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Bevacizumab and pegylated liposomal doxorubicin linked to activity, toxicity
Combination therapy with bevacizumab and pegylated liposomal doxorubicin yielded strong survival outcomes but increased toxicity in a cohort of patients with resistant or refractory ovarian cancer, according to study results.
The study involved 46 patients who had had no more than two prior treatments with platinum-containing regimens and one additional regimen that did not contain anthracyclines.
Therapy consisted of bevacizumab (Avastin, Genentech) 15 mg/kg beginning on cycle 2 and pegylated liposomal doxorubicin 30 mg/m2. Treatment was administered every 3 weeks.
Six-month PFS served as the primary outcome measure. Secondary endpoints included adverse event profile, overall response rate and OS.
Patients underwent an average of seven courses of treatment.
Median PFS was 6.6 months (range 1-24.6 months) when evaluated according to Gynecologic Cancer Intergroup Committee criteria and 7.8 months (range 2-13.3 months) according to Response Evaluation Criteria in Solid Tumors.
A median OS of 33.2 months (range 3-37.5 months) was reported, as was an overall response rate of 30.2% (95% CI, 17.2-46.1). The researchers reported a clinical benefit rate of 86.1% (95% CI, 72.1-94.7).
Grade-3 mucosal and dermal erosions occurred in 30% of patients. Other reported adverse events were asymptomatic cardiac dysfunction, hypertension, headache, renal dysfunction and proteinuria, and wound healing delay. One episode each of central nervous system ischemia and hemolytic uremic syndrome occurred.