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Biomarkers of small intestinal mucosal damage induced by chemotherapy: an emerging role for the 13C sucrose breath test
Gastrointestinal mucosal toxicity is extremely common following cytotoxic therapies. The alimentary mucosa is particularly susceptible to injury and dysfunction, leading to many debilitating complications. Despite much research, there is currently no single noninvasive biomarker to detect gut injury. Several biomarkers have been investigated in the context of gastrointestinal diseases, which may prove useful in the oncology arena. Identification of a biomarker that is easy to obtain and measure and that accurately identifies mucosal damage would allow for improved patient diagnosis of toxicities and for personalized treatment regimens. In this review, we highlight the effectiveness of urine and breath tests as potential clinically effective biomarkers, with significant focus placed on the emerging role of the carbon-13 sucrose breath test (13C SBT). The 13C SBT provides a simple, noninvasive, and integrated measure of gut function. The 13C SBT also has the potential to monitor gut function in the setting of cytotoxic therapy–induced mucositis, or in the assessment of the efficacy of antimucositis agents.
*For a PDF of the full article, click on the link to the left of this introduction.
Gastrointestinal mucosal toxicity is extremely common following cytotoxic therapies. The alimentary mucosa is particularly susceptible to injury and dysfunction, leading to many debilitating complications. Despite much research, there is currently no single noninvasive biomarker to detect gut injury. Several biomarkers have been investigated in the context of gastrointestinal diseases, which may prove useful in the oncology arena. Identification of a biomarker that is easy to obtain and measure and that accurately identifies mucosal damage would allow for improved patient diagnosis of toxicities and for personalized treatment regimens. In this review, we highlight the effectiveness of urine and breath tests as potential clinically effective biomarkers, with significant focus placed on the emerging role of the carbon-13 sucrose breath test (13C SBT). The 13C SBT provides a simple, noninvasive, and integrated measure of gut function. The 13C SBT also has the potential to monitor gut function in the setting of cytotoxic therapy–induced mucositis, or in the assessment of the efficacy of antimucositis agents.
*For a PDF of the full article, click on the link to the left of this introduction.
Gastrointestinal mucosal toxicity is extremely common following cytotoxic therapies. The alimentary mucosa is particularly susceptible to injury and dysfunction, leading to many debilitating complications. Despite much research, there is currently no single noninvasive biomarker to detect gut injury. Several biomarkers have been investigated in the context of gastrointestinal diseases, which may prove useful in the oncology arena. Identification of a biomarker that is easy to obtain and measure and that accurately identifies mucosal damage would allow for improved patient diagnosis of toxicities and for personalized treatment regimens. In this review, we highlight the effectiveness of urine and breath tests as potential clinically effective biomarkers, with significant focus placed on the emerging role of the carbon-13 sucrose breath test (13C SBT). The 13C SBT provides a simple, noninvasive, and integrated measure of gut function. The 13C SBT also has the potential to monitor gut function in the setting of cytotoxic therapy–induced mucositis, or in the assessment of the efficacy of antimucositis agents.
*For a PDF of the full article, click on the link to the left of this introduction.
Predicting life expectancy in patients with advanced incurable cancer: a review
ABSTRACT
Oncologists frequently face the difficult task of estimating prognosis in patients with incurable malignancies. Their prediction of prognosis informs decision-making ranging from recommendations of cancer treatments to hospice enrollment. Unfortunately, physicians’ estimates of prognosis are often inaccurate and overly optimistic. Further, physicians often fail to disclose their prognosis estimates, despite patient wishes to the contrary. Several studies have examined patient factors that might improve physicians’ prognostic accuracy, including performance status, clinical symptoms and laboratory values. Prognostic models have been developed and validated but, to date, none are able to provide accurate estimates throughout the spectrum of advanced illness. This review examines tools utilized to predict life expectancy for patients with advanced, incurable cancer.
*For a PDF of the full article, click on the link to the left of this introduction.
ABSTRACT
Oncologists frequently face the difficult task of estimating prognosis in patients with incurable malignancies. Their prediction of prognosis informs decision-making ranging from recommendations of cancer treatments to hospice enrollment. Unfortunately, physicians’ estimates of prognosis are often inaccurate and overly optimistic. Further, physicians often fail to disclose their prognosis estimates, despite patient wishes to the contrary. Several studies have examined patient factors that might improve physicians’ prognostic accuracy, including performance status, clinical symptoms and laboratory values. Prognostic models have been developed and validated but, to date, none are able to provide accurate estimates throughout the spectrum of advanced illness. This review examines tools utilized to predict life expectancy for patients with advanced, incurable cancer.
*For a PDF of the full article, click on the link to the left of this introduction.
ABSTRACT
Oncologists frequently face the difficult task of estimating prognosis in patients with incurable malignancies. Their prediction of prognosis informs decision-making ranging from recommendations of cancer treatments to hospice enrollment. Unfortunately, physicians’ estimates of prognosis are often inaccurate and overly optimistic. Further, physicians often fail to disclose their prognosis estimates, despite patient wishes to the contrary. Several studies have examined patient factors that might improve physicians’ prognostic accuracy, including performance status, clinical symptoms and laboratory values. Prognostic models have been developed and validated but, to date, none are able to provide accurate estimates throughout the spectrum of advanced illness. This review examines tools utilized to predict life expectancy for patients with advanced, incurable cancer.
*For a PDF of the full article, click on the link to the left of this introduction.
Utilization of radiotherapy services by a palliative care unit: pattern and implication
Background The role of radiotherapy in palliation is well recognized. Analyzing referrals from an inpatient palliative care unit to the radiation oncology service may help in planning palliative care services and educational programs.
Objective To determine the pattern and rate of referrals from a PCU to the RO service at a tertiary oncology facility in Saudi Arabia.
Methods Referrals from the PCU to the RO service were prospectively identified over the period beginning November 27, 2007 and ending March 9, 2011. The appropriateness of referrals was determined by 2 radiation oncologists.
Results Of the 635 cancer admissions to the PCU, 25 (3.9%) referrals to RO were made, and 32 sites were irradiated. All patients had a poor performance status (ECOG 3). The most common areas irradiated were vertebrae (40.6%), pelvis (18.7%) and other bony structures (28.1%). Pain control was the most frequent reason for referral (87.5%). Only one referral was regarded by the RO service as inappropriate, indicating that 96% of the referrals were appropriate. The mean time lapse between referral and starting radiation was 4 3.6 days. A total of 75% of the patients died in the PCU within a median of 30 days post radiotherapy.
Conclusion The small minority of patients in the PCU referred for radiotherapy were deemed appropriate referrals by the radiation oncologists despite their poor performance status and limited time remaining. When planning a PCU with similar admission criteria, the availability of a radiotherapy facility in close proximity may not be a priority.
Click on the PDF icon at the top of this introduction to read the full article.
Background The role of radiotherapy in palliation is well recognized. Analyzing referrals from an inpatient palliative care unit to the radiation oncology service may help in planning palliative care services and educational programs.
Objective To determine the pattern and rate of referrals from a PCU to the RO service at a tertiary oncology facility in Saudi Arabia.
Methods Referrals from the PCU to the RO service were prospectively identified over the period beginning November 27, 2007 and ending March 9, 2011. The appropriateness of referrals was determined by 2 radiation oncologists.
Results Of the 635 cancer admissions to the PCU, 25 (3.9%) referrals to RO were made, and 32 sites were irradiated. All patients had a poor performance status (ECOG 3). The most common areas irradiated were vertebrae (40.6%), pelvis (18.7%) and other bony structures (28.1%). Pain control was the most frequent reason for referral (87.5%). Only one referral was regarded by the RO service as inappropriate, indicating that 96% of the referrals were appropriate. The mean time lapse between referral and starting radiation was 4 3.6 days. A total of 75% of the patients died in the PCU within a median of 30 days post radiotherapy.
Conclusion The small minority of patients in the PCU referred for radiotherapy were deemed appropriate referrals by the radiation oncologists despite their poor performance status and limited time remaining. When planning a PCU with similar admission criteria, the availability of a radiotherapy facility in close proximity may not be a priority.
Click on the PDF icon at the top of this introduction to read the full article.
Background The role of radiotherapy in palliation is well recognized. Analyzing referrals from an inpatient palliative care unit to the radiation oncology service may help in planning palliative care services and educational programs.
Objective To determine the pattern and rate of referrals from a PCU to the RO service at a tertiary oncology facility in Saudi Arabia.
Methods Referrals from the PCU to the RO service were prospectively identified over the period beginning November 27, 2007 and ending March 9, 2011. The appropriateness of referrals was determined by 2 radiation oncologists.
Results Of the 635 cancer admissions to the PCU, 25 (3.9%) referrals to RO were made, and 32 sites were irradiated. All patients had a poor performance status (ECOG 3). The most common areas irradiated were vertebrae (40.6%), pelvis (18.7%) and other bony structures (28.1%). Pain control was the most frequent reason for referral (87.5%). Only one referral was regarded by the RO service as inappropriate, indicating that 96% of the referrals were appropriate. The mean time lapse between referral and starting radiation was 4 3.6 days. A total of 75% of the patients died in the PCU within a median of 30 days post radiotherapy.
Conclusion The small minority of patients in the PCU referred for radiotherapy were deemed appropriate referrals by the radiation oncologists despite their poor performance status and limited time remaining. When planning a PCU with similar admission criteria, the availability of a radiotherapy facility in close proximity may not be a priority.
Click on the PDF icon at the top of this introduction to read the full article.
Measuring priority symptoms in advanced bladder cancer: development and initial validation of a brief symptom index
Background Improved measurement of clinically meaningful symptoms is needed in advanced bladder cancer.
Objective This study developed and examined the initial reliability and validity of a new measure of advanced bladder cancer specific symptoms, the NCCN-FACT Bladder Symptom Index-18 (NFBlSI-18), which assesses the symptoms perceived as most important by patients and oncology clinical experts.
Methods A total of 31 individuals with advanced bladder cancer rated the importance of 28 symptoms. In addition, 10 oncology clinical experts rated symptoms as treatment- or disease-related. Patient-rated symptoms were reconciled with published clinicians’ symptom priorities, producing the NFBlSI-18. Participants completed measures of quality of life (QoL) and performance status to examine initial validity.
Results An 18-item symptom index for advanced bladder cancer included 3 subscales: disease-related symptoms, treatment side effects, and general function/well-being. Lower scores indicate greater symptom burden. Preliminary reliability reveals good internal consistency for the full NFBlSI-18 ( 0.83). The NFBlSI-18 was significantly associated with QOL criteria and performance status, in the expected direction.
Limitations Limitations include the cross-sectional design and the relatively low reliability of the disease-related symptoms subscale.
Conclusion The NFBlSI-18 demonstrates preliminary evidence as a valid brief measure of the most important symptoms of advanced bladder cancer, as rated by both patients and oncology clinical experts. The NFBlSI-18 should have greater acceptability to regulatory authorities than previously developed questionnaires.
*Click on the PDF icon at the top of this introduction to read the full article.
Background Improved measurement of clinically meaningful symptoms is needed in advanced bladder cancer.
Objective This study developed and examined the initial reliability and validity of a new measure of advanced bladder cancer specific symptoms, the NCCN-FACT Bladder Symptom Index-18 (NFBlSI-18), which assesses the symptoms perceived as most important by patients and oncology clinical experts.
Methods A total of 31 individuals with advanced bladder cancer rated the importance of 28 symptoms. In addition, 10 oncology clinical experts rated symptoms as treatment- or disease-related. Patient-rated symptoms were reconciled with published clinicians’ symptom priorities, producing the NFBlSI-18. Participants completed measures of quality of life (QoL) and performance status to examine initial validity.
Results An 18-item symptom index for advanced bladder cancer included 3 subscales: disease-related symptoms, treatment side effects, and general function/well-being. Lower scores indicate greater symptom burden. Preliminary reliability reveals good internal consistency for the full NFBlSI-18 ( 0.83). The NFBlSI-18 was significantly associated with QOL criteria and performance status, in the expected direction.
Limitations Limitations include the cross-sectional design and the relatively low reliability of the disease-related symptoms subscale.
Conclusion The NFBlSI-18 demonstrates preliminary evidence as a valid brief measure of the most important symptoms of advanced bladder cancer, as rated by both patients and oncology clinical experts. The NFBlSI-18 should have greater acceptability to regulatory authorities than previously developed questionnaires.
*Click on the PDF icon at the top of this introduction to read the full article.
Background Improved measurement of clinically meaningful symptoms is needed in advanced bladder cancer.
Objective This study developed and examined the initial reliability and validity of a new measure of advanced bladder cancer specific symptoms, the NCCN-FACT Bladder Symptom Index-18 (NFBlSI-18), which assesses the symptoms perceived as most important by patients and oncology clinical experts.
Methods A total of 31 individuals with advanced bladder cancer rated the importance of 28 symptoms. In addition, 10 oncology clinical experts rated symptoms as treatment- or disease-related. Patient-rated symptoms were reconciled with published clinicians’ symptom priorities, producing the NFBlSI-18. Participants completed measures of quality of life (QoL) and performance status to examine initial validity.
Results An 18-item symptom index for advanced bladder cancer included 3 subscales: disease-related symptoms, treatment side effects, and general function/well-being. Lower scores indicate greater symptom burden. Preliminary reliability reveals good internal consistency for the full NFBlSI-18 ( 0.83). The NFBlSI-18 was significantly associated with QOL criteria and performance status, in the expected direction.
Limitations Limitations include the cross-sectional design and the relatively low reliability of the disease-related symptoms subscale.
Conclusion The NFBlSI-18 demonstrates preliminary evidence as a valid brief measure of the most important symptoms of advanced bladder cancer, as rated by both patients and oncology clinical experts. The NFBlSI-18 should have greater acceptability to regulatory authorities than previously developed questionnaires.
*Click on the PDF icon at the top of this introduction to read the full article.
CDC urges doctors to help patients quit smoking
WASHINGTON – Doctors need to step up their efforts to counsel patients on smoking cessation.
That was the message from officials at the Centers for Disease Control and Prevention and primary care physicians group at a press briefing May 22.
"Every doctor can help their patients quit, and every doctor should do everything possible to help their patients quit," Dr. Tom Frieden, CDC director, said at a press conference. "Even spending 3-5 minutes on personalized, clear advice will double the likelihood that they will quit for good."
He added that talking about smoking – or about quitting – is still not a part of routine doctor visits.
"That extra moment can make all the difference and help them quit," agreed Surgeon General Regina Benjamin, who also spoke at the briefing.
The CDC estimates that 43 million American adults smoke, and that smoking kills about 440,000 of them each year.
Representatives of the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Physicians, the American Congress of Obstetricians and Gynecologists, and the American Medical Association, joined Dr. Frieden in urging their members and other physicians to do more.
"It’s very important for all of the medical associations to be speaking with one voice," Dr. Charles Cutler, chair of the ACP Board of Regents, said in an interview. "When we’re all saying the same thing, the message for doctors throughout America becomes more resonant."
Advertisements that are part of the CDC’s current "Tips From Former Smokers" campaignwill be tagged with a new line from May 27 through June 2. During that time, ads will say "You can quit. Talk with your doctor for help."
So far, the Tips campaign, which features individuals disfigured from a lifetime of smoking, has generated 200,000 excess calls to the 1-800-QUIT-NOW line managed by the CDC, Dr. Frieden said. The campaign is funded at about $50 million a year with money from the Public Health and Prevention Fund, which was established by the Affordable Care Act.
AAFP president Jeffrey Cain said that physicians are crucial allies for patients who are trying to quit. He noted that the AAFP has several tools to help physicians counsel and care for smokers, including the "Ask and Act Practice Toolkit," and a treating tobacco dependence practice manual. "You have to make it so that tobacco is a vital sign when a patient comes in," said Dr. Cain.
The Tips campaign gives patients a critical way to start conversations about smoking, said Dr. Patrice Harris of the AMA Board of Trustees. "Physicians should talk to every patient who smokes about quitting at every office visit," she said. The AMA’s Healthier Life Steps program helps direct physicians toward resources they can share with patients, she said.
The AAP joined the effort because so many children are exposed to second-hand smoke and because very often, the smoking habit begins in adolescence, said AAP President Thomas K. McInerny. He said that many pediatricians had been remiss in either asking patients or parents about smoking, or encouraging them to quit.
"Pediatricians must intervene during a clinical encounter, yet, unfortunately, many don’t do so," he said.
ACOG president Jeanne A. Conry said that the Tips campaign would help her colleagues improve women’s health and support healthier pregnancies – but only if ob.gyns. make it a part of every visit. "If we are able to discuss tobacco use and well-woman health care with every woman at every time, we will make a difference," she said.
In an editorial published simultaneously in JAMA, Dr. Tim McAfee of the CDC Office on Smoking and Health further underlined and explained the resources available to physicians for smoking cessation counseling (2013;1-2 [doi:10.1001/jama.2013.5975]).
"Physicians have made major strides over the past 2 decades in helping smokers quit, but still fall short of making cessation treatment a routine part of standard care," he wrote. "By making it easier to discuss smoking, the ‘talk with your doctor’ initiative can help bring the nation a step closer to achieving the goal of substantially reducing smoking and smoking-related disease and death."
For smoking cessation counseling information and tools, visit the CDC’s Tips website.
On Twitter @aliciaault
WASHINGTON – Doctors need to step up their efforts to counsel patients on smoking cessation.
That was the message from officials at the Centers for Disease Control and Prevention and primary care physicians group at a press briefing May 22.
"Every doctor can help their patients quit, and every doctor should do everything possible to help their patients quit," Dr. Tom Frieden, CDC director, said at a press conference. "Even spending 3-5 minutes on personalized, clear advice will double the likelihood that they will quit for good."
He added that talking about smoking – or about quitting – is still not a part of routine doctor visits.
"That extra moment can make all the difference and help them quit," agreed Surgeon General Regina Benjamin, who also spoke at the briefing.
The CDC estimates that 43 million American adults smoke, and that smoking kills about 440,000 of them each year.
Representatives of the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Physicians, the American Congress of Obstetricians and Gynecologists, and the American Medical Association, joined Dr. Frieden in urging their members and other physicians to do more.
"It’s very important for all of the medical associations to be speaking with one voice," Dr. Charles Cutler, chair of the ACP Board of Regents, said in an interview. "When we’re all saying the same thing, the message for doctors throughout America becomes more resonant."
Advertisements that are part of the CDC’s current "Tips From Former Smokers" campaignwill be tagged with a new line from May 27 through June 2. During that time, ads will say "You can quit. Talk with your doctor for help."
So far, the Tips campaign, which features individuals disfigured from a lifetime of smoking, has generated 200,000 excess calls to the 1-800-QUIT-NOW line managed by the CDC, Dr. Frieden said. The campaign is funded at about $50 million a year with money from the Public Health and Prevention Fund, which was established by the Affordable Care Act.
AAFP president Jeffrey Cain said that physicians are crucial allies for patients who are trying to quit. He noted that the AAFP has several tools to help physicians counsel and care for smokers, including the "Ask and Act Practice Toolkit," and a treating tobacco dependence practice manual. "You have to make it so that tobacco is a vital sign when a patient comes in," said Dr. Cain.
The Tips campaign gives patients a critical way to start conversations about smoking, said Dr. Patrice Harris of the AMA Board of Trustees. "Physicians should talk to every patient who smokes about quitting at every office visit," she said. The AMA’s Healthier Life Steps program helps direct physicians toward resources they can share with patients, she said.
The AAP joined the effort because so many children are exposed to second-hand smoke and because very often, the smoking habit begins in adolescence, said AAP President Thomas K. McInerny. He said that many pediatricians had been remiss in either asking patients or parents about smoking, or encouraging them to quit.
"Pediatricians must intervene during a clinical encounter, yet, unfortunately, many don’t do so," he said.
ACOG president Jeanne A. Conry said that the Tips campaign would help her colleagues improve women’s health and support healthier pregnancies – but only if ob.gyns. make it a part of every visit. "If we are able to discuss tobacco use and well-woman health care with every woman at every time, we will make a difference," she said.
In an editorial published simultaneously in JAMA, Dr. Tim McAfee of the CDC Office on Smoking and Health further underlined and explained the resources available to physicians for smoking cessation counseling (2013;1-2 [doi:10.1001/jama.2013.5975]).
"Physicians have made major strides over the past 2 decades in helping smokers quit, but still fall short of making cessation treatment a routine part of standard care," he wrote. "By making it easier to discuss smoking, the ‘talk with your doctor’ initiative can help bring the nation a step closer to achieving the goal of substantially reducing smoking and smoking-related disease and death."
For smoking cessation counseling information and tools, visit the CDC’s Tips website.
On Twitter @aliciaault
WASHINGTON – Doctors need to step up their efforts to counsel patients on smoking cessation.
That was the message from officials at the Centers for Disease Control and Prevention and primary care physicians group at a press briefing May 22.
"Every doctor can help their patients quit, and every doctor should do everything possible to help their patients quit," Dr. Tom Frieden, CDC director, said at a press conference. "Even spending 3-5 minutes on personalized, clear advice will double the likelihood that they will quit for good."
He added that talking about smoking – or about quitting – is still not a part of routine doctor visits.
"That extra moment can make all the difference and help them quit," agreed Surgeon General Regina Benjamin, who also spoke at the briefing.
The CDC estimates that 43 million American adults smoke, and that smoking kills about 440,000 of them each year.
Representatives of the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Physicians, the American Congress of Obstetricians and Gynecologists, and the American Medical Association, joined Dr. Frieden in urging their members and other physicians to do more.
"It’s very important for all of the medical associations to be speaking with one voice," Dr. Charles Cutler, chair of the ACP Board of Regents, said in an interview. "When we’re all saying the same thing, the message for doctors throughout America becomes more resonant."
Advertisements that are part of the CDC’s current "Tips From Former Smokers" campaignwill be tagged with a new line from May 27 through June 2. During that time, ads will say "You can quit. Talk with your doctor for help."
So far, the Tips campaign, which features individuals disfigured from a lifetime of smoking, has generated 200,000 excess calls to the 1-800-QUIT-NOW line managed by the CDC, Dr. Frieden said. The campaign is funded at about $50 million a year with money from the Public Health and Prevention Fund, which was established by the Affordable Care Act.
AAFP president Jeffrey Cain said that physicians are crucial allies for patients who are trying to quit. He noted that the AAFP has several tools to help physicians counsel and care for smokers, including the "Ask and Act Practice Toolkit," and a treating tobacco dependence practice manual. "You have to make it so that tobacco is a vital sign when a patient comes in," said Dr. Cain.
The Tips campaign gives patients a critical way to start conversations about smoking, said Dr. Patrice Harris of the AMA Board of Trustees. "Physicians should talk to every patient who smokes about quitting at every office visit," she said. The AMA’s Healthier Life Steps program helps direct physicians toward resources they can share with patients, she said.
The AAP joined the effort because so many children are exposed to second-hand smoke and because very often, the smoking habit begins in adolescence, said AAP President Thomas K. McInerny. He said that many pediatricians had been remiss in either asking patients or parents about smoking, or encouraging them to quit.
"Pediatricians must intervene during a clinical encounter, yet, unfortunately, many don’t do so," he said.
ACOG president Jeanne A. Conry said that the Tips campaign would help her colleagues improve women’s health and support healthier pregnancies – but only if ob.gyns. make it a part of every visit. "If we are able to discuss tobacco use and well-woman health care with every woman at every time, we will make a difference," she said.
In an editorial published simultaneously in JAMA, Dr. Tim McAfee of the CDC Office on Smoking and Health further underlined and explained the resources available to physicians for smoking cessation counseling (2013;1-2 [doi:10.1001/jama.2013.5975]).
"Physicians have made major strides over the past 2 decades in helping smokers quit, but still fall short of making cessation treatment a routine part of standard care," he wrote. "By making it easier to discuss smoking, the ‘talk with your doctor’ initiative can help bring the nation a step closer to achieving the goal of substantially reducing smoking and smoking-related disease and death."
For smoking cessation counseling information and tools, visit the CDC’s Tips website.
On Twitter @aliciaault
FROM A CDC PRESS BRIEFING
Resistance exercise interventions during and following cancer treatment: a systematic review
Findings from prior systematic reviews suggest that exercise results in meaningful improvements in many clinically relevant physiologic and quality of life (QoL) outcomes during and following cancer treatment. However, the majority of exercise-cancer studies have focused upon the benefits of aerobic exercise (AE) and knowledge of the efficacy of resistance exercise (RE) alone as a supportive care intervention for cancer patients and survivors remains limited. Consequently, the purpose of this review was to provide the first systematic evaluation of the effects of RE alone upon clinically relevant physiologic and QoL outcomes during and following cancer treatment. Literature searches were conducted to identify studies examining RE interventions in cancer patients and survivors. Data were extracted on physiologic (fitness, physical function, and body composition) and QoL (fatigue, psychological well-being, and cancer-specific and global QoL outcomes. Cohen’s d effect sizes were calculated for each outcome. A total of 15 studies (6 in samples undergoing active cancer treatment and 9 in samples having completed cancer treatment) involving 1,077 participants met the inclusion criteria. Findings revealed that, on average, RE resulted in large effectsize improvements in muscular strength (d 0.86), moderate effect-size improvements in physical function (d 0.66), and small effect-size improvements in body composition (d 0.28) and QoL (d 0.25) outcomes. The effect sizes observed following RE are comparable in magnitude to the effects of exercise interventions reported in prior comprehensive reviews of the exercise cancer literature which primarily focused upon AE. Additionally, the methodologic quality of the studies was generally strong. Taken collectively, results of this systematic review suggest that RE is a promising supportive care intervention that results in meaningful improvements in clinically relevant physiologic and QoL outcomes during and following cancer treatment.
Click on the PDF icon at the top of this introduction to read the full article.
Findings from prior systematic reviews suggest that exercise results in meaningful improvements in many clinically relevant physiologic and quality of life (QoL) outcomes during and following cancer treatment. However, the majority of exercise-cancer studies have focused upon the benefits of aerobic exercise (AE) and knowledge of the efficacy of resistance exercise (RE) alone as a supportive care intervention for cancer patients and survivors remains limited. Consequently, the purpose of this review was to provide the first systematic evaluation of the effects of RE alone upon clinically relevant physiologic and QoL outcomes during and following cancer treatment. Literature searches were conducted to identify studies examining RE interventions in cancer patients and survivors. Data were extracted on physiologic (fitness, physical function, and body composition) and QoL (fatigue, psychological well-being, and cancer-specific and global QoL outcomes. Cohen’s d effect sizes were calculated for each outcome. A total of 15 studies (6 in samples undergoing active cancer treatment and 9 in samples having completed cancer treatment) involving 1,077 participants met the inclusion criteria. Findings revealed that, on average, RE resulted in large effectsize improvements in muscular strength (d 0.86), moderate effect-size improvements in physical function (d 0.66), and small effect-size improvements in body composition (d 0.28) and QoL (d 0.25) outcomes. The effect sizes observed following RE are comparable in magnitude to the effects of exercise interventions reported in prior comprehensive reviews of the exercise cancer literature which primarily focused upon AE. Additionally, the methodologic quality of the studies was generally strong. Taken collectively, results of this systematic review suggest that RE is a promising supportive care intervention that results in meaningful improvements in clinically relevant physiologic and QoL outcomes during and following cancer treatment.
Click on the PDF icon at the top of this introduction to read the full article.
Findings from prior systematic reviews suggest that exercise results in meaningful improvements in many clinically relevant physiologic and quality of life (QoL) outcomes during and following cancer treatment. However, the majority of exercise-cancer studies have focused upon the benefits of aerobic exercise (AE) and knowledge of the efficacy of resistance exercise (RE) alone as a supportive care intervention for cancer patients and survivors remains limited. Consequently, the purpose of this review was to provide the first systematic evaluation of the effects of RE alone upon clinically relevant physiologic and QoL outcomes during and following cancer treatment. Literature searches were conducted to identify studies examining RE interventions in cancer patients and survivors. Data were extracted on physiologic (fitness, physical function, and body composition) and QoL (fatigue, psychological well-being, and cancer-specific and global QoL outcomes. Cohen’s d effect sizes were calculated for each outcome. A total of 15 studies (6 in samples undergoing active cancer treatment and 9 in samples having completed cancer treatment) involving 1,077 participants met the inclusion criteria. Findings revealed that, on average, RE resulted in large effectsize improvements in muscular strength (d 0.86), moderate effect-size improvements in physical function (d 0.66), and small effect-size improvements in body composition (d 0.28) and QoL (d 0.25) outcomes. The effect sizes observed following RE are comparable in magnitude to the effects of exercise interventions reported in prior comprehensive reviews of the exercise cancer literature which primarily focused upon AE. Additionally, the methodologic quality of the studies was generally strong. Taken collectively, results of this systematic review suggest that RE is a promising supportive care intervention that results in meaningful improvements in clinically relevant physiologic and QoL outcomes during and following cancer treatment.
Click on the PDF icon at the top of this introduction to read the full article.
Timely palliative consult affects end-of-life care in gynecologic cancer patients
LOS ANGELES – A palliative care consultation within the last month of life improves a variety of end-of-life outcomes in patients dying from gynecologic cancers, based on a retrospective analysis.
Among the 100 patients studied, about one-fourth had a timely palliative care consultation, defined in one study as 14 days before death and in another study as 30 days before death, lead investigator Dr. Nicole S. Nevadunsky of Montefiore Medical Center, New York, reported at the annual meeting of the Society of Gynecologic Oncology.
Compared with their counterparts who had late or no consultations, patients who had timely consultations had lower scores for aggressive end-of-life events such as emergency department visits, chemotherapy, and death in an acute care setting.
In addition, in their last 14 days of life, this group had median direct inpatient hospital costs that were $5,106 less, and they were half as likely to be admitted.
"Our data suggest that early palliative medicine consultation results in decreased aggressive measures at the end of life [and] was associated with decreased direct inpatient costs for women who died from gynecologic malignancies," Dr. Nevadunsky noted. "Further research is needed to evaluate the quality of life in relation to [the aggressiveness of care] for patients and their families."
While it is unclear how many gynecologic oncologists are also board certified in palliative care, "I think more clinicians actually do palliative medicine as part of their everyday practice," Dr. Nevadunsky said. Also, palliative care is truly a multidisciplinary undertaking involving, for example, nurses, pastoral care personnel, social workers, and others.
"As far as the best metric for palliative medicine, I think it is quality of life. But how to define that is extremely complicated and still evolving," she added.
"I think it’s an experience where the patient is getting what they want most out of things, and sometimes that’s saying to the patient, ‘If we can’t cure you, what is the most important thing to you?’ " she replied. "Each patient is different, and that’s what makes (defining quality of life) so complicated."
The American Society of Clinical Oncology recommends consideration of palliative care early in the course of metastatic or symptomatic disease.
"This is a very vague recommendation: who, what, when, where, how? How will patients respond to this? Who’s going to pay for this? What’s the patient going to get out of this?" Dr. Nevadunsky commented.
She and her colleagues studied 100 consecutive patients who died from gynecologic cancer between 2006 and 2009 and received care at Montefiore in the year before death.
In the first study, they defined a timely palliative care consultation as one occurring more than 30 days before death.
"The ideal timing for palliative medicine consultation is unknown; however, 30 days was chosen as the minimal exposure time because the standard metrics utilized to compare aggressive measures at the end of life included a minimum of 30 days," Dr. Nevadunsky explained.
"Overall, I was surprised to find that 49 of the 100 women actually had a palliative medicine consultation at some time or another during their care," she said.
However, the median number of days between consultation and death was 16, and only 18% of patients had a timely consultation.
Late diagnosis did not explain this finding, as less than 10% of patients received their diagnosis in the month before they died.
"The scope of this study was not inclusive to determine why this [late palliative care consultation] was happening," Dr. Nevadunsky said. Data showed that although the two groups were demographically similar, the patients who received a timely consultation were more likely to be married.
The group with timely consultations were less likely to receive aggressive end-of-life care, based on measures of eight indicators of aggressive care (0 vs. 2, P = .025).
The difference between those patients who had timely consultation and those with untimely or no consultation was greatest for the indicators of a hospital stay lasting more than 14 days in the last month of life (22% vs. 40%) and death in the acute care setting (28% vs. 45%).
In the second study, the investigators found that 29% of patients had a timely palliative care consultation, defined in this case as one occurring 14 days or more before death.
Patients with a timely consultation had lower median direct hospital inpatient costs per day in the last 30 days of life ($613 vs. $702, P = .02). They also had lower median direct hospital inpatient costs in the last 14 days overall ($0 vs. $5,106, P = .007) and on a per-day basis ($0 vs. $676, P = .007).
"The patients who had the timely consultations actually weren’t admitted to the hospital as often," Dr. Nevadunsky noted. In fact, they were half as likely to be admitted in the last 14 days (35% vs. 71%, P = .001).
"Shortcomings [of the study] include small numbers and the retrospective collection of data. Also, our study did not account for outpatient costs, including those assumed by families, or for those costs incurred by loss of time out of work by families to care for the patient," acknowledged Dr. Nevadunsky, who disclosed no relevant conflicts of interest.
LOS ANGELES – A palliative care consultation within the last month of life improves a variety of end-of-life outcomes in patients dying from gynecologic cancers, based on a retrospective analysis.
Among the 100 patients studied, about one-fourth had a timely palliative care consultation, defined in one study as 14 days before death and in another study as 30 days before death, lead investigator Dr. Nicole S. Nevadunsky of Montefiore Medical Center, New York, reported at the annual meeting of the Society of Gynecologic Oncology.
Compared with their counterparts who had late or no consultations, patients who had timely consultations had lower scores for aggressive end-of-life events such as emergency department visits, chemotherapy, and death in an acute care setting.
In addition, in their last 14 days of life, this group had median direct inpatient hospital costs that were $5,106 less, and they were half as likely to be admitted.
"Our data suggest that early palliative medicine consultation results in decreased aggressive measures at the end of life [and] was associated with decreased direct inpatient costs for women who died from gynecologic malignancies," Dr. Nevadunsky noted. "Further research is needed to evaluate the quality of life in relation to [the aggressiveness of care] for patients and their families."
While it is unclear how many gynecologic oncologists are also board certified in palliative care, "I think more clinicians actually do palliative medicine as part of their everyday practice," Dr. Nevadunsky said. Also, palliative care is truly a multidisciplinary undertaking involving, for example, nurses, pastoral care personnel, social workers, and others.
"As far as the best metric for palliative medicine, I think it is quality of life. But how to define that is extremely complicated and still evolving," she added.
"I think it’s an experience where the patient is getting what they want most out of things, and sometimes that’s saying to the patient, ‘If we can’t cure you, what is the most important thing to you?’ " she replied. "Each patient is different, and that’s what makes (defining quality of life) so complicated."
The American Society of Clinical Oncology recommends consideration of palliative care early in the course of metastatic or symptomatic disease.
"This is a very vague recommendation: who, what, when, where, how? How will patients respond to this? Who’s going to pay for this? What’s the patient going to get out of this?" Dr. Nevadunsky commented.
She and her colleagues studied 100 consecutive patients who died from gynecologic cancer between 2006 and 2009 and received care at Montefiore in the year before death.
In the first study, they defined a timely palliative care consultation as one occurring more than 30 days before death.
"The ideal timing for palliative medicine consultation is unknown; however, 30 days was chosen as the minimal exposure time because the standard metrics utilized to compare aggressive measures at the end of life included a minimum of 30 days," Dr. Nevadunsky explained.
"Overall, I was surprised to find that 49 of the 100 women actually had a palliative medicine consultation at some time or another during their care," she said.
However, the median number of days between consultation and death was 16, and only 18% of patients had a timely consultation.
Late diagnosis did not explain this finding, as less than 10% of patients received their diagnosis in the month before they died.
"The scope of this study was not inclusive to determine why this [late palliative care consultation] was happening," Dr. Nevadunsky said. Data showed that although the two groups were demographically similar, the patients who received a timely consultation were more likely to be married.
The group with timely consultations were less likely to receive aggressive end-of-life care, based on measures of eight indicators of aggressive care (0 vs. 2, P = .025).
The difference between those patients who had timely consultation and those with untimely or no consultation was greatest for the indicators of a hospital stay lasting more than 14 days in the last month of life (22% vs. 40%) and death in the acute care setting (28% vs. 45%).
In the second study, the investigators found that 29% of patients had a timely palliative care consultation, defined in this case as one occurring 14 days or more before death.
Patients with a timely consultation had lower median direct hospital inpatient costs per day in the last 30 days of life ($613 vs. $702, P = .02). They also had lower median direct hospital inpatient costs in the last 14 days overall ($0 vs. $5,106, P = .007) and on a per-day basis ($0 vs. $676, P = .007).
"The patients who had the timely consultations actually weren’t admitted to the hospital as often," Dr. Nevadunsky noted. In fact, they were half as likely to be admitted in the last 14 days (35% vs. 71%, P = .001).
"Shortcomings [of the study] include small numbers and the retrospective collection of data. Also, our study did not account for outpatient costs, including those assumed by families, or for those costs incurred by loss of time out of work by families to care for the patient," acknowledged Dr. Nevadunsky, who disclosed no relevant conflicts of interest.
LOS ANGELES – A palliative care consultation within the last month of life improves a variety of end-of-life outcomes in patients dying from gynecologic cancers, based on a retrospective analysis.
Among the 100 patients studied, about one-fourth had a timely palliative care consultation, defined in one study as 14 days before death and in another study as 30 days before death, lead investigator Dr. Nicole S. Nevadunsky of Montefiore Medical Center, New York, reported at the annual meeting of the Society of Gynecologic Oncology.
Compared with their counterparts who had late or no consultations, patients who had timely consultations had lower scores for aggressive end-of-life events such as emergency department visits, chemotherapy, and death in an acute care setting.
In addition, in their last 14 days of life, this group had median direct inpatient hospital costs that were $5,106 less, and they were half as likely to be admitted.
"Our data suggest that early palliative medicine consultation results in decreased aggressive measures at the end of life [and] was associated with decreased direct inpatient costs for women who died from gynecologic malignancies," Dr. Nevadunsky noted. "Further research is needed to evaluate the quality of life in relation to [the aggressiveness of care] for patients and their families."
While it is unclear how many gynecologic oncologists are also board certified in palliative care, "I think more clinicians actually do palliative medicine as part of their everyday practice," Dr. Nevadunsky said. Also, palliative care is truly a multidisciplinary undertaking involving, for example, nurses, pastoral care personnel, social workers, and others.
"As far as the best metric for palliative medicine, I think it is quality of life. But how to define that is extremely complicated and still evolving," she added.
"I think it’s an experience where the patient is getting what they want most out of things, and sometimes that’s saying to the patient, ‘If we can’t cure you, what is the most important thing to you?’ " she replied. "Each patient is different, and that’s what makes (defining quality of life) so complicated."
The American Society of Clinical Oncology recommends consideration of palliative care early in the course of metastatic or symptomatic disease.
"This is a very vague recommendation: who, what, when, where, how? How will patients respond to this? Who’s going to pay for this? What’s the patient going to get out of this?" Dr. Nevadunsky commented.
She and her colleagues studied 100 consecutive patients who died from gynecologic cancer between 2006 and 2009 and received care at Montefiore in the year before death.
In the first study, they defined a timely palliative care consultation as one occurring more than 30 days before death.
"The ideal timing for palliative medicine consultation is unknown; however, 30 days was chosen as the minimal exposure time because the standard metrics utilized to compare aggressive measures at the end of life included a minimum of 30 days," Dr. Nevadunsky explained.
"Overall, I was surprised to find that 49 of the 100 women actually had a palliative medicine consultation at some time or another during their care," she said.
However, the median number of days between consultation and death was 16, and only 18% of patients had a timely consultation.
Late diagnosis did not explain this finding, as less than 10% of patients received their diagnosis in the month before they died.
"The scope of this study was not inclusive to determine why this [late palliative care consultation] was happening," Dr. Nevadunsky said. Data showed that although the two groups were demographically similar, the patients who received a timely consultation were more likely to be married.
The group with timely consultations were less likely to receive aggressive end-of-life care, based on measures of eight indicators of aggressive care (0 vs. 2, P = .025).
The difference between those patients who had timely consultation and those with untimely or no consultation was greatest for the indicators of a hospital stay lasting more than 14 days in the last month of life (22% vs. 40%) and death in the acute care setting (28% vs. 45%).
In the second study, the investigators found that 29% of patients had a timely palliative care consultation, defined in this case as one occurring 14 days or more before death.
Patients with a timely consultation had lower median direct hospital inpatient costs per day in the last 30 days of life ($613 vs. $702, P = .02). They also had lower median direct hospital inpatient costs in the last 14 days overall ($0 vs. $5,106, P = .007) and on a per-day basis ($0 vs. $676, P = .007).
"The patients who had the timely consultations actually weren’t admitted to the hospital as often," Dr. Nevadunsky noted. In fact, they were half as likely to be admitted in the last 14 days (35% vs. 71%, P = .001).
"Shortcomings [of the study] include small numbers and the retrospective collection of data. Also, our study did not account for outpatient costs, including those assumed by families, or for those costs incurred by loss of time out of work by families to care for the patient," acknowledged Dr. Nevadunsky, who disclosed no relevant conflicts of interest.
AT THE ANNUAL MEETING ON WOMEN'S CANCER
Major finding: Patients receiving timely palliative care had lower scores for aggressive care at the end of life (0 vs. 2) and, in their last 14 days, had lower median direct inpatient hospital costs ($0 vs. $5,106) and were half as likely to be admitted (35% vs. 71%).
Data source: A pair of retrospective cohort studies among 100 patients who died from gynecologic cancers.
Disclosures: Dr. Nevadunsky disclosed no relevant conflicts of interest.
Weight loss, exercise can impact cancer incidence and recurrence
Community Oncology Editor Dr. Linda Bosserman spoke with Dr. Rowan Chlebowski at the Oncology Practice Summit in Las Vegas about the effect of diet and exercise on breast cancer patients.
The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice. Dr. Bosserman was a co-chair of the Summit, which was hosted this year by Community Oncology as well as The Journal of Supportive Oncology and The Oncology Report.
Community Oncology Editor Dr. Linda Bosserman spoke with Dr. Rowan Chlebowski at the Oncology Practice Summit in Las Vegas about the effect of diet and exercise on breast cancer patients.
The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice. Dr. Bosserman was a co-chair of the Summit, which was hosted this year by Community Oncology as well as The Journal of Supportive Oncology and The Oncology Report.
Community Oncology Editor Dr. Linda Bosserman spoke with Dr. Rowan Chlebowski at the Oncology Practice Summit in Las Vegas about the effect of diet and exercise on breast cancer patients.
The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice. Dr. Bosserman was a co-chair of the Summit, which was hosted this year by Community Oncology as well as The Journal of Supportive Oncology and The Oncology Report.
SPIKES protocol offers guidance for 'active listening' when talking to cancer patients
Mr. William Goeren provides personal insight and practical tips for communicating with cancer patients using the SPIKES method. Mr. Goeren is a recent cancer survivor and director of clinical services at CancerCare, a national nonprofit organization that provides counseling, educational programs, and practical and financial assistance to people affected by cancer.
The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice. The conference was hosted this year by Community Oncology as well as The Journal of Supportive Oncology and The Oncology Report.
Mr. William Goeren provides personal insight and practical tips for communicating with cancer patients using the SPIKES method. Mr. Goeren is a recent cancer survivor and director of clinical services at CancerCare, a national nonprofit organization that provides counseling, educational programs, and practical and financial assistance to people affected by cancer.
The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice. The conference was hosted this year by Community Oncology as well as The Journal of Supportive Oncology and The Oncology Report.
Mr. William Goeren provides personal insight and practical tips for communicating with cancer patients using the SPIKES method. Mr. Goeren is a recent cancer survivor and director of clinical services at CancerCare, a national nonprofit organization that provides counseling, educational programs, and practical and financial assistance to people affected by cancer.
The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice. The conference was hosted this year by Community Oncology as well as The Journal of Supportive Oncology and The Oncology Report.
USPSTF draft recommendations update chemoprevention for breast cancer
Draft recommendations being considered by the U.S. Preventive Services Task Force encourage clinicians to offer tamoxifen or raloxifene to women who have an increased risk of developing a first breast cancer and a low risk of side effects.
The document reaffirms 2002 recommendations from the Task Force with updated evidence on the risks and benefits of this prophylactic strategy and somewhat stronger wording, saying clinicians should "offer to prescribe" the drugs to appropriate candidates rather than simply "discuss" this option and "inform" patients of the risks and benefits.
The Task Force is accepting online comments about its draft until May 13 before finalizing its recommendations.
The draft document was informed by a systematic review of the literature that suggests tamoxifen or raloxifene can reduce the incidence of invasive breast cancer in higher-risk women by 7-9 cases per 100,000 women over 5 years, compared with placebo. The review by Dr. Heidi D. Nelson and her associates was published online in advance of print by the Task Force and by the Annals of Internal Medicine (Ann. Intern. Med. 2013;158:604-14). The incidence of breast cancer was lower with tamoxifen in a head-to-head trial, the Study of Tamoxifen and Raloxifene (STAR), with 5 fewer cases per 1,000 women on tamoxifen compared with raloxifene.
The drugs also reduce the incidence of fracture, with 7 fewer vertebral fractures per 1,000 women on raloxifene or 3 fewer nonvertebral fractures per 1,000 women on tamoxifen, the literature suggests.
Neither drug reduced deaths from breast cancer or deaths from any cause in the published studies, reported Dr. Nelson, a research professor in the departments of medical informatics and clinical epidemiology and medicine at Oregon Health and Sciences University, Portland. Data were lacking on use of these drugs by nonwhite, premenopausal, or elderly women who have comorbid conditions or are taking other medications
Because both of these selective estrogen receptor modulator drugs have potentially serious side effects, the Task Force recommended in both its 2002 guidelines and the 2013 draft that they not be used by women who are not at increased risk for breast cancer. In higher-risk women, both drugs increase the risk of thromboembolic events. Studies have associated tamoxifen with 4 extra thromboembolic events per 1,000 women and raloxifene with 7 excess events per 1,000 women. Tamoxifen use was associated with 4 extra endometrial cancers compared with placebo and increased the risk for ischemic stroke and cataracts. Both drugs can cause less serious side effects, most commonly vasomotor symptoms (hot flashes).
Few U.S. women use tamoxifen or raloxifene to prevent primary breast cancer, in part because it is not clear how to indentify candidates for this therapy, according to Dr. Nelson’s report. Models estimate that women with at least a 3% risk of developing breast cancer in the next 5 years are more likely to benefit than be harmed from tamoxifen or raloxifene, the Task Force draft states. The recommendations would apply to asymptomatic women aged 40-70 years with no history of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or thromboembolic events.
An online risk assessment tool from the National Cancer Institute that is based on the Gail model of risk assessment can help estimate a person’s 5-year risk of invasive breast cancer, one of 13 risk-stratification models examined in the medical literature. Most models performed only slightly better than use of age alone to predict risk, Dr. Nelson reported. The Food and Drug Administration approved use of tamoxifen or raloxifene to prevent breast cancer if the 5-year risk is at least 1.67% under the Gail model, but women aged 60 years or older who had no other risk factors would meet this threshold using age alone, her review found.
Data are lacking on the optimal doses, and the duration and timing of therapy. The typical doses used to reduce invasive breast cancer risk in several randomized trials are 20 mg/day of tamoxifen or 60 mg/day of raloxifene for 5 years.
The Task Force draft deals only with tamoxifen and raloxifene because these are the only two drugs approved by the FDA to reduce the risk of hormone receptor–positive breast cancer. The draft recommendations note, however, that more data should be coming from trials of possible drug candidates such as aromatase inhibitors. Dr. Nelson’s review notes that tibolone, lasofoxifene, and exemestane reduced breast cancer risk in some trials and "may expand clinical options."
The American Cancer Society in 2013 urged women who are considering chemoprevention for breast cancer to discuss the risks and benefits with their physicians. A 2009 clinical practice guideline update by the American Society of Clinical Oncology said tamoxifen may be offered to women at increased risk of breast cancer and raloxifene may be offered to postmenopausal women at increased risk (J. Clin. Oncol. 2009;27:3235-58).
The American College of Obstetricians and Gynecologists’ 2002 Practice Bulletin #39 on selective estrogen receptor modulators said tamoxifen may be offered to women at high risk of breast cancer (Obstet. Gynecol. 2002;100:839-44). Joint guidelines from the Canadian Task Force on Preventive Health Care and the Canadian Breast Cancer Initiative’ Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer suggested in 2001 that women whose 5-year risk for breast cancer under the Gail model exceeds 5% may be candidates for tamoxifen preventive therapy (CMAJ 2001;164:1681-90).
The National Cancer Institute estimates that 232,340 breast cancers will be diagnosed in 2013 and 39,620 women will die from the disease.
Dr. Nelson and her associates reported having no financial disclosures other than receiving grants from the Agency for Healthcare Research and Quality, which funded the study.
Twitter: @sherryboschert
Draft recommendations being considered by the U.S. Preventive Services Task Force encourage clinicians to offer tamoxifen or raloxifene to women who have an increased risk of developing a first breast cancer and a low risk of side effects.
The document reaffirms 2002 recommendations from the Task Force with updated evidence on the risks and benefits of this prophylactic strategy and somewhat stronger wording, saying clinicians should "offer to prescribe" the drugs to appropriate candidates rather than simply "discuss" this option and "inform" patients of the risks and benefits.
The Task Force is accepting online comments about its draft until May 13 before finalizing its recommendations.
The draft document was informed by a systematic review of the literature that suggests tamoxifen or raloxifene can reduce the incidence of invasive breast cancer in higher-risk women by 7-9 cases per 100,000 women over 5 years, compared with placebo. The review by Dr. Heidi D. Nelson and her associates was published online in advance of print by the Task Force and by the Annals of Internal Medicine (Ann. Intern. Med. 2013;158:604-14). The incidence of breast cancer was lower with tamoxifen in a head-to-head trial, the Study of Tamoxifen and Raloxifene (STAR), with 5 fewer cases per 1,000 women on tamoxifen compared with raloxifene.
The drugs also reduce the incidence of fracture, with 7 fewer vertebral fractures per 1,000 women on raloxifene or 3 fewer nonvertebral fractures per 1,000 women on tamoxifen, the literature suggests.
Neither drug reduced deaths from breast cancer or deaths from any cause in the published studies, reported Dr. Nelson, a research professor in the departments of medical informatics and clinical epidemiology and medicine at Oregon Health and Sciences University, Portland. Data were lacking on use of these drugs by nonwhite, premenopausal, or elderly women who have comorbid conditions or are taking other medications
Because both of these selective estrogen receptor modulator drugs have potentially serious side effects, the Task Force recommended in both its 2002 guidelines and the 2013 draft that they not be used by women who are not at increased risk for breast cancer. In higher-risk women, both drugs increase the risk of thromboembolic events. Studies have associated tamoxifen with 4 extra thromboembolic events per 1,000 women and raloxifene with 7 excess events per 1,000 women. Tamoxifen use was associated with 4 extra endometrial cancers compared with placebo and increased the risk for ischemic stroke and cataracts. Both drugs can cause less serious side effects, most commonly vasomotor symptoms (hot flashes).
Few U.S. women use tamoxifen or raloxifene to prevent primary breast cancer, in part because it is not clear how to indentify candidates for this therapy, according to Dr. Nelson’s report. Models estimate that women with at least a 3% risk of developing breast cancer in the next 5 years are more likely to benefit than be harmed from tamoxifen or raloxifene, the Task Force draft states. The recommendations would apply to asymptomatic women aged 40-70 years with no history of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or thromboembolic events.
An online risk assessment tool from the National Cancer Institute that is based on the Gail model of risk assessment can help estimate a person’s 5-year risk of invasive breast cancer, one of 13 risk-stratification models examined in the medical literature. Most models performed only slightly better than use of age alone to predict risk, Dr. Nelson reported. The Food and Drug Administration approved use of tamoxifen or raloxifene to prevent breast cancer if the 5-year risk is at least 1.67% under the Gail model, but women aged 60 years or older who had no other risk factors would meet this threshold using age alone, her review found.
Data are lacking on the optimal doses, and the duration and timing of therapy. The typical doses used to reduce invasive breast cancer risk in several randomized trials are 20 mg/day of tamoxifen or 60 mg/day of raloxifene for 5 years.
The Task Force draft deals only with tamoxifen and raloxifene because these are the only two drugs approved by the FDA to reduce the risk of hormone receptor–positive breast cancer. The draft recommendations note, however, that more data should be coming from trials of possible drug candidates such as aromatase inhibitors. Dr. Nelson’s review notes that tibolone, lasofoxifene, and exemestane reduced breast cancer risk in some trials and "may expand clinical options."
The American Cancer Society in 2013 urged women who are considering chemoprevention for breast cancer to discuss the risks and benefits with their physicians. A 2009 clinical practice guideline update by the American Society of Clinical Oncology said tamoxifen may be offered to women at increased risk of breast cancer and raloxifene may be offered to postmenopausal women at increased risk (J. Clin. Oncol. 2009;27:3235-58).
The American College of Obstetricians and Gynecologists’ 2002 Practice Bulletin #39 on selective estrogen receptor modulators said tamoxifen may be offered to women at high risk of breast cancer (Obstet. Gynecol. 2002;100:839-44). Joint guidelines from the Canadian Task Force on Preventive Health Care and the Canadian Breast Cancer Initiative’ Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer suggested in 2001 that women whose 5-year risk for breast cancer under the Gail model exceeds 5% may be candidates for tamoxifen preventive therapy (CMAJ 2001;164:1681-90).
The National Cancer Institute estimates that 232,340 breast cancers will be diagnosed in 2013 and 39,620 women will die from the disease.
Dr. Nelson and her associates reported having no financial disclosures other than receiving grants from the Agency for Healthcare Research and Quality, which funded the study.
Twitter: @sherryboschert
Draft recommendations being considered by the U.S. Preventive Services Task Force encourage clinicians to offer tamoxifen or raloxifene to women who have an increased risk of developing a first breast cancer and a low risk of side effects.
The document reaffirms 2002 recommendations from the Task Force with updated evidence on the risks and benefits of this prophylactic strategy and somewhat stronger wording, saying clinicians should "offer to prescribe" the drugs to appropriate candidates rather than simply "discuss" this option and "inform" patients of the risks and benefits.
The Task Force is accepting online comments about its draft until May 13 before finalizing its recommendations.
The draft document was informed by a systematic review of the literature that suggests tamoxifen or raloxifene can reduce the incidence of invasive breast cancer in higher-risk women by 7-9 cases per 100,000 women over 5 years, compared with placebo. The review by Dr. Heidi D. Nelson and her associates was published online in advance of print by the Task Force and by the Annals of Internal Medicine (Ann. Intern. Med. 2013;158:604-14). The incidence of breast cancer was lower with tamoxifen in a head-to-head trial, the Study of Tamoxifen and Raloxifene (STAR), with 5 fewer cases per 1,000 women on tamoxifen compared with raloxifene.
The drugs also reduce the incidence of fracture, with 7 fewer vertebral fractures per 1,000 women on raloxifene or 3 fewer nonvertebral fractures per 1,000 women on tamoxifen, the literature suggests.
Neither drug reduced deaths from breast cancer or deaths from any cause in the published studies, reported Dr. Nelson, a research professor in the departments of medical informatics and clinical epidemiology and medicine at Oregon Health and Sciences University, Portland. Data were lacking on use of these drugs by nonwhite, premenopausal, or elderly women who have comorbid conditions or are taking other medications
Because both of these selective estrogen receptor modulator drugs have potentially serious side effects, the Task Force recommended in both its 2002 guidelines and the 2013 draft that they not be used by women who are not at increased risk for breast cancer. In higher-risk women, both drugs increase the risk of thromboembolic events. Studies have associated tamoxifen with 4 extra thromboembolic events per 1,000 women and raloxifene with 7 excess events per 1,000 women. Tamoxifen use was associated with 4 extra endometrial cancers compared with placebo and increased the risk for ischemic stroke and cataracts. Both drugs can cause less serious side effects, most commonly vasomotor symptoms (hot flashes).
Few U.S. women use tamoxifen or raloxifene to prevent primary breast cancer, in part because it is not clear how to indentify candidates for this therapy, according to Dr. Nelson’s report. Models estimate that women with at least a 3% risk of developing breast cancer in the next 5 years are more likely to benefit than be harmed from tamoxifen or raloxifene, the Task Force draft states. The recommendations would apply to asymptomatic women aged 40-70 years with no history of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or thromboembolic events.
An online risk assessment tool from the National Cancer Institute that is based on the Gail model of risk assessment can help estimate a person’s 5-year risk of invasive breast cancer, one of 13 risk-stratification models examined in the medical literature. Most models performed only slightly better than use of age alone to predict risk, Dr. Nelson reported. The Food and Drug Administration approved use of tamoxifen or raloxifene to prevent breast cancer if the 5-year risk is at least 1.67% under the Gail model, but women aged 60 years or older who had no other risk factors would meet this threshold using age alone, her review found.
Data are lacking on the optimal doses, and the duration and timing of therapy. The typical doses used to reduce invasive breast cancer risk in several randomized trials are 20 mg/day of tamoxifen or 60 mg/day of raloxifene for 5 years.
The Task Force draft deals only with tamoxifen and raloxifene because these are the only two drugs approved by the FDA to reduce the risk of hormone receptor–positive breast cancer. The draft recommendations note, however, that more data should be coming from trials of possible drug candidates such as aromatase inhibitors. Dr. Nelson’s review notes that tibolone, lasofoxifene, and exemestane reduced breast cancer risk in some trials and "may expand clinical options."
The American Cancer Society in 2013 urged women who are considering chemoprevention for breast cancer to discuss the risks and benefits with their physicians. A 2009 clinical practice guideline update by the American Society of Clinical Oncology said tamoxifen may be offered to women at increased risk of breast cancer and raloxifene may be offered to postmenopausal women at increased risk (J. Clin. Oncol. 2009;27:3235-58).
The American College of Obstetricians and Gynecologists’ 2002 Practice Bulletin #39 on selective estrogen receptor modulators said tamoxifen may be offered to women at high risk of breast cancer (Obstet. Gynecol. 2002;100:839-44). Joint guidelines from the Canadian Task Force on Preventive Health Care and the Canadian Breast Cancer Initiative’ Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer suggested in 2001 that women whose 5-year risk for breast cancer under the Gail model exceeds 5% may be candidates for tamoxifen preventive therapy (CMAJ 2001;164:1681-90).
The National Cancer Institute estimates that 232,340 breast cancers will be diagnosed in 2013 and 39,620 women will die from the disease.
Dr. Nelson and her associates reported having no financial disclosures other than receiving grants from the Agency for Healthcare Research and Quality, which funded the study.
Twitter: @sherryboschert
FROM ANNALS OF INTERNAL MEDICINE




