Over the past century, the management of American hospitals has changed dramatically. These changes have occurred as a result of major shifts in the social and financial environment and have had a major effect on how medicine was practiced in the past and how it will be practiced in the future.

The American hospital as we know it today was established in the late 19th and early 20th centuries largely by the Catholic, Protestant, and Jewish communities to provide care for the elderly and chronically ill patients who otherwise would not be cared for at home.

With the development of surgical techniques from tonsillectomies to cholecystectomies in the mid-20th century, they became the workshop of general surgeons, who largely controlled the hospitals. With the subsequent development of antibiotics and medical treatment for cardiovascular disease, the internal medicine specialties demanded a larger role in institutional management.

The increased complexity and expense of medical care led to concerns about how to provide a financial base for medical care and led to the establishment of private medical insurance programs, and ultimately, to Medicare and Medicaid. Hospitals were no longer concerned about being a health resource but suddenly became a profit center. Community hospitals expanded in order to meet the needs of new technologies with the support of grants and loans from the federal government.

With this growth, the management of the hospital of the 20th century required the creation of a new breed of hospital staff: the hospital administrator. They were hired to manage the financial and administrative aspects of these new and growing organizations. Although the hospital administration was structured to provide equipoise between the medical and financial priorities of the hospital, that balance was not easily maintained, and as the financial aspects became central, the hospital administrator became supreme and physicians lost control.

Today, the American hospital has become central to the support of nonprofit and for-profit regional and national health care conglomerates, and control has become the province of boards of directors with little medical input and larger community control. As a consequence, the physician has now become a real or quasi-employee of the hospital.

In a recent perspective paper, Dr. Richard Gunderson (Acad. Med. 2009;84:1348-51) emphasizes the need to train physicians to provide leadership for the future management of the hospital. He points out that in 1935, physicians were in charge of 35% of the nation's hospitals, but that number has shrunk to 4% of our current 6,500 U.S. hospitals. The academic medical community has largely ignored its role in preparing medical students for administrative leadership as it focused on the clinical knowledge required for the medical competence.

Dr. Gunderson, of Indiana University in Indianapolis, advocates the identification of student leaders in the selection of medical students and proposes the inclusion of courses in medical finance and social issues in the medical school curriculum in order to prepare them for a leadership role in redefining the future of medical care and hospital management.

Amanda Goodall, Ph.D., a senior research fellow at the Institute for the Study of Labor in Bonn, Germany, provides an even more challenging analysis of the importance of medical leadership at the hospital (Social Science Med. 2011;73:535-9). She notes that these changes in leadership are not unique to the United States but also have taken place in European hospitals. Using a quality scoring system, she analyzed the quality performance of 100 of the U.S. News and World Report's Best Hospitals 2009 in the fields of cancer, digestive disorders, and heart and heart surgery. She found a positive correlation between hospital quality ranking and physician CEO leadership.

Those of us who have grown up through this management evolution have seen its real impact on the care of hospital patients. Some of the changes have been positive, while others have proved frustrating for both patients and physicians who practice in the new environment.

The need for leadership by those of us who have direct patient care responsibilities is essential for an inclusive decision-making process. When patient care comes to discussion at the board meeting, physicians and nurses bring to the process a perspective that only they can provide. It is essential that their voices be heard.

Over the past century, the management of American hospitals has changed dramatically. These changes have occurred as a result of major shifts in the social and financial environment and have had a major effect on how medicine was practiced in the past and how it will be practiced in the future.

The American hospital as we know it today was established in the late 19th and early 20th centuries largely by the Catholic, Protestant, and Jewish communities to provide care for the elderly and chronically ill patients who otherwise would not be cared for at home.

With the development of surgical techniques from tonsillectomies to cholecystectomies in the mid-20th century, they became the workshop of general surgeons, who largely controlled the hospitals. With the subsequent development of antibiotics and medical treatment for cardiovascular disease, the internal medicine specialties demanded a larger role in institutional management.

The increased complexity and expense of medical care led to concerns about how to provide a financial base for medical care and led to the establishment of private medical insurance programs, and ultimately, to Medicare and Medicaid. Hospitals were no longer concerned about being a health resource but suddenly became a profit center. Community hospitals expanded in order to meet the needs of new technologies with the support of grants and loans from the federal government.

With this growth, the management of the hospital of the 20th century required the creation of a new breed of hospital staff: the hospital administrator. They were hired to manage the financial and administrative aspects of these new and growing organizations. Although the hospital administration was structured to provide equipoise between the medical and financial priorities of the hospital, that balance was not easily maintained, and as the financial aspects became central, the hospital administrator became supreme and physicians lost control.

Today, the American hospital has become central to the support of nonprofit and for-profit regional and national health care conglomerates, and control has become the province of boards of directors with little medical input and larger community control. As a consequence, the physician has now become a real or quasi-employee of the hospital.

In a recent perspective paper, Dr. Richard Gunderson (Acad. Med. 2009;84:1348-51) emphasizes the need to train physicians to provide leadership for the future management of the hospital. He points out that in 1935, physicians were in charge of 35% of the nation's hospitals, but that number has shrunk to 4% of our current 6,500 U.S. hospitals. The academic medical community has largely ignored its role in preparing medical students for administrative leadership as it focused on the clinical knowledge required for the medical competence.

Dr. Gunderson, of Indiana University in Indianapolis, advocates the identification of student leaders in the selection of medical students and proposes the inclusion of courses in medical finance and social issues in the medical school curriculum in order to prepare them for a leadership role in redefining the future of medical care and hospital management.

Amanda Goodall, Ph.D., a senior research fellow at the Institute for the Study of Labor in Bonn, Germany, provides an even more challenging analysis of the importance of medical leadership at the hospital (Social Science Med. 2011;73:535-9). She notes that these changes in leadership are not unique to the United States but also have taken place in European hospitals. Using a quality scoring system, she analyzed the quality performance of 100 of the U.S. News and World Report's Best Hospitals 2009 in the fields of cancer, digestive disorders, and heart and heart surgery. She found a positive correlation between hospital quality ranking and physician CEO leadership.

Those of us who have grown up through this management evolution have seen its real impact on the care of hospital patients. Some of the changes have been positive, while others have proved frustrating for both patients and physicians who practice in the new environment.

The need for leadership by those of us who have direct patient care responsibilities is essential for an inclusive decision-making process. When patient care comes to discussion at the board meeting, physicians and nurses bring to the process a perspective that only they can provide. It is essential that their voices be heard.

Over the past century, the management of American hospitals has changed dramatically. These changes have occurred as a result of major shifts in the social and financial environment and have had a major effect on how medicine was practiced in the past and how it will be practiced in the future.

The American hospital as we know it today was established in the late 19th and early 20th centuries largely by the Catholic, Protestant, and Jewish communities to provide care for the elderly and chronically ill patients who otherwise would not be cared for at home.

With the development of surgical techniques from tonsillectomies to cholecystectomies in the mid-20th century, they became the workshop of general surgeons, who largely controlled the hospitals. With the subsequent development of antibiotics and medical treatment for cardiovascular disease, the internal medicine specialties demanded a larger role in institutional management.

The increased complexity and expense of medical care led to concerns about how to provide a financial base for medical care and led to the establishment of private medical insurance programs, and ultimately, to Medicare and Medicaid. Hospitals were no longer concerned about being a health resource but suddenly became a profit center. Community hospitals expanded in order to meet the needs of new technologies with the support of grants and loans from the federal government.

With this growth, the management of the hospital of the 20th century required the creation of a new breed of hospital staff: the hospital administrator. They were hired to manage the financial and administrative aspects of these new and growing organizations. Although the hospital administration was structured to provide equipoise between the medical and financial priorities of the hospital, that balance was not easily maintained, and as the financial aspects became central, the hospital administrator became supreme and physicians lost control.

Today, the American hospital has become central to the support of nonprofit and for-profit regional and national health care conglomerates, and control has become the province of boards of directors with little medical input and larger community control. As a consequence, the physician has now become a real or quasi-employee of the hospital.

In a recent perspective paper, Dr. Richard Gunderson (Acad. Med. 2009;84:1348-51) emphasizes the need to train physicians to provide leadership for the future management of the hospital. He points out that in 1935, physicians were in charge of 35% of the nation's hospitals, but that number has shrunk to 4% of our current 6,500 U.S. hospitals. The academic medical community has largely ignored its role in preparing medical students for administrative leadership as it focused on the clinical knowledge required for the medical competence.

Dr. Gunderson, of Indiana University in Indianapolis, advocates the identification of student leaders in the selection of medical students and proposes the inclusion of courses in medical finance and social issues in the medical school curriculum in order to prepare them for a leadership role in redefining the future of medical care and hospital management.

Amanda Goodall, Ph.D., a senior research fellow at the Institute for the Study of Labor in Bonn, Germany, provides an even more challenging analysis of the importance of medical leadership at the hospital (Social Science Med. 2011;73:535-9). She notes that these changes in leadership are not unique to the United States but also have taken place in European hospitals. Using a quality scoring system, she analyzed the quality performance of 100 of the U.S. News and World Report's Best Hospitals 2009 in the fields of cancer, digestive disorders, and heart and heart surgery. She found a positive correlation between hospital quality ranking and physician CEO leadership.

Those of us who have grown up through this management evolution have seen its real impact on the care of hospital patients. Some of the changes have been positive, while others have proved frustrating for both patients and physicians who practice in the new environment.

The need for leadership by those of us who have direct patient care responsibilities is essential for an inclusive decision-making process. When patient care comes to discussion at the board meeting, physicians and nurses bring to the process a perspective that only they can provide. It is essential that their voices be heard.

Induced pluripotent stem cells
Credit: James Thomson

Using induced pluripotent stem (iPS) cells, researchers have corrected the genetic alteration that causes sickle cell disease (SCD).

The corrected stem cells were coaxed in vitro into immature red blood cells that then turned on a normal version of the gene.

The researchers caution that the work is years away from clinical use in patients, but it should provide tools for developing gene therapies for SCD and a variety of other hematologic disorders.

“We’re now one step closer to developing a combination cell and gene therapy method that will allow us to use patients’ own cells to treat them,” said lead study author Linzhao Cheng, PhD, of The Johns Hopkins School of Medicine.

Using an adult patient at The Johns Hopkins Hospital as their first case, the researchers isolated the patient’s bone marrow cells. After generating iPS cells from the bone marrow, the team put a normal copy of the hemoglobin gene in place of the defective one using genetic engineering techniques.

The researchers sequenced the DNA from 300 different samples of iPS cells to identify those that contained correct copies of the hemoglobin gene and found 4. Three of these iPS cell lines didn’t pass muster in subsequent tests.

“The beauty of iPS cells is that we can grow a lot of them and then coax them into becoming cells of any kind, including red blood cells,” Dr Cheng said.

In their process, his team converted the corrected iPS cells into immature red blood cells by giving them growth factors. Further testing showed that the normal hemoglobin gene was turned on properly in these cells, although at less than half of normal levels.

“We think these immature red blood cells still behave like embryonic cells and, as a result, are unable to turn on high enough levels of the adult hemoglobin gene,” Dr Cheng said. “We next have to learn how to properly convert these cells into mature red blood cells.”

This research was recently published online in Blood.

Induced pluripotent stem cells
Credit: James Thomson

Using induced pluripotent stem (iPS) cells, researchers have corrected the genetic alteration that causes sickle cell disease (SCD).

The corrected stem cells were coaxed in vitro into immature red blood cells that then turned on a normal version of the gene.

The researchers caution that the work is years away from clinical use in patients, but it should provide tools for developing gene therapies for SCD and a variety of other hematologic disorders.

“We’re now one step closer to developing a combination cell and gene therapy method that will allow us to use patients’ own cells to treat them,” said lead study author Linzhao Cheng, PhD, of The Johns Hopkins School of Medicine.

Using an adult patient at The Johns Hopkins Hospital as their first case, the researchers isolated the patient’s bone marrow cells. After generating iPS cells from the bone marrow, the team put a normal copy of the hemoglobin gene in place of the defective one using genetic engineering techniques.

The researchers sequenced the DNA from 300 different samples of iPS cells to identify those that contained correct copies of the hemoglobin gene and found 4. Three of these iPS cell lines didn’t pass muster in subsequent tests.

“The beauty of iPS cells is that we can grow a lot of them and then coax them into becoming cells of any kind, including red blood cells,” Dr Cheng said.

In their process, his team converted the corrected iPS cells into immature red blood cells by giving them growth factors. Further testing showed that the normal hemoglobin gene was turned on properly in these cells, although at less than half of normal levels.

“We think these immature red blood cells still behave like embryonic cells and, as a result, are unable to turn on high enough levels of the adult hemoglobin gene,” Dr Cheng said. “We next have to learn how to properly convert these cells into mature red blood cells.”

This research was recently published online in Blood.

Induced pluripotent stem cells
Credit: James Thomson

Using induced pluripotent stem (iPS) cells, researchers have corrected the genetic alteration that causes sickle cell disease (SCD).

The corrected stem cells were coaxed in vitro into immature red blood cells that then turned on a normal version of the gene.

The researchers caution that the work is years away from clinical use in patients, but it should provide tools for developing gene therapies for SCD and a variety of other hematologic disorders.

“We’re now one step closer to developing a combination cell and gene therapy method that will allow us to use patients’ own cells to treat them,” said lead study author Linzhao Cheng, PhD, of The Johns Hopkins School of Medicine.

Using an adult patient at The Johns Hopkins Hospital as their first case, the researchers isolated the patient’s bone marrow cells. After generating iPS cells from the bone marrow, the team put a normal copy of the hemoglobin gene in place of the defective one using genetic engineering techniques.

The researchers sequenced the DNA from 300 different samples of iPS cells to identify those that contained correct copies of the hemoglobin gene and found 4. Three of these iPS cell lines didn’t pass muster in subsequent tests.

“The beauty of iPS cells is that we can grow a lot of them and then coax them into becoming cells of any kind, including red blood cells,” Dr Cheng said.

In their process, his team converted the corrected iPS cells into immature red blood cells by giving them growth factors. Further testing showed that the normal hemoglobin gene was turned on properly in these cells, although at less than half of normal levels.

“We think these immature red blood cells still behave like embryonic cells and, as a result, are unable to turn on high enough levels of the adult hemoglobin gene,” Dr Cheng said. “We next have to learn how to properly convert these cells into mature red blood cells.”

This research was recently published online in Blood.

A new report in the Journal of Hospital Medicine suggests that more than 60% of 30-day readmissions are viewed as potentially preventable by hospitalists.

The study, “Hospitalists Assess the Causes of Early Hospital Readmissions,” found that of 298 cases reviewed, 15% were deemed “preventable” by a team of 17 hospitalist reviewers at Providence Health & Services in Portland, Ore. (DOI: 10.1002/jhm.909). Another 40% were tagged as “possibly preventable,” the authors reported.

When the reviewers analyzed cases to determine what interventions could have prevented readmissions, team-based approaches were the answer much of the time, says lead author and hospitalist Douglas Koekkoek, MD. Those potential answers included earlier follow-up conversations with primary-care physicians (PCPs), palliative care-consults, and more education about home-care management.

“When a physician looks at just his locus of control, they tend to be a little pessimistic,” Dr. Koekkoek says. “When they take a systems approach ... then they gain that optimism.”

The report found that in 23% of the cases, hospitalists found that extending length of stay by a day or two could have prevented a readmission. Dr. Koekkoek says that inherent conflict?balancing the cost of every hospitalized day against keeping patients long enough to prevent readmission?is “the bread and butter of hospitalist care.”

“There is going to be a natural conflict of ‘I can’t keep people in the hospital forever,’” he adds.

Given that the federal government is likely to start reducing reimbursements for unnecessary readmissions, Dr. Koekkoek says HM groups have to view their work as one front in the battle to keep patients from returning. And that has to include outpatient physicians, patient education, and other techniques.

“The take-home is we are part of a care team,” he adds. “And the team extends beyond the hospital’s walls.”

A new report in the Journal of Hospital Medicine suggests that more than 60% of 30-day readmissions are viewed as potentially preventable by hospitalists.

The study, “Hospitalists Assess the Causes of Early Hospital Readmissions,” found that of 298 cases reviewed, 15% were deemed “preventable” by a team of 17 hospitalist reviewers at Providence Health & Services in Portland, Ore. (DOI: 10.1002/jhm.909). Another 40% were tagged as “possibly preventable,” the authors reported.

When the reviewers analyzed cases to determine what interventions could have prevented readmissions, team-based approaches were the answer much of the time, says lead author and hospitalist Douglas Koekkoek, MD. Those potential answers included earlier follow-up conversations with primary-care physicians (PCPs), palliative care-consults, and more education about home-care management.

“When a physician looks at just his locus of control, they tend to be a little pessimistic,” Dr. Koekkoek says. “When they take a systems approach ... then they gain that optimism.”

The report found that in 23% of the cases, hospitalists found that extending length of stay by a day or two could have prevented a readmission. Dr. Koekkoek says that inherent conflict?balancing the cost of every hospitalized day against keeping patients long enough to prevent readmission?is “the bread and butter of hospitalist care.”

“There is going to be a natural conflict of ‘I can’t keep people in the hospital forever,’” he adds.

Given that the federal government is likely to start reducing reimbursements for unnecessary readmissions, Dr. Koekkoek says HM groups have to view their work as one front in the battle to keep patients from returning. And that has to include outpatient physicians, patient education, and other techniques.

“The take-home is we are part of a care team,” he adds. “And the team extends beyond the hospital’s walls.”

A new report in the Journal of Hospital Medicine suggests that more than 60% of 30-day readmissions are viewed as potentially preventable by hospitalists.

The study, “Hospitalists Assess the Causes of Early Hospital Readmissions,” found that of 298 cases reviewed, 15% were deemed “preventable” by a team of 17 hospitalist reviewers at Providence Health & Services in Portland, Ore. (DOI: 10.1002/jhm.909). Another 40% were tagged as “possibly preventable,” the authors reported.

When the reviewers analyzed cases to determine what interventions could have prevented readmissions, team-based approaches were the answer much of the time, says lead author and hospitalist Douglas Koekkoek, MD. Those potential answers included earlier follow-up conversations with primary-care physicians (PCPs), palliative care-consults, and more education about home-care management.

“When a physician looks at just his locus of control, they tend to be a little pessimistic,” Dr. Koekkoek says. “When they take a systems approach ... then they gain that optimism.”

The report found that in 23% of the cases, hospitalists found that extending length of stay by a day or two could have prevented a readmission. Dr. Koekkoek says that inherent conflict?balancing the cost of every hospitalized day against keeping patients long enough to prevent readmission?is “the bread and butter of hospitalist care.”

“There is going to be a natural conflict of ‘I can’t keep people in the hospital forever,’” he adds.

Given that the federal government is likely to start reducing reimbursements for unnecessary readmissions, Dr. Koekkoek says HM groups have to view their work as one front in the battle to keep patients from returning. And that has to include outpatient physicians, patient education, and other techniques.

“The take-home is we are part of a care team,” he adds. “And the team extends beyond the hospital’s walls.”

In a career with many HM “firsts," Robert M. Wachter, MD, MHM, is in line to become the first hospitalist to chair the American Board of Internal Medicine (ABIM), which provides certification for the majority of working hospitalists. Dr. Wachter, chief of the 50-faculty Division of Hospital Medicine at the University of California at San Francisco, was elected chair-elect by ABIM’s board on July 1, and is expected to become chair in July 2012.

“Bob Wachter becoming chair-elect of the ABIM is certainly an important milestone for our field,” says Scott Flanders, MD, SFHM, a hospitalist at the University of Michigan Health System and past president of SHM. “The ABIM recognized the importance of hospital medicine several years ago when they decided to add a hospitalist to the board. It should come as no surprise that they reached out to the man who is viewed as the father of hospital medicine.”

Christine K. Cassel, MD, ABIM’s president and CEO, says the election is less about recognition for the specialty and more about recognizing Dr. Wachter's transformational leadership in a number of areas, including hospital medicine.

“He has done the same kind of thing in the areas of patient safety and medical errors, and is now focusing on diagnostic accuracy,” she adds. According to Dr. Cassel, Dr. Wachter has helped ABIM focus on the need for transparency in physician performance information and report cards. “But it does indicate the maturity of the [HM] field that you have leaders like Bob—and he’s not the only one. Many emerging national leaders in healthcare are hospitalists,” she says.

ABIM sets standards and certifies physicians practicing in internal medicine and its 19 subspecialties. The board, whose members are all board-certified and represent those various subspecialties, guides the overall mission and direction in improving healthcare quality by the way it sets standards for certification, Dr. Cassel says. “The chair’s specific power and responsibility is to make sure the board runs effectively,” she adds.

In the first year of a Maintenance of Certification (MOC) program for physicians focused in hospital medicine offered by ABIM, 93 hospitalists completed the requirement and earned that designation.

In a career with many HM “firsts," Robert M. Wachter, MD, MHM, is in line to become the first hospitalist to chair the American Board of Internal Medicine (ABIM), which provides certification for the majority of working hospitalists. Dr. Wachter, chief of the 50-faculty Division of Hospital Medicine at the University of California at San Francisco, was elected chair-elect by ABIM’s board on July 1, and is expected to become chair in July 2012.

“Bob Wachter becoming chair-elect of the ABIM is certainly an important milestone for our field,” says Scott Flanders, MD, SFHM, a hospitalist at the University of Michigan Health System and past president of SHM. “The ABIM recognized the importance of hospital medicine several years ago when they decided to add a hospitalist to the board. It should come as no surprise that they reached out to the man who is viewed as the father of hospital medicine.”

Christine K. Cassel, MD, ABIM’s president and CEO, says the election is less about recognition for the specialty and more about recognizing Dr. Wachter's transformational leadership in a number of areas, including hospital medicine.

“He has done the same kind of thing in the areas of patient safety and medical errors, and is now focusing on diagnostic accuracy,” she adds. According to Dr. Cassel, Dr. Wachter has helped ABIM focus on the need for transparency in physician performance information and report cards. “But it does indicate the maturity of the [HM] field that you have leaders like Bob—and he’s not the only one. Many emerging national leaders in healthcare are hospitalists,” she says.

ABIM sets standards and certifies physicians practicing in internal medicine and its 19 subspecialties. The board, whose members are all board-certified and represent those various subspecialties, guides the overall mission and direction in improving healthcare quality by the way it sets standards for certification, Dr. Cassel says. “The chair’s specific power and responsibility is to make sure the board runs effectively,” she adds.

In the first year of a Maintenance of Certification (MOC) program for physicians focused in hospital medicine offered by ABIM, 93 hospitalists completed the requirement and earned that designation.

In a career with many HM “firsts," Robert M. Wachter, MD, MHM, is in line to become the first hospitalist to chair the American Board of Internal Medicine (ABIM), which provides certification for the majority of working hospitalists. Dr. Wachter, chief of the 50-faculty Division of Hospital Medicine at the University of California at San Francisco, was elected chair-elect by ABIM’s board on July 1, and is expected to become chair in July 2012.

“Bob Wachter becoming chair-elect of the ABIM is certainly an important milestone for our field,” says Scott Flanders, MD, SFHM, a hospitalist at the University of Michigan Health System and past president of SHM. “The ABIM recognized the importance of hospital medicine several years ago when they decided to add a hospitalist to the board. It should come as no surprise that they reached out to the man who is viewed as the father of hospital medicine.”

Christine K. Cassel, MD, ABIM’s president and CEO, says the election is less about recognition for the specialty and more about recognizing Dr. Wachter's transformational leadership in a number of areas, including hospital medicine.

“He has done the same kind of thing in the areas of patient safety and medical errors, and is now focusing on diagnostic accuracy,” she adds. According to Dr. Cassel, Dr. Wachter has helped ABIM focus on the need for transparency in physician performance information and report cards. “But it does indicate the maturity of the [HM] field that you have leaders like Bob—and he’s not the only one. Many emerging national leaders in healthcare are hospitalists,” she says.

ABIM sets standards and certifies physicians practicing in internal medicine and its 19 subspecialties. The board, whose members are all board-certified and represent those various subspecialties, guides the overall mission and direction in improving healthcare quality by the way it sets standards for certification, Dr. Cassel says. “The chair’s specific power and responsibility is to make sure the board runs effectively,” she adds.

In the first year of a Maintenance of Certification (MOC) program for physicians focused in hospital medicine offered by ABIM, 93 hospitalists completed the requirement and earned that designation.

STOCKHOLM – The results of the largest clinical trial to date in malignant pleural mesothelioma have left patients still without a standard second-line-treatment for this deadly tumor in the chest lining.

"Vorinostat [Zolinza] did not improve survival compared with placebo," Dr. Lee M. Krug said at the European Multidisciplinary Cancer Congress, where he reported outcomes of the disappointing phase III VANTAGE 014 trial.

Overall survival was not significantly different with a median of 31 weeks in patients on vorinostat and 27 weeks in those on placebo (hazard ratio, 0.98; P = 0.858). Planned analyses found no subgroups had any advantage in overall survival from vorinostat, said Dr. Krug of Memorial Sloan-Kettering Cancer Center in New York City.

Discussant Dr. Rolf A. Stahel of the University Hospital Zurich lamented, "This has been the largest study ever in mesothelioma. ... Despite this huge effort, the result is negative."

Patients were included if they had a diagnosis of malignant pleural mesothelioma with a pleural lesion at least 1 cm in thickness. They could have received up to two prior systemic regimens with pemetrexed (Alimta) and a platinum. They had to have a Karnofsky performance status of at least 70 and adequate organ function.

Vorinostat is a histone deacetylase (HDAC) inhibitor. In all, 660 patients were randomized to vorinostat (300 mg) or placebo. Both were given orally twice daily for 3 days out of 7 days in a 3-week cycle. The population was predominantly male, with a slightly greater percentage in the vorinostat arm (86% vs. 81%). Almost all patients (90%) had stage III-IV disease.

Researchers were puzzled by a change in survival rates in patients who were measured at the time of the third interim analysis, compared with those who were enrolled after the third interim analysis, said Dr. Krug.

At the third interim analysis, the hazard ratio for overall survival was 0.86, "which was just shy of the 0.83 hazard ratio required for this to be a positive trial." After the interim analysis – which occurred halfway through the study – the hazard ratio was 1.32.

The test of interaction between survival effect and time of enrollment, suggested that there was a less-than-2% chance that this switch occurred randomly. "As yet, we have not identified any causes," Dr. Krug said.

Median progression-free survival (determined by independent radiologic review) was significantly improved statistically in the vorinostat arm but not in a clinically-significant way: 6.3 weeks for vorinostat vs. 6.1 weeks for placebo (HR, 0.75; P less than 0.001).

Secondary end points (overall objective response rate, the dyspnea score on the Lung Cancer Symptom Scale as modified for mesothelioma, and forced vital capacity – were no better with vorinostat than with placebo. There were two confirmed radiologic responses, one in each arm.

"The adverse events were comparable between the two arms. ... [S]erious adverse events were slightly increased for some toxicities that you might expect to see with vorinostat," said Dr. Krug. These included fatigue, nausea, and dehydration. Tumor pain was greater in the placebo arm.

Despite the negative results, just by its sheer size, the trial "provides an excellent source of information with regards to this patient population, such as data on their pulmonary function, [symptomatology], serum markers, and also the large tumor bank that was collected," Dr. Krug told attendees at the joint congress of the European Cancer Organization (ECCO), the European Society For Medical Oncology (ESMO) and the European Society for Radiotherapy and Oncology (ESTRO).

The study was supported by Merck Laboratories. No conflicts were reported at the meeting. Dr. Krug previously reported relationships with numerous companies, including receiving research funding from Merck.

STOCKHOLM – The results of the largest clinical trial to date in malignant pleural mesothelioma have left patients still without a standard second-line-treatment for this deadly tumor in the chest lining.

"Vorinostat [Zolinza] did not improve survival compared with placebo," Dr. Lee M. Krug said at the European Multidisciplinary Cancer Congress, where he reported outcomes of the disappointing phase III VANTAGE 014 trial.

Overall survival was not significantly different with a median of 31 weeks in patients on vorinostat and 27 weeks in those on placebo (hazard ratio, 0.98; P = 0.858). Planned analyses found no subgroups had any advantage in overall survival from vorinostat, said Dr. Krug of Memorial Sloan-Kettering Cancer Center in New York City.

Discussant Dr. Rolf A. Stahel of the University Hospital Zurich lamented, "This has been the largest study ever in mesothelioma. ... Despite this huge effort, the result is negative."

Patients were included if they had a diagnosis of malignant pleural mesothelioma with a pleural lesion at least 1 cm in thickness. They could have received up to two prior systemic regimens with pemetrexed (Alimta) and a platinum. They had to have a Karnofsky performance status of at least 70 and adequate organ function.

Vorinostat is a histone deacetylase (HDAC) inhibitor. In all, 660 patients were randomized to vorinostat (300 mg) or placebo. Both were given orally twice daily for 3 days out of 7 days in a 3-week cycle. The population was predominantly male, with a slightly greater percentage in the vorinostat arm (86% vs. 81%). Almost all patients (90%) had stage III-IV disease.

Researchers were puzzled by a change in survival rates in patients who were measured at the time of the third interim analysis, compared with those who were enrolled after the third interim analysis, said Dr. Krug.

At the third interim analysis, the hazard ratio for overall survival was 0.86, "which was just shy of the 0.83 hazard ratio required for this to be a positive trial." After the interim analysis – which occurred halfway through the study – the hazard ratio was 1.32.

The test of interaction between survival effect and time of enrollment, suggested that there was a less-than-2% chance that this switch occurred randomly. "As yet, we have not identified any causes," Dr. Krug said.

Median progression-free survival (determined by independent radiologic review) was significantly improved statistically in the vorinostat arm but not in a clinically-significant way: 6.3 weeks for vorinostat vs. 6.1 weeks for placebo (HR, 0.75; P less than 0.001).

Secondary end points (overall objective response rate, the dyspnea score on the Lung Cancer Symptom Scale as modified for mesothelioma, and forced vital capacity – were no better with vorinostat than with placebo. There were two confirmed radiologic responses, one in each arm.

"The adverse events were comparable between the two arms. ... [S]erious adverse events were slightly increased for some toxicities that you might expect to see with vorinostat," said Dr. Krug. These included fatigue, nausea, and dehydration. Tumor pain was greater in the placebo arm.

Despite the negative results, just by its sheer size, the trial "provides an excellent source of information with regards to this patient population, such as data on their pulmonary function, [symptomatology], serum markers, and also the large tumor bank that was collected," Dr. Krug told attendees at the joint congress of the European Cancer Organization (ECCO), the European Society For Medical Oncology (ESMO) and the European Society for Radiotherapy and Oncology (ESTRO).

The study was supported by Merck Laboratories. No conflicts were reported at the meeting. Dr. Krug previously reported relationships with numerous companies, including receiving research funding from Merck.

STOCKHOLM – The results of the largest clinical trial to date in malignant pleural mesothelioma have left patients still without a standard second-line-treatment for this deadly tumor in the chest lining.

"Vorinostat [Zolinza] did not improve survival compared with placebo," Dr. Lee M. Krug said at the European Multidisciplinary Cancer Congress, where he reported outcomes of the disappointing phase III VANTAGE 014 trial.

Overall survival was not significantly different with a median of 31 weeks in patients on vorinostat and 27 weeks in those on placebo (hazard ratio, 0.98; P = 0.858). Planned analyses found no subgroups had any advantage in overall survival from vorinostat, said Dr. Krug of Memorial Sloan-Kettering Cancer Center in New York City.

Discussant Dr. Rolf A. Stahel of the University Hospital Zurich lamented, "This has been the largest study ever in mesothelioma. ... Despite this huge effort, the result is negative."

Patients were included if they had a diagnosis of malignant pleural mesothelioma with a pleural lesion at least 1 cm in thickness. They could have received up to two prior systemic regimens with pemetrexed (Alimta) and a platinum. They had to have a Karnofsky performance status of at least 70 and adequate organ function.

Vorinostat is a histone deacetylase (HDAC) inhibitor. In all, 660 patients were randomized to vorinostat (300 mg) or placebo. Both were given orally twice daily for 3 days out of 7 days in a 3-week cycle. The population was predominantly male, with a slightly greater percentage in the vorinostat arm (86% vs. 81%). Almost all patients (90%) had stage III-IV disease.

Researchers were puzzled by a change in survival rates in patients who were measured at the time of the third interim analysis, compared with those who were enrolled after the third interim analysis, said Dr. Krug.

At the third interim analysis, the hazard ratio for overall survival was 0.86, "which was just shy of the 0.83 hazard ratio required for this to be a positive trial." After the interim analysis – which occurred halfway through the study – the hazard ratio was 1.32.

The test of interaction between survival effect and time of enrollment, suggested that there was a less-than-2% chance that this switch occurred randomly. "As yet, we have not identified any causes," Dr. Krug said.

Median progression-free survival (determined by independent radiologic review) was significantly improved statistically in the vorinostat arm but not in a clinically-significant way: 6.3 weeks for vorinostat vs. 6.1 weeks for placebo (HR, 0.75; P less than 0.001).

Secondary end points (overall objective response rate, the dyspnea score on the Lung Cancer Symptom Scale as modified for mesothelioma, and forced vital capacity – were no better with vorinostat than with placebo. There were two confirmed radiologic responses, one in each arm.

"The adverse events were comparable between the two arms. ... [S]erious adverse events were slightly increased for some toxicities that you might expect to see with vorinostat," said Dr. Krug. These included fatigue, nausea, and dehydration. Tumor pain was greater in the placebo arm.

Despite the negative results, just by its sheer size, the trial "provides an excellent source of information with regards to this patient population, such as data on their pulmonary function, [symptomatology], serum markers, and also the large tumor bank that was collected," Dr. Krug told attendees at the joint congress of the European Cancer Organization (ECCO), the European Society For Medical Oncology (ESMO) and the European Society for Radiotherapy and Oncology (ESTRO).

The study was supported by Merck Laboratories. No conflicts were reported at the meeting. Dr. Krug previously reported relationships with numerous companies, including receiving research funding from Merck.

Erin Alesi MD, Barton Bobb RN, MSN, Thomas J. Smith MD 

Article Outline

• Futile Is as Futile Does
• Palliative Care: It's Not Just Giving Up on People
• Oncology: Palliative Care Is Giving Up
• Take-Home Messages
• Acknowledgments
• References

Futile Is as Futile Does

When deciding whether or not chemotherapy is “futile,” the concept of medical futility must be explored.^[1] Though it remains difficult to adequately define, the qualitative and quantitative descriptions offered by Schneiderman et al^[2] are widely used. Qualitatively, futile treatment “merely preserves permanent unconsciousness or cannot end dependence on intensive medical care.” More precisely, it is a medical treatment “that in the last 100 cases … has been useless.”^[2] A useful, albeit imprecise, definition of futile chemotherapy is that in which the burdens and risks outweigh the benefits. As an example, studies on chemotherapy for advanced non-small-cell lung cancer (NSCLC) have shown that patients with poor performance status or chemotherapy-unresponsive disease receive little benefit in terms of response rates and survival. ^{[3] and [4]} A retrospective analysis by Massarelli et al³ showed dismal response rates for third- and fourth-line NSCLC chemotherapy of 2.3% and 0%, respectively. Additionally, an observational study by Zietemann and Duell^[4] showed that 40% and 50% of patients receiving second- and third-line chemotherapy for NSCLC die during or soon after treatment, respectively, and that over 20% receive chemotherapy within 14 days of death. Neither study commented on quality of life experienced by patients. However, a recent study by Temel et al^[5] demonstrated that NSCLC patients receiving concurrent palliative care and standard oncologic care had better quality of life and even longer survival than patients receiving only standard oncologic care, despite being less likely to receive aggressive end-of-life care. Though limited to patients with NSCLC, these studies illustrate that chemotherapy in advanced cancer is often futile, especially when less aggressive care can improve quality of life as well as survival.

Addressing the futility of chemotherapy with patients is challenging for most oncologists. Although defining treatments as “futile” is suitable in the medical literature, it is a word that may carry negative connotations, such as hopelessness or abandonment, to patients. A more descriptive and less negative term, “nonbeneficial,” may be used when discussing futile chemotherapy with patients. The point when chemotherapy becomes nonbeneficial, and thus futile, is different for each patient and might even change over time. Addressing the patient's definition of nonbeneficial chemotherapy regularly during treatment ensures that the patient's goals are clear and allows the oncologist to direct conversation toward alternative options, such as palliative and hospice care, when chemotherapy cannot provide the benefits sought by the patient. This can be as simple as asking the patient, “Do you think the chemotherapy is giving you enough benefit to continue?”

Palliative Care: It's Not Just Giving Up on People

Both the physician and the patient face several decisions when considering whether or not to pursue chemotherapy for advanced cancer. First of all, the patient must decide how much information he or she wants from the oncologist. If the patient is the decision maker, he or she must choose to accept chemotherapy that is palliative, not curative. After a frank discussion about the anticipated outcomes and symptoms associated with chemotherapy, the patient must consider whether he or she can accept the burden of treatment for the potential of prolonging life by days, weeks, or months. On the other hand, the oncologist must decide if chemotherapy should even be offered, based on patient performance status, known therapeutic outcomes, and patient values and goals. The oncologist can reassure patients that the best available data show that patients who use hospice for even one day actually live longer than those who do not.^[6] Once informed about what palliative care and hospice offer, the patient may determine whether or not alternatives to chemotherapy are more favorable. If the patient qualifies for clinical trials, he or she must decide to accept treatment with uncertain outcome. When reflecting upon such difficult issues, both the patient and oncologist should involve others to help guide decision making. Oncologists can consult trusted colleagues for their expertise and to ensure that they are using the best information available. Patients should involve loved ones whom they trust to help make decisions in their best interest. Table 1 provides key questions that the oncologist faces when making these decisions and how to approach them.

As an alternative to addressing the above issues with the patient independently, oncologists may involve a palliative care specialist to facilitate this conversation.^[7] Particularly in cases where the oncologist decides that chemotherapy is no longer a viable option, it may be easier, from both the patient and the provider perspectives, for the palliative care specialist to have this discussion. In a recent survey of patients on our oncology ward, the great majority did not want to discuss advance directives (ADs) with their oncologist—these patients thought ADs were important and should be discussed but were more comfortable discussing them with the admitting provider than the oncologist.^[8] Patients may feel that they are disappointing their oncologist by being unable to take further treatment or by admitting that treatment has failed them. Similarly, oncologists might view having this discussion as an admission of their failure as a provider. The palliative care specialist, on the other hand, has no responsibility for chemotherapy and possibly no prior relationship with the patient, thus alleviating this type of emotional association between provider and patient. Furthermore, the conversation about nonbeneficial chemotherapy provides a segue for the palliative care provider to discuss with patients what he or she does best: establishing goals of care, managing symptoms, and maintaining comfort. For the palliative care specialist, providing symptom management and the best possible quality of life for patients are the fundamental goals. Death is generally not viewed with a sense of failure when palliation is the focus of care.

Oncology: Palliative Care Is Giving Up

We still hear from oncologists like ourselves the dreaded words “What do you want me to do, give up on the patient?” or, to the patient, “What, are you giving up? I thought you'd keep fighting!” We would argue that current best practices include knowing when the risks and harms of chemotherapy outweigh any potential chance of benefit. Physicians and patients should follow current National Comprehensive Cancer Network (NCCN) guidelines for solid tumors such as breast⁹ and lung¹⁰ cancer and stop chemotherapy when the chance of success is minimal. If the doctor cannot describe a specific, substantial benefit that outweighs the toxicity, he or she should not recommend it.^[11] And all the relevant guidelines call for considering a switch to nonchemotherapy palliative care when the patient's performance status is Eastern Cooperative Oncology Group (ECOG) ≥3, defined as “3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.”^[12] Such a simple threshold could dramatically reduce the use of chemotherapy at the end of life and lessen downstream toxicities.

Oncologists can implement several strategies to help facilitate the transition from aggressive care to comfort care (Table 2). For patients with incurable cancer, oncologists can hold early discussions about palliative and hospice options that will need to be implemented when chemotherapy is no longer able to control their disease. This discussion introduces palliative medicine as part of the care plan for incurable disease and allows the patient to anticipate such a transition. Oncologists can also provide reassurance that they will continue to be involved in their patient's care and to support them, even if the patient does not undergo further chemotherapy. There are at least four studies that show equal^[13] or better^[6] survival, smoother transitions to hospice when death is inevitable, less intensive end-of-life care, and superior patient and family outcomes with concurrent palliative care. ^{[14] and [15]} By helping patients establish legal documents, such as ADs and power of attorney, oncologists and palliative care specialists can alleviate some of the stress related to the end of life and make the transition to comfort care easier. Finally, oncologists can review guidelines such as those from the NCCN and American Society of Clinical Oncology, which call for a switch to palliative care when the cancer has grown on three regimens or the patient's ECOG performance status is three or above. ^{[11] and [12]}

Communication tools, such as the National Cancer Institute's Oncotalk and EPEC-O, are useful for oncologists seeking to further enhance their communication skills.

Take-Home Messages

Guiding patients in making decisions about nonbeneficial, or futile, chemotherapy presents a challenge for many oncologists as well as their patients and families. Though futility is difficult to define, oncologists and their patients can decide through regular, open discussion if the burdens of chemotherapy outweigh the benefits and whether or not chemotherapy can achieve the reasonable benefits desired by the patient. “Your cancer is advancing despite our best efforts to keep it from growing. Let's talk about what options we have at this point and see what will work best for you.” To make such decisions, oncologists must obtain the most current information and convey it to patients (or their designated decision makers) as clearly as possible. “Based on the latest evidence, there is a 20% chance that the cancer will shrink or stay the same size with this treatment and an 80% chance that it will continue to grow despite treatment.” Both oncologists and their patients should involve those whom they trust to help with decision making. In cases where chemotherapy is nonbeneficial, oncologists may prefer to involve palliative and hospice care specialists to discuss the transition to comfort care with the patient. “At this time, I do not have any treatments that are likely to help you live longer or more comfortably, but I want to make sure that we get the most out of the rest of your life. I have asked a palliative care specialist to help us make this possible.” In order to ease the transition from aggressive or curative care to comfort care, oncologists can employ approaches such as early discussion of palliative and hospice care, assuring the patient of continued involvement in their care, and helping patients with ADs. These approaches not only benefit patients and their families but also strengthen the relationship between the oncologist and the patients and their families.

Acknowledgments

This research was supported by grants GO8 LM0095259 from the National Library of Medicine and R01CA116227-01 (both to T. J. S.) from the National Cancer Institute.

References [PubMed ID in brackets]

1 P.R. Helft, M. Siegler and J. Lantos, The rise and fall of the medical futility movement, . N Engl J Med,  343  (2000), pp. 293–296 [10911014].

2 L.J. Schneiderman, N.S. Jecker and A.R. Jonsen, Medical futility: its meaning and ethical implications, . Ann Intern Med,  112  (1990), pp. 949–954 [2187394].

3 E. Massarelli, F. Andre, D.D. Liu, J.J. Lee, M. Wolf, A. Fandi, J. Ochs, T. Le Chevalier, F. Fossella and R.S. Herbst, A retrospective analysis of the outcome of patients who have received two prior chemotherapy regimens including platinum and docetaxel for recurrent non-small-cell lung cancer, . Lung Cancer,  39 1 (2003), pp. 55–61 [12499095].

4 V. Zietemann and T. Duell, Every-day clinical practice in patients with advanced non-small-cell lung cancer, . Lung Cancer,  68 2 (2010), pp. 273–277 [19632737].

5 J.S. Temel, J.A. Greer, A. Muzikansky, E.R. Gallagher, S. Admane, V.A. Jackson, C.M. Dahlin, C.D. Blinderman, J. Jacobsen, W.F. Pirl, J.A. Billings and T.J. Lynch, Early palliative care for patients with metastatic non-small-cell lung cancer, . N Engl J Med,  363  (2010), pp. 733–742 [20818875].

6 S.R. Connor, B. Pyenson, K. Fitch, C. Spence and K. Iwasaki, Comparing hospice and nonhospice patient survival among patients who die within a three-year window. J Pain Symptom Manage,  33 3 (2007), pp. 238–246.

7 S.E. Harrington and T.J. Smith, The role of chemotherapy at the end of life: “when is enough, enough?”. JAMA,  299 22 (2008), pp. 2667–2678.

8 L. Dow, R. Matsuyama, L. Kuhn, L. Lyckholm, E.B. Lamont and T.J. Smith, Paradoxes in advance care planning. J Clin Oncol,  28 2 (2010), pp. 299–304.

9 NCCN Breast Cancer Clinical Practice Guidelines Panel, R.W. Carlson, D.C. Allred, B.O. Anderson, H.J. Burstein, W.B. Carter, S.B. Edge, J.K. Erban, W.B. Farrar, L.J. Goldstein, W.J. Gradishar, D.F. Hayes, C.A. Hudis, M. Jahanzeb, K. Kiel, B.M. Ljung, P.K. Marcom, I.A. Mayer, B. McCormick, L.M. Nabell, L.J. Pierce, E.C. Reed, M.L. Smith, G. Somlo, R.L. Theriault, N.S. Topham, J.H. Ward, E.P. Winer and A.C. Wolff, Breast cancer. J Natl Compr Canc Netw,  7 2 (2009), pp. 122–192.

10 NCCN Non-Small Cell Lung Cancer Panel Members, D.S. Ettinger, W. Akerley, G. Bepler, M.G. Blum, A. Chang, R.T. Cheney, L.R. Chirieac, T.A. D'Amico, T.L. Demmy, A.K. Ganti, R. Govindan, F.W. Grannis, T. Jahan, M. Jahanzeb, D.H. Johnson, A. Kessinger, R. Komaki, F.M. Kong, M.G. Kris, L.M. Krug, Q.T. Le, I.T. Lennes, R. Martins, J. O'Malley, R.U. Osarogiagbon, G.A. Otterson, J.D. Patel, K.M. Pisters, K. Reckamp, G.J. Riely, E. Rohren, G.R. Simon, S.J. Swanson, D.E. Wood and S.C. Yang, Non-small cell lung cancer. J Natl Compr Canc Netw,  8 7 (2010), pp. 740–801.

11 American Society of Clinical Oncology Outcomes Working Group, Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. J Clin Oncol,  14  (1996), pp. 671–679.

12 Eastern Cooperative Oncology Group, ECOG Performance Status, http://ecog.dfci.harvard.edu/general/perf_stat.html Accessed November 30, 2010. 

13 J. Finn, K. Pienta and J. Parzuchowski, Bridging cancer treatment and hospice care. Proc Am Soc Clin Oncol,  21  (2002), p. 1452. 

14 G. Gade, I. Venohr, D. Conner, K. McGrady, J. Beane, R.H. Richardson, M.P. Williams, M. Liberson, M. Blum and R. Della Penna, Impact of an inpatient palliative care team: a randomized control trial. J Palliat Med,  11 2 (2008), pp. 180–190.

Copyright © 2011 Elsevier Inc. All rights reserved.

Erin Alesi MD, Barton Bobb RN, MSN, Thomas J. Smith MD 

Article Outline

• Futile Is as Futile Does
• Palliative Care: It's Not Just Giving Up on People
• Oncology: Palliative Care Is Giving Up
• Take-Home Messages
• Acknowledgments
• References

Futile Is as Futile Does

When deciding whether or not chemotherapy is “futile,” the concept of medical futility must be explored.^[1] Though it remains difficult to adequately define, the qualitative and quantitative descriptions offered by Schneiderman et al^[2] are widely used. Qualitatively, futile treatment “merely preserves permanent unconsciousness or cannot end dependence on intensive medical care.” More precisely, it is a medical treatment “that in the last 100 cases … has been useless.”^[2] A useful, albeit imprecise, definition of futile chemotherapy is that in which the burdens and risks outweigh the benefits. As an example, studies on chemotherapy for advanced non-small-cell lung cancer (NSCLC) have shown that patients with poor performance status or chemotherapy-unresponsive disease receive little benefit in terms of response rates and survival. ^{[3] and [4]} A retrospective analysis by Massarelli et al³ showed dismal response rates for third- and fourth-line NSCLC chemotherapy of 2.3% and 0%, respectively. Additionally, an observational study by Zietemann and Duell^[4] showed that 40% and 50% of patients receiving second- and third-line chemotherapy for NSCLC die during or soon after treatment, respectively, and that over 20% receive chemotherapy within 14 days of death. Neither study commented on quality of life experienced by patients. However, a recent study by Temel et al^[5] demonstrated that NSCLC patients receiving concurrent palliative care and standard oncologic care had better quality of life and even longer survival than patients receiving only standard oncologic care, despite being less likely to receive aggressive end-of-life care. Though limited to patients with NSCLC, these studies illustrate that chemotherapy in advanced cancer is often futile, especially when less aggressive care can improve quality of life as well as survival.

Addressing the futility of chemotherapy with patients is challenging for most oncologists. Although defining treatments as “futile” is suitable in the medical literature, it is a word that may carry negative connotations, such as hopelessness or abandonment, to patients. A more descriptive and less negative term, “nonbeneficial,” may be used when discussing futile chemotherapy with patients. The point when chemotherapy becomes nonbeneficial, and thus futile, is different for each patient and might even change over time. Addressing the patient's definition of nonbeneficial chemotherapy regularly during treatment ensures that the patient's goals are clear and allows the oncologist to direct conversation toward alternative options, such as palliative and hospice care, when chemotherapy cannot provide the benefits sought by the patient. This can be as simple as asking the patient, “Do you think the chemotherapy is giving you enough benefit to continue?”

Palliative Care: It's Not Just Giving Up on People

Both the physician and the patient face several decisions when considering whether or not to pursue chemotherapy for advanced cancer. First of all, the patient must decide how much information he or she wants from the oncologist. If the patient is the decision maker, he or she must choose to accept chemotherapy that is palliative, not curative. After a frank discussion about the anticipated outcomes and symptoms associated with chemotherapy, the patient must consider whether he or she can accept the burden of treatment for the potential of prolonging life by days, weeks, or months. On the other hand, the oncologist must decide if chemotherapy should even be offered, based on patient performance status, known therapeutic outcomes, and patient values and goals. The oncologist can reassure patients that the best available data show that patients who use hospice for even one day actually live longer than those who do not.^[6] Once informed about what palliative care and hospice offer, the patient may determine whether or not alternatives to chemotherapy are more favorable. If the patient qualifies for clinical trials, he or she must decide to accept treatment with uncertain outcome. When reflecting upon such difficult issues, both the patient and oncologist should involve others to help guide decision making. Oncologists can consult trusted colleagues for their expertise and to ensure that they are using the best information available. Patients should involve loved ones whom they trust to help make decisions in their best interest. Table 1 provides key questions that the oncologist faces when making these decisions and how to approach them.

As an alternative to addressing the above issues with the patient independently, oncologists may involve a palliative care specialist to facilitate this conversation.^[7] Particularly in cases where the oncologist decides that chemotherapy is no longer a viable option, it may be easier, from both the patient and the provider perspectives, for the palliative care specialist to have this discussion. In a recent survey of patients on our oncology ward, the great majority did not want to discuss advance directives (ADs) with their oncologist—these patients thought ADs were important and should be discussed but were more comfortable discussing them with the admitting provider than the oncologist.^[8] Patients may feel that they are disappointing their oncologist by being unable to take further treatment or by admitting that treatment has failed them. Similarly, oncologists might view having this discussion as an admission of their failure as a provider. The palliative care specialist, on the other hand, has no responsibility for chemotherapy and possibly no prior relationship with the patient, thus alleviating this type of emotional association between provider and patient. Furthermore, the conversation about nonbeneficial chemotherapy provides a segue for the palliative care provider to discuss with patients what he or she does best: establishing goals of care, managing symptoms, and maintaining comfort. For the palliative care specialist, providing symptom management and the best possible quality of life for patients are the fundamental goals. Death is generally not viewed with a sense of failure when palliation is the focus of care.

Oncology: Palliative Care Is Giving Up

We still hear from oncologists like ourselves the dreaded words “What do you want me to do, give up on the patient?” or, to the patient, “What, are you giving up? I thought you'd keep fighting!” We would argue that current best practices include knowing when the risks and harms of chemotherapy outweigh any potential chance of benefit. Physicians and patients should follow current National Comprehensive Cancer Network (NCCN) guidelines for solid tumors such as breast⁹ and lung¹⁰ cancer and stop chemotherapy when the chance of success is minimal. If the doctor cannot describe a specific, substantial benefit that outweighs the toxicity, he or she should not recommend it.^[11] And all the relevant guidelines call for considering a switch to nonchemotherapy palliative care when the patient's performance status is Eastern Cooperative Oncology Group (ECOG) ≥3, defined as “3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.”^[12] Such a simple threshold could dramatically reduce the use of chemotherapy at the end of life and lessen downstream toxicities.

Oncologists can implement several strategies to help facilitate the transition from aggressive care to comfort care (Table 2). For patients with incurable cancer, oncologists can hold early discussions about palliative and hospice options that will need to be implemented when chemotherapy is no longer able to control their disease. This discussion introduces palliative medicine as part of the care plan for incurable disease and allows the patient to anticipate such a transition. Oncologists can also provide reassurance that they will continue to be involved in their patient's care and to support them, even if the patient does not undergo further chemotherapy. There are at least four studies that show equal^[13] or better^[6] survival, smoother transitions to hospice when death is inevitable, less intensive end-of-life care, and superior patient and family outcomes with concurrent palliative care. ^{[14] and [15]} By helping patients establish legal documents, such as ADs and power of attorney, oncologists and palliative care specialists can alleviate some of the stress related to the end of life and make the transition to comfort care easier. Finally, oncologists can review guidelines such as those from the NCCN and American Society of Clinical Oncology, which call for a switch to palliative care when the cancer has grown on three regimens or the patient's ECOG performance status is three or above. ^{[11] and [12]}

Communication tools, such as the National Cancer Institute's Oncotalk and EPEC-O, are useful for oncologists seeking to further enhance their communication skills.

Take-Home Messages

Guiding patients in making decisions about nonbeneficial, or futile, chemotherapy presents a challenge for many oncologists as well as their patients and families. Though futility is difficult to define, oncologists and their patients can decide through regular, open discussion if the burdens of chemotherapy outweigh the benefits and whether or not chemotherapy can achieve the reasonable benefits desired by the patient. “Your cancer is advancing despite our best efforts to keep it from growing. Let's talk about what options we have at this point and see what will work best for you.” To make such decisions, oncologists must obtain the most current information and convey it to patients (or their designated decision makers) as clearly as possible. “Based on the latest evidence, there is a 20% chance that the cancer will shrink or stay the same size with this treatment and an 80% chance that it will continue to grow despite treatment.” Both oncologists and their patients should involve those whom they trust to help with decision making. In cases where chemotherapy is nonbeneficial, oncologists may prefer to involve palliative and hospice care specialists to discuss the transition to comfort care with the patient. “At this time, I do not have any treatments that are likely to help you live longer or more comfortably, but I want to make sure that we get the most out of the rest of your life. I have asked a palliative care specialist to help us make this possible.” In order to ease the transition from aggressive or curative care to comfort care, oncologists can employ approaches such as early discussion of palliative and hospice care, assuring the patient of continued involvement in their care, and helping patients with ADs. These approaches not only benefit patients and their families but also strengthen the relationship between the oncologist and the patients and their families.

Acknowledgments

This research was supported by grants GO8 LM0095259 from the National Library of Medicine and R01CA116227-01 (both to T. J. S.) from the National Cancer Institute.

References [PubMed ID in brackets]

1 P.R. Helft, M. Siegler and J. Lantos, The rise and fall of the medical futility movement, . N Engl J Med,  343  (2000), pp. 293–296 [10911014].

2 L.J. Schneiderman, N.S. Jecker and A.R. Jonsen, Medical futility: its meaning and ethical implications, . Ann Intern Med,  112  (1990), pp. 949–954 [2187394].

3 E. Massarelli, F. Andre, D.D. Liu, J.J. Lee, M. Wolf, A. Fandi, J. Ochs, T. Le Chevalier, F. Fossella and R.S. Herbst, A retrospective analysis of the outcome of patients who have received two prior chemotherapy regimens including platinum and docetaxel for recurrent non-small-cell lung cancer, . Lung Cancer,  39 1 (2003), pp. 55–61 [12499095].

4 V. Zietemann and T. Duell, Every-day clinical practice in patients with advanced non-small-cell lung cancer, . Lung Cancer,  68 2 (2010), pp. 273–277 [19632737].

5 J.S. Temel, J.A. Greer, A. Muzikansky, E.R. Gallagher, S. Admane, V.A. Jackson, C.M. Dahlin, C.D. Blinderman, J. Jacobsen, W.F. Pirl, J.A. Billings and T.J. Lynch, Early palliative care for patients with metastatic non-small-cell lung cancer, . N Engl J Med,  363  (2010), pp. 733–742 [20818875].

6 S.R. Connor, B. Pyenson, K. Fitch, C. Spence and K. Iwasaki, Comparing hospice and nonhospice patient survival among patients who die within a three-year window. J Pain Symptom Manage,  33 3 (2007), pp. 238–246.

7 S.E. Harrington and T.J. Smith, The role of chemotherapy at the end of life: “when is enough, enough?”. JAMA,  299 22 (2008), pp. 2667–2678.

8 L. Dow, R. Matsuyama, L. Kuhn, L. Lyckholm, E.B. Lamont and T.J. Smith, Paradoxes in advance care planning. J Clin Oncol,  28 2 (2010), pp. 299–304.

9 NCCN Breast Cancer Clinical Practice Guidelines Panel, R.W. Carlson, D.C. Allred, B.O. Anderson, H.J. Burstein, W.B. Carter, S.B. Edge, J.K. Erban, W.B. Farrar, L.J. Goldstein, W.J. Gradishar, D.F. Hayes, C.A. Hudis, M. Jahanzeb, K. Kiel, B.M. Ljung, P.K. Marcom, I.A. Mayer, B. McCormick, L.M. Nabell, L.J. Pierce, E.C. Reed, M.L. Smith, G. Somlo, R.L. Theriault, N.S. Topham, J.H. Ward, E.P. Winer and A.C. Wolff, Breast cancer. J Natl Compr Canc Netw,  7 2 (2009), pp. 122–192.

10 NCCN Non-Small Cell Lung Cancer Panel Members, D.S. Ettinger, W. Akerley, G. Bepler, M.G. Blum, A. Chang, R.T. Cheney, L.R. Chirieac, T.A. D'Amico, T.L. Demmy, A.K. Ganti, R. Govindan, F.W. Grannis, T. Jahan, M. Jahanzeb, D.H. Johnson, A. Kessinger, R. Komaki, F.M. Kong, M.G. Kris, L.M. Krug, Q.T. Le, I.T. Lennes, R. Martins, J. O'Malley, R.U. Osarogiagbon, G.A. Otterson, J.D. Patel, K.M. Pisters, K. Reckamp, G.J. Riely, E. Rohren, G.R. Simon, S.J. Swanson, D.E. Wood and S.C. Yang, Non-small cell lung cancer. J Natl Compr Canc Netw,  8 7 (2010), pp. 740–801.

11 American Society of Clinical Oncology Outcomes Working Group, Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. J Clin Oncol,  14  (1996), pp. 671–679.

12 Eastern Cooperative Oncology Group, ECOG Performance Status, http://ecog.dfci.harvard.edu/general/perf_stat.html Accessed November 30, 2010. 

13 J. Finn, K. Pienta and J. Parzuchowski, Bridging cancer treatment and hospice care. Proc Am Soc Clin Oncol,  21  (2002), p. 1452. 

14 G. Gade, I. Venohr, D. Conner, K. McGrady, J. Beane, R.H. Richardson, M.P. Williams, M. Liberson, M. Blum and R. Della Penna, Impact of an inpatient palliative care team: a randomized control trial. J Palliat Med,  11 2 (2008), pp. 180–190.

Copyright © 2011 Elsevier Inc. All rights reserved.

Erin Alesi MD, Barton Bobb RN, MSN, Thomas J. Smith MD 

Article Outline

• Futile Is as Futile Does
• Palliative Care: It's Not Just Giving Up on People
• Oncology: Palliative Care Is Giving Up
• Take-Home Messages
• Acknowledgments
• References

Futile Is as Futile Does

When deciding whether or not chemotherapy is “futile,” the concept of medical futility must be explored.^[1] Though it remains difficult to adequately define, the qualitative and quantitative descriptions offered by Schneiderman et al^[2] are widely used. Qualitatively, futile treatment “merely preserves permanent unconsciousness or cannot end dependence on intensive medical care.” More precisely, it is a medical treatment “that in the last 100 cases … has been useless.”^[2] A useful, albeit imprecise, definition of futile chemotherapy is that in which the burdens and risks outweigh the benefits. As an example, studies on chemotherapy for advanced non-small-cell lung cancer (NSCLC) have shown that patients with poor performance status or chemotherapy-unresponsive disease receive little benefit in terms of response rates and survival. ^{[3] and [4]} A retrospective analysis by Massarelli et al³ showed dismal response rates for third- and fourth-line NSCLC chemotherapy of 2.3% and 0%, respectively. Additionally, an observational study by Zietemann and Duell^[4] showed that 40% and 50% of patients receiving second- and third-line chemotherapy for NSCLC die during or soon after treatment, respectively, and that over 20% receive chemotherapy within 14 days of death. Neither study commented on quality of life experienced by patients. However, a recent study by Temel et al^[5] demonstrated that NSCLC patients receiving concurrent palliative care and standard oncologic care had better quality of life and even longer survival than patients receiving only standard oncologic care, despite being less likely to receive aggressive end-of-life care. Though limited to patients with NSCLC, these studies illustrate that chemotherapy in advanced cancer is often futile, especially when less aggressive care can improve quality of life as well as survival.

Addressing the futility of chemotherapy with patients is challenging for most oncologists. Although defining treatments as “futile” is suitable in the medical literature, it is a word that may carry negative connotations, such as hopelessness or abandonment, to patients. A more descriptive and less negative term, “nonbeneficial,” may be used when discussing futile chemotherapy with patients. The point when chemotherapy becomes nonbeneficial, and thus futile, is different for each patient and might even change over time. Addressing the patient's definition of nonbeneficial chemotherapy regularly during treatment ensures that the patient's goals are clear and allows the oncologist to direct conversation toward alternative options, such as palliative and hospice care, when chemotherapy cannot provide the benefits sought by the patient. This can be as simple as asking the patient, “Do you think the chemotherapy is giving you enough benefit to continue?”

Palliative Care: It's Not Just Giving Up on People

Both the physician and the patient face several decisions when considering whether or not to pursue chemotherapy for advanced cancer. First of all, the patient must decide how much information he or she wants from the oncologist. If the patient is the decision maker, he or she must choose to accept chemotherapy that is palliative, not curative. After a frank discussion about the anticipated outcomes and symptoms associated with chemotherapy, the patient must consider whether he or she can accept the burden of treatment for the potential of prolonging life by days, weeks, or months. On the other hand, the oncologist must decide if chemotherapy should even be offered, based on patient performance status, known therapeutic outcomes, and patient values and goals. The oncologist can reassure patients that the best available data show that patients who use hospice for even one day actually live longer than those who do not.^[6] Once informed about what palliative care and hospice offer, the patient may determine whether or not alternatives to chemotherapy are more favorable. If the patient qualifies for clinical trials, he or she must decide to accept treatment with uncertain outcome. When reflecting upon such difficult issues, both the patient and oncologist should involve others to help guide decision making. Oncologists can consult trusted colleagues for their expertise and to ensure that they are using the best information available. Patients should involve loved ones whom they trust to help make decisions in their best interest. Table 1 provides key questions that the oncologist faces when making these decisions and how to approach them.

As an alternative to addressing the above issues with the patient independently, oncologists may involve a palliative care specialist to facilitate this conversation.^[7] Particularly in cases where the oncologist decides that chemotherapy is no longer a viable option, it may be easier, from both the patient and the provider perspectives, for the palliative care specialist to have this discussion. In a recent survey of patients on our oncology ward, the great majority did not want to discuss advance directives (ADs) with their oncologist—these patients thought ADs were important and should be discussed but were more comfortable discussing them with the admitting provider than the oncologist.^[8] Patients may feel that they are disappointing their oncologist by being unable to take further treatment or by admitting that treatment has failed them. Similarly, oncologists might view having this discussion as an admission of their failure as a provider. The palliative care specialist, on the other hand, has no responsibility for chemotherapy and possibly no prior relationship with the patient, thus alleviating this type of emotional association between provider and patient. Furthermore, the conversation about nonbeneficial chemotherapy provides a segue for the palliative care provider to discuss with patients what he or she does best: establishing goals of care, managing symptoms, and maintaining comfort. For the palliative care specialist, providing symptom management and the best possible quality of life for patients are the fundamental goals. Death is generally not viewed with a sense of failure when palliation is the focus of care.

Oncology: Palliative Care Is Giving Up

We still hear from oncologists like ourselves the dreaded words “What do you want me to do, give up on the patient?” or, to the patient, “What, are you giving up? I thought you'd keep fighting!” We would argue that current best practices include knowing when the risks and harms of chemotherapy outweigh any potential chance of benefit. Physicians and patients should follow current National Comprehensive Cancer Network (NCCN) guidelines for solid tumors such as breast⁹ and lung¹⁰ cancer and stop chemotherapy when the chance of success is minimal. If the doctor cannot describe a specific, substantial benefit that outweighs the toxicity, he or she should not recommend it.^[11] And all the relevant guidelines call for considering a switch to nonchemotherapy palliative care when the patient's performance status is Eastern Cooperative Oncology Group (ECOG) ≥3, defined as “3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.”^[12] Such a simple threshold could dramatically reduce the use of chemotherapy at the end of life and lessen downstream toxicities.

Oncologists can implement several strategies to help facilitate the transition from aggressive care to comfort care (Table 2). For patients with incurable cancer, oncologists can hold early discussions about palliative and hospice options that will need to be implemented when chemotherapy is no longer able to control their disease. This discussion introduces palliative medicine as part of the care plan for incurable disease and allows the patient to anticipate such a transition. Oncologists can also provide reassurance that they will continue to be involved in their patient's care and to support them, even if the patient does not undergo further chemotherapy. There are at least four studies that show equal^[13] or better^[6] survival, smoother transitions to hospice when death is inevitable, less intensive end-of-life care, and superior patient and family outcomes with concurrent palliative care. ^{[14] and [15]} By helping patients establish legal documents, such as ADs and power of attorney, oncologists and palliative care specialists can alleviate some of the stress related to the end of life and make the transition to comfort care easier. Finally, oncologists can review guidelines such as those from the NCCN and American Society of Clinical Oncology, which call for a switch to palliative care when the cancer has grown on three regimens or the patient's ECOG performance status is three or above. ^{[11] and [12]}

Communication tools, such as the National Cancer Institute's Oncotalk and EPEC-O, are useful for oncologists seeking to further enhance their communication skills.

Take-Home Messages

Guiding patients in making decisions about nonbeneficial, or futile, chemotherapy presents a challenge for many oncologists as well as their patients and families. Though futility is difficult to define, oncologists and their patients can decide through regular, open discussion if the burdens of chemotherapy outweigh the benefits and whether or not chemotherapy can achieve the reasonable benefits desired by the patient. “Your cancer is advancing despite our best efforts to keep it from growing. Let's talk about what options we have at this point and see what will work best for you.” To make such decisions, oncologists must obtain the most current information and convey it to patients (or their designated decision makers) as clearly as possible. “Based on the latest evidence, there is a 20% chance that the cancer will shrink or stay the same size with this treatment and an 80% chance that it will continue to grow despite treatment.” Both oncologists and their patients should involve those whom they trust to help with decision making. In cases where chemotherapy is nonbeneficial, oncologists may prefer to involve palliative and hospice care specialists to discuss the transition to comfort care with the patient. “At this time, I do not have any treatments that are likely to help you live longer or more comfortably, but I want to make sure that we get the most out of the rest of your life. I have asked a palliative care specialist to help us make this possible.” In order to ease the transition from aggressive or curative care to comfort care, oncologists can employ approaches such as early discussion of palliative and hospice care, assuring the patient of continued involvement in their care, and helping patients with ADs. These approaches not only benefit patients and their families but also strengthen the relationship between the oncologist and the patients and their families.

Acknowledgments

This research was supported by grants GO8 LM0095259 from the National Library of Medicine and R01CA116227-01 (both to T. J. S.) from the National Cancer Institute.

References [PubMed ID in brackets]

1 P.R. Helft, M. Siegler and J. Lantos, The rise and fall of the medical futility movement, . N Engl J Med,  343  (2000), pp. 293–296 [10911014].

2 L.J. Schneiderman, N.S. Jecker and A.R. Jonsen, Medical futility: its meaning and ethical implications, . Ann Intern Med,  112  (1990), pp. 949–954 [2187394].

3 E. Massarelli, F. Andre, D.D. Liu, J.J. Lee, M. Wolf, A. Fandi, J. Ochs, T. Le Chevalier, F. Fossella and R.S. Herbst, A retrospective analysis of the outcome of patients who have received two prior chemotherapy regimens including platinum and docetaxel for recurrent non-small-cell lung cancer, . Lung Cancer,  39 1 (2003), pp. 55–61 [12499095].

4 V. Zietemann and T. Duell, Every-day clinical practice in patients with advanced non-small-cell lung cancer, . Lung Cancer,  68 2 (2010), pp. 273–277 [19632737].

5 J.S. Temel, J.A. Greer, A. Muzikansky, E.R. Gallagher, S. Admane, V.A. Jackson, C.M. Dahlin, C.D. Blinderman, J. Jacobsen, W.F. Pirl, J.A. Billings and T.J. Lynch, Early palliative care for patients with metastatic non-small-cell lung cancer, . N Engl J Med,  363  (2010), pp. 733–742 [20818875].

6 S.R. Connor, B. Pyenson, K. Fitch, C. Spence and K. Iwasaki, Comparing hospice and nonhospice patient survival among patients who die within a three-year window. J Pain Symptom Manage,  33 3 (2007), pp. 238–246.

7 S.E. Harrington and T.J. Smith, The role of chemotherapy at the end of life: “when is enough, enough?”. JAMA,  299 22 (2008), pp. 2667–2678.

8 L. Dow, R. Matsuyama, L. Kuhn, L. Lyckholm, E.B. Lamont and T.J. Smith, Paradoxes in advance care planning. J Clin Oncol,  28 2 (2010), pp. 299–304.

9 NCCN Breast Cancer Clinical Practice Guidelines Panel, R.W. Carlson, D.C. Allred, B.O. Anderson, H.J. Burstein, W.B. Carter, S.B. Edge, J.K. Erban, W.B. Farrar, L.J. Goldstein, W.J. Gradishar, D.F. Hayes, C.A. Hudis, M. Jahanzeb, K. Kiel, B.M. Ljung, P.K. Marcom, I.A. Mayer, B. McCormick, L.M. Nabell, L.J. Pierce, E.C. Reed, M.L. Smith, G. Somlo, R.L. Theriault, N.S. Topham, J.H. Ward, E.P. Winer and A.C. Wolff, Breast cancer. J Natl Compr Canc Netw,  7 2 (2009), pp. 122–192.

10 NCCN Non-Small Cell Lung Cancer Panel Members, D.S. Ettinger, W. Akerley, G. Bepler, M.G. Blum, A. Chang, R.T. Cheney, L.R. Chirieac, T.A. D'Amico, T.L. Demmy, A.K. Ganti, R. Govindan, F.W. Grannis, T. Jahan, M. Jahanzeb, D.H. Johnson, A. Kessinger, R. Komaki, F.M. Kong, M.G. Kris, L.M. Krug, Q.T. Le, I.T. Lennes, R. Martins, J. O'Malley, R.U. Osarogiagbon, G.A. Otterson, J.D. Patel, K.M. Pisters, K. Reckamp, G.J. Riely, E. Rohren, G.R. Simon, S.J. Swanson, D.E. Wood and S.C. Yang, Non-small cell lung cancer. J Natl Compr Canc Netw,  8 7 (2010), pp. 740–801.

11 American Society of Clinical Oncology Outcomes Working Group, Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. J Clin Oncol,  14  (1996), pp. 671–679.

12 Eastern Cooperative Oncology Group, ECOG Performance Status, http://ecog.dfci.harvard.edu/general/perf_stat.html Accessed November 30, 2010. 

13 J. Finn, K. Pienta and J. Parzuchowski, Bridging cancer treatment and hospice care. Proc Am Soc Clin Oncol,  21  (2002), p. 1452. 

14 G. Gade, I. Venohr, D. Conner, K. McGrady, J. Beane, R.H. Richardson, M.P. Williams, M. Liberson, M. Blum and R. Della Penna, Impact of an inpatient palliative care team: a randomized control trial. J Palliat Med,  11 2 (2008), pp. 180–190.

Copyright © 2011 Elsevier Inc. All rights reserved.

Editors’ Note: Patients are part of family systems, and understanding these systems can help psychiatrists advance treatment. That’s why we’re launching a new column we are calling Families in Psychiatry. In this column, Dr. Alison M. Heru will examine issues faced by psychiatrists who are involved in family therapy and psychoeducation. She will also look at family research and at the impact that caring for patients with mental illness has on caregivers. Often, she will also offer a global perspective on these issues. If you have an idea for Dr. Heru, e-mail her at [email protected].

At age 7, Maggie Jarry watched her mother "walk around the apartment trying to catch her eyes because she believed they had floated out of her face." Her mother often locked herself in the bathroom and talked to herself in the mirror because she believed that had telepathic powers.

"We lived like this for a year, until a babysitter and her mother figured out what was going on" and got professional help for Maggie’s mother. Her mother was diagnosed with schizoaffective disorder, and after she died in 2007, Maggie Jarry felt free to share her experience (Psychiatr. Serv. 2009;60:1587-8). "During these years, no one asked me about my experiences of living with my mom while she was ill. I was expected to just go play and be a child while she was in the hospital," Maggie wrote.

Maggie, now a community organizer, is part of a new consumer organization that seeks to provide support and resources to those who have a parent with mental illness. In the organization’s blog, called "Daughters and Sons," one writer expressed the burden of children living with parents with mental illness this way:

"People can be told that your family member is ‘sick’ but until they have concrete examples of how a day becomes an eternity as a child sits unknowingly, waiting for a storm to pass that has no time limit, they really have no idea what it is like. Until people ‘get it,’ they won’t be inclined to help change it and deal with it on a societal level. Unlike the adults who can get away from dysfunction, the child growing up in a crooked house has no escape."

In Maggie’s case, when her mother was doing well, the two had a good relationship. The bond that existed between the two underscores the essential human role that parenting can have in helping patients with mental illness reach wellness.

Many resources are available for children of parents with mental illness, although there are more in Europe, Australia, and New Zealand than in the United States. In the Netherlands, an online group course for Parents With Mental Illness has been piloted, and in Finland, clinician training has been studied. In the United States, the National Research Council and the Institute of Medicine produced a report on Depression in Parents, Parenting and Children: Opportunities to Improve Identification, Treatment, and Prevention. In addition, excellent web resources are listed at end of the column.

What can individual adult psychiatrists do? We can include children in family meetings about the parent’s illness. We can answer their questions about psychiatric illness. Children can also provide great insight into family functioning – strengths and weaknesses. We can provide age-appropriate literature when they visit the hospital or come with their parent to our office. We can ask our patients, their spouses, and other caregiving adults about their children. We can ask if they need help with parenting, and provide appropriate resources. We can reassure our patients that we want to help them become better parents, not remove their children! Families can be referred for help and support. If you see your patient as being part of a family, then you have a family or systems perspective of health care.

There are many family psychiatrists and many of us are members of the Association of Family Psychiatrists, which is an organization allied with the American Psychiatric Association. We have a website and a newsletter. Family psychiatrists are found in diverse settings, such as child and adolescent inpatient units, geriatric clinics, and psychosomatic medicine services. Those of us in outpatient practice may use family therapy as a single modality. Most of us, however, incorporate a family approach in our care of the patient. We use medication, individual therapy, and family interventions.

Several international family psychiatry resources are available online. Among them are the "Mental Health and Growing Up" leaflets, the "Children of Parents With a Mental Illness" website, and the Effective Family Programme.

I look forward to bringing you updates on family psychiatry, the latest in evidence-based family interventions, and other information aimed at helping you keep an updated family systems approach in your practice. Let me hear from you.

Editors’ Note: Patients are part of family systems, and understanding these systems can help psychiatrists advance treatment. That’s why we’re launching a new column we are calling Families in Psychiatry. In this column, Dr. Alison M. Heru will examine issues faced by psychiatrists who are involved in family therapy and psychoeducation. She will also look at family research and at the impact that caring for patients with mental illness has on caregivers. Often, she will also offer a global perspective on these issues. If you have an idea for Dr. Heru, e-mail her at [email protected].

At age 7, Maggie Jarry watched her mother "walk around the apartment trying to catch her eyes because she believed they had floated out of her face." Her mother often locked herself in the bathroom and talked to herself in the mirror because she believed that had telepathic powers.

"We lived like this for a year, until a babysitter and her mother figured out what was going on" and got professional help for Maggie’s mother. Her mother was diagnosed with schizoaffective disorder, and after she died in 2007, Maggie Jarry felt free to share her experience (Psychiatr. Serv. 2009;60:1587-8). "During these years, no one asked me about my experiences of living with my mom while she was ill. I was expected to just go play and be a child while she was in the hospital," Maggie wrote.

Maggie, now a community organizer, is part of a new consumer organization that seeks to provide support and resources to those who have a parent with mental illness. In the organization’s blog, called "Daughters and Sons," one writer expressed the burden of children living with parents with mental illness this way:

"People can be told that your family member is ‘sick’ but until they have concrete examples of how a day becomes an eternity as a child sits unknowingly, waiting for a storm to pass that has no time limit, they really have no idea what it is like. Until people ‘get it,’ they won’t be inclined to help change it and deal with it on a societal level. Unlike the adults who can get away from dysfunction, the child growing up in a crooked house has no escape."

In Maggie’s case, when her mother was doing well, the two had a good relationship. The bond that existed between the two underscores the essential human role that parenting can have in helping patients with mental illness reach wellness.

Many resources are available for children of parents with mental illness, although there are more in Europe, Australia, and New Zealand than in the United States. In the Netherlands, an online group course for Parents With Mental Illness has been piloted, and in Finland, clinician training has been studied. In the United States, the National Research Council and the Institute of Medicine produced a report on Depression in Parents, Parenting and Children: Opportunities to Improve Identification, Treatment, and Prevention. In addition, excellent web resources are listed at end of the column.

What can individual adult psychiatrists do? We can include children in family meetings about the parent’s illness. We can answer their questions about psychiatric illness. Children can also provide great insight into family functioning – strengths and weaknesses. We can provide age-appropriate literature when they visit the hospital or come with their parent to our office. We can ask our patients, their spouses, and other caregiving adults about their children. We can ask if they need help with parenting, and provide appropriate resources. We can reassure our patients that we want to help them become better parents, not remove their children! Families can be referred for help and support. If you see your patient as being part of a family, then you have a family or systems perspective of health care.

There are many family psychiatrists and many of us are members of the Association of Family Psychiatrists, which is an organization allied with the American Psychiatric Association. We have a website and a newsletter. Family psychiatrists are found in diverse settings, such as child and adolescent inpatient units, geriatric clinics, and psychosomatic medicine services. Those of us in outpatient practice may use family therapy as a single modality. Most of us, however, incorporate a family approach in our care of the patient. We use medication, individual therapy, and family interventions.

Several international family psychiatry resources are available online. Among them are the "Mental Health and Growing Up" leaflets, the "Children of Parents With a Mental Illness" website, and the Effective Family Programme.

I look forward to bringing you updates on family psychiatry, the latest in evidence-based family interventions, and other information aimed at helping you keep an updated family systems approach in your practice. Let me hear from you.

Editors’ Note: Patients are part of family systems, and understanding these systems can help psychiatrists advance treatment. That’s why we’re launching a new column we are calling Families in Psychiatry. In this column, Dr. Alison M. Heru will examine issues faced by psychiatrists who are involved in family therapy and psychoeducation. She will also look at family research and at the impact that caring for patients with mental illness has on caregivers. Often, she will also offer a global perspective on these issues. If you have an idea for Dr. Heru, e-mail her at [email protected].

At age 7, Maggie Jarry watched her mother "walk around the apartment trying to catch her eyes because she believed they had floated out of her face." Her mother often locked herself in the bathroom and talked to herself in the mirror because she believed that had telepathic powers.

"We lived like this for a year, until a babysitter and her mother figured out what was going on" and got professional help for Maggie’s mother. Her mother was diagnosed with schizoaffective disorder, and after she died in 2007, Maggie Jarry felt free to share her experience (Psychiatr. Serv. 2009;60:1587-8). "During these years, no one asked me about my experiences of living with my mom while she was ill. I was expected to just go play and be a child while she was in the hospital," Maggie wrote.

Maggie, now a community organizer, is part of a new consumer organization that seeks to provide support and resources to those who have a parent with mental illness. In the organization’s blog, called "Daughters and Sons," one writer expressed the burden of children living with parents with mental illness this way:

"People can be told that your family member is ‘sick’ but until they have concrete examples of how a day becomes an eternity as a child sits unknowingly, waiting for a storm to pass that has no time limit, they really have no idea what it is like. Until people ‘get it,’ they won’t be inclined to help change it and deal with it on a societal level. Unlike the adults who can get away from dysfunction, the child growing up in a crooked house has no escape."

In Maggie’s case, when her mother was doing well, the two had a good relationship. The bond that existed between the two underscores the essential human role that parenting can have in helping patients with mental illness reach wellness.

Many resources are available for children of parents with mental illness, although there are more in Europe, Australia, and New Zealand than in the United States. In the Netherlands, an online group course for Parents With Mental Illness has been piloted, and in Finland, clinician training has been studied. In the United States, the National Research Council and the Institute of Medicine produced a report on Depression in Parents, Parenting and Children: Opportunities to Improve Identification, Treatment, and Prevention. In addition, excellent web resources are listed at end of the column.

What can individual adult psychiatrists do? We can include children in family meetings about the parent’s illness. We can answer their questions about psychiatric illness. Children can also provide great insight into family functioning – strengths and weaknesses. We can provide age-appropriate literature when they visit the hospital or come with their parent to our office. We can ask our patients, their spouses, and other caregiving adults about their children. We can ask if they need help with parenting, and provide appropriate resources. We can reassure our patients that we want to help them become better parents, not remove their children! Families can be referred for help and support. If you see your patient as being part of a family, then you have a family or systems perspective of health care.

There are many family psychiatrists and many of us are members of the Association of Family Psychiatrists, which is an organization allied with the American Psychiatric Association. We have a website and a newsletter. Family psychiatrists are found in diverse settings, such as child and adolescent inpatient units, geriatric clinics, and psychosomatic medicine services. Those of us in outpatient practice may use family therapy as a single modality. Most of us, however, incorporate a family approach in our care of the patient. We use medication, individual therapy, and family interventions.

Several international family psychiatry resources are available online. Among them are the "Mental Health and Growing Up" leaflets, the "Children of Parents With a Mental Illness" website, and the Effective Family Programme.

I look forward to bringing you updates on family psychiatry, the latest in evidence-based family interventions, and other information aimed at helping you keep an updated family systems approach in your practice. Let me hear from you.

STOCKHOLM – Adding pemetrexed to bevacizumab maintenance therapy cut the relative risk of disease progression for patients with advanced nonsquamous non–small cell lung cancer in a phase III clinical trial.

Patients on the combination had a median progression-free survival of 10.2 months from the start of first-line induction therapy vs. 6.6 months with solo bevacizumab maintenance in the randomized open label study (hazard ratio, 0.50; P less than.001).

The same measure from randomization to maintenance therapy was twice as long with the combination therapy as with bevacizumab alone – 7.4 months vs. 3.7 months (HR = 0.48; P less than.001).

"First-line cisplatin/pemetrexed/bevacizumab followed by continuation maintenance with bevacizumab and pemetrexed achieved a patient PFS [progression-free survival] benefit of unprecedented magnitude," said Dr. Fabrice Barlesi, who presented the results of the AVAPERL trial at the European Multidisciplinary Cancer Congress.

The researchers recruited patients with previously untreated stage IIIB-IV advanced nonsquamous non–small cell lung cancer (nsNSCLC). All patients received four 3-week cycles of first-line induction with bevacizumab, pemetrexed (Alimta), and cisplatin.

Patients with complete response, partial response, or stable disease at the end of this treatment were randomized to continuation maintenance with bevacizumab or bevacizumab and pemetrexed in 3-week cycles until disease progression. Progression-free survival was assessed from the beginning of induction therapy to first progressive disease or death from any cause.

A total of 376 patients started first-line induction therapy; 123 were not eligible for randomization due to disease progression. Of the remainder, 253 patients were randomized to maintenance therapy with bevacizumab alone (125) or bevacizumab plus pemetrexed (128). Three patients did not receive maintenance treatment.

Median follow-up was 11 months for this analysis presented at the joint congress of the European Cancer Organization (ECCO), the European Society for Medical Oncology (ESMO), and the European Society for Radiotherapy and Oncology (ESTRO).

Overall survival from induction was 15.7 months with bevacizumab alone but has not been reached yet with the combination maintenance therapy, according to Dr. Barlesi of the multidisciplinary oncology and therapeutic innovations department at the Assistance Publique Hôpitaux de Marseille, France.

First-line therapy with cisplatin, pemetrexed, and bevacizumab was well tolerated with no new or unexpected toxicities.

Notably, grade 3-5 hematologic adverse events were greater with the bevacizumab plus pemetrexed arm vs. the control group (10% vs. 0%). Grade 3-5 nonhematologic events also were greater with the combination maintenance treatment (31% vs. 22%).

Pemetrexed is approved in the United States for maintenance treatment of nonsquamous locally advanced or metastatic non–small cell lung cancer that has not progressed after four cycles of platinum-based chemotherapy. AVAPERL was the first phase III trial to investigate the combination of pemetrexed and bevacizumab as maintenance therapy in this disease.

The study was funded by Hoffman-La Roche. Dr. Barlesi reported that he has been a consultant for and received research funding from Roche and Lilly. One of the study authors is an employee for Hoffman-La Roche.

STOCKHOLM – Adding pemetrexed to bevacizumab maintenance therapy cut the relative risk of disease progression for patients with advanced nonsquamous non–small cell lung cancer in a phase III clinical trial.

Patients on the combination had a median progression-free survival of 10.2 months from the start of first-line induction therapy vs. 6.6 months with solo bevacizumab maintenance in the randomized open label study (hazard ratio, 0.50; P less than.001).

The same measure from randomization to maintenance therapy was twice as long with the combination therapy as with bevacizumab alone – 7.4 months vs. 3.7 months (HR = 0.48; P less than.001).

"First-line cisplatin/pemetrexed/bevacizumab followed by continuation maintenance with bevacizumab and pemetrexed achieved a patient PFS [progression-free survival] benefit of unprecedented magnitude," said Dr. Fabrice Barlesi, who presented the results of the AVAPERL trial at the European Multidisciplinary Cancer Congress.

The researchers recruited patients with previously untreated stage IIIB-IV advanced nonsquamous non–small cell lung cancer (nsNSCLC). All patients received four 3-week cycles of first-line induction with bevacizumab, pemetrexed (Alimta), and cisplatin.

Patients with complete response, partial response, or stable disease at the end of this treatment were randomized to continuation maintenance with bevacizumab or bevacizumab and pemetrexed in 3-week cycles until disease progression. Progression-free survival was assessed from the beginning of induction therapy to first progressive disease or death from any cause.

A total of 376 patients started first-line induction therapy; 123 were not eligible for randomization due to disease progression. Of the remainder, 253 patients were randomized to maintenance therapy with bevacizumab alone (125) or bevacizumab plus pemetrexed (128). Three patients did not receive maintenance treatment.

Median follow-up was 11 months for this analysis presented at the joint congress of the European Cancer Organization (ECCO), the European Society for Medical Oncology (ESMO), and the European Society for Radiotherapy and Oncology (ESTRO).

Overall survival from induction was 15.7 months with bevacizumab alone but has not been reached yet with the combination maintenance therapy, according to Dr. Barlesi of the multidisciplinary oncology and therapeutic innovations department at the Assistance Publique Hôpitaux de Marseille, France.

First-line therapy with cisplatin, pemetrexed, and bevacizumab was well tolerated with no new or unexpected toxicities.

Notably, grade 3-5 hematologic adverse events were greater with the bevacizumab plus pemetrexed arm vs. the control group (10% vs. 0%). Grade 3-5 nonhematologic events also were greater with the combination maintenance treatment (31% vs. 22%).

Pemetrexed is approved in the United States for maintenance treatment of nonsquamous locally advanced or metastatic non–small cell lung cancer that has not progressed after four cycles of platinum-based chemotherapy. AVAPERL was the first phase III trial to investigate the combination of pemetrexed and bevacizumab as maintenance therapy in this disease.

The study was funded by Hoffman-La Roche. Dr. Barlesi reported that he has been a consultant for and received research funding from Roche and Lilly. One of the study authors is an employee for Hoffman-La Roche.

STOCKHOLM – Adding pemetrexed to bevacizumab maintenance therapy cut the relative risk of disease progression for patients with advanced nonsquamous non–small cell lung cancer in a phase III clinical trial.

Patients on the combination had a median progression-free survival of 10.2 months from the start of first-line induction therapy vs. 6.6 months with solo bevacizumab maintenance in the randomized open label study (hazard ratio, 0.50; P less than.001).

The same measure from randomization to maintenance therapy was twice as long with the combination therapy as with bevacizumab alone – 7.4 months vs. 3.7 months (HR = 0.48; P less than.001).

"First-line cisplatin/pemetrexed/bevacizumab followed by continuation maintenance with bevacizumab and pemetrexed achieved a patient PFS [progression-free survival] benefit of unprecedented magnitude," said Dr. Fabrice Barlesi, who presented the results of the AVAPERL trial at the European Multidisciplinary Cancer Congress.

The researchers recruited patients with previously untreated stage IIIB-IV advanced nonsquamous non–small cell lung cancer (nsNSCLC). All patients received four 3-week cycles of first-line induction with bevacizumab, pemetrexed (Alimta), and cisplatin.

Patients with complete response, partial response, or stable disease at the end of this treatment were randomized to continuation maintenance with bevacizumab or bevacizumab and pemetrexed in 3-week cycles until disease progression. Progression-free survival was assessed from the beginning of induction therapy to first progressive disease or death from any cause.

A total of 376 patients started first-line induction therapy; 123 were not eligible for randomization due to disease progression. Of the remainder, 253 patients were randomized to maintenance therapy with bevacizumab alone (125) or bevacizumab plus pemetrexed (128). Three patients did not receive maintenance treatment.

Median follow-up was 11 months for this analysis presented at the joint congress of the European Cancer Organization (ECCO), the European Society for Medical Oncology (ESMO), and the European Society for Radiotherapy and Oncology (ESTRO).

Overall survival from induction was 15.7 months with bevacizumab alone but has not been reached yet with the combination maintenance therapy, according to Dr. Barlesi of the multidisciplinary oncology and therapeutic innovations department at the Assistance Publique Hôpitaux de Marseille, France.

First-line therapy with cisplatin, pemetrexed, and bevacizumab was well tolerated with no new or unexpected toxicities.

Notably, grade 3-5 hematologic adverse events were greater with the bevacizumab plus pemetrexed arm vs. the control group (10% vs. 0%). Grade 3-5 nonhematologic events also were greater with the combination maintenance treatment (31% vs. 22%).

Pemetrexed is approved in the United States for maintenance treatment of nonsquamous locally advanced or metastatic non–small cell lung cancer that has not progressed after four cycles of platinum-based chemotherapy. AVAPERL was the first phase III trial to investigate the combination of pemetrexed and bevacizumab as maintenance therapy in this disease.

The study was funded by Hoffman-La Roche. Dr. Barlesi reported that he has been a consultant for and received research funding from Roche and Lilly. One of the study authors is an employee for Hoffman-La Roche.

If our readers have any doubt, all they need do is casually scan the program for the recent VAM in Chicago or examine the content and Editorial Board of a current copy of the JVS to realize that the Society for Vascular Surgery is unquestionably an international organization. This sort of globalization, in contrast to the variety that, according to Tom Friedman, makes the world flat instead makes our specialty more vibrant and interesting than ever.

Because of this world change we believe that our journals should better represent the people that write and read our journals, and so, too, this newspaper. For this reason, we introduce in this issue our two newest members of the Vascular Specialist Editorial Board: From England, we have Professor Cliff Shearman, and from Australia, Professor Rob Fitridge. Both have a well-deserved preeminence and will broaden the view and the viewpoint of your SVS newspaper.

Professor Shearman is professor of vascular surgery at the University of Southampton and a consultant vascular surgeon at Southampton University Hospitals NHS Trust. He was on the Council and Chairman of the Training and Education Committee of the Vascular Society of Great Britain and Ireland, and President of the Society (2009-2010) He has a long time interest in training and was appointed head of the Wessex Post Graduate School of Surgery in 2007. He is currently president elect of the Society for Academic Research Surgery and Director of Professional Practice for the Association of Surgeons of Great Britain and Ireland. His main clinical interest is in the vascular complications of diabetes and in particular trying to reduce the rate of amputation in this group.

Professor Fitridge is professor of vascular surgery at the University of Adelaide and Head of Vascular Surgery at The Queen Elizabeth Hospital. He became chairman of the Board of Vascular Surgery in 2002 and during his tenure the online curriculum was developed. In collaboration with Matt Thompson he edited "Mechanisms of Vascular Disease: A Textbook for Vascular Surgeons" published by Cambridge University Press. His research interests include the systemic effects of skeletal muscle reperfusion injury and outcome modelling in aortic surgery. He recently was elected president of the ANZSVS and is president of the World Federation of Vascular Societies.

We welcome these new additions to our editorial team.

George Andros, M.D.

Medical Editor

If our readers have any doubt, all they need do is casually scan the program for the recent VAM in Chicago or examine the content and Editorial Board of a current copy of the JVS to realize that the Society for Vascular Surgery is unquestionably an international organization. This sort of globalization, in contrast to the variety that, according to Tom Friedman, makes the world flat instead makes our specialty more vibrant and interesting than ever.

Because of this world change we believe that our journals should better represent the people that write and read our journals, and so, too, this newspaper. For this reason, we introduce in this issue our two newest members of the Vascular Specialist Editorial Board: From England, we have Professor Cliff Shearman, and from Australia, Professor Rob Fitridge. Both have a well-deserved preeminence and will broaden the view and the viewpoint of your SVS newspaper.

Professor Shearman is professor of vascular surgery at the University of Southampton and a consultant vascular surgeon at Southampton University Hospitals NHS Trust. He was on the Council and Chairman of the Training and Education Committee of the Vascular Society of Great Britain and Ireland, and President of the Society (2009-2010) He has a long time interest in training and was appointed head of the Wessex Post Graduate School of Surgery in 2007. He is currently president elect of the Society for Academic Research Surgery and Director of Professional Practice for the Association of Surgeons of Great Britain and Ireland. His main clinical interest is in the vascular complications of diabetes and in particular trying to reduce the rate of amputation in this group.

Professor Fitridge is professor of vascular surgery at the University of Adelaide and Head of Vascular Surgery at The Queen Elizabeth Hospital. He became chairman of the Board of Vascular Surgery in 2002 and during his tenure the online curriculum was developed. In collaboration with Matt Thompson he edited "Mechanisms of Vascular Disease: A Textbook for Vascular Surgeons" published by Cambridge University Press. His research interests include the systemic effects of skeletal muscle reperfusion injury and outcome modelling in aortic surgery. He recently was elected president of the ANZSVS and is president of the World Federation of Vascular Societies.

We welcome these new additions to our editorial team.

George Andros, M.D.

Medical Editor

If our readers have any doubt, all they need do is casually scan the program for the recent VAM in Chicago or examine the content and Editorial Board of a current copy of the JVS to realize that the Society for Vascular Surgery is unquestionably an international organization. This sort of globalization, in contrast to the variety that, according to Tom Friedman, makes the world flat instead makes our specialty more vibrant and interesting than ever.

Because of this world change we believe that our journals should better represent the people that write and read our journals, and so, too, this newspaper. For this reason, we introduce in this issue our two newest members of the Vascular Specialist Editorial Board: From England, we have Professor Cliff Shearman, and from Australia, Professor Rob Fitridge. Both have a well-deserved preeminence and will broaden the view and the viewpoint of your SVS newspaper.

Professor Shearman is professor of vascular surgery at the University of Southampton and a consultant vascular surgeon at Southampton University Hospitals NHS Trust. He was on the Council and Chairman of the Training and Education Committee of the Vascular Society of Great Britain and Ireland, and President of the Society (2009-2010) He has a long time interest in training and was appointed head of the Wessex Post Graduate School of Surgery in 2007. He is currently president elect of the Society for Academic Research Surgery and Director of Professional Practice for the Association of Surgeons of Great Britain and Ireland. His main clinical interest is in the vascular complications of diabetes and in particular trying to reduce the rate of amputation in this group.

Professor Fitridge is professor of vascular surgery at the University of Adelaide and Head of Vascular Surgery at The Queen Elizabeth Hospital. He became chairman of the Board of Vascular Surgery in 2002 and during his tenure the online curriculum was developed. In collaboration with Matt Thompson he edited "Mechanisms of Vascular Disease: A Textbook for Vascular Surgeons" published by Cambridge University Press. His research interests include the systemic effects of skeletal muscle reperfusion injury and outcome modelling in aortic surgery. He recently was elected president of the ANZSVS and is president of the World Federation of Vascular Societies.

We welcome these new additions to our editorial team.

George Andros, M.D.

Medical Editor