June 5, 2011 (Chicago, Illinois) — Adding bevacizumab (Avastin) to chemotherapy appears to extend progression-free survival in women with recurrent ovarian cancer.
According to data presented here at the American Society of Clinical Oncology 2011 Annual Meeting, there was a "statistically significant and clinically relevant benefit" when bevacizumab was added to chemotherapy in patients with recurrent platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer, and fallopian tube cancer.
This is the first phase 3 trial of an antiangiogenic to demonstrate a clinical benefit in this population, and a 52% reduction in the risk for disease progression was observed.
The study, known as OCEANS, showed that bevacizumab plus chemotherapy (carboplatin and gemcitabine), followed by bevacizumab until disease progression provides a clinically meaningful benefit in recurrent ovarian cancer, said lead author Carol Aghajanian, MD, chief of the gynecologic medical oncology service at Memorial Sloan-Kettering Cancer Center in New York City.
"This regimen should be considered a new option for recurrent platinum-sensitive ovarian cancer," she said.
At a median follow-up of 24 months, the median progression-free survival was 12.4 months for those in the bevacizumab group, compared with 8.4 months for those in the control group (log-rank P value < .0001).
The authors also note that a larger percentage of women in the bevacizumab group experienced significant tumor shrinkage than in the control group (79% vs 57%). In addition, the duration of response was longer in the bevacizumab group than in the control group (10.4 vs 7.4 months), which was a difference of 21.1% (P < .0001).
Many Chapters in the Story
"In advanced ovarian cancer, just as in advanced breast cancer, there is often an opportunity to intervene with different lines of chemotherapy," said Andrew Seidman, MD, attending physician, breast cancer medicine service at Memorial Sloan-Kettering Cancer Center and professor of medicine at Weill Medical College of Cornell University in New York City.
"There are many chapters in the story, so to speak," said Dr. Seidman, who moderated a press briefing held in advance of the presentation. "We want to prolong each and every chapter in the disease, and make the story longer and ultimately improve survival. These trials results are certainly an important step in that direction."
Bevacizumab is a humanized anti-VEGF monoclonal antibody that demonstrated a progression-free survival benefit in 2 frontline phase 3 trials in patients with epithelial ovarian cancer, primary peritoneal cancer, and fallopian tube cancer.
No New Safety Signals
The OCEANS study involved 484 patients (242 per group), enrolled from April 2007 to January 2010, who had undergone 1 previous chemotherapy regimen.
Those in the control group received carboplatin (Area Under the Curve [AUC] 4 on day 1) plus gemcitabine (1000 mg/m2 on days 1 and 8) plus placebo on day 1 every 21 days for 6 cycles. then placebo every 21 days until disease progression or unacceptable toxicity. Those in the bevacizumab group received carboplatin plus gemcitabine plus bevacizumab (15 mg/kg) on day 1 every 21 days for 6 cycles, then bevacizumab every 21 days until disease progression or unacceptable toxicity.
The overall survival data are still immature, but only 29% of patients have had an event.
"As expected, the rate of adverse events was higher among patients who received bevacizumab," explained Dr. Aghajanian. "Hypertension and proteinuria were increased, but febrile neutropenia was the same in both arms."
Hypertension was higher in the bevacizumab group than in the control group (17% vs <1%), as was proteinuria (9% vs 1%) and non-central nervous system bleeding of grade 3 or higher (6% vs 1%). Of note, there were no gastrointestinal perforations in either group.
"The safety data are reassuring and consistent with the known bevacizumab side-effect profile, and there were no new safety signals," said Dr. Aghajanian.
Dr. Aghajanian reports serving as a consultant/advisor and receiving research funding from Genentech. Several coauthors report financial relationships, as noted in the abstract. Dr. Seidman reports serving as a consultant/advisor for Enzon and Wyeth; receiving honoraria from Abraxis BioScience, Genentech, and Genomic Health; and receiving research funding from Abraxis BioScience.
American Society of Clinical Oncology (ASCO®) 2011 Annual Meeting: Abstract LBA5007. Presented June 4, 2011.
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Cite this: Bevacizumab Benefits Patients With Recurrent Ovarian Cancer - Medscape - Jun 05, 2011.