To improve your hospital’s reimbursements and key indicators, including observed and expected (O/E) mortality ratios, personalize your collaboration with clinical documentation specialists (CDSs). That’s what has worked at two medical centers where hospitalists teamed up with CDSs to improve their hospitals’ claims processes.

At Northwestern Memorial Hospital in Chicago, the hematology/oncology service was selected for a pilot program to focus on improving expected mortality rates. The specialists needed to ensure that coded data sent to state- and hospital-associated databases (as well as payor claims, such as those submitted to Medicare) accurately represented the severity of patients’ conditions upon admission. To do that, they needed buy-in from hospitalists to make their notes as complete as possible.

Hospitalists usually encounter CDSs anonymously, through an electronic query in the electronic health record (EHR). Kristine Green, RN, a CDS, quality leader, and interim manager at Northwestern’s clinical documentation program, approached hospitalist Charlotta Weaver, MD, medical director of the oncology HM service and a clinical instructor at Northwestern University’s Feinberg School of Medicine. Green suggested she shadow Dr. Weaver on rounds.

“We had implemented this technique in a couple of our other service lines, with good results,” Green says. She compared her notes on patient visits with Dr. Weaver’s notes and was able to catch conditions that were being undercoded. They generated a list, now posted in the work room, disseminated via email, and included in the orientation binder, of frequently missed coding diagnoses.

For example, Dr. Weaver explains, “instead of writing ‘AKI-obstructive,’ we now write ‘AKI due to ureteral obstruction from peritoneal carcinomatosis from metastatic gastric cancer.’ ”

Such specificity in physicians’ notes translates to a more accurate level of billing for the hospital and a more accurate reflection of patients’ acuity in comparative databases. With Dr. Weaver paving the way, Green has forged “a nice rapport” with the other hospitalists in the oncology medicine service.

Audiences for Your Notes

CDS and hospitalists might initially view notes differently. Most physicians train in programs where the “primary intent of a note” is to communicate to the rest of the medical team what’s happening with the patient, Dr. Weaver says.

Listen to The Hospitalist's interview with Dr. Tsomides discussing billing and coding improvements available to your HM program.

“When we train, we’re always thinking about communicating with each other,” says Theodore (Ted) Tsomides, MD, PhD, an attending physician on the hospital medicine service at WakeMed Hospital and assistant professor of medicine at the University of North Carolina’s School of Medicine in Raleigh. “But as we get into the system, we realize that there are a lot of eyes on those documents. And whether we think about it or not, those are all our different audiences.”

Once hospitalists develop confidence and comfort on the job, Dr. Tsomides says, they can move on to aligning themselves with the hospital’s interests. Dr. Weaver thinks hospitalists are uniquely positioned to help champion the CDI efforts. “We’re here to improve the mission of the hospital,” she says.

As physician liaison for quality programs, Dr. Tsomides began working on clinical documentation improvement. He became a resource for the department, and then worked to achieve a financial incentive plan for hospital physicians when their documentation improved. He’s also been pushing his institution to make the documentation process easier by using electronic queries, and by introducing residents to the “real world” of clinical documentation in their curriculum. (Click here to listen to more of Dr. Tsomides’ ideas to improve clinical documentation.)

He advises hospitalists meet their clinical documentation specialists face to face. “Once you know there are people who are doing their part, and have a relationship with them, you approach the whole problem differently,” Dr. Tsomides says, “as opposed to [viewing them] as anonymous reviewers breathing down your neck and giving you yet another thing to worry about.”

Gretchen Henkel is a freelance writer based in California.

To improve your hospital’s reimbursements and key indicators, including observed and expected (O/E) mortality ratios, personalize your collaboration with clinical documentation specialists (CDSs). That’s what has worked at two medical centers where hospitalists teamed up with CDSs to improve their hospitals’ claims processes.

At Northwestern Memorial Hospital in Chicago, the hematology/oncology service was selected for a pilot program to focus on improving expected mortality rates. The specialists needed to ensure that coded data sent to state- and hospital-associated databases (as well as payor claims, such as those submitted to Medicare) accurately represented the severity of patients’ conditions upon admission. To do that, they needed buy-in from hospitalists to make their notes as complete as possible.

Hospitalists usually encounter CDSs anonymously, through an electronic query in the electronic health record (EHR). Kristine Green, RN, a CDS, quality leader, and interim manager at Northwestern’s clinical documentation program, approached hospitalist Charlotta Weaver, MD, medical director of the oncology HM service and a clinical instructor at Northwestern University’s Feinberg School of Medicine. Green suggested she shadow Dr. Weaver on rounds.

“We had implemented this technique in a couple of our other service lines, with good results,” Green says. She compared her notes on patient visits with Dr. Weaver’s notes and was able to catch conditions that were being undercoded. They generated a list, now posted in the work room, disseminated via email, and included in the orientation binder, of frequently missed coding diagnoses.

For example, Dr. Weaver explains, “instead of writing ‘AKI-obstructive,’ we now write ‘AKI due to ureteral obstruction from peritoneal carcinomatosis from metastatic gastric cancer.’ ”

Such specificity in physicians’ notes translates to a more accurate level of billing for the hospital and a more accurate reflection of patients’ acuity in comparative databases. With Dr. Weaver paving the way, Green has forged “a nice rapport” with the other hospitalists in the oncology medicine service.

Audiences for Your Notes

CDS and hospitalists might initially view notes differently. Most physicians train in programs where the “primary intent of a note” is to communicate to the rest of the medical team what’s happening with the patient, Dr. Weaver says.

Listen to The Hospitalist's interview with Dr. Tsomides discussing billing and coding improvements available to your HM program.

“When we train, we’re always thinking about communicating with each other,” says Theodore (Ted) Tsomides, MD, PhD, an attending physician on the hospital medicine service at WakeMed Hospital and assistant professor of medicine at the University of North Carolina’s School of Medicine in Raleigh. “But as we get into the system, we realize that there are a lot of eyes on those documents. And whether we think about it or not, those are all our different audiences.”

Once hospitalists develop confidence and comfort on the job, Dr. Tsomides says, they can move on to aligning themselves with the hospital’s interests. Dr. Weaver thinks hospitalists are uniquely positioned to help champion the CDI efforts. “We’re here to improve the mission of the hospital,” she says.

As physician liaison for quality programs, Dr. Tsomides began working on clinical documentation improvement. He became a resource for the department, and then worked to achieve a financial incentive plan for hospital physicians when their documentation improved. He’s also been pushing his institution to make the documentation process easier by using electronic queries, and by introducing residents to the “real world” of clinical documentation in their curriculum. (Click here to listen to more of Dr. Tsomides’ ideas to improve clinical documentation.)

He advises hospitalists meet their clinical documentation specialists face to face. “Once you know there are people who are doing their part, and have a relationship with them, you approach the whole problem differently,” Dr. Tsomides says, “as opposed to [viewing them] as anonymous reviewers breathing down your neck and giving you yet another thing to worry about.”

Gretchen Henkel is a freelance writer based in California.

To improve your hospital’s reimbursements and key indicators, including observed and expected (O/E) mortality ratios, personalize your collaboration with clinical documentation specialists (CDSs). That’s what has worked at two medical centers where hospitalists teamed up with CDSs to improve their hospitals’ claims processes.

At Northwestern Memorial Hospital in Chicago, the hematology/oncology service was selected for a pilot program to focus on improving expected mortality rates. The specialists needed to ensure that coded data sent to state- and hospital-associated databases (as well as payor claims, such as those submitted to Medicare) accurately represented the severity of patients’ conditions upon admission. To do that, they needed buy-in from hospitalists to make their notes as complete as possible.

Hospitalists usually encounter CDSs anonymously, through an electronic query in the electronic health record (EHR). Kristine Green, RN, a CDS, quality leader, and interim manager at Northwestern’s clinical documentation program, approached hospitalist Charlotta Weaver, MD, medical director of the oncology HM service and a clinical instructor at Northwestern University’s Feinberg School of Medicine. Green suggested she shadow Dr. Weaver on rounds.

“We had implemented this technique in a couple of our other service lines, with good results,” Green says. She compared her notes on patient visits with Dr. Weaver’s notes and was able to catch conditions that were being undercoded. They generated a list, now posted in the work room, disseminated via email, and included in the orientation binder, of frequently missed coding diagnoses.

For example, Dr. Weaver explains, “instead of writing ‘AKI-obstructive,’ we now write ‘AKI due to ureteral obstruction from peritoneal carcinomatosis from metastatic gastric cancer.’ ”

Such specificity in physicians’ notes translates to a more accurate level of billing for the hospital and a more accurate reflection of patients’ acuity in comparative databases. With Dr. Weaver paving the way, Green has forged “a nice rapport” with the other hospitalists in the oncology medicine service.

Audiences for Your Notes

CDS and hospitalists might initially view notes differently. Most physicians train in programs where the “primary intent of a note” is to communicate to the rest of the medical team what’s happening with the patient, Dr. Weaver says.

Listen to The Hospitalist's interview with Dr. Tsomides discussing billing and coding improvements available to your HM program.

“When we train, we’re always thinking about communicating with each other,” says Theodore (Ted) Tsomides, MD, PhD, an attending physician on the hospital medicine service at WakeMed Hospital and assistant professor of medicine at the University of North Carolina’s School of Medicine in Raleigh. “But as we get into the system, we realize that there are a lot of eyes on those documents. And whether we think about it or not, those are all our different audiences.”

Once hospitalists develop confidence and comfort on the job, Dr. Tsomides says, they can move on to aligning themselves with the hospital’s interests. Dr. Weaver thinks hospitalists are uniquely positioned to help champion the CDI efforts. “We’re here to improve the mission of the hospital,” she says.

As physician liaison for quality programs, Dr. Tsomides began working on clinical documentation improvement. He became a resource for the department, and then worked to achieve a financial incentive plan for hospital physicians when their documentation improved. He’s also been pushing his institution to make the documentation process easier by using electronic queries, and by introducing residents to the “real world” of clinical documentation in their curriculum. (Click here to listen to more of Dr. Tsomides’ ideas to improve clinical documentation.)

He advises hospitalists meet their clinical documentation specialists face to face. “Once you know there are people who are doing their part, and have a relationship with them, you approach the whole problem differently,” Dr. Tsomides says, “as opposed to [viewing them] as anonymous reviewers breathing down your neck and giving you yet another thing to worry about.”

Gretchen Henkel is a freelance writer based in California.

Final results from the National Lung Screening Trial show a significant reduction in lung cancer mortality with the use of annual low-dose CT screening, compared with standard chest x-rays among former heavy smokers at high risk for lung cancer.

Low-dose CT screening led to a relative reduction of 20% in the rate of death from lung cancer, according to findings released online by the New England Journal of Medicine on June 29 (doi: 10.1056/NEJMoa1102873).The number needed to screen with low-dose CT to prevent one death from lung cancer was 320.

Although preliminary study results were announced in November 2010, the article by the National Lung Screening Trial (NLST) research team marks the first time that the results appear in a peer-reviewed journal. Acknowledging that the earlier announcement has led to calls for lung cancer screening, the authors urge rigorous analysis of cost-effectiveness before public policy recommendations are made.

"The reduction in lung-cancer mortality must be weighed against the harms from positive screening results and overdiagnosis, as well as the costs," they wrote.

In the study, 53,454 men and women aged 55-74 years – who were current or former smokers with a smoking history of at least 30 pack-years – were recruited at 33 U.S. medical centers. A total of 26,722 participants were randomized to receive three annual screens with low-dose helical CT; 26,732 were randomized to three annual screens using chest x-ray. The two groups were virtually identical in demographics and smoking history.

In all three screening rounds, positive screening tests were substantially more common in the low-dose CT group than in the radiography group (27.3% vs. 9.2% in the first round; 27.9% vs. 6.2% in the second; and 16.8% vs. 5% in the third). All told, 39.1% of the CT group and 16% of the radiography group had at least one positive result.

The percentage of screening tests that identified a clinically significant abnormality -- other than an abnormality suspicious for lung cancer – also was more than three times as high in the low-dose CT group as in the radiography group (7.5% vs. 2.1%).

More than 90% of positive screenings in the first round of the study led to a diagnostic evaluation, though the follow-up rates were lower in the later rounds. Diagnostic evaluation most often consisted of additional imaging with invasive procedures being performed infrequently.

Across the three screenings, most of the positive results were false positives – 96.4% in the CT group and 94.5% in the radiography group. Of the total number of low-dose CT screening tests, 24.2% were classified as positive and 23.4% had false-positive results; of the total number of radiographic screening tests, 6.9% were classified as positive and 6.5% were false-positive results.

In all, 1,060 lung cancers were diagnosed in the low-dose CT group (645/100,000 person-years) vs. 941 in the radiography group (572/100,000 person-years). Of these cancers, 649 in the low-dose CT group were diagnosed after a positive screening test and 44 were diagnosed after a negative screening test. In the radiography group, 279 cancers were diagnosed after a positive screening test and 137 were diagnosed after a negative screening test.

In both groups, the remaining cases were among participants who missed screening or were diagnosed after their trial screening phase was over

Analysis of lung cancer-specific mortality showed that in the CT group 356 lung cancer deaths occurred after 144,103 person-years; in the radiography group 443 lung cancer deaths occurred after 143,368 person-years. This corresponded to 247 and 309 lung cancer deaths, respectively, per 100,000 person-years in the CT and radiography groups.

There were 1,877 and 2,000 deaths from all causes in the CT and radiography groups, respectively, "representing a significant reduction with low-dose CT screening of 6.7% ... in the rate of death from any cause," the investigators wrote. While lung cancer accounted for 24.1% of all the deaths in the trial, 60.3% of the excess deaths in the radiography group were due to lung cancer.

The authors concluded that "although some agencies and organizations are contemplating the establishment of lung-cancer screening recommendations on the basis of the findings of the NLST, the current NLST data alone are, in our opinion, insufficient to fully inform such important decisions."

They noted that "The observation that low-dose CT screening can reduce the rate of death from lung cancer has generated many questions." Among these they listed: Will populations with different risk profiles benefit from screening? Could less frequent screening programs be equally effective? Would the use of different criteria for a positive screening result translate to similar benefit? For how long should people be screened?

In an accompanying editorial, Dr. Harold C. Sox, professor of medicine at the Dartmouth Institute in Hanover, N. H., agreed with the investigators’ reservations. In particular, the cost effectiveness of low-dose CT screening for lung cancer must be analyzed, he said: "Policy makers should wait for cost-effectiveness analyses to determine the amount of overdiagnosis in the NLST, and, perhaps identification of biologic markers of cancers that do not progress."

In addition, "it may be possible to define subgroups of smokers who are at higher or lower risk for lung cancer and tailor the screening strategy accordingly," he said. "The findings of the NLST regarding lung-cancer mortality signal the beginning of the end of one era of research on lung-cancer screening and the start of another. The focus will shift to informing the difficult patient-centered and policy decisions that are yet to come."

Dr. Sox also noted that "overdiagnosis is a problem because predicting which early-stage cancers will not progress is in an early stage of development, so that everyone with screen-detected cancer receives treatment that some do not need," he wrote in an accompanying editorial (doi: 10.1056/NEJME1103776).

All but two of the NLST study authors reported that they have no relevant financial relationships. Jonathan D. Clap reported having financial interest in Human Genome Sciences. Constantine Gatsonis, Ph.D., is a consultant for Wilex AG, Mela Sciences, and Endocyte Inc., has received speaker fees from Bayer Health and payment for education development by the Radiologic Society of North America. He also has invested in the Vanguard Health Fund. Dr. Sox had no conflicts.

Final results from the National Lung Screening Trial show a significant reduction in lung cancer mortality with the use of annual low-dose CT screening, compared with standard chest x-rays among former heavy smokers at high risk for lung cancer.

Low-dose CT screening led to a relative reduction of 20% in the rate of death from lung cancer, according to findings released online by the New England Journal of Medicine on June 29 (doi: 10.1056/NEJMoa1102873).The number needed to screen with low-dose CT to prevent one death from lung cancer was 320.

Although preliminary study results were announced in November 2010, the article by the National Lung Screening Trial (NLST) research team marks the first time that the results appear in a peer-reviewed journal. Acknowledging that the earlier announcement has led to calls for lung cancer screening, the authors urge rigorous analysis of cost-effectiveness before public policy recommendations are made.

"The reduction in lung-cancer mortality must be weighed against the harms from positive screening results and overdiagnosis, as well as the costs," they wrote.

In the study, 53,454 men and women aged 55-74 years – who were current or former smokers with a smoking history of at least 30 pack-years – were recruited at 33 U.S. medical centers. A total of 26,722 participants were randomized to receive three annual screens with low-dose helical CT; 26,732 were randomized to three annual screens using chest x-ray. The two groups were virtually identical in demographics and smoking history.

In all three screening rounds, positive screening tests were substantially more common in the low-dose CT group than in the radiography group (27.3% vs. 9.2% in the first round; 27.9% vs. 6.2% in the second; and 16.8% vs. 5% in the third). All told, 39.1% of the CT group and 16% of the radiography group had at least one positive result.

The percentage of screening tests that identified a clinically significant abnormality -- other than an abnormality suspicious for lung cancer – also was more than three times as high in the low-dose CT group as in the radiography group (7.5% vs. 2.1%).

More than 90% of positive screenings in the first round of the study led to a diagnostic evaluation, though the follow-up rates were lower in the later rounds. Diagnostic evaluation most often consisted of additional imaging with invasive procedures being performed infrequently.

Across the three screenings, most of the positive results were false positives – 96.4% in the CT group and 94.5% in the radiography group. Of the total number of low-dose CT screening tests, 24.2% were classified as positive and 23.4% had false-positive results; of the total number of radiographic screening tests, 6.9% were classified as positive and 6.5% were false-positive results.

In all, 1,060 lung cancers were diagnosed in the low-dose CT group (645/100,000 person-years) vs. 941 in the radiography group (572/100,000 person-years). Of these cancers, 649 in the low-dose CT group were diagnosed after a positive screening test and 44 were diagnosed after a negative screening test. In the radiography group, 279 cancers were diagnosed after a positive screening test and 137 were diagnosed after a negative screening test.

In both groups, the remaining cases were among participants who missed screening or were diagnosed after their trial screening phase was over

Analysis of lung cancer-specific mortality showed that in the CT group 356 lung cancer deaths occurred after 144,103 person-years; in the radiography group 443 lung cancer deaths occurred after 143,368 person-years. This corresponded to 247 and 309 lung cancer deaths, respectively, per 100,000 person-years in the CT and radiography groups.

There were 1,877 and 2,000 deaths from all causes in the CT and radiography groups, respectively, "representing a significant reduction with low-dose CT screening of 6.7% ... in the rate of death from any cause," the investigators wrote. While lung cancer accounted for 24.1% of all the deaths in the trial, 60.3% of the excess deaths in the radiography group were due to lung cancer.

The authors concluded that "although some agencies and organizations are contemplating the establishment of lung-cancer screening recommendations on the basis of the findings of the NLST, the current NLST data alone are, in our opinion, insufficient to fully inform such important decisions."

They noted that "The observation that low-dose CT screening can reduce the rate of death from lung cancer has generated many questions." Among these they listed: Will populations with different risk profiles benefit from screening? Could less frequent screening programs be equally effective? Would the use of different criteria for a positive screening result translate to similar benefit? For how long should people be screened?

In an accompanying editorial, Dr. Harold C. Sox, professor of medicine at the Dartmouth Institute in Hanover, N. H., agreed with the investigators’ reservations. In particular, the cost effectiveness of low-dose CT screening for lung cancer must be analyzed, he said: "Policy makers should wait for cost-effectiveness analyses to determine the amount of overdiagnosis in the NLST, and, perhaps identification of biologic markers of cancers that do not progress."

In addition, "it may be possible to define subgroups of smokers who are at higher or lower risk for lung cancer and tailor the screening strategy accordingly," he said. "The findings of the NLST regarding lung-cancer mortality signal the beginning of the end of one era of research on lung-cancer screening and the start of another. The focus will shift to informing the difficult patient-centered and policy decisions that are yet to come."

Dr. Sox also noted that "overdiagnosis is a problem because predicting which early-stage cancers will not progress is in an early stage of development, so that everyone with screen-detected cancer receives treatment that some do not need," he wrote in an accompanying editorial (doi: 10.1056/NEJME1103776).

All but two of the NLST study authors reported that they have no relevant financial relationships. Jonathan D. Clap reported having financial interest in Human Genome Sciences. Constantine Gatsonis, Ph.D., is a consultant for Wilex AG, Mela Sciences, and Endocyte Inc., has received speaker fees from Bayer Health and payment for education development by the Radiologic Society of North America. He also has invested in the Vanguard Health Fund. Dr. Sox had no conflicts.

Final results from the National Lung Screening Trial show a significant reduction in lung cancer mortality with the use of annual low-dose CT screening, compared with standard chest x-rays among former heavy smokers at high risk for lung cancer.

Low-dose CT screening led to a relative reduction of 20% in the rate of death from lung cancer, according to findings released online by the New England Journal of Medicine on June 29 (doi: 10.1056/NEJMoa1102873).The number needed to screen with low-dose CT to prevent one death from lung cancer was 320.

Although preliminary study results were announced in November 2010, the article by the National Lung Screening Trial (NLST) research team marks the first time that the results appear in a peer-reviewed journal. Acknowledging that the earlier announcement has led to calls for lung cancer screening, the authors urge rigorous analysis of cost-effectiveness before public policy recommendations are made.

"The reduction in lung-cancer mortality must be weighed against the harms from positive screening results and overdiagnosis, as well as the costs," they wrote.

In the study, 53,454 men and women aged 55-74 years – who were current or former smokers with a smoking history of at least 30 pack-years – were recruited at 33 U.S. medical centers. A total of 26,722 participants were randomized to receive three annual screens with low-dose helical CT; 26,732 were randomized to three annual screens using chest x-ray. The two groups were virtually identical in demographics and smoking history.

In all three screening rounds, positive screening tests were substantially more common in the low-dose CT group than in the radiography group (27.3% vs. 9.2% in the first round; 27.9% vs. 6.2% in the second; and 16.8% vs. 5% in the third). All told, 39.1% of the CT group and 16% of the radiography group had at least one positive result.

The percentage of screening tests that identified a clinically significant abnormality -- other than an abnormality suspicious for lung cancer – also was more than three times as high in the low-dose CT group as in the radiography group (7.5% vs. 2.1%).

More than 90% of positive screenings in the first round of the study led to a diagnostic evaluation, though the follow-up rates were lower in the later rounds. Diagnostic evaluation most often consisted of additional imaging with invasive procedures being performed infrequently.

Across the three screenings, most of the positive results were false positives – 96.4% in the CT group and 94.5% in the radiography group. Of the total number of low-dose CT screening tests, 24.2% were classified as positive and 23.4% had false-positive results; of the total number of radiographic screening tests, 6.9% were classified as positive and 6.5% were false-positive results.

In all, 1,060 lung cancers were diagnosed in the low-dose CT group (645/100,000 person-years) vs. 941 in the radiography group (572/100,000 person-years). Of these cancers, 649 in the low-dose CT group were diagnosed after a positive screening test and 44 were diagnosed after a negative screening test. In the radiography group, 279 cancers were diagnosed after a positive screening test and 137 were diagnosed after a negative screening test.

In both groups, the remaining cases were among participants who missed screening or were diagnosed after their trial screening phase was over

Analysis of lung cancer-specific mortality showed that in the CT group 356 lung cancer deaths occurred after 144,103 person-years; in the radiography group 443 lung cancer deaths occurred after 143,368 person-years. This corresponded to 247 and 309 lung cancer deaths, respectively, per 100,000 person-years in the CT and radiography groups.

There were 1,877 and 2,000 deaths from all causes in the CT and radiography groups, respectively, "representing a significant reduction with low-dose CT screening of 6.7% ... in the rate of death from any cause," the investigators wrote. While lung cancer accounted for 24.1% of all the deaths in the trial, 60.3% of the excess deaths in the radiography group were due to lung cancer.

The authors concluded that "although some agencies and organizations are contemplating the establishment of lung-cancer screening recommendations on the basis of the findings of the NLST, the current NLST data alone are, in our opinion, insufficient to fully inform such important decisions."

They noted that "The observation that low-dose CT screening can reduce the rate of death from lung cancer has generated many questions." Among these they listed: Will populations with different risk profiles benefit from screening? Could less frequent screening programs be equally effective? Would the use of different criteria for a positive screening result translate to similar benefit? For how long should people be screened?

In an accompanying editorial, Dr. Harold C. Sox, professor of medicine at the Dartmouth Institute in Hanover, N. H., agreed with the investigators’ reservations. In particular, the cost effectiveness of low-dose CT screening for lung cancer must be analyzed, he said: "Policy makers should wait for cost-effectiveness analyses to determine the amount of overdiagnosis in the NLST, and, perhaps identification of biologic markers of cancers that do not progress."

In addition, "it may be possible to define subgroups of smokers who are at higher or lower risk for lung cancer and tailor the screening strategy accordingly," he said. "The findings of the NLST regarding lung-cancer mortality signal the beginning of the end of one era of research on lung-cancer screening and the start of another. The focus will shift to informing the difficult patient-centered and policy decisions that are yet to come."

Dr. Sox also noted that "overdiagnosis is a problem because predicting which early-stage cancers will not progress is in an early stage of development, so that everyone with screen-detected cancer receives treatment that some do not need," he wrote in an accompanying editorial (doi: 10.1056/NEJME1103776).

All but two of the NLST study authors reported that they have no relevant financial relationships. Jonathan D. Clap reported having financial interest in Human Genome Sciences. Constantine Gatsonis, Ph.D., is a consultant for Wilex AG, Mela Sciences, and Endocyte Inc., has received speaker fees from Bayer Health and payment for education development by the Radiologic Society of North America. He also has invested in the Vanguard Health Fund. Dr. Sox had no conflicts.

A quickly-scuttled plan by the Department of Health and Human Services (HHS) to use "mystery shoppers" to test the availability of primary-care physicians (PCPs) would likely never be extended to HM—but the federal tack has certainly touched a nerve with some practitioners. (Ed note: updated June 29, 2011)

"Using surrogate patients or a sneaky way to get the data feels a bit less straightforward," says James Levy, PA-C, vice president of personnel for Traverse City-based Hospitalists of Northern Michigan. "If I were the government, I'm sure it would occur to me to do it that way. Nobody is going to be comfortable with surreptitious observations. That would seem to carry the message that the government doesn’t trust the providers it's reimbursing."

The government proposed using people pretending to be patients, both insured and uninsured, to gauge how long it takes to get PCP appointments. The action was proposed in the April 28 Federal Register. Comments were solicited, but negative feedback prompted HHS to drop the plan in a June 29 announcement.

Levy and David Friar, MD, CEO of Northern Hospitalists, say that the logistics of hospital admission make it near impossible for the government to have anybody pose as something they're not. Still, in an email, Dr. Friar adds that, aside from "philosophical indignation," he would likely not object should HHS try a similar tack with hospitalist groups.

"In essence, every patient that sees a hospitalist is a mystery patient," he writes. "We don't control who comes in, or what their diagnosis is or when they'll arrive. We have little control over any of those things. Since payors are collecting data on every aspect of hospitalists’ performance, and what they aren't, the hospitals we work for are, we have little left to hide."

A quickly-scuttled plan by the Department of Health and Human Services (HHS) to use "mystery shoppers" to test the availability of primary-care physicians (PCPs) would likely never be extended to HM—but the federal tack has certainly touched a nerve with some practitioners. (Ed note: updated June 29, 2011)

"Using surrogate patients or a sneaky way to get the data feels a bit less straightforward," says James Levy, PA-C, vice president of personnel for Traverse City-based Hospitalists of Northern Michigan. "If I were the government, I'm sure it would occur to me to do it that way. Nobody is going to be comfortable with surreptitious observations. That would seem to carry the message that the government doesn’t trust the providers it's reimbursing."

The government proposed using people pretending to be patients, both insured and uninsured, to gauge how long it takes to get PCP appointments. The action was proposed in the April 28 Federal Register. Comments were solicited, but negative feedback prompted HHS to drop the plan in a June 29 announcement.

Levy and David Friar, MD, CEO of Northern Hospitalists, say that the logistics of hospital admission make it near impossible for the government to have anybody pose as something they're not. Still, in an email, Dr. Friar adds that, aside from "philosophical indignation," he would likely not object should HHS try a similar tack with hospitalist groups.

"In essence, every patient that sees a hospitalist is a mystery patient," he writes. "We don't control who comes in, or what their diagnosis is or when they'll arrive. We have little control over any of those things. Since payors are collecting data on every aspect of hospitalists’ performance, and what they aren't, the hospitals we work for are, we have little left to hide."

A quickly-scuttled plan by the Department of Health and Human Services (HHS) to use "mystery shoppers" to test the availability of primary-care physicians (PCPs) would likely never be extended to HM—but the federal tack has certainly touched a nerve with some practitioners. (Ed note: updated June 29, 2011)

"Using surrogate patients or a sneaky way to get the data feels a bit less straightforward," says James Levy, PA-C, vice president of personnel for Traverse City-based Hospitalists of Northern Michigan. "If I were the government, I'm sure it would occur to me to do it that way. Nobody is going to be comfortable with surreptitious observations. That would seem to carry the message that the government doesn’t trust the providers it's reimbursing."

The government proposed using people pretending to be patients, both insured and uninsured, to gauge how long it takes to get PCP appointments. The action was proposed in the April 28 Federal Register. Comments were solicited, but negative feedback prompted HHS to drop the plan in a June 29 announcement.

Levy and David Friar, MD, CEO of Northern Hospitalists, say that the logistics of hospital admission make it near impossible for the government to have anybody pose as something they're not. Still, in an email, Dr. Friar adds that, aside from "philosophical indignation," he would likely not object should HHS try a similar tack with hospitalist groups.

"In essence, every patient that sees a hospitalist is a mystery patient," he writes. "We don't control who comes in, or what their diagnosis is or when they'll arrive. We have little control over any of those things. Since payors are collecting data on every aspect of hospitalists’ performance, and what they aren't, the hospitals we work for are, we have little left to hide."

The Quality Institute of the Ohio Hospital Association (OHA) recently launched its fifth regional quality collaborative in the state, bringing together hospital administrators, physicians, and other clinicians to tackle statewide goals of reducing infections, readmissions, and adverse events while increasing patient satisfaction. A hospitalist involved in the initiative says it sets an example for other states to follow.

"Hospitalists are on the front lines of quality," says Craig Cairns, MD, MPH, a hospitalist and vice president of medical affairs at Licking Memorial Health Systems in Newark, Ohio. "But it helps to get a statewide or regional group together to share problems and potential solutions."

Licking Memorial, for example, participates in OHA's statewide quality initiatives, including one on physician handwashing and STAAR (State Action on Avoidable Rehospitalizations), a multistate care-transitions initiative developed by the Institute for Healthcare Improvement.

Licking has set a goal of reducing its readmission rate to 10.5%, Dr. Cairns says. "Trying to get the patient back to the primary medical home as quickly as possible can be difficult," he adds. "We work with support people at medical offices to try to ensure a spot for our patients going home."

Because one of the risk factors for preventable rehospitalizations is heart failure, Licking also recently instituted a heart-failure clinic, staffed by two hospital cardiologists.

The first of the regional collaborations started in the Dayton area in 1998, according to David Engler, PhD, vice president of OHA's Quality Institute. The collaborative has posted a 36% reduction in heart-attack mortality over the past three years, the equivalent of 52 lives saved.

"We were brought in to help them on a specific issue: a higher-than-expected acute myocardial infarction mortality rate," Dr. Engler says. "We held collaborative meetings, developed risk management models, and began to track data across sites." Peer-review protocols developed by OHA make it possible to share quality data among the participating hospitals, with participants agreeing not to use these for marketing or competitive advantage.

A total of 133 hospitals participate in one of OHA's regional or statewide quality collaborations.

The Quality Institute of the Ohio Hospital Association (OHA) recently launched its fifth regional quality collaborative in the state, bringing together hospital administrators, physicians, and other clinicians to tackle statewide goals of reducing infections, readmissions, and adverse events while increasing patient satisfaction. A hospitalist involved in the initiative says it sets an example for other states to follow.

"Hospitalists are on the front lines of quality," says Craig Cairns, MD, MPH, a hospitalist and vice president of medical affairs at Licking Memorial Health Systems in Newark, Ohio. "But it helps to get a statewide or regional group together to share problems and potential solutions."

Licking Memorial, for example, participates in OHA's statewide quality initiatives, including one on physician handwashing and STAAR (State Action on Avoidable Rehospitalizations), a multistate care-transitions initiative developed by the Institute for Healthcare Improvement.

Licking has set a goal of reducing its readmission rate to 10.5%, Dr. Cairns says. "Trying to get the patient back to the primary medical home as quickly as possible can be difficult," he adds. "We work with support people at medical offices to try to ensure a spot for our patients going home."

Because one of the risk factors for preventable rehospitalizations is heart failure, Licking also recently instituted a heart-failure clinic, staffed by two hospital cardiologists.

The first of the regional collaborations started in the Dayton area in 1998, according to David Engler, PhD, vice president of OHA's Quality Institute. The collaborative has posted a 36% reduction in heart-attack mortality over the past three years, the equivalent of 52 lives saved.

"We were brought in to help them on a specific issue: a higher-than-expected acute myocardial infarction mortality rate," Dr. Engler says. "We held collaborative meetings, developed risk management models, and began to track data across sites." Peer-review protocols developed by OHA make it possible to share quality data among the participating hospitals, with participants agreeing not to use these for marketing or competitive advantage.

A total of 133 hospitals participate in one of OHA's regional or statewide quality collaborations.

The Quality Institute of the Ohio Hospital Association (OHA) recently launched its fifth regional quality collaborative in the state, bringing together hospital administrators, physicians, and other clinicians to tackle statewide goals of reducing infections, readmissions, and adverse events while increasing patient satisfaction. A hospitalist involved in the initiative says it sets an example for other states to follow.

"Hospitalists are on the front lines of quality," says Craig Cairns, MD, MPH, a hospitalist and vice president of medical affairs at Licking Memorial Health Systems in Newark, Ohio. "But it helps to get a statewide or regional group together to share problems and potential solutions."

Licking Memorial, for example, participates in OHA's statewide quality initiatives, including one on physician handwashing and STAAR (State Action on Avoidable Rehospitalizations), a multistate care-transitions initiative developed by the Institute for Healthcare Improvement.

Licking has set a goal of reducing its readmission rate to 10.5%, Dr. Cairns says. "Trying to get the patient back to the primary medical home as quickly as possible can be difficult," he adds. "We work with support people at medical offices to try to ensure a spot for our patients going home."

Because one of the risk factors for preventable rehospitalizations is heart failure, Licking also recently instituted a heart-failure clinic, staffed by two hospital cardiologists.

The first of the regional collaborations started in the Dayton area in 1998, according to David Engler, PhD, vice president of OHA's Quality Institute. The collaborative has posted a 36% reduction in heart-attack mortality over the past three years, the equivalent of 52 lives saved.

"We were brought in to help them on a specific issue: a higher-than-expected acute myocardial infarction mortality rate," Dr. Engler says. "We held collaborative meetings, developed risk management models, and began to track data across sites." Peer-review protocols developed by OHA make it possible to share quality data among the participating hospitals, with participants agreeing not to use these for marketing or competitive advantage.

A total of 133 hospitals participate in one of OHA's regional or statewide quality collaborations.

BOCA RATON, FLA. – Coexisting subspecialty fellowship programs have at most only minimal adverse impact on general surgery residency training operative volumes, according to a national study sponsored by the American Board of Surgery.

The analysis also demonstrated that fellowship-bound general surgery residents tend to select additional cases in their chosen future subspecialty, thereby in effect creating a self-directed early tracking program, Dr. John B. Hanks said at the annual meeting of the American Surgical Association.

The American Board of Surgery (ABS) conducted the study in response to concerns that because 80% of general surgery residents pursue fellowship training, an insufficient number of cases could be available for resident training. But the national data indicate that this is not a problem, according to Dr. Hanks, professor and chief of general surgery at the University of Virginia, Charlottesville.

The study entailed detailed analysis of the operative logs of 976 applicants to the 2009 ABS qualifying exam. The applicants came from 246 general surgery residency programs. In all, 97 of these residency programs coexisted with a vascular surgery fellowship program, 35 with a colorectal surgery fellowship program, 80 with a minimally invasive surgery training program, and 12 with an endocrine surgery fellowship program. The investigators scrutinized case volumes for predefined key operations in the areas of vascular, colorectal, endocrine, and minimally invasive surgery (MIS).

Residents bound for fellowships in vascular, colorectal, and endocrine surgery performed significantly more total cases in each of those areas than did general surgery residents who were not bound for fellowships. For example, operative logs for the 90 vascular surgery fellowship–bound residents showed a mean experience of 165 vascular cases, compared with 123 cases for the other general surgery residents. And residents headed for colorectal surgery fellowships had a mean of 204 colorectal surgery cases, compared with 163 for all other general surgery residents.

In contrast, residents who were headed for an MIS fellowship and those who were not averaged a similar number of minimally invasive operations.

With regard to the effect of coexisting fellowship programs on general surgery residents’ operative experience in those specific areas, there was a negative impact only for MIS. Residents in general surgery training programs with a coexisting MIS fellowship averaged about 10% fewer MIS cases than did residents in institutions without a fellowship.

"That difference reaches statistical significance, although the practical significance of this effect may be open for debate," Dr. Hanks observed.

The situation was different for residents at institutions with coexisting colorectal or vascular surgery fellowships; those fellowships had no impact on general surgery residents’ case volumes in those specialty-specific areas. And the presence of a coexisting endocrine surgery fellowship was actually associated with a significant increase in endocrine surgery case volumes for all residents, he continued.

Discussant Dr. Layton F. Rikkers cautioned that the ABS study describes national trends using broad strokes, and the data don’t necessarily apply to any individual residency program.

"As an example, the only fellowship we developed at the University of Wisconsin, Madison, during the time I was chairman there was a vascular surgery fellowship," said Dr. Rikkers, professor of surgery at the university and past president of the ABS. "The year prior to developing the fellowship, our residents were in the 93rd percentile nationally with respect to vascular surgery cases done. Over the many years since that fellowship was established, our residents are in the 10th to 20th percentile for vascular surgery cases."

Dr. Hanks declared having no financial conflict of interest.

BOCA RATON, FLA. – Coexisting subspecialty fellowship programs have at most only minimal adverse impact on general surgery residency training operative volumes, according to a national study sponsored by the American Board of Surgery.

The analysis also demonstrated that fellowship-bound general surgery residents tend to select additional cases in their chosen future subspecialty, thereby in effect creating a self-directed early tracking program, Dr. John B. Hanks said at the annual meeting of the American Surgical Association.

The American Board of Surgery (ABS) conducted the study in response to concerns that because 80% of general surgery residents pursue fellowship training, an insufficient number of cases could be available for resident training. But the national data indicate that this is not a problem, according to Dr. Hanks, professor and chief of general surgery at the University of Virginia, Charlottesville.

The study entailed detailed analysis of the operative logs of 976 applicants to the 2009 ABS qualifying exam. The applicants came from 246 general surgery residency programs. In all, 97 of these residency programs coexisted with a vascular surgery fellowship program, 35 with a colorectal surgery fellowship program, 80 with a minimally invasive surgery training program, and 12 with an endocrine surgery fellowship program. The investigators scrutinized case volumes for predefined key operations in the areas of vascular, colorectal, endocrine, and minimally invasive surgery (MIS).

Residents bound for fellowships in vascular, colorectal, and endocrine surgery performed significantly more total cases in each of those areas than did general surgery residents who were not bound for fellowships. For example, operative logs for the 90 vascular surgery fellowship–bound residents showed a mean experience of 165 vascular cases, compared with 123 cases for the other general surgery residents. And residents headed for colorectal surgery fellowships had a mean of 204 colorectal surgery cases, compared with 163 for all other general surgery residents.

In contrast, residents who were headed for an MIS fellowship and those who were not averaged a similar number of minimally invasive operations.

With regard to the effect of coexisting fellowship programs on general surgery residents’ operative experience in those specific areas, there was a negative impact only for MIS. Residents in general surgery training programs with a coexisting MIS fellowship averaged about 10% fewer MIS cases than did residents in institutions without a fellowship.

"That difference reaches statistical significance, although the practical significance of this effect may be open for debate," Dr. Hanks observed.

The situation was different for residents at institutions with coexisting colorectal or vascular surgery fellowships; those fellowships had no impact on general surgery residents’ case volumes in those specialty-specific areas. And the presence of a coexisting endocrine surgery fellowship was actually associated with a significant increase in endocrine surgery case volumes for all residents, he continued.

Discussant Dr. Layton F. Rikkers cautioned that the ABS study describes national trends using broad strokes, and the data don’t necessarily apply to any individual residency program.

"As an example, the only fellowship we developed at the University of Wisconsin, Madison, during the time I was chairman there was a vascular surgery fellowship," said Dr. Rikkers, professor of surgery at the university and past president of the ABS. "The year prior to developing the fellowship, our residents were in the 93rd percentile nationally with respect to vascular surgery cases done. Over the many years since that fellowship was established, our residents are in the 10th to 20th percentile for vascular surgery cases."

Dr. Hanks declared having no financial conflict of interest.

BOCA RATON, FLA. – Coexisting subspecialty fellowship programs have at most only minimal adverse impact on general surgery residency training operative volumes, according to a national study sponsored by the American Board of Surgery.

The analysis also demonstrated that fellowship-bound general surgery residents tend to select additional cases in their chosen future subspecialty, thereby in effect creating a self-directed early tracking program, Dr. John B. Hanks said at the annual meeting of the American Surgical Association.

The American Board of Surgery (ABS) conducted the study in response to concerns that because 80% of general surgery residents pursue fellowship training, an insufficient number of cases could be available for resident training. But the national data indicate that this is not a problem, according to Dr. Hanks, professor and chief of general surgery at the University of Virginia, Charlottesville.

The study entailed detailed analysis of the operative logs of 976 applicants to the 2009 ABS qualifying exam. The applicants came from 246 general surgery residency programs. In all, 97 of these residency programs coexisted with a vascular surgery fellowship program, 35 with a colorectal surgery fellowship program, 80 with a minimally invasive surgery training program, and 12 with an endocrine surgery fellowship program. The investigators scrutinized case volumes for predefined key operations in the areas of vascular, colorectal, endocrine, and minimally invasive surgery (MIS).

Residents bound for fellowships in vascular, colorectal, and endocrine surgery performed significantly more total cases in each of those areas than did general surgery residents who were not bound for fellowships. For example, operative logs for the 90 vascular surgery fellowship–bound residents showed a mean experience of 165 vascular cases, compared with 123 cases for the other general surgery residents. And residents headed for colorectal surgery fellowships had a mean of 204 colorectal surgery cases, compared with 163 for all other general surgery residents.

In contrast, residents who were headed for an MIS fellowship and those who were not averaged a similar number of minimally invasive operations.

With regard to the effect of coexisting fellowship programs on general surgery residents’ operative experience in those specific areas, there was a negative impact only for MIS. Residents in general surgery training programs with a coexisting MIS fellowship averaged about 10% fewer MIS cases than did residents in institutions without a fellowship.

"That difference reaches statistical significance, although the practical significance of this effect may be open for debate," Dr. Hanks observed.

The situation was different for residents at institutions with coexisting colorectal or vascular surgery fellowships; those fellowships had no impact on general surgery residents’ case volumes in those specialty-specific areas. And the presence of a coexisting endocrine surgery fellowship was actually associated with a significant increase in endocrine surgery case volumes for all residents, he continued.

Discussant Dr. Layton F. Rikkers cautioned that the ABS study describes national trends using broad strokes, and the data don’t necessarily apply to any individual residency program.

"As an example, the only fellowship we developed at the University of Wisconsin, Madison, during the time I was chairman there was a vascular surgery fellowship," said Dr. Rikkers, professor of surgery at the university and past president of the ABS. "The year prior to developing the fellowship, our residents were in the 93rd percentile nationally with respect to vascular surgery cases done. Over the many years since that fellowship was established, our residents are in the 10th to 20th percentile for vascular surgery cases."

Dr. Hanks declared having no financial conflict of interest.

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Two new drug therapies to treat chronic hepatitis C (HCV) are the first new options for hospitalists in 20 years. But freedom of choice doesn't come cheap.

Telaprevir, from Vertex Pharmaceuticals, will cost $49,200 for a 12-week regimen, while boceprevir, from Merck & Co., will cost from $26,400 to $48,000 for regimens of 24 and 48 weeks, respectively, Reuters reports. Telaprevir will go by the brand name Incivek, while boceprevir is known as Victrelis.

"The price is expensive," but financial support for some patients is expected early on, says Satya Chelamkuri, MD, a hospitalist with Cogent Healthcare at Allegiance Health in Jackson, Mich. "When the generic comes out, it will be a great help to patients with hepatitis C. Cost is a worry, but with help from pharmaceutical companies, the majority of the patients who need it will hopefully get the treatment."

Still, Dr. Chelamkuri expects the drugs to appear relatively quickly on hospital formularies, in large part because of the efficacy they showed in trials. The standard treatment for years, a cocktail of peginterferon-alpha and ribavirin, has a roughly 50% response rate. Both of the new treatments, which have been formally approved by the FDA in the past six weeks, boost the cure rates to a range of 66% to 80% by working in tandem with the current therapy.

"A less than 50% [response rate] for the previous regime and around 70% for the new regime. That’s a considerable difference," Dr. Chelamkuri says.

Two new drug therapies to treat chronic hepatitis C (HCV) are the first new options for hospitalists in 20 years. But freedom of choice doesn't come cheap.

Telaprevir, from Vertex Pharmaceuticals, will cost $49,200 for a 12-week regimen, while boceprevir, from Merck & Co., will cost from $26,400 to $48,000 for regimens of 24 and 48 weeks, respectively, Reuters reports. Telaprevir will go by the brand name Incivek, while boceprevir is known as Victrelis.

"The price is expensive," but financial support for some patients is expected early on, says Satya Chelamkuri, MD, a hospitalist with Cogent Healthcare at Allegiance Health in Jackson, Mich. "When the generic comes out, it will be a great help to patients with hepatitis C. Cost is a worry, but with help from pharmaceutical companies, the majority of the patients who need it will hopefully get the treatment."

Still, Dr. Chelamkuri expects the drugs to appear relatively quickly on hospital formularies, in large part because of the efficacy they showed in trials. The standard treatment for years, a cocktail of peginterferon-alpha and ribavirin, has a roughly 50% response rate. Both of the new treatments, which have been formally approved by the FDA in the past six weeks, boost the cure rates to a range of 66% to 80% by working in tandem with the current therapy.

"A less than 50% [response rate] for the previous regime and around 70% for the new regime. That’s a considerable difference," Dr. Chelamkuri says.

Two new drug therapies to treat chronic hepatitis C (HCV) are the first new options for hospitalists in 20 years. But freedom of choice doesn't come cheap.

Telaprevir, from Vertex Pharmaceuticals, will cost $49,200 for a 12-week regimen, while boceprevir, from Merck & Co., will cost from $26,400 to $48,000 for regimens of 24 and 48 weeks, respectively, Reuters reports. Telaprevir will go by the brand name Incivek, while boceprevir is known as Victrelis.

"The price is expensive," but financial support for some patients is expected early on, says Satya Chelamkuri, MD, a hospitalist with Cogent Healthcare at Allegiance Health in Jackson, Mich. "When the generic comes out, it will be a great help to patients with hepatitis C. Cost is a worry, but with help from pharmaceutical companies, the majority of the patients who need it will hopefully get the treatment."

Still, Dr. Chelamkuri expects the drugs to appear relatively quickly on hospital formularies, in large part because of the efficacy they showed in trials. The standard treatment for years, a cocktail of peginterferon-alpha and ribavirin, has a roughly 50% response rate. Both of the new treatments, which have been formally approved by the FDA in the past six weeks, boost the cure rates to a range of 66% to 80% by working in tandem with the current therapy.

"A less than 50% [response rate] for the previous regime and around 70% for the new regime. That’s a considerable difference," Dr. Chelamkuri says.

Clinical question: Does the mortality rate differ between patients treated perioperatively with atenolol versus metoprolol?

Background: Perioperative beta-blockers have been shown to reduce mortality in patients with significant cardiac risk factors. Different beta-blockers have been used in the studies demonstrating benefit, and it is uncertain which beta-blocker is the preferred agent. The purpose of this study was to compare the perioperative benefits of metoprolol versus atenolol.

Study design: Retrospective cohort study.

Setting: San Francisco Veterans Affairs Medical Center.

Synopsis: Computerized records of patients who underwent surgery from 1996 to 2008 were extracted into a database, and patients who received inpatient beta-blockers after surgery were included. Of these patients, 3,787 received beta-blockade exclusively with either atenolol (n=1,011) or metoprolol (n=2,776) during hospitalization. Perioperative risk reduction was better with atenolol versus metoprolol. Mortality rates were 1% versus 3% at 30 days (P=0.0008), and 7% versus 13% at one year (P=<0.0001) with atenolol and metoprolol, respectively. Similar results were found in the analysis of 1,871 patients who were on their respective beta-blocker as an outpatient before surgery.

Because the metoprolol group had higher prevalence of risk factors, such as coronary artery disease, peripheral vascular disease, and congestive heart failure, a propensity-matched analysis was performed to remove differences in risk factors between the groups. After propensity matching, the metoprolol group still had statistically significant higher mortality at 30 days and one year, even though causality cannot be established in this retrospective study.

Bottom line: Atenolol was associated with fewer cases of perioperative mortality compared with metoprolol in patients with cardiac risk factors or established cardiovascular disease.

Citation: Wallace AW, Au S, Cason BA. Perioperative ß-blockade: atenolol is associated with reduced mortality when compared to metoprolol. Anesthesiology. 2011;114:824-836.

For more physician reviews of HM-related research, visit our website.

Clinical question: Does the mortality rate differ between patients treated perioperatively with atenolol versus metoprolol?

Background: Perioperative beta-blockers have been shown to reduce mortality in patients with significant cardiac risk factors. Different beta-blockers have been used in the studies demonstrating benefit, and it is uncertain which beta-blocker is the preferred agent. The purpose of this study was to compare the perioperative benefits of metoprolol versus atenolol.

Study design: Retrospective cohort study.

Setting: San Francisco Veterans Affairs Medical Center.

Synopsis: Computerized records of patients who underwent surgery from 1996 to 2008 were extracted into a database, and patients who received inpatient beta-blockers after surgery were included. Of these patients, 3,787 received beta-blockade exclusively with either atenolol (n=1,011) or metoprolol (n=2,776) during hospitalization. Perioperative risk reduction was better with atenolol versus metoprolol. Mortality rates were 1% versus 3% at 30 days (P=0.0008), and 7% versus 13% at one year (P=<0.0001) with atenolol and metoprolol, respectively. Similar results were found in the analysis of 1,871 patients who were on their respective beta-blocker as an outpatient before surgery.

Because the metoprolol group had higher prevalence of risk factors, such as coronary artery disease, peripheral vascular disease, and congestive heart failure, a propensity-matched analysis was performed to remove differences in risk factors between the groups. After propensity matching, the metoprolol group still had statistically significant higher mortality at 30 days and one year, even though causality cannot be established in this retrospective study.

Bottom line: Atenolol was associated with fewer cases of perioperative mortality compared with metoprolol in patients with cardiac risk factors or established cardiovascular disease.

Citation: Wallace AW, Au S, Cason BA. Perioperative ß-blockade: atenolol is associated with reduced mortality when compared to metoprolol. Anesthesiology. 2011;114:824-836.

For more physician reviews of HM-related research, visit our website.

Clinical question: Does the mortality rate differ between patients treated perioperatively with atenolol versus metoprolol?

Background: Perioperative beta-blockers have been shown to reduce mortality in patients with significant cardiac risk factors. Different beta-blockers have been used in the studies demonstrating benefit, and it is uncertain which beta-blocker is the preferred agent. The purpose of this study was to compare the perioperative benefits of metoprolol versus atenolol.

Study design: Retrospective cohort study.

Setting: San Francisco Veterans Affairs Medical Center.

Synopsis: Computerized records of patients who underwent surgery from 1996 to 2008 were extracted into a database, and patients who received inpatient beta-blockers after surgery were included. Of these patients, 3,787 received beta-blockade exclusively with either atenolol (n=1,011) or metoprolol (n=2,776) during hospitalization. Perioperative risk reduction was better with atenolol versus metoprolol. Mortality rates were 1% versus 3% at 30 days (P=0.0008), and 7% versus 13% at one year (P=<0.0001) with atenolol and metoprolol, respectively. Similar results were found in the analysis of 1,871 patients who were on their respective beta-blocker as an outpatient before surgery.

Because the metoprolol group had higher prevalence of risk factors, such as coronary artery disease, peripheral vascular disease, and congestive heart failure, a propensity-matched analysis was performed to remove differences in risk factors between the groups. After propensity matching, the metoprolol group still had statistically significant higher mortality at 30 days and one year, even though causality cannot be established in this retrospective study.

Bottom line: Atenolol was associated with fewer cases of perioperative mortality compared with metoprolol in patients with cardiac risk factors or established cardiovascular disease.

Citation: Wallace AW, Au S, Cason BA. Perioperative ß-blockade: atenolol is associated with reduced mortality when compared to metoprolol. Anesthesiology. 2011;114:824-836.

For more physician reviews of HM-related research, visit our website.

The Food and Drug Administration unveiled on June 21 the final nine warning images that will appear on every package of cigarettes by 2012 – graphic photos and drawings intended to educate and even deter consumers from buying cigarettes.

The images, set to debut in stores this September, are required by the 2009 Tobacco Control Act, according to FDA spokesman Jeffrey Ventura, who added that these are the first changes to cigarette pack warnings in 25 years. By Oct. 22, 2012, cigarette manufacturers will no longer be able to distribute cigarettes for sale in the United States unless they display these warnings.

Courtesy of Food and Drug Administration

The law required the warnings to cover the top half of the front and back of cigarette packs and 20% of cigarette advertisements, and they must contain color graphics depicting the negative health consequences of smoking.

"This is something Congress wanted to happen and mandated that the FDA carry out," Mr. Ventura said in an interview. Based on a study of 18,000 smokers conducted for the FDA by RTI International, federal officials said they firmly believe that visually communicating smoking’s harm will deter cigarette consumption over the long run.

The images include photos of tobacco-diseased lungs beside healthy lungs, a corpse in casket, a man exhaling smoke though a tracheostomy, and lip cancer. There are also several cartoons and photos of mothers blowing smoke into infants’ faces. One positive image shows a burly man exposing a T-shirt saying, "I Quit."

Blunt statements accompany each image, intended to drive home the messages that cigarette smoke not only directly harms the smoker, but the smokers’ children and people in close proximity.

"The introduction of these warnings is expected to have a significant public health impact by decreasing the number of smokers, resulting in lives saved, increased life expectancy, and improved health status," FDA officials said in a press statement.

Mr. Ventura said the images were selected after the consumer study involving smokers aged 15-50 years. After viewing each of the images, subjects rated their emotional and cognitive responses, their ability to recall the images, and their opinions on whether the pictures could alter their beliefs about the danger of smoking and the desire to buy tobacco products and quitting tobacco.

Young people responded most strongly to a cartoon image depicting tobacco addiction – a cigarette being injected into an arm vein as well as a puppet controlled by strings.

Adults, on the other hand, responded most strongly to photos showing the direct effects of cancer on their bodies – the man with the tracheostomy and a woman smoking in the pouring rain, trying to shield her cigarette with a folded newspaper. Adults also reacted more strongly than did young people to images depicting harm to young children.

The study did conclude, however, that none of the images were significantly related to an increased likelihood of quitting smoking within the next 30 days, or the likelihood of smoking a year after viewing the images. Thus, the report noted, the campaign is more likely to exert a long-term behavioral impact than any immediate effects.

Courtesy of Food and Drug Administration

"Eliciting strong emotional and cognitive reactions to the graphic cigarette warning label enhances recall and processing of the health warning, which helps ensure that the warning is better processed, understood, and remembered," the study said. "As attitudes and beliefs change, they eventually lead to changes in intentions to quit or start smoking and then later to lower smoking initiation and successful cessation. The time scale on which this behavior change process occurs is largely unknown in the context of the impact of exposure to graphic warning labels on smoking behaviors, but the effects on behavior change are unlikely to be immediate or short-term.

Nevertheless, groups promoting antitobacco messages – including the American Heart Association – strongly believe that the warnings will enhance consumer education and change behavior.

"Undoubtedly, the new graphic health warnings will heighten awareness about the dangers of smoking and, more importantly, encourage smokers to quit and discourage smoking initiation," an AHA press statement read. "We’re confident that the new labels will move us closer to our goal of making the nation 100% smoke free."

Tobacco-Free Kids, a group dedicated to educating children and teens about the dangers of smoking, also issued a statement of support, but with a moderated view on the campaign’s possible impact. The group also called on political leaders to financially commit to "waging war" against tobacco.

"The warnings and other FDA regulations are powerful tools, but they are a complement – not a replacement – to other federal and state strategies to reduce tobacco use," Matthew L. Meyers, the group’s president, said in the statement. "To win the fight against tobacco, elected leaders must also fund and implement public education campaigns, expand health care coverage for therapies to help smokers quit, increase tobacco taxes, and enact strong smoke-free laws in every state."

The Food and Drug Administration unveiled on June 21 the final nine warning images that will appear on every package of cigarettes by 2012 – graphic photos and drawings intended to educate and even deter consumers from buying cigarettes.

The images, set to debut in stores this September, are required by the 2009 Tobacco Control Act, according to FDA spokesman Jeffrey Ventura, who added that these are the first changes to cigarette pack warnings in 25 years. By Oct. 22, 2012, cigarette manufacturers will no longer be able to distribute cigarettes for sale in the United States unless they display these warnings.

Courtesy of Food and Drug Administration

The law required the warnings to cover the top half of the front and back of cigarette packs and 20% of cigarette advertisements, and they must contain color graphics depicting the negative health consequences of smoking.

"This is something Congress wanted to happen and mandated that the FDA carry out," Mr. Ventura said in an interview. Based on a study of 18,000 smokers conducted for the FDA by RTI International, federal officials said they firmly believe that visually communicating smoking’s harm will deter cigarette consumption over the long run.

The images include photos of tobacco-diseased lungs beside healthy lungs, a corpse in casket, a man exhaling smoke though a tracheostomy, and lip cancer. There are also several cartoons and photos of mothers blowing smoke into infants’ faces. One positive image shows a burly man exposing a T-shirt saying, "I Quit."

Blunt statements accompany each image, intended to drive home the messages that cigarette smoke not only directly harms the smoker, but the smokers’ children and people in close proximity.

"The introduction of these warnings is expected to have a significant public health impact by decreasing the number of smokers, resulting in lives saved, increased life expectancy, and improved health status," FDA officials said in a press statement.

Mr. Ventura said the images were selected after the consumer study involving smokers aged 15-50 years. After viewing each of the images, subjects rated their emotional and cognitive responses, their ability to recall the images, and their opinions on whether the pictures could alter their beliefs about the danger of smoking and the desire to buy tobacco products and quitting tobacco.

Young people responded most strongly to a cartoon image depicting tobacco addiction – a cigarette being injected into an arm vein as well as a puppet controlled by strings.

Adults, on the other hand, responded most strongly to photos showing the direct effects of cancer on their bodies – the man with the tracheostomy and a woman smoking in the pouring rain, trying to shield her cigarette with a folded newspaper. Adults also reacted more strongly than did young people to images depicting harm to young children.

The study did conclude, however, that none of the images were significantly related to an increased likelihood of quitting smoking within the next 30 days, or the likelihood of smoking a year after viewing the images. Thus, the report noted, the campaign is more likely to exert a long-term behavioral impact than any immediate effects.

Courtesy of Food and Drug Administration

"Eliciting strong emotional and cognitive reactions to the graphic cigarette warning label enhances recall and processing of the health warning, which helps ensure that the warning is better processed, understood, and remembered," the study said. "As attitudes and beliefs change, they eventually lead to changes in intentions to quit or start smoking and then later to lower smoking initiation and successful cessation. The time scale on which this behavior change process occurs is largely unknown in the context of the impact of exposure to graphic warning labels on smoking behaviors, but the effects on behavior change are unlikely to be immediate or short-term.

Nevertheless, groups promoting antitobacco messages – including the American Heart Association – strongly believe that the warnings will enhance consumer education and change behavior.

"Undoubtedly, the new graphic health warnings will heighten awareness about the dangers of smoking and, more importantly, encourage smokers to quit and discourage smoking initiation," an AHA press statement read. "We’re confident that the new labels will move us closer to our goal of making the nation 100% smoke free."

Tobacco-Free Kids, a group dedicated to educating children and teens about the dangers of smoking, also issued a statement of support, but with a moderated view on the campaign’s possible impact. The group also called on political leaders to financially commit to "waging war" against tobacco.

"The warnings and other FDA regulations are powerful tools, but they are a complement – not a replacement – to other federal and state strategies to reduce tobacco use," Matthew L. Meyers, the group’s president, said in the statement. "To win the fight against tobacco, elected leaders must also fund and implement public education campaigns, expand health care coverage for therapies to help smokers quit, increase tobacco taxes, and enact strong smoke-free laws in every state."

The Food and Drug Administration unveiled on June 21 the final nine warning images that will appear on every package of cigarettes by 2012 – graphic photos and drawings intended to educate and even deter consumers from buying cigarettes.

The images, set to debut in stores this September, are required by the 2009 Tobacco Control Act, according to FDA spokesman Jeffrey Ventura, who added that these are the first changes to cigarette pack warnings in 25 years. By Oct. 22, 2012, cigarette manufacturers will no longer be able to distribute cigarettes for sale in the United States unless they display these warnings.

Courtesy of Food and Drug Administration

The law required the warnings to cover the top half of the front and back of cigarette packs and 20% of cigarette advertisements, and they must contain color graphics depicting the negative health consequences of smoking.

"This is something Congress wanted to happen and mandated that the FDA carry out," Mr. Ventura said in an interview. Based on a study of 18,000 smokers conducted for the FDA by RTI International, federal officials said they firmly believe that visually communicating smoking’s harm will deter cigarette consumption over the long run.

The images include photos of tobacco-diseased lungs beside healthy lungs, a corpse in casket, a man exhaling smoke though a tracheostomy, and lip cancer. There are also several cartoons and photos of mothers blowing smoke into infants’ faces. One positive image shows a burly man exposing a T-shirt saying, "I Quit."

Blunt statements accompany each image, intended to drive home the messages that cigarette smoke not only directly harms the smoker, but the smokers’ children and people in close proximity.

"The introduction of these warnings is expected to have a significant public health impact by decreasing the number of smokers, resulting in lives saved, increased life expectancy, and improved health status," FDA officials said in a press statement.

Mr. Ventura said the images were selected after the consumer study involving smokers aged 15-50 years. After viewing each of the images, subjects rated their emotional and cognitive responses, their ability to recall the images, and their opinions on whether the pictures could alter their beliefs about the danger of smoking and the desire to buy tobacco products and quitting tobacco.

Young people responded most strongly to a cartoon image depicting tobacco addiction – a cigarette being injected into an arm vein as well as a puppet controlled by strings.

Adults, on the other hand, responded most strongly to photos showing the direct effects of cancer on their bodies – the man with the tracheostomy and a woman smoking in the pouring rain, trying to shield her cigarette with a folded newspaper. Adults also reacted more strongly than did young people to images depicting harm to young children.

The study did conclude, however, that none of the images were significantly related to an increased likelihood of quitting smoking within the next 30 days, or the likelihood of smoking a year after viewing the images. Thus, the report noted, the campaign is more likely to exert a long-term behavioral impact than any immediate effects.

Courtesy of Food and Drug Administration

"Eliciting strong emotional and cognitive reactions to the graphic cigarette warning label enhances recall and processing of the health warning, which helps ensure that the warning is better processed, understood, and remembered," the study said. "As attitudes and beliefs change, they eventually lead to changes in intentions to quit or start smoking and then later to lower smoking initiation and successful cessation. The time scale on which this behavior change process occurs is largely unknown in the context of the impact of exposure to graphic warning labels on smoking behaviors, but the effects on behavior change are unlikely to be immediate or short-term.

Nevertheless, groups promoting antitobacco messages – including the American Heart Association – strongly believe that the warnings will enhance consumer education and change behavior.

"Undoubtedly, the new graphic health warnings will heighten awareness about the dangers of smoking and, more importantly, encourage smokers to quit and discourage smoking initiation," an AHA press statement read. "We’re confident that the new labels will move us closer to our goal of making the nation 100% smoke free."

Tobacco-Free Kids, a group dedicated to educating children and teens about the dangers of smoking, also issued a statement of support, but with a moderated view on the campaign’s possible impact. The group also called on political leaders to financially commit to "waging war" against tobacco.

"The warnings and other FDA regulations are powerful tools, but they are a complement – not a replacement – to other federal and state strategies to reduce tobacco use," Matthew L. Meyers, the group’s president, said in the statement. "To win the fight against tobacco, elected leaders must also fund and implement public education campaigns, expand health care coverage for therapies to help smokers quit, increase tobacco taxes, and enact strong smoke-free laws in every state."

CHICAGO – That lenalidomide can improve overall and progression-free survival rates in multiple myeloma patients is evident, but whether the drug also increases their risk of second primary cancers is debatable.

Of three studies looking at the question, only one found an association between secondary primary malignancies and lenalidomide (Revlimid) in first-line therapy, investigators reported at the American Society of Clinical Oncology annual meeting.

And even then the risk was low – far less than the risk of death from multiple myeloma without a lenalidomide-containing regimen, said Dr. Antonio P. Palumbo of the University of Torino (Italy) and the Italian Multiple Myeloma Study Group.

Two other studies – one with 6-year follow-up data on continuous lenalidomide in first-line therapy and the other on lenalidomide in relapsed/refractory disease – failed to spot a signal for second cancer risk.

"I think it’s fair to say that currently we lack clear answers due to small numbers and study limitations," said Dr. C. Ola Landgren of the National Cancer Institute, the invited discussant for all three papers.

"I think we need to put both benefits and risks into the algorithms when we think about these things. ... I also think despite the fact that we don’t have clear data, we always have to discuss these things with our patients, and we as doctors have to stay updated as more information emerges," he said.

Three randomized clinical trials stirred the debate by reporting in separate presentations at the 2010 annual meeting of the American Society of Hematology that they saw more hematologic malignancies in lenalidomide treatment arms than in control groups (McCarthy, P.L. et al, abstract 37; Attal, M. et al, abstract 310; Palumbo, A. et al, abstract 622).

Despite these reports, 25 years after a multiple myeloma diagnosis, the cumulative incidence of all second cancers is about 8%, whereas the cumulative probability of death from competing causes is more than 90%, suggesting that any risk of a second malignancy is far outweighed by the risk of multiple myeloma and its sequelae, Dr. Landgren pointed out.

First-Line Therapy: Italian Experience

In the first of the three studies presented at ASCO 2011, Dr. Palumbo’s group looked at second-cancer rates among patients randomly assigned to first-line therapy with either melphalan and prednisone alone, or to melphalan, prednisone, and lenalidomide with or without lenalidomide maintenance in the international MM-015 trial.

They found that at a median follow-up of 30 months, 12 of 150 (8%) patients on melphalan-prednisone plus lenalidomide with maintenance (MPR-R) developed an invasive second primary malignancy, compared with 9 of 152 patients (5.9%) on the same combination without lenalidomide maintenance (MPR), and 4 of 153 (2.6%) patients on melphalan and prednisone only.

Hematologic malignancies accounted for 7 of the 12 new cancers among patients treated with MPR-R, 5 of 9 on MPR, and 1 of 4 on MP. Solid tumors accounted for the remaining invasive cancers in each group. In addition, one patient on MPR-R, four on MPR, and five on MP developed nonmelanoma skin cancers.

In an additional analysis of 9 pooled experimental studies, the investigators found that among 1,788 patients followed for more than 1 year, the risk of dying of myeloma was greater than 40% out to 7 years compared with about a 2% risk of developing a second hematologic malignancy, and a 3% risk of developing a solid tumor.

Among patients receiving lenalidomide and an alkylating agent, the risk of developing any malignancy was around 7%, and the risk of dying of myeloma was about 27%. The risk of a second malignancy was lower – about 2% out to 6 years– among those patients who did not receive lenalidomide, but their risk of dying of myeloma was about 45%, Dr. Palumbo said.

He also pointed out that in the general population, the risk of a second primary malignancy among 65- to 74-year-olds is around 2% per 100 patient-years, and that the risk doubles among people 85 and older.

First-Line Therapy: BiRD Regimen

In the second study, Dr. Adriana Rossi and her colleagues at Cornell University, New York, and New York–Presbyterian Hospital examined the incidence of second primary cancers in 68 transplant-eligible patients receiving lenalidomide in first-line therapy as part of the BiRD regimen (clarithromycin [Biaxin], lenalidomide, and dexamethasone).

There were five solid tumors (two colon, one metastatic melanoma, one pancreas, and one prostate), but no hematologic malignancies. The melanoma was diagnosed 8 months after the primary myeloma diagnosis; the other cases occurred 25-53 months after the initial myeloma diagnosis (median, 31.2 months). The authors found no association between second primary cancers and a specific multiple myeloma chromosomal abnormality, prior malignancy, transplant status, study status, or sex.

The incidence rate of second primary malignancy was similar to that of all primary cancers reported among people 65 and older in the U.S. Surveillance, Epidemiology, and End Results (SEER) data set spanning 2003-2007, they noted.

"Routine screening and prevention measures should continue as medically indicated for all patients, including examination for skin cancers, and as survival in patients with multiple myeloma continues to improve, so will our understanding of their risk of development of second primary malignancies," she said.

Relapsed/Refractory Disease

The third trial looked at the risk of new primary cancers in patients receiving lenalidomide and dexamethasone for relapsed/refractory disease.

Dr. Meletios Dimopoulos of the University of Athens and colleagues in the international MM-009/010 trials performed a pooled analysis comparing the incidence of second primary cancers in 704 patients who received dexamethasone with either lenalidomide or placebo, and compared them with standard incidence rates.

They found that there were no differences in incidence rates of invasive second primary malignancies between patients in the lenalidomide plus dexamethasone arm or dexamethasone-only arms, and that the incidence rates of second primary cancers in general were low and similar to the background rate among people of similar age in the general population.

Additionally, patients who received lenalidomide and dexamethasone had significantly better overall survival (median, 38 months) despite the fact that about half of all patients in the placebo/dexamathesaone arm (median, 31.6 months) were crossed over to lenalidomide-based therapy (P = .045).

"The overall benefit-risk ratio of the use of lenalidomide in the relapsed/refractory setting remains strongly positive," said the presenter of the abstract, Dr. Ruben Niesvizky of Cornell University.

Lenalidomide is not approved as first-line therapy in the United States. Dr. Palumbo’s study was supported by the Fondazione Neoplasie Sangue Onlus. Dr. Rossi’s and Dr. Dimopoulos’s studies were funded by Celgene. Dr. Palumbo has received honoraria and served as a consultant to Celgene and other companies. Dr. Rossi said she had no relevant financial relationships to disclose. Dr. Dimopoulos disclosed receiving honoraria from Celgene. Dr. Niesvizky said he had received honoraria and research funding from Celgene; he also served in a consulting/advisory role for Celgene and other companies.

CHICAGO – That lenalidomide can improve overall and progression-free survival rates in multiple myeloma patients is evident, but whether the drug also increases their risk of second primary cancers is debatable.

Of three studies looking at the question, only one found an association between secondary primary malignancies and lenalidomide (Revlimid) in first-line therapy, investigators reported at the American Society of Clinical Oncology annual meeting.

And even then the risk was low – far less than the risk of death from multiple myeloma without a lenalidomide-containing regimen, said Dr. Antonio P. Palumbo of the University of Torino (Italy) and the Italian Multiple Myeloma Study Group.

Two other studies – one with 6-year follow-up data on continuous lenalidomide in first-line therapy and the other on lenalidomide in relapsed/refractory disease – failed to spot a signal for second cancer risk.

"I think it’s fair to say that currently we lack clear answers due to small numbers and study limitations," said Dr. C. Ola Landgren of the National Cancer Institute, the invited discussant for all three papers.

"I think we need to put both benefits and risks into the algorithms when we think about these things. ... I also think despite the fact that we don’t have clear data, we always have to discuss these things with our patients, and we as doctors have to stay updated as more information emerges," he said.

Three randomized clinical trials stirred the debate by reporting in separate presentations at the 2010 annual meeting of the American Society of Hematology that they saw more hematologic malignancies in lenalidomide treatment arms than in control groups (McCarthy, P.L. et al, abstract 37; Attal, M. et al, abstract 310; Palumbo, A. et al, abstract 622).

Despite these reports, 25 years after a multiple myeloma diagnosis, the cumulative incidence of all second cancers is about 8%, whereas the cumulative probability of death from competing causes is more than 90%, suggesting that any risk of a second malignancy is far outweighed by the risk of multiple myeloma and its sequelae, Dr. Landgren pointed out.

First-Line Therapy: Italian Experience

In the first of the three studies presented at ASCO 2011, Dr. Palumbo’s group looked at second-cancer rates among patients randomly assigned to first-line therapy with either melphalan and prednisone alone, or to melphalan, prednisone, and lenalidomide with or without lenalidomide maintenance in the international MM-015 trial.

They found that at a median follow-up of 30 months, 12 of 150 (8%) patients on melphalan-prednisone plus lenalidomide with maintenance (MPR-R) developed an invasive second primary malignancy, compared with 9 of 152 patients (5.9%) on the same combination without lenalidomide maintenance (MPR), and 4 of 153 (2.6%) patients on melphalan and prednisone only.

Hematologic malignancies accounted for 7 of the 12 new cancers among patients treated with MPR-R, 5 of 9 on MPR, and 1 of 4 on MP. Solid tumors accounted for the remaining invasive cancers in each group. In addition, one patient on MPR-R, four on MPR, and five on MP developed nonmelanoma skin cancers.

In an additional analysis of 9 pooled experimental studies, the investigators found that among 1,788 patients followed for more than 1 year, the risk of dying of myeloma was greater than 40% out to 7 years compared with about a 2% risk of developing a second hematologic malignancy, and a 3% risk of developing a solid tumor.

Among patients receiving lenalidomide and an alkylating agent, the risk of developing any malignancy was around 7%, and the risk of dying of myeloma was about 27%. The risk of a second malignancy was lower – about 2% out to 6 years– among those patients who did not receive lenalidomide, but their risk of dying of myeloma was about 45%, Dr. Palumbo said.

He also pointed out that in the general population, the risk of a second primary malignancy among 65- to 74-year-olds is around 2% per 100 patient-years, and that the risk doubles among people 85 and older.

First-Line Therapy: BiRD Regimen

In the second study, Dr. Adriana Rossi and her colleagues at Cornell University, New York, and New York–Presbyterian Hospital examined the incidence of second primary cancers in 68 transplant-eligible patients receiving lenalidomide in first-line therapy as part of the BiRD regimen (clarithromycin [Biaxin], lenalidomide, and dexamethasone).

There were five solid tumors (two colon, one metastatic melanoma, one pancreas, and one prostate), but no hematologic malignancies. The melanoma was diagnosed 8 months after the primary myeloma diagnosis; the other cases occurred 25-53 months after the initial myeloma diagnosis (median, 31.2 months). The authors found no association between second primary cancers and a specific multiple myeloma chromosomal abnormality, prior malignancy, transplant status, study status, or sex.

The incidence rate of second primary malignancy was similar to that of all primary cancers reported among people 65 and older in the U.S. Surveillance, Epidemiology, and End Results (SEER) data set spanning 2003-2007, they noted.

"Routine screening and prevention measures should continue as medically indicated for all patients, including examination for skin cancers, and as survival in patients with multiple myeloma continues to improve, so will our understanding of their risk of development of second primary malignancies," she said.

Relapsed/Refractory Disease

The third trial looked at the risk of new primary cancers in patients receiving lenalidomide and dexamethasone for relapsed/refractory disease.

Dr. Meletios Dimopoulos of the University of Athens and colleagues in the international MM-009/010 trials performed a pooled analysis comparing the incidence of second primary cancers in 704 patients who received dexamethasone with either lenalidomide or placebo, and compared them with standard incidence rates.

They found that there were no differences in incidence rates of invasive second primary malignancies between patients in the lenalidomide plus dexamethasone arm or dexamethasone-only arms, and that the incidence rates of second primary cancers in general were low and similar to the background rate among people of similar age in the general population.

Additionally, patients who received lenalidomide and dexamethasone had significantly better overall survival (median, 38 months) despite the fact that about half of all patients in the placebo/dexamathesaone arm (median, 31.6 months) were crossed over to lenalidomide-based therapy (P = .045).

"The overall benefit-risk ratio of the use of lenalidomide in the relapsed/refractory setting remains strongly positive," said the presenter of the abstract, Dr. Ruben Niesvizky of Cornell University.

Lenalidomide is not approved as first-line therapy in the United States. Dr. Palumbo’s study was supported by the Fondazione Neoplasie Sangue Onlus. Dr. Rossi’s and Dr. Dimopoulos’s studies were funded by Celgene. Dr. Palumbo has received honoraria and served as a consultant to Celgene and other companies. Dr. Rossi said she had no relevant financial relationships to disclose. Dr. Dimopoulos disclosed receiving honoraria from Celgene. Dr. Niesvizky said he had received honoraria and research funding from Celgene; he also served in a consulting/advisory role for Celgene and other companies.

CHICAGO – That lenalidomide can improve overall and progression-free survival rates in multiple myeloma patients is evident, but whether the drug also increases their risk of second primary cancers is debatable.

Of three studies looking at the question, only one found an association between secondary primary malignancies and lenalidomide (Revlimid) in first-line therapy, investigators reported at the American Society of Clinical Oncology annual meeting.

And even then the risk was low – far less than the risk of death from multiple myeloma without a lenalidomide-containing regimen, said Dr. Antonio P. Palumbo of the University of Torino (Italy) and the Italian Multiple Myeloma Study Group.

Two other studies – one with 6-year follow-up data on continuous lenalidomide in first-line therapy and the other on lenalidomide in relapsed/refractory disease – failed to spot a signal for second cancer risk.

"I think it’s fair to say that currently we lack clear answers due to small numbers and study limitations," said Dr. C. Ola Landgren of the National Cancer Institute, the invited discussant for all three papers.

"I think we need to put both benefits and risks into the algorithms when we think about these things. ... I also think despite the fact that we don’t have clear data, we always have to discuss these things with our patients, and we as doctors have to stay updated as more information emerges," he said.

Three randomized clinical trials stirred the debate by reporting in separate presentations at the 2010 annual meeting of the American Society of Hematology that they saw more hematologic malignancies in lenalidomide treatment arms than in control groups (McCarthy, P.L. et al, abstract 37; Attal, M. et al, abstract 310; Palumbo, A. et al, abstract 622).

Despite these reports, 25 years after a multiple myeloma diagnosis, the cumulative incidence of all second cancers is about 8%, whereas the cumulative probability of death from competing causes is more than 90%, suggesting that any risk of a second malignancy is far outweighed by the risk of multiple myeloma and its sequelae, Dr. Landgren pointed out.

First-Line Therapy: Italian Experience

In the first of the three studies presented at ASCO 2011, Dr. Palumbo’s group looked at second-cancer rates among patients randomly assigned to first-line therapy with either melphalan and prednisone alone, or to melphalan, prednisone, and lenalidomide with or without lenalidomide maintenance in the international MM-015 trial.

They found that at a median follow-up of 30 months, 12 of 150 (8%) patients on melphalan-prednisone plus lenalidomide with maintenance (MPR-R) developed an invasive second primary malignancy, compared with 9 of 152 patients (5.9%) on the same combination without lenalidomide maintenance (MPR), and 4 of 153 (2.6%) patients on melphalan and prednisone only.

Hematologic malignancies accounted for 7 of the 12 new cancers among patients treated with MPR-R, 5 of 9 on MPR, and 1 of 4 on MP. Solid tumors accounted for the remaining invasive cancers in each group. In addition, one patient on MPR-R, four on MPR, and five on MP developed nonmelanoma skin cancers.

In an additional analysis of 9 pooled experimental studies, the investigators found that among 1,788 patients followed for more than 1 year, the risk of dying of myeloma was greater than 40% out to 7 years compared with about a 2% risk of developing a second hematologic malignancy, and a 3% risk of developing a solid tumor.

Among patients receiving lenalidomide and an alkylating agent, the risk of developing any malignancy was around 7%, and the risk of dying of myeloma was about 27%. The risk of a second malignancy was lower – about 2% out to 6 years– among those patients who did not receive lenalidomide, but their risk of dying of myeloma was about 45%, Dr. Palumbo said.

He also pointed out that in the general population, the risk of a second primary malignancy among 65- to 74-year-olds is around 2% per 100 patient-years, and that the risk doubles among people 85 and older.

First-Line Therapy: BiRD Regimen

In the second study, Dr. Adriana Rossi and her colleagues at Cornell University, New York, and New York–Presbyterian Hospital examined the incidence of second primary cancers in 68 transplant-eligible patients receiving lenalidomide in first-line therapy as part of the BiRD regimen (clarithromycin [Biaxin], lenalidomide, and dexamethasone).

There were five solid tumors (two colon, one metastatic melanoma, one pancreas, and one prostate), but no hematologic malignancies. The melanoma was diagnosed 8 months after the primary myeloma diagnosis; the other cases occurred 25-53 months after the initial myeloma diagnosis (median, 31.2 months). The authors found no association between second primary cancers and a specific multiple myeloma chromosomal abnormality, prior malignancy, transplant status, study status, or sex.

The incidence rate of second primary malignancy was similar to that of all primary cancers reported among people 65 and older in the U.S. Surveillance, Epidemiology, and End Results (SEER) data set spanning 2003-2007, they noted.

"Routine screening and prevention measures should continue as medically indicated for all patients, including examination for skin cancers, and as survival in patients with multiple myeloma continues to improve, so will our understanding of their risk of development of second primary malignancies," she said.

Relapsed/Refractory Disease

The third trial looked at the risk of new primary cancers in patients receiving lenalidomide and dexamethasone for relapsed/refractory disease.

Dr. Meletios Dimopoulos of the University of Athens and colleagues in the international MM-009/010 trials performed a pooled analysis comparing the incidence of second primary cancers in 704 patients who received dexamethasone with either lenalidomide or placebo, and compared them with standard incidence rates.

They found that there were no differences in incidence rates of invasive second primary malignancies between patients in the lenalidomide plus dexamethasone arm or dexamethasone-only arms, and that the incidence rates of second primary cancers in general were low and similar to the background rate among people of similar age in the general population.

Additionally, patients who received lenalidomide and dexamethasone had significantly better overall survival (median, 38 months) despite the fact that about half of all patients in the placebo/dexamathesaone arm (median, 31.6 months) were crossed over to lenalidomide-based therapy (P = .045).

"The overall benefit-risk ratio of the use of lenalidomide in the relapsed/refractory setting remains strongly positive," said the presenter of the abstract, Dr. Ruben Niesvizky of Cornell University.

Lenalidomide is not approved as first-line therapy in the United States. Dr. Palumbo’s study was supported by the Fondazione Neoplasie Sangue Onlus. Dr. Rossi’s and Dr. Dimopoulos’s studies were funded by Celgene. Dr. Palumbo has received honoraria and served as a consultant to Celgene and other companies. Dr. Rossi said she had no relevant financial relationships to disclose. Dr. Dimopoulos disclosed receiving honoraria from Celgene. Dr. Niesvizky said he had received honoraria and research funding from Celgene; he also served in a consulting/advisory role for Celgene and other companies.