HOLLYWOOD, FL—A breast cancer guideline panel of the National Comprehensive Cancer Network decided to retain in its treatment algorithm the use of bevacizumab for women with metastatic disease.
Although acknowledging pending Food and Drug Administration action to remove the recommendation for bevacizumab among women with advanced breast cancer, guideline committee chairman Robert W. Carlson, MD, Professor of Medicine at Stanford University, said he and his 26-member breast cancer panel agreed unanimously to keep listing treatment of recurrent or metastatic disease with bevacizumab, preferentially combined with paclitaxel therapy.
“The data observed in the E2100 Study really had not changed from its approval previously, and we thought that if the data were compelling two years ago, why isn‘t it compelling enough today?,” he explained.
Dr. Carlson said the NCCN panel met three times in the past six months to discuss the FDA recommendations to withdraw the indication, including a two-hour marathon conference call.
“The end result was that the panel voted unanimously that we should retain the indication for bevacizumab in combination with paclitaxel on our guideline,” he said.
The panel, which presented the guidelines here at the 16th annual NCCN Conference on Clinical Practice Guidelines & Quality Cancer Care, added a footnote to the treatment recommendations to explain its decision:
“Randomized clinical trials in metas-tatic breast cancer document that the addition of bevacizumab to some first-line or second-line chemotherapy agents modestly improves time to progression and response rates but does not improve overall survival. The time to progression impact may vary among cytotoxic agents and appears greatest with bevacizumab in combination with weekly paclitaxel.”
Asked for his opinion, Len Lichtenfeld, MD, Deputy Chief Medical Officer for the American Cancer Society, said, “The panel appeared to dismiss the toxicity issue of bevacizumab, although that‘s what the FDA believes is important. The FDA is questioning the value of progression-free survival if there is no overall benefit in overall survival. There are toxicities with bevacizumab.”
Dr. Lichtenfeld noted, however, that there are clearly women who benefit greatly from bevacizumab therapy, but that the challenge is how to identify which women will have the greatest benefit from the drug.
Other Breast Cancer Recommendations
In other recommendation by the breast cancer panel, Dr. Carlson said the group:
* Added eribulin mesylate as one of the possible treatments for recurrent or metastatic breast cancer.
* Added denosumab as an optional treatment for the prevention of skeletal-related events in breast cancer patients with bone metastases.
* Encourages the determination of estrogen receptor, progesterone receptor, and HER2 receptor status in metastatic disease.
* Remained silent on the issue of testing for the breast cancer biomarker CYP2D6 and its possible impact on tamoxifen. Dr. Carlson said that the panel‘s decision not to mention the biomarker could be interpreted as a suggestion “not to do it.”