March 14, 2011 — The updated 2011 National Comprehensive Cancer Network (NCCN) Ovarian Cancer Guidelines have added a new treatment option — dose-dense paclitaxel — for the first-line treatment of stage II, III, or IV epithelial ovarian cancer. The category 1 recommendation comes from data from the Japanese Gynecologic Oncology Group, said panel chair Robert J. Morgan, MD, professor of medicine at the City of Hope Comprehensive Cancer Center in Duarte, California, here at the NCCN 16th Annual Conference.
In a phase 3 open-label randomized controlled trial published in the Lancet (2009; 374:1331-1338), Noriyuki Katsumata and colleagues reported that dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer resulted in a significant survival advantage. The study concluded that paclitaxel and carboplatin given every 3 weeks is standard treatment for advanced ovarian carcinoma.
"This was an important addition," Dr. Morgan told Medscape Medical News.
The current guidelines emphasize that intraperitoneal chemotherapy (IP) should be used in stage III patients, and that IP can also be used in optimally debulked (tumor no greater than 1 cm) stage II patients.
Personally, I favor the IP, or the Armstrong regimen," Dr. Morgan said in an interview. "But it has to be done in a center that has experience with the regimen because it is very toxic."
The newly added dose-dense regimen is also very toxic, he added. "Clinicians need to inform their patients about this and patients need to weigh the potential risks and benefits with regard to these effective but toxic therapies," he said.
The NCCN panel also recognized that data for first-line and maintenance bevacizumab are becoming available and urged patients to participate in clinical trials whenever possible.
Dr. Morgan discussed 2 phase 3 trials — GOG 218 and ICON7 — comparing bevacizumab combined with carboplatin/paclitaxel in the upfront setting with carboplatin/paclitaxel alone in women with advanced ovarian cancer.
"Although data regarding overall survival and quality of life have not been reported yet, median progression-free survival was significantly increased in patients receiving bevacizumab upfront and as maintenance therapy, compared with chemotherapy alone," he said.
The panel does not recommend the routine addition of bevacizumab to upfront or maintenance therapy until there are more mature results from GOG 218 and ICON7, Dr. Morgan said.
"There was a lot of discussion about this among the panel and there were some variances of degrees of strength of opinion, but eventually we all agreed on the wording about bevacizumab," he told Medscape Medical News.
In phase 2 trials, bevacizumab has shown a higher activity level in ovarian cancer than it has in any of the other tumors for which it has been approved as a single agent. "A lot of thought and careful consideration went into our recommendation for bevacizumab this time, and we are waiting for new data," he said. "The gist of the bevacizumab recommendations is that patients should go into clinical trials because we really do need the data."
The bevacizumab recommendation is "pretty revolutionary," he noted. "Honestly, I think there is going to be all kinds of discussion about this."
Also in the guidelines is an algorithm for the management of allergy to platinum. "This was added last year, but we have rewritten them this year to be more understandable. The main thing is to desensitize patients gradually. We outline specifically how this should be done," Dr. Morgan said.
Monitoring CA-125 levels is still valuable, but there are pros and cons associated with routine monitoring, he said. The updated guidelines use language that encourages patients and their physicians to actively discuss these, he noted.
Guidelines a "Tremendous Resource"
Asked to comment on the 2011 ovarian cancer guidelines by Medscape Medical News, Andrew Berchuck, MD, director of the division of gynecologic oncology at the Duke University Medical Center in Durham, North Carolina, said they represent a tremendous resource for all stakeholders, “including patients, healthcare providers, and insurers.”
“One of the main strengths of the guidelines,” he continued, “is that they include all appropriate management options, rather than dogmatically focusing on a single idealized approach. The most recent revisions to the guidelines continue in that thoughtful tradition and bring them up to date with the latest developments.”
Dr. Morgan reports owning Abbott stock.
National Comprehensive Cancer Network (NCCN) 16th Annual Conference. Presented March 12, 2011.
In a phase 3 open-label randomized controlled trial published in the Lancet (2009; 374:1331-1338), Noriyuki Katsumata and colleagues reported that dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer resulted in a significant survival advantage. The study concluded that paclitaxel and carboplatin given every 3 weeks is standard treatment for advanced ovarian carcinoma.
"This was an important addition," Dr. Morgan told Medscape Medical News.
The current guidelines emphasize that intraperitoneal chemotherapy (IP) should be used in stage III patients, and that IP can also be used in optimally debulked (tumor no greater than 1 cm) stage II patients.
Personally, I favor the IP, or the Armstrong regimen," Dr. Morgan said in an interview. "But it has to be done in a center that has experience with the regimen because it is very toxic."
The newly added dose-dense regimen is also very toxic, he added. "Clinicians need to inform their patients about this and patients need to weigh the potential risks and benefits with regard to these effective but toxic therapies," he said.
The NCCN panel also recognized that data for first-line and maintenance bevacizumab are becoming available and urged patients to participate in clinical trials whenever possible.
Dr. Morgan discussed 2 phase 3 trials — GOG 218 and ICON7 — comparing bevacizumab combined with carboplatin/paclitaxel in the upfront setting with carboplatin/paclitaxel alone in women with advanced ovarian cancer.
"Although data regarding overall survival and quality of life have not been reported yet, median progression-free survival was significantly increased in patients receiving bevacizumab upfront and as maintenance therapy, compared with chemotherapy alone," he said.
The panel does not recommend the routine addition of bevacizumab to upfront or maintenance therapy until there are more mature results from GOG 218 and ICON7, Dr. Morgan said.
"There was a lot of discussion about this among the panel and there were some variances of degrees of strength of opinion, but eventually we all agreed on the wording about bevacizumab," he told Medscape Medical News.
In phase 2 trials, bevacizumab has shown a higher activity level in ovarian cancer than it has in any of the other tumors for which it has been approved as a single agent. "A lot of thought and careful consideration went into our recommendation for bevacizumab this time, and we are waiting for new data," he said. "The gist of the bevacizumab recommendations is that patients should go into clinical trials because we really do need the data."
The bevacizumab recommendation is "pretty revolutionary," he noted. "Honestly, I think there is going to be all kinds of discussion about this."
Also in the guidelines is an algorithm for the management of allergy to platinum. "This was added last year, but we have rewritten them this year to be more understandable. The main thing is to desensitize patients gradually. We outline specifically how this should be done," Dr. Morgan said.
Monitoring CA-125 levels is still valuable, but there are pros and cons associated with routine monitoring, he said. The updated guidelines use language that encourages patients and their physicians to actively discuss these, he noted.
Guidelines a "Tremendous Resource"
Asked to comment on the 2011 ovarian cancer guidelines by Medscape Medical News, Andrew Berchuck, MD, director of the division of gynecologic oncology at the Duke University Medical Center in Durham, North Carolina, said they represent a tremendous resource for all stakeholders, “including patients, healthcare providers, and insurers.”
“One of the main strengths of the guidelines,” he continued, “is that they include all appropriate management options, rather than dogmatically focusing on a single idealized approach. The most recent revisions to the guidelines continue in that thoughtful tradition and bring them up to date with the latest developments.”
Dr. Morgan reports owning Abbott stock.
National Comprehensive Cancer Network (NCCN) 16th Annual Conference. Presented March 12, 2011.
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