2012 ASCO Annual Meeting

Many primary care physicians – and even some oncologists – are unaware of common long-term side effects of four widely used breast and colorectal cancer drugs, a national survey by the National Cancer Institute reveals.

Only 6% of primary care physicians were able to identify the main long-term effects (LEs) of doxorubicin (Adriamycin), paclitaxel (Taxol), oxaliplatin (Eloxatin), and cyclophosphamide (Cytoxan), compared with 65% of oncologists surveyed.

The results are not surprising, but they underscore the need for ongoing education among all physicians who care for the more than 12 million cancer survivors in the United States, lead author Dr. Larissa Nekhlyudov said during a press briefing highlighting research to be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO).

"These findings emphasize that in the transition of patients from oncology to primary care settings, primary care providers should be informed about the late effects of cancer treatment so that they may be better prepared to recognize and address these among cancer survivors in their care," said Dr. Nekhlyudov, a primary care physician (PCP) with Harvard Medical School in Boston and Harvard Vanguard Medical Associates in Kenmore, Mass. "Whether this will be achieved with survivorship care plans needs to be evaluated."

The "Survey of Physician Attitudes Regarding the Care of Cancer Survivors" was launched by the National Cancer Institute in 2009, with one survey mailed to a nationally representative sample of 1,072 PCPs and the other to 1,130 medical oncologists who only cared for patients with colorectal or breast cancer.

When asked to report the five LEs they had observed and/or had seen reported in the literature for each of the four standard chemotherapy drugs, 95% of oncologists identified cardiac dysfunction as an LE of doxorubicin, compared with 55% of PCPs (P less than .0001), Dr. Nekhlyudov said.

Similarly, peripheral neuropathy was correctly identified as an LE of paclitaxel and of oxaliplatin by 97% of oncologists, but by only 27% and 22%, respectively, of PCPs (both P less than .0001).

The survey suggests, however, that some oncologists could also use additional continuing education. Premature menopause and secondary malignancies – two long-term effects associated with the alkylating agent cyclophosphamide – were identified by only 71% and 62% of oncologists, respectively, along with 15% and 17%, respectively, of PCPs.

Oncologists and PCPs mostly missed pulmonary fibrosis as a late effect for paclitaxel (5% and 6%, respectively; P = .42) or oxaliplatin (5% and. 9%, respectively; P = .0002). They did a little better in pointing out a possible association with cyclophosphamide (20.6% and 13%; P less than .0001), which has been noted in the literature, she observed.

Dr. Nekhlyudov suggested that the lack of awareness among oncologists is likely because much of the focus has been on the treatment of cancer, and only recently have physicians become aware of the importance of survivorship and the potential for late effects.

"While it is surprising that oncologists were not more aware of late effects, I think that as more and more attention is placed on cancer survivorship, oncologists will become more equipped with that information," she said.

ASCO president and press briefing comoderator Dr. Michael Link said the problem of survivorship has long been recognized in pediatric oncology, where patients frequently relocate, outgrow their pediatrician, or even deny they ever had cancer. Groups such as ASCO and the Institute of Medicine, most recently through its "Lost in Transition" report, have offered guidance for improving transitions among survivors, including the provision of a cancer care plan.

"I think the need for all of this has been highlighted in this abstract and certainly, it’s a shot across the bow with things that need to be done," he said.

In adjusted analyses, oncologists who were not board certified were less likely to identify the main LEs for all four drugs (odds ratio, 0.58).Oncologists were more likely to know their LEs if they spent 51%-90% of their time on patient care (OR, 1.87) or more than 90% of their time with patients (OR, 1.82). Age, sex, race, U.S. training, type of practice, and percentage of uninsured patients were not associated with LE awareness, Dr. Nekhlyudov said.

Previous results from the survey reported at last year’s ASCO annual meeting indicated that PCPs had low confidence in their knowledge of breast and colon cancer survivors, and reported low marks for their skills in caring for these patients. In addition, neither PCPs nor oncologists felt that a PCP-led model was ideal for survivorship care (J. Clin. Oncol. 2011;29[suppl.];abstract CRA9006).

Dr. Nekhlyudov will formally present her study at ASCO at 5:30 p.m. June 2. The abstract can be viewed at www.abstract.asco.org.

The authors reported no disclosures.

Many primary care physicians – and even some oncologists – are unaware of common long-term side effects of four widely used breast and colorectal cancer drugs, a national survey by the National Cancer Institute reveals.

Only 6% of primary care physicians were able to identify the main long-term effects (LEs) of doxorubicin (Adriamycin), paclitaxel (Taxol), oxaliplatin (Eloxatin), and cyclophosphamide (Cytoxan), compared with 65% of oncologists surveyed.

The results are not surprising, but they underscore the need for ongoing education among all physicians who care for the more than 12 million cancer survivors in the United States, lead author Dr. Larissa Nekhlyudov said during a press briefing highlighting research to be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO).

"These findings emphasize that in the transition of patients from oncology to primary care settings, primary care providers should be informed about the late effects of cancer treatment so that they may be better prepared to recognize and address these among cancer survivors in their care," said Dr. Nekhlyudov, a primary care physician (PCP) with Harvard Medical School in Boston and Harvard Vanguard Medical Associates in Kenmore, Mass. "Whether this will be achieved with survivorship care plans needs to be evaluated."

The "Survey of Physician Attitudes Regarding the Care of Cancer Survivors" was launched by the National Cancer Institute in 2009, with one survey mailed to a nationally representative sample of 1,072 PCPs and the other to 1,130 medical oncologists who only cared for patients with colorectal or breast cancer.

When asked to report the five LEs they had observed and/or had seen reported in the literature for each of the four standard chemotherapy drugs, 95% of oncologists identified cardiac dysfunction as an LE of doxorubicin, compared with 55% of PCPs (P less than .0001), Dr. Nekhlyudov said.

Similarly, peripheral neuropathy was correctly identified as an LE of paclitaxel and of oxaliplatin by 97% of oncologists, but by only 27% and 22%, respectively, of PCPs (both P less than .0001).

The survey suggests, however, that some oncologists could also use additional continuing education. Premature menopause and secondary malignancies – two long-term effects associated with the alkylating agent cyclophosphamide – were identified by only 71% and 62% of oncologists, respectively, along with 15% and 17%, respectively, of PCPs.

Oncologists and PCPs mostly missed pulmonary fibrosis as a late effect for paclitaxel (5% and 6%, respectively; P = .42) or oxaliplatin (5% and. 9%, respectively; P = .0002). They did a little better in pointing out a possible association with cyclophosphamide (20.6% and 13%; P less than .0001), which has been noted in the literature, she observed.

Dr. Nekhlyudov suggested that the lack of awareness among oncologists is likely because much of the focus has been on the treatment of cancer, and only recently have physicians become aware of the importance of survivorship and the potential for late effects.

"While it is surprising that oncologists were not more aware of late effects, I think that as more and more attention is placed on cancer survivorship, oncologists will become more equipped with that information," she said.

ASCO president and press briefing comoderator Dr. Michael Link said the problem of survivorship has long been recognized in pediatric oncology, where patients frequently relocate, outgrow their pediatrician, or even deny they ever had cancer. Groups such as ASCO and the Institute of Medicine, most recently through its "Lost in Transition" report, have offered guidance for improving transitions among survivors, including the provision of a cancer care plan.

"I think the need for all of this has been highlighted in this abstract and certainly, it’s a shot across the bow with things that need to be done," he said.

In adjusted analyses, oncologists who were not board certified were less likely to identify the main LEs for all four drugs (odds ratio, 0.58).Oncologists were more likely to know their LEs if they spent 51%-90% of their time on patient care (OR, 1.87) or more than 90% of their time with patients (OR, 1.82). Age, sex, race, U.S. training, type of practice, and percentage of uninsured patients were not associated with LE awareness, Dr. Nekhlyudov said.

Previous results from the survey reported at last year’s ASCO annual meeting indicated that PCPs had low confidence in their knowledge of breast and colon cancer survivors, and reported low marks for their skills in caring for these patients. In addition, neither PCPs nor oncologists felt that a PCP-led model was ideal for survivorship care (J. Clin. Oncol. 2011;29[suppl.];abstract CRA9006).

Dr. Nekhlyudov will formally present her study at ASCO at 5:30 p.m. June 2. The abstract can be viewed at www.abstract.asco.org.

The authors reported no disclosures.

Many primary care physicians – and even some oncologists – are unaware of common long-term side effects of four widely used breast and colorectal cancer drugs, a national survey by the National Cancer Institute reveals.

Only 6% of primary care physicians were able to identify the main long-term effects (LEs) of doxorubicin (Adriamycin), paclitaxel (Taxol), oxaliplatin (Eloxatin), and cyclophosphamide (Cytoxan), compared with 65% of oncologists surveyed.

The results are not surprising, but they underscore the need for ongoing education among all physicians who care for the more than 12 million cancer survivors in the United States, lead author Dr. Larissa Nekhlyudov said during a press briefing highlighting research to be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO).

"These findings emphasize that in the transition of patients from oncology to primary care settings, primary care providers should be informed about the late effects of cancer treatment so that they may be better prepared to recognize and address these among cancer survivors in their care," said Dr. Nekhlyudov, a primary care physician (PCP) with Harvard Medical School in Boston and Harvard Vanguard Medical Associates in Kenmore, Mass. "Whether this will be achieved with survivorship care plans needs to be evaluated."

The "Survey of Physician Attitudes Regarding the Care of Cancer Survivors" was launched by the National Cancer Institute in 2009, with one survey mailed to a nationally representative sample of 1,072 PCPs and the other to 1,130 medical oncologists who only cared for patients with colorectal or breast cancer.

When asked to report the five LEs they had observed and/or had seen reported in the literature for each of the four standard chemotherapy drugs, 95% of oncologists identified cardiac dysfunction as an LE of doxorubicin, compared with 55% of PCPs (P less than .0001), Dr. Nekhlyudov said.

Similarly, peripheral neuropathy was correctly identified as an LE of paclitaxel and of oxaliplatin by 97% of oncologists, but by only 27% and 22%, respectively, of PCPs (both P less than .0001).

The survey suggests, however, that some oncologists could also use additional continuing education. Premature menopause and secondary malignancies – two long-term effects associated with the alkylating agent cyclophosphamide – were identified by only 71% and 62% of oncologists, respectively, along with 15% and 17%, respectively, of PCPs.

Oncologists and PCPs mostly missed pulmonary fibrosis as a late effect for paclitaxel (5% and 6%, respectively; P = .42) or oxaliplatin (5% and. 9%, respectively; P = .0002). They did a little better in pointing out a possible association with cyclophosphamide (20.6% and 13%; P less than .0001), which has been noted in the literature, she observed.

Dr. Nekhlyudov suggested that the lack of awareness among oncologists is likely because much of the focus has been on the treatment of cancer, and only recently have physicians become aware of the importance of survivorship and the potential for late effects.

"While it is surprising that oncologists were not more aware of late effects, I think that as more and more attention is placed on cancer survivorship, oncologists will become more equipped with that information," she said.

ASCO president and press briefing comoderator Dr. Michael Link said the problem of survivorship has long been recognized in pediatric oncology, where patients frequently relocate, outgrow their pediatrician, or even deny they ever had cancer. Groups such as ASCO and the Institute of Medicine, most recently through its "Lost in Transition" report, have offered guidance for improving transitions among survivors, including the provision of a cancer care plan.

"I think the need for all of this has been highlighted in this abstract and certainly, it’s a shot across the bow with things that need to be done," he said.

In adjusted analyses, oncologists who were not board certified were less likely to identify the main LEs for all four drugs (odds ratio, 0.58).Oncologists were more likely to know their LEs if they spent 51%-90% of their time on patient care (OR, 1.87) or more than 90% of their time with patients (OR, 1.82). Age, sex, race, U.S. training, type of practice, and percentage of uninsured patients were not associated with LE awareness, Dr. Nekhlyudov said.

Previous results from the survey reported at last year’s ASCO annual meeting indicated that PCPs had low confidence in their knowledge of breast and colon cancer survivors, and reported low marks for their skills in caring for these patients. In addition, neither PCPs nor oncologists felt that a PCP-led model was ideal for survivorship care (J. Clin. Oncol. 2011;29[suppl.];abstract CRA9006).

Dr. Nekhlyudov will formally present her study at ASCO at 5:30 p.m. June 2. The abstract can be viewed at www.abstract.asco.org.

The authors reported no disclosures.

Neoadjuvant abiraterone helped clear tumors in one-third of men with localized, high-risk prostate cancer in an ongoing randomized phase II trial, investigators report.

At 6 months, a pathological complete response (pCR) or near pCR was achieved by 34% of men given abiraterone (Zytiga) plus prednisone and leuprolide, compared with 15% of men given leuprolide alone (P = .089). Both groups underwent biopsy and further combination therapy with abiraterone, prednisone, and leuprolide before radical prostatectomy.

The 34% response rate is higher than historic controls and unique in the treatment of prostate cancer, where unlike breast and other cancers, neoadjuvant therapies have not shown a benefit to date, Dr. Mary-Ellen Taplin said during a press briefing highlighting research to be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO).

Abiraterone, a highly selective oral CYP17A1 (17 alpha-hydroxylase/C17,20 lyase complex) inhibitor, was approved last September, for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer previously treated with chemotherapy containing docetaxel (Taxotere).

Dr. Taplin, a medical oncologist at the Dana-Farber Cancer Institute in Boston, said the long-term significance of obtaining a complete response needs to be validated in large, randomized trials, but characterized the response rates as "very impressive given the high-risk features of these patients."

Notably, 71% of the 58 patients had a Gleason score of 8-10, 19% had a prostate-specific antigen (PSA) of more than 20 ng/mL, and all had T3 or T4 disease on prostate exam.

Presscast moderator Dr. Nicholas Vogelzang, cochair of the genitourinary committee for U.S. Oncology and the Southwestern Oncology Group, remarked that "This is one of the first, if not the first study, to show that you can make prostate cancer in the prostate gland itself disappear in a reproducible number of patients.

"This is reminiscent of what we see with rectal cancer when we give chemotherapy and radiation prior to surgery and this is what has now become a standard for breast cancer. Theoretically, at least in the breast cancer literature, when you get a complete disappearance in the primary disease, the outcomes are much better than historically."

When asked whether the current data will push clinicians to use abiraterone off-label in earlier-stage disease, Dr. Taplin said it’s unlikely based on results from a safety trial and the cost of the drug at roughly $7,000/month.

The trial enrolled patients with newly diagnosed intermediate and high-risk prostate cancer with at least three positive biopsies and either a Gleason score of 7 or more, stage T3 disease and a PSA of at least 20 ng/mL or a PSA velocity of more than 2 ng/mL per year. Their median age was 58 years.

The men were randomized to 12 weeks of abiraterone 1,000 mg/day plus prednisone 5 mg/day and leuprolide 22.5 mg or leuprolide 22.5 mg alone. A prostate biopsy was then performed and the men received 12 additional weeks of the triple-combination therapy followed by radical prostatectomy.

A pCR was observed in 10% of the 29 men given all 24 weeks of combination abiraterone and 4% of the 27 men given only 12 weeks of the combination therapy (P = .33), Dr. Taplin said.

A near CR, defined by tumor size of 5 mm or less, was reported in 24% and 11% of patients, respectively.

When asked whether patients with a pCR could forgo surgery, Dr. Taplin said it’s possible, but that it would take a very carefully designed trial to make that leap at this point.

"We’re relatively far from doing this at this point, but these drugs, these new hormonal agents are very powerful and it will definitely be an area of investigation," she said.

The neoadjuvant therapy resulted in low systemic and surgical toxicity. Grade 3 adverse events included elevated AST/ALT in 9% and hypokalemia in 5% of all patients. No grade 4 mineralocorticoid-related adverse events were observed.

"We were able to prove in this study that half the amount of prednisone given in more advanced patients – that is just 5 mg/day – prevented any side effects from abiraterone and may reduce the use of higher doses of steroids in all patients being treated with this drug," Dr. Taplin said.

She noted that a similar trial is being planned that would add the novel androgen-receptor antagonist ARN509 to abiraterone and leuprolide, while a second study is ongoing investigating abiraterone and the experimental hormone drug MDV3100 in this group of patients.

The abstract can be viewed at www.abstract.asco.org and will be formally presented at ASCO on June 2 (Abstract 4521).

In related news, the European National Institute for Health and Clinical Excellence just gave abiraterone the nod for late-stage cancer patients in England and Wales, after initially rejecting the drug for not being cost effective at roughly £3,000 a month.

Cougar Biotechnology sponsored the trial. Dr. Taplin reported consulting or advising for and honoraria and research funding from Johnson & Johnson, which markets abiraterone through Janssen Pharmaceuticals. Her coauthors reported financial relationships with several firms including employment and stock ownership with Johnson & Johnson.

Neoadjuvant abiraterone helped clear tumors in one-third of men with localized, high-risk prostate cancer in an ongoing randomized phase II trial, investigators report.

At 6 months, a pathological complete response (pCR) or near pCR was achieved by 34% of men given abiraterone (Zytiga) plus prednisone and leuprolide, compared with 15% of men given leuprolide alone (P = .089). Both groups underwent biopsy and further combination therapy with abiraterone, prednisone, and leuprolide before radical prostatectomy.

The 34% response rate is higher than historic controls and unique in the treatment of prostate cancer, where unlike breast and other cancers, neoadjuvant therapies have not shown a benefit to date, Dr. Mary-Ellen Taplin said during a press briefing highlighting research to be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO).

Abiraterone, a highly selective oral CYP17A1 (17 alpha-hydroxylase/C17,20 lyase complex) inhibitor, was approved last September, for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer previously treated with chemotherapy containing docetaxel (Taxotere).

Dr. Taplin, a medical oncologist at the Dana-Farber Cancer Institute in Boston, said the long-term significance of obtaining a complete response needs to be validated in large, randomized trials, but characterized the response rates as "very impressive given the high-risk features of these patients."

Notably, 71% of the 58 patients had a Gleason score of 8-10, 19% had a prostate-specific antigen (PSA) of more than 20 ng/mL, and all had T3 or T4 disease on prostate exam.

Presscast moderator Dr. Nicholas Vogelzang, cochair of the genitourinary committee for U.S. Oncology and the Southwestern Oncology Group, remarked that "This is one of the first, if not the first study, to show that you can make prostate cancer in the prostate gland itself disappear in a reproducible number of patients.

"This is reminiscent of what we see with rectal cancer when we give chemotherapy and radiation prior to surgery and this is what has now become a standard for breast cancer. Theoretically, at least in the breast cancer literature, when you get a complete disappearance in the primary disease, the outcomes are much better than historically."

When asked whether the current data will push clinicians to use abiraterone off-label in earlier-stage disease, Dr. Taplin said it’s unlikely based on results from a safety trial and the cost of the drug at roughly $7,000/month.

The trial enrolled patients with newly diagnosed intermediate and high-risk prostate cancer with at least three positive biopsies and either a Gleason score of 7 or more, stage T3 disease and a PSA of at least 20 ng/mL or a PSA velocity of more than 2 ng/mL per year. Their median age was 58 years.

The men were randomized to 12 weeks of abiraterone 1,000 mg/day plus prednisone 5 mg/day and leuprolide 22.5 mg or leuprolide 22.5 mg alone. A prostate biopsy was then performed and the men received 12 additional weeks of the triple-combination therapy followed by radical prostatectomy.

A pCR was observed in 10% of the 29 men given all 24 weeks of combination abiraterone and 4% of the 27 men given only 12 weeks of the combination therapy (P = .33), Dr. Taplin said.

A near CR, defined by tumor size of 5 mm or less, was reported in 24% and 11% of patients, respectively.

When asked whether patients with a pCR could forgo surgery, Dr. Taplin said it’s possible, but that it would take a very carefully designed trial to make that leap at this point.

"We’re relatively far from doing this at this point, but these drugs, these new hormonal agents are very powerful and it will definitely be an area of investigation," she said.

The neoadjuvant therapy resulted in low systemic and surgical toxicity. Grade 3 adverse events included elevated AST/ALT in 9% and hypokalemia in 5% of all patients. No grade 4 mineralocorticoid-related adverse events were observed.

"We were able to prove in this study that half the amount of prednisone given in more advanced patients – that is just 5 mg/day – prevented any side effects from abiraterone and may reduce the use of higher doses of steroids in all patients being treated with this drug," Dr. Taplin said.

She noted that a similar trial is being planned that would add the novel androgen-receptor antagonist ARN509 to abiraterone and leuprolide, while a second study is ongoing investigating abiraterone and the experimental hormone drug MDV3100 in this group of patients.

The abstract can be viewed at www.abstract.asco.org and will be formally presented at ASCO on June 2 (Abstract 4521).

In related news, the European National Institute for Health and Clinical Excellence just gave abiraterone the nod for late-stage cancer patients in England and Wales, after initially rejecting the drug for not being cost effective at roughly £3,000 a month.

Cougar Biotechnology sponsored the trial. Dr. Taplin reported consulting or advising for and honoraria and research funding from Johnson & Johnson, which markets abiraterone through Janssen Pharmaceuticals. Her coauthors reported financial relationships with several firms including employment and stock ownership with Johnson & Johnson.

Neoadjuvant abiraterone helped clear tumors in one-third of men with localized, high-risk prostate cancer in an ongoing randomized phase II trial, investigators report.

At 6 months, a pathological complete response (pCR) or near pCR was achieved by 34% of men given abiraterone (Zytiga) plus prednisone and leuprolide, compared with 15% of men given leuprolide alone (P = .089). Both groups underwent biopsy and further combination therapy with abiraterone, prednisone, and leuprolide before radical prostatectomy.

The 34% response rate is higher than historic controls and unique in the treatment of prostate cancer, where unlike breast and other cancers, neoadjuvant therapies have not shown a benefit to date, Dr. Mary-Ellen Taplin said during a press briefing highlighting research to be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO).

Abiraterone, a highly selective oral CYP17A1 (17 alpha-hydroxylase/C17,20 lyase complex) inhibitor, was approved last September, for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer previously treated with chemotherapy containing docetaxel (Taxotere).

Dr. Taplin, a medical oncologist at the Dana-Farber Cancer Institute in Boston, said the long-term significance of obtaining a complete response needs to be validated in large, randomized trials, but characterized the response rates as "very impressive given the high-risk features of these patients."

Notably, 71% of the 58 patients had a Gleason score of 8-10, 19% had a prostate-specific antigen (PSA) of more than 20 ng/mL, and all had T3 or T4 disease on prostate exam.

Presscast moderator Dr. Nicholas Vogelzang, cochair of the genitourinary committee for U.S. Oncology and the Southwestern Oncology Group, remarked that "This is one of the first, if not the first study, to show that you can make prostate cancer in the prostate gland itself disappear in a reproducible number of patients.

"This is reminiscent of what we see with rectal cancer when we give chemotherapy and radiation prior to surgery and this is what has now become a standard for breast cancer. Theoretically, at least in the breast cancer literature, when you get a complete disappearance in the primary disease, the outcomes are much better than historically."

When asked whether the current data will push clinicians to use abiraterone off-label in earlier-stage disease, Dr. Taplin said it’s unlikely based on results from a safety trial and the cost of the drug at roughly $7,000/month.

The trial enrolled patients with newly diagnosed intermediate and high-risk prostate cancer with at least three positive biopsies and either a Gleason score of 7 or more, stage T3 disease and a PSA of at least 20 ng/mL or a PSA velocity of more than 2 ng/mL per year. Their median age was 58 years.

The men were randomized to 12 weeks of abiraterone 1,000 mg/day plus prednisone 5 mg/day and leuprolide 22.5 mg or leuprolide 22.5 mg alone. A prostate biopsy was then performed and the men received 12 additional weeks of the triple-combination therapy followed by radical prostatectomy.

A pCR was observed in 10% of the 29 men given all 24 weeks of combination abiraterone and 4% of the 27 men given only 12 weeks of the combination therapy (P = .33), Dr. Taplin said.

A near CR, defined by tumor size of 5 mm or less, was reported in 24% and 11% of patients, respectively.

When asked whether patients with a pCR could forgo surgery, Dr. Taplin said it’s possible, but that it would take a very carefully designed trial to make that leap at this point.

"We’re relatively far from doing this at this point, but these drugs, these new hormonal agents are very powerful and it will definitely be an area of investigation," she said.

The neoadjuvant therapy resulted in low systemic and surgical toxicity. Grade 3 adverse events included elevated AST/ALT in 9% and hypokalemia in 5% of all patients. No grade 4 mineralocorticoid-related adverse events were observed.

"We were able to prove in this study that half the amount of prednisone given in more advanced patients – that is just 5 mg/day – prevented any side effects from abiraterone and may reduce the use of higher doses of steroids in all patients being treated with this drug," Dr. Taplin said.

She noted that a similar trial is being planned that would add the novel androgen-receptor antagonist ARN509 to abiraterone and leuprolide, while a second study is ongoing investigating abiraterone and the experimental hormone drug MDV3100 in this group of patients.

The abstract can be viewed at www.abstract.asco.org and will be formally presented at ASCO on June 2 (Abstract 4521).

In related news, the European National Institute for Health and Clinical Excellence just gave abiraterone the nod for late-stage cancer patients in England and Wales, after initially rejecting the drug for not being cost effective at roughly £3,000 a month.

Cougar Biotechnology sponsored the trial. Dr. Taplin reported consulting or advising for and honoraria and research funding from Johnson & Johnson, which markets abiraterone through Janssen Pharmaceuticals. Her coauthors reported financial relationships with several firms including employment and stock ownership with Johnson & Johnson.

The antipsychotic olanzapine trounced standard therapy for breakthrough chemotherapy-induced nausea and vomiting in a clinical trial that could change the way some cancer patients are treated.

In the double-blind phase III study, 30 (71%) of 42 patients, who received olanzapine (Zyprexa) had no emesis, compared with 12 (32%) of 38 patients who received metoclopramide (P less than .01) during a 72-hour observation period after highly emetic chemotherapy.

In addition, 28 (67%) patients on olanzapine had no nausea, compared with 9 (24%) of those patients on metoclopramide (P less than .01), said Dr. Rudolph M. Navari, who presented the study during a press briefing in advance of the annual meeting of American Society of Clinical Oncology, June 1-5, in Chicago. Dr. Navari is the director of the Harper Cancer Institute at Indiana University in South Bend.

ASCO president-elect Dr. Sandra M. Swain, medical director of the Cancer Institute at Washington Hospital Center, called the findings "a great step forward for quality of life for our patients.

"This is a huge advance," said Dr. Swain, a breast cancer expert, who comoderated the teleconference. "We’ve come a long way to really treat and cure these patients ... these side effects can be intolerable to patients. Sometimes patients will opt out of curative treatment, and we certainly don’t want that, when we know we’ve made advances."

The researchers included chemotherapy-naive patients who received highly emetogenic chemotherapy: more than 70 mg/m² cisplatin, or more than 50 mg/m² doxorubicin and more than 600 mg/m² cyclophosphamide.

Patients who developed breakthrough emesis or nausea despite guideline-directed prophylaxis were randomized to receive olanzapine or metoclopramide. Pre-chemotherapy prophylaxis included intravenous dexamethasone (12 mg), intravenous palonosetron (0.25 mg), and intravenous fosaprepitant (150 mg); post-chemotherapy prophylaxis was daily oral dexamethasone (8 mg, days 2-4).

Patients received 10 mg oral olanzapine for 3 days or 10 mg oral metoclopramide three times daily for 3 days. Patients were monitored for emesis and nausea for the 72 hours after the initiation of therapy. In addition, nausea was measured by patients on a visual analog scale (0-10), with 0 being no nausea and 10 being maximal nausea.

Patients in the two groups were similar for age, sex, Eastern Cooperative Oncology Group (ECOG) performance status, and diagnosis (5 bladder cancers, 40 breast cancers, 8 lymphomas, and 27 lung cancers).

"Both olanzapine and metoclopramide were well tolerated with no grade 3 or 4 toxicities," said Dr. Navari. No central nervous system toxicities were observed in either group.

Olanzapine is indicated for treatment of psychosis and is associated with weight gain, but the side effect should not be a problem for cancer patients.

"The side effect of weight gain occurs in patients, who receive the drug for 3 to 6 to 9 months," Dr. Ravari noted. "So using it for a short period of 3-4 days once a month – we did not see that in the current study, nor did we see that in previous studies."

Dr. Navari had previously reported that patients receiving highly emetogenic chemotherapy were about twice as likely not to experience any delayed nausea with an olanzapine regimen compared with a standard aprepitant (Emend) regimen (68% vs. 37%) in a phase III clinical trial. The two regimens worked similarly well for preventing acute nausea and for preventing both acute and delayed vomiting, that study found (Support. Oncol. 2011;9:188-95).

ASCO presented a preview of some meeting highlights with many of the abstracts being posted online as of 6 p.m. EST at www.asco.org.

The authors reported that they have nothing to disclose.

The antipsychotic olanzapine trounced standard therapy for breakthrough chemotherapy-induced nausea and vomiting in a clinical trial that could change the way some cancer patients are treated.

In the double-blind phase III study, 30 (71%) of 42 patients, who received olanzapine (Zyprexa) had no emesis, compared with 12 (32%) of 38 patients who received metoclopramide (P less than .01) during a 72-hour observation period after highly emetic chemotherapy.

In addition, 28 (67%) patients on olanzapine had no nausea, compared with 9 (24%) of those patients on metoclopramide (P less than .01), said Dr. Rudolph M. Navari, who presented the study during a press briefing in advance of the annual meeting of American Society of Clinical Oncology, June 1-5, in Chicago. Dr. Navari is the director of the Harper Cancer Institute at Indiana University in South Bend.

ASCO president-elect Dr. Sandra M. Swain, medical director of the Cancer Institute at Washington Hospital Center, called the findings "a great step forward for quality of life for our patients.

"This is a huge advance," said Dr. Swain, a breast cancer expert, who comoderated the teleconference. "We’ve come a long way to really treat and cure these patients ... these side effects can be intolerable to patients. Sometimes patients will opt out of curative treatment, and we certainly don’t want that, when we know we’ve made advances."

The researchers included chemotherapy-naive patients who received highly emetogenic chemotherapy: more than 70 mg/m² cisplatin, or more than 50 mg/m² doxorubicin and more than 600 mg/m² cyclophosphamide.

Patients who developed breakthrough emesis or nausea despite guideline-directed prophylaxis were randomized to receive olanzapine or metoclopramide. Pre-chemotherapy prophylaxis included intravenous dexamethasone (12 mg), intravenous palonosetron (0.25 mg), and intravenous fosaprepitant (150 mg); post-chemotherapy prophylaxis was daily oral dexamethasone (8 mg, days 2-4).

Patients received 10 mg oral olanzapine for 3 days or 10 mg oral metoclopramide three times daily for 3 days. Patients were monitored for emesis and nausea for the 72 hours after the initiation of therapy. In addition, nausea was measured by patients on a visual analog scale (0-10), with 0 being no nausea and 10 being maximal nausea.

Patients in the two groups were similar for age, sex, Eastern Cooperative Oncology Group (ECOG) performance status, and diagnosis (5 bladder cancers, 40 breast cancers, 8 lymphomas, and 27 lung cancers).

"Both olanzapine and metoclopramide were well tolerated with no grade 3 or 4 toxicities," said Dr. Navari. No central nervous system toxicities were observed in either group.

Olanzapine is indicated for treatment of psychosis and is associated with weight gain, but the side effect should not be a problem for cancer patients.

"The side effect of weight gain occurs in patients, who receive the drug for 3 to 6 to 9 months," Dr. Ravari noted. "So using it for a short period of 3-4 days once a month – we did not see that in the current study, nor did we see that in previous studies."

Dr. Navari had previously reported that patients receiving highly emetogenic chemotherapy were about twice as likely not to experience any delayed nausea with an olanzapine regimen compared with a standard aprepitant (Emend) regimen (68% vs. 37%) in a phase III clinical trial. The two regimens worked similarly well for preventing acute nausea and for preventing both acute and delayed vomiting, that study found (Support. Oncol. 2011;9:188-95).

ASCO presented a preview of some meeting highlights with many of the abstracts being posted online as of 6 p.m. EST at www.asco.org.

The authors reported that they have nothing to disclose.

The antipsychotic olanzapine trounced standard therapy for breakthrough chemotherapy-induced nausea and vomiting in a clinical trial that could change the way some cancer patients are treated.

In the double-blind phase III study, 30 (71%) of 42 patients, who received olanzapine (Zyprexa) had no emesis, compared with 12 (32%) of 38 patients who received metoclopramide (P less than .01) during a 72-hour observation period after highly emetic chemotherapy.

In addition, 28 (67%) patients on olanzapine had no nausea, compared with 9 (24%) of those patients on metoclopramide (P less than .01), said Dr. Rudolph M. Navari, who presented the study during a press briefing in advance of the annual meeting of American Society of Clinical Oncology, June 1-5, in Chicago. Dr. Navari is the director of the Harper Cancer Institute at Indiana University in South Bend.

ASCO president-elect Dr. Sandra M. Swain, medical director of the Cancer Institute at Washington Hospital Center, called the findings "a great step forward for quality of life for our patients.

"This is a huge advance," said Dr. Swain, a breast cancer expert, who comoderated the teleconference. "We’ve come a long way to really treat and cure these patients ... these side effects can be intolerable to patients. Sometimes patients will opt out of curative treatment, and we certainly don’t want that, when we know we’ve made advances."

The researchers included chemotherapy-naive patients who received highly emetogenic chemotherapy: more than 70 mg/m² cisplatin, or more than 50 mg/m² doxorubicin and more than 600 mg/m² cyclophosphamide.

Patients who developed breakthrough emesis or nausea despite guideline-directed prophylaxis were randomized to receive olanzapine or metoclopramide. Pre-chemotherapy prophylaxis included intravenous dexamethasone (12 mg), intravenous palonosetron (0.25 mg), and intravenous fosaprepitant (150 mg); post-chemotherapy prophylaxis was daily oral dexamethasone (8 mg, days 2-4).

Patients received 10 mg oral olanzapine for 3 days or 10 mg oral metoclopramide three times daily for 3 days. Patients were monitored for emesis and nausea for the 72 hours after the initiation of therapy. In addition, nausea was measured by patients on a visual analog scale (0-10), with 0 being no nausea and 10 being maximal nausea.

Patients in the two groups were similar for age, sex, Eastern Cooperative Oncology Group (ECOG) performance status, and diagnosis (5 bladder cancers, 40 breast cancers, 8 lymphomas, and 27 lung cancers).

"Both olanzapine and metoclopramide were well tolerated with no grade 3 or 4 toxicities," said Dr. Navari. No central nervous system toxicities were observed in either group.

Olanzapine is indicated for treatment of psychosis and is associated with weight gain, but the side effect should not be a problem for cancer patients.

"The side effect of weight gain occurs in patients, who receive the drug for 3 to 6 to 9 months," Dr. Ravari noted. "So using it for a short period of 3-4 days once a month – we did not see that in the current study, nor did we see that in previous studies."

Dr. Navari had previously reported that patients receiving highly emetogenic chemotherapy were about twice as likely not to experience any delayed nausea with an olanzapine regimen compared with a standard aprepitant (Emend) regimen (68% vs. 37%) in a phase III clinical trial. The two regimens worked similarly well for preventing acute nausea and for preventing both acute and delayed vomiting, that study found (Support. Oncol. 2011;9:188-95).

ASCO presented a preview of some meeting highlights with many of the abstracts being posted online as of 6 p.m. EST at www.asco.org.

The authors reported that they have nothing to disclose.