The Food and Drug Administration has granted accelerated approval to atezolizumab for the treatment of locally advanced or metastatic urothelial carcinoma in patients who experienced disease progression during or following platinum-based chemotherapy, along with a complementary diagnostic.

Atezolizumab, marketed as Tecentriq by Genentech, is the first and only FDA-approved anti-PDL1 immunotherapy for urothelial carcinoma.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

This accelerated approval is based on a 14.8% overall response rate (95% confidence interval, 11.1-19.3) reported from the open-label, multicenter, phase II IMvigor clinical trial of 310 patients, the FDA said in a written statement.

Just over one-fourth (26%) of participants who tested positive for PD-L1 expression experienced a tumor response, compared with 9.5% of participants who were negative for PD-L1 expression. The FDA, therefore, also approved the Ventana PD-L1 (SP142) assay to detect PD-L1 protein expression levels on patients’ tumor-infiltrating immune cells, which will help guide treatment decisions.

The most common adverse events reported in the single-arm trail of atezolizumab were urinary tract infection (9%), anemia (8%), fatigue (6%), and difficulty breathing (4%). Other serious side effects included pneumonitis, hepatitis, colitis, hormone gland problems, neuropathy, meningocephalitis, eye problems, severe infections, and severe infusion reactions. Three people (0.9%) experienced sepsis, pneumonitis, or intestinal obstruction that led to death, Genentech reported in a written statement.

[email protected]

On Twitter @JessCraig_OP

The Food and Drug Administration has granted accelerated approval to atezolizumab for the treatment of locally advanced or metastatic urothelial carcinoma in patients who experienced disease progression during or following platinum-based chemotherapy, along with a complementary diagnostic.

Atezolizumab, marketed as Tecentriq by Genentech, is the first and only FDA-approved anti-PDL1 immunotherapy for urothelial carcinoma.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

This accelerated approval is based on a 14.8% overall response rate (95% confidence interval, 11.1-19.3) reported from the open-label, multicenter, phase II IMvigor clinical trial of 310 patients, the FDA said in a written statement.

Just over one-fourth (26%) of participants who tested positive for PD-L1 expression experienced a tumor response, compared with 9.5% of participants who were negative for PD-L1 expression. The FDA, therefore, also approved the Ventana PD-L1 (SP142) assay to detect PD-L1 protein expression levels on patients’ tumor-infiltrating immune cells, which will help guide treatment decisions.

The most common adverse events reported in the single-arm trail of atezolizumab were urinary tract infection (9%), anemia (8%), fatigue (6%), and difficulty breathing (4%). Other serious side effects included pneumonitis, hepatitis, colitis, hormone gland problems, neuropathy, meningocephalitis, eye problems, severe infections, and severe infusion reactions. Three people (0.9%) experienced sepsis, pneumonitis, or intestinal obstruction that led to death, Genentech reported in a written statement.

[email protected]

On Twitter @JessCraig_OP

The Food and Drug Administration has granted accelerated approval to atezolizumab for the treatment of locally advanced or metastatic urothelial carcinoma in patients who experienced disease progression during or following platinum-based chemotherapy, along with a complementary diagnostic.

Atezolizumab, marketed as Tecentriq by Genentech, is the first and only FDA-approved anti-PDL1 immunotherapy for urothelial carcinoma.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

This accelerated approval is based on a 14.8% overall response rate (95% confidence interval, 11.1-19.3) reported from the open-label, multicenter, phase II IMvigor clinical trial of 310 patients, the FDA said in a written statement.

Just over one-fourth (26%) of participants who tested positive for PD-L1 expression experienced a tumor response, compared with 9.5% of participants who were negative for PD-L1 expression. The FDA, therefore, also approved the Ventana PD-L1 (SP142) assay to detect PD-L1 protein expression levels on patients’ tumor-infiltrating immune cells, which will help guide treatment decisions.

The most common adverse events reported in the single-arm trail of atezolizumab were urinary tract infection (9%), anemia (8%), fatigue (6%), and difficulty breathing (4%). Other serious side effects included pneumonitis, hepatitis, colitis, hormone gland problems, neuropathy, meningocephalitis, eye problems, severe infections, and severe infusion reactions. Three people (0.9%) experienced sepsis, pneumonitis, or intestinal obstruction that led to death, Genentech reported in a written statement.

[email protected]

On Twitter @JessCraig_OP

Here’s one more reason to take a break and exercise: A recent study links leisure-time physical activities with a lower risk of developing 13 different types of cancer. The international team of investigators pooled data from 12 prospective U.S. and European cohorts with self-reported physical activity that included more than 1.4 million participants and 186,932 cases of cancer. The greatest risk reductions were for esophageal adenocarcinoma, liver cancer, cancer of the gastric cardia, kidney cancer, and myeloid leukemia. Previous research has examined the links between physical activity and cancer risk and shown reduced risks for colon, breast, and endometrial cancers, but these studies have been underpowered to make the connection with other forms of cancer.

Related: IBD and the Risk of Oral Cancer

“Leisure-time physical activity is known to reduce risks of heart disease and risk of death from all causes, and our study demonstrates that it is also associated with lower risks of many types of cancer,” said Steven C. Moore, PhD, MPH, an investigator at the National Cancer Institute. “Furthermore, our results support that these associations are broadly generalizable to different populations, including people who are overweight or obese, or those with a history of smoking. Health care professionals counseling inactive adults should promote physical activity as a component of a healthy lifestyle and cancer prevention.”

For 13 cancers, increased levels of leisure-time physical activity were associated with lower risk: esophageal adenocarcinoma (hazard ratio [HR] 0.58, 95%; confidence interval [CI] 0.37-0.89); liver (HR 0.73, 95% CI 0.55-0.98); lung (HR 0.74, 95% CI 0.71-0.77); kidney (HR 0.77, 95% CI 0.70-0.85); gastric cardia (HR 0.78, 95% CI 0.64-0.95); endometrial (HR 0.79, 95% CI 0.68-0.92); myeloid leukemia (HR 0.80, 95% CI 0.70-0.92); myeloma (HR 0.83, 95% CI 0.72-0.95); colon (HR 0.84, 95% CI 0.77-0.91); head and neck (HR 0.85, 95% CI 0.78-0.93); rectal (HR 0.87, 95% CI 0.80-0.95); bladder (HR 0.87, 95% CI 0.82-0.92); and breast (HR 0.90, 95% CI 0.87-0.93). Conversely, leisure-time physical activity increased the risks of malignant melanoma (HR 1.27, 95% CI 1.16-1.40) and prostate cancer (HR 1.05, 95% CI 1.03-1.08).

Related: Sexual Orientation and Cancer Risk

According to the authors, the associations were similar between patients who were overweight/obese and those who were normal weight. They also noted that smoking status modified the association with lung cancer but not other smoking-related cancers.

The amount of exercise was important for some of the cancers. The risk of developing 7 of the cancer types was at least 20% lower for the most active participants (90th percentile of activity) compared with the least active participants (10th percentile of activity).

A number of physical activity mechanisms can affect cancer risk. It has been hypothesized that cancer growth could be initiated or abetted by 3 metabolic pathways that also are affected by exercise: sex steroids (estrogens and androgens); insulin and insulin-like growth factors; and proteins involved with both insulin metabolism and inflammation. Additionally, several non-hormonal mechanisms have been hypothesized to link physical activity to cancer risk, including inflammation, immune function, oxidative stress, and, for colon cancer, a reduction in time that it takes for waste to pass through the gastrointestinal tract.

Related: Alcohol Intake Increases Cancer Risk

“For years, we’ve had substantial evidence supporting a role for physical activity in three leading cancers: colon, breast, and endometrial cancers, which together account for nearly one in four cancers in the United States,” said another study author, Alpa V. Patel, PhD, a cancer epidemiologist at the American Cancer Society. “This study linking physical activity to 10 additional cancers shows its impact may be even more relevant, and that physical activity has far reaching value for cancer prevention.”

Source:

Increased physical activity associated with lower risk of 13 types of cancer [press release]. Bethesda, MD: National Institutes of Health; May 16, 2016.

Here’s one more reason to take a break and exercise: A recent study links leisure-time physical activities with a lower risk of developing 13 different types of cancer. The international team of investigators pooled data from 12 prospective U.S. and European cohorts with self-reported physical activity that included more than 1.4 million participants and 186,932 cases of cancer. The greatest risk reductions were for esophageal adenocarcinoma, liver cancer, cancer of the gastric cardia, kidney cancer, and myeloid leukemia. Previous research has examined the links between physical activity and cancer risk and shown reduced risks for colon, breast, and endometrial cancers, but these studies have been underpowered to make the connection with other forms of cancer.

Related: IBD and the Risk of Oral Cancer

“Leisure-time physical activity is known to reduce risks of heart disease and risk of death from all causes, and our study demonstrates that it is also associated with lower risks of many types of cancer,” said Steven C. Moore, PhD, MPH, an investigator at the National Cancer Institute. “Furthermore, our results support that these associations are broadly generalizable to different populations, including people who are overweight or obese, or those with a history of smoking. Health care professionals counseling inactive adults should promote physical activity as a component of a healthy lifestyle and cancer prevention.”

For 13 cancers, increased levels of leisure-time physical activity were associated with lower risk: esophageal adenocarcinoma (hazard ratio [HR] 0.58, 95%; confidence interval [CI] 0.37-0.89); liver (HR 0.73, 95% CI 0.55-0.98); lung (HR 0.74, 95% CI 0.71-0.77); kidney (HR 0.77, 95% CI 0.70-0.85); gastric cardia (HR 0.78, 95% CI 0.64-0.95); endometrial (HR 0.79, 95% CI 0.68-0.92); myeloid leukemia (HR 0.80, 95% CI 0.70-0.92); myeloma (HR 0.83, 95% CI 0.72-0.95); colon (HR 0.84, 95% CI 0.77-0.91); head and neck (HR 0.85, 95% CI 0.78-0.93); rectal (HR 0.87, 95% CI 0.80-0.95); bladder (HR 0.87, 95% CI 0.82-0.92); and breast (HR 0.90, 95% CI 0.87-0.93). Conversely, leisure-time physical activity increased the risks of malignant melanoma (HR 1.27, 95% CI 1.16-1.40) and prostate cancer (HR 1.05, 95% CI 1.03-1.08).

Related: Sexual Orientation and Cancer Risk

According to the authors, the associations were similar between patients who were overweight/obese and those who were normal weight. They also noted that smoking status modified the association with lung cancer but not other smoking-related cancers.

The amount of exercise was important for some of the cancers. The risk of developing 7 of the cancer types was at least 20% lower for the most active participants (90th percentile of activity) compared with the least active participants (10th percentile of activity).

A number of physical activity mechanisms can affect cancer risk. It has been hypothesized that cancer growth could be initiated or abetted by 3 metabolic pathways that also are affected by exercise: sex steroids (estrogens and androgens); insulin and insulin-like growth factors; and proteins involved with both insulin metabolism and inflammation. Additionally, several non-hormonal mechanisms have been hypothesized to link physical activity to cancer risk, including inflammation, immune function, oxidative stress, and, for colon cancer, a reduction in time that it takes for waste to pass through the gastrointestinal tract.

Related: Alcohol Intake Increases Cancer Risk

“For years, we’ve had substantial evidence supporting a role for physical activity in three leading cancers: colon, breast, and endometrial cancers, which together account for nearly one in four cancers in the United States,” said another study author, Alpa V. Patel, PhD, a cancer epidemiologist at the American Cancer Society. “This study linking physical activity to 10 additional cancers shows its impact may be even more relevant, and that physical activity has far reaching value for cancer prevention.”

Source:

Increased physical activity associated with lower risk of 13 types of cancer [press release]. Bethesda, MD: National Institutes of Health; May 16, 2016.

Here’s one more reason to take a break and exercise: A recent study links leisure-time physical activities with a lower risk of developing 13 different types of cancer. The international team of investigators pooled data from 12 prospective U.S. and European cohorts with self-reported physical activity that included more than 1.4 million participants and 186,932 cases of cancer. The greatest risk reductions were for esophageal adenocarcinoma, liver cancer, cancer of the gastric cardia, kidney cancer, and myeloid leukemia. Previous research has examined the links between physical activity and cancer risk and shown reduced risks for colon, breast, and endometrial cancers, but these studies have been underpowered to make the connection with other forms of cancer.

Related: IBD and the Risk of Oral Cancer

“Leisure-time physical activity is known to reduce risks of heart disease and risk of death from all causes, and our study demonstrates that it is also associated with lower risks of many types of cancer,” said Steven C. Moore, PhD, MPH, an investigator at the National Cancer Institute. “Furthermore, our results support that these associations are broadly generalizable to different populations, including people who are overweight or obese, or those with a history of smoking. Health care professionals counseling inactive adults should promote physical activity as a component of a healthy lifestyle and cancer prevention.”

For 13 cancers, increased levels of leisure-time physical activity were associated with lower risk: esophageal adenocarcinoma (hazard ratio [HR] 0.58, 95%; confidence interval [CI] 0.37-0.89); liver (HR 0.73, 95% CI 0.55-0.98); lung (HR 0.74, 95% CI 0.71-0.77); kidney (HR 0.77, 95% CI 0.70-0.85); gastric cardia (HR 0.78, 95% CI 0.64-0.95); endometrial (HR 0.79, 95% CI 0.68-0.92); myeloid leukemia (HR 0.80, 95% CI 0.70-0.92); myeloma (HR 0.83, 95% CI 0.72-0.95); colon (HR 0.84, 95% CI 0.77-0.91); head and neck (HR 0.85, 95% CI 0.78-0.93); rectal (HR 0.87, 95% CI 0.80-0.95); bladder (HR 0.87, 95% CI 0.82-0.92); and breast (HR 0.90, 95% CI 0.87-0.93). Conversely, leisure-time physical activity increased the risks of malignant melanoma (HR 1.27, 95% CI 1.16-1.40) and prostate cancer (HR 1.05, 95% CI 1.03-1.08).

Related: Sexual Orientation and Cancer Risk

According to the authors, the associations were similar between patients who were overweight/obese and those who were normal weight. They also noted that smoking status modified the association with lung cancer but not other smoking-related cancers.

The amount of exercise was important for some of the cancers. The risk of developing 7 of the cancer types was at least 20% lower for the most active participants (90th percentile of activity) compared with the least active participants (10th percentile of activity).

A number of physical activity mechanisms can affect cancer risk. It has been hypothesized that cancer growth could be initiated or abetted by 3 metabolic pathways that also are affected by exercise: sex steroids (estrogens and androgens); insulin and insulin-like growth factors; and proteins involved with both insulin metabolism and inflammation. Additionally, several non-hormonal mechanisms have been hypothesized to link physical activity to cancer risk, including inflammation, immune function, oxidative stress, and, for colon cancer, a reduction in time that it takes for waste to pass through the gastrointestinal tract.

Related: Alcohol Intake Increases Cancer Risk

“For years, we’ve had substantial evidence supporting a role for physical activity in three leading cancers: colon, breast, and endometrial cancers, which together account for nearly one in four cancers in the United States,” said another study author, Alpa V. Patel, PhD, a cancer epidemiologist at the American Cancer Society. “This study linking physical activity to 10 additional cancers shows its impact may be even more relevant, and that physical activity has far reaching value for cancer prevention.”

Source:

Increased physical activity associated with lower risk of 13 types of cancer [press release]. Bethesda, MD: National Institutes of Health; May 16, 2016.

The State of Hospital Medicine (SoHM) report is the most comprehensive survey of hospital medicine in the country and provides current data on hospitalist compensation and production and also covers practice demographics, staffing levels, staff growth, and compensation models.

“The SoHM report is an indispensable tool for hospital medicine group directors,” says Andrew White, MD, SFHM, a member of SHM’s Practice Analysis Committee. “It has helped us to evaluate and benchmark the support we receive from our hospital. I really appreciate the breakdown by characteristics, such as region of the country, academic practice, pediatrics, family medicine, and the involvement of NP and PA providers.

“The SoHM represents an excellent value—it has a ton of information in an easy-to-read format.”

Don’t miss out on getting your copy when it becomes available. Sign up to be notified when the report is released in September 2016 at www.hospitalmedicine.org/Survey.

Brett Radler is SHM’s communications coordinator.

The State of Hospital Medicine (SoHM) report is the most comprehensive survey of hospital medicine in the country and provides current data on hospitalist compensation and production and also covers practice demographics, staffing levels, staff growth, and compensation models.

“The SoHM report is an indispensable tool for hospital medicine group directors,” says Andrew White, MD, SFHM, a member of SHM’s Practice Analysis Committee. “It has helped us to evaluate and benchmark the support we receive from our hospital. I really appreciate the breakdown by characteristics, such as region of the country, academic practice, pediatrics, family medicine, and the involvement of NP and PA providers.

“The SoHM represents an excellent value—it has a ton of information in an easy-to-read format.”

Don’t miss out on getting your copy when it becomes available. Sign up to be notified when the report is released in September 2016 at www.hospitalmedicine.org/Survey.

Brett Radler is SHM’s communications coordinator.

The State of Hospital Medicine (SoHM) report is the most comprehensive survey of hospital medicine in the country and provides current data on hospitalist compensation and production and also covers practice demographics, staffing levels, staff growth, and compensation models.

“The SoHM report is an indispensable tool for hospital medicine group directors,” says Andrew White, MD, SFHM, a member of SHM’s Practice Analysis Committee. “It has helped us to evaluate and benchmark the support we receive from our hospital. I really appreciate the breakdown by characteristics, such as region of the country, academic practice, pediatrics, family medicine, and the involvement of NP and PA providers.

“The SoHM represents an excellent value—it has a ton of information in an easy-to-read format.”

Don’t miss out on getting your copy when it becomes available. Sign up to be notified when the report is released in September 2016 at www.hospitalmedicine.org/Survey.

Brett Radler is SHM’s communications coordinator.

Resource:
Choosemyplate.org

Resource:
Choosemyplate.org

Resource:
Choosemyplate.org

Question: What attracted you to become involved with SHM?

Q: How has your experience with SHM brought value to your professional career?

A: Not long after I joined, I realized that SHM features a very welcoming body of members, and it encourages regular conversation about how to solve complex problems in our continuously evolving world of healthcare delivery. What I find so valuable is that SHM provides members with ample avenues to share results, success stories, challenges, and more—whether that is at the annual meetings or through the Journal of Hospital Medicine, The Hospitalist, the Hospital Medicine Exchange (HMX), social media, and more.

As a result of this culture of inclusivity, I accepted a role on the Practice Administrators Committee and subsequently on the Practice Analysis Committee as a way to further engage with SHM and network with other hospital medicine professionals. Two SHM resources I refer to on a regular basis are the Key Principles and Characteristics of an Effective Hospital Medicine Group and the biannual State of Hospital Medicine survey. Having access to key recommendations and research about hospital medicine is critical, but knowing that it was endorsed by the society dedicated to hospital medicine added extra emphasis to its relevance.

Q: How has CHI used these resources to inform decisions about hospitalist practice and leadership?

A: The list of key principles and characteristics is especially helpful with our hospitalist dyad leadership model at CHI, in which we pair strong medical and business leaders together to collectively lead and improve each division. The two key principles we always come back to are the first two: effective leadership and engaged hospitalists. The foundation of high-quality care and financial success is engaged hospitalists, requiring a meaningful relationship between hospitalists and hospital leaders. Both strategic business and medical leadership are essential to sustaining performance. For example, by having strong leadership and engaged hospitalists, we have been able to develop and implement clinical standards based on primary evidence to improve patient outcomes. By incorporating recommendations from the key principles and characteristics, we continue to advance and evolve our model to best meet our hospitalists’—and our communities’—needs.

The State of Hospital Medicine survey is a valuable asset when we’re evaluating care teams and staffing models. Reviewing data that cover what others have done—whether it is about incorporating advanced practice clinicians (NPs and PAs) into the hospital medicine group, evaluating a nocturnist model, or looking at how others have handled differentiation of schedules—ensures we not only incorporate these best practices into our decision-making process but also allows us to consider how our processes compare to others. Tie this back in with the key characteristics, and you can understand what staffing model and resources you need to build the hospital medicine group that best fits your hospital and its local needs.

Q: SHM is celebrating the 20th anniversary of hospital medicine with the “Year of the Hospitalist.” Why do you think hospital medicine continues to experience such unparalleled growth and success?

A: Hospital medicine continues to grow because it has been proven that with a focused team of caregivers, outcomes can be much better. Everyone in the industry is trying to improve quality outcomes, optimizing the right care in the right place at the right time while accomplishing this with the highest of patient satisfaction. As a result, the bar continues to be raised. There is an increasing demand for subspecialty hospitalists, and hospitalists are also in high demand in the continuum of care, outside the walls of the hospital, to care for patients in pre- and post-acute-care settings. All of this, in addition to the shift to payment for value versus volume, increases the demand for hospitalists. TH

Brett Radler is SHM’s communications coordinator.

Question: What attracted you to become involved with SHM?

Q: How has your experience with SHM brought value to your professional career?

A: Not long after I joined, I realized that SHM features a very welcoming body of members, and it encourages regular conversation about how to solve complex problems in our continuously evolving world of healthcare delivery. What I find so valuable is that SHM provides members with ample avenues to share results, success stories, challenges, and more—whether that is at the annual meetings or through the Journal of Hospital Medicine, The Hospitalist, the Hospital Medicine Exchange (HMX), social media, and more.

As a result of this culture of inclusivity, I accepted a role on the Practice Administrators Committee and subsequently on the Practice Analysis Committee as a way to further engage with SHM and network with other hospital medicine professionals. Two SHM resources I refer to on a regular basis are the Key Principles and Characteristics of an Effective Hospital Medicine Group and the biannual State of Hospital Medicine survey. Having access to key recommendations and research about hospital medicine is critical, but knowing that it was endorsed by the society dedicated to hospital medicine added extra emphasis to its relevance.

Q: How has CHI used these resources to inform decisions about hospitalist practice and leadership?

A: The list of key principles and characteristics is especially helpful with our hospitalist dyad leadership model at CHI, in which we pair strong medical and business leaders together to collectively lead and improve each division. The two key principles we always come back to are the first two: effective leadership and engaged hospitalists. The foundation of high-quality care and financial success is engaged hospitalists, requiring a meaningful relationship between hospitalists and hospital leaders. Both strategic business and medical leadership are essential to sustaining performance. For example, by having strong leadership and engaged hospitalists, we have been able to develop and implement clinical standards based on primary evidence to improve patient outcomes. By incorporating recommendations from the key principles and characteristics, we continue to advance and evolve our model to best meet our hospitalists’—and our communities’—needs.

The State of Hospital Medicine survey is a valuable asset when we’re evaluating care teams and staffing models. Reviewing data that cover what others have done—whether it is about incorporating advanced practice clinicians (NPs and PAs) into the hospital medicine group, evaluating a nocturnist model, or looking at how others have handled differentiation of schedules—ensures we not only incorporate these best practices into our decision-making process but also allows us to consider how our processes compare to others. Tie this back in with the key characteristics, and you can understand what staffing model and resources you need to build the hospital medicine group that best fits your hospital and its local needs.

Q: SHM is celebrating the 20th anniversary of hospital medicine with the “Year of the Hospitalist.” Why do you think hospital medicine continues to experience such unparalleled growth and success?

A: Hospital medicine continues to grow because it has been proven that with a focused team of caregivers, outcomes can be much better. Everyone in the industry is trying to improve quality outcomes, optimizing the right care in the right place at the right time while accomplishing this with the highest of patient satisfaction. As a result, the bar continues to be raised. There is an increasing demand for subspecialty hospitalists, and hospitalists are also in high demand in the continuum of care, outside the walls of the hospital, to care for patients in pre- and post-acute-care settings. All of this, in addition to the shift to payment for value versus volume, increases the demand for hospitalists. TH

Brett Radler is SHM’s communications coordinator.

Question: What attracted you to become involved with SHM?

Q: How has your experience with SHM brought value to your professional career?

A: Not long after I joined, I realized that SHM features a very welcoming body of members, and it encourages regular conversation about how to solve complex problems in our continuously evolving world of healthcare delivery. What I find so valuable is that SHM provides members with ample avenues to share results, success stories, challenges, and more—whether that is at the annual meetings or through the Journal of Hospital Medicine, The Hospitalist, the Hospital Medicine Exchange (HMX), social media, and more.

As a result of this culture of inclusivity, I accepted a role on the Practice Administrators Committee and subsequently on the Practice Analysis Committee as a way to further engage with SHM and network with other hospital medicine professionals. Two SHM resources I refer to on a regular basis are the Key Principles and Characteristics of an Effective Hospital Medicine Group and the biannual State of Hospital Medicine survey. Having access to key recommendations and research about hospital medicine is critical, but knowing that it was endorsed by the society dedicated to hospital medicine added extra emphasis to its relevance.

Q: How has CHI used these resources to inform decisions about hospitalist practice and leadership?

A: The list of key principles and characteristics is especially helpful with our hospitalist dyad leadership model at CHI, in which we pair strong medical and business leaders together to collectively lead and improve each division. The two key principles we always come back to are the first two: effective leadership and engaged hospitalists. The foundation of high-quality care and financial success is engaged hospitalists, requiring a meaningful relationship between hospitalists and hospital leaders. Both strategic business and medical leadership are essential to sustaining performance. For example, by having strong leadership and engaged hospitalists, we have been able to develop and implement clinical standards based on primary evidence to improve patient outcomes. By incorporating recommendations from the key principles and characteristics, we continue to advance and evolve our model to best meet our hospitalists’—and our communities’—needs.

The State of Hospital Medicine survey is a valuable asset when we’re evaluating care teams and staffing models. Reviewing data that cover what others have done—whether it is about incorporating advanced practice clinicians (NPs and PAs) into the hospital medicine group, evaluating a nocturnist model, or looking at how others have handled differentiation of schedules—ensures we not only incorporate these best practices into our decision-making process but also allows us to consider how our processes compare to others. Tie this back in with the key characteristics, and you can understand what staffing model and resources you need to build the hospital medicine group that best fits your hospital and its local needs.

Q: SHM is celebrating the 20th anniversary of hospital medicine with the “Year of the Hospitalist.” Why do you think hospital medicine continues to experience such unparalleled growth and success?

A: Hospital medicine continues to grow because it has been proven that with a focused team of caregivers, outcomes can be much better. Everyone in the industry is trying to improve quality outcomes, optimizing the right care in the right place at the right time while accomplishing this with the highest of patient satisfaction. As a result, the bar continues to be raised. There is an increasing demand for subspecialty hospitalists, and hospitalists are also in high demand in the continuum of care, outside the walls of the hospital, to care for patients in pre- and post-acute-care settings. All of this, in addition to the shift to payment for value versus volume, increases the demand for hospitalists. TH

Brett Radler is SHM’s communications coordinator.

BALTIMORE – By 2035, U.S. cardiothoracic surgeons will see a 61% increase in the national caseload, and potentially a 121% increase in cases for each surgeon, according to a data analysis presented at the annual meeting of the American Association for Thoracic Surgery.

Using data from the American Board of Thoracic Surgery, a research team at Ohio State University performed case load calculations for 2035 based on cases per surgeon per year in 2010. The researchers estimated that the average caseload per surgeon in 2035 will be 299 cases, compared with a 2010 caseload of 135 per surgeon. This increase is not matched by the number of surgeons currently trained and certified annually.

Dr. John Ikonomidis, chief of the division of cardiothoracic surgery at the Medical University of South Carolina in Charleston, and a discussant on the presentation, said surgeon retirements and an increase in the population needing treatment have put the specialty in a bind.

“We have a bit of a crisis now, honestly, but this particular paper puts it in even further perspective,” Dr. Ikonomidis said in a video interview. “By 2035 we’re looking at a 3,000-surgeon shortage, relative to what would be available.” He noted that approximately 90 medical residents per year are certified as cardiothoracic surgeons, a rate which will not produce enough CT surgeons to meet the projected shortage.

“We need to continue to have this conversation,” he concluded. “It is a reminder that the predictions we made 15 years ago appear to be true, and we probably need to do something about it, at least in the short term.”

Dr. Ikonomidis reported no relevant financial disclosures.

[email protected]

On Twitter @richpizzi

BALTIMORE – By 2035, U.S. cardiothoracic surgeons will see a 61% increase in the national caseload, and potentially a 121% increase in cases for each surgeon, according to a data analysis presented at the annual meeting of the American Association for Thoracic Surgery.

Using data from the American Board of Thoracic Surgery, a research team at Ohio State University performed case load calculations for 2035 based on cases per surgeon per year in 2010. The researchers estimated that the average caseload per surgeon in 2035 will be 299 cases, compared with a 2010 caseload of 135 per surgeon. This increase is not matched by the number of surgeons currently trained and certified annually.

Dr. John Ikonomidis, chief of the division of cardiothoracic surgery at the Medical University of South Carolina in Charleston, and a discussant on the presentation, said surgeon retirements and an increase in the population needing treatment have put the specialty in a bind.

“We have a bit of a crisis now, honestly, but this particular paper puts it in even further perspective,” Dr. Ikonomidis said in a video interview. “By 2035 we’re looking at a 3,000-surgeon shortage, relative to what would be available.” He noted that approximately 90 medical residents per year are certified as cardiothoracic surgeons, a rate which will not produce enough CT surgeons to meet the projected shortage.

“We need to continue to have this conversation,” he concluded. “It is a reminder that the predictions we made 15 years ago appear to be true, and we probably need to do something about it, at least in the short term.”

Dr. Ikonomidis reported no relevant financial disclosures.

[email protected]

On Twitter @richpizzi

BALTIMORE – By 2035, U.S. cardiothoracic surgeons will see a 61% increase in the national caseload, and potentially a 121% increase in cases for each surgeon, according to a data analysis presented at the annual meeting of the American Association for Thoracic Surgery.

Using data from the American Board of Thoracic Surgery, a research team at Ohio State University performed case load calculations for 2035 based on cases per surgeon per year in 2010. The researchers estimated that the average caseload per surgeon in 2035 will be 299 cases, compared with a 2010 caseload of 135 per surgeon. This increase is not matched by the number of surgeons currently trained and certified annually.

Dr. John Ikonomidis, chief of the division of cardiothoracic surgery at the Medical University of South Carolina in Charleston, and a discussant on the presentation, said surgeon retirements and an increase in the population needing treatment have put the specialty in a bind.

“We have a bit of a crisis now, honestly, but this particular paper puts it in even further perspective,” Dr. Ikonomidis said in a video interview. “By 2035 we’re looking at a 3,000-surgeon shortage, relative to what would be available.” He noted that approximately 90 medical residents per year are certified as cardiothoracic surgeons, a rate which will not produce enough CT surgeons to meet the projected shortage.

“We need to continue to have this conversation,” he concluded. “It is a reminder that the predictions we made 15 years ago appear to be true, and we probably need to do something about it, at least in the short term.”

Dr. Ikonomidis reported no relevant financial disclosures.

[email protected]

On Twitter @richpizzi

Although multiple surveys have been published regarding patient gender preference when choosing an ObGyn, overall results have not been analyzed. To address this literature gap, Kyle J. Tobler, MD, and colleagues at the Womack Army Medical Center in Fort Bragg, North Carolina, and Uniformed Services University of the Health Sciences in Bethesda, Maryland, searched multiple sources to provide a conglomerate analysis of patients’ gender preference when choosing an ObGyn. An abstract describing their study was published in Obstetrics & Gynecology in May 2016 and presented at the American College of Obstetricians and Gynecologists 2016 Annual Clinical and Scientific Meeting May 14−17, in Washington, DC.

A personal impetus for studying gender preference
The impetus for this project truly was initiated for Dr. Tobler when he was a 4th-year medical student. “I was trying to decide if Obstetrics and Gynecology was the right field for me,” he said. “I was discouraged by many people around me, who told me that men in ObGyn would not have a place, as female patients only wanted female ObGyns. And with the residency match at 60% to 70% women for ObGyn, it did seem that men would not have a place. Thus, I began searching the literature to verify if the question for gender preference for their ObGyn provider had been evaluated previously, and I found mixed results.” After medical school Dr. Tobler pursued this current meta-analysis to address the conflicting results.

Details of the study
Dr. Tobler and his colleagues explored PubMed, Embase, PsycINFO (American Psychological Association’s medical literature database), Cumulative Index to Nursing and Allied Health Literature (EBSCO Health’s database), Scopus (Elsevier’s abstract and citation database of peer-reviewed literature), and references of relevant articles. Included were 4,822 electronically-identified citations of English-language studies, including surveys administered to patients that specifically asked for gender preference of their ObGyn provider.

The researchers found that 23 studies met their inclusion criteria, comprising 14,736 patients. Overall, 8.3% (95% confidence interval [CI], 0.08-0.09) of ObGyn patients reported a preference for a male provider, 50.2% (95% CI, 0.49-0.51) preferred a female provider, and 41.3% (95% CI, 0.40-0.42) reported no gender preference when choosing an ObGyn.

What about US patients?
A subanalysis of studies (n = 9,861) conducted in the United States from 1999 to 2008 (with the last search undertaken in April 2015) showed that 8.4% (95% CI, 0.08-0.09) preferred a male ObGyn, 53.2% (95% CI, 0.52-0.54) preferred a female ObGyn, and 38.5% (95% CI, 0.38-0.39) had no gender preference.

“We were surprised by the numbers,” comments Dr. Tobler. “The general trend demonstrated a mix between no preference or a preference for female providers, but not by a large margin.”

“We considered analyzing for age,” he said, “but most of the studies gave a mean or median age value and were widely distributed. We were able, however, to break our analysis down into regions where one would expect a very strong preference for female providers—the Middle East and Africa. But in fact results were not much different than for Western countries. Our results for this subanalysis of Middle Eastern countries and Nigeria (n = 1,951) demonstrated that 8.7% of women (95% CI, 4.1-13.3) preferred a male provider, 51.2% (95% CI, 17.2-85.1) preferred a female provider, and 46.9% (95% CI, 9.3-84.5) had no gender preference.”

Updated May 20, 2016.

Although multiple surveys have been published regarding patient gender preference when choosing an ObGyn, overall results have not been analyzed. To address this literature gap, Kyle J. Tobler, MD, and colleagues at the Womack Army Medical Center in Fort Bragg, North Carolina, and Uniformed Services University of the Health Sciences in Bethesda, Maryland, searched multiple sources to provide a conglomerate analysis of patients’ gender preference when choosing an ObGyn. An abstract describing their study was published in Obstetrics & Gynecology in May 2016 and presented at the American College of Obstetricians and Gynecologists 2016 Annual Clinical and Scientific Meeting May 14−17, in Washington, DC.

A personal impetus for studying gender preference
The impetus for this project truly was initiated for Dr. Tobler when he was a 4th-year medical student. “I was trying to decide if Obstetrics and Gynecology was the right field for me,” he said. “I was discouraged by many people around me, who told me that men in ObGyn would not have a place, as female patients only wanted female ObGyns. And with the residency match at 60% to 70% women for ObGyn, it did seem that men would not have a place. Thus, I began searching the literature to verify if the question for gender preference for their ObGyn provider had been evaluated previously, and I found mixed results.” After medical school Dr. Tobler pursued this current meta-analysis to address the conflicting results.

Details of the study
Dr. Tobler and his colleagues explored PubMed, Embase, PsycINFO (American Psychological Association’s medical literature database), Cumulative Index to Nursing and Allied Health Literature (EBSCO Health’s database), Scopus (Elsevier’s abstract and citation database of peer-reviewed literature), and references of relevant articles. Included were 4,822 electronically-identified citations of English-language studies, including surveys administered to patients that specifically asked for gender preference of their ObGyn provider.

The researchers found that 23 studies met their inclusion criteria, comprising 14,736 patients. Overall, 8.3% (95% confidence interval [CI], 0.08-0.09) of ObGyn patients reported a preference for a male provider, 50.2% (95% CI, 0.49-0.51) preferred a female provider, and 41.3% (95% CI, 0.40-0.42) reported no gender preference when choosing an ObGyn.

What about US patients?
A subanalysis of studies (n = 9,861) conducted in the United States from 1999 to 2008 (with the last search undertaken in April 2015) showed that 8.4% (95% CI, 0.08-0.09) preferred a male ObGyn, 53.2% (95% CI, 0.52-0.54) preferred a female ObGyn, and 38.5% (95% CI, 0.38-0.39) had no gender preference.

“We were surprised by the numbers,” comments Dr. Tobler. “The general trend demonstrated a mix between no preference or a preference for female providers, but not by a large margin.”

“We considered analyzing for age,” he said, “but most of the studies gave a mean or median age value and were widely distributed. We were able, however, to break our analysis down into regions where one would expect a very strong preference for female providers—the Middle East and Africa. But in fact results were not much different than for Western countries. Our results for this subanalysis of Middle Eastern countries and Nigeria (n = 1,951) demonstrated that 8.7% of women (95% CI, 4.1-13.3) preferred a male provider, 51.2% (95% CI, 17.2-85.1) preferred a female provider, and 46.9% (95% CI, 9.3-84.5) had no gender preference.”

Updated May 20, 2016.

Although multiple surveys have been published regarding patient gender preference when choosing an ObGyn, overall results have not been analyzed. To address this literature gap, Kyle J. Tobler, MD, and colleagues at the Womack Army Medical Center in Fort Bragg, North Carolina, and Uniformed Services University of the Health Sciences in Bethesda, Maryland, searched multiple sources to provide a conglomerate analysis of patients’ gender preference when choosing an ObGyn. An abstract describing their study was published in Obstetrics & Gynecology in May 2016 and presented at the American College of Obstetricians and Gynecologists 2016 Annual Clinical and Scientific Meeting May 14−17, in Washington, DC.

A personal impetus for studying gender preference
The impetus for this project truly was initiated for Dr. Tobler when he was a 4th-year medical student. “I was trying to decide if Obstetrics and Gynecology was the right field for me,” he said. “I was discouraged by many people around me, who told me that men in ObGyn would not have a place, as female patients only wanted female ObGyns. And with the residency match at 60% to 70% women for ObGyn, it did seem that men would not have a place. Thus, I began searching the literature to verify if the question for gender preference for their ObGyn provider had been evaluated previously, and I found mixed results.” After medical school Dr. Tobler pursued this current meta-analysis to address the conflicting results.

Details of the study
Dr. Tobler and his colleagues explored PubMed, Embase, PsycINFO (American Psychological Association’s medical literature database), Cumulative Index to Nursing and Allied Health Literature (EBSCO Health’s database), Scopus (Elsevier’s abstract and citation database of peer-reviewed literature), and references of relevant articles. Included were 4,822 electronically-identified citations of English-language studies, including surveys administered to patients that specifically asked for gender preference of their ObGyn provider.

The researchers found that 23 studies met their inclusion criteria, comprising 14,736 patients. Overall, 8.3% (95% confidence interval [CI], 0.08-0.09) of ObGyn patients reported a preference for a male provider, 50.2% (95% CI, 0.49-0.51) preferred a female provider, and 41.3% (95% CI, 0.40-0.42) reported no gender preference when choosing an ObGyn.

What about US patients?
A subanalysis of studies (n = 9,861) conducted in the United States from 1999 to 2008 (with the last search undertaken in April 2015) showed that 8.4% (95% CI, 0.08-0.09) preferred a male ObGyn, 53.2% (95% CI, 0.52-0.54) preferred a female ObGyn, and 38.5% (95% CI, 0.38-0.39) had no gender preference.

“We were surprised by the numbers,” comments Dr. Tobler. “The general trend demonstrated a mix between no preference or a preference for female providers, but not by a large margin.”

“We considered analyzing for age,” he said, “but most of the studies gave a mean or median age value and were widely distributed. We were able, however, to break our analysis down into regions where one would expect a very strong preference for female providers—the Middle East and Africa. But in fact results were not much different than for Western countries. Our results for this subanalysis of Middle Eastern countries and Nigeria (n = 1,951) demonstrated that 8.7% of women (95% CI, 4.1-13.3) preferred a male provider, 51.2% (95% CI, 17.2-85.1) preferred a female provider, and 46.9% (95% CI, 9.3-84.5) had no gender preference.”

Updated May 20, 2016.

BALTIMORE – Surgical resection of early-stage non–small cell lung cancer afforded a superior survival advantage for patients than stereotactic body radiation therapy (SBRT), according to a study presented at the 2016 annual meeting of the American Association for Thoracic Surgery.

While an increasing number of non–small cell lung cancer patients have been treated with SBRT, it appears that surgery may still be the better option. Analysis of both matched and unmatched patient groups found that SBRT was associated with significantly lower survival than wedge resection.

“Frankly, I was surprised to see such a big difference between SBRT and wedge resection,” said Dr. Walter Weder, professor of surgery at University Hospital Zürich, in an interview at AATS 2016. Dr Weder served as a discussant on the paper, and said the results confirm that surgeons should be involved in discussions with patients when they are considering treatment options. “Surgery can be done safely... and patients should know this information.”

Dr. Weder reported no relevant financial disclosures.

[email protected]

On Twitter @richpizzi

BALTIMORE – Surgical resection of early-stage non–small cell lung cancer afforded a superior survival advantage for patients than stereotactic body radiation therapy (SBRT), according to a study presented at the 2016 annual meeting of the American Association for Thoracic Surgery.

While an increasing number of non–small cell lung cancer patients have been treated with SBRT, it appears that surgery may still be the better option. Analysis of both matched and unmatched patient groups found that SBRT was associated with significantly lower survival than wedge resection.

“Frankly, I was surprised to see such a big difference between SBRT and wedge resection,” said Dr. Walter Weder, professor of surgery at University Hospital Zürich, in an interview at AATS 2016. Dr Weder served as a discussant on the paper, and said the results confirm that surgeons should be involved in discussions with patients when they are considering treatment options. “Surgery can be done safely... and patients should know this information.”

Dr. Weder reported no relevant financial disclosures.

[email protected]

On Twitter @richpizzi

BALTIMORE – Surgical resection of early-stage non–small cell lung cancer afforded a superior survival advantage for patients than stereotactic body radiation therapy (SBRT), according to a study presented at the 2016 annual meeting of the American Association for Thoracic Surgery.

While an increasing number of non–small cell lung cancer patients have been treated with SBRT, it appears that surgery may still be the better option. Analysis of both matched and unmatched patient groups found that SBRT was associated with significantly lower survival than wedge resection.

“Frankly, I was surprised to see such a big difference between SBRT and wedge resection,” said Dr. Walter Weder, professor of surgery at University Hospital Zürich, in an interview at AATS 2016. Dr Weder served as a discussant on the paper, and said the results confirm that surgeons should be involved in discussions with patients when they are considering treatment options. “Surgery can be done safely... and patients should know this information.”

Dr. Weder reported no relevant financial disclosures.

[email protected]

On Twitter @richpizzi

Micrograph showing ALL

Patients with high-risk, relapsed/refractory acute lymphoblastic leukemia (ALL) may be sensitive to treatment with SMAC mimetics, according to researchers.

One SMAC mimetic in particular, birinapant, demonstrated varied activity in samples from ALL patients, but samples from patients with resistant disease were the most sensitive to the drug.

Birinapant also had “marked antileukemic effects” in some mice with ALL.

The researchers found this antileukemic activity was dependent on simultaneous activation of apoptosis and necroptosis.

The team reported these findings in Science Translational Medicine.

“Our research reveals that an alternative cell-death program, necroptosis, can be activated in human ALL cells,” said study author Beat Bornhauser, PhD, of the Children’s Hospital Zurich in Switzerland.

“This enables leukemia cells that barely respond to existing chemotherapeutic drugs to be killed off.”

In vitro and in vivo activity

The researchers tested the efficacy of SMAC mimetics in a set of 51 patient-derived B-cell precursor ALL xenografts, which was enriched for samples from relapsed and drug-resistant disease.

The response to birinapant varied greatly, but samples from high-risk or relapsed patients tended to be highly sensitive to the drug.

The researchers observed similar response profiles with the SMAC mimetic LCL161, although this drug proved less potent than birinapant.

The team also evaluated the antileukemic activity of SMAC mimetics in mouse models of ALL.

Birinapant delayed disease progression and induced complete responses in sensitive ALL cases. LCL161, on the other hand, did not display any in vivo activity.

Determining the mechanism of activity

The researchers used CRISPR-Cas9 to determine how SMAC mimetics fight ALL, and they discovered that the drugs trigger both apoptosis and necroptosis.

If the genes responsible for apoptosis were disabled via genome editing, leukemia cells died due to necroptosis after SMAC mimetics had been administered. If necroptotic genes were disabled, apoptosis led to cell death.

Only the simultaneous deactivation of apoptotic and necroptotic genes resulted in the complete resistance of leukemic cells to SMAC mimetics.

Therefore, the researchers concluded that simultaneous activation of apoptosis and necroptosis is responsible for the strong anti-leukemic effect of SMAC mimetics.

“SMAC mimetics have great potential to eliminate leukemia cells in patients that aren’t sensitive to established chemotherapeutic drugs,” Dr Bornhauser said. “They are effectively a double-edged sword. They kill cells that block apoptosis through necroptosis.”

The researchers are now looking for suitable biomarkers to identify patients who might benefit from treatment with SMAC mimetics in clinical trials.

Micrograph showing ALL

Patients with high-risk, relapsed/refractory acute lymphoblastic leukemia (ALL) may be sensitive to treatment with SMAC mimetics, according to researchers.

One SMAC mimetic in particular, birinapant, demonstrated varied activity in samples from ALL patients, but samples from patients with resistant disease were the most sensitive to the drug.

Birinapant also had “marked antileukemic effects” in some mice with ALL.

The researchers found this antileukemic activity was dependent on simultaneous activation of apoptosis and necroptosis.

The team reported these findings in Science Translational Medicine.

“Our research reveals that an alternative cell-death program, necroptosis, can be activated in human ALL cells,” said study author Beat Bornhauser, PhD, of the Children’s Hospital Zurich in Switzerland.

“This enables leukemia cells that barely respond to existing chemotherapeutic drugs to be killed off.”

In vitro and in vivo activity

The researchers tested the efficacy of SMAC mimetics in a set of 51 patient-derived B-cell precursor ALL xenografts, which was enriched for samples from relapsed and drug-resistant disease.

The response to birinapant varied greatly, but samples from high-risk or relapsed patients tended to be highly sensitive to the drug.

The researchers observed similar response profiles with the SMAC mimetic LCL161, although this drug proved less potent than birinapant.

The team also evaluated the antileukemic activity of SMAC mimetics in mouse models of ALL.

Birinapant delayed disease progression and induced complete responses in sensitive ALL cases. LCL161, on the other hand, did not display any in vivo activity.

Determining the mechanism of activity

The researchers used CRISPR-Cas9 to determine how SMAC mimetics fight ALL, and they discovered that the drugs trigger both apoptosis and necroptosis.

If the genes responsible for apoptosis were disabled via genome editing, leukemia cells died due to necroptosis after SMAC mimetics had been administered. If necroptotic genes were disabled, apoptosis led to cell death.

Only the simultaneous deactivation of apoptotic and necroptotic genes resulted in the complete resistance of leukemic cells to SMAC mimetics.

Therefore, the researchers concluded that simultaneous activation of apoptosis and necroptosis is responsible for the strong anti-leukemic effect of SMAC mimetics.

“SMAC mimetics have great potential to eliminate leukemia cells in patients that aren’t sensitive to established chemotherapeutic drugs,” Dr Bornhauser said. “They are effectively a double-edged sword. They kill cells that block apoptosis through necroptosis.”

The researchers are now looking for suitable biomarkers to identify patients who might benefit from treatment with SMAC mimetics in clinical trials.

Micrograph showing ALL

Patients with high-risk, relapsed/refractory acute lymphoblastic leukemia (ALL) may be sensitive to treatment with SMAC mimetics, according to researchers.

One SMAC mimetic in particular, birinapant, demonstrated varied activity in samples from ALL patients, but samples from patients with resistant disease were the most sensitive to the drug.

Birinapant also had “marked antileukemic effects” in some mice with ALL.

The researchers found this antileukemic activity was dependent on simultaneous activation of apoptosis and necroptosis.

The team reported these findings in Science Translational Medicine.

“Our research reveals that an alternative cell-death program, necroptosis, can be activated in human ALL cells,” said study author Beat Bornhauser, PhD, of the Children’s Hospital Zurich in Switzerland.

“This enables leukemia cells that barely respond to existing chemotherapeutic drugs to be killed off.”

In vitro and in vivo activity

The researchers tested the efficacy of SMAC mimetics in a set of 51 patient-derived B-cell precursor ALL xenografts, which was enriched for samples from relapsed and drug-resistant disease.

The response to birinapant varied greatly, but samples from high-risk or relapsed patients tended to be highly sensitive to the drug.

The researchers observed similar response profiles with the SMAC mimetic LCL161, although this drug proved less potent than birinapant.

The team also evaluated the antileukemic activity of SMAC mimetics in mouse models of ALL.

Birinapant delayed disease progression and induced complete responses in sensitive ALL cases. LCL161, on the other hand, did not display any in vivo activity.

Determining the mechanism of activity

The researchers used CRISPR-Cas9 to determine how SMAC mimetics fight ALL, and they discovered that the drugs trigger both apoptosis and necroptosis.

If the genes responsible for apoptosis were disabled via genome editing, leukemia cells died due to necroptosis after SMAC mimetics had been administered. If necroptotic genes were disabled, apoptosis led to cell death.

Only the simultaneous deactivation of apoptotic and necroptotic genes resulted in the complete resistance of leukemic cells to SMAC mimetics.

Therefore, the researchers concluded that simultaneous activation of apoptosis and necroptosis is responsible for the strong anti-leukemic effect of SMAC mimetics.

“SMAC mimetics have great potential to eliminate leukemia cells in patients that aren’t sensitive to established chemotherapeutic drugs,” Dr Bornhauser said. “They are effectively a double-edged sword. They kill cells that block apoptosis through necroptosis.”

The researchers are now looking for suitable biomarkers to identify patients who might benefit from treatment with SMAC mimetics in clinical trials.

Transplant preparation

Photo by Chad McNeeley

CHICAGO—An interim analysis of a large, phase 3 study has confirmed that upfront autologous stem cell transplantation (ASCT) is still the preferred

treatment for newly diagnosed, young multiple myeloma (MM) patients, even in the age of novel agents such as bortezomib.

Investigators compared 4 cycles of bortezomib-melphalan-prednisone (VMP) with high-dose melphalan (HDM) and single or double ASCT, depending upon the policy of the treating institution.

At a median follow-up of 24 months, the 3-year progression-free survival (PFS) was significantly better for patients who had received ASCT.

Michele Cavo, MD, of Seràgnoli Institute of Hematology in Bologna, Italy, reported the results of this first interim analysis of the European Myeloma Network trial (EMN/HO95 MM) at a press briefing preceding the 2016 ASCO Annual Meeting. More details will be presented at the meeting itself (abstract 8000).

Study investigators enrolled 1503 patients from February 2011 through April 2014. They performed the specified interim analysis in January 2016.

Patients were 65 years or younger, and all received bortezomib-based induction therapy followed by stem cell collection. Investigators then randomized 1266 patients to receive either VMP (n=754) or HDM plus single or double ASCT (n=512).

Patients underwent a second randomization to either 2 cycles of bortezomib-based consolidation or no consolidation therapy.

All patients received lenalidomide maintenance until disease progression. The primary endpoint was PFS after the first randomization.

Results

PFS was significantly longer in patients who had received a transplant, with a hazard ratio (HR) of 0.76, 95% confidence interval (CI) of 0.61-0.94, and P value of 0.01.

This benefit held true for patients with revised ISS stage III (HR=0.52, 95% CI 0.32-0.84, P=0.01).

And patients with high-risk cytogenetics also retained the benefit (HR=0.72, 95% CI 0.54-0.97, P=0.03). High-risk was defined as t(4;14), del(17p), del(1p), or gain of 1q.

Investigators also performed a multivariate analysis and found randomization to the HDM arm to be an independent predictor of prolonged PFS (HR=0.61, 95% CI 0.45-0.82, P=0.001).

There was no significant difference between the 2 arms in terms of stringent complete response and complete response.

However, when very good partial response was included in the best-response analysis, patients in the transplant arm fared significantly better (P<0.0001) than patients in the VMP arm—84% and 74%, respectively.

Investigators have not yet completed the interim data analysis related to the second randomization. The study is ongoing, and future analyses will include overall survival, toxicity, quality of life, and other measures.

This study was funded by the Haemato Oncology Foundation for Adults in the Netherlands (HOVON).

Transplant preparation

Photo by Chad McNeeley

CHICAGO—An interim analysis of a large, phase 3 study has confirmed that upfront autologous stem cell transplantation (ASCT) is still the preferred

treatment for newly diagnosed, young multiple myeloma (MM) patients, even in the age of novel agents such as bortezomib.

Investigators compared 4 cycles of bortezomib-melphalan-prednisone (VMP) with high-dose melphalan (HDM) and single or double ASCT, depending upon the policy of the treating institution.

At a median follow-up of 24 months, the 3-year progression-free survival (PFS) was significantly better for patients who had received ASCT.

Michele Cavo, MD, of Seràgnoli Institute of Hematology in Bologna, Italy, reported the results of this first interim analysis of the European Myeloma Network trial (EMN/HO95 MM) at a press briefing preceding the 2016 ASCO Annual Meeting. More details will be presented at the meeting itself (abstract 8000).

Study investigators enrolled 1503 patients from February 2011 through April 2014. They performed the specified interim analysis in January 2016.

Patients were 65 years or younger, and all received bortezomib-based induction therapy followed by stem cell collection. Investigators then randomized 1266 patients to receive either VMP (n=754) or HDM plus single or double ASCT (n=512).

Patients underwent a second randomization to either 2 cycles of bortezomib-based consolidation or no consolidation therapy.

All patients received lenalidomide maintenance until disease progression. The primary endpoint was PFS after the first randomization.

Results

PFS was significantly longer in patients who had received a transplant, with a hazard ratio (HR) of 0.76, 95% confidence interval (CI) of 0.61-0.94, and P value of 0.01.

This benefit held true for patients with revised ISS stage III (HR=0.52, 95% CI 0.32-0.84, P=0.01).

And patients with high-risk cytogenetics also retained the benefit (HR=0.72, 95% CI 0.54-0.97, P=0.03). High-risk was defined as t(4;14), del(17p), del(1p), or gain of 1q.

Investigators also performed a multivariate analysis and found randomization to the HDM arm to be an independent predictor of prolonged PFS (HR=0.61, 95% CI 0.45-0.82, P=0.001).

There was no significant difference between the 2 arms in terms of stringent complete response and complete response.

However, when very good partial response was included in the best-response analysis, patients in the transplant arm fared significantly better (P<0.0001) than patients in the VMP arm—84% and 74%, respectively.

Investigators have not yet completed the interim data analysis related to the second randomization. The study is ongoing, and future analyses will include overall survival, toxicity, quality of life, and other measures.

This study was funded by the Haemato Oncology Foundation for Adults in the Netherlands (HOVON).

Transplant preparation

Photo by Chad McNeeley

CHICAGO—An interim analysis of a large, phase 3 study has confirmed that upfront autologous stem cell transplantation (ASCT) is still the preferred

treatment for newly diagnosed, young multiple myeloma (MM) patients, even in the age of novel agents such as bortezomib.

Investigators compared 4 cycles of bortezomib-melphalan-prednisone (VMP) with high-dose melphalan (HDM) and single or double ASCT, depending upon the policy of the treating institution.

At a median follow-up of 24 months, the 3-year progression-free survival (PFS) was significantly better for patients who had received ASCT.

Michele Cavo, MD, of Seràgnoli Institute of Hematology in Bologna, Italy, reported the results of this first interim analysis of the European Myeloma Network trial (EMN/HO95 MM) at a press briefing preceding the 2016 ASCO Annual Meeting. More details will be presented at the meeting itself (abstract 8000).

Study investigators enrolled 1503 patients from February 2011 through April 2014. They performed the specified interim analysis in January 2016.

Patients were 65 years or younger, and all received bortezomib-based induction therapy followed by stem cell collection. Investigators then randomized 1266 patients to receive either VMP (n=754) or HDM plus single or double ASCT (n=512).

Patients underwent a second randomization to either 2 cycles of bortezomib-based consolidation or no consolidation therapy.

All patients received lenalidomide maintenance until disease progression. The primary endpoint was PFS after the first randomization.

Results

PFS was significantly longer in patients who had received a transplant, with a hazard ratio (HR) of 0.76, 95% confidence interval (CI) of 0.61-0.94, and P value of 0.01.

This benefit held true for patients with revised ISS stage III (HR=0.52, 95% CI 0.32-0.84, P=0.01).

And patients with high-risk cytogenetics also retained the benefit (HR=0.72, 95% CI 0.54-0.97, P=0.03). High-risk was defined as t(4;14), del(17p), del(1p), or gain of 1q.

Investigators also performed a multivariate analysis and found randomization to the HDM arm to be an independent predictor of prolonged PFS (HR=0.61, 95% CI 0.45-0.82, P=0.001).

There was no significant difference between the 2 arms in terms of stringent complete response and complete response.

However, when very good partial response was included in the best-response analysis, patients in the transplant arm fared significantly better (P<0.0001) than patients in the VMP arm—84% and 74%, respectively.

Investigators have not yet completed the interim data analysis related to the second randomization. The study is ongoing, and future analyses will include overall survival, toxicity, quality of life, and other measures.

This study was funded by the Haemato Oncology Foundation for Adults in the Netherlands (HOVON).