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Bevacizumab plus chemotherapy improves OS in recurrent ovarian cancer
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The addition of bevacizumab to a standard chemotherapy regimen conferred a median 5-month survival improvement among women with ovarian cancer, according to results of a phase 3 study presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
Robert L. Coleman, MD, FACOG, FACS, the Ann Rife Cox chair in gynecology, vice chair of clinical research and professor in the department of gynecologic oncology and reproductive medicine at The University of Texas MD Anderson Cancer Center, and colleagues sought to evaluate the addition of bevacizumab (Avastin, Genentech) to standard chemotherapy followed by bevacizumab maintenance in women with platinum-sensitive, recurrent ovarian cancer. Researchers also sought to evaluate the role of secondary cytoreduction before chemotherapy initiation in this population; however, enrollment for this phase is ongoing.
Robert L. Coleman
Researchers randomly assigned patients to 175 mg/m² paclitaxel and carboplatin alone (area under the curve [AUC] = 5; n = 374) or with 15 mg/kg bevacizumab followed by maintenance bevacizumab (n = 374). The median age of the population was 60 years, and 81% of the women had serous histology.
OS served as the study’s primary endpoint, and secondary endpoints included safety, PFS, rate for allergy and intervention-dependent quality of life.
Both cohorts received six cycles of chemotherapy. The bevacizumab group continued with the study drug as maintenance thereafter.
The addition of bevacizumab improved the stratified estimated treatment HR for death by 18.6% (HR for OS = 0.83; 95% CI, 0.68-1.005) compared with chemotherapy alone. Median OS was 42.2 months in the bevacizumab arm compared with 37.3 months in the chemotherapy alone arm.
Bevacizumab also was associated with a reduced risk for disease progression (HR for PFS = 0.61; 95% CI, 0.52-0.72). Median PFS was 13.8 months in the bevacizumab arm, whereas patients in the chemotherapy alone arm demonstrated a median PFS of 10.4 months.
Significantly more patients in the bevacizumab arm experienced gastrointestinal perforations necrosis fistula (14.8% vs. 4%; P ˂ .001), infections (13% vs. 5.8%; P = .002), joint pain (15.1% vs. 4.6%; P ˂ .001), proteinuria (8.1% vs. 0%; P ˂ .001) and venous thrombosis (3.9% vs. 1.2%; P = .046). Allergy of all grades occurred in a similar proportion of patients who received chemotherapy alone or with bevacizumab (25.1% vs. 26.7%).
Quality of life and the role of the secondary surgery assessments are ongoing.
“Most women whose ovarian cancer is recurring want every edge to extend their lives,” Coleman said in a press release. “This trial, while not completely definitive, builds on previous data, offering hope that we can hone in on treatments to achieve that goal.” – by Anthony SanFilippo
Reference:
Coleman RL, et al. Abstract #3. Presented at: Society of Gynecologic Oncology Annual Meeting on Women’s Cancer; March 28-31, 2015; Chicago.
Disclosure: HemOnc Today was unable to obtain a list of relevant financial disclosures from the researchers at the time of reporting.