Patient & Survivor Care

Writing the "Vitality Signs" column is part of my routine, and naturally offers me the opportunity to ponder and put forth reassuringly straightforward numbers. Statistical significances, clinically meaningful results. Each potentially offers insight, in some small way, about how the oncology community might ease the distress or minimize the suffering or sorrow of an individual or a family stricken by cancer.

It is the sort of task that psychologists like myself recommend to those in the aftermath of a tragedy such as the inexplicable shooting of 20 first-graders and their heroic protectors in a bucolic Connecticut town.

Grieve, yes. Pull your family close.

But do not spend hours watching network coverage, as minuscule facts or fallacies emerge, the latter to be discounted later in the interminable cycle of televised despair.

Minimize exposure to the event unless there is something tangible you can do.

Focus on your routine.

Concentrate on positive ways that can make a difference in your world.

I heard the heartbreaking news, as you likely did, in the middle of a busy workday filled with the day-to-day challenges, personal tragedies, and yes, small joys, that cancer leaves in its wake.

I noticed that my colleagues and coworkers spoke of the horror unfolding in hushed tones, behind closed doors, tears brimming. I later wondered if we were trying to protect some of our patients, even for a brief time, from having to hear of sadnesses beyond the ones they bravely faced that day. For others, perhaps celebrating a last day of chemotherapy or radiation treatment, we may have felt compelled to preserve their relief: Freezing in time a moment of silent peace in the village snow globe before the storm swirls once again.

Tragedy spares no one who works in the field of oncology.

It is a specialty infused by existential questions; why heartache touched this family, why so young, why so poor a prognosis or response.

Yet we have in common with each other, our patients – even feuding family members – a simple enemy, cancer. It’s the bad guy who rallies us in solidarity. When it wins, the ending at least is in accordance with life’s rhythm of beginnings and endings, birth followed by life and then a natural, if not always easy, death. Ideally, peace comes at last to the family, who may have been there to offer comfort, perhaps to a 6-year-old.

I spoke recently with a gifted pediatric hospice nurse who described moments of beauty, relief, and spiritual connection in such exquisitely painful bedside moments.

The memory of that conversation only deepens my sorrow about the 6-year-olds who died in horror at Sandy Hook Elementary School.

I’m sure that people ask you, not infrequently, how you could have chosen oncology as your specialty, when so many specialties would keep you far from the angst that is a part of that world. Of course, such questioners do not consider the joy of an unexpected remission; the deep connections reforged between family members once estranged; the bravery, grace, and abiding loyalty unfolding before us every day.

As the days have passed since the Connecticut tragedy, I hope you have been especially attuned to the indescribable beauty in the world of your chosen calling. I hope you are gratefully holding your family close. I hope you see clearly now the difference you make to the world in ways great and small.

Dr. Freed is a clinical psychologist in Santa Barbara, California, and a medical journalist. This column "Vitality Signs," appears regularly in The Oncology Report. Visit www.oncologyreport.com to see what is new in Vitality Signs.

Writing the "Vitality Signs" column is part of my routine, and naturally offers me the opportunity to ponder and put forth reassuringly straightforward numbers. Statistical significances, clinically meaningful results. Each potentially offers insight, in some small way, about how the oncology community might ease the distress or minimize the suffering or sorrow of an individual or a family stricken by cancer.

It is the sort of task that psychologists like myself recommend to those in the aftermath of a tragedy such as the inexplicable shooting of 20 first-graders and their heroic protectors in a bucolic Connecticut town.

Grieve, yes. Pull your family close.

But do not spend hours watching network coverage, as minuscule facts or fallacies emerge, the latter to be discounted later in the interminable cycle of televised despair.

Minimize exposure to the event unless there is something tangible you can do.

Focus on your routine.

Concentrate on positive ways that can make a difference in your world.

I heard the heartbreaking news, as you likely did, in the middle of a busy workday filled with the day-to-day challenges, personal tragedies, and yes, small joys, that cancer leaves in its wake.

I noticed that my colleagues and coworkers spoke of the horror unfolding in hushed tones, behind closed doors, tears brimming. I later wondered if we were trying to protect some of our patients, even for a brief time, from having to hear of sadnesses beyond the ones they bravely faced that day. For others, perhaps celebrating a last day of chemotherapy or radiation treatment, we may have felt compelled to preserve their relief: Freezing in time a moment of silent peace in the village snow globe before the storm swirls once again.

Tragedy spares no one who works in the field of oncology.

It is a specialty infused by existential questions; why heartache touched this family, why so young, why so poor a prognosis or response.

Yet we have in common with each other, our patients – even feuding family members – a simple enemy, cancer. It’s the bad guy who rallies us in solidarity. When it wins, the ending at least is in accordance with life’s rhythm of beginnings and endings, birth followed by life and then a natural, if not always easy, death. Ideally, peace comes at last to the family, who may have been there to offer comfort, perhaps to a 6-year-old.

I spoke recently with a gifted pediatric hospice nurse who described moments of beauty, relief, and spiritual connection in such exquisitely painful bedside moments.

The memory of that conversation only deepens my sorrow about the 6-year-olds who died in horror at Sandy Hook Elementary School.

I’m sure that people ask you, not infrequently, how you could have chosen oncology as your specialty, when so many specialties would keep you far from the angst that is a part of that world. Of course, such questioners do not consider the joy of an unexpected remission; the deep connections reforged between family members once estranged; the bravery, grace, and abiding loyalty unfolding before us every day.

As the days have passed since the Connecticut tragedy, I hope you have been especially attuned to the indescribable beauty in the world of your chosen calling. I hope you are gratefully holding your family close. I hope you see clearly now the difference you make to the world in ways great and small.

Dr. Freed is a clinical psychologist in Santa Barbara, California, and a medical journalist. This column "Vitality Signs," appears regularly in The Oncology Report. Visit www.oncologyreport.com to see what is new in Vitality Signs.

Writing the "Vitality Signs" column is part of my routine, and naturally offers me the opportunity to ponder and put forth reassuringly straightforward numbers. Statistical significances, clinically meaningful results. Each potentially offers insight, in some small way, about how the oncology community might ease the distress or minimize the suffering or sorrow of an individual or a family stricken by cancer.

It is the sort of task that psychologists like myself recommend to those in the aftermath of a tragedy such as the inexplicable shooting of 20 first-graders and their heroic protectors in a bucolic Connecticut town.

Grieve, yes. Pull your family close.

But do not spend hours watching network coverage, as minuscule facts or fallacies emerge, the latter to be discounted later in the interminable cycle of televised despair.

Minimize exposure to the event unless there is something tangible you can do.

Focus on your routine.

Concentrate on positive ways that can make a difference in your world.

I heard the heartbreaking news, as you likely did, in the middle of a busy workday filled with the day-to-day challenges, personal tragedies, and yes, small joys, that cancer leaves in its wake.

I noticed that my colleagues and coworkers spoke of the horror unfolding in hushed tones, behind closed doors, tears brimming. I later wondered if we were trying to protect some of our patients, even for a brief time, from having to hear of sadnesses beyond the ones they bravely faced that day. For others, perhaps celebrating a last day of chemotherapy or radiation treatment, we may have felt compelled to preserve their relief: Freezing in time a moment of silent peace in the village snow globe before the storm swirls once again.

Tragedy spares no one who works in the field of oncology.

It is a specialty infused by existential questions; why heartache touched this family, why so young, why so poor a prognosis or response.

Yet we have in common with each other, our patients – even feuding family members – a simple enemy, cancer. It’s the bad guy who rallies us in solidarity. When it wins, the ending at least is in accordance with life’s rhythm of beginnings and endings, birth followed by life and then a natural, if not always easy, death. Ideally, peace comes at last to the family, who may have been there to offer comfort, perhaps to a 6-year-old.

I spoke recently with a gifted pediatric hospice nurse who described moments of beauty, relief, and spiritual connection in such exquisitely painful bedside moments.

The memory of that conversation only deepens my sorrow about the 6-year-olds who died in horror at Sandy Hook Elementary School.

I’m sure that people ask you, not infrequently, how you could have chosen oncology as your specialty, when so many specialties would keep you far from the angst that is a part of that world. Of course, such questioners do not consider the joy of an unexpected remission; the deep connections reforged between family members once estranged; the bravery, grace, and abiding loyalty unfolding before us every day.

As the days have passed since the Connecticut tragedy, I hope you have been especially attuned to the indescribable beauty in the world of your chosen calling. I hope you are gratefully holding your family close. I hope you see clearly now the difference you make to the world in ways great and small.

Dr. Freed is a clinical psychologist in Santa Barbara, California, and a medical journalist. This column "Vitality Signs," appears regularly in The Oncology Report. Visit www.oncologyreport.com to see what is new in Vitality Signs.

From Hollywood to Washington, care at the end of life increasingly is part of the national conversation.

As more than 70 million baby boomers (Americans born between 1946 and 1964) approach the end of their life spans, the cultural, clinical and socioeconomic impacts of end-of-life care have become high-profile topics. The French film "Amour," which depicts the challenges faced by an octogenarian couple after the wife has a series of strokes, has received an Academy Award Best Picture nomination. The Institute of Medicine will convene a panel of experts on Feb. 22-24 in Washington to examine the state of end-of-life care. The goal of the IOM Committee on Transforming End of Life Care is to produce a consensus report by 2014 to address end-of-life care. "Coordinated, expert, compassionate care for people dying from chronic diseases continues to challenge the American health care system," according to the IOM’s online announcement of the meeting.

In addition, the Coalition to Transform Advanced Care is hosting a National Summit on Advanced Illness Care on Jan. 29-30 in Washington. The Coalition includes a wide range of constituencies including the IOM, the American Heart Association, the American Academy of Hospice and Palliative Medicine, and the American Geriatrics Society, as well as insurers, health systems, patient advocacy groups, and others.

As policy issues are discussed and begin to take shape, outcomes research focused on end-of-life care will increasingly gain importance. In the area of cancer care, here are some of the highlights of such research presented at a Quality Care Symposium sponsored by the American Society of Clinical Oncology in December 2012 in San Diego.

Palliative care teams: A palliative care team formed by Dr. Allen R. Chen and his associates at Johns Hopkins’s comprehensive cancer center helped change patient and family decisions regarding end-of-life care during a 4-year period and decreased use of intensive or invasive procedures in the last 6 months of life.

The team offered inpatient and clinic consultations and didactic sessions to physicians to improve how they discuss end-of-life issues with patients, plus support for family meetings to discuss and document the goals of care, said Dr. Chen, associate professor of oncology and pediatrics at Johns Hopkins University, Baltimore.

Of the 525 oncology patients who died in the cancer center while hospitalized from 2008 through 2011, the proportion who chose to have do-not-resuscitate (DNR) orders, withdrew ICU support, or chose comfort care instead of more aggressive care increased from 81% to 95% over the course of the 4 years, a statistically significant difference, he reported.

The rate of ICU care during patients’ final hospitalizations did not change significantly, but the proportion of patients who were put on mechanical ventilation for more than 14 days decreased significantly from 10% to 5%. These earlier withdrawals of care did not increase the risk of death, Dr. Chen said – the rate of survival to discharge from the oncology ICU did not change significantly.

The investigators now are looking for ways to minimize ICU visits at the end of life, he said. The presence of advanced cancer, being on a cardiac monitor, or needing supplemental oxygen foreshadowed critical illness in patients in the study. "We want to facilitate the difficult discussion" about end-of-life care choices "before critical care is needed," he said. So far, their efforts haven’t resulted in decreased use of ICU services at the end of life.

Minimizing surgical risks: One of the first comprehensive analyses of surgical outcomes in patients with disseminated cancer found that the risk of death increases greatly with emergency surgery.

John Pesavento, a medical student at Creighton University, Omaha, Neb., and his associates analyzed preoperative and postoperative data from the American College of Surgeon’s National Surgical Quality Improvement Program database on move than 147,000 patients who underwent surgical procedures between 2005 and 2008.

Eight of the 10 most common procedures resulted in significantly higher 30-day mortality rates in the cancer patients as compared with the same surgeries in patients who did not have disseminated cancer.

Comparing patients with and without disseminated cancer, 30-day mortality rates were 21% and 15%, respectively, after exploration of the abdomen, 15% and 9% after removal of the small bowel, 11% and 6% after colon removal, 11% and 5% after colostomy, 10% and 5% after partial removal of the colon, 10% and 0.5% after cholecystectomy, 1.8% and 0.9% after repair of a bowel opening, and 1% and 0.1% after mastectomy, he reported. The most common operations in patients with disseminated cancer were partial removal of the colon (in 11%), partial removal of the liver (9%), partial removal of the intestine (5%), and abdominal exploration (5%), he reported in a poster presentation.

When done as emergency procedures, however, 7 of the top 10 surgeries led to significantly higher 30-day mortality rates for disseminated cancer patients. Death rates in patients with disseminated cancer were 44% for emergency surgery and 12% for nonemergent surgery to explore the abdomen; the respective rates were 33% and 6% after bowel-to-bowel fusion, 31% and 4% after removal of the colon, 28% and 10% after removal of the small intestine, 23% and 5% after cholecystectomy, 22% and 7% after partial removal of the colon, and 19% and 9% after colostomy.

The findings should help physicians counsel their patients with disseminated cancer to help them decide whether it’s worth undergoing surgery – especially emergency surgery – given the higher risks of death, Mr. Pesavento said.

Physicians’ attitudes and education: In a separate study, 16 urologists and four primary care physicians who were undergoing surgical training in urology were interviewed about their attitudes regarding end-of-life care for men dying of prostate cancer. They viewed current end-of-life care as shoddily organized and poorly integrated, and said that ideal outcomes should be defined by patients’ own values and preferences, Dr. Jonathan Bergman and his associates reported in a poster presentation.

The physicians said that, ideally, a multidisciplinary team would care for dying patients, but respondents varied in the degree to which they saw themselves participating, reported Dr. Bergman of the University of California, Los Angeles.

The findings suggest that physician education about end-of-life care needs improvement, and that clinicians should be guided to deliver end-of-life care that is patient-centered and congruent with patients’ values, he said.

Dying in the hospital: Among 2,621 patients with solid tumors, those who had contact with a specialist palliative care team more than a month before their deaths were less likely to die in the hospital (16%) than were patients who had later or no contact with the team (20%), J. Brian Cassel, Ph.D., reported in a poster presentation.

Dr. Cassel and his associates analyzed claims data on the last 6 months of life for 3,128 adults with cancer who had at least one contact with the Virginia Commonwealth University cancer center in Richmond between January 2009 and July 2011. The data set included patients who had solid tumors, underwent bone marrow transfer, or had other hematologic malignancies.

The findings provided a snapshot of end-of-life care at the university, where 32% of the cancer patients were admitted to the hospital within their last 30 days of life, 19% had at least one readmission during their last 6 months of life, and 15% died in the hospital. Chemotherapy was given to 11% in their last month of life, and to 7% in their last 2 weeks of life, said Dr. Cassel of the university.

The specialist palliative care team made contact with 28% of patients a median of 6-10 days before the death of patients with bone marrow transfer or other nonhematologic malignancies and a median of 25 days before the death of patients with solid tumors.

Chemotherapy at the end of life: Patients with hematologic malignancies were significantly more likely to get chemotherapy in the last 30 days of life (38%) compared with patients with solid tumors (8%), Dr. Alma Rodriguez and her associates reported in a poster presentation.

The investigators reviewed data on 7,399 patients who received care for a solid tumor or hematological malignancy at the University of Texas M.D. Anderson Cancer Center, Houston, and died between December 2010 and May 2012. Overall, 14% of patients received chemotherapy within the last 30 days of life.

Of the 1,262 patients who died in the hospital, 44% received chemotherapy within the last 30 days of life, compared with 7% of the 6,137 patients who died in other locations, reported Dr. Rodriguez, professor of medicine at the cancer center.

Chemotherapy within the last 30 days of life was 3 times more likely in patients with metastatic solid tumors, 14 times more likely in patients with nonrelapsed hematologic malignancy, and 36 times more likely in patients with historical or current relapse of hematologic malignancy.

Patients 65 years or older were 38% less likely than were younger patients to get chemotherapy within the last 30 days of life. Patients with one or more comorbidity (most frequently heart failure and coronary artery diseases) were 28% less likely to get chemotherapy within the last 30 days of life as compared with patients without comorbidities.

"As oncologists, we must communicate clearly with our patients about realistic goals of treatment and the likelihood of life-threatening complications of chemotherapy," Dr. Rodriguez said in the poster.

Outpatient palliative care: Dr. Kavitha Ramchandran and her associates at Stanford (Calif.) University studied their system’s electronic medical records to look at the use of palliative care in outpatient clinics from January through September 2012. The number of palliative care contacts with outpatient clinic patients increased from 10 in January to 45 in September. The number of physicians referring outpatients to palliative care increased from 6 in January to 21 in September, she said in a poster presentation.

More than 65% of patients who were referred for palliative care were younger than 65 years, said Dr. Ramchandran of the university. Most patients had only one visit with palliative care (41%) or two visits (23%).

The findings suggest that outpatient palliative care is a growing specialty, she suggested. The data are not mature enough to assess any impact on the quality of end-of-life care or on the efficiency of care, she added.

Dr. Chen and Mr. Pesavento reported having no financial disclosures. Dr. Ramchandran’s study was funded in part by the Stanford Corporate Partners Fund and by various Stanford departments. No financial disclosures were available for the other presenters.

From Hollywood to Washington, care at the end of life increasingly is part of the national conversation.

As more than 70 million baby boomers (Americans born between 1946 and 1964) approach the end of their life spans, the cultural, clinical and socioeconomic impacts of end-of-life care have become high-profile topics. The French film "Amour," which depicts the challenges faced by an octogenarian couple after the wife has a series of strokes, has received an Academy Award Best Picture nomination. The Institute of Medicine will convene a panel of experts on Feb. 22-24 in Washington to examine the state of end-of-life care. The goal of the IOM Committee on Transforming End of Life Care is to produce a consensus report by 2014 to address end-of-life care. "Coordinated, expert, compassionate care for people dying from chronic diseases continues to challenge the American health care system," according to the IOM’s online announcement of the meeting.

In addition, the Coalition to Transform Advanced Care is hosting a National Summit on Advanced Illness Care on Jan. 29-30 in Washington. The Coalition includes a wide range of constituencies including the IOM, the American Heart Association, the American Academy of Hospice and Palliative Medicine, and the American Geriatrics Society, as well as insurers, health systems, patient advocacy groups, and others.

As policy issues are discussed and begin to take shape, outcomes research focused on end-of-life care will increasingly gain importance. In the area of cancer care, here are some of the highlights of such research presented at a Quality Care Symposium sponsored by the American Society of Clinical Oncology in December 2012 in San Diego.

Palliative care teams: A palliative care team formed by Dr. Allen R. Chen and his associates at Johns Hopkins’s comprehensive cancer center helped change patient and family decisions regarding end-of-life care during a 4-year period and decreased use of intensive or invasive procedures in the last 6 months of life.

The team offered inpatient and clinic consultations and didactic sessions to physicians to improve how they discuss end-of-life issues with patients, plus support for family meetings to discuss and document the goals of care, said Dr. Chen, associate professor of oncology and pediatrics at Johns Hopkins University, Baltimore.

Of the 525 oncology patients who died in the cancer center while hospitalized from 2008 through 2011, the proportion who chose to have do-not-resuscitate (DNR) orders, withdrew ICU support, or chose comfort care instead of more aggressive care increased from 81% to 95% over the course of the 4 years, a statistically significant difference, he reported.

The rate of ICU care during patients’ final hospitalizations did not change significantly, but the proportion of patients who were put on mechanical ventilation for more than 14 days decreased significantly from 10% to 5%. These earlier withdrawals of care did not increase the risk of death, Dr. Chen said – the rate of survival to discharge from the oncology ICU did not change significantly.

The investigators now are looking for ways to minimize ICU visits at the end of life, he said. The presence of advanced cancer, being on a cardiac monitor, or needing supplemental oxygen foreshadowed critical illness in patients in the study. "We want to facilitate the difficult discussion" about end-of-life care choices "before critical care is needed," he said. So far, their efforts haven’t resulted in decreased use of ICU services at the end of life.

Minimizing surgical risks: One of the first comprehensive analyses of surgical outcomes in patients with disseminated cancer found that the risk of death increases greatly with emergency surgery.

John Pesavento, a medical student at Creighton University, Omaha, Neb., and his associates analyzed preoperative and postoperative data from the American College of Surgeon’s National Surgical Quality Improvement Program database on move than 147,000 patients who underwent surgical procedures between 2005 and 2008.

Eight of the 10 most common procedures resulted in significantly higher 30-day mortality rates in the cancer patients as compared with the same surgeries in patients who did not have disseminated cancer.

Comparing patients with and without disseminated cancer, 30-day mortality rates were 21% and 15%, respectively, after exploration of the abdomen, 15% and 9% after removal of the small bowel, 11% and 6% after colon removal, 11% and 5% after colostomy, 10% and 5% after partial removal of the colon, 10% and 0.5% after cholecystectomy, 1.8% and 0.9% after repair of a bowel opening, and 1% and 0.1% after mastectomy, he reported. The most common operations in patients with disseminated cancer were partial removal of the colon (in 11%), partial removal of the liver (9%), partial removal of the intestine (5%), and abdominal exploration (5%), he reported in a poster presentation.

When done as emergency procedures, however, 7 of the top 10 surgeries led to significantly higher 30-day mortality rates for disseminated cancer patients. Death rates in patients with disseminated cancer were 44% for emergency surgery and 12% for nonemergent surgery to explore the abdomen; the respective rates were 33% and 6% after bowel-to-bowel fusion, 31% and 4% after removal of the colon, 28% and 10% after removal of the small intestine, 23% and 5% after cholecystectomy, 22% and 7% after partial removal of the colon, and 19% and 9% after colostomy.

The findings should help physicians counsel their patients with disseminated cancer to help them decide whether it’s worth undergoing surgery – especially emergency surgery – given the higher risks of death, Mr. Pesavento said.

Physicians’ attitudes and education: In a separate study, 16 urologists and four primary care physicians who were undergoing surgical training in urology were interviewed about their attitudes regarding end-of-life care for men dying of prostate cancer. They viewed current end-of-life care as shoddily organized and poorly integrated, and said that ideal outcomes should be defined by patients’ own values and preferences, Dr. Jonathan Bergman and his associates reported in a poster presentation.

The physicians said that, ideally, a multidisciplinary team would care for dying patients, but respondents varied in the degree to which they saw themselves participating, reported Dr. Bergman of the University of California, Los Angeles.

The findings suggest that physician education about end-of-life care needs improvement, and that clinicians should be guided to deliver end-of-life care that is patient-centered and congruent with patients’ values, he said.

Dying in the hospital: Among 2,621 patients with solid tumors, those who had contact with a specialist palliative care team more than a month before their deaths were less likely to die in the hospital (16%) than were patients who had later or no contact with the team (20%), J. Brian Cassel, Ph.D., reported in a poster presentation.

Dr. Cassel and his associates analyzed claims data on the last 6 months of life for 3,128 adults with cancer who had at least one contact with the Virginia Commonwealth University cancer center in Richmond between January 2009 and July 2011. The data set included patients who had solid tumors, underwent bone marrow transfer, or had other hematologic malignancies.

The findings provided a snapshot of end-of-life care at the university, where 32% of the cancer patients were admitted to the hospital within their last 30 days of life, 19% had at least one readmission during their last 6 months of life, and 15% died in the hospital. Chemotherapy was given to 11% in their last month of life, and to 7% in their last 2 weeks of life, said Dr. Cassel of the university.

The specialist palliative care team made contact with 28% of patients a median of 6-10 days before the death of patients with bone marrow transfer or other nonhematologic malignancies and a median of 25 days before the death of patients with solid tumors.

Chemotherapy at the end of life: Patients with hematologic malignancies were significantly more likely to get chemotherapy in the last 30 days of life (38%) compared with patients with solid tumors (8%), Dr. Alma Rodriguez and her associates reported in a poster presentation.

The investigators reviewed data on 7,399 patients who received care for a solid tumor or hematological malignancy at the University of Texas M.D. Anderson Cancer Center, Houston, and died between December 2010 and May 2012. Overall, 14% of patients received chemotherapy within the last 30 days of life.

Of the 1,262 patients who died in the hospital, 44% received chemotherapy within the last 30 days of life, compared with 7% of the 6,137 patients who died in other locations, reported Dr. Rodriguez, professor of medicine at the cancer center.

Chemotherapy within the last 30 days of life was 3 times more likely in patients with metastatic solid tumors, 14 times more likely in patients with nonrelapsed hematologic malignancy, and 36 times more likely in patients with historical or current relapse of hematologic malignancy.

Patients 65 years or older were 38% less likely than were younger patients to get chemotherapy within the last 30 days of life. Patients with one or more comorbidity (most frequently heart failure and coronary artery diseases) were 28% less likely to get chemotherapy within the last 30 days of life as compared with patients without comorbidities.

"As oncologists, we must communicate clearly with our patients about realistic goals of treatment and the likelihood of life-threatening complications of chemotherapy," Dr. Rodriguez said in the poster.

Outpatient palliative care: Dr. Kavitha Ramchandran and her associates at Stanford (Calif.) University studied their system’s electronic medical records to look at the use of palliative care in outpatient clinics from January through September 2012. The number of palliative care contacts with outpatient clinic patients increased from 10 in January to 45 in September. The number of physicians referring outpatients to palliative care increased from 6 in January to 21 in September, she said in a poster presentation.

More than 65% of patients who were referred for palliative care were younger than 65 years, said Dr. Ramchandran of the university. Most patients had only one visit with palliative care (41%) or two visits (23%).

The findings suggest that outpatient palliative care is a growing specialty, she suggested. The data are not mature enough to assess any impact on the quality of end-of-life care or on the efficiency of care, she added.

Dr. Chen and Mr. Pesavento reported having no financial disclosures. Dr. Ramchandran’s study was funded in part by the Stanford Corporate Partners Fund and by various Stanford departments. No financial disclosures were available for the other presenters.

From Hollywood to Washington, care at the end of life increasingly is part of the national conversation.

As more than 70 million baby boomers (Americans born between 1946 and 1964) approach the end of their life spans, the cultural, clinical and socioeconomic impacts of end-of-life care have become high-profile topics. The French film "Amour," which depicts the challenges faced by an octogenarian couple after the wife has a series of strokes, has received an Academy Award Best Picture nomination. The Institute of Medicine will convene a panel of experts on Feb. 22-24 in Washington to examine the state of end-of-life care. The goal of the IOM Committee on Transforming End of Life Care is to produce a consensus report by 2014 to address end-of-life care. "Coordinated, expert, compassionate care for people dying from chronic diseases continues to challenge the American health care system," according to the IOM’s online announcement of the meeting.

In addition, the Coalition to Transform Advanced Care is hosting a National Summit on Advanced Illness Care on Jan. 29-30 in Washington. The Coalition includes a wide range of constituencies including the IOM, the American Heart Association, the American Academy of Hospice and Palliative Medicine, and the American Geriatrics Society, as well as insurers, health systems, patient advocacy groups, and others.

As policy issues are discussed and begin to take shape, outcomes research focused on end-of-life care will increasingly gain importance. In the area of cancer care, here are some of the highlights of such research presented at a Quality Care Symposium sponsored by the American Society of Clinical Oncology in December 2012 in San Diego.

Palliative care teams: A palliative care team formed by Dr. Allen R. Chen and his associates at Johns Hopkins’s comprehensive cancer center helped change patient and family decisions regarding end-of-life care during a 4-year period and decreased use of intensive or invasive procedures in the last 6 months of life.

The team offered inpatient and clinic consultations and didactic sessions to physicians to improve how they discuss end-of-life issues with patients, plus support for family meetings to discuss and document the goals of care, said Dr. Chen, associate professor of oncology and pediatrics at Johns Hopkins University, Baltimore.

Of the 525 oncology patients who died in the cancer center while hospitalized from 2008 through 2011, the proportion who chose to have do-not-resuscitate (DNR) orders, withdrew ICU support, or chose comfort care instead of more aggressive care increased from 81% to 95% over the course of the 4 years, a statistically significant difference, he reported.

The rate of ICU care during patients’ final hospitalizations did not change significantly, but the proportion of patients who were put on mechanical ventilation for more than 14 days decreased significantly from 10% to 5%. These earlier withdrawals of care did not increase the risk of death, Dr. Chen said – the rate of survival to discharge from the oncology ICU did not change significantly.

The investigators now are looking for ways to minimize ICU visits at the end of life, he said. The presence of advanced cancer, being on a cardiac monitor, or needing supplemental oxygen foreshadowed critical illness in patients in the study. "We want to facilitate the difficult discussion" about end-of-life care choices "before critical care is needed," he said. So far, their efforts haven’t resulted in decreased use of ICU services at the end of life.

Minimizing surgical risks: One of the first comprehensive analyses of surgical outcomes in patients with disseminated cancer found that the risk of death increases greatly with emergency surgery.

John Pesavento, a medical student at Creighton University, Omaha, Neb., and his associates analyzed preoperative and postoperative data from the American College of Surgeon’s National Surgical Quality Improvement Program database on move than 147,000 patients who underwent surgical procedures between 2005 and 2008.

Eight of the 10 most common procedures resulted in significantly higher 30-day mortality rates in the cancer patients as compared with the same surgeries in patients who did not have disseminated cancer.

Comparing patients with and without disseminated cancer, 30-day mortality rates were 21% and 15%, respectively, after exploration of the abdomen, 15% and 9% after removal of the small bowel, 11% and 6% after colon removal, 11% and 5% after colostomy, 10% and 5% after partial removal of the colon, 10% and 0.5% after cholecystectomy, 1.8% and 0.9% after repair of a bowel opening, and 1% and 0.1% after mastectomy, he reported. The most common operations in patients with disseminated cancer were partial removal of the colon (in 11%), partial removal of the liver (9%), partial removal of the intestine (5%), and abdominal exploration (5%), he reported in a poster presentation.

When done as emergency procedures, however, 7 of the top 10 surgeries led to significantly higher 30-day mortality rates for disseminated cancer patients. Death rates in patients with disseminated cancer were 44% for emergency surgery and 12% for nonemergent surgery to explore the abdomen; the respective rates were 33% and 6% after bowel-to-bowel fusion, 31% and 4% after removal of the colon, 28% and 10% after removal of the small intestine, 23% and 5% after cholecystectomy, 22% and 7% after partial removal of the colon, and 19% and 9% after colostomy.

The findings should help physicians counsel their patients with disseminated cancer to help them decide whether it’s worth undergoing surgery – especially emergency surgery – given the higher risks of death, Mr. Pesavento said.

Physicians’ attitudes and education: In a separate study, 16 urologists and four primary care physicians who were undergoing surgical training in urology were interviewed about their attitudes regarding end-of-life care for men dying of prostate cancer. They viewed current end-of-life care as shoddily organized and poorly integrated, and said that ideal outcomes should be defined by patients’ own values and preferences, Dr. Jonathan Bergman and his associates reported in a poster presentation.

The physicians said that, ideally, a multidisciplinary team would care for dying patients, but respondents varied in the degree to which they saw themselves participating, reported Dr. Bergman of the University of California, Los Angeles.

The findings suggest that physician education about end-of-life care needs improvement, and that clinicians should be guided to deliver end-of-life care that is patient-centered and congruent with patients’ values, he said.

Dying in the hospital: Among 2,621 patients with solid tumors, those who had contact with a specialist palliative care team more than a month before their deaths were less likely to die in the hospital (16%) than were patients who had later or no contact with the team (20%), J. Brian Cassel, Ph.D., reported in a poster presentation.

Dr. Cassel and his associates analyzed claims data on the last 6 months of life for 3,128 adults with cancer who had at least one contact with the Virginia Commonwealth University cancer center in Richmond between January 2009 and July 2011. The data set included patients who had solid tumors, underwent bone marrow transfer, or had other hematologic malignancies.

The findings provided a snapshot of end-of-life care at the university, where 32% of the cancer patients were admitted to the hospital within their last 30 days of life, 19% had at least one readmission during their last 6 months of life, and 15% died in the hospital. Chemotherapy was given to 11% in their last month of life, and to 7% in their last 2 weeks of life, said Dr. Cassel of the university.

The specialist palliative care team made contact with 28% of patients a median of 6-10 days before the death of patients with bone marrow transfer or other nonhematologic malignancies and a median of 25 days before the death of patients with solid tumors.

Chemotherapy at the end of life: Patients with hematologic malignancies were significantly more likely to get chemotherapy in the last 30 days of life (38%) compared with patients with solid tumors (8%), Dr. Alma Rodriguez and her associates reported in a poster presentation.

The investigators reviewed data on 7,399 patients who received care for a solid tumor or hematological malignancy at the University of Texas M.D. Anderson Cancer Center, Houston, and died between December 2010 and May 2012. Overall, 14% of patients received chemotherapy within the last 30 days of life.

Of the 1,262 patients who died in the hospital, 44% received chemotherapy within the last 30 days of life, compared with 7% of the 6,137 patients who died in other locations, reported Dr. Rodriguez, professor of medicine at the cancer center.

Chemotherapy within the last 30 days of life was 3 times more likely in patients with metastatic solid tumors, 14 times more likely in patients with nonrelapsed hematologic malignancy, and 36 times more likely in patients with historical or current relapse of hematologic malignancy.

Patients 65 years or older were 38% less likely than were younger patients to get chemotherapy within the last 30 days of life. Patients with one or more comorbidity (most frequently heart failure and coronary artery diseases) were 28% less likely to get chemotherapy within the last 30 days of life as compared with patients without comorbidities.

"As oncologists, we must communicate clearly with our patients about realistic goals of treatment and the likelihood of life-threatening complications of chemotherapy," Dr. Rodriguez said in the poster.

Outpatient palliative care: Dr. Kavitha Ramchandran and her associates at Stanford (Calif.) University studied their system’s electronic medical records to look at the use of palliative care in outpatient clinics from January through September 2012. The number of palliative care contacts with outpatient clinic patients increased from 10 in January to 45 in September. The number of physicians referring outpatients to palliative care increased from 6 in January to 21 in September, she said in a poster presentation.

More than 65% of patients who were referred for palliative care were younger than 65 years, said Dr. Ramchandran of the university. Most patients had only one visit with palliative care (41%) or two visits (23%).

The findings suggest that outpatient palliative care is a growing specialty, she suggested. The data are not mature enough to assess any impact on the quality of end-of-life care or on the efficiency of care, she added.

Dr. Chen and Mr. Pesavento reported having no financial disclosures. Dr. Ramchandran’s study was funded in part by the Stanford Corporate Partners Fund and by various Stanford departments. No financial disclosures were available for the other presenters.

Dr. David Henry, the editor-in-chief of the Community Oncology journal, shares some of his "did you know" picks from the annual meeting of the American Society of Hematology. His 5-minute report reviews the new international prognostic scoring system for myelodysplastic syndromes, gene expression profiling for diffuse large b-cell lymphoma, approach to Waldenstrom's macroglobulin anemia, gray zone lymphoma, multiple myeloma updates, and more.

Dr. David Henry, the editor-in-chief of the Community Oncology journal, shares some of his "did you know" picks from the annual meeting of the American Society of Hematology. His 5-minute report reviews the new international prognostic scoring system for myelodysplastic syndromes, gene expression profiling for diffuse large b-cell lymphoma, approach to Waldenstrom's macroglobulin anemia, gray zone lymphoma, multiple myeloma updates, and more.

Dr. David Henry, the editor-in-chief of the Community Oncology journal, shares some of his "did you know" picks from the annual meeting of the American Society of Hematology. His 5-minute report reviews the new international prognostic scoring system for myelodysplastic syndromes, gene expression profiling for diffuse large b-cell lymphoma, approach to Waldenstrom's macroglobulin anemia, gray zone lymphoma, multiple myeloma updates, and more.

We caught up with Dr. Michael Fisch of MD Anderson Cancer Center at the close of American Society of Clinical Oncology's first Quality Care Symposium to review the meeting's highlights.

According to Dr Fisch, palliative care pervaded the entire meeting, and its principles resonated from talk to talk, including assessing and managing symptoms to improve cancer care, the importance of communicating goals of care, and end-of-life planning.

We caught up with Dr. Michael Fisch of MD Anderson Cancer Center at the close of American Society of Clinical Oncology's first Quality Care Symposium to review the meeting's highlights.

According to Dr Fisch, palliative care pervaded the entire meeting, and its principles resonated from talk to talk, including assessing and managing symptoms to improve cancer care, the importance of communicating goals of care, and end-of-life planning.

We caught up with Dr. Michael Fisch of MD Anderson Cancer Center at the close of American Society of Clinical Oncology's first Quality Care Symposium to review the meeting's highlights.

According to Dr Fisch, palliative care pervaded the entire meeting, and its principles resonated from talk to talk, including assessing and managing symptoms to improve cancer care, the importance of communicating goals of care, and end-of-life planning.

Encouraging manufacturers to develop opioid products that are formulated to deter abuse is one of the main goals of a new draft guidance released Jan. 9 by the Food and Drug Administration.

"Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling" provides information for companies interested in developing formulations of opioids with potential abuse deterrent properties, Dr. Douglas Throckmorton, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said at a briefing.

The document explains the agency’s views on the types of studies that should be conducted to show that a product can deter abuse, how those studies will be evaluated by the agency, and what labeling claims would be allowed based on the results of the FDA’s evaluations of those data. The ability to add abuse deterrent claims to a product’s label is expected to encourage companies to develop these products, he said.

The technology of formulations that deter abuse and the clinical epidemiology and statistical methods used to evaluate the potential of such products for abuse deterrence is a relatively new area of research, and the FDA plans "to take a flexible approach" in evaluating these products as the science evolves, Dr. Throckmorton said.

During the briefing, he pointed out that the guidance is one of the components of the FDA’s effort to prevent prescription drug abuse and misuse, "while ensuring patients in pain continue to have access to these medicines." In 2009, almost 425,000 visits to emergency departments involving nonmedical or inappropriate use of opioids and an estimated 15,600 deaths in the United States were attributed to opioid products, he said.

This draft guidance fulfills mandates under the Food and Drug Administration Safety and Innovation Act and the Office of National Drug Control Policy’s Prescription Drug Abuse Prevention Plan.

The FDA statement announcing the guidance explains that abuse deterrent formulations "target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the specific opioid drug substance in that formulation" and that the agency believes these formulations have "promise to help reduce prescription drug abuse."

Two opioid products with abuse deterrent formulations are currently available: Since 2010, OxyContin (controlled-release oxycodone) has been available in a formulation that prevents it from being chewed, crushed, or dissolved. A crush-resistant formulation of hydromorphone (Opana ER) was approved in September 2012. But the prescribing information for these products do not include claims regarding abuse deterrence properties.

The lack of abuse deterrent features was the main reason an FDA advisory panel recommended against approval of an extended-release, single-ingredient capsule formulation of hydrocodone at a meeting in December. Without such a feature, the product would quickly become widely abused once it was approved and marketed, some of the panelists predicted.

The FDA plans to hold a public meeting to discuss public feedback on the draft guidance.

During the briefing, Dr. Throckmorton said that the FDA had not yet decided what to do about generic formulations of opioids that have no abuse deterrent properties.

The guidance "is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse," and the agency is "extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation," FDA commissioner Dr. Margaret Hamburg said in the statement.

Comments and suggestions can be submitted to the FDA within 60 days of publication in the Federal Register, to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md., 20852 , with the docket number listed.

[email protected]

Encouraging manufacturers to develop opioid products that are formulated to deter abuse is one of the main goals of a new draft guidance released Jan. 9 by the Food and Drug Administration.

"Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling" provides information for companies interested in developing formulations of opioids with potential abuse deterrent properties, Dr. Douglas Throckmorton, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said at a briefing.

The document explains the agency’s views on the types of studies that should be conducted to show that a product can deter abuse, how those studies will be evaluated by the agency, and what labeling claims would be allowed based on the results of the FDA’s evaluations of those data. The ability to add abuse deterrent claims to a product’s label is expected to encourage companies to develop these products, he said.

The technology of formulations that deter abuse and the clinical epidemiology and statistical methods used to evaluate the potential of such products for abuse deterrence is a relatively new area of research, and the FDA plans "to take a flexible approach" in evaluating these products as the science evolves, Dr. Throckmorton said.

During the briefing, he pointed out that the guidance is one of the components of the FDA’s effort to prevent prescription drug abuse and misuse, "while ensuring patients in pain continue to have access to these medicines." In 2009, almost 425,000 visits to emergency departments involving nonmedical or inappropriate use of opioids and an estimated 15,600 deaths in the United States were attributed to opioid products, he said.

This draft guidance fulfills mandates under the Food and Drug Administration Safety and Innovation Act and the Office of National Drug Control Policy’s Prescription Drug Abuse Prevention Plan.

The FDA statement announcing the guidance explains that abuse deterrent formulations "target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the specific opioid drug substance in that formulation" and that the agency believes these formulations have "promise to help reduce prescription drug abuse."

Two opioid products with abuse deterrent formulations are currently available: Since 2010, OxyContin (controlled-release oxycodone) has been available in a formulation that prevents it from being chewed, crushed, or dissolved. A crush-resistant formulation of hydromorphone (Opana ER) was approved in September 2012. But the prescribing information for these products do not include claims regarding abuse deterrence properties.

The lack of abuse deterrent features was the main reason an FDA advisory panel recommended against approval of an extended-release, single-ingredient capsule formulation of hydrocodone at a meeting in December. Without such a feature, the product would quickly become widely abused once it was approved and marketed, some of the panelists predicted.

The FDA plans to hold a public meeting to discuss public feedback on the draft guidance.

During the briefing, Dr. Throckmorton said that the FDA had not yet decided what to do about generic formulations of opioids that have no abuse deterrent properties.

The guidance "is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse," and the agency is "extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation," FDA commissioner Dr. Margaret Hamburg said in the statement.

Comments and suggestions can be submitted to the FDA within 60 days of publication in the Federal Register, to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md., 20852 , with the docket number listed.

[email protected]

Encouraging manufacturers to develop opioid products that are formulated to deter abuse is one of the main goals of a new draft guidance released Jan. 9 by the Food and Drug Administration.

"Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling" provides information for companies interested in developing formulations of opioids with potential abuse deterrent properties, Dr. Douglas Throckmorton, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said at a briefing.

The document explains the agency’s views on the types of studies that should be conducted to show that a product can deter abuse, how those studies will be evaluated by the agency, and what labeling claims would be allowed based on the results of the FDA’s evaluations of those data. The ability to add abuse deterrent claims to a product’s label is expected to encourage companies to develop these products, he said.

The technology of formulations that deter abuse and the clinical epidemiology and statistical methods used to evaluate the potential of such products for abuse deterrence is a relatively new area of research, and the FDA plans "to take a flexible approach" in evaluating these products as the science evolves, Dr. Throckmorton said.

During the briefing, he pointed out that the guidance is one of the components of the FDA’s effort to prevent prescription drug abuse and misuse, "while ensuring patients in pain continue to have access to these medicines." In 2009, almost 425,000 visits to emergency departments involving nonmedical or inappropriate use of opioids and an estimated 15,600 deaths in the United States were attributed to opioid products, he said.

This draft guidance fulfills mandates under the Food and Drug Administration Safety and Innovation Act and the Office of National Drug Control Policy’s Prescription Drug Abuse Prevention Plan.

The FDA statement announcing the guidance explains that abuse deterrent formulations "target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the specific opioid drug substance in that formulation" and that the agency believes these formulations have "promise to help reduce prescription drug abuse."

Two opioid products with abuse deterrent formulations are currently available: Since 2010, OxyContin (controlled-release oxycodone) has been available in a formulation that prevents it from being chewed, crushed, or dissolved. A crush-resistant formulation of hydromorphone (Opana ER) was approved in September 2012. But the prescribing information for these products do not include claims regarding abuse deterrence properties.

The lack of abuse deterrent features was the main reason an FDA advisory panel recommended against approval of an extended-release, single-ingredient capsule formulation of hydrocodone at a meeting in December. Without such a feature, the product would quickly become widely abused once it was approved and marketed, some of the panelists predicted.

The FDA plans to hold a public meeting to discuss public feedback on the draft guidance.

During the briefing, Dr. Throckmorton said that the FDA had not yet decided what to do about generic formulations of opioids that have no abuse deterrent properties.

The guidance "is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse," and the agency is "extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation," FDA commissioner Dr. Margaret Hamburg said in the statement.

Comments and suggestions can be submitted to the FDA within 60 days of publication in the Federal Register, to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md., 20852 , with the docket number listed.

[email protected]

SAN ANTONIO – The 10-year incidence of leukemia after adjuvant chemotherapy for breast cancer appears to hover around 0.5%, twice as high as previously reported.

A review of more than 20,000 patient records included in the National Comprehensive Cancer Network (NCCN) database found 51 cases of leukemia that developed within 10 years of treatment. Women who had only chemotherapy were at the greatest risk – almost six times more likely to develop the disease than the surgery-only control group, Dr. Antonio Wolff said at that annual San Antonio Breast Cancer Symposium.

"We know that the observed survival benefit with adjuvant therapy does take into account the potential mortality associated with leukemia," said Dr. Wolff of Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore. "But often we are in the situation where we make the decision to give chemotherapy ‘just because.’ We need to be very careful here, because some of those patients will potentially derive none of the benefits of chemo, and be at risk of its toxicities."

Dr. Wolff and colleagues examined the 1997-2008 data from eight facilities in the NCCN database – a total of 20,533 women with a first diagnosis of breast cancer. The median follow-up was 5 years, but some data were available for up to 15 years after treatment.

About half of the cohort had stage I disease; in most, the cancer was invasive ductal. Slightly more than half had hormone receptor–positive/HER2 negative disease.

The only baseline characteristic significantly different between the groups was age. Women who developed leukemia were significantly older at the time of their cancer treatment (60 vs. 54 years; P = .02); 78% of those with leukemia were older than 50 years.

Of the 51 cases, 44 were acute myeloid leukemia (AML), with a median onset time of 3.5 years after treatment. One-third of these occurred in women with a family history of breast or ovarian cancer. The median time to onset in the AML cases was 2 years.

None of the tumor characteristics were significantly associated with the development of leukemia. There were no significant differences among those who had breast-conserving surgery, mastectomy, or no surgery; or between those who had no radiation therapy, radiation without surgery, radiation after breast-conserving surgery, or radiation after mastectomy, though larger numbers of patients are needed for some of these smaller subset analyses.

The overall rate of leukemia per 1,000 patient/years was 0.46; in the surgery-only group, the rate was 0.16 per 1,000 patient-years. "Of interest is that the rates in each of the treatment groups were similar to the overall rate," – 0.43 in the radiation-only group, 0.52 in the chemotherapy-only group, and 0.54 in the combination therapy group.

At 5 years, the cumulative incidence of leukemia was 0.05% in the surgery-only group; 0.19% in the radiation-only group; 0.30% in the chemotherapy-only group; and 0.32% in the combination therapy group.

But the onset accelerated over the study period, Dr. Wolff noted, with the bulk of cases developing from years 6 to 10. .By the end of the 10-year period, the incidence was 0.2% in the surgery-only group; 0.44% in the radiation-only group; 0.52% in the chemotherapy group; and 0.51% in the combination group.

In a risk analysis using surgery as the control, the overall hazard ratio of leukemia was 2.7 in the radiation-only group; 5.68 in the chemotherapy only group; and 5.64 in the combination group.

Radiation appeared to confer no significant additional risk when it was combined with chemotherapy, Dr. Wolff added.

The findings are strikingly different than previously identified. The largest study of the association was published in 2003, when researchers from the National Surgical Adjuvant Breast and Bowel Project Operations Center reviewed six trials that examined rates of acute myeloid leukemia and myelodysplastic syndrome after doxorubicin and cyclophosphamide therapy (Clin. Breast Cancer 2003;4:273-9).

The subgroup that received anthracycline/cyclophosphamide in that review had a cumulative 8-year incidence of 0.24%. In Dr. Wolff’s chemotherapy subgroup, the cumulative 8-year incidence was 0.52%.

"It’s very important to keep in mind that the known leukemia latency period for anthracycline is 1-3 years, but that of alkylating drugs like cyclophosphamide is 4-6 years and there are case reports of it developing after 10 years," he said. "We need to be very careful when we talk about survival at 5 years vs. 10 years in exposed patients, because they could be at risk for a decade and, potentially, even longer."

SAN ANTONIO – The 10-year incidence of leukemia after adjuvant chemotherapy for breast cancer appears to hover around 0.5%, twice as high as previously reported.

A review of more than 20,000 patient records included in the National Comprehensive Cancer Network (NCCN) database found 51 cases of leukemia that developed within 10 years of treatment. Women who had only chemotherapy were at the greatest risk – almost six times more likely to develop the disease than the surgery-only control group, Dr. Antonio Wolff said at that annual San Antonio Breast Cancer Symposium.

"We know that the observed survival benefit with adjuvant therapy does take into account the potential mortality associated with leukemia," said Dr. Wolff of Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore. "But often we are in the situation where we make the decision to give chemotherapy ‘just because.’ We need to be very careful here, because some of those patients will potentially derive none of the benefits of chemo, and be at risk of its toxicities."

Dr. Wolff and colleagues examined the 1997-2008 data from eight facilities in the NCCN database – a total of 20,533 women with a first diagnosis of breast cancer. The median follow-up was 5 years, but some data were available for up to 15 years after treatment.

About half of the cohort had stage I disease; in most, the cancer was invasive ductal. Slightly more than half had hormone receptor–positive/HER2 negative disease.

The only baseline characteristic significantly different between the groups was age. Women who developed leukemia were significantly older at the time of their cancer treatment (60 vs. 54 years; P = .02); 78% of those with leukemia were older than 50 years.

Of the 51 cases, 44 were acute myeloid leukemia (AML), with a median onset time of 3.5 years after treatment. One-third of these occurred in women with a family history of breast or ovarian cancer. The median time to onset in the AML cases was 2 years.

None of the tumor characteristics were significantly associated with the development of leukemia. There were no significant differences among those who had breast-conserving surgery, mastectomy, or no surgery; or between those who had no radiation therapy, radiation without surgery, radiation after breast-conserving surgery, or radiation after mastectomy, though larger numbers of patients are needed for some of these smaller subset analyses.

The overall rate of leukemia per 1,000 patient/years was 0.46; in the surgery-only group, the rate was 0.16 per 1,000 patient-years. "Of interest is that the rates in each of the treatment groups were similar to the overall rate," – 0.43 in the radiation-only group, 0.52 in the chemotherapy-only group, and 0.54 in the combination therapy group.

At 5 years, the cumulative incidence of leukemia was 0.05% in the surgery-only group; 0.19% in the radiation-only group; 0.30% in the chemotherapy-only group; and 0.32% in the combination therapy group.

But the onset accelerated over the study period, Dr. Wolff noted, with the bulk of cases developing from years 6 to 10. .By the end of the 10-year period, the incidence was 0.2% in the surgery-only group; 0.44% in the radiation-only group; 0.52% in the chemotherapy group; and 0.51% in the combination group.

In a risk analysis using surgery as the control, the overall hazard ratio of leukemia was 2.7 in the radiation-only group; 5.68 in the chemotherapy only group; and 5.64 in the combination group.

Radiation appeared to confer no significant additional risk when it was combined with chemotherapy, Dr. Wolff added.

The findings are strikingly different than previously identified. The largest study of the association was published in 2003, when researchers from the National Surgical Adjuvant Breast and Bowel Project Operations Center reviewed six trials that examined rates of acute myeloid leukemia and myelodysplastic syndrome after doxorubicin and cyclophosphamide therapy (Clin. Breast Cancer 2003;4:273-9).

The subgroup that received anthracycline/cyclophosphamide in that review had a cumulative 8-year incidence of 0.24%. In Dr. Wolff’s chemotherapy subgroup, the cumulative 8-year incidence was 0.52%.

"It’s very important to keep in mind that the known leukemia latency period for anthracycline is 1-3 years, but that of alkylating drugs like cyclophosphamide is 4-6 years and there are case reports of it developing after 10 years," he said. "We need to be very careful when we talk about survival at 5 years vs. 10 years in exposed patients, because they could be at risk for a decade and, potentially, even longer."

SAN ANTONIO – The 10-year incidence of leukemia after adjuvant chemotherapy for breast cancer appears to hover around 0.5%, twice as high as previously reported.

A review of more than 20,000 patient records included in the National Comprehensive Cancer Network (NCCN) database found 51 cases of leukemia that developed within 10 years of treatment. Women who had only chemotherapy were at the greatest risk – almost six times more likely to develop the disease than the surgery-only control group, Dr. Antonio Wolff said at that annual San Antonio Breast Cancer Symposium.

"We know that the observed survival benefit with adjuvant therapy does take into account the potential mortality associated with leukemia," said Dr. Wolff of Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore. "But often we are in the situation where we make the decision to give chemotherapy ‘just because.’ We need to be very careful here, because some of those patients will potentially derive none of the benefits of chemo, and be at risk of its toxicities."

Dr. Wolff and colleagues examined the 1997-2008 data from eight facilities in the NCCN database – a total of 20,533 women with a first diagnosis of breast cancer. The median follow-up was 5 years, but some data were available for up to 15 years after treatment.

About half of the cohort had stage I disease; in most, the cancer was invasive ductal. Slightly more than half had hormone receptor–positive/HER2 negative disease.

The only baseline characteristic significantly different between the groups was age. Women who developed leukemia were significantly older at the time of their cancer treatment (60 vs. 54 years; P = .02); 78% of those with leukemia were older than 50 years.

Of the 51 cases, 44 were acute myeloid leukemia (AML), with a median onset time of 3.5 years after treatment. One-third of these occurred in women with a family history of breast or ovarian cancer. The median time to onset in the AML cases was 2 years.

None of the tumor characteristics were significantly associated with the development of leukemia. There were no significant differences among those who had breast-conserving surgery, mastectomy, or no surgery; or between those who had no radiation therapy, radiation without surgery, radiation after breast-conserving surgery, or radiation after mastectomy, though larger numbers of patients are needed for some of these smaller subset analyses.

The overall rate of leukemia per 1,000 patient/years was 0.46; in the surgery-only group, the rate was 0.16 per 1,000 patient-years. "Of interest is that the rates in each of the treatment groups were similar to the overall rate," – 0.43 in the radiation-only group, 0.52 in the chemotherapy-only group, and 0.54 in the combination therapy group.

At 5 years, the cumulative incidence of leukemia was 0.05% in the surgery-only group; 0.19% in the radiation-only group; 0.30% in the chemotherapy-only group; and 0.32% in the combination therapy group.

But the onset accelerated over the study period, Dr. Wolff noted, with the bulk of cases developing from years 6 to 10. .By the end of the 10-year period, the incidence was 0.2% in the surgery-only group; 0.44% in the radiation-only group; 0.52% in the chemotherapy group; and 0.51% in the combination group.

In a risk analysis using surgery as the control, the overall hazard ratio of leukemia was 2.7 in the radiation-only group; 5.68 in the chemotherapy only group; and 5.64 in the combination group.

Radiation appeared to confer no significant additional risk when it was combined with chemotherapy, Dr. Wolff added.

The findings are strikingly different than previously identified. The largest study of the association was published in 2003, when researchers from the National Surgical Adjuvant Breast and Bowel Project Operations Center reviewed six trials that examined rates of acute myeloid leukemia and myelodysplastic syndrome after doxorubicin and cyclophosphamide therapy (Clin. Breast Cancer 2003;4:273-9).

The subgroup that received anthracycline/cyclophosphamide in that review had a cumulative 8-year incidence of 0.24%. In Dr. Wolff’s chemotherapy subgroup, the cumulative 8-year incidence was 0.52%.

"It’s very important to keep in mind that the known leukemia latency period for anthracycline is 1-3 years, but that of alkylating drugs like cyclophosphamide is 4-6 years and there are case reports of it developing after 10 years," he said. "We need to be very careful when we talk about survival at 5 years vs. 10 years in exposed patients, because they could be at risk for a decade and, potentially, even longer."

SAN ANTONIO – Women with breast cancer shouldn't have to relinquish the life-affirming power of sexual intimacy.

Breast cancer brings many challenges that can relegate sexual health to the bottom of the problem list, but helping women preserve or regain that facet of the lives is an important part of a holistic treatment plan, Dr. Michael L. Krychman said at the San Antonio Breast Cancer Symposium.

Nick Piegari/IMNG Medical Media

Unfortunately, most plans don’t include any discussion of sexual intimacy and many women don’t broach the subject alone, said Dr. Krychman, executive director of the Southern California Center for Sexual Health and Survivorship Medicine, Newport Beach, and a clinical professor at the University of California, Irvine.

"We now recognize that cancer can be a chronic disease that our patients can often live with for a very long time. Intimacy and relationships are very important for women, as they progress through their cancer care," he noted.

‘Just Be Glad You’re Alive’

Breast cancer patients don’t always get the kind of team approach afforded to those with other illnesses, he said.

"When a patient has diabetes, the treatment team includes an endocrinologist, a dietitian. There are lifestyle changes, foot exams, eye exams. It’s a team approach designed to target and improve every area the disorder affects. But when we talk about sexuality and breast cancer, the reaction often is, ‘Just be glad you’re alive.’ Women can be told to just say goodbye to that part of their lives."

It doesn’t have to be that way, said Dr. Krychman, who spoke at a session on breast cancer survivorship.

"We need to get past this problem with talking about women’s sexuality. Women are embarrassed to bring it up, and when they do they’re often subjected to a paternalistic reaction" that sends a very clear negative message about their feeling and desires, he said.

Addressing sexuality, however, isn’t just about helping women feel good emotionally. It also can be about helping women stay compliant with the drugs that keep them physically healthy.

"One woman came to me after she stopped taking her maintenance therapy because of the effect it was having on her sex life," Dr. Krychman said. "She told me, ‘I’d rather have 5 years of a life lived in color than 10 years of a life lived in shadow.’ "

He was able to convince her that she could have both the years and the enjoyment of those years.

"I follow what I call a conservative-aggressive approach. We start with the conservative interventions, like addressing vaginal dryness and atrophy with moisturizers and lubricants, getting back on a healthy diet, and exercising. But we don’t send a woman away with a bottle of lubricant and say, ‘Come back in 6 months.’ We like to see patients at least once a month to check on progress, and if things aren’t going well we move on to something more," he explained.

Topical estrogens are the go-to treatment for sexual problems in women without cancer, but the jury is still out on whether they are good for women with breast cancer. "We now know that topical may not really be just topical. Hormones can be absorbed systemically even in the small doses seen in vaginal preparations."

Nonhormonal Drugs in the Pipeline

But two nonhormonal drugs in development – flibanserin and bremelanotide – could be promising treatments, Dr. Krychman said.

Flibanserin, a postsynaptic 5-HT(1A) agonist/5-HT(2A) antagonist, has been studied in more than 10,000 women and shown to increase libido and response in those with female sexual arousal disorder (FSAD) and hypoactive sexual desire disorder (HSDD).

In 2010, the Food and Drug Administration refused to approve it, saying that the side effects of dizziness, nausea, and vomiting seemed to outweigh its benefits.

Last year, however, Sprout Pharmaceuticals of Raleigh, N.C., purchased the drug and raised $20 million for its further development. The company is planning to resubmit data from the 14 existing trials, along with a new validation study, next year.

In October, a 12-month open-label extension study in 1,723 women reported some positive results. By 52 weeks, HSDD symptoms had fallen to remission levels in 90% of the group (J. Sex. Med. 2012 Oct 11. [doi:10.1111/j.1743-6109.2012.02942.x.]).

Bremelanotide is another promising drug, Dr. Krychman said. Like flibanserin, the melanocortin receptor 4 agonist got a new lease on life after the FDA nipped its development in 2007. At that point, the drug was being investigated for erectile dysfunction and female sexual dysfunction in both pre- and postmenopausal women. It was formulated as an intranasal powder but caused blood pressure spikes in some of the men who used it. FDA rejected the initial application as a libido-boosting drug but didn’t rule out its development for other purposes.

Palatin Technologies, the New Jersey company developing the drug, reformulated it into a subcutaneous injection, which did not affect blood pressure in new safety studies. On that basis, Palatin went ahead with a phase IIB trial in 327 premenopausal women with FSAD, HSDD, or both. The company announced positive results last month.

According to a statement, "[the results] demonstrate that women taking bremelanotide showed clinically meaningful and statistically significant increases in the number of satisfying sexual events and also showed clinically meaningful and statistically significant improved measures of overall sexual functioning and distress related to sexual dysfunction, compared to placebo."

There were no blood pressure problems, although some women did quit the drug because of nausea and vomiting of mild to moderate intensity. Palatin intends to launch a phase III trial next year.

Dr. Krychman has disclosed that he is a consultant/advisor for Warner Chilcott, Pfizer, and Sprout.

SAN ANTONIO – Women with breast cancer shouldn't have to relinquish the life-affirming power of sexual intimacy.

Breast cancer brings many challenges that can relegate sexual health to the bottom of the problem list, but helping women preserve or regain that facet of the lives is an important part of a holistic treatment plan, Dr. Michael L. Krychman said at the San Antonio Breast Cancer Symposium.

Nick Piegari/IMNG Medical Media

Unfortunately, most plans don’t include any discussion of sexual intimacy and many women don’t broach the subject alone, said Dr. Krychman, executive director of the Southern California Center for Sexual Health and Survivorship Medicine, Newport Beach, and a clinical professor at the University of California, Irvine.

"We now recognize that cancer can be a chronic disease that our patients can often live with for a very long time. Intimacy and relationships are very important for women, as they progress through their cancer care," he noted.

‘Just Be Glad You’re Alive’

Breast cancer patients don’t always get the kind of team approach afforded to those with other illnesses, he said.

"When a patient has diabetes, the treatment team includes an endocrinologist, a dietitian. There are lifestyle changes, foot exams, eye exams. It’s a team approach designed to target and improve every area the disorder affects. But when we talk about sexuality and breast cancer, the reaction often is, ‘Just be glad you’re alive.’ Women can be told to just say goodbye to that part of their lives."

It doesn’t have to be that way, said Dr. Krychman, who spoke at a session on breast cancer survivorship.

"We need to get past this problem with talking about women’s sexuality. Women are embarrassed to bring it up, and when they do they’re often subjected to a paternalistic reaction" that sends a very clear negative message about their feeling and desires, he said.

Addressing sexuality, however, isn’t just about helping women feel good emotionally. It also can be about helping women stay compliant with the drugs that keep them physically healthy.

"One woman came to me after she stopped taking her maintenance therapy because of the effect it was having on her sex life," Dr. Krychman said. "She told me, ‘I’d rather have 5 years of a life lived in color than 10 years of a life lived in shadow.’ "

He was able to convince her that she could have both the years and the enjoyment of those years.

"I follow what I call a conservative-aggressive approach. We start with the conservative interventions, like addressing vaginal dryness and atrophy with moisturizers and lubricants, getting back on a healthy diet, and exercising. But we don’t send a woman away with a bottle of lubricant and say, ‘Come back in 6 months.’ We like to see patients at least once a month to check on progress, and if things aren’t going well we move on to something more," he explained.

Topical estrogens are the go-to treatment for sexual problems in women without cancer, but the jury is still out on whether they are good for women with breast cancer. "We now know that topical may not really be just topical. Hormones can be absorbed systemically even in the small doses seen in vaginal preparations."

Nonhormonal Drugs in the Pipeline

But two nonhormonal drugs in development – flibanserin and bremelanotide – could be promising treatments, Dr. Krychman said.

Flibanserin, a postsynaptic 5-HT(1A) agonist/5-HT(2A) antagonist, has been studied in more than 10,000 women and shown to increase libido and response in those with female sexual arousal disorder (FSAD) and hypoactive sexual desire disorder (HSDD).

In 2010, the Food and Drug Administration refused to approve it, saying that the side effects of dizziness, nausea, and vomiting seemed to outweigh its benefits.

Last year, however, Sprout Pharmaceuticals of Raleigh, N.C., purchased the drug and raised $20 million for its further development. The company is planning to resubmit data from the 14 existing trials, along with a new validation study, next year.

In October, a 12-month open-label extension study in 1,723 women reported some positive results. By 52 weeks, HSDD symptoms had fallen to remission levels in 90% of the group (J. Sex. Med. 2012 Oct 11. [doi:10.1111/j.1743-6109.2012.02942.x.]).

Bremelanotide is another promising drug, Dr. Krychman said. Like flibanserin, the melanocortin receptor 4 agonist got a new lease on life after the FDA nipped its development in 2007. At that point, the drug was being investigated for erectile dysfunction and female sexual dysfunction in both pre- and postmenopausal women. It was formulated as an intranasal powder but caused blood pressure spikes in some of the men who used it. FDA rejected the initial application as a libido-boosting drug but didn’t rule out its development for other purposes.

Palatin Technologies, the New Jersey company developing the drug, reformulated it into a subcutaneous injection, which did not affect blood pressure in new safety studies. On that basis, Palatin went ahead with a phase IIB trial in 327 premenopausal women with FSAD, HSDD, or both. The company announced positive results last month.

According to a statement, "[the results] demonstrate that women taking bremelanotide showed clinically meaningful and statistically significant increases in the number of satisfying sexual events and also showed clinically meaningful and statistically significant improved measures of overall sexual functioning and distress related to sexual dysfunction, compared to placebo."

There were no blood pressure problems, although some women did quit the drug because of nausea and vomiting of mild to moderate intensity. Palatin intends to launch a phase III trial next year.

Dr. Krychman has disclosed that he is a consultant/advisor for Warner Chilcott, Pfizer, and Sprout.

SAN ANTONIO – Women with breast cancer shouldn't have to relinquish the life-affirming power of sexual intimacy.

Breast cancer brings many challenges that can relegate sexual health to the bottom of the problem list, but helping women preserve or regain that facet of the lives is an important part of a holistic treatment plan, Dr. Michael L. Krychman said at the San Antonio Breast Cancer Symposium.

Nick Piegari/IMNG Medical Media

Unfortunately, most plans don’t include any discussion of sexual intimacy and many women don’t broach the subject alone, said Dr. Krychman, executive director of the Southern California Center for Sexual Health and Survivorship Medicine, Newport Beach, and a clinical professor at the University of California, Irvine.

"We now recognize that cancer can be a chronic disease that our patients can often live with for a very long time. Intimacy and relationships are very important for women, as they progress through their cancer care," he noted.

‘Just Be Glad You’re Alive’

Breast cancer patients don’t always get the kind of team approach afforded to those with other illnesses, he said.

"When a patient has diabetes, the treatment team includes an endocrinologist, a dietitian. There are lifestyle changes, foot exams, eye exams. It’s a team approach designed to target and improve every area the disorder affects. But when we talk about sexuality and breast cancer, the reaction often is, ‘Just be glad you’re alive.’ Women can be told to just say goodbye to that part of their lives."

It doesn’t have to be that way, said Dr. Krychman, who spoke at a session on breast cancer survivorship.

"We need to get past this problem with talking about women’s sexuality. Women are embarrassed to bring it up, and when they do they’re often subjected to a paternalistic reaction" that sends a very clear negative message about their feeling and desires, he said.

Addressing sexuality, however, isn’t just about helping women feel good emotionally. It also can be about helping women stay compliant with the drugs that keep them physically healthy.

"One woman came to me after she stopped taking her maintenance therapy because of the effect it was having on her sex life," Dr. Krychman said. "She told me, ‘I’d rather have 5 years of a life lived in color than 10 years of a life lived in shadow.’ "

He was able to convince her that she could have both the years and the enjoyment of those years.

"I follow what I call a conservative-aggressive approach. We start with the conservative interventions, like addressing vaginal dryness and atrophy with moisturizers and lubricants, getting back on a healthy diet, and exercising. But we don’t send a woman away with a bottle of lubricant and say, ‘Come back in 6 months.’ We like to see patients at least once a month to check on progress, and if things aren’t going well we move on to something more," he explained.

Topical estrogens are the go-to treatment for sexual problems in women without cancer, but the jury is still out on whether they are good for women with breast cancer. "We now know that topical may not really be just topical. Hormones can be absorbed systemically even in the small doses seen in vaginal preparations."

Nonhormonal Drugs in the Pipeline

But two nonhormonal drugs in development – flibanserin and bremelanotide – could be promising treatments, Dr. Krychman said.

Flibanserin, a postsynaptic 5-HT(1A) agonist/5-HT(2A) antagonist, has been studied in more than 10,000 women and shown to increase libido and response in those with female sexual arousal disorder (FSAD) and hypoactive sexual desire disorder (HSDD).

In 2010, the Food and Drug Administration refused to approve it, saying that the side effects of dizziness, nausea, and vomiting seemed to outweigh its benefits.

Last year, however, Sprout Pharmaceuticals of Raleigh, N.C., purchased the drug and raised $20 million for its further development. The company is planning to resubmit data from the 14 existing trials, along with a new validation study, next year.

In October, a 12-month open-label extension study in 1,723 women reported some positive results. By 52 weeks, HSDD symptoms had fallen to remission levels in 90% of the group (J. Sex. Med. 2012 Oct 11. [doi:10.1111/j.1743-6109.2012.02942.x.]).

Bremelanotide is another promising drug, Dr. Krychman said. Like flibanserin, the melanocortin receptor 4 agonist got a new lease on life after the FDA nipped its development in 2007. At that point, the drug was being investigated for erectile dysfunction and female sexual dysfunction in both pre- and postmenopausal women. It was formulated as an intranasal powder but caused blood pressure spikes in some of the men who used it. FDA rejected the initial application as a libido-boosting drug but didn’t rule out its development for other purposes.

Palatin Technologies, the New Jersey company developing the drug, reformulated it into a subcutaneous injection, which did not affect blood pressure in new safety studies. On that basis, Palatin went ahead with a phase IIB trial in 327 premenopausal women with FSAD, HSDD, or both. The company announced positive results last month.

According to a statement, "[the results] demonstrate that women taking bremelanotide showed clinically meaningful and statistically significant increases in the number of satisfying sexual events and also showed clinically meaningful and statistically significant improved measures of overall sexual functioning and distress related to sexual dysfunction, compared to placebo."

There were no blood pressure problems, although some women did quit the drug because of nausea and vomiting of mild to moderate intensity. Palatin intends to launch a phase III trial next year.

Dr. Krychman has disclosed that he is a consultant/advisor for Warner Chilcott, Pfizer, and Sprout.

An 81-year-old African American man presented to the emergency department with right flank pain for 3 days. He had first noticed the pain after lifting a heavy box. He described the pain as sharp, nonradiating, and worsening with movement. He denied nausea, vomiting, diarrhea, fever, chills, cough, abdominal or back pain, dysuria, hematuria, or increased urinary frequency. The differential diagnosis for flank pain is broad. In this case, the pain started after lifting a heavy box, suggestive of musculoskeletal etiology such as muscle strain or rib fracture. Although less likely, both nephrolithiasis with passage of a stone and pyelonephritis must be ruled out. Other genitourinary pathologic processes to be considered would include renal infarct or hemorrhage, ureteral obstruction, and malignancy. The pain may also be of hepatic or biliary origin. Diverticulitis and colitis need to be considered. Finally, the pain may be referred from a pulmonary process such as right lower lobe pneumonia. Further history and a thorough physical exam are needed to narrow down these possibilities...

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

An 81-year-old African American man presented to the emergency department with right flank pain for 3 days. He had first noticed the pain after lifting a heavy box. He described the pain as sharp, nonradiating, and worsening with movement. He denied nausea, vomiting, diarrhea, fever, chills, cough, abdominal or back pain, dysuria, hematuria, or increased urinary frequency. The differential diagnosis for flank pain is broad. In this case, the pain started after lifting a heavy box, suggestive of musculoskeletal etiology such as muscle strain or rib fracture. Although less likely, both nephrolithiasis with passage of a stone and pyelonephritis must be ruled out. Other genitourinary pathologic processes to be considered would include renal infarct or hemorrhage, ureteral obstruction, and malignancy. The pain may also be of hepatic or biliary origin. Diverticulitis and colitis need to be considered. Finally, the pain may be referred from a pulmonary process such as right lower lobe pneumonia. Further history and a thorough physical exam are needed to narrow down these possibilities...

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

An 81-year-old African American man presented to the emergency department with right flank pain for 3 days. He had first noticed the pain after lifting a heavy box. He described the pain as sharp, nonradiating, and worsening with movement. He denied nausea, vomiting, diarrhea, fever, chills, cough, abdominal or back pain, dysuria, hematuria, or increased urinary frequency. The differential diagnosis for flank pain is broad. In this case, the pain started after lifting a heavy box, suggestive of musculoskeletal etiology such as muscle strain or rib fracture. Although less likely, both nephrolithiasis with passage of a stone and pyelonephritis must be ruled out. Other genitourinary pathologic processes to be considered would include renal infarct or hemorrhage, ureteral obstruction, and malignancy. The pain may also be of hepatic or biliary origin. Diverticulitis and colitis need to be considered. Finally, the pain may be referred from a pulmonary process such as right lower lobe pneumonia. Further history and a thorough physical exam are needed to narrow down these possibilities...

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