Patient & Survivor Care

Background Prostate cancer affects not only men with the disease, but their partners and families as well. These affects can include changes to everyday lifestyle activities, incontinence, and sexual dysfunction, and sometimes, relationships.

Click on the PDF icon at the top of this introduction to read the full article.

Background Prostate cancer affects not only men with the disease, but their partners and families as well. These affects can include changes to everyday lifestyle activities, incontinence, and sexual dysfunction, and sometimes, relationships.

Click on the PDF icon at the top of this introduction to read the full article.

Background Prostate cancer affects not only men with the disease, but their partners and families as well. These affects can include changes to everyday lifestyle activities, incontinence, and sexual dysfunction, and sometimes, relationships.

Click on the PDF icon at the top of this introduction to read the full article.

The dentition of head and neck cancer patients is of utmost importance when they receive radiation therapy, especially because patients are living longer after a course of head and neck radiation. Good communication among the oncology team members (the radiation and medical oncologists, the maxillofacial prosthodontist/dental oncologist, otolaryngologist, reconstructive surgeon, nursing support) and the patient is essential initially, and subsequently including the general dentist as well. The aim of this primer for all those caring for patients with head and neck cancer is to underscore the important role of the dental oncologist during all phases of radiation therapy, and to provide guidelines to minimize and prevent dental complications such as radiation-induced caries and ORN.

Click on the PDF icon at the top of this introduction to read the full article.

The dentition of head and neck cancer patients is of utmost importance when they receive radiation therapy, especially because patients are living longer after a course of head and neck radiation. Good communication among the oncology team members (the radiation and medical oncologists, the maxillofacial prosthodontist/dental oncologist, otolaryngologist, reconstructive surgeon, nursing support) and the patient is essential initially, and subsequently including the general dentist as well. The aim of this primer for all those caring for patients with head and neck cancer is to underscore the important role of the dental oncologist during all phases of radiation therapy, and to provide guidelines to minimize and prevent dental complications such as radiation-induced caries and ORN.

Click on the PDF icon at the top of this introduction to read the full article.

The dentition of head and neck cancer patients is of utmost importance when they receive radiation therapy, especially because patients are living longer after a course of head and neck radiation. Good communication among the oncology team members (the radiation and medical oncologists, the maxillofacial prosthodontist/dental oncologist, otolaryngologist, reconstructive surgeon, nursing support) and the patient is essential initially, and subsequently including the general dentist as well. The aim of this primer for all those caring for patients with head and neck cancer is to underscore the important role of the dental oncologist during all phases of radiation therapy, and to provide guidelines to minimize and prevent dental complications such as radiation-induced caries and ORN.

Click on the PDF icon at the top of this introduction to read the full article.

There is increased anxiety and depression among family caregivers who do not take care of themselves, according to a study to be presented at the 2016 ASCO Palliative Care in Oncology Symposium.

Nearly a quarter of 294 caregivers of Medicare patients with advanced cancer reported high depression scores (23%) and 34% reported borderline or high anxiety scores. Worse caregiver anxiety, depression, and mental health–related quality of life scores were significantly associated with lower scores in every self-care measure (P less than .05 for all). Lower self-care behavior scores were associated with longer durations, higher hours, and more days/week of caregiving and with fair or poor patient health.

The cross-sectional survey was conducted in community settings of eight cancer centers in Alabama, Florida, and Tennessee. The family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head & neck, hematologic, or stage IV cancer completed measures of self-care behaviors, including health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, stress management, and sleep. Caregivers averaged 66 years and were mostly female (72.8%), white (91.2%), Protestant (76.2%), retired (54.4%), and patients’ spouse/partner (60.2%). Approximately half were rural dwellers (46.9%) and had incomes less than $50,000 (53.8%). The majority provided support 6-7 days per week (71%) for greater than 1 year (68%).

“This research serves as an important call to action for the oncology community to implement support networks and services that care for the caregiver,” ASCO representative Andrew Epstein, MD, of Memorial Sloan Kettering Cancer Center, New York, said in a written statement ahead of the symposium.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” lead author James Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham, said in the statement.

[email protected]

On Twitter @jessnicolecraig

There is increased anxiety and depression among family caregivers who do not take care of themselves, according to a study to be presented at the 2016 ASCO Palliative Care in Oncology Symposium.

Nearly a quarter of 294 caregivers of Medicare patients with advanced cancer reported high depression scores (23%) and 34% reported borderline or high anxiety scores. Worse caregiver anxiety, depression, and mental health–related quality of life scores were significantly associated with lower scores in every self-care measure (P less than .05 for all). Lower self-care behavior scores were associated with longer durations, higher hours, and more days/week of caregiving and with fair or poor patient health.

The cross-sectional survey was conducted in community settings of eight cancer centers in Alabama, Florida, and Tennessee. The family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head & neck, hematologic, or stage IV cancer completed measures of self-care behaviors, including health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, stress management, and sleep. Caregivers averaged 66 years and were mostly female (72.8%), white (91.2%), Protestant (76.2%), retired (54.4%), and patients’ spouse/partner (60.2%). Approximately half were rural dwellers (46.9%) and had incomes less than $50,000 (53.8%). The majority provided support 6-7 days per week (71%) for greater than 1 year (68%).

“This research serves as an important call to action for the oncology community to implement support networks and services that care for the caregiver,” ASCO representative Andrew Epstein, MD, of Memorial Sloan Kettering Cancer Center, New York, said in a written statement ahead of the symposium.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” lead author James Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham, said in the statement.

[email protected]

On Twitter @jessnicolecraig

There is increased anxiety and depression among family caregivers who do not take care of themselves, according to a study to be presented at the 2016 ASCO Palliative Care in Oncology Symposium.

Nearly a quarter of 294 caregivers of Medicare patients with advanced cancer reported high depression scores (23%) and 34% reported borderline or high anxiety scores. Worse caregiver anxiety, depression, and mental health–related quality of life scores were significantly associated with lower scores in every self-care measure (P less than .05 for all). Lower self-care behavior scores were associated with longer durations, higher hours, and more days/week of caregiving and with fair or poor patient health.

The cross-sectional survey was conducted in community settings of eight cancer centers in Alabama, Florida, and Tennessee. The family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head & neck, hematologic, or stage IV cancer completed measures of self-care behaviors, including health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, stress management, and sleep. Caregivers averaged 66 years and were mostly female (72.8%), white (91.2%), Protestant (76.2%), retired (54.4%), and patients’ spouse/partner (60.2%). Approximately half were rural dwellers (46.9%) and had incomes less than $50,000 (53.8%). The majority provided support 6-7 days per week (71%) for greater than 1 year (68%).

“This research serves as an important call to action for the oncology community to implement support networks and services that care for the caregiver,” ASCO representative Andrew Epstein, MD, of Memorial Sloan Kettering Cancer Center, New York, said in a written statement ahead of the symposium.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” lead author James Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham, said in the statement.

[email protected]

On Twitter @jessnicolecraig

Whole brain radiotherapy, a standard treatment for patients with metastatic non–small-cell lung cancer, provided no clinical benefit in a noninferiority trial specifically designed to assess both patient survival and quality of life.

The findings were published online Sept. 4 in the Lancet.

Whole brain radiotherapy, with or without concomitant steroid treatment, has been widely used for decades in that patient population, even though no sufficiently powered, definitive studies support the approach. It is likely that patients and clinicians alike continue to embrace it because of the absence of alternative treatment options.

The Quality of Life After Treatment for Brain Metastases (QUARTZ) trial was intended to assess whether any improvement in survival offered by whole brain radiotherapy is balanced by deterioration in quality of life, said Paula Mulvenna, MBBS, of the Northern Center for Cancer Care, Newcastle (England) Hospitals, and her associates (Lancet 2016 Sep 4. doi: 10.1016/S0140-6736(16)30825-X).

QUARTZ involved 538 adults seen during a 7-year period who had NSCLC with brain metastases and who were not suited for either brain surgery or stereotactic radiotherapy. The median age was 66 years (range, 35-85 years), and 38% had a Karnofsky Performance Status score of less than 70.

The participants were randomly assigned to receive either optimal supportive care plus whole brain radiotherapy (269 patients) or optimal supportive care alone (269 patients) at 69 U.K. and 3 Australian medical centers. They reported on 20 symptoms and adverse effects, as well as health-related quality of life, approximately once per week.

The primary outcome measure – quality-adjusted life-years (QALY), which combines overall survival and quality of life – was 46.4 days with radiotherapy and 41.7 days without it.

Symptoms, adverse effects, and quality of life (QOL) were similar between the two study groups at 4 weeks, except that the radiotherapy group reported more moderate or severe episodes of drowsiness, hair loss, nausea, and dry or itchy scalp. The number and severity of serious adverse events were similar through 12 weeks of follow-up.

The percentage of patients whose QOL was either maintained or improved over time was similar between the two groups at 4 weeks (54% vs. 57%), 8 weeks (44% vs. 51%), and 12 weeks (44% vs. 49%). Changes in Karnofsky scores also were similar.

The study refuted the widely held belief that whole brain radiotherapy allows patients to reduce or discontinue steroid treatment, averting the associated adverse effects. Steroid doses were not significantly different between the two study groups through the first 8 weeks of treatment, which “challenges the dogma that whole brain radiotherapy can be seen as a steroid-sparing modality,” the investigators said.

Taken together, the findings “suggest that whole brain radiotherapy can be omitted and patients treated with optimal supportive care alone, without an important reduction in either overall survival or quality of life,” Dr. Mulvenna and her associates said.

The approximately 5-day difference between the two study groups in median overall survival highlights both the limited benefit offered by radiotherapy and the poor prognosis of this patient population, the researchers added.

Whole brain radiotherapy did offer a small survival benefit to the youngest patients who had good performance status and a “controlled” primary NSCLC. “For all other groups, [it] does not significantly affect QALY or overall survival,” they said.

Cancer Research U.K., the Medical Research Council in the U.K., the Trans Tasman Radiation Oncology Group, and the National Health and Medical Research Council Australia supported the study. Dr. Mulvenna and her associates reported having no relevant financial disclosures.

Whole brain radiotherapy, a standard treatment for patients with metastatic non–small-cell lung cancer, provided no clinical benefit in a noninferiority trial specifically designed to assess both patient survival and quality of life.

The findings were published online Sept. 4 in the Lancet.

Whole brain radiotherapy, with or without concomitant steroid treatment, has been widely used for decades in that patient population, even though no sufficiently powered, definitive studies support the approach. It is likely that patients and clinicians alike continue to embrace it because of the absence of alternative treatment options.

The Quality of Life After Treatment for Brain Metastases (QUARTZ) trial was intended to assess whether any improvement in survival offered by whole brain radiotherapy is balanced by deterioration in quality of life, said Paula Mulvenna, MBBS, of the Northern Center for Cancer Care, Newcastle (England) Hospitals, and her associates (Lancet 2016 Sep 4. doi: 10.1016/S0140-6736(16)30825-X).

QUARTZ involved 538 adults seen during a 7-year period who had NSCLC with brain metastases and who were not suited for either brain surgery or stereotactic radiotherapy. The median age was 66 years (range, 35-85 years), and 38% had a Karnofsky Performance Status score of less than 70.

The participants were randomly assigned to receive either optimal supportive care plus whole brain radiotherapy (269 patients) or optimal supportive care alone (269 patients) at 69 U.K. and 3 Australian medical centers. They reported on 20 symptoms and adverse effects, as well as health-related quality of life, approximately once per week.

The primary outcome measure – quality-adjusted life-years (QALY), which combines overall survival and quality of life – was 46.4 days with radiotherapy and 41.7 days without it.

Symptoms, adverse effects, and quality of life (QOL) were similar between the two study groups at 4 weeks, except that the radiotherapy group reported more moderate or severe episodes of drowsiness, hair loss, nausea, and dry or itchy scalp. The number and severity of serious adverse events were similar through 12 weeks of follow-up.

The percentage of patients whose QOL was either maintained or improved over time was similar between the two groups at 4 weeks (54% vs. 57%), 8 weeks (44% vs. 51%), and 12 weeks (44% vs. 49%). Changes in Karnofsky scores also were similar.

The study refuted the widely held belief that whole brain radiotherapy allows patients to reduce or discontinue steroid treatment, averting the associated adverse effects. Steroid doses were not significantly different between the two study groups through the first 8 weeks of treatment, which “challenges the dogma that whole brain radiotherapy can be seen as a steroid-sparing modality,” the investigators said.

Taken together, the findings “suggest that whole brain radiotherapy can be omitted and patients treated with optimal supportive care alone, without an important reduction in either overall survival or quality of life,” Dr. Mulvenna and her associates said.

The approximately 5-day difference between the two study groups in median overall survival highlights both the limited benefit offered by radiotherapy and the poor prognosis of this patient population, the researchers added.

Whole brain radiotherapy did offer a small survival benefit to the youngest patients who had good performance status and a “controlled” primary NSCLC. “For all other groups, [it] does not significantly affect QALY or overall survival,” they said.

Cancer Research U.K., the Medical Research Council in the U.K., the Trans Tasman Radiation Oncology Group, and the National Health and Medical Research Council Australia supported the study. Dr. Mulvenna and her associates reported having no relevant financial disclosures.

Whole brain radiotherapy, a standard treatment for patients with metastatic non–small-cell lung cancer, provided no clinical benefit in a noninferiority trial specifically designed to assess both patient survival and quality of life.

The findings were published online Sept. 4 in the Lancet.

Whole brain radiotherapy, with or without concomitant steroid treatment, has been widely used for decades in that patient population, even though no sufficiently powered, definitive studies support the approach. It is likely that patients and clinicians alike continue to embrace it because of the absence of alternative treatment options.

The Quality of Life After Treatment for Brain Metastases (QUARTZ) trial was intended to assess whether any improvement in survival offered by whole brain radiotherapy is balanced by deterioration in quality of life, said Paula Mulvenna, MBBS, of the Northern Center for Cancer Care, Newcastle (England) Hospitals, and her associates (Lancet 2016 Sep 4. doi: 10.1016/S0140-6736(16)30825-X).

QUARTZ involved 538 adults seen during a 7-year period who had NSCLC with brain metastases and who were not suited for either brain surgery or stereotactic radiotherapy. The median age was 66 years (range, 35-85 years), and 38% had a Karnofsky Performance Status score of less than 70.

The participants were randomly assigned to receive either optimal supportive care plus whole brain radiotherapy (269 patients) or optimal supportive care alone (269 patients) at 69 U.K. and 3 Australian medical centers. They reported on 20 symptoms and adverse effects, as well as health-related quality of life, approximately once per week.

The primary outcome measure – quality-adjusted life-years (QALY), which combines overall survival and quality of life – was 46.4 days with radiotherapy and 41.7 days without it.

Symptoms, adverse effects, and quality of life (QOL) were similar between the two study groups at 4 weeks, except that the radiotherapy group reported more moderate or severe episodes of drowsiness, hair loss, nausea, and dry or itchy scalp. The number and severity of serious adverse events were similar through 12 weeks of follow-up.

The percentage of patients whose QOL was either maintained or improved over time was similar between the two groups at 4 weeks (54% vs. 57%), 8 weeks (44% vs. 51%), and 12 weeks (44% vs. 49%). Changes in Karnofsky scores also were similar.

The study refuted the widely held belief that whole brain radiotherapy allows patients to reduce or discontinue steroid treatment, averting the associated adverse effects. Steroid doses were not significantly different between the two study groups through the first 8 weeks of treatment, which “challenges the dogma that whole brain radiotherapy can be seen as a steroid-sparing modality,” the investigators said.

Taken together, the findings “suggest that whole brain radiotherapy can be omitted and patients treated with optimal supportive care alone, without an important reduction in either overall survival or quality of life,” Dr. Mulvenna and her associates said.

The approximately 5-day difference between the two study groups in median overall survival highlights both the limited benefit offered by radiotherapy and the poor prognosis of this patient population, the researchers added.

Whole brain radiotherapy did offer a small survival benefit to the youngest patients who had good performance status and a “controlled” primary NSCLC. “For all other groups, [it] does not significantly affect QALY or overall survival,” they said.

Cancer Research U.K., the Medical Research Council in the U.K., the Trans Tasman Radiation Oncology Group, and the National Health and Medical Research Council Australia supported the study. Dr. Mulvenna and her associates reported having no relevant financial disclosures.

A study of cancer patients enrolled in trials of the programmed cell death-1 inhibiting medicine nivolumab found that among a minority who developed pneumonitis during treatment, distinct radiographic patterns were significantly associated with the level of pneumonitis severity.

Investigators found that cryptic organizing pneumonia pattern (COP) was the most common, though not the most severe. Led by Mizuki Nishino, MD, of Brigham and Women’s Hospital, Boston, the researchers looked at the 20 patients out of a cohort of 170 (11.8%) who had developed pneumonitis, and found that radiologic patterns indicating acute interstitial pneumonia/acute respiratory distress syndrome (n = 2) had the highest severity grade on a scale of 1-5 (median 3), followed by those with COP pattern (n = 13, median grade 2), hypersensitivity pneumonitis (n = 2, median grade 1), and nonspecific interstitial pneumonia (n = 3, median grade 1). The pattern was significantly associated with severity (P = .0006).

The study cohort included patients being treated with nivolumab for lung cancer, melanoma, and lymphoma; the COP patten was the most common across tumor types and observed in patients receiving monotherapy and combination therapy alike. Therapy with nivolumab was suspended for all 20 pneumonitis patients, and most (n = 17) received treatment for pneumonitis with corticosteroids with or without infliximab, for a median treatment time of 6 weeks. Seven patients were able to restart nivolumab, though pneumonitis recurred in two, the investigators reported (Clin Cancer Res. 2016 Aug 17. doi: 10.1158/1078-0432.CCR-16-1320).

“Time from initiation of therapy to the development of pneumonitis had a wide range (0.5-11.5 months), indicating an importance of careful observation and follow-up for signs and symptoms of pneumonitis throughout treatment,” Dr. Nishino and colleagues wrote in their analysis, adding that shorter times were observed for lung cancer patients, possibly because of their higher pulmonary burden, a lower threshold for performing chest scans in these patients, or both. “In most patients, clinical and radiographic improvements were noted after treatment, indicating that [PD-1 inhibitor-related pneumonitis], although potentially serious, is treatable if diagnosed and managed appropriately. The observation emphasizes the importance of timely recognition, accurate diagnosis, and early intervention.”

The lead author and several coauthors disclosed funding from Bristol-Myers Squibb, which sponsored the trial, as well as from other manufacturers.

A study of cancer patients enrolled in trials of the programmed cell death-1 inhibiting medicine nivolumab found that among a minority who developed pneumonitis during treatment, distinct radiographic patterns were significantly associated with the level of pneumonitis severity.

Investigators found that cryptic organizing pneumonia pattern (COP) was the most common, though not the most severe. Led by Mizuki Nishino, MD, of Brigham and Women’s Hospital, Boston, the researchers looked at the 20 patients out of a cohort of 170 (11.8%) who had developed pneumonitis, and found that radiologic patterns indicating acute interstitial pneumonia/acute respiratory distress syndrome (n = 2) had the highest severity grade on a scale of 1-5 (median 3), followed by those with COP pattern (n = 13, median grade 2), hypersensitivity pneumonitis (n = 2, median grade 1), and nonspecific interstitial pneumonia (n = 3, median grade 1). The pattern was significantly associated with severity (P = .0006).

The study cohort included patients being treated with nivolumab for lung cancer, melanoma, and lymphoma; the COP patten was the most common across tumor types and observed in patients receiving monotherapy and combination therapy alike. Therapy with nivolumab was suspended for all 20 pneumonitis patients, and most (n = 17) received treatment for pneumonitis with corticosteroids with or without infliximab, for a median treatment time of 6 weeks. Seven patients were able to restart nivolumab, though pneumonitis recurred in two, the investigators reported (Clin Cancer Res. 2016 Aug 17. doi: 10.1158/1078-0432.CCR-16-1320).

“Time from initiation of therapy to the development of pneumonitis had a wide range (0.5-11.5 months), indicating an importance of careful observation and follow-up for signs and symptoms of pneumonitis throughout treatment,” Dr. Nishino and colleagues wrote in their analysis, adding that shorter times were observed for lung cancer patients, possibly because of their higher pulmonary burden, a lower threshold for performing chest scans in these patients, or both. “In most patients, clinical and radiographic improvements were noted after treatment, indicating that [PD-1 inhibitor-related pneumonitis], although potentially serious, is treatable if diagnosed and managed appropriately. The observation emphasizes the importance of timely recognition, accurate diagnosis, and early intervention.”

The lead author and several coauthors disclosed funding from Bristol-Myers Squibb, which sponsored the trial, as well as from other manufacturers.

A study of cancer patients enrolled in trials of the programmed cell death-1 inhibiting medicine nivolumab found that among a minority who developed pneumonitis during treatment, distinct radiographic patterns were significantly associated with the level of pneumonitis severity.

Investigators found that cryptic organizing pneumonia pattern (COP) was the most common, though not the most severe. Led by Mizuki Nishino, MD, of Brigham and Women’s Hospital, Boston, the researchers looked at the 20 patients out of a cohort of 170 (11.8%) who had developed pneumonitis, and found that radiologic patterns indicating acute interstitial pneumonia/acute respiratory distress syndrome (n = 2) had the highest severity grade on a scale of 1-5 (median 3), followed by those with COP pattern (n = 13, median grade 2), hypersensitivity pneumonitis (n = 2, median grade 1), and nonspecific interstitial pneumonia (n = 3, median grade 1). The pattern was significantly associated with severity (P = .0006).

The study cohort included patients being treated with nivolumab for lung cancer, melanoma, and lymphoma; the COP patten was the most common across tumor types and observed in patients receiving monotherapy and combination therapy alike. Therapy with nivolumab was suspended for all 20 pneumonitis patients, and most (n = 17) received treatment for pneumonitis with corticosteroids with or without infliximab, for a median treatment time of 6 weeks. Seven patients were able to restart nivolumab, though pneumonitis recurred in two, the investigators reported (Clin Cancer Res. 2016 Aug 17. doi: 10.1158/1078-0432.CCR-16-1320).

“Time from initiation of therapy to the development of pneumonitis had a wide range (0.5-11.5 months), indicating an importance of careful observation and follow-up for signs and symptoms of pneumonitis throughout treatment,” Dr. Nishino and colleagues wrote in their analysis, adding that shorter times were observed for lung cancer patients, possibly because of their higher pulmonary burden, a lower threshold for performing chest scans in these patients, or both. “In most patients, clinical and radiographic improvements were noted after treatment, indicating that [PD-1 inhibitor-related pneumonitis], although potentially serious, is treatable if diagnosed and managed appropriately. The observation emphasizes the importance of timely recognition, accurate diagnosis, and early intervention.”

The lead author and several coauthors disclosed funding from Bristol-Myers Squibb, which sponsored the trial, as well as from other manufacturers.

SAN DIEGO – An investigational extended-release formulation of granisetron outperformed ondansetron as a component of triple-drug antiemetic therapy for patients on cisplatin-based highly emetogenic chemotherapy, Dr. Lee Schwartzberg reported at the annual meeting of the Society of Gynecologic Oncology.

He presented a post hoc subgroup analysis drawn from the previously reported pivotal phase III 942-patient MAGIC trial of extended-release granisetron (Sustol), formerly known as APF530, versus ondansetron (Zofran) as part of the triple-drug antiemetic regimen recommended in National Community Cancer Network guidelines for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients on highly emetogenic chemotherapy .

©BluePlanetEarth/thinkstockphotos.com

Dr. Schwartzberg and coinvestigators focused on the 251 MAGIC participants on high-dose cisplatin-based chemotherapy. The reason? Few studies have examined the management of CINV in patients on platinum-based regimens, commonly used in treating gynecologic cancers, explained Dr. Schwartzberg, medical director of the West Clinic in Memphis.

Sustol consists of 2% granisetron in a proprietary slow-release vehicle. A single 500-mg subcutaneous dose containing 10 mg of granisetron maintains therapeutic blood levels of granisetron for 5 days or longer. These pharmacokinetics make APF530 an attractive strategy for preventing both acute and delayed chemotherapy-induced nausea and vomiting. The delayed phase, which affects many cancer patients 2-5 days following administration of chemotherapy, has traditionally been a particularly difficult management challenge.

National Community Cancer Network guidelines recommend that patients on highly emetogenic chemotherapy receive a potent three-drug antiemetic regimen consisting of a 5-hydroxytryptoamine-3 receptor antagonist – ondansetron and granisetron fall within this class – along with a neurokinin-1 receptor antagonist and dexamethasone.

MAGIC was a double-blind, prospective, multicenter trial in which 942 patients on highly emetogenic chemotherapy received either 500 mg of subcutaneous extended-release granisetron or intravenous ondansetron at 0.15 mg/kg. In addition, all participants concomitantly got 150 mg of the neurokinin-1 receptor antagonist fosaprepitant (Emend) plus 12 mg of IV dexamethasone on day 1, followed by 8 mg of oral dexamethasone once on day 2 and 8 mg twice daily on days 3 and 4.

In the overall trial, extended-release granisetron significantly outperformed ondansetron. The primary endpoint – complete response defined as no emesis and no use of rescue medication for CINV during the delayed phase – was achieved in 64.7% of the Sustol group, compared with 56.6% on ondansetron.

Results in Dr. Schwartzberg’s post hoc analysis confined to the 251 randomized patients on high-dose cisplatin-based chemotherapy paralleled those in the overall trial: a 64.8% complete response rate in the delayed phase in the granisetron group versus 56.3% with ondansetron. That absolute 8.5% difference favoring the investigational agent translates to a number needed to treat (NNT) of 12.

In the 112 women on highly emetogenic cisplatin-based chemotherapy, the complete response rates in the delayed phase were 61.6% with extended-release granisetron and 53.2% with ondansetron, for an absolute 10.3% difference and an NNT of 10.

Heron Therapeutics, which is developing extended-release granisetron, is awaiting word from the Food and Drug Administration regarding the company’s application for marketing approval.

The MAGIC trial was sponsored by Heron Therapeutics. Dr. Schwartzberg is a consultant to the company.

[email protected]

SAN DIEGO – An investigational extended-release formulation of granisetron outperformed ondansetron as a component of triple-drug antiemetic therapy for patients on cisplatin-based highly emetogenic chemotherapy, Dr. Lee Schwartzberg reported at the annual meeting of the Society of Gynecologic Oncology.

He presented a post hoc subgroup analysis drawn from the previously reported pivotal phase III 942-patient MAGIC trial of extended-release granisetron (Sustol), formerly known as APF530, versus ondansetron (Zofran) as part of the triple-drug antiemetic regimen recommended in National Community Cancer Network guidelines for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients on highly emetogenic chemotherapy .

©BluePlanetEarth/thinkstockphotos.com

Dr. Schwartzberg and coinvestigators focused on the 251 MAGIC participants on high-dose cisplatin-based chemotherapy. The reason? Few studies have examined the management of CINV in patients on platinum-based regimens, commonly used in treating gynecologic cancers, explained Dr. Schwartzberg, medical director of the West Clinic in Memphis.

Sustol consists of 2% granisetron in a proprietary slow-release vehicle. A single 500-mg subcutaneous dose containing 10 mg of granisetron maintains therapeutic blood levels of granisetron for 5 days or longer. These pharmacokinetics make APF530 an attractive strategy for preventing both acute and delayed chemotherapy-induced nausea and vomiting. The delayed phase, which affects many cancer patients 2-5 days following administration of chemotherapy, has traditionally been a particularly difficult management challenge.

National Community Cancer Network guidelines recommend that patients on highly emetogenic chemotherapy receive a potent three-drug antiemetic regimen consisting of a 5-hydroxytryptoamine-3 receptor antagonist – ondansetron and granisetron fall within this class – along with a neurokinin-1 receptor antagonist and dexamethasone.

MAGIC was a double-blind, prospective, multicenter trial in which 942 patients on highly emetogenic chemotherapy received either 500 mg of subcutaneous extended-release granisetron or intravenous ondansetron at 0.15 mg/kg. In addition, all participants concomitantly got 150 mg of the neurokinin-1 receptor antagonist fosaprepitant (Emend) plus 12 mg of IV dexamethasone on day 1, followed by 8 mg of oral dexamethasone once on day 2 and 8 mg twice daily on days 3 and 4.

In the overall trial, extended-release granisetron significantly outperformed ondansetron. The primary endpoint – complete response defined as no emesis and no use of rescue medication for CINV during the delayed phase – was achieved in 64.7% of the Sustol group, compared with 56.6% on ondansetron.

Results in Dr. Schwartzberg’s post hoc analysis confined to the 251 randomized patients on high-dose cisplatin-based chemotherapy paralleled those in the overall trial: a 64.8% complete response rate in the delayed phase in the granisetron group versus 56.3% with ondansetron. That absolute 8.5% difference favoring the investigational agent translates to a number needed to treat (NNT) of 12.

In the 112 women on highly emetogenic cisplatin-based chemotherapy, the complete response rates in the delayed phase were 61.6% with extended-release granisetron and 53.2% with ondansetron, for an absolute 10.3% difference and an NNT of 10.

Heron Therapeutics, which is developing extended-release granisetron, is awaiting word from the Food and Drug Administration regarding the company’s application for marketing approval.

The MAGIC trial was sponsored by Heron Therapeutics. Dr. Schwartzberg is a consultant to the company.

[email protected]

SAN DIEGO – An investigational extended-release formulation of granisetron outperformed ondansetron as a component of triple-drug antiemetic therapy for patients on cisplatin-based highly emetogenic chemotherapy, Dr. Lee Schwartzberg reported at the annual meeting of the Society of Gynecologic Oncology.

He presented a post hoc subgroup analysis drawn from the previously reported pivotal phase III 942-patient MAGIC trial of extended-release granisetron (Sustol), formerly known as APF530, versus ondansetron (Zofran) as part of the triple-drug antiemetic regimen recommended in National Community Cancer Network guidelines for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients on highly emetogenic chemotherapy .

©BluePlanetEarth/thinkstockphotos.com

Dr. Schwartzberg and coinvestigators focused on the 251 MAGIC participants on high-dose cisplatin-based chemotherapy. The reason? Few studies have examined the management of CINV in patients on platinum-based regimens, commonly used in treating gynecologic cancers, explained Dr. Schwartzberg, medical director of the West Clinic in Memphis.

Sustol consists of 2% granisetron in a proprietary slow-release vehicle. A single 500-mg subcutaneous dose containing 10 mg of granisetron maintains therapeutic blood levels of granisetron for 5 days or longer. These pharmacokinetics make APF530 an attractive strategy for preventing both acute and delayed chemotherapy-induced nausea and vomiting. The delayed phase, which affects many cancer patients 2-5 days following administration of chemotherapy, has traditionally been a particularly difficult management challenge.

National Community Cancer Network guidelines recommend that patients on highly emetogenic chemotherapy receive a potent three-drug antiemetic regimen consisting of a 5-hydroxytryptoamine-3 receptor antagonist – ondansetron and granisetron fall within this class – along with a neurokinin-1 receptor antagonist and dexamethasone.

MAGIC was a double-blind, prospective, multicenter trial in which 942 patients on highly emetogenic chemotherapy received either 500 mg of subcutaneous extended-release granisetron or intravenous ondansetron at 0.15 mg/kg. In addition, all participants concomitantly got 150 mg of the neurokinin-1 receptor antagonist fosaprepitant (Emend) plus 12 mg of IV dexamethasone on day 1, followed by 8 mg of oral dexamethasone once on day 2 and 8 mg twice daily on days 3 and 4.

In the overall trial, extended-release granisetron significantly outperformed ondansetron. The primary endpoint – complete response defined as no emesis and no use of rescue medication for CINV during the delayed phase – was achieved in 64.7% of the Sustol group, compared with 56.6% on ondansetron.

Results in Dr. Schwartzberg’s post hoc analysis confined to the 251 randomized patients on high-dose cisplatin-based chemotherapy paralleled those in the overall trial: a 64.8% complete response rate in the delayed phase in the granisetron group versus 56.3% with ondansetron. That absolute 8.5% difference favoring the investigational agent translates to a number needed to treat (NNT) of 12.

In the 112 women on highly emetogenic cisplatin-based chemotherapy, the complete response rates in the delayed phase were 61.6% with extended-release granisetron and 53.2% with ondansetron, for an absolute 10.3% difference and an NNT of 10.

Heron Therapeutics, which is developing extended-release granisetron, is awaiting word from the Food and Drug Administration regarding the company’s application for marketing approval.

The MAGIC trial was sponsored by Heron Therapeutics. Dr. Schwartzberg is a consultant to the company.

[email protected]

NEWPORT BEACH, CALIF. – In medical school you may have been taught that herpes zoster infection primarily impacts elderly patients, but the burden of disease is shifting – along with the understanding of herpes zoster itself.

“Herpes zoster is a disease that can lull us into a false sense of security because we see it all the time,” Iris Ahronowitz, MD, said at the annual meeting of the Pacific Dermatologic Association. “But our understanding of how to manage this disease is still very much a work in progress.”

She noted that while 50% of people will acquire herpes zoster by the time they reach 85 years of age due to diminishing cell-mediated immunity, the major burden of disease impacts immunocompromised patients of all ages. HIV patients and solid-organ transplant recipients are well known to face an increased risk of acquiring herpes zoster, but the most overwhelming risk is seen in leukemia patients, who have rates as high as 100-fold that of the general population.

“More recent data on stem cell transplant patients show that about 50% of them will get zoster,” added Dr. Ahronowitz, a dermatologist at the University of Southern California, Los Angeles. “Most of that’s happening within the first year and a half after their transplant.”

Several recent epidemiologic studies in the medical literature have reported herpes zoster in patients who are not traditionally believed to be immunosuppressed, such as those with lupus, dermatomyositis, rheumatoid arthritis, asthma, and atopic dermatitis. “It begs the question: is it the disease or is it the treatment?” Dr. Ahronowitz said. “We don’t know the answer to that yet. In dermatomyositis and lupus, use of antimalarials has been found to be most associated with the risk of herpes zoster. Other studies looking at one disease are so heterogeneous, some saying that it’s one medication, some saying that it’s another. There’s no cohesive message yet about which medications cause the highest risk of zoster.”

Herpes zoster was originally believed to be far less transmissible than varicella. “Later it was thought that the only way that you can get VZV [varicella zoster virus] from a zoster patient was by direct contact with vesicle fluid,” Dr. Ahronowitz said. “That turns out to be wrong as well.” One study of pediatric patients found similar rates of secondary varicella cases from varicella and herpes zoster cases (15% vs. 9%, respectively), regardless of anatomic location of zoster (J Infect Dis. 2012; 205[9]:1336-41).

Another report that called into question prevailing beliefs about the disease involved an immunocompetent patient in a long-term care facility who developed localized herpes zoster (J Infect Dis. 2008;197[5]:646-53). That individual turned out to be “patient zero” in a varicella outbreak in the facility, even though the person’s lesions had been covered by gauze and clothing at all times. “The next patient who got infected was one of the health care workers who had never been in the room at the same time as the patient but who had changed the patient’s bed linens,” said Dr. Ahronowitz, who was not involved with the study. “Environmental samples were collected from the patient’s room and were contaminated with VZV DNA.”

She went on to note that VZV DNA has been found in vesicle fluid, serum, peripheral blood mononuclear cells, and saliva. One randomized, controlled trial found that hydrocolloid dressings are superior to traditional gauze and paper dressings in preventing the excretion of aerosolized VZV DNA from skin lesions of patients with localized herpes zoster (J Infect Dis. 2004;189[6]:1009-12). Using hydrocolloid dressings to cover lesions “does seem to make a difference,” she said. “Because of all this new data coming out, I think it’s time to reconsider isolation precautions in all hospitalized patients with herpes zoster, because the consequences of VZV transmission within a hospital where there are other patients nearby who have low immune systems could be absolutely devastating.”

The impact of herpes zoster infection on the central nervous system can be significant, including cranial nerve palsy, encephalitis, encephalopathy, and aseptic meningitis. “Patients can have long-lasting residual neurologic deficits from this at 6 months or longer despite appropriate treatment,” she said. “No correlation between CSF viral load and neurologic sequelae has been found at 3 months.”

More recent research has found an association between herpes zoster infection and an increased risk of stroke – up to threefold in some cases. “That risk doesn’t normalize until 6 months after the infection,” Dr. Ahronowitz said. “We’re even seeing it in kids, who have two times the risk of stroke in the first 6 months after VZV infection.” MI risk also seems to be elevated as a secondary outcome (a 1.7-fold increase in the first week of infection).

“There have also been recent reports of VZV antigen/DNA found in the vessel wall of patients with giant cell arteritis and granulomatous arteritis of the aorta,” she said. “This is an evolving story about zoster that we never knew about.”

Drug-induced hypersensitivity syndrome (DIHS) is also associated with CNS manifestations, but they resolve much faster, unlike those of CNS zoster. “As long as you take away the offending medication and put them on steroids they will recover very quickly,” she said. At least one case in the medical literature to date has reported DIHS in association with VZV (Acta Derm Venereol. 2015;95[4]:503-4).

The zoster vaccine (Zostavax, Merck & Co.) is currently indicated in patients aged 60 years and older, but since it is a live attenuated vaccine, it is contraindicated in many patients who could most benefit from it, including those with primary immunodeficiency disorders, those with a hematologic malignancy, those who have had a hematopoietic stem cell transplant within the last 2 years, pregnant patients, and patients taking high-dose steroids or anti–tumor necrosis factor biologics.

“There is an inactivated vaccine in the works being tested, and that is showing good efficacy,” Dr. Ahronowitz said. “Hopefully we’ll be able to prevaccinate patients, even young patients, prior to immune suppression.”

She reported having no relevant disclosures.

[email protected]

NEWPORT BEACH, CALIF. – In medical school you may have been taught that herpes zoster infection primarily impacts elderly patients, but the burden of disease is shifting – along with the understanding of herpes zoster itself.

“Herpes zoster is a disease that can lull us into a false sense of security because we see it all the time,” Iris Ahronowitz, MD, said at the annual meeting of the Pacific Dermatologic Association. “But our understanding of how to manage this disease is still very much a work in progress.”

She noted that while 50% of people will acquire herpes zoster by the time they reach 85 years of age due to diminishing cell-mediated immunity, the major burden of disease impacts immunocompromised patients of all ages. HIV patients and solid-organ transplant recipients are well known to face an increased risk of acquiring herpes zoster, but the most overwhelming risk is seen in leukemia patients, who have rates as high as 100-fold that of the general population.

“More recent data on stem cell transplant patients show that about 50% of them will get zoster,” added Dr. Ahronowitz, a dermatologist at the University of Southern California, Los Angeles. “Most of that’s happening within the first year and a half after their transplant.”

Several recent epidemiologic studies in the medical literature have reported herpes zoster in patients who are not traditionally believed to be immunosuppressed, such as those with lupus, dermatomyositis, rheumatoid arthritis, asthma, and atopic dermatitis. “It begs the question: is it the disease or is it the treatment?” Dr. Ahronowitz said. “We don’t know the answer to that yet. In dermatomyositis and lupus, use of antimalarials has been found to be most associated with the risk of herpes zoster. Other studies looking at one disease are so heterogeneous, some saying that it’s one medication, some saying that it’s another. There’s no cohesive message yet about which medications cause the highest risk of zoster.”

Herpes zoster was originally believed to be far less transmissible than varicella. “Later it was thought that the only way that you can get VZV [varicella zoster virus] from a zoster patient was by direct contact with vesicle fluid,” Dr. Ahronowitz said. “That turns out to be wrong as well.” One study of pediatric patients found similar rates of secondary varicella cases from varicella and herpes zoster cases (15% vs. 9%, respectively), regardless of anatomic location of zoster (J Infect Dis. 2012; 205[9]:1336-41).

Another report that called into question prevailing beliefs about the disease involved an immunocompetent patient in a long-term care facility who developed localized herpes zoster (J Infect Dis. 2008;197[5]:646-53). That individual turned out to be “patient zero” in a varicella outbreak in the facility, even though the person’s lesions had been covered by gauze and clothing at all times. “The next patient who got infected was one of the health care workers who had never been in the room at the same time as the patient but who had changed the patient’s bed linens,” said Dr. Ahronowitz, who was not involved with the study. “Environmental samples were collected from the patient’s room and were contaminated with VZV DNA.”

She went on to note that VZV DNA has been found in vesicle fluid, serum, peripheral blood mononuclear cells, and saliva. One randomized, controlled trial found that hydrocolloid dressings are superior to traditional gauze and paper dressings in preventing the excretion of aerosolized VZV DNA from skin lesions of patients with localized herpes zoster (J Infect Dis. 2004;189[6]:1009-12). Using hydrocolloid dressings to cover lesions “does seem to make a difference,” she said. “Because of all this new data coming out, I think it’s time to reconsider isolation precautions in all hospitalized patients with herpes zoster, because the consequences of VZV transmission within a hospital where there are other patients nearby who have low immune systems could be absolutely devastating.”

The impact of herpes zoster infection on the central nervous system can be significant, including cranial nerve palsy, encephalitis, encephalopathy, and aseptic meningitis. “Patients can have long-lasting residual neurologic deficits from this at 6 months or longer despite appropriate treatment,” she said. “No correlation between CSF viral load and neurologic sequelae has been found at 3 months.”

More recent research has found an association between herpes zoster infection and an increased risk of stroke – up to threefold in some cases. “That risk doesn’t normalize until 6 months after the infection,” Dr. Ahronowitz said. “We’re even seeing it in kids, who have two times the risk of stroke in the first 6 months after VZV infection.” MI risk also seems to be elevated as a secondary outcome (a 1.7-fold increase in the first week of infection).

“There have also been recent reports of VZV antigen/DNA found in the vessel wall of patients with giant cell arteritis and granulomatous arteritis of the aorta,” she said. “This is an evolving story about zoster that we never knew about.”

Drug-induced hypersensitivity syndrome (DIHS) is also associated with CNS manifestations, but they resolve much faster, unlike those of CNS zoster. “As long as you take away the offending medication and put them on steroids they will recover very quickly,” she said. At least one case in the medical literature to date has reported DIHS in association with VZV (Acta Derm Venereol. 2015;95[4]:503-4).

The zoster vaccine (Zostavax, Merck & Co.) is currently indicated in patients aged 60 years and older, but since it is a live attenuated vaccine, it is contraindicated in many patients who could most benefit from it, including those with primary immunodeficiency disorders, those with a hematologic malignancy, those who have had a hematopoietic stem cell transplant within the last 2 years, pregnant patients, and patients taking high-dose steroids or anti–tumor necrosis factor biologics.

“There is an inactivated vaccine in the works being tested, and that is showing good efficacy,” Dr. Ahronowitz said. “Hopefully we’ll be able to prevaccinate patients, even young patients, prior to immune suppression.”

She reported having no relevant disclosures.

[email protected]

NEWPORT BEACH, CALIF. – In medical school you may have been taught that herpes zoster infection primarily impacts elderly patients, but the burden of disease is shifting – along with the understanding of herpes zoster itself.

“Herpes zoster is a disease that can lull us into a false sense of security because we see it all the time,” Iris Ahronowitz, MD, said at the annual meeting of the Pacific Dermatologic Association. “But our understanding of how to manage this disease is still very much a work in progress.”

She noted that while 50% of people will acquire herpes zoster by the time they reach 85 years of age due to diminishing cell-mediated immunity, the major burden of disease impacts immunocompromised patients of all ages. HIV patients and solid-organ transplant recipients are well known to face an increased risk of acquiring herpes zoster, but the most overwhelming risk is seen in leukemia patients, who have rates as high as 100-fold that of the general population.

“More recent data on stem cell transplant patients show that about 50% of them will get zoster,” added Dr. Ahronowitz, a dermatologist at the University of Southern California, Los Angeles. “Most of that’s happening within the first year and a half after their transplant.”

Several recent epidemiologic studies in the medical literature have reported herpes zoster in patients who are not traditionally believed to be immunosuppressed, such as those with lupus, dermatomyositis, rheumatoid arthritis, asthma, and atopic dermatitis. “It begs the question: is it the disease or is it the treatment?” Dr. Ahronowitz said. “We don’t know the answer to that yet. In dermatomyositis and lupus, use of antimalarials has been found to be most associated with the risk of herpes zoster. Other studies looking at one disease are so heterogeneous, some saying that it’s one medication, some saying that it’s another. There’s no cohesive message yet about which medications cause the highest risk of zoster.”

Herpes zoster was originally believed to be far less transmissible than varicella. “Later it was thought that the only way that you can get VZV [varicella zoster virus] from a zoster patient was by direct contact with vesicle fluid,” Dr. Ahronowitz said. “That turns out to be wrong as well.” One study of pediatric patients found similar rates of secondary varicella cases from varicella and herpes zoster cases (15% vs. 9%, respectively), regardless of anatomic location of zoster (J Infect Dis. 2012; 205[9]:1336-41).

Another report that called into question prevailing beliefs about the disease involved an immunocompetent patient in a long-term care facility who developed localized herpes zoster (J Infect Dis. 2008;197[5]:646-53). That individual turned out to be “patient zero” in a varicella outbreak in the facility, even though the person’s lesions had been covered by gauze and clothing at all times. “The next patient who got infected was one of the health care workers who had never been in the room at the same time as the patient but who had changed the patient’s bed linens,” said Dr. Ahronowitz, who was not involved with the study. “Environmental samples were collected from the patient’s room and were contaminated with VZV DNA.”

She went on to note that VZV DNA has been found in vesicle fluid, serum, peripheral blood mononuclear cells, and saliva. One randomized, controlled trial found that hydrocolloid dressings are superior to traditional gauze and paper dressings in preventing the excretion of aerosolized VZV DNA from skin lesions of patients with localized herpes zoster (J Infect Dis. 2004;189[6]:1009-12). Using hydrocolloid dressings to cover lesions “does seem to make a difference,” she said. “Because of all this new data coming out, I think it’s time to reconsider isolation precautions in all hospitalized patients with herpes zoster, because the consequences of VZV transmission within a hospital where there are other patients nearby who have low immune systems could be absolutely devastating.”

The impact of herpes zoster infection on the central nervous system can be significant, including cranial nerve palsy, encephalitis, encephalopathy, and aseptic meningitis. “Patients can have long-lasting residual neurologic deficits from this at 6 months or longer despite appropriate treatment,” she said. “No correlation between CSF viral load and neurologic sequelae has been found at 3 months.”

More recent research has found an association between herpes zoster infection and an increased risk of stroke – up to threefold in some cases. “That risk doesn’t normalize until 6 months after the infection,” Dr. Ahronowitz said. “We’re even seeing it in kids, who have two times the risk of stroke in the first 6 months after VZV infection.” MI risk also seems to be elevated as a secondary outcome (a 1.7-fold increase in the first week of infection).

“There have also been recent reports of VZV antigen/DNA found in the vessel wall of patients with giant cell arteritis and granulomatous arteritis of the aorta,” she said. “This is an evolving story about zoster that we never knew about.”

Drug-induced hypersensitivity syndrome (DIHS) is also associated with CNS manifestations, but they resolve much faster, unlike those of CNS zoster. “As long as you take away the offending medication and put them on steroids they will recover very quickly,” she said. At least one case in the medical literature to date has reported DIHS in association with VZV (Acta Derm Venereol. 2015;95[4]:503-4).

The zoster vaccine (Zostavax, Merck & Co.) is currently indicated in patients aged 60 years and older, but since it is a live attenuated vaccine, it is contraindicated in many patients who could most benefit from it, including those with primary immunodeficiency disorders, those with a hematologic malignancy, those who have had a hematopoietic stem cell transplant within the last 2 years, pregnant patients, and patients taking high-dose steroids or anti–tumor necrosis factor biologics.

“There is an inactivated vaccine in the works being tested, and that is showing good efficacy,” Dr. Ahronowitz said. “Hopefully we’ll be able to prevaccinate patients, even young patients, prior to immune suppression.”

She reported having no relevant disclosures.

[email protected]

Click on the PDF icon at the top of this introduction to read the full article.

Click on the PDF icon at the top of this introduction to read the full article.

Click on the PDF icon at the top of this introduction to read the full article.

Background Sleep impairment, fatigue, and anxiety are common conditions in cancer survivors. Small studies suggest mindfulness- based interventions may be helpful for cancer-related fatigue.

Objective To evaluate mindfulness-based cancer recovery (MBCR) for cancer survivors who are recovering from chemotherapy or radiation therapy.

Methods 42 cancer survivors who were within 6 months of completion of chemotherapy or radiation were randomized 2:1 to 8 weekly MBCR classes (n = 28) or wait-list control (n = 14). The Pittsburgh Sleep Quality Index (PSQI), Functional Assessment in Cancer Therapy – Fatigue (FACT-F), and 20-item State-Trait Anxiety Inventory (STAI) were used to assess sleep, fatigue, and anxiety at baseline (time of enrollment), at 2 months (on completion of the MBCR course), and 4 months (2 months after completion of the course). 32 of 42 participants participated in an optional blood draw to assess immune function.

Results 79% of the MBCR group attended at least 7 of the 9 MBCR sessions. At the 2-month assessment, sleep quality (PSQI, range 0-21, >5 = poorer sleep quality) in the MBCR group improved from the baseline 8.9 to 6.4, compared with the wait-list group (baseline 7.2 to 7.6); and at 4 months after course completion, it was 6.1 compared with 7.8, respectively (P = .03). There was a non-statistically significant improvement in fatigue (FACIT-F, P = .19). There was a trend toward improvement in the anxiety scores (STAI, range 20-80, higher score = greater anxiety) in the MBCR group compared with the wait-list group at 2 months (31.8 vs 39.4, respectively; P = .07) and 4 months (32.8 vs 40.7; P = .10). Immune function measures were not statistically significant.

Limitations It is possible the psychological support of being in contact with a facilitator and/or other cancer survivors had a beneficial effect in the outcomes of those in the MBCR group.

Conclusion MBCR has a high compliance rate and results in sustained improvements in sleep quality, fatigue, and anxiety. MBCR may be useful for cancer survivors struggling with sleep, fatigue, and anxiety.

Funding Hourglass Fund, Masonic Cancer Center, University of Minnesota; University of Minnesota Foundation (immune function protocol); National Institutes of Health Office of Women’s Health Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) NIH # K12-HD055887.

Click on the PDF icon at the top of this introduction to read the full article.

Background Sleep impairment, fatigue, and anxiety are common conditions in cancer survivors. Small studies suggest mindfulness- based interventions may be helpful for cancer-related fatigue.

Objective To evaluate mindfulness-based cancer recovery (MBCR) for cancer survivors who are recovering from chemotherapy or radiation therapy.

Methods 42 cancer survivors who were within 6 months of completion of chemotherapy or radiation were randomized 2:1 to 8 weekly MBCR classes (n = 28) or wait-list control (n = 14). The Pittsburgh Sleep Quality Index (PSQI), Functional Assessment in Cancer Therapy – Fatigue (FACT-F), and 20-item State-Trait Anxiety Inventory (STAI) were used to assess sleep, fatigue, and anxiety at baseline (time of enrollment), at 2 months (on completion of the MBCR course), and 4 months (2 months after completion of the course). 32 of 42 participants participated in an optional blood draw to assess immune function.

Results 79% of the MBCR group attended at least 7 of the 9 MBCR sessions. At the 2-month assessment, sleep quality (PSQI, range 0-21, >5 = poorer sleep quality) in the MBCR group improved from the baseline 8.9 to 6.4, compared with the wait-list group (baseline 7.2 to 7.6); and at 4 months after course completion, it was 6.1 compared with 7.8, respectively (P = .03). There was a non-statistically significant improvement in fatigue (FACIT-F, P = .19). There was a trend toward improvement in the anxiety scores (STAI, range 20-80, higher score = greater anxiety) in the MBCR group compared with the wait-list group at 2 months (31.8 vs 39.4, respectively; P = .07) and 4 months (32.8 vs 40.7; P = .10). Immune function measures were not statistically significant.

Limitations It is possible the psychological support of being in contact with a facilitator and/or other cancer survivors had a beneficial effect in the outcomes of those in the MBCR group.

Conclusion MBCR has a high compliance rate and results in sustained improvements in sleep quality, fatigue, and anxiety. MBCR may be useful for cancer survivors struggling with sleep, fatigue, and anxiety.

Funding Hourglass Fund, Masonic Cancer Center, University of Minnesota; University of Minnesota Foundation (immune function protocol); National Institutes of Health Office of Women’s Health Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) NIH # K12-HD055887.

Click on the PDF icon at the top of this introduction to read the full article.

Background Sleep impairment, fatigue, and anxiety are common conditions in cancer survivors. Small studies suggest mindfulness- based interventions may be helpful for cancer-related fatigue.

Objective To evaluate mindfulness-based cancer recovery (MBCR) for cancer survivors who are recovering from chemotherapy or radiation therapy.

Methods 42 cancer survivors who were within 6 months of completion of chemotherapy or radiation were randomized 2:1 to 8 weekly MBCR classes (n = 28) or wait-list control (n = 14). The Pittsburgh Sleep Quality Index (PSQI), Functional Assessment in Cancer Therapy – Fatigue (FACT-F), and 20-item State-Trait Anxiety Inventory (STAI) were used to assess sleep, fatigue, and anxiety at baseline (time of enrollment), at 2 months (on completion of the MBCR course), and 4 months (2 months after completion of the course). 32 of 42 participants participated in an optional blood draw to assess immune function.

Results 79% of the MBCR group attended at least 7 of the 9 MBCR sessions. At the 2-month assessment, sleep quality (PSQI, range 0-21, >5 = poorer sleep quality) in the MBCR group improved from the baseline 8.9 to 6.4, compared with the wait-list group (baseline 7.2 to 7.6); and at 4 months after course completion, it was 6.1 compared with 7.8, respectively (P = .03). There was a non-statistically significant improvement in fatigue (FACIT-F, P = .19). There was a trend toward improvement in the anxiety scores (STAI, range 20-80, higher score = greater anxiety) in the MBCR group compared with the wait-list group at 2 months (31.8 vs 39.4, respectively; P = .07) and 4 months (32.8 vs 40.7; P = .10). Immune function measures were not statistically significant.

Limitations It is possible the psychological support of being in contact with a facilitator and/or other cancer survivors had a beneficial effect in the outcomes of those in the MBCR group.

Conclusion MBCR has a high compliance rate and results in sustained improvements in sleep quality, fatigue, and anxiety. MBCR may be useful for cancer survivors struggling with sleep, fatigue, and anxiety.

Funding Hourglass Fund, Masonic Cancer Center, University of Minnesota; University of Minnesota Foundation (immune function protocol); National Institutes of Health Office of Women’s Health Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) NIH # K12-HD055887.

Click on the PDF icon at the top of this introduction to read the full article.