four phases of increasing severity; in Germany, capacity planning has been coordinated among 18 hospitals and the federal ministry of health, in order to prevent shortages of cancer services.

“We note that the optimal downscaling strategies depend on country- and center-specific capacities and preferences,” they write. “Therefore, it is difficult to propose a common schedule, and it will be most effective if hospitals outline their own phase-specific downscaling strategies based on the prioritization schemes and practical handles discussed above.”
 

Future research

Better strategies will be needed to reduce the impact of COVID-19 in cancer care, and four research priorities were identified to allow for evidence-based adjustments of cancer care protocols while the pandemic continues:

  • Collect real-world data about the effects of adjustment and de-escalation of treatment regimens on outcomes
  • Determine the incidence of COVID-19 in both the general population and among patients with cancer who have received systemic therapies, with large-scale serological testing
  • Develop an epidemiological model that will allow estimates of the cumulative incidence of COVID-19 for a patient with cancer, within a specific time frame
  • Determine COVID-19 related morbidity and mortality in patients with cancer who have been treated with systemic therapies and/or granulocyte colony-stimulating factor (G-CSF). Several projects are currently underway, such as the UK Coronavirus Cancer Monitoring Project.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

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Delivering cancer care during the COVID-19 pandemic has proved particularly challenging, as minimizing the risk of infection must be balanced with maintaining optimal outcomes.

Healthcare systems and oncologists have had to reorganize standard oncologic care in order to protect vulnerable patients from exposure to COVID-19 as well as deal with pandemic-related issues of equipment and staffing shortages.

A new article now describes how seven cancer centers in Europe rapidly reorganized their oncologic services and are tackling this crisis, as well as offering guidance to other institutions.

This was a major undertaking, to work out a system where patients can still get care but in a safer manner, explained coauthor Emile Voest, MD, medical director of the Netherlands Cancer Institute in Amsterdam.

“Decisions needed to be taken based on availability of personnel, protective materials, and urgencies,” he told Medscape Medical News. “Because every country had its own speed of development of the COVID pandemic, there were different scenarios in all institutions, but all with a common factor of key expertise on how to de-escalate in a safe manner.”

The article was published April 16 in Nature Medicine.

The Netherlands Cancer Institute (the Netherlands), Karolinska Institute (Sweden), Institute Gustave Roussy (France), Cambridge Cancer Center (United Kingdom), Istituto Nazionale dei Tumori di Milano (Italy), German Cancer Research Center (Germany), and Vall d’Hebron Institute of Oncology (Spain) have been working closely together in a legal entity since 2014, and have created ‘Cancer Core Europe’ (CCE). The goal is to “maximize coherence and critical mass in cancer research,” the authors note.

The consortium represents roughly 60,000 patients with newly diagnosed cancer, delivers approximately 300,000 treatment courses, and conducts about 1.2 million consultations annually, with more than 1,500 ongoing clinical trials. In a joint effort, the centers collected, translated, and compared the guidelines that had been put in place to treat patients with cancer during the COVID-19 pandemic.

Cancer treatment is multidisciplinary and involves many specialties including surgery, radiology, pathology, radiation oncology, and medical oncology. Coordinating care among disciplines is a very complex process, Voest noted.

“Changing treatment also means that you need to reconsider capacities and requirements,” he said. “Hospitals have installed crisis teams that were very good at coordinating these efforts.”
 

Restructuring care

Cancer care had to be reorganized on multiple levels, and the CCE centers looked at several aspects that needed to be accounted for, to ensure continuity in cancer care.

“The biggest challenge for the NHS and other healthcare systems is the surge of patients requiring oxygen and/or intensive care, and the nature and infectiousness of the virus,” said coauthor Carlos Caldas, MD, FMedSci, professor of cancer medicine at the University of Cambridge, United Kingdom. “In hospitals that are mostly run close to capacity, and where all kinds of patients are treated, this has created major resource and logistical problems.”

For regular clinical activities, the institutions with dedicated cancer centers (German Cancer Research Center, Institute Gustave Roussy, Istituto Nazionale dei Tumori di Milano, and Netherlands Cancer Institute) have attempted to stay COVID-19 free. This policy would in turn help ensure that sufficient clinical and intensive-care capacity could be reserved for critical cancer surgeries or management of treatment-related side effects, and allow hospitals outside of the CCE to transfer patients with cancer to these centers. The general hospitals can then focus on caring for patients with COVID-19, as well as other illnesses/injuries that require inpatient care.

As the CCE centers located within general hospitals (Cambridge Cancer Center, Vall d’Hebron Institute of Oncology and Karolinska Institute) have to admit patients with suspected and positive cases of COVID-19, being “COVID-19 free” was never a realistic or pursued goal.

The authors note that it is the responsibility of all healthcare professionals to ensure patients are not exposed to COVID-19, and this has meant minimizing hospital visits and person-to-person contact. For example, whenever possible, consultations take place via telephone calls or over the Internet, and nonurgent appointments that would require a patient’s physical presence at the clinic have been postponed. Visitors are also not permitted to accompany patients when admitted to the hospital or during procedures.

Standard-of-care treatment regimens have been adapted across all centers to minimize the number of hospital visits and hospitalizations and prevent “anticancer treatment-induced” complications of COVID-19.

To minimize visits and hospitalizations, strategies include converting intravenous treatments to oral or subcutaneous regimens when possible; switching from cytotoxic chemotherapy to a less-toxic approach to minimize the risk of complications requiring hospitalization; or to pause therapies when possible (stable disease reached or better). In addition, nonemergency surgeries have been postponed or replaced by radiotherapy.

To prevent anticancer treatment-induced complications of COVID-19, most centers use the paradigm that the added benefit for tumor control should be weighed against the potential risk for COVID-19–related morbidity and mortality. To prevent or reduce the risk of neutropenia and lymphopenia, for example, all centers have suggested a de-escalation of cytotoxic chemotherapy or targeted treatment strategies, or to forgo second or subsequent lines of palliative treatments if response rates from up-front therapy are low.

Some of these changes may be here to stay, noted Caldas. “One of the positive messages that comes out of this is that, clearly, care can be delivered in a safe and compassionate manner without requiring as many hospital visits as in the pre-COVID-19 era,” he said. “In the future, we will take heed of the COVID-19 experience to improve delivery of cancer care.”
 

 

 

Capacity of facilities

Many healthcare systems have become overwhelmed as the pandemic has intensified, thus making it necessary to prioritize. To prepare for this possibility, CCE centers have established protocols to categorize and prioritize patients for systemic treatment or surgery. While the protocols vary by center, they are comparable with one another as they prioritize on the basis of anticipated treatment outcome, the authors note.

The guidelines in CCE centers unanimously recommend that neoadjuvant therapies and curative surgeries be the top priority, for the times when operating room and/or ICU capacity is limited. As an alternative, neoadjuvant systemic treatments may be initiated or extended to postpone surgery, and other nonsurgical interventions can be considered.

In addition, some centers agree that certain elective surgeries can be safely delayed if backed by scientific evidence. As an example, an 11-week deferment of surgery may be acceptable for patients with rectal cancer after downstaging.

Cancer centers may also need to upscale and downscale quickly, depending on how the pandemic evolves, and many have already outlined scenarios to prepare for increasing or decreasing their capacity using phased approaches.

The Netherlands Cancer Institute, for example, has defined four phases of increasing severity; in Germany, capacity planning has been coordinated among 18 hospitals and the federal ministry of health, in order to prevent shortages of cancer services.

“We note that the optimal downscaling strategies depend on country- and center-specific capacities and preferences,” they write. “Therefore, it is difficult to propose a common schedule, and it will be most effective if hospitals outline their own phase-specific downscaling strategies based on the prioritization schemes and practical handles discussed above.”
 

Future research

Better strategies will be needed to reduce the impact of COVID-19 in cancer care, and four research priorities were identified to allow for evidence-based adjustments of cancer care protocols while the pandemic continues:

  • Collect real-world data about the effects of adjustment and de-escalation of treatment regimens on outcomes
  • Determine the incidence of COVID-19 in both the general population and among patients with cancer who have received systemic therapies, with large-scale serological testing
  • Develop an epidemiological model that will allow estimates of the cumulative incidence of COVID-19 for a patient with cancer, within a specific time frame
  • Determine COVID-19 related morbidity and mortality in patients with cancer who have been treated with systemic therapies and/or granulocyte colony-stimulating factor (G-CSF). Several projects are currently underway, such as the UK Coronavirus Cancer Monitoring Project.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Delivering cancer care during the COVID-19 pandemic has proved particularly challenging, as minimizing the risk of infection must be balanced with maintaining optimal outcomes.

Healthcare systems and oncologists have had to reorganize standard oncologic care in order to protect vulnerable patients from exposure to COVID-19 as well as deal with pandemic-related issues of equipment and staffing shortages.

A new article now describes how seven cancer centers in Europe rapidly reorganized their oncologic services and are tackling this crisis, as well as offering guidance to other institutions.

This was a major undertaking, to work out a system where patients can still get care but in a safer manner, explained coauthor Emile Voest, MD, medical director of the Netherlands Cancer Institute in Amsterdam.

“Decisions needed to be taken based on availability of personnel, protective materials, and urgencies,” he told Medscape Medical News. “Because every country had its own speed of development of the COVID pandemic, there were different scenarios in all institutions, but all with a common factor of key expertise on how to de-escalate in a safe manner.”

The article was published April 16 in Nature Medicine.

The Netherlands Cancer Institute (the Netherlands), Karolinska Institute (Sweden), Institute Gustave Roussy (France), Cambridge Cancer Center (United Kingdom), Istituto Nazionale dei Tumori di Milano (Italy), German Cancer Research Center (Germany), and Vall d’Hebron Institute of Oncology (Spain) have been working closely together in a legal entity since 2014, and have created ‘Cancer Core Europe’ (CCE). The goal is to “maximize coherence and critical mass in cancer research,” the authors note.

The consortium represents roughly 60,000 patients with newly diagnosed cancer, delivers approximately 300,000 treatment courses, and conducts about 1.2 million consultations annually, with more than 1,500 ongoing clinical trials. In a joint effort, the centers collected, translated, and compared the guidelines that had been put in place to treat patients with cancer during the COVID-19 pandemic.

Cancer treatment is multidisciplinary and involves many specialties including surgery, radiology, pathology, radiation oncology, and medical oncology. Coordinating care among disciplines is a very complex process, Voest noted.

“Changing treatment also means that you need to reconsider capacities and requirements,” he said. “Hospitals have installed crisis teams that were very good at coordinating these efforts.”
 

Restructuring care

Cancer care had to be reorganized on multiple levels, and the CCE centers looked at several aspects that needed to be accounted for, to ensure continuity in cancer care.

“The biggest challenge for the NHS and other healthcare systems is the surge of patients requiring oxygen and/or intensive care, and the nature and infectiousness of the virus,” said coauthor Carlos Caldas, MD, FMedSci, professor of cancer medicine at the University of Cambridge, United Kingdom. “In hospitals that are mostly run close to capacity, and where all kinds of patients are treated, this has created major resource and logistical problems.”

For regular clinical activities, the institutions with dedicated cancer centers (German Cancer Research Center, Institute Gustave Roussy, Istituto Nazionale dei Tumori di Milano, and Netherlands Cancer Institute) have attempted to stay COVID-19 free. This policy would in turn help ensure that sufficient clinical and intensive-care capacity could be reserved for critical cancer surgeries or management of treatment-related side effects, and allow hospitals outside of the CCE to transfer patients with cancer to these centers. The general hospitals can then focus on caring for patients with COVID-19, as well as other illnesses/injuries that require inpatient care.

As the CCE centers located within general hospitals (Cambridge Cancer Center, Vall d’Hebron Institute of Oncology and Karolinska Institute) have to admit patients with suspected and positive cases of COVID-19, being “COVID-19 free” was never a realistic or pursued goal.

The authors note that it is the responsibility of all healthcare professionals to ensure patients are not exposed to COVID-19, and this has meant minimizing hospital visits and person-to-person contact. For example, whenever possible, consultations take place via telephone calls or over the Internet, and nonurgent appointments that would require a patient’s physical presence at the clinic have been postponed. Visitors are also not permitted to accompany patients when admitted to the hospital or during procedures.

Standard-of-care treatment regimens have been adapted across all centers to minimize the number of hospital visits and hospitalizations and prevent “anticancer treatment-induced” complications of COVID-19.

To minimize visits and hospitalizations, strategies include converting intravenous treatments to oral or subcutaneous regimens when possible; switching from cytotoxic chemotherapy to a less-toxic approach to minimize the risk of complications requiring hospitalization; or to pause therapies when possible (stable disease reached or better). In addition, nonemergency surgeries have been postponed or replaced by radiotherapy.

To prevent anticancer treatment-induced complications of COVID-19, most centers use the paradigm that the added benefit for tumor control should be weighed against the potential risk for COVID-19–related morbidity and mortality. To prevent or reduce the risk of neutropenia and lymphopenia, for example, all centers have suggested a de-escalation of cytotoxic chemotherapy or targeted treatment strategies, or to forgo second or subsequent lines of palliative treatments if response rates from up-front therapy are low.

Some of these changes may be here to stay, noted Caldas. “One of the positive messages that comes out of this is that, clearly, care can be delivered in a safe and compassionate manner without requiring as many hospital visits as in the pre-COVID-19 era,” he said. “In the future, we will take heed of the COVID-19 experience to improve delivery of cancer care.”
 

 

 

Capacity of facilities

Many healthcare systems have become overwhelmed as the pandemic has intensified, thus making it necessary to prioritize. To prepare for this possibility, CCE centers have established protocols to categorize and prioritize patients for systemic treatment or surgery. While the protocols vary by center, they are comparable with one another as they prioritize on the basis of anticipated treatment outcome, the authors note.

The guidelines in CCE centers unanimously recommend that neoadjuvant therapies and curative surgeries be the top priority, for the times when operating room and/or ICU capacity is limited. As an alternative, neoadjuvant systemic treatments may be initiated or extended to postpone surgery, and other nonsurgical interventions can be considered.

In addition, some centers agree that certain elective surgeries can be safely delayed if backed by scientific evidence. As an example, an 11-week deferment of surgery may be acceptable for patients with rectal cancer after downstaging.

Cancer centers may also need to upscale and downscale quickly, depending on how the pandemic evolves, and many have already outlined scenarios to prepare for increasing or decreasing their capacity using phased approaches.

The Netherlands Cancer Institute, for example, has defined four phases of increasing severity; in Germany, capacity planning has been coordinated among 18 hospitals and the federal ministry of health, in order to prevent shortages of cancer services.

“We note that the optimal downscaling strategies depend on country- and center-specific capacities and preferences,” they write. “Therefore, it is difficult to propose a common schedule, and it will be most effective if hospitals outline their own phase-specific downscaling strategies based on the prioritization schemes and practical handles discussed above.”
 

Future research

Better strategies will be needed to reduce the impact of COVID-19 in cancer care, and four research priorities were identified to allow for evidence-based adjustments of cancer care protocols while the pandemic continues:

  • Collect real-world data about the effects of adjustment and de-escalation of treatment regimens on outcomes
  • Determine the incidence of COVID-19 in both the general population and among patients with cancer who have received systemic therapies, with large-scale serological testing
  • Develop an epidemiological model that will allow estimates of the cumulative incidence of COVID-19 for a patient with cancer, within a specific time frame
  • Determine COVID-19 related morbidity and mortality in patients with cancer who have been treated with systemic therapies and/or granulocyte colony-stimulating factor (G-CSF). Several projects are currently underway, such as the UK Coronavirus Cancer Monitoring Project.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

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Medscape Article

Want to keep cancer patients and providers safe during the pandemic? Here’s how

Article Type
Changed
Thu, 12/15/2022 - 17:37

With careful review and some changes, cancer centers can provide effective care during the COVID-19 pandemic without sacrificing the safety of patients, caregivers, and health care workers, according to the authors of a special feature article in the Journal of the National Comprehensive Cancer Network.

Dr. Pelin Cinar

Prescreening, telemedicine, and limiting procedures top the authors’ list of 10 recommendations for ensuring patient safety in U.S. oncology practices. Assuring appropriate personal proctective equipment (PPE), encouraging telecommuting, and providing wellness/stress management are a few of the ways to look out for health care worker safety during the crisis.

These recommendations were drafted to provide guidance during the rapidly evolving global pandemic that, in some cases, has deluged health care delivery systems and strained the ability of providers to assure safe and effective care, said lead author Pelin Cinar, MD, of the Hellen Diller Family Comprehensive Cancer Center at the University of California, San Francisco.

“I think we have been so overwhelmed that sometimes it’s difficult to get organized in our thought processes,” Dr. Cinar said in an interview. “So this [article] was really trying to provide some structure to each of the different steps that we should be addressing at minimum.”
 

Screening patients

Prescreening systems are a critical first step to ensure cancer centers are helping control community spread of the virus, according to the article. Whether done by phone or online, prescreening 1-2 days before a patient’s visit can help identify COVID-19 symptoms and exposure history, guiding whether patients need to be evaluated, monitored, or referred to an ED.

Next, screening clinics can help ensure cancer patients with COVID-19 symptoms are evaluated and tested in a unit with dedicated staff, according to the article.

“If symptomatic patients present to the cancer center for treatment after a negative prescreening assessment, they must be provided with a mask and directed to a screening clinic for evaluation and potential testing before moving forward with any cancer-directed therapy,” the article states.
 

Telemedicine and treatment

Telemedicine visits should be done whenever possible to avoid in-person visits, according to the article. Dr. Cinar said that her center, like other cancer centers, has seen a major uptick in these visits, which are typically done over video. In February, there were a total of 232 video visits at her center, which jumped to 1,702 in March, or an approximate 600% increase.

“Even though we had a relatively robust presence [before the pandemic], we still weren’t at a level where we are now,” Dr. Cinar said.

When it comes to cancer treatment, surgeries and procedures should be limited to essential or urgent cases, and, if possible, chemotherapy and systemic therapy regimens can be modified to allow for fewer visits to the cancer center or infusion center, according to the article.

Transitions to outpatient care can help further reduce the need for in-person visits, while intervals between scans can be increased, or biochemical markers can be used instead of scans.
 

 

 

Protecting providers

Health care workers providing cancer care should be assured appropriate PPE, and websites or other centralized resources should be in place to make sure workers are aware of current PPE guidelines and changes in workflow, according to the article.

The authors note that daily screening tools or temperature checks of symptomatic workers can help decrease the risk of exposure to others. The authors also recommend establishing clear rules for when health care workers with suspected or confirmed COVID-19 should be staying at home and returning to the job.

Telecommuting should be encouraged, with limited staff participating in onsite rotations to further reduce exposure risks, the article states.

Anxiety, insomnia, and distress have been reported among frontline health care workers managing patients with COVID-19, according to the article, which recommends wellness and stress management resources be available as an “invaluable resource” in cancer centers.

“We have to take care of ourselves to be able to take care of others,” Dr. Cinar said. “With PPE, you’re physically protecting yourself, while self-care, stress management, and wellness are also a big component of protecting ourselves.”

The report by Dr. Cinar and colleagues was an invited article from the NCCN Best Practices Committee. One coauthor reported relationships with Abbvie, Adaptive Biotechnologies, Aduro, and several other companies. Dr. Cinar and the remaining authors said they had no relevant conflicts of interest.

SOURCE: Cinar P et al. J Natl Compr Canc Netw. 2020 Apr 15. doi: 10.6004/jnccn.2020.7572.

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With careful review and some changes, cancer centers can provide effective care during the COVID-19 pandemic without sacrificing the safety of patients, caregivers, and health care workers, according to the authors of a special feature article in the Journal of the National Comprehensive Cancer Network.

Dr. Pelin Cinar

Prescreening, telemedicine, and limiting procedures top the authors’ list of 10 recommendations for ensuring patient safety in U.S. oncology practices. Assuring appropriate personal proctective equipment (PPE), encouraging telecommuting, and providing wellness/stress management are a few of the ways to look out for health care worker safety during the crisis.

These recommendations were drafted to provide guidance during the rapidly evolving global pandemic that, in some cases, has deluged health care delivery systems and strained the ability of providers to assure safe and effective care, said lead author Pelin Cinar, MD, of the Hellen Diller Family Comprehensive Cancer Center at the University of California, San Francisco.

“I think we have been so overwhelmed that sometimes it’s difficult to get organized in our thought processes,” Dr. Cinar said in an interview. “So this [article] was really trying to provide some structure to each of the different steps that we should be addressing at minimum.”
 

Screening patients

Prescreening systems are a critical first step to ensure cancer centers are helping control community spread of the virus, according to the article. Whether done by phone or online, prescreening 1-2 days before a patient’s visit can help identify COVID-19 symptoms and exposure history, guiding whether patients need to be evaluated, monitored, or referred to an ED.

Next, screening clinics can help ensure cancer patients with COVID-19 symptoms are evaluated and tested in a unit with dedicated staff, according to the article.

“If symptomatic patients present to the cancer center for treatment after a negative prescreening assessment, they must be provided with a mask and directed to a screening clinic for evaluation and potential testing before moving forward with any cancer-directed therapy,” the article states.
 

Telemedicine and treatment

Telemedicine visits should be done whenever possible to avoid in-person visits, according to the article. Dr. Cinar said that her center, like other cancer centers, has seen a major uptick in these visits, which are typically done over video. In February, there were a total of 232 video visits at her center, which jumped to 1,702 in March, or an approximate 600% increase.

“Even though we had a relatively robust presence [before the pandemic], we still weren’t at a level where we are now,” Dr. Cinar said.

When it comes to cancer treatment, surgeries and procedures should be limited to essential or urgent cases, and, if possible, chemotherapy and systemic therapy regimens can be modified to allow for fewer visits to the cancer center or infusion center, according to the article.

Transitions to outpatient care can help further reduce the need for in-person visits, while intervals between scans can be increased, or biochemical markers can be used instead of scans.
 

 

 

Protecting providers

Health care workers providing cancer care should be assured appropriate PPE, and websites or other centralized resources should be in place to make sure workers are aware of current PPE guidelines and changes in workflow, according to the article.

The authors note that daily screening tools or temperature checks of symptomatic workers can help decrease the risk of exposure to others. The authors also recommend establishing clear rules for when health care workers with suspected or confirmed COVID-19 should be staying at home and returning to the job.

Telecommuting should be encouraged, with limited staff participating in onsite rotations to further reduce exposure risks, the article states.

Anxiety, insomnia, and distress have been reported among frontline health care workers managing patients with COVID-19, according to the article, which recommends wellness and stress management resources be available as an “invaluable resource” in cancer centers.

“We have to take care of ourselves to be able to take care of others,” Dr. Cinar said. “With PPE, you’re physically protecting yourself, while self-care, stress management, and wellness are also a big component of protecting ourselves.”

The report by Dr. Cinar and colleagues was an invited article from the NCCN Best Practices Committee. One coauthor reported relationships with Abbvie, Adaptive Biotechnologies, Aduro, and several other companies. Dr. Cinar and the remaining authors said they had no relevant conflicts of interest.

SOURCE: Cinar P et al. J Natl Compr Canc Netw. 2020 Apr 15. doi: 10.6004/jnccn.2020.7572.

With careful review and some changes, cancer centers can provide effective care during the COVID-19 pandemic without sacrificing the safety of patients, caregivers, and health care workers, according to the authors of a special feature article in the Journal of the National Comprehensive Cancer Network.

Dr. Pelin Cinar

Prescreening, telemedicine, and limiting procedures top the authors’ list of 10 recommendations for ensuring patient safety in U.S. oncology practices. Assuring appropriate personal proctective equipment (PPE), encouraging telecommuting, and providing wellness/stress management are a few of the ways to look out for health care worker safety during the crisis.

These recommendations were drafted to provide guidance during the rapidly evolving global pandemic that, in some cases, has deluged health care delivery systems and strained the ability of providers to assure safe and effective care, said lead author Pelin Cinar, MD, of the Hellen Diller Family Comprehensive Cancer Center at the University of California, San Francisco.

“I think we have been so overwhelmed that sometimes it’s difficult to get organized in our thought processes,” Dr. Cinar said in an interview. “So this [article] was really trying to provide some structure to each of the different steps that we should be addressing at minimum.”
 

Screening patients

Prescreening systems are a critical first step to ensure cancer centers are helping control community spread of the virus, according to the article. Whether done by phone or online, prescreening 1-2 days before a patient’s visit can help identify COVID-19 symptoms and exposure history, guiding whether patients need to be evaluated, monitored, or referred to an ED.

Next, screening clinics can help ensure cancer patients with COVID-19 symptoms are evaluated and tested in a unit with dedicated staff, according to the article.

“If symptomatic patients present to the cancer center for treatment after a negative prescreening assessment, they must be provided with a mask and directed to a screening clinic for evaluation and potential testing before moving forward with any cancer-directed therapy,” the article states.
 

Telemedicine and treatment

Telemedicine visits should be done whenever possible to avoid in-person visits, according to the article. Dr. Cinar said that her center, like other cancer centers, has seen a major uptick in these visits, which are typically done over video. In February, there were a total of 232 video visits at her center, which jumped to 1,702 in March, or an approximate 600% increase.

“Even though we had a relatively robust presence [before the pandemic], we still weren’t at a level where we are now,” Dr. Cinar said.

When it comes to cancer treatment, surgeries and procedures should be limited to essential or urgent cases, and, if possible, chemotherapy and systemic therapy regimens can be modified to allow for fewer visits to the cancer center or infusion center, according to the article.

Transitions to outpatient care can help further reduce the need for in-person visits, while intervals between scans can be increased, or biochemical markers can be used instead of scans.
 

 

 

Protecting providers

Health care workers providing cancer care should be assured appropriate PPE, and websites or other centralized resources should be in place to make sure workers are aware of current PPE guidelines and changes in workflow, according to the article.

The authors note that daily screening tools or temperature checks of symptomatic workers can help decrease the risk of exposure to others. The authors also recommend establishing clear rules for when health care workers with suspected or confirmed COVID-19 should be staying at home and returning to the job.

Telecommuting should be encouraged, with limited staff participating in onsite rotations to further reduce exposure risks, the article states.

Anxiety, insomnia, and distress have been reported among frontline health care workers managing patients with COVID-19, according to the article, which recommends wellness and stress management resources be available as an “invaluable resource” in cancer centers.

“We have to take care of ourselves to be able to take care of others,” Dr. Cinar said. “With PPE, you’re physically protecting yourself, while self-care, stress management, and wellness are also a big component of protecting ourselves.”

The report by Dr. Cinar and colleagues was an invited article from the NCCN Best Practices Committee. One coauthor reported relationships with Abbvie, Adaptive Biotechnologies, Aduro, and several other companies. Dr. Cinar and the remaining authors said they had no relevant conflicts of interest.

SOURCE: Cinar P et al. J Natl Compr Canc Netw. 2020 Apr 15. doi: 10.6004/jnccn.2020.7572.

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FROM THE JOURNAL OF THE NATIONAL COMPREHENSIVE CANCER NETWORK

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CLAM trial regimen shown safe, effective for r/r AML

Article Type
Changed
Fri, 04/17/2020 - 12:18

A clofarabine-based treatment was found to be safe and effective in refractory/relapsed acute myeloid leukemia (AML) in the phase 2 CLAM trial.

The CLAM protocol treatment was clofarabine, cytarabine, and mitoxantrone (intravenous infusion, days 1‐5), cytarabine (intravenous infusion starting 4 hours after clofarabine, days 1‐5), and mitoxantrone (intravenous infusion, days 3‐5).

Bone marrow aspiration and trephine biopsy were performed on day 28. A total of 52 patients (16 women), with an age range of 22-65 years and refractory/relapsed AML were treated.

The overall response rate after the first cycle of CLAM was 90.4% (complete remission, 69.2%; CR with incomplete hematologic recovery, 21.2%). In addition, the efficacy of CLAM was not apparently affected by high‐risk karyotypes and genetic mutations among the patients.

Patients with a response (marrow < 5% blasts) received a maximum of two cycles of CLAM consolidation, each at 50% dose reduction, given 6‐8 weeks apart. Responding patients with an HLA‐matched sibling or volunteer‐unrelated donor were offered allogeneic hematopoietic stem cell transplantation (HSCT). Toxicity of CLAM was manageable and did not compromise subsequent allogeneic HSCT, the researchers added.

“In this era of molecular targeting, CLAM might still have a role to play,” according to the researchers. “It offers the advantage of a highly effective regimen that is readily available. It provides a median DOR of 5 months, which is meaningful for organization of HSCT. Delays associated with recruitment into clinical trials or sourcing of targeted drugs are obviated. Precious time is saved, so that patients can quickly be bridged to a potentially curative allogeneic HSCT.”

No disclosures or conflicts of interest were reported.

SOURCE: Gill H et al. Cancer Med. 2020 Mar 20. doi:10.1002/cam4.2865.

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A clofarabine-based treatment was found to be safe and effective in refractory/relapsed acute myeloid leukemia (AML) in the phase 2 CLAM trial.

The CLAM protocol treatment was clofarabine, cytarabine, and mitoxantrone (intravenous infusion, days 1‐5), cytarabine (intravenous infusion starting 4 hours after clofarabine, days 1‐5), and mitoxantrone (intravenous infusion, days 3‐5).

Bone marrow aspiration and trephine biopsy were performed on day 28. A total of 52 patients (16 women), with an age range of 22-65 years and refractory/relapsed AML were treated.

The overall response rate after the first cycle of CLAM was 90.4% (complete remission, 69.2%; CR with incomplete hematologic recovery, 21.2%). In addition, the efficacy of CLAM was not apparently affected by high‐risk karyotypes and genetic mutations among the patients.

Patients with a response (marrow < 5% blasts) received a maximum of two cycles of CLAM consolidation, each at 50% dose reduction, given 6‐8 weeks apart. Responding patients with an HLA‐matched sibling or volunteer‐unrelated donor were offered allogeneic hematopoietic stem cell transplantation (HSCT). Toxicity of CLAM was manageable and did not compromise subsequent allogeneic HSCT, the researchers added.

“In this era of molecular targeting, CLAM might still have a role to play,” according to the researchers. “It offers the advantage of a highly effective regimen that is readily available. It provides a median DOR of 5 months, which is meaningful for organization of HSCT. Delays associated with recruitment into clinical trials or sourcing of targeted drugs are obviated. Precious time is saved, so that patients can quickly be bridged to a potentially curative allogeneic HSCT.”

No disclosures or conflicts of interest were reported.

SOURCE: Gill H et al. Cancer Med. 2020 Mar 20. doi:10.1002/cam4.2865.

A clofarabine-based treatment was found to be safe and effective in refractory/relapsed acute myeloid leukemia (AML) in the phase 2 CLAM trial.

The CLAM protocol treatment was clofarabine, cytarabine, and mitoxantrone (intravenous infusion, days 1‐5), cytarabine (intravenous infusion starting 4 hours after clofarabine, days 1‐5), and mitoxantrone (intravenous infusion, days 3‐5).

Bone marrow aspiration and trephine biopsy were performed on day 28. A total of 52 patients (16 women), with an age range of 22-65 years and refractory/relapsed AML were treated.

The overall response rate after the first cycle of CLAM was 90.4% (complete remission, 69.2%; CR with incomplete hematologic recovery, 21.2%). In addition, the efficacy of CLAM was not apparently affected by high‐risk karyotypes and genetic mutations among the patients.

Patients with a response (marrow < 5% blasts) received a maximum of two cycles of CLAM consolidation, each at 50% dose reduction, given 6‐8 weeks apart. Responding patients with an HLA‐matched sibling or volunteer‐unrelated donor were offered allogeneic hematopoietic stem cell transplantation (HSCT). Toxicity of CLAM was manageable and did not compromise subsequent allogeneic HSCT, the researchers added.

“In this era of molecular targeting, CLAM might still have a role to play,” according to the researchers. “It offers the advantage of a highly effective regimen that is readily available. It provides a median DOR of 5 months, which is meaningful for organization of HSCT. Delays associated with recruitment into clinical trials or sourcing of targeted drugs are obviated. Precious time is saved, so that patients can quickly be bridged to a potentially curative allogeneic HSCT.”

No disclosures or conflicts of interest were reported.

SOURCE: Gill H et al. Cancer Med. 2020 Mar 20. doi:10.1002/cam4.2865.

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Cancer patients report delays in treatment because of COVID-19

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Thu, 12/15/2022 - 17:37

As the COVID-19 pandemic continues, many cancer patients are finding it increasingly difficult to receive the care they need and are facing financial challenges.

Half of the cancer patients and survivors who responded to a recent survey reported changes, delays, or disruptions to the care they were receiving. The survey, with 1,219 respondents, was conducted by the American Cancer Society Cancer Action Network (ACS CAN).

“The circumstances of this virus – from the fact cancer patients are at higher risk of severe complications should they be diagnosed with COVID-19, to the fact many patients are facing serious financial strain caused by the virus’ economic effect – make getting care especially difficult,” Keysha Brooks-Coley, vice president of federal advocacy for ACS CAN, told Medscape Medical News.

Nearly a quarter (24%) of survey respondents reported a delay in care or treatment. The proportion was slightly more (27%) among those currently receiving active treatment.

In addition, 12% (13% in active treatment) stated that not only was their care delayed but that they also have not been told when services would be rescheduled.

As previously reported by Medscape Medical News, many oncology groups have issued new guidelines for cancer care in reaction to the current crisis. These include recommendations to delay cancer treatment in order to avoid exposing cancer patients to the virus.

Half of those in active treatment report disruptions

The survey was initiated by ACS CAN on March 25 and was distributed over a 2-week period. The goal was to gain a better understanding of how COVID-19 was affecting cancer patients and survivors in the United States. Of the 1,219 respondents, half (51%) were cancer patients currently undergoing active treatment.

Among the patients and survivors who were currently in active treatment, 55% reported that there have been changes, delays, or disruptions in their care. The services most frequently affected included in-person provider visits (50%), supportive services (20%), and imaging procedures to monitor tumor growth (20%).

In addition, 8% reported that their treatment, including chemotherapy and immunotherapy, had been affected by the COVID-19 pandemic.

Financial concerns

Almost all of the survey respondents were covered by some type of insurance; 49% had coverage through an employer, 32% were covered by Medicare, 7% had privately purchased insurance, and 4% were covered through Medicaid.

Many cancer patients had already been having difficulty paying for their care, but for a substantial proportion of survey respondents, the COVID-19 pandemic has exacerbated the problem. More than one-third (38%) stated that COVID-19 “has had a notable impact on their financial situation that affects their ability to pay for health care.”

The most common financial problems that were related to access to care include reduced work hours (14%), reduced investment values (11%), having difficulty affording food and supplies because of staying at home to avoid contracting the virus (9%), and becoming unemployed (8%).

A reduction in work hours and job loss were of particular concern to respondents because of the possible effects these would have on their health insurance coverage. Of those who reported that they or a family member living with them had lost a job, 43% had employer-sponsored health insurance. Additionally, 58% of patients or a family member whose working hours had been reduced also had health insurance through their employer

Among the entire cohort, 28% reported that they were worried that the financial impact of COVID-19 would make it difficult to pay for the health care they need as cancer survivors. This concern was highly correlated with income. Almost half (46%) of patients who earned $30,000 or less reported that they were worried, but even in household with incomes over $110,000 per year, 21% were also concerned about the financial impact.

“Now more than ever, patients need to be able to get, keep, and afford health coverage to treat their disease,” commented Brooks-Coley.
 

 

 

Taking action

“ACS CAN is working every day to make clear to Congress and the administration the real and immediate challenges cancer patients and survivors face during this pandemic,” said Brooks-Coley.

With nearly 50 other professional and advocacy groups, ACS CAN has sent letters to congressional leadership and the Secretary of the Department of Health & Human Services asking them to make policy changes that would help patients.

The proposed action points include having insurers allow patients to use providers who are out of network if necessary; waiving site-specific precertification and prior authorization for cancer treatment; utilizing shared decision making between patients and providers in deciding whether to use home infusion without pressure from the insurer; allowing patients to obtain 90-day supplies of medication; increasing funding for state Medicaid programs and assistance for those who have lost employee-sponsored coverage; and improving telehealth services.

“We urge Congress and the administration to keep the needs of cancer patients and survivors in mind as they continue to address the public health crisis,” she said.

This article first appeared on Medscape.com.

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As the COVID-19 pandemic continues, many cancer patients are finding it increasingly difficult to receive the care they need and are facing financial challenges.

Half of the cancer patients and survivors who responded to a recent survey reported changes, delays, or disruptions to the care they were receiving. The survey, with 1,219 respondents, was conducted by the American Cancer Society Cancer Action Network (ACS CAN).

“The circumstances of this virus – from the fact cancer patients are at higher risk of severe complications should they be diagnosed with COVID-19, to the fact many patients are facing serious financial strain caused by the virus’ economic effect – make getting care especially difficult,” Keysha Brooks-Coley, vice president of federal advocacy for ACS CAN, told Medscape Medical News.

Nearly a quarter (24%) of survey respondents reported a delay in care or treatment. The proportion was slightly more (27%) among those currently receiving active treatment.

In addition, 12% (13% in active treatment) stated that not only was their care delayed but that they also have not been told when services would be rescheduled.

As previously reported by Medscape Medical News, many oncology groups have issued new guidelines for cancer care in reaction to the current crisis. These include recommendations to delay cancer treatment in order to avoid exposing cancer patients to the virus.

Half of those in active treatment report disruptions

The survey was initiated by ACS CAN on March 25 and was distributed over a 2-week period. The goal was to gain a better understanding of how COVID-19 was affecting cancer patients and survivors in the United States. Of the 1,219 respondents, half (51%) were cancer patients currently undergoing active treatment.

Among the patients and survivors who were currently in active treatment, 55% reported that there have been changes, delays, or disruptions in their care. The services most frequently affected included in-person provider visits (50%), supportive services (20%), and imaging procedures to monitor tumor growth (20%).

In addition, 8% reported that their treatment, including chemotherapy and immunotherapy, had been affected by the COVID-19 pandemic.

Financial concerns

Almost all of the survey respondents were covered by some type of insurance; 49% had coverage through an employer, 32% were covered by Medicare, 7% had privately purchased insurance, and 4% were covered through Medicaid.

Many cancer patients had already been having difficulty paying for their care, but for a substantial proportion of survey respondents, the COVID-19 pandemic has exacerbated the problem. More than one-third (38%) stated that COVID-19 “has had a notable impact on their financial situation that affects their ability to pay for health care.”

The most common financial problems that were related to access to care include reduced work hours (14%), reduced investment values (11%), having difficulty affording food and supplies because of staying at home to avoid contracting the virus (9%), and becoming unemployed (8%).

A reduction in work hours and job loss were of particular concern to respondents because of the possible effects these would have on their health insurance coverage. Of those who reported that they or a family member living with them had lost a job, 43% had employer-sponsored health insurance. Additionally, 58% of patients or a family member whose working hours had been reduced also had health insurance through their employer

Among the entire cohort, 28% reported that they were worried that the financial impact of COVID-19 would make it difficult to pay for the health care they need as cancer survivors. This concern was highly correlated with income. Almost half (46%) of patients who earned $30,000 or less reported that they were worried, but even in household with incomes over $110,000 per year, 21% were also concerned about the financial impact.

“Now more than ever, patients need to be able to get, keep, and afford health coverage to treat their disease,” commented Brooks-Coley.
 

 

 

Taking action

“ACS CAN is working every day to make clear to Congress and the administration the real and immediate challenges cancer patients and survivors face during this pandemic,” said Brooks-Coley.

With nearly 50 other professional and advocacy groups, ACS CAN has sent letters to congressional leadership and the Secretary of the Department of Health & Human Services asking them to make policy changes that would help patients.

The proposed action points include having insurers allow patients to use providers who are out of network if necessary; waiving site-specific precertification and prior authorization for cancer treatment; utilizing shared decision making between patients and providers in deciding whether to use home infusion without pressure from the insurer; allowing patients to obtain 90-day supplies of medication; increasing funding for state Medicaid programs and assistance for those who have lost employee-sponsored coverage; and improving telehealth services.

“We urge Congress and the administration to keep the needs of cancer patients and survivors in mind as they continue to address the public health crisis,” she said.

This article first appeared on Medscape.com.

As the COVID-19 pandemic continues, many cancer patients are finding it increasingly difficult to receive the care they need and are facing financial challenges.

Half of the cancer patients and survivors who responded to a recent survey reported changes, delays, or disruptions to the care they were receiving. The survey, with 1,219 respondents, was conducted by the American Cancer Society Cancer Action Network (ACS CAN).

“The circumstances of this virus – from the fact cancer patients are at higher risk of severe complications should they be diagnosed with COVID-19, to the fact many patients are facing serious financial strain caused by the virus’ economic effect – make getting care especially difficult,” Keysha Brooks-Coley, vice president of federal advocacy for ACS CAN, told Medscape Medical News.

Nearly a quarter (24%) of survey respondents reported a delay in care or treatment. The proportion was slightly more (27%) among those currently receiving active treatment.

In addition, 12% (13% in active treatment) stated that not only was their care delayed but that they also have not been told when services would be rescheduled.

As previously reported by Medscape Medical News, many oncology groups have issued new guidelines for cancer care in reaction to the current crisis. These include recommendations to delay cancer treatment in order to avoid exposing cancer patients to the virus.

Half of those in active treatment report disruptions

The survey was initiated by ACS CAN on March 25 and was distributed over a 2-week period. The goal was to gain a better understanding of how COVID-19 was affecting cancer patients and survivors in the United States. Of the 1,219 respondents, half (51%) were cancer patients currently undergoing active treatment.

Among the patients and survivors who were currently in active treatment, 55% reported that there have been changes, delays, or disruptions in their care. The services most frequently affected included in-person provider visits (50%), supportive services (20%), and imaging procedures to monitor tumor growth (20%).

In addition, 8% reported that their treatment, including chemotherapy and immunotherapy, had been affected by the COVID-19 pandemic.

Financial concerns

Almost all of the survey respondents were covered by some type of insurance; 49% had coverage through an employer, 32% were covered by Medicare, 7% had privately purchased insurance, and 4% were covered through Medicaid.

Many cancer patients had already been having difficulty paying for their care, but for a substantial proportion of survey respondents, the COVID-19 pandemic has exacerbated the problem. More than one-third (38%) stated that COVID-19 “has had a notable impact on their financial situation that affects their ability to pay for health care.”

The most common financial problems that were related to access to care include reduced work hours (14%), reduced investment values (11%), having difficulty affording food and supplies because of staying at home to avoid contracting the virus (9%), and becoming unemployed (8%).

A reduction in work hours and job loss were of particular concern to respondents because of the possible effects these would have on their health insurance coverage. Of those who reported that they or a family member living with them had lost a job, 43% had employer-sponsored health insurance. Additionally, 58% of patients or a family member whose working hours had been reduced also had health insurance through their employer

Among the entire cohort, 28% reported that they were worried that the financial impact of COVID-19 would make it difficult to pay for the health care they need as cancer survivors. This concern was highly correlated with income. Almost half (46%) of patients who earned $30,000 or less reported that they were worried, but even in household with incomes over $110,000 per year, 21% were also concerned about the financial impact.

“Now more than ever, patients need to be able to get, keep, and afford health coverage to treat their disease,” commented Brooks-Coley.
 

 

 

Taking action

“ACS CAN is working every day to make clear to Congress and the administration the real and immediate challenges cancer patients and survivors face during this pandemic,” said Brooks-Coley.

With nearly 50 other professional and advocacy groups, ACS CAN has sent letters to congressional leadership and the Secretary of the Department of Health & Human Services asking them to make policy changes that would help patients.

The proposed action points include having insurers allow patients to use providers who are out of network if necessary; waiving site-specific precertification and prior authorization for cancer treatment; utilizing shared decision making between patients and providers in deciding whether to use home infusion without pressure from the insurer; allowing patients to obtain 90-day supplies of medication; increasing funding for state Medicaid programs and assistance for those who have lost employee-sponsored coverage; and improving telehealth services.

“We urge Congress and the administration to keep the needs of cancer patients and survivors in mind as they continue to address the public health crisis,” she said.

This article first appeared on Medscape.com.

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Cancer care ‘transformed in space of a month’ because of pandemic

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There will be some change for the better when oncology care emerges from the COVID-19 pandemic, the most “revolutionary” being a deep dive into telehealth, predicts Deborah Schrag, MD, MPH, a medical oncologist specializing in gastrointestinal cancers at the Dana Farber Cancer Institute in Boston, Massachusetts.

“In the space of a month, approaches and accepted norms of cancer care delivery have been transformed of necessity,” Schrag and colleagues write in an article published in JAMA on April 13.

“Most of these changes would not have occurred without the pandemic,” they add. They predict that some changes will last after the crisis is over.

“None of us want to be thrown in the deep end.... On the other hand, sometimes it works,” Schrag told Medscape Medical News.

“The in-person visit between patient and physician has been upended,” she said.

“I don’t think there’s any going back to the way it was before because cancer patients won’t stand for it,” she said. “They’re not going to drive in to get the results of a blood test.

“I think that on balance, of course, there are situations where you need eye-to-eye contact. No one wants to have an initial oncology meeting by telehealth – doctors or patients – that’s ridiculous,” she said. “But for follow-up visits, patients are now going to be more demanding, and doctors will be more willing.”

The “essential empathy” of oncologists can still “transcend the new physical barriers presented by masks and telehealth,” Schrag and colleagues comment.

“Doctors are figuring out how to deliver empathy by Zoom,” she told Medscape Medical News. “It’s not the same, but we all convey empathy to our elderly relatives over the phone.”

Pandemic impact on oncology

While the crisis has affected all of medicine – dismantling how care is delivered and forcing clinicians to make difficult decisions regarding triage – the fact that some cancers present an immediate threat to survival means that oncology “provides a lens into the major shifts currently underway in clinical care,” Schrag and colleagues write.

They illustrate the point by highlighting systemic chemotherapy, which is provided to a large proportion of patients with advanced cancer. The pandemic has tipped the risk-benefit ratio away from treatments that have a marginal effect on quality or quantity of life, they note. It has forced an “elimination of low-value treatments that were identified by the Choosing Wisely campaign,” the authors write. Up to now, the uptake of recommendations to eliminate these treatments has been slow.

“For example, for most metastatic solid tumors, chemotherapy beyond the third regimen does not improve survival for more than a few weeks; therefore, oncologists are advising supportive care instead. For patients receiving adjuvant therapy for curable cancers, delaying initiation or abbreviating the number of cycles is appropriate. Oncologists are postponing initiation of adjuvant chemotherapy for some estrogen receptor–negative stage II breast cancers by 8 weeks and administering 6 rather than 12 cycles of adjuvant chemotherapy for stage III colorectal cancers,” Schrag and colleagues write.

On the other hand, even in the epicenters of the pandemic, thus far, oncologists are still delivering cancer treatments that have the potential to cure and cannot safely be delayed, they point out. “This includes most patients with new diagnoses of acute leukemia, high-grade lymphoma, and those with chemotherapy-responsive tumors such as testicular, ovarian, and small cell lung cancer. Despite the risks, oncologists are not modifying such treatments because these cancers are likely more lethal than COVID-19.”

It’s the cancer patients who fall in between these two extremes who pose the biggest treatment challenge during this crisis – the patients for whom a delay would have “moderate clinically important adverse influence on quality of life or survival.” In these cases, oncologists are “prescribing marginally less effective regimens that have lower risk of precipitating hospitalization,” the authors note.

These treatments include the use of “white cell growth factor, more stringent neutrophil counts for proceeding with a next cycle of therapy, and omitting use of steroids to manage nausea.” In addition, where possible, oncologists are substituting oral agents for intravenous agents and “myriad other modifications to minimize visits and hospitalizations.”

Most hospitals and outpatient infusion centers now prohibit visitors from accompanying patients, and oncologists are prioritizing conversations with patients about advance directives, healthcare proxies, and end-of-life care preferences. Yet, even here, telehealth offers a new, enhanced layer to those conversations by enabling families to gather with their loved one and the doctor, she said.

This article first appeared on Medscape.com.

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There will be some change for the better when oncology care emerges from the COVID-19 pandemic, the most “revolutionary” being a deep dive into telehealth, predicts Deborah Schrag, MD, MPH, a medical oncologist specializing in gastrointestinal cancers at the Dana Farber Cancer Institute in Boston, Massachusetts.

“In the space of a month, approaches and accepted norms of cancer care delivery have been transformed of necessity,” Schrag and colleagues write in an article published in JAMA on April 13.

“Most of these changes would not have occurred without the pandemic,” they add. They predict that some changes will last after the crisis is over.

“None of us want to be thrown in the deep end.... On the other hand, sometimes it works,” Schrag told Medscape Medical News.

“The in-person visit between patient and physician has been upended,” she said.

“I don’t think there’s any going back to the way it was before because cancer patients won’t stand for it,” she said. “They’re not going to drive in to get the results of a blood test.

“I think that on balance, of course, there are situations where you need eye-to-eye contact. No one wants to have an initial oncology meeting by telehealth – doctors or patients – that’s ridiculous,” she said. “But for follow-up visits, patients are now going to be more demanding, and doctors will be more willing.”

The “essential empathy” of oncologists can still “transcend the new physical barriers presented by masks and telehealth,” Schrag and colleagues comment.

“Doctors are figuring out how to deliver empathy by Zoom,” she told Medscape Medical News. “It’s not the same, but we all convey empathy to our elderly relatives over the phone.”

Pandemic impact on oncology

While the crisis has affected all of medicine – dismantling how care is delivered and forcing clinicians to make difficult decisions regarding triage – the fact that some cancers present an immediate threat to survival means that oncology “provides a lens into the major shifts currently underway in clinical care,” Schrag and colleagues write.

They illustrate the point by highlighting systemic chemotherapy, which is provided to a large proportion of patients with advanced cancer. The pandemic has tipped the risk-benefit ratio away from treatments that have a marginal effect on quality or quantity of life, they note. It has forced an “elimination of low-value treatments that were identified by the Choosing Wisely campaign,” the authors write. Up to now, the uptake of recommendations to eliminate these treatments has been slow.

“For example, for most metastatic solid tumors, chemotherapy beyond the third regimen does not improve survival for more than a few weeks; therefore, oncologists are advising supportive care instead. For patients receiving adjuvant therapy for curable cancers, delaying initiation or abbreviating the number of cycles is appropriate. Oncologists are postponing initiation of adjuvant chemotherapy for some estrogen receptor–negative stage II breast cancers by 8 weeks and administering 6 rather than 12 cycles of adjuvant chemotherapy for stage III colorectal cancers,” Schrag and colleagues write.

On the other hand, even in the epicenters of the pandemic, thus far, oncologists are still delivering cancer treatments that have the potential to cure and cannot safely be delayed, they point out. “This includes most patients with new diagnoses of acute leukemia, high-grade lymphoma, and those with chemotherapy-responsive tumors such as testicular, ovarian, and small cell lung cancer. Despite the risks, oncologists are not modifying such treatments because these cancers are likely more lethal than COVID-19.”

It’s the cancer patients who fall in between these two extremes who pose the biggest treatment challenge during this crisis – the patients for whom a delay would have “moderate clinically important adverse influence on quality of life or survival.” In these cases, oncologists are “prescribing marginally less effective regimens that have lower risk of precipitating hospitalization,” the authors note.

These treatments include the use of “white cell growth factor, more stringent neutrophil counts for proceeding with a next cycle of therapy, and omitting use of steroids to manage nausea.” In addition, where possible, oncologists are substituting oral agents for intravenous agents and “myriad other modifications to minimize visits and hospitalizations.”

Most hospitals and outpatient infusion centers now prohibit visitors from accompanying patients, and oncologists are prioritizing conversations with patients about advance directives, healthcare proxies, and end-of-life care preferences. Yet, even here, telehealth offers a new, enhanced layer to those conversations by enabling families to gather with their loved one and the doctor, she said.

This article first appeared on Medscape.com.

There will be some change for the better when oncology care emerges from the COVID-19 pandemic, the most “revolutionary” being a deep dive into telehealth, predicts Deborah Schrag, MD, MPH, a medical oncologist specializing in gastrointestinal cancers at the Dana Farber Cancer Institute in Boston, Massachusetts.

“In the space of a month, approaches and accepted norms of cancer care delivery have been transformed of necessity,” Schrag and colleagues write in an article published in JAMA on April 13.

“Most of these changes would not have occurred without the pandemic,” they add. They predict that some changes will last after the crisis is over.

“None of us want to be thrown in the deep end.... On the other hand, sometimes it works,” Schrag told Medscape Medical News.

“The in-person visit between patient and physician has been upended,” she said.

“I don’t think there’s any going back to the way it was before because cancer patients won’t stand for it,” she said. “They’re not going to drive in to get the results of a blood test.

“I think that on balance, of course, there are situations where you need eye-to-eye contact. No one wants to have an initial oncology meeting by telehealth – doctors or patients – that’s ridiculous,” she said. “But for follow-up visits, patients are now going to be more demanding, and doctors will be more willing.”

The “essential empathy” of oncologists can still “transcend the new physical barriers presented by masks and telehealth,” Schrag and colleagues comment.

“Doctors are figuring out how to deliver empathy by Zoom,” she told Medscape Medical News. “It’s not the same, but we all convey empathy to our elderly relatives over the phone.”

Pandemic impact on oncology

While the crisis has affected all of medicine – dismantling how care is delivered and forcing clinicians to make difficult decisions regarding triage – the fact that some cancers present an immediate threat to survival means that oncology “provides a lens into the major shifts currently underway in clinical care,” Schrag and colleagues write.

They illustrate the point by highlighting systemic chemotherapy, which is provided to a large proportion of patients with advanced cancer. The pandemic has tipped the risk-benefit ratio away from treatments that have a marginal effect on quality or quantity of life, they note. It has forced an “elimination of low-value treatments that were identified by the Choosing Wisely campaign,” the authors write. Up to now, the uptake of recommendations to eliminate these treatments has been slow.

“For example, for most metastatic solid tumors, chemotherapy beyond the third regimen does not improve survival for more than a few weeks; therefore, oncologists are advising supportive care instead. For patients receiving adjuvant therapy for curable cancers, delaying initiation or abbreviating the number of cycles is appropriate. Oncologists are postponing initiation of adjuvant chemotherapy for some estrogen receptor–negative stage II breast cancers by 8 weeks and administering 6 rather than 12 cycles of adjuvant chemotherapy for stage III colorectal cancers,” Schrag and colleagues write.

On the other hand, even in the epicenters of the pandemic, thus far, oncologists are still delivering cancer treatments that have the potential to cure and cannot safely be delayed, they point out. “This includes most patients with new diagnoses of acute leukemia, high-grade lymphoma, and those with chemotherapy-responsive tumors such as testicular, ovarian, and small cell lung cancer. Despite the risks, oncologists are not modifying such treatments because these cancers are likely more lethal than COVID-19.”

It’s the cancer patients who fall in between these two extremes who pose the biggest treatment challenge during this crisis – the patients for whom a delay would have “moderate clinically important adverse influence on quality of life or survival.” In these cases, oncologists are “prescribing marginally less effective regimens that have lower risk of precipitating hospitalization,” the authors note.

These treatments include the use of “white cell growth factor, more stringent neutrophil counts for proceeding with a next cycle of therapy, and omitting use of steroids to manage nausea.” In addition, where possible, oncologists are substituting oral agents for intravenous agents and “myriad other modifications to minimize visits and hospitalizations.”

Most hospitals and outpatient infusion centers now prohibit visitors from accompanying patients, and oncologists are prioritizing conversations with patients about advance directives, healthcare proxies, and end-of-life care preferences. Yet, even here, telehealth offers a new, enhanced layer to those conversations by enabling families to gather with their loved one and the doctor, she said.

This article first appeared on Medscape.com.

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Oncologists need to advocate for scarce COVID-19 resources: ASCO

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As the COVID-19 pandemic forces rationing of ventilators, intensive care beds, and other resources, oncologists need to advocate for their patients and to support informed decision making as to resource allocation, both at the institutional and regional level, according to new recommendations from the American Society for Clinical Oncology (ASCO).

“There was a lot of concern from the oncology community that if a patient had cancer, they would be arbitrarily excluded from consideration for critical care resources,” said Jonathan M. Marron, MD, chair-elect of ASCO’s Ethics Committee and lead author of the recommendations.

“The hope is that we’ll never have to make any of these decisions ... but the primary reason for putting together these recommendations was that if such decisions have to be made, we hope to inform them,” he told Medscape Medical News.

Marron, who is a pediatric hematologist at Boston Children’s Hospital, says ASCO’s main recommendation is that decisions about the allocation of resources must be separated from bedside clinical care, meaning that clinicians who are caring for individual patients should not also be the ones making the allocation decisions.

“Those dueling responsibilities are a conflict of interest and make that physician unable to make an unbiased decision,” he said.

“It’s also just an unbearable burden to try and do those two things simultaneously,” he added. “It’s an incredible burden to do them individually, but it’s multifold worse to try to do them both simultaneously.”

He said the vital role of oncologists who provide treatment is to offer the kind of personalized information that triage committees need in order to make appropriate decisions.

“They should be asked – maybe even must be asked – to provide the most high-quality evidence-based data about their patients’ diagnosis and prognosis,” Marron commented. “Because oncology is evolving so rapidly, and cancer is so many different diseases, it’s impossible for someone making these decisions to know everything they would need to know about why this patient is likely to survive their cancer and this patient is not.”

He says that during the COVID-19 pandemic, concerns regarding public health transcend the well-being of individual patients and that consideration must be given to providing the maximum benefit to the greatest number of people.

“That makes perfect sense and is the appropriate and laudable goal during a public health emergency like this ... but one of the challenges is that there is this belief that a diagnosis of cancer is uniformly fatal,” Marron said.

“It’s certainly conceivable that it would be a better use of resources to give the last ventilator to a young, otherwise healthy patient rather than a patient with multiply recurrent progressive metastatic cancer,” he continued. “However, we want to ensure that there is at least a discussion where that information is made available, rather than just saying, ‘She’s got cancer. She’s a lost cause.’ ”
 

Cancer patients are doing very well

Concerns about cancer misconceptions have been circulating in the oncology community since the start of the pandemic. “It’s really important that people understand that cancer patients are doing very well nowadays, and even with a diagnosis of cancer, they can potentially live for many years,” Anne Chiang, MD, PhD, from the Smilow Cancer Network, New Haven, Connecticut, told Medscape Medical News in a recent interview.

Thus far, even in hard-hit New York City, fears that cancer patients may not be receiving appropriate care have not materialized, according to Mark Robson, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center (MSKCC). “I would emphasize that cancer patients are ABSOLUTELY getting the care they need, including patients with metastatic disease,” he recently tweeted. “NOONE at @sloan_kettering (or anywhere else) is being ‘triaged’ because of advanced cancer. Period.”

Robson told Medscape Medical News that although MSKCC continues to provide oncology care to patients with cancer, “we are [also] treating them if they develop COVID. ... I am trying to help pivot the institution towards care in this setting.”

He said he agrees with Craig Spencer, MD, MPH, director of global health in emergency medicine at the New York–Presbyterian/Columbia University Medical Center, who recently tweeted, “If you need a ventilator, you get a ventilator. Let’s be clear – this isn’t being ‘rationed.’ ”

Marron emphasized that an important safeguard against uninformed decision making is appropriate planning. For hospitalized patients, this means oncologists who provide treatment should offer information even before it is requested. But he said the “duty to plan” begins long before that.

“Clinicians haven’t always been great at talking about death and long-term outcomes with their patients, but this really cranks up the importance of having those conversations, and having them early, even though it’s incredibly hard. If someone has expressed that they would never want to be put on a ventilator, it’s important now even more so that is made clear,” he said.

He said early responses to the ASCO statement suggest that it has calmed some concerns in the oncology community, “but it still remains to be seen whether individual institutions will take this to heart, because this unto itself cannot enforce anything – it is up to individual institutions. I am hopeful this will get to the people it needs to get to.”

This article first appeared on Medscape.com.

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As the COVID-19 pandemic forces rationing of ventilators, intensive care beds, and other resources, oncologists need to advocate for their patients and to support informed decision making as to resource allocation, both at the institutional and regional level, according to new recommendations from the American Society for Clinical Oncology (ASCO).

“There was a lot of concern from the oncology community that if a patient had cancer, they would be arbitrarily excluded from consideration for critical care resources,” said Jonathan M. Marron, MD, chair-elect of ASCO’s Ethics Committee and lead author of the recommendations.

“The hope is that we’ll never have to make any of these decisions ... but the primary reason for putting together these recommendations was that if such decisions have to be made, we hope to inform them,” he told Medscape Medical News.

Marron, who is a pediatric hematologist at Boston Children’s Hospital, says ASCO’s main recommendation is that decisions about the allocation of resources must be separated from bedside clinical care, meaning that clinicians who are caring for individual patients should not also be the ones making the allocation decisions.

“Those dueling responsibilities are a conflict of interest and make that physician unable to make an unbiased decision,” he said.

“It’s also just an unbearable burden to try and do those two things simultaneously,” he added. “It’s an incredible burden to do them individually, but it’s multifold worse to try to do them both simultaneously.”

He said the vital role of oncologists who provide treatment is to offer the kind of personalized information that triage committees need in order to make appropriate decisions.

“They should be asked – maybe even must be asked – to provide the most high-quality evidence-based data about their patients’ diagnosis and prognosis,” Marron commented. “Because oncology is evolving so rapidly, and cancer is so many different diseases, it’s impossible for someone making these decisions to know everything they would need to know about why this patient is likely to survive their cancer and this patient is not.”

He says that during the COVID-19 pandemic, concerns regarding public health transcend the well-being of individual patients and that consideration must be given to providing the maximum benefit to the greatest number of people.

“That makes perfect sense and is the appropriate and laudable goal during a public health emergency like this ... but one of the challenges is that there is this belief that a diagnosis of cancer is uniformly fatal,” Marron said.

“It’s certainly conceivable that it would be a better use of resources to give the last ventilator to a young, otherwise healthy patient rather than a patient with multiply recurrent progressive metastatic cancer,” he continued. “However, we want to ensure that there is at least a discussion where that information is made available, rather than just saying, ‘She’s got cancer. She’s a lost cause.’ ”
 

Cancer patients are doing very well

Concerns about cancer misconceptions have been circulating in the oncology community since the start of the pandemic. “It’s really important that people understand that cancer patients are doing very well nowadays, and even with a diagnosis of cancer, they can potentially live for many years,” Anne Chiang, MD, PhD, from the Smilow Cancer Network, New Haven, Connecticut, told Medscape Medical News in a recent interview.

Thus far, even in hard-hit New York City, fears that cancer patients may not be receiving appropriate care have not materialized, according to Mark Robson, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center (MSKCC). “I would emphasize that cancer patients are ABSOLUTELY getting the care they need, including patients with metastatic disease,” he recently tweeted. “NOONE at @sloan_kettering (or anywhere else) is being ‘triaged’ because of advanced cancer. Period.”

Robson told Medscape Medical News that although MSKCC continues to provide oncology care to patients with cancer, “we are [also] treating them if they develop COVID. ... I am trying to help pivot the institution towards care in this setting.”

He said he agrees with Craig Spencer, MD, MPH, director of global health in emergency medicine at the New York–Presbyterian/Columbia University Medical Center, who recently tweeted, “If you need a ventilator, you get a ventilator. Let’s be clear – this isn’t being ‘rationed.’ ”

Marron emphasized that an important safeguard against uninformed decision making is appropriate planning. For hospitalized patients, this means oncologists who provide treatment should offer information even before it is requested. But he said the “duty to plan” begins long before that.

“Clinicians haven’t always been great at talking about death and long-term outcomes with their patients, but this really cranks up the importance of having those conversations, and having them early, even though it’s incredibly hard. If someone has expressed that they would never want to be put on a ventilator, it’s important now even more so that is made clear,” he said.

He said early responses to the ASCO statement suggest that it has calmed some concerns in the oncology community, “but it still remains to be seen whether individual institutions will take this to heart, because this unto itself cannot enforce anything – it is up to individual institutions. I am hopeful this will get to the people it needs to get to.”

This article first appeared on Medscape.com.

As the COVID-19 pandemic forces rationing of ventilators, intensive care beds, and other resources, oncologists need to advocate for their patients and to support informed decision making as to resource allocation, both at the institutional and regional level, according to new recommendations from the American Society for Clinical Oncology (ASCO).

“There was a lot of concern from the oncology community that if a patient had cancer, they would be arbitrarily excluded from consideration for critical care resources,” said Jonathan M. Marron, MD, chair-elect of ASCO’s Ethics Committee and lead author of the recommendations.

“The hope is that we’ll never have to make any of these decisions ... but the primary reason for putting together these recommendations was that if such decisions have to be made, we hope to inform them,” he told Medscape Medical News.

Marron, who is a pediatric hematologist at Boston Children’s Hospital, says ASCO’s main recommendation is that decisions about the allocation of resources must be separated from bedside clinical care, meaning that clinicians who are caring for individual patients should not also be the ones making the allocation decisions.

“Those dueling responsibilities are a conflict of interest and make that physician unable to make an unbiased decision,” he said.

“It’s also just an unbearable burden to try and do those two things simultaneously,” he added. “It’s an incredible burden to do them individually, but it’s multifold worse to try to do them both simultaneously.”

He said the vital role of oncologists who provide treatment is to offer the kind of personalized information that triage committees need in order to make appropriate decisions.

“They should be asked – maybe even must be asked – to provide the most high-quality evidence-based data about their patients’ diagnosis and prognosis,” Marron commented. “Because oncology is evolving so rapidly, and cancer is so many different diseases, it’s impossible for someone making these decisions to know everything they would need to know about why this patient is likely to survive their cancer and this patient is not.”

He says that during the COVID-19 pandemic, concerns regarding public health transcend the well-being of individual patients and that consideration must be given to providing the maximum benefit to the greatest number of people.

“That makes perfect sense and is the appropriate and laudable goal during a public health emergency like this ... but one of the challenges is that there is this belief that a diagnosis of cancer is uniformly fatal,” Marron said.

“It’s certainly conceivable that it would be a better use of resources to give the last ventilator to a young, otherwise healthy patient rather than a patient with multiply recurrent progressive metastatic cancer,” he continued. “However, we want to ensure that there is at least a discussion where that information is made available, rather than just saying, ‘She’s got cancer. She’s a lost cause.’ ”
 

Cancer patients are doing very well

Concerns about cancer misconceptions have been circulating in the oncology community since the start of the pandemic. “It’s really important that people understand that cancer patients are doing very well nowadays, and even with a diagnosis of cancer, they can potentially live for many years,” Anne Chiang, MD, PhD, from the Smilow Cancer Network, New Haven, Connecticut, told Medscape Medical News in a recent interview.

Thus far, even in hard-hit New York City, fears that cancer patients may not be receiving appropriate care have not materialized, according to Mark Robson, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center (MSKCC). “I would emphasize that cancer patients are ABSOLUTELY getting the care they need, including patients with metastatic disease,” he recently tweeted. “NOONE at @sloan_kettering (or anywhere else) is being ‘triaged’ because of advanced cancer. Period.”

Robson told Medscape Medical News that although MSKCC continues to provide oncology care to patients with cancer, “we are [also] treating them if they develop COVID. ... I am trying to help pivot the institution towards care in this setting.”

He said he agrees with Craig Spencer, MD, MPH, director of global health in emergency medicine at the New York–Presbyterian/Columbia University Medical Center, who recently tweeted, “If you need a ventilator, you get a ventilator. Let’s be clear – this isn’t being ‘rationed.’ ”

Marron emphasized that an important safeguard against uninformed decision making is appropriate planning. For hospitalized patients, this means oncologists who provide treatment should offer information even before it is requested. But he said the “duty to plan” begins long before that.

“Clinicians haven’t always been great at talking about death and long-term outcomes with their patients, but this really cranks up the importance of having those conversations, and having them early, even though it’s incredibly hard. If someone has expressed that they would never want to be put on a ventilator, it’s important now even more so that is made clear,” he said.

He said early responses to the ASCO statement suggest that it has calmed some concerns in the oncology community, “but it still remains to be seen whether individual institutions will take this to heart, because this unto itself cannot enforce anything – it is up to individual institutions. I am hopeful this will get to the people it needs to get to.”

This article first appeared on Medscape.com.

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ASCO announces its own COVID-19 and cancer registry

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Thu, 12/15/2022 - 17:37

Data will not be commercialized, unlike CancerLinQ

The American Society of Clinical Oncology (ASCO) has launched a registry to collect data on cancer patients with COVID-19 and is asking oncology practices across the United States to share information about their patients with the infection for educational purposes.

The new registry joins at least two other cancer and COVID-19 patient registries already underway in the U.S.

In a statement, ASCO President Howard “Skip” Burris III, MD said there is a need to know “how the virus is impacting our patients, their cancer treatment, and outcomes to inform current cancer care” and future care.

The web-based registry, known as the American Society of Clinical Oncology (ASCO) Survey on COVID-19 in Oncology Registry, is open to all U.S. oncology practices. Participating practices will receive an unspecified “nominal” payment for their data entry efforts.

The registry patient information will be stored on ASCO’s “Big Data” platform, known as CancerLinQ, but is being held apart from that pool of data. The registry information will not be available for commercial purposes, ASCO spokesperson Rachel Martin recently told Medscape Medical News.

Separately, CancerLinQ, which is a wholly owned subsidiary of ASCO, will continue to collect data from its participant oncology practices (as usual), including COVID-19 information.

CancerLinQ has been criticized by ethicists for allowing partner companies to sell access to its data (after stripping off patient identifiers), but without asking for patients’ permission, as reported last year by Medscape Medical News.

Eleven practices, including academic enterprises, have so far expressed interested in participating in the ASCO COVID-19 Registry.

Participating practices are requested to send in details about cancer patients with a confirmed COVID-19 diagnosis. As well as a baseline data capture form, they will need to provide details of subsequent status, treatment, and outcomes. Some patient-identifying data, including zip code, date of birth, gender, race, ethnicity, type of cancer, and comorbidities, will be collected for the purposes of analysis.

ASCO hopes to learn about characteristics of patients with cancer most impacted by COVID-19; estimates of disease severity; treatment modifications or delays; implementation of telemedicine in the cancer treatment setting; and clinical outcomes related to both COVID-19 and cancer.

ASCO says it will deliver periodic reports to the cancer community and the broader public on these and other “key learnings.” It also says that the registry is designed to capture point-in-time data as well as longitudinal data on how the virus will impact care and outcomes into 2021.

ASCO is not alone in its data collection efforts.

The COVID-19 and Cancer Consortium is already collecting information from more than 50 cancer centers and organizations on COVID-19 in patients with cancer. The American Society of Hematology (ASH) Research Collaborative COVID-19 Registry for Hematologic Malignancy is doing the same but with a focus on hematologic malignancies.

This article first appeared on Medscape.com.

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Data will not be commercialized, unlike CancerLinQ

Data will not be commercialized, unlike CancerLinQ

The American Society of Clinical Oncology (ASCO) has launched a registry to collect data on cancer patients with COVID-19 and is asking oncology practices across the United States to share information about their patients with the infection for educational purposes.

The new registry joins at least two other cancer and COVID-19 patient registries already underway in the U.S.

In a statement, ASCO President Howard “Skip” Burris III, MD said there is a need to know “how the virus is impacting our patients, their cancer treatment, and outcomes to inform current cancer care” and future care.

The web-based registry, known as the American Society of Clinical Oncology (ASCO) Survey on COVID-19 in Oncology Registry, is open to all U.S. oncology practices. Participating practices will receive an unspecified “nominal” payment for their data entry efforts.

The registry patient information will be stored on ASCO’s “Big Data” platform, known as CancerLinQ, but is being held apart from that pool of data. The registry information will not be available for commercial purposes, ASCO spokesperson Rachel Martin recently told Medscape Medical News.

Separately, CancerLinQ, which is a wholly owned subsidiary of ASCO, will continue to collect data from its participant oncology practices (as usual), including COVID-19 information.

CancerLinQ has been criticized by ethicists for allowing partner companies to sell access to its data (after stripping off patient identifiers), but without asking for patients’ permission, as reported last year by Medscape Medical News.

Eleven practices, including academic enterprises, have so far expressed interested in participating in the ASCO COVID-19 Registry.

Participating practices are requested to send in details about cancer patients with a confirmed COVID-19 diagnosis. As well as a baseline data capture form, they will need to provide details of subsequent status, treatment, and outcomes. Some patient-identifying data, including zip code, date of birth, gender, race, ethnicity, type of cancer, and comorbidities, will be collected for the purposes of analysis.

ASCO hopes to learn about characteristics of patients with cancer most impacted by COVID-19; estimates of disease severity; treatment modifications or delays; implementation of telemedicine in the cancer treatment setting; and clinical outcomes related to both COVID-19 and cancer.

ASCO says it will deliver periodic reports to the cancer community and the broader public on these and other “key learnings.” It also says that the registry is designed to capture point-in-time data as well as longitudinal data on how the virus will impact care and outcomes into 2021.

ASCO is not alone in its data collection efforts.

The COVID-19 and Cancer Consortium is already collecting information from more than 50 cancer centers and organizations on COVID-19 in patients with cancer. The American Society of Hematology (ASH) Research Collaborative COVID-19 Registry for Hematologic Malignancy is doing the same but with a focus on hematologic malignancies.

This article first appeared on Medscape.com.

The American Society of Clinical Oncology (ASCO) has launched a registry to collect data on cancer patients with COVID-19 and is asking oncology practices across the United States to share information about their patients with the infection for educational purposes.

The new registry joins at least two other cancer and COVID-19 patient registries already underway in the U.S.

In a statement, ASCO President Howard “Skip” Burris III, MD said there is a need to know “how the virus is impacting our patients, their cancer treatment, and outcomes to inform current cancer care” and future care.

The web-based registry, known as the American Society of Clinical Oncology (ASCO) Survey on COVID-19 in Oncology Registry, is open to all U.S. oncology practices. Participating practices will receive an unspecified “nominal” payment for their data entry efforts.

The registry patient information will be stored on ASCO’s “Big Data” platform, known as CancerLinQ, but is being held apart from that pool of data. The registry information will not be available for commercial purposes, ASCO spokesperson Rachel Martin recently told Medscape Medical News.

Separately, CancerLinQ, which is a wholly owned subsidiary of ASCO, will continue to collect data from its participant oncology practices (as usual), including COVID-19 information.

CancerLinQ has been criticized by ethicists for allowing partner companies to sell access to its data (after stripping off patient identifiers), but without asking for patients’ permission, as reported last year by Medscape Medical News.

Eleven practices, including academic enterprises, have so far expressed interested in participating in the ASCO COVID-19 Registry.

Participating practices are requested to send in details about cancer patients with a confirmed COVID-19 diagnosis. As well as a baseline data capture form, they will need to provide details of subsequent status, treatment, and outcomes. Some patient-identifying data, including zip code, date of birth, gender, race, ethnicity, type of cancer, and comorbidities, will be collected for the purposes of analysis.

ASCO hopes to learn about characteristics of patients with cancer most impacted by COVID-19; estimates of disease severity; treatment modifications or delays; implementation of telemedicine in the cancer treatment setting; and clinical outcomes related to both COVID-19 and cancer.

ASCO says it will deliver periodic reports to the cancer community and the broader public on these and other “key learnings.” It also says that the registry is designed to capture point-in-time data as well as longitudinal data on how the virus will impact care and outcomes into 2021.

ASCO is not alone in its data collection efforts.

The COVID-19 and Cancer Consortium is already collecting information from more than 50 cancer centers and organizations on COVID-19 in patients with cancer. The American Society of Hematology (ASH) Research Collaborative COVID-19 Registry for Hematologic Malignancy is doing the same but with a focus on hematologic malignancies.

This article first appeared on Medscape.com.

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