Patient & Survivor Care

Personalized medicine is a reality for many cancer patients, and getting closer for others, but the oncology community is struggling with a number of questions surrounding genomic testing, a key to providing that care.

As a result, oncology leaders have started to take a closer look at how to resolve these issues, and how to do it as quickly as possible.

Among the most basic questions are when to use the testing, what to do with the information that’s generated, and how to secure reimbursement for diagnostics that may not have fully proven their clinical utility.

The science of genomics – from profiling a tumor’s genetic make-up to sequencing a cancer patient’s entire genome – is growing exponentially, leading to a rush to commercialize diagnostics based on the discoveries and a push among big cancer centers to leverage the knowledge to help develop therapeutics and inform clinical trials. Meanwhile, the Food and Drug Administration hasn’t articulated a clear regulatory strategy around genomic testing.

"We need an infrastructure in place that quickly translates verified advances in treatment into practice," said Mark Fleury, Ph.D., of the American Cancer Society Cancer Action Network (ACS CAN). Now, genomic advances are relying on what he calls "passive diffusion."

Currently, there’s a kind of free-for-all, agreed Dr. Richard L. Schilsky, medical director of the American Society of Clinical Oncology.

"People need tests to guide treatment decisions, but there are very few controls over how tests are offered and developed," said Dr. Schilsky. He also noted that there is not a huge evidence base yet on the usefulness of some of the testing.

The oncology community is trying to bring some civility to the "Wild West" of genomics, starting by establishing standards, Dr. Schilsky said.

Among the issues being discussed:

• What genetic variants should oncologists be testing for in all common cancers?

• What is level of evidence that supports testing for those particular variants?

• What are the recommended clinical actions to be taken once certain variants are discovered?

• What information should be reported to the oncologist?

• What information should be reported to the patient, and how?

In early April, ASCO convened a meeting of representatives from clinical oncology, pathology, the genetic sequencing community, and the regulatory community, among others, to discuss those issues and more, Dr. Schilsky said. "We didn’t come away with any consensus, but we put all the issues on the table," he said.

ACS CAN held a policy forum in April to delve into some of the same issues.

"There are three main things you need to make personalized medicine work," said Dr. Fleury. The information generated has to be accurate, it has to somehow translate to having meaning for the disease, and the diagnostic has to provide some sort of change in treatment for the better, said Dr. Fleury. Now, though, "there are breakdowns in all three of those steps."

Understandably, said Dr. Fleury, payers don’t want to reimburse for tests or services that don’t provide any measurable utility. And, he said, the patient won’t want the information if he or she "doesn’t understand the usefulness."

Dr. Tanguy L. Seiwert of the department of medicine at the University of Chicago who focuses on head and neck and lung cancer, said, "Physicians want to do this, and there’s a growing movement that [genomic testing] is beneficial." But he added that the uncertainty over payment had helped contribute to an uncertainty overall about personalized medicine.

There’s not a lot of good data on exactly how many genomic tests are available – either as a single mutation test or a panel of tests – and how often they are being used.

The FDA has approved 19 diagnostics that are meant to help clinicians determine whether certain targeted therapies would be useful. They are used in colorectal, lung and breast cancers, gastrointestinal stromal tumors, and melanoma.

But that’s only a small fraction of the available tests. In July 2013, the Agency for Healthcare Research and Quality identified 178 different genetic tests for 10 common cancer conditions. Sixty-six were new since it last surveyed the field in 2011; the largest number of tests were being used for breast cancer.

The commercial potential of genomic testing is growing, despite the many outstanding questions. Myriad Genetics said in its most recent quarterly report that there was "wider acceptance of our molecular diagnostic tests by the medical community and increased patient testing volumes." Still, Myriad’s oncology testing revenues grew relatively slowly, by about 12% from the previous year to $102 million for the second quarter. Most of Myriad’s diagnostics are predictive, like its BRACAnalysis test. But the company is also branching out into genomics that will help guide treatment decisions.

In Oct. 2013, it launched the myPlan Lung Cancer test, which it says will help clinicians determine a newly diagnosed patient’s risk of dying from lung cancer within 5 years, and in turn help decide whether an early-stage patient should receive surgery alone or surgery plus adjuvant chemotherapy or radiation therapy.

Foundation Medicine, based in Cambridge, Mass., is working with drug makers to develop companion diagnostics for targeted chemotherapies but is also offering direct to oncologists genomic panels that provide analysis of up to 200 genes. One of the tests is for solid tumors and the other is for hematologic malignancies, sarcomas, and pediatric cancers. The company said in its most recent quarterly report that testing revenues had grown by a third from the year ago quarter.

The FDA is also approving new targeted therapies that would probably be made more useful through the use of genomic testing to winnow down the number of potential patients who could benefit. For instance, in May, the agency approved certinib (Zykadia), a drug that blocks the anaplastic lymphoma kinase (ALK) protein. There is an FDA-approved diagnostic – the Vysis ALK Break Apart FISH Probe Kit – designed to detect ALK gene mutations, but it’s indicated for use only to identify patients eligible for treatment with another therapy, crizotinib (Xalkori).

There’s nothing to stop off-label use, or use of so-called "home brew" tests that are developed in-house at hospitals or clinical labs but not FDA-approved.

The FDA may soon step up its regulation of those diagnostics, said ACS CAN’s Dr. Fleury. "They’ve been very public that they fully intend to bring high-risk lab tests into their purview," he said, adding that many in the field believe that the regulations have already been written. It appears that the only thing delaying those regulations from being issued is White House clearance, Dr. Fleury said.

Meanwhile, many institutions are moving on to next generation sequencing, which involves taking a look at hundreds of genes, not just a single variant. Even with a limited amount of tumor tissue, it maximizes the information that can be gleaned from a biopsy sample, said Dr. Schilsky. It may be less expensive and more efficient than conducting multiple different single mutation diagnostics, he said.

However, right now, "it gives you way more information than you could possibly use at any point in time," said Dr. Schilsky. And, many clinicians have difficulty interpreting such a huge amount of complex information.

Most payers are not approving reimbursement for these multiple gene panels, he said. Even so, "many cancer centers are doing this because they think it provides an important platform for their research, and it attracts patients to their institutions," said Dr. Schilsky.

Dr. Seiwert helped develop a multigene assay, which the University of Chicago recently began offering to its oncology patients. In general, it is not being covered by insurers, he said. But, while the cost of molecular diagnostics – which can run from $1,500-$8,000 per patient – is high, it is not that large when compared with the cost of many chemotherapies, he said. If the testing "leads to treatment that has a higher chance of working, then it’s a very small cost, compared with blindly using a drug," Dr. Seiwert said.

His cancer center is covering the cost of testing when it is not reimbursed. Dr. Schilsky said that, from what he has heard, that is not uncommon. "My understanding from many lab directors is that they are basically eating the costs," he said.

Partly because of economics, genomic testing has not disseminated out of the academic centers. Dr. Seiwert said that he thought that testing for specific mutations like EGFR in lung cancer or HER2 in breast cancer was becoming a standard of practice, but that it was a "moving target" in the community. And, when it comes to larger, multi-gene assays, "my sense is that this is largely confined to academic centers," he said.

Single mutation genomic testing, especially for lung cancer "should be the standard of care, but the evidence is that it has not permeated out to the smaller practices," said Dr. Fleury, of ACS CAN.

"When you come in, you should get the diagnosis and be tested for a mutation right away," said Dr. Fleury, who added that this is not happening on a widespread basis.

Oncologists can often be in an awkward position when a test they want to offer is not covered by the patient’s insurance. If the patient can’t afford the cost, they might feel like they’re not getting something that others can, said Dr. Seiwert. "It’s a messy situation," he said.

But, it’s one that oncologists at academic centers don’t have to encounter very often, as they usually find a way to cover the cost of testing.

"When it comes to genetic testing, we have both under- and over-utilization," said Dr. Fleury. "We need that happy medium."

Things will start evening out with the right infrastructure, Dr. Fleury said. He sees things falling into place with organizations like ASCO and ACS CAN developing guidelines and standards, and the FDA about to step up its oversight of genomic assays that are developed in-house by hospital and commercial labs.

Also, as the market evolves towards panels of tests, instead of just single mutations, the process will likely become more efficient, Dr. Fleury added.

Currently, for instance, there are only two targeted therapies and two companion diagnostics for lung cancer but a dozen known mutations. In the future, as more therapies are developed to go after those mutations, it won’t be cost-effective or efficient to conduct a dozen different tests with a dozen different charges and copays, said Dr. Fleury.

[email protected]

On Twitter @aliciaault

Personalized medicine is a reality for many cancer patients, and getting closer for others, but the oncology community is struggling with a number of questions surrounding genomic testing, a key to providing that care.

As a result, oncology leaders have started to take a closer look at how to resolve these issues, and how to do it as quickly as possible.

Among the most basic questions are when to use the testing, what to do with the information that’s generated, and how to secure reimbursement for diagnostics that may not have fully proven their clinical utility.

The science of genomics – from profiling a tumor’s genetic make-up to sequencing a cancer patient’s entire genome – is growing exponentially, leading to a rush to commercialize diagnostics based on the discoveries and a push among big cancer centers to leverage the knowledge to help develop therapeutics and inform clinical trials. Meanwhile, the Food and Drug Administration hasn’t articulated a clear regulatory strategy around genomic testing.

"We need an infrastructure in place that quickly translates verified advances in treatment into practice," said Mark Fleury, Ph.D., of the American Cancer Society Cancer Action Network (ACS CAN). Now, genomic advances are relying on what he calls "passive diffusion."

Currently, there’s a kind of free-for-all, agreed Dr. Richard L. Schilsky, medical director of the American Society of Clinical Oncology.

"People need tests to guide treatment decisions, but there are very few controls over how tests are offered and developed," said Dr. Schilsky. He also noted that there is not a huge evidence base yet on the usefulness of some of the testing.

The oncology community is trying to bring some civility to the "Wild West" of genomics, starting by establishing standards, Dr. Schilsky said.

Among the issues being discussed:

• What genetic variants should oncologists be testing for in all common cancers?

• What is level of evidence that supports testing for those particular variants?

• What are the recommended clinical actions to be taken once certain variants are discovered?

• What information should be reported to the oncologist?

• What information should be reported to the patient, and how?

In early April, ASCO convened a meeting of representatives from clinical oncology, pathology, the genetic sequencing community, and the regulatory community, among others, to discuss those issues and more, Dr. Schilsky said. "We didn’t come away with any consensus, but we put all the issues on the table," he said.

ACS CAN held a policy forum in April to delve into some of the same issues.

"There are three main things you need to make personalized medicine work," said Dr. Fleury. The information generated has to be accurate, it has to somehow translate to having meaning for the disease, and the diagnostic has to provide some sort of change in treatment for the better, said Dr. Fleury. Now, though, "there are breakdowns in all three of those steps."

Understandably, said Dr. Fleury, payers don’t want to reimburse for tests or services that don’t provide any measurable utility. And, he said, the patient won’t want the information if he or she "doesn’t understand the usefulness."

Dr. Tanguy L. Seiwert of the department of medicine at the University of Chicago who focuses on head and neck and lung cancer, said, "Physicians want to do this, and there’s a growing movement that [genomic testing] is beneficial." But he added that the uncertainty over payment had helped contribute to an uncertainty overall about personalized medicine.

There’s not a lot of good data on exactly how many genomic tests are available – either as a single mutation test or a panel of tests – and how often they are being used.

The FDA has approved 19 diagnostics that are meant to help clinicians determine whether certain targeted therapies would be useful. They are used in colorectal, lung and breast cancers, gastrointestinal stromal tumors, and melanoma.

But that’s only a small fraction of the available tests. In July 2013, the Agency for Healthcare Research and Quality identified 178 different genetic tests for 10 common cancer conditions. Sixty-six were new since it last surveyed the field in 2011; the largest number of tests were being used for breast cancer.

The commercial potential of genomic testing is growing, despite the many outstanding questions. Myriad Genetics said in its most recent quarterly report that there was "wider acceptance of our molecular diagnostic tests by the medical community and increased patient testing volumes." Still, Myriad’s oncology testing revenues grew relatively slowly, by about 12% from the previous year to $102 million for the second quarter. Most of Myriad’s diagnostics are predictive, like its BRACAnalysis test. But the company is also branching out into genomics that will help guide treatment decisions.

In Oct. 2013, it launched the myPlan Lung Cancer test, which it says will help clinicians determine a newly diagnosed patient’s risk of dying from lung cancer within 5 years, and in turn help decide whether an early-stage patient should receive surgery alone or surgery plus adjuvant chemotherapy or radiation therapy.

Foundation Medicine, based in Cambridge, Mass., is working with drug makers to develop companion diagnostics for targeted chemotherapies but is also offering direct to oncologists genomic panels that provide analysis of up to 200 genes. One of the tests is for solid tumors and the other is for hematologic malignancies, sarcomas, and pediatric cancers. The company said in its most recent quarterly report that testing revenues had grown by a third from the year ago quarter.

The FDA is also approving new targeted therapies that would probably be made more useful through the use of genomic testing to winnow down the number of potential patients who could benefit. For instance, in May, the agency approved certinib (Zykadia), a drug that blocks the anaplastic lymphoma kinase (ALK) protein. There is an FDA-approved diagnostic – the Vysis ALK Break Apart FISH Probe Kit – designed to detect ALK gene mutations, but it’s indicated for use only to identify patients eligible for treatment with another therapy, crizotinib (Xalkori).

There’s nothing to stop off-label use, or use of so-called "home brew" tests that are developed in-house at hospitals or clinical labs but not FDA-approved.

The FDA may soon step up its regulation of those diagnostics, said ACS CAN’s Dr. Fleury. "They’ve been very public that they fully intend to bring high-risk lab tests into their purview," he said, adding that many in the field believe that the regulations have already been written. It appears that the only thing delaying those regulations from being issued is White House clearance, Dr. Fleury said.

Meanwhile, many institutions are moving on to next generation sequencing, which involves taking a look at hundreds of genes, not just a single variant. Even with a limited amount of tumor tissue, it maximizes the information that can be gleaned from a biopsy sample, said Dr. Schilsky. It may be less expensive and more efficient than conducting multiple different single mutation diagnostics, he said.

However, right now, "it gives you way more information than you could possibly use at any point in time," said Dr. Schilsky. And, many clinicians have difficulty interpreting such a huge amount of complex information.

Most payers are not approving reimbursement for these multiple gene panels, he said. Even so, "many cancer centers are doing this because they think it provides an important platform for their research, and it attracts patients to their institutions," said Dr. Schilsky.

Dr. Seiwert helped develop a multigene assay, which the University of Chicago recently began offering to its oncology patients. In general, it is not being covered by insurers, he said. But, while the cost of molecular diagnostics – which can run from $1,500-$8,000 per patient – is high, it is not that large when compared with the cost of many chemotherapies, he said. If the testing "leads to treatment that has a higher chance of working, then it’s a very small cost, compared with blindly using a drug," Dr. Seiwert said.

His cancer center is covering the cost of testing when it is not reimbursed. Dr. Schilsky said that, from what he has heard, that is not uncommon. "My understanding from many lab directors is that they are basically eating the costs," he said.

Partly because of economics, genomic testing has not disseminated out of the academic centers. Dr. Seiwert said that he thought that testing for specific mutations like EGFR in lung cancer or HER2 in breast cancer was becoming a standard of practice, but that it was a "moving target" in the community. And, when it comes to larger, multi-gene assays, "my sense is that this is largely confined to academic centers," he said.

Single mutation genomic testing, especially for lung cancer "should be the standard of care, but the evidence is that it has not permeated out to the smaller practices," said Dr. Fleury, of ACS CAN.

"When you come in, you should get the diagnosis and be tested for a mutation right away," said Dr. Fleury, who added that this is not happening on a widespread basis.

Oncologists can often be in an awkward position when a test they want to offer is not covered by the patient’s insurance. If the patient can’t afford the cost, they might feel like they’re not getting something that others can, said Dr. Seiwert. "It’s a messy situation," he said.

But, it’s one that oncologists at academic centers don’t have to encounter very often, as they usually find a way to cover the cost of testing.

"When it comes to genetic testing, we have both under- and over-utilization," said Dr. Fleury. "We need that happy medium."

Things will start evening out with the right infrastructure, Dr. Fleury said. He sees things falling into place with organizations like ASCO and ACS CAN developing guidelines and standards, and the FDA about to step up its oversight of genomic assays that are developed in-house by hospital and commercial labs.

Also, as the market evolves towards panels of tests, instead of just single mutations, the process will likely become more efficient, Dr. Fleury added.

Currently, for instance, there are only two targeted therapies and two companion diagnostics for lung cancer but a dozen known mutations. In the future, as more therapies are developed to go after those mutations, it won’t be cost-effective or efficient to conduct a dozen different tests with a dozen different charges and copays, said Dr. Fleury.

[email protected]

On Twitter @aliciaault

Personalized medicine is a reality for many cancer patients, and getting closer for others, but the oncology community is struggling with a number of questions surrounding genomic testing, a key to providing that care.

As a result, oncology leaders have started to take a closer look at how to resolve these issues, and how to do it as quickly as possible.

Among the most basic questions are when to use the testing, what to do with the information that’s generated, and how to secure reimbursement for diagnostics that may not have fully proven their clinical utility.

The science of genomics – from profiling a tumor’s genetic make-up to sequencing a cancer patient’s entire genome – is growing exponentially, leading to a rush to commercialize diagnostics based on the discoveries and a push among big cancer centers to leverage the knowledge to help develop therapeutics and inform clinical trials. Meanwhile, the Food and Drug Administration hasn’t articulated a clear regulatory strategy around genomic testing.

"We need an infrastructure in place that quickly translates verified advances in treatment into practice," said Mark Fleury, Ph.D., of the American Cancer Society Cancer Action Network (ACS CAN). Now, genomic advances are relying on what he calls "passive diffusion."

Currently, there’s a kind of free-for-all, agreed Dr. Richard L. Schilsky, medical director of the American Society of Clinical Oncology.

"People need tests to guide treatment decisions, but there are very few controls over how tests are offered and developed," said Dr. Schilsky. He also noted that there is not a huge evidence base yet on the usefulness of some of the testing.

The oncology community is trying to bring some civility to the "Wild West" of genomics, starting by establishing standards, Dr. Schilsky said.

Among the issues being discussed:

• What genetic variants should oncologists be testing for in all common cancers?

• What is level of evidence that supports testing for those particular variants?

• What are the recommended clinical actions to be taken once certain variants are discovered?

• What information should be reported to the oncologist?

• What information should be reported to the patient, and how?

In early April, ASCO convened a meeting of representatives from clinical oncology, pathology, the genetic sequencing community, and the regulatory community, among others, to discuss those issues and more, Dr. Schilsky said. "We didn’t come away with any consensus, but we put all the issues on the table," he said.

ACS CAN held a policy forum in April to delve into some of the same issues.

"There are three main things you need to make personalized medicine work," said Dr. Fleury. The information generated has to be accurate, it has to somehow translate to having meaning for the disease, and the diagnostic has to provide some sort of change in treatment for the better, said Dr. Fleury. Now, though, "there are breakdowns in all three of those steps."

Understandably, said Dr. Fleury, payers don’t want to reimburse for tests or services that don’t provide any measurable utility. And, he said, the patient won’t want the information if he or she "doesn’t understand the usefulness."

Dr. Tanguy L. Seiwert of the department of medicine at the University of Chicago who focuses on head and neck and lung cancer, said, "Physicians want to do this, and there’s a growing movement that [genomic testing] is beneficial." But he added that the uncertainty over payment had helped contribute to an uncertainty overall about personalized medicine.

There’s not a lot of good data on exactly how many genomic tests are available – either as a single mutation test or a panel of tests – and how often they are being used.

The FDA has approved 19 diagnostics that are meant to help clinicians determine whether certain targeted therapies would be useful. They are used in colorectal, lung and breast cancers, gastrointestinal stromal tumors, and melanoma.

But that’s only a small fraction of the available tests. In July 2013, the Agency for Healthcare Research and Quality identified 178 different genetic tests for 10 common cancer conditions. Sixty-six were new since it last surveyed the field in 2011; the largest number of tests were being used for breast cancer.

The commercial potential of genomic testing is growing, despite the many outstanding questions. Myriad Genetics said in its most recent quarterly report that there was "wider acceptance of our molecular diagnostic tests by the medical community and increased patient testing volumes." Still, Myriad’s oncology testing revenues grew relatively slowly, by about 12% from the previous year to $102 million for the second quarter. Most of Myriad’s diagnostics are predictive, like its BRACAnalysis test. But the company is also branching out into genomics that will help guide treatment decisions.

In Oct. 2013, it launched the myPlan Lung Cancer test, which it says will help clinicians determine a newly diagnosed patient’s risk of dying from lung cancer within 5 years, and in turn help decide whether an early-stage patient should receive surgery alone or surgery plus adjuvant chemotherapy or radiation therapy.

Foundation Medicine, based in Cambridge, Mass., is working with drug makers to develop companion diagnostics for targeted chemotherapies but is also offering direct to oncologists genomic panels that provide analysis of up to 200 genes. One of the tests is for solid tumors and the other is for hematologic malignancies, sarcomas, and pediatric cancers. The company said in its most recent quarterly report that testing revenues had grown by a third from the year ago quarter.

The FDA is also approving new targeted therapies that would probably be made more useful through the use of genomic testing to winnow down the number of potential patients who could benefit. For instance, in May, the agency approved certinib (Zykadia), a drug that blocks the anaplastic lymphoma kinase (ALK) protein. There is an FDA-approved diagnostic – the Vysis ALK Break Apart FISH Probe Kit – designed to detect ALK gene mutations, but it’s indicated for use only to identify patients eligible for treatment with another therapy, crizotinib (Xalkori).

There’s nothing to stop off-label use, or use of so-called "home brew" tests that are developed in-house at hospitals or clinical labs but not FDA-approved.

The FDA may soon step up its regulation of those diagnostics, said ACS CAN’s Dr. Fleury. "They’ve been very public that they fully intend to bring high-risk lab tests into their purview," he said, adding that many in the field believe that the regulations have already been written. It appears that the only thing delaying those regulations from being issued is White House clearance, Dr. Fleury said.

Meanwhile, many institutions are moving on to next generation sequencing, which involves taking a look at hundreds of genes, not just a single variant. Even with a limited amount of tumor tissue, it maximizes the information that can be gleaned from a biopsy sample, said Dr. Schilsky. It may be less expensive and more efficient than conducting multiple different single mutation diagnostics, he said.

However, right now, "it gives you way more information than you could possibly use at any point in time," said Dr. Schilsky. And, many clinicians have difficulty interpreting such a huge amount of complex information.

Most payers are not approving reimbursement for these multiple gene panels, he said. Even so, "many cancer centers are doing this because they think it provides an important platform for their research, and it attracts patients to their institutions," said Dr. Schilsky.

Dr. Seiwert helped develop a multigene assay, which the University of Chicago recently began offering to its oncology patients. In general, it is not being covered by insurers, he said. But, while the cost of molecular diagnostics – which can run from $1,500-$8,000 per patient – is high, it is not that large when compared with the cost of many chemotherapies, he said. If the testing "leads to treatment that has a higher chance of working, then it’s a very small cost, compared with blindly using a drug," Dr. Seiwert said.

His cancer center is covering the cost of testing when it is not reimbursed. Dr. Schilsky said that, from what he has heard, that is not uncommon. "My understanding from many lab directors is that they are basically eating the costs," he said.

Partly because of economics, genomic testing has not disseminated out of the academic centers. Dr. Seiwert said that he thought that testing for specific mutations like EGFR in lung cancer or HER2 in breast cancer was becoming a standard of practice, but that it was a "moving target" in the community. And, when it comes to larger, multi-gene assays, "my sense is that this is largely confined to academic centers," he said.

Single mutation genomic testing, especially for lung cancer "should be the standard of care, but the evidence is that it has not permeated out to the smaller practices," said Dr. Fleury, of ACS CAN.

"When you come in, you should get the diagnosis and be tested for a mutation right away," said Dr. Fleury, who added that this is not happening on a widespread basis.

Oncologists can often be in an awkward position when a test they want to offer is not covered by the patient’s insurance. If the patient can’t afford the cost, they might feel like they’re not getting something that others can, said Dr. Seiwert. "It’s a messy situation," he said.

But, it’s one that oncologists at academic centers don’t have to encounter very often, as they usually find a way to cover the cost of testing.

"When it comes to genetic testing, we have both under- and over-utilization," said Dr. Fleury. "We need that happy medium."

Things will start evening out with the right infrastructure, Dr. Fleury said. He sees things falling into place with organizations like ASCO and ACS CAN developing guidelines and standards, and the FDA about to step up its oversight of genomic assays that are developed in-house by hospital and commercial labs.

Also, as the market evolves towards panels of tests, instead of just single mutations, the process will likely become more efficient, Dr. Fleury added.

Currently, for instance, there are only two targeted therapies and two companion diagnostics for lung cancer but a dozen known mutations. In the future, as more therapies are developed to go after those mutations, it won’t be cost-effective or efficient to conduct a dozen different tests with a dozen different charges and copays, said Dr. Fleury.

[email protected]

On Twitter @aliciaault

LIVERPOOL, ENGLAND – The risk of recurrent cancer in patients with rheumatoid arthritis did not increase with the use of biologic therapies, according to data just released from the British Society for Rheumatology Biologics Registers’ Rheumatoid Arthritis Register.

In fact, the risk of repeated cancer in patients with prior malignancies treated with biologic therapies was apparently decreased by around 50%, when compared with treatment with nonbiologic disease-modifying antirheumatic drugs (nbDMARDs).

The hazard ratios, adjusted for age and sex, for recurrent cancer were 0.55 for patients treated with drugs directed at tumor necrosis factor (TNF)-alpha and 0.47 for patients treated, off-label, with rituximab vs. nbDMARDs.

However, Dr. Luca Silva-Fernandez, who presented the findings at the British Society for Rheumatology annual conference, noted that patients treated with nbDMARDs were perhaps at higher risk of recurrent disease than were those who were treated with biologic agents at the start of their treatment, so the data do not imply that biologic agents are less likely to cause recurrent disease than do the older RA therapies.

"Our data suggest that patients with RA and prior malignancy selected to receive either an anti-TNF or rituximab therapy in the U.K. do not seem to have an increased risk of future incident malignancy," said Dr. Silva-Fernandez.

Patients treated with anti-TNFs or rituximab were more likely to have incident cancers, added Dr. Silva-Fernandez of the Arthritis Research UK Epidemiology Unit at the University of Manchester, England, where the BSRBR-RA Register is run.

Previous data on the use of biologic therapies in patients with prior cancer were published from the British Society for Rheumatology Biologics Registers (BSRBR) 4 years ago (Arthritis Care Res. 2010;62:755-63). These considered 293 patients with a prior malignancy identified from over 14,000 patients with RA enrolled in the register at the time. The present analysis included 425 patients who had cancer before being enrolled in the BSRBR-RA Register, which at the time of the updated analysis included around 19,000 patients.

In total, 425 new malignancies were detected in 159 of 3,787 (1.7%) patients who had been treated with an nbDMARD, 243 of 14,168 (8.9%) patients treated with an anti-TNF drug, and 23 of 257 (4.2%) patients who had received rituximab for the treatment of their RA.

There were several differences in baseline characteristics among the three groups. The mean age of patients in each treatment arm was 66.1, 62.7, and 67.3 years, respectively. A higher percentage (81%) of anti-TNF-treated patients were female when compared with the nbDMARD (74%) and rituximab (65%) arms. Biologic-treated patients tended to have a longer mean RA disease duration (anti-TNF 12 years and rituximab 14 years) than did the nbDMARD-treated patients (8 years), and higher disease severity scores at enrollment into the BSRBR-RA Register. The median time between the previous and current malignancy was 7.9 years for nbDMARDs, 11.5 years for anti-TNFs, and 5.4 years for rituximab.

The crude incident malignancy rates were 47/1,000 person-years in the nbDMARD cohort, 24/1,000 person-years in the anti-TNF-treated patients, and 25/1,000 person-years in the group treated with rituximab. Dr. Silva-Fernandez reported that the median follow-up was much shorter in rituximab-treated patients, at 3.9 years, than both the nbDMARD- (6.6 years) and anti-TNF–treated (6.9 years) groups.

After her presentation, Dr. Silva-Fernandez was asked to comment on the apparent "protective" effect of anti-TNFs on the recurrence of cancer. She replied that the nbDMARD and biologic groups were not really comparable, referring back to the differences in baseline characteristics, so such an association cannot be claimed.

With regards to a question on the use of rituximab in RA patients with a history of prior cancer, which was "off label" in this instance as it wasn’t used after anti-TNFs but "up-front," this might reflect a "channeling bias" on the part of the physicians, commented Dr. Kimmie Hyrich.

"These patients were those who had received rituximab as their first biologic for a number of reasons," said Dr. Hyrich, one of the principal investigators for the BSRBR-RA Register. "For many of them, it may have been a past cancer that made that decision," she added.

"I think, as physicians, we have a comfort in using rituximab in patients with past cancer, because it is not an absolute contraindication, so I think this is physician choice, and that’s probably why an off-license decision to treat with rituximab was made in these patients," said Dr. Hyrich, also from the University of Manchester, England.

Although patients with nonmelanoma skin cancer (NSMC) were excluded from the present analysis, Dr. Hyrich also noted in response to a question that the BSRBR RA Register team had previously reported on the rates of recurrence in patients with and without a prior history of this type of skin cancer.

Findings had shown that anti-TNFs did not appear to increase the risk of NSMC in patients without a prior history of skin cancer. In patients with a history of the disease, there was elevated risk of recurrence, regardless of whether patients received nbDMARDs or anti-TNFs, and it did not seem to occur more in the biologic-treated patients.

"I think the most striking finding, however, was regardless of treatment, all patients in the register, overall, have a marked increased risk of skin cancer, compared with general population, so I think RA itself and its treatment is probably the strongest risk factor," Dr. Hyrich said.

The BSRBR is funded by a grant from the British Society for Rheumatology (BSR), which receives funding from multiple drug companies. This income finances a separate contract between the BSR and the University of Manchester that provides and runs the BSRBR RA Register. Dr. Silva-Fernandez and Dr. Hyrich had no personal conflicts of interest.

LIVERPOOL, ENGLAND – The risk of recurrent cancer in patients with rheumatoid arthritis did not increase with the use of biologic therapies, according to data just released from the British Society for Rheumatology Biologics Registers’ Rheumatoid Arthritis Register.

In fact, the risk of repeated cancer in patients with prior malignancies treated with biologic therapies was apparently decreased by around 50%, when compared with treatment with nonbiologic disease-modifying antirheumatic drugs (nbDMARDs).

The hazard ratios, adjusted for age and sex, for recurrent cancer were 0.55 for patients treated with drugs directed at tumor necrosis factor (TNF)-alpha and 0.47 for patients treated, off-label, with rituximab vs. nbDMARDs.

However, Dr. Luca Silva-Fernandez, who presented the findings at the British Society for Rheumatology annual conference, noted that patients treated with nbDMARDs were perhaps at higher risk of recurrent disease than were those who were treated with biologic agents at the start of their treatment, so the data do not imply that biologic agents are less likely to cause recurrent disease than do the older RA therapies.

"Our data suggest that patients with RA and prior malignancy selected to receive either an anti-TNF or rituximab therapy in the U.K. do not seem to have an increased risk of future incident malignancy," said Dr. Silva-Fernandez.

Patients treated with anti-TNFs or rituximab were more likely to have incident cancers, added Dr. Silva-Fernandez of the Arthritis Research UK Epidemiology Unit at the University of Manchester, England, where the BSRBR-RA Register is run.

Previous data on the use of biologic therapies in patients with prior cancer were published from the British Society for Rheumatology Biologics Registers (BSRBR) 4 years ago (Arthritis Care Res. 2010;62:755-63). These considered 293 patients with a prior malignancy identified from over 14,000 patients with RA enrolled in the register at the time. The present analysis included 425 patients who had cancer before being enrolled in the BSRBR-RA Register, which at the time of the updated analysis included around 19,000 patients.

In total, 425 new malignancies were detected in 159 of 3,787 (1.7%) patients who had been treated with an nbDMARD, 243 of 14,168 (8.9%) patients treated with an anti-TNF drug, and 23 of 257 (4.2%) patients who had received rituximab for the treatment of their RA.

There were several differences in baseline characteristics among the three groups. The mean age of patients in each treatment arm was 66.1, 62.7, and 67.3 years, respectively. A higher percentage (81%) of anti-TNF-treated patients were female when compared with the nbDMARD (74%) and rituximab (65%) arms. Biologic-treated patients tended to have a longer mean RA disease duration (anti-TNF 12 years and rituximab 14 years) than did the nbDMARD-treated patients (8 years), and higher disease severity scores at enrollment into the BSRBR-RA Register. The median time between the previous and current malignancy was 7.9 years for nbDMARDs, 11.5 years for anti-TNFs, and 5.4 years for rituximab.

The crude incident malignancy rates were 47/1,000 person-years in the nbDMARD cohort, 24/1,000 person-years in the anti-TNF-treated patients, and 25/1,000 person-years in the group treated with rituximab. Dr. Silva-Fernandez reported that the median follow-up was much shorter in rituximab-treated patients, at 3.9 years, than both the nbDMARD- (6.6 years) and anti-TNF–treated (6.9 years) groups.

After her presentation, Dr. Silva-Fernandez was asked to comment on the apparent "protective" effect of anti-TNFs on the recurrence of cancer. She replied that the nbDMARD and biologic groups were not really comparable, referring back to the differences in baseline characteristics, so such an association cannot be claimed.

With regards to a question on the use of rituximab in RA patients with a history of prior cancer, which was "off label" in this instance as it wasn’t used after anti-TNFs but "up-front," this might reflect a "channeling bias" on the part of the physicians, commented Dr. Kimmie Hyrich.

"These patients were those who had received rituximab as their first biologic for a number of reasons," said Dr. Hyrich, one of the principal investigators for the BSRBR-RA Register. "For many of them, it may have been a past cancer that made that decision," she added.

"I think, as physicians, we have a comfort in using rituximab in patients with past cancer, because it is not an absolute contraindication, so I think this is physician choice, and that’s probably why an off-license decision to treat with rituximab was made in these patients," said Dr. Hyrich, also from the University of Manchester, England.

Although patients with nonmelanoma skin cancer (NSMC) were excluded from the present analysis, Dr. Hyrich also noted in response to a question that the BSRBR RA Register team had previously reported on the rates of recurrence in patients with and without a prior history of this type of skin cancer.

Findings had shown that anti-TNFs did not appear to increase the risk of NSMC in patients without a prior history of skin cancer. In patients with a history of the disease, there was elevated risk of recurrence, regardless of whether patients received nbDMARDs or anti-TNFs, and it did not seem to occur more in the biologic-treated patients.

"I think the most striking finding, however, was regardless of treatment, all patients in the register, overall, have a marked increased risk of skin cancer, compared with general population, so I think RA itself and its treatment is probably the strongest risk factor," Dr. Hyrich said.

The BSRBR is funded by a grant from the British Society for Rheumatology (BSR), which receives funding from multiple drug companies. This income finances a separate contract between the BSR and the University of Manchester that provides and runs the BSRBR RA Register. Dr. Silva-Fernandez and Dr. Hyrich had no personal conflicts of interest.

LIVERPOOL, ENGLAND – The risk of recurrent cancer in patients with rheumatoid arthritis did not increase with the use of biologic therapies, according to data just released from the British Society for Rheumatology Biologics Registers’ Rheumatoid Arthritis Register.

In fact, the risk of repeated cancer in patients with prior malignancies treated with biologic therapies was apparently decreased by around 50%, when compared with treatment with nonbiologic disease-modifying antirheumatic drugs (nbDMARDs).

The hazard ratios, adjusted for age and sex, for recurrent cancer were 0.55 for patients treated with drugs directed at tumor necrosis factor (TNF)-alpha and 0.47 for patients treated, off-label, with rituximab vs. nbDMARDs.

However, Dr. Luca Silva-Fernandez, who presented the findings at the British Society for Rheumatology annual conference, noted that patients treated with nbDMARDs were perhaps at higher risk of recurrent disease than were those who were treated with biologic agents at the start of their treatment, so the data do not imply that biologic agents are less likely to cause recurrent disease than do the older RA therapies.

"Our data suggest that patients with RA and prior malignancy selected to receive either an anti-TNF or rituximab therapy in the U.K. do not seem to have an increased risk of future incident malignancy," said Dr. Silva-Fernandez.

Patients treated with anti-TNFs or rituximab were more likely to have incident cancers, added Dr. Silva-Fernandez of the Arthritis Research UK Epidemiology Unit at the University of Manchester, England, where the BSRBR-RA Register is run.

Previous data on the use of biologic therapies in patients with prior cancer were published from the British Society for Rheumatology Biologics Registers (BSRBR) 4 years ago (Arthritis Care Res. 2010;62:755-63). These considered 293 patients with a prior malignancy identified from over 14,000 patients with RA enrolled in the register at the time. The present analysis included 425 patients who had cancer before being enrolled in the BSRBR-RA Register, which at the time of the updated analysis included around 19,000 patients.

In total, 425 new malignancies were detected in 159 of 3,787 (1.7%) patients who had been treated with an nbDMARD, 243 of 14,168 (8.9%) patients treated with an anti-TNF drug, and 23 of 257 (4.2%) patients who had received rituximab for the treatment of their RA.

There were several differences in baseline characteristics among the three groups. The mean age of patients in each treatment arm was 66.1, 62.7, and 67.3 years, respectively. A higher percentage (81%) of anti-TNF-treated patients were female when compared with the nbDMARD (74%) and rituximab (65%) arms. Biologic-treated patients tended to have a longer mean RA disease duration (anti-TNF 12 years and rituximab 14 years) than did the nbDMARD-treated patients (8 years), and higher disease severity scores at enrollment into the BSRBR-RA Register. The median time between the previous and current malignancy was 7.9 years for nbDMARDs, 11.5 years for anti-TNFs, and 5.4 years for rituximab.

The crude incident malignancy rates were 47/1,000 person-years in the nbDMARD cohort, 24/1,000 person-years in the anti-TNF-treated patients, and 25/1,000 person-years in the group treated with rituximab. Dr. Silva-Fernandez reported that the median follow-up was much shorter in rituximab-treated patients, at 3.9 years, than both the nbDMARD- (6.6 years) and anti-TNF–treated (6.9 years) groups.

After her presentation, Dr. Silva-Fernandez was asked to comment on the apparent "protective" effect of anti-TNFs on the recurrence of cancer. She replied that the nbDMARD and biologic groups were not really comparable, referring back to the differences in baseline characteristics, so such an association cannot be claimed.

With regards to a question on the use of rituximab in RA patients with a history of prior cancer, which was "off label" in this instance as it wasn’t used after anti-TNFs but "up-front," this might reflect a "channeling bias" on the part of the physicians, commented Dr. Kimmie Hyrich.

"These patients were those who had received rituximab as their first biologic for a number of reasons," said Dr. Hyrich, one of the principal investigators for the BSRBR-RA Register. "For many of them, it may have been a past cancer that made that decision," she added.

"I think, as physicians, we have a comfort in using rituximab in patients with past cancer, because it is not an absolute contraindication, so I think this is physician choice, and that’s probably why an off-license decision to treat with rituximab was made in these patients," said Dr. Hyrich, also from the University of Manchester, England.

Although patients with nonmelanoma skin cancer (NSMC) were excluded from the present analysis, Dr. Hyrich also noted in response to a question that the BSRBR RA Register team had previously reported on the rates of recurrence in patients with and without a prior history of this type of skin cancer.

Findings had shown that anti-TNFs did not appear to increase the risk of NSMC in patients without a prior history of skin cancer. In patients with a history of the disease, there was elevated risk of recurrence, regardless of whether patients received nbDMARDs or anti-TNFs, and it did not seem to occur more in the biologic-treated patients.

"I think the most striking finding, however, was regardless of treatment, all patients in the register, overall, have a marked increased risk of skin cancer, compared with general population, so I think RA itself and its treatment is probably the strongest risk factor," Dr. Hyrich said.

The BSRBR is funded by a grant from the British Society for Rheumatology (BSR), which receives funding from multiple drug companies. This income finances a separate contract between the BSR and the University of Manchester that provides and runs the BSRBR RA Register. Dr. Silva-Fernandez and Dr. Hyrich had no personal conflicts of interest.

PHILADELPHIA – Few templates exist for creating a pediatric oncofertility clinic, particularly in the context of the nascent trend of pediatric oncologists treating adults with pediatric cancers.

Dr. Karen Burns is a pediatric oncologist at Cincinnati Children’s Hospital who was part of the team that created that institution’s own oncofertility clinic. She offered tips to others who are interested in creating a similar clinic or who would like to incorporate protocols honoring ASCO’s recent position statement that all persons with cancer deserve the right to have fertility discussed as part of their standard of care.

In this audio interview, from the annual meeting of the North American Society for Pediatric and Adolescent Gynecology, Dr. Burns addresses the challenges of treating adults with pediatric cancers, having conversations about fertility with minors, the role of advance directives in oncofertility, and what burdens oncologists with patients in these situations face and how they can be eased by working with a team.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Few templates exist for creating a pediatric oncofertility clinic, particularly in the context of the nascent trend of pediatric oncologists treating adults with pediatric cancers.

Dr. Karen Burns is a pediatric oncologist at Cincinnati Children’s Hospital who was part of the team that created that institution’s own oncofertility clinic. She offered tips to others who are interested in creating a similar clinic or who would like to incorporate protocols honoring ASCO’s recent position statement that all persons with cancer deserve the right to have fertility discussed as part of their standard of care.

In this audio interview, from the annual meeting of the North American Society for Pediatric and Adolescent Gynecology, Dr. Burns addresses the challenges of treating adults with pediatric cancers, having conversations about fertility with minors, the role of advance directives in oncofertility, and what burdens oncologists with patients in these situations face and how they can be eased by working with a team.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Few templates exist for creating a pediatric oncofertility clinic, particularly in the context of the nascent trend of pediatric oncologists treating adults with pediatric cancers.

Dr. Karen Burns is a pediatric oncologist at Cincinnati Children’s Hospital who was part of the team that created that institution’s own oncofertility clinic. She offered tips to others who are interested in creating a similar clinic or who would like to incorporate protocols honoring ASCO’s recent position statement that all persons with cancer deserve the right to have fertility discussed as part of their standard of care.

In this audio interview, from the annual meeting of the North American Society for Pediatric and Adolescent Gynecology, Dr. Burns addresses the challenges of treating adults with pediatric cancers, having conversations about fertility with minors, the role of advance directives in oncofertility, and what burdens oncologists with patients in these situations face and how they can be eased by working with a team.

[email protected]

On Twitter @whitneymcknight

Applying topical liquid lidocaine to the vulvar vestibule prior to penetration allows for comfortable intercourse in breast cancer survivors with severe menopausal dyspareunia, according to findings from a randomized, controlled study involving 46 women.

During a double-blind phase of the study, patients randomized to apply 4% aqueous lidocaine had less intercourse pain than those who applied saline (median pain scores of 1.0 and 5.3 out of 10, respectively), according to Dr. Martha F. Goetsch of Oregon Health and Science University, Portland, who will report the finding at the annual meeting of the American Congress of Obstetricians and Gynecologists.

During an open-label phase of the study in which all patients were allowed to apply lidocaine, 37 of 41 (90%) reported comfortable penetration, and sexual distress scores decreased from a median of 30.5 to a median of 14. Additionally, 17 of 20 women (85%) who were abstaining from intercourse because of the discomfort had resumed penetrative intimacy, said Dr. Goetsch, whose abstract was awarded first prize among oral presentations by ACOG.

Patients included in the study were estrogen-deficient breast cancer survivors with severe penetrative dyspareunia not associated with pelvic muscle or organ pain. All had severe vulvovaginal atrophy. During the 1-month blinded phase of the study, the women applied either the lidocaine or the saline to the vulvar vestibule for 3 minutes prior to penetration. Effects of twice-weekly tampon insertion or intercourse were documented in a diary. No partners complained of numbness resulting from the lidocaine.

The findings are notable, because breast cancer survivors number in the millions in the United States alone.

"They often suffer from severe dyspareunia and are urged to refrain from using estrogen, which is the therapy most effective for dyspareunia in menopause," Dr. Goetsch said in an interview.

Furthermore, prior research has focused primarily on vaginal atrophy as the cause of dyspareunia in postmenopausal women.

"This study showed that pain could be prevented even though atrophy was unchanged," she said, noting that this suggests that perhaps atrophy is the wrong therapeutic focus.

"Success came with therapy to the vestibule, not the vagina," she said.

Dr. Goetsch reported having no disclosures.

Applying topical liquid lidocaine to the vulvar vestibule prior to penetration allows for comfortable intercourse in breast cancer survivors with severe menopausal dyspareunia, according to findings from a randomized, controlled study involving 46 women.

During a double-blind phase of the study, patients randomized to apply 4% aqueous lidocaine had less intercourse pain than those who applied saline (median pain scores of 1.0 and 5.3 out of 10, respectively), according to Dr. Martha F. Goetsch of Oregon Health and Science University, Portland, who will report the finding at the annual meeting of the American Congress of Obstetricians and Gynecologists.

During an open-label phase of the study in which all patients were allowed to apply lidocaine, 37 of 41 (90%) reported comfortable penetration, and sexual distress scores decreased from a median of 30.5 to a median of 14. Additionally, 17 of 20 women (85%) who were abstaining from intercourse because of the discomfort had resumed penetrative intimacy, said Dr. Goetsch, whose abstract was awarded first prize among oral presentations by ACOG.

Patients included in the study were estrogen-deficient breast cancer survivors with severe penetrative dyspareunia not associated with pelvic muscle or organ pain. All had severe vulvovaginal atrophy. During the 1-month blinded phase of the study, the women applied either the lidocaine or the saline to the vulvar vestibule for 3 minutes prior to penetration. Effects of twice-weekly tampon insertion or intercourse were documented in a diary. No partners complained of numbness resulting from the lidocaine.

The findings are notable, because breast cancer survivors number in the millions in the United States alone.

"They often suffer from severe dyspareunia and are urged to refrain from using estrogen, which is the therapy most effective for dyspareunia in menopause," Dr. Goetsch said in an interview.

Furthermore, prior research has focused primarily on vaginal atrophy as the cause of dyspareunia in postmenopausal women.

"This study showed that pain could be prevented even though atrophy was unchanged," she said, noting that this suggests that perhaps atrophy is the wrong therapeutic focus.

"Success came with therapy to the vestibule, not the vagina," she said.

Dr. Goetsch reported having no disclosures.

Applying topical liquid lidocaine to the vulvar vestibule prior to penetration allows for comfortable intercourse in breast cancer survivors with severe menopausal dyspareunia, according to findings from a randomized, controlled study involving 46 women.

During a double-blind phase of the study, patients randomized to apply 4% aqueous lidocaine had less intercourse pain than those who applied saline (median pain scores of 1.0 and 5.3 out of 10, respectively), according to Dr. Martha F. Goetsch of Oregon Health and Science University, Portland, who will report the finding at the annual meeting of the American Congress of Obstetricians and Gynecologists.

During an open-label phase of the study in which all patients were allowed to apply lidocaine, 37 of 41 (90%) reported comfortable penetration, and sexual distress scores decreased from a median of 30.5 to a median of 14. Additionally, 17 of 20 women (85%) who were abstaining from intercourse because of the discomfort had resumed penetrative intimacy, said Dr. Goetsch, whose abstract was awarded first prize among oral presentations by ACOG.

Patients included in the study were estrogen-deficient breast cancer survivors with severe penetrative dyspareunia not associated with pelvic muscle or organ pain. All had severe vulvovaginal atrophy. During the 1-month blinded phase of the study, the women applied either the lidocaine or the saline to the vulvar vestibule for 3 minutes prior to penetration. Effects of twice-weekly tampon insertion or intercourse were documented in a diary. No partners complained of numbness resulting from the lidocaine.

The findings are notable, because breast cancer survivors number in the millions in the United States alone.

"They often suffer from severe dyspareunia and are urged to refrain from using estrogen, which is the therapy most effective for dyspareunia in menopause," Dr. Goetsch said in an interview.

Furthermore, prior research has focused primarily on vaginal atrophy as the cause of dyspareunia in postmenopausal women.

"This study showed that pain could be prevented even though atrophy was unchanged," she said, noting that this suggests that perhaps atrophy is the wrong therapeutic focus.

"Success came with therapy to the vestibule, not the vagina," she said.

Dr. Goetsch reported having no disclosures.

Background Palliative care services in the United States are increasing in their prevalence but continue to vary in their implementation, with different referral policies and timing of patient access to services.

Objective To better define a late referral and to understand the association of late referrals to palliative care with patient health outcomes, including postreferral length of hospital stay and in-hospital mortality.

Methods We performed a retrospective study using multiple linear and logistic regressions on 1,225 patients with preexisting oncologic diagnoses who received a referral to Stanford Hospital’s palliative care service.

Results Those oncologic patients who were referred to palliative care in the first week following admission had significantly shorter lengths of stay after referral, as well as lower in-hospital mortality, compared with patients who were referred later than 1 week following admission. Regression analyses, adjusted for demographic variables, DNR status, and sickness, revealed that waiting 1 week or longer to refer a patient was associated with an overall increased length of stay of 2.70 days (P < .001). This increased to 3.40 days (P < .001) when patients who died in the hospital were removed from the data, suggesting that in-hospital mortality was not solely responsible for the trend. Waiting 1 week to refer was associated with increased odds of a patient’s dying in the hospital vs being discharged alive by a factor of 3.04 (P < .001).

Limitations This study was limited to analyzing inpatient palliative care consultation services with a emphasis on patients with metastatic solid tumors. We used a proxy for patient sickness burden but did not analyze outcomes specific to cancer stage or individual oncologic diagnosis separately.

Conclusions Our study suggests that late referrals may have a marked negative impact on health outcomes, which argues for the design and implementation of hospital policies that encourage early referral to palliative care for advanced cancer patients.

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

Background Palliative care services in the United States are increasing in their prevalence but continue to vary in their implementation, with different referral policies and timing of patient access to services.

Objective To better define a late referral and to understand the association of late referrals to palliative care with patient health outcomes, including postreferral length of hospital stay and in-hospital mortality.

Methods We performed a retrospective study using multiple linear and logistic regressions on 1,225 patients with preexisting oncologic diagnoses who received a referral to Stanford Hospital’s palliative care service.

Results Those oncologic patients who were referred to palliative care in the first week following admission had significantly shorter lengths of stay after referral, as well as lower in-hospital mortality, compared with patients who were referred later than 1 week following admission. Regression analyses, adjusted for demographic variables, DNR status, and sickness, revealed that waiting 1 week or longer to refer a patient was associated with an overall increased length of stay of 2.70 days (P < .001). This increased to 3.40 days (P < .001) when patients who died in the hospital were removed from the data, suggesting that in-hospital mortality was not solely responsible for the trend. Waiting 1 week to refer was associated with increased odds of a patient’s dying in the hospital vs being discharged alive by a factor of 3.04 (P < .001).

Limitations This study was limited to analyzing inpatient palliative care consultation services with a emphasis on patients with metastatic solid tumors. We used a proxy for patient sickness burden but did not analyze outcomes specific to cancer stage or individual oncologic diagnosis separately.

Conclusions Our study suggests that late referrals may have a marked negative impact on health outcomes, which argues for the design and implementation of hospital policies that encourage early referral to palliative care for advanced cancer patients.

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

Background Palliative care services in the United States are increasing in their prevalence but continue to vary in their implementation, with different referral policies and timing of patient access to services.

Objective To better define a late referral and to understand the association of late referrals to palliative care with patient health outcomes, including postreferral length of hospital stay and in-hospital mortality.

Methods We performed a retrospective study using multiple linear and logistic regressions on 1,225 patients with preexisting oncologic diagnoses who received a referral to Stanford Hospital’s palliative care service.

Results Those oncologic patients who were referred to palliative care in the first week following admission had significantly shorter lengths of stay after referral, as well as lower in-hospital mortality, compared with patients who were referred later than 1 week following admission. Regression analyses, adjusted for demographic variables, DNR status, and sickness, revealed that waiting 1 week or longer to refer a patient was associated with an overall increased length of stay of 2.70 days (P < .001). This increased to 3.40 days (P < .001) when patients who died in the hospital were removed from the data, suggesting that in-hospital mortality was not solely responsible for the trend. Waiting 1 week to refer was associated with increased odds of a patient’s dying in the hospital vs being discharged alive by a factor of 3.04 (P < .001).

Limitations This study was limited to analyzing inpatient palliative care consultation services with a emphasis on patients with metastatic solid tumors. We used a proxy for patient sickness burden but did not analyze outcomes specific to cancer stage or individual oncologic diagnosis separately.

Conclusions Our study suggests that late referrals may have a marked negative impact on health outcomes, which argues for the design and implementation of hospital policies that encourage early referral to palliative care for advanced cancer patients.

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

Bacground Colorectal cancer is one of the leading causes of morbidity and mortality in Canada. A report of community dwelling seniors showed that 25% received some sort of home care, and that the quantity of home care increased with age and disability. Few population-based studies have examined home care and the associated costs in elderly persons with cancer.

Objective To determine overall utilization and costs associated with home care services in Ontario, Canada by linking a home care database to a stage IV colorectal cancer cohort.

Methods The names of patients with stage IV colorectal cancer at time of diagnosis (diagnosed from 2005 through 2009) were extracted from the Ontario Cancer Registry. The study cohort comprised those who died before the end of the study. The terminal phase of care was the period of time between diagnosis and death, with a maximum value of 180 days (6 months). Patients were linked to home care services datasets. The type, frequency, and cost of home care services were determined. Regression analysis was used to examine factors associated with utilization and cost.

Results In all, 3,613 stage IV colorectal cancer patients (median age, 71 years) were diagnosed and died during the study’s time horizon. During the terminal phase, 79.3% received at least 1 home care visit, and 58.0% had at least 1 palliative visit. Terminal metastatic colorectal cancer patients received an average of 8 home care visits at Canadian $800 within a 30-day time horizon. Home care costs were highest in the month before death. Male sex, a history of moderate or high utilization of health care services, and hospitalization were associated with lower home care costs.

Limitations Administrative data do not reveal the purpose, efficiency, effectiveness/sufficiency, quality, or appropriateness of home care.

Conclusion Patients with advanced colorectal cancer who were approaching death required a moderate level of home care support, resulting in costs of about $5,000 over the 6-month time horizon.

Funding This study was conducted with the support of the Ontario Institute for Cancer Research and Cancer Care Ontario through funding provided by the government of Ontario. Data were provided by Cancer Care Ontario and the Institute for Clinical Evaluative Sciences. The ICES also provided funding for the study from an annual grant by the Ontario Ministry of Health and Long-term Care.

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

Bacground Colorectal cancer is one of the leading causes of morbidity and mortality in Canada. A report of community dwelling seniors showed that 25% received some sort of home care, and that the quantity of home care increased with age and disability. Few population-based studies have examined home care and the associated costs in elderly persons with cancer.

Objective To determine overall utilization and costs associated with home care services in Ontario, Canada by linking a home care database to a stage IV colorectal cancer cohort.

Methods The names of patients with stage IV colorectal cancer at time of diagnosis (diagnosed from 2005 through 2009) were extracted from the Ontario Cancer Registry. The study cohort comprised those who died before the end of the study. The terminal phase of care was the period of time between diagnosis and death, with a maximum value of 180 days (6 months). Patients were linked to home care services datasets. The type, frequency, and cost of home care services were determined. Regression analysis was used to examine factors associated with utilization and cost.

Results In all, 3,613 stage IV colorectal cancer patients (median age, 71 years) were diagnosed and died during the study’s time horizon. During the terminal phase, 79.3% received at least 1 home care visit, and 58.0% had at least 1 palliative visit. Terminal metastatic colorectal cancer patients received an average of 8 home care visits at Canadian $800 within a 30-day time horizon. Home care costs were highest in the month before death. Male sex, a history of moderate or high utilization of health care services, and hospitalization were associated with lower home care costs.

Limitations Administrative data do not reveal the purpose, efficiency, effectiveness/sufficiency, quality, or appropriateness of home care.

Conclusion Patients with advanced colorectal cancer who were approaching death required a moderate level of home care support, resulting in costs of about $5,000 over the 6-month time horizon.

Funding This study was conducted with the support of the Ontario Institute for Cancer Research and Cancer Care Ontario through funding provided by the government of Ontario. Data were provided by Cancer Care Ontario and the Institute for Clinical Evaluative Sciences. The ICES also provided funding for the study from an annual grant by the Ontario Ministry of Health and Long-term Care.

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

Bacground Colorectal cancer is one of the leading causes of morbidity and mortality in Canada. A report of community dwelling seniors showed that 25% received some sort of home care, and that the quantity of home care increased with age and disability. Few population-based studies have examined home care and the associated costs in elderly persons with cancer.

Objective To determine overall utilization and costs associated with home care services in Ontario, Canada by linking a home care database to a stage IV colorectal cancer cohort.

Methods The names of patients with stage IV colorectal cancer at time of diagnosis (diagnosed from 2005 through 2009) were extracted from the Ontario Cancer Registry. The study cohort comprised those who died before the end of the study. The terminal phase of care was the period of time between diagnosis and death, with a maximum value of 180 days (6 months). Patients were linked to home care services datasets. The type, frequency, and cost of home care services were determined. Regression analysis was used to examine factors associated with utilization and cost.

Results In all, 3,613 stage IV colorectal cancer patients (median age, 71 years) were diagnosed and died during the study’s time horizon. During the terminal phase, 79.3% received at least 1 home care visit, and 58.0% had at least 1 palliative visit. Terminal metastatic colorectal cancer patients received an average of 8 home care visits at Canadian $800 within a 30-day time horizon. Home care costs were highest in the month before death. Male sex, a history of moderate or high utilization of health care services, and hospitalization were associated with lower home care costs.

Limitations Administrative data do not reveal the purpose, efficiency, effectiveness/sufficiency, quality, or appropriateness of home care.

Conclusion Patients with advanced colorectal cancer who were approaching death required a moderate level of home care support, resulting in costs of about $5,000 over the 6-month time horizon.

Funding This study was conducted with the support of the Ontario Institute for Cancer Research and Cancer Care Ontario through funding provided by the government of Ontario. Data were provided by Cancer Care Ontario and the Institute for Clinical Evaluative Sciences. The ICES also provided funding for the study from an annual grant by the Ontario Ministry of Health and Long-term Care.

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

Routinely measuring aspects of health status from the oncology patient’s point of view and using these measures in care improves selected outcomes, according to Grigorios Kotronoulas, Ph.D., and his associates.

The report was published online April 7 in Journal of Clinical Oncology.

For a systematic review, Dr. Kotronoulas and his associates searched five electronic databases through May 2012 to identify controlled trials (whether randomized or not) that tested patient-reported outcome measure (PROM) interventions among adults receiving active anticancer treatment or supportive care, irrespective of type of cancer or stage. The trials had to provide PROM-generated feedback to health care professionals or patients in an effort to improve the quality of care.

The investigators assessed potential impact of the routine PROM use in three broad areas: patient outcomes (e.g., symptom burden, health-related quality of life), processes of care (patient adherence and satisfaction, patient–health professional communication, referrals), and health service outcomes (patient safety, cost-effectiveness).

The search identified 26 articles that reported on 24 unique controlled trials having a total of 6,279 patients and 713 health professionals, reported Dr. Kotronoulas of University of Surrey, Guildford, England, and his colleagues.

The trials had a wide range of designs and used diverse interventions (J. Clin. Oncol. 2014 April 7 [doi:10.1200/JCO.2013.53.5948]). In addition, the outcomes evaluated and cancer- and modality-specific context varied considerably. Although 87.5% of trials reported on patient outcomes and 79.2% reported on processes of care, only 20.8% reported any health service outcomes as endpoints.

Analyses showed that overall, there were few statistically significant associations between routine use of PROMs and a variety of outcomes. Additionally, the intervention effect sizes were generally small to moderate.

Routine use of PROMs did increase the frequency of discussion of patient outcomes during consultations. Interventions had the greatest impact in the context of palliative chemotherapy, where they improved discussion of dyspnea; social functioning and fatigue; and sleep problems, constipation, diarrhea, and cognitive functioning.

Seven trials found that PROMs were associated with improved symptom control, positive effects seen in terms of reduced prevalence or severity of physical symptoms, and reduced prevalence, severity, or impact of psychological symptoms, the investigators reported.

Some trials found PROMs to be associated with increased supportive care measures and greater patient satisfaction.

"More research is necessary on the effects of PROM interventions on health outcomes across different types of cancers and treatment modalities," the researchers wrote.

"Additional effort is required to ensure patient adherence, as well as additional support to clinicians who will respond to patient concerns and issues, with clear system guidelines in place to guide their responses. More research is required to support PROM cost-benefit in terms of patient safety, clinician burden, and health," they added.

Dr. Kotronoulas reported no disclosures. Dr. Nora Kearney, a coauthor, disclosed that she received funding from Philips HealthCare. The other authors disclosed no conflicts of interest.

Routinely measuring aspects of health status from the oncology patient’s point of view and using these measures in care improves selected outcomes, according to Grigorios Kotronoulas, Ph.D., and his associates.

The report was published online April 7 in Journal of Clinical Oncology.

For a systematic review, Dr. Kotronoulas and his associates searched five electronic databases through May 2012 to identify controlled trials (whether randomized or not) that tested patient-reported outcome measure (PROM) interventions among adults receiving active anticancer treatment or supportive care, irrespective of type of cancer or stage. The trials had to provide PROM-generated feedback to health care professionals or patients in an effort to improve the quality of care.

The investigators assessed potential impact of the routine PROM use in three broad areas: patient outcomes (e.g., symptom burden, health-related quality of life), processes of care (patient adherence and satisfaction, patient–health professional communication, referrals), and health service outcomes (patient safety, cost-effectiveness).

The search identified 26 articles that reported on 24 unique controlled trials having a total of 6,279 patients and 713 health professionals, reported Dr. Kotronoulas of University of Surrey, Guildford, England, and his colleagues.

The trials had a wide range of designs and used diverse interventions (J. Clin. Oncol. 2014 April 7 [doi:10.1200/JCO.2013.53.5948]). In addition, the outcomes evaluated and cancer- and modality-specific context varied considerably. Although 87.5% of trials reported on patient outcomes and 79.2% reported on processes of care, only 20.8% reported any health service outcomes as endpoints.

Analyses showed that overall, there were few statistically significant associations between routine use of PROMs and a variety of outcomes. Additionally, the intervention effect sizes were generally small to moderate.

Routine use of PROMs did increase the frequency of discussion of patient outcomes during consultations. Interventions had the greatest impact in the context of palliative chemotherapy, where they improved discussion of dyspnea; social functioning and fatigue; and sleep problems, constipation, diarrhea, and cognitive functioning.

Seven trials found that PROMs were associated with improved symptom control, positive effects seen in terms of reduced prevalence or severity of physical symptoms, and reduced prevalence, severity, or impact of psychological symptoms, the investigators reported.

Some trials found PROMs to be associated with increased supportive care measures and greater patient satisfaction.

"More research is necessary on the effects of PROM interventions on health outcomes across different types of cancers and treatment modalities," the researchers wrote.

"Additional effort is required to ensure patient adherence, as well as additional support to clinicians who will respond to patient concerns and issues, with clear system guidelines in place to guide their responses. More research is required to support PROM cost-benefit in terms of patient safety, clinician burden, and health," they added.

Dr. Kotronoulas reported no disclosures. Dr. Nora Kearney, a coauthor, disclosed that she received funding from Philips HealthCare. The other authors disclosed no conflicts of interest.

Routinely measuring aspects of health status from the oncology patient’s point of view and using these measures in care improves selected outcomes, according to Grigorios Kotronoulas, Ph.D., and his associates.

The report was published online April 7 in Journal of Clinical Oncology.

For a systematic review, Dr. Kotronoulas and his associates searched five electronic databases through May 2012 to identify controlled trials (whether randomized or not) that tested patient-reported outcome measure (PROM) interventions among adults receiving active anticancer treatment or supportive care, irrespective of type of cancer or stage. The trials had to provide PROM-generated feedback to health care professionals or patients in an effort to improve the quality of care.

The investigators assessed potential impact of the routine PROM use in three broad areas: patient outcomes (e.g., symptom burden, health-related quality of life), processes of care (patient adherence and satisfaction, patient–health professional communication, referrals), and health service outcomes (patient safety, cost-effectiveness).

The search identified 26 articles that reported on 24 unique controlled trials having a total of 6,279 patients and 713 health professionals, reported Dr. Kotronoulas of University of Surrey, Guildford, England, and his colleagues.

The trials had a wide range of designs and used diverse interventions (J. Clin. Oncol. 2014 April 7 [doi:10.1200/JCO.2013.53.5948]). In addition, the outcomes evaluated and cancer- and modality-specific context varied considerably. Although 87.5% of trials reported on patient outcomes and 79.2% reported on processes of care, only 20.8% reported any health service outcomes as endpoints.

Analyses showed that overall, there were few statistically significant associations between routine use of PROMs and a variety of outcomes. Additionally, the intervention effect sizes were generally small to moderate.

Routine use of PROMs did increase the frequency of discussion of patient outcomes during consultations. Interventions had the greatest impact in the context of palliative chemotherapy, where they improved discussion of dyspnea; social functioning and fatigue; and sleep problems, constipation, diarrhea, and cognitive functioning.

Seven trials found that PROMs were associated with improved symptom control, positive effects seen in terms of reduced prevalence or severity of physical symptoms, and reduced prevalence, severity, or impact of psychological symptoms, the investigators reported.

Some trials found PROMs to be associated with increased supportive care measures and greater patient satisfaction.

"More research is necessary on the effects of PROM interventions on health outcomes across different types of cancers and treatment modalities," the researchers wrote.

"Additional effort is required to ensure patient adherence, as well as additional support to clinicians who will respond to patient concerns and issues, with clear system guidelines in place to guide their responses. More research is required to support PROM cost-benefit in terms of patient safety, clinician burden, and health," they added.

Dr. Kotronoulas reported no disclosures. Dr. Nora Kearney, a coauthor, disclosed that she received funding from Philips HealthCare. The other authors disclosed no conflicts of interest.

The American Society of Clinical Oncology has issued three new practice guidelines related to fatigue; anxiety and depression; and chemotherapy-induced peripheral neuropathy in patients with cancer.

For fatigue, the guideline emphasizes regular screening, treatment of treatable contributing factors, and nonpharmacological interventions such as exercise and cognitive behavioral therapy, allowing for the use of psychostimulants in some patients. For depression and anxiety, the guidelines name no favored medications or regimens but stress identification of at-risk patients through regular screening, along with careful referral to treatment. The guidelines recommend duloxetine to treat chemotherapy-induced peripheral neuropathy.

The guidelines represent the first of what ASCO says is a continuing series on survivorship care. The organization cited the growing importance of managing late treatment and cancer-related effects, as cancer survivors are expected to reach 18 million in the United States by 2022, an increase of nearly 4 million from 2012.

ASCO’s anxiety and depression guideline (doi: 10.1200/JCO.2013.52.4611) derives largely from a Pan-Canadian practice guideline. For its guideline on fatigue in survivors (doi: 10.1200/JCO.2013.53.4495), ASCO integrated recommendations from existing Pan-Canadian guidelines, along with guidelines published by the National Comprehensive Cancer Network. ASCO’s guideline on chemotherapy-induced peripheral neuropathy (CIPN) is original (doi: 10.1200/JCO.2013.54.0914).

The CIPN guideline is based on a review of 48 randomized controlled trials of interventions designed to prevent or alleviate CIPN, which is "relatively distinct from other forms of neuropathic pain in many ways, including pathophysiology and symptomatology," the guideline authors noted, and affects nearly 40% of patients treated with multiple agents.

The new guideline does not recommended any agents for the prevention of CIPN, and rejects a host of agents used in other forms of neuropathic pain – including acetyl-l-carnitine, amifostine, amitriptyline, nimodipine, and vitamin E, among others – for treating established CIPN. Venlafaxine is not recommended either, though "data support its potential utility," the guideline authors acknowledged, saying that further evidence was needed. "The identification of new agents to prevent and/or treat CIPN is essential," they wrote.

Only duloxetine, also used in patients with diabetic neuropathy, is recommended for CIPN. Duloxetine may work better for oxaliplatin-induced, as opposed to paclitaxel-induced, painful neuropathy, the guideline noted, adding that more studies were necessary to confirm this.

ASCO cited three other options as acceptable to try, despite limited evidence, in patients with CIPN: a tricyclic antidepressant such as nortriptyline; gabapentin or pregabalin; and a compounded topical gel made containing baclofen, amitriptyline HCl, and ketamine. But the guideline authors stopped short of making formal recommendations for any of these, citing unproven benefit.

The fatigue guideline promotes a program of physical activity after cancer treatment, also recommending cognitive behavioral therapy and other psychosocial interventions. Yoga and other mind-body interventions are sanctioned, and the stimulant wakefulness agents modafinil and methylphenidate are given cautious recommendation with the caveat that there is limited evidence for their use in patients who have completed treatment and are disease free.

The anxiety and depression guideline stresses that all patients with cancer and who have completed treatment be evaluated regularly for symptoms of depression and anxiety, using validated measures, throughout the trajectory of care. Clinicians are asked to identify the resources available in their communities to treat these disorders.

Four of the CIPN guideline authors, Robert Dworkin, Bryan Schneider, Ellen M. Lavoie Smith, and Charles L. Loprinzi, disclosed receiving compensation or research funding from biomedical or pharmaceutical firms. Of the fatigue guideline authors, Carmelita P. Escalante, Patricia A. Ganz, Gary Lyman, and Paul Jacobsen disclosed research support. None of the depression and anxiety guideline authors disclosed conflicts of interest.

The American Society of Clinical Oncology has issued three new practice guidelines related to fatigue; anxiety and depression; and chemotherapy-induced peripheral neuropathy in patients with cancer.

For fatigue, the guideline emphasizes regular screening, treatment of treatable contributing factors, and nonpharmacological interventions such as exercise and cognitive behavioral therapy, allowing for the use of psychostimulants in some patients. For depression and anxiety, the guidelines name no favored medications or regimens but stress identification of at-risk patients through regular screening, along with careful referral to treatment. The guidelines recommend duloxetine to treat chemotherapy-induced peripheral neuropathy.

The guidelines represent the first of what ASCO says is a continuing series on survivorship care. The organization cited the growing importance of managing late treatment and cancer-related effects, as cancer survivors are expected to reach 18 million in the United States by 2022, an increase of nearly 4 million from 2012.

ASCO’s anxiety and depression guideline (doi: 10.1200/JCO.2013.52.4611) derives largely from a Pan-Canadian practice guideline. For its guideline on fatigue in survivors (doi: 10.1200/JCO.2013.53.4495), ASCO integrated recommendations from existing Pan-Canadian guidelines, along with guidelines published by the National Comprehensive Cancer Network. ASCO’s guideline on chemotherapy-induced peripheral neuropathy (CIPN) is original (doi: 10.1200/JCO.2013.54.0914).

The CIPN guideline is based on a review of 48 randomized controlled trials of interventions designed to prevent or alleviate CIPN, which is "relatively distinct from other forms of neuropathic pain in many ways, including pathophysiology and symptomatology," the guideline authors noted, and affects nearly 40% of patients treated with multiple agents.

The new guideline does not recommended any agents for the prevention of CIPN, and rejects a host of agents used in other forms of neuropathic pain – including acetyl-l-carnitine, amifostine, amitriptyline, nimodipine, and vitamin E, among others – for treating established CIPN. Venlafaxine is not recommended either, though "data support its potential utility," the guideline authors acknowledged, saying that further evidence was needed. "The identification of new agents to prevent and/or treat CIPN is essential," they wrote.

Only duloxetine, also used in patients with diabetic neuropathy, is recommended for CIPN. Duloxetine may work better for oxaliplatin-induced, as opposed to paclitaxel-induced, painful neuropathy, the guideline noted, adding that more studies were necessary to confirm this.

ASCO cited three other options as acceptable to try, despite limited evidence, in patients with CIPN: a tricyclic antidepressant such as nortriptyline; gabapentin or pregabalin; and a compounded topical gel made containing baclofen, amitriptyline HCl, and ketamine. But the guideline authors stopped short of making formal recommendations for any of these, citing unproven benefit.

The fatigue guideline promotes a program of physical activity after cancer treatment, also recommending cognitive behavioral therapy and other psychosocial interventions. Yoga and other mind-body interventions are sanctioned, and the stimulant wakefulness agents modafinil and methylphenidate are given cautious recommendation with the caveat that there is limited evidence for their use in patients who have completed treatment and are disease free.

The anxiety and depression guideline stresses that all patients with cancer and who have completed treatment be evaluated regularly for symptoms of depression and anxiety, using validated measures, throughout the trajectory of care. Clinicians are asked to identify the resources available in their communities to treat these disorders.

Four of the CIPN guideline authors, Robert Dworkin, Bryan Schneider, Ellen M. Lavoie Smith, and Charles L. Loprinzi, disclosed receiving compensation or research funding from biomedical or pharmaceutical firms. Of the fatigue guideline authors, Carmelita P. Escalante, Patricia A. Ganz, Gary Lyman, and Paul Jacobsen disclosed research support. None of the depression and anxiety guideline authors disclosed conflicts of interest.

The American Society of Clinical Oncology has issued three new practice guidelines related to fatigue; anxiety and depression; and chemotherapy-induced peripheral neuropathy in patients with cancer.

For fatigue, the guideline emphasizes regular screening, treatment of treatable contributing factors, and nonpharmacological interventions such as exercise and cognitive behavioral therapy, allowing for the use of psychostimulants in some patients. For depression and anxiety, the guidelines name no favored medications or regimens but stress identification of at-risk patients through regular screening, along with careful referral to treatment. The guidelines recommend duloxetine to treat chemotherapy-induced peripheral neuropathy.

The guidelines represent the first of what ASCO says is a continuing series on survivorship care. The organization cited the growing importance of managing late treatment and cancer-related effects, as cancer survivors are expected to reach 18 million in the United States by 2022, an increase of nearly 4 million from 2012.

ASCO’s anxiety and depression guideline (doi: 10.1200/JCO.2013.52.4611) derives largely from a Pan-Canadian practice guideline. For its guideline on fatigue in survivors (doi: 10.1200/JCO.2013.53.4495), ASCO integrated recommendations from existing Pan-Canadian guidelines, along with guidelines published by the National Comprehensive Cancer Network. ASCO’s guideline on chemotherapy-induced peripheral neuropathy (CIPN) is original (doi: 10.1200/JCO.2013.54.0914).

The CIPN guideline is based on a review of 48 randomized controlled trials of interventions designed to prevent or alleviate CIPN, which is "relatively distinct from other forms of neuropathic pain in many ways, including pathophysiology and symptomatology," the guideline authors noted, and affects nearly 40% of patients treated with multiple agents.

The new guideline does not recommended any agents for the prevention of CIPN, and rejects a host of agents used in other forms of neuropathic pain – including acetyl-l-carnitine, amifostine, amitriptyline, nimodipine, and vitamin E, among others – for treating established CIPN. Venlafaxine is not recommended either, though "data support its potential utility," the guideline authors acknowledged, saying that further evidence was needed. "The identification of new agents to prevent and/or treat CIPN is essential," they wrote.

Only duloxetine, also used in patients with diabetic neuropathy, is recommended for CIPN. Duloxetine may work better for oxaliplatin-induced, as opposed to paclitaxel-induced, painful neuropathy, the guideline noted, adding that more studies were necessary to confirm this.

ASCO cited three other options as acceptable to try, despite limited evidence, in patients with CIPN: a tricyclic antidepressant such as nortriptyline; gabapentin or pregabalin; and a compounded topical gel made containing baclofen, amitriptyline HCl, and ketamine. But the guideline authors stopped short of making formal recommendations for any of these, citing unproven benefit.

The fatigue guideline promotes a program of physical activity after cancer treatment, also recommending cognitive behavioral therapy and other psychosocial interventions. Yoga and other mind-body interventions are sanctioned, and the stimulant wakefulness agents modafinil and methylphenidate are given cautious recommendation with the caveat that there is limited evidence for their use in patients who have completed treatment and are disease free.

The anxiety and depression guideline stresses that all patients with cancer and who have completed treatment be evaluated regularly for symptoms of depression and anxiety, using validated measures, throughout the trajectory of care. Clinicians are asked to identify the resources available in their communities to treat these disorders.

Four of the CIPN guideline authors, Robert Dworkin, Bryan Schneider, Ellen M. Lavoie Smith, and Charles L. Loprinzi, disclosed receiving compensation or research funding from biomedical or pharmaceutical firms. Of the fatigue guideline authors, Carmelita P. Escalante, Patricia A. Ganz, Gary Lyman, and Paul Jacobsen disclosed research support. None of the depression and anxiety guideline authors disclosed conflicts of interest.