Journal
GYNECOLOGIC ONCOLOGY
Volume 126, Issue 3, Pages 369-374Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.ygyno.2012.05.028
Keywords
Pegylated liposomal doxorubicin; Carboplatin; Bevacizumab; Ovarian cancer; Fallopian tube cancer; Primary peritoneal cancer
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Funding
- Janssen Services, LLC, Horsham, PA, USA
- JJ
- Genentech
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Objective. To assess the safety and efficacy of pegylated liposomal doxorubicin (PLD), carboplatin, plus bevacizumab in patients with ovarian, fallopian tube, or primary peritoneal cancer. Methods. Patients with platinum-sensitive, recurrent disease received PLD 30 mg/m(2) and carboplatin area under the curve (AUC) 5 on Day 1 plus bevacizumab 10 mg/kg on Days 1 and 15 of every 28-day cycle, for a maximum of 10 cycles. The primary endpoint was objective response rate (ORR) [complete + partial response]: additional endpoints were safety, duration of response, progression-free survival (PFS), and time to progression (TTP). Results. Of the 54 patients enrolled, 15(27.8%) completed the study treatment as planned. Intent-to-treat (all enrolled patients) ORR was 72.2% (95% Cl: 58.4, 83.5). Median duration of response was 11.9 months (95% Cl: 9.3, not estimable) and median TTP was 13.9 months (95% Cl: 11.4, 16.0). PFS was virtually the same as TTP. Three (5.6%) patients discontinued therapy due to disease progression, and another 3 (5.6%) patients discontinued therapy due to serious adverse events (Grade 4 thrombocytopenia, Grade 3 small/large intestinal obstruction/small intestinal perforation, and Grade 3 abdominal abscess). Fifty (92.6%) patients had >= 1 adverse event of interest, most commonly neutropenia (42.6%), hypertension (37.0%), stomatitis (37.0%), proteinuria (37.0%), and palmar-plantar erythrodysesthesia (27.8%). No appreciable decreases in left-ventricular ejection fraction were observed. Conclusion. Most patients responded to PLD, carboplatin, and bevacizumab combination therapy. The safety profile was consistent with the known toxicities of these agents. These findings present a potential treatment option for women with ovarian, fallopian tube, or primary peritoneal cancer. (C) 2012 Elsevier Inc. All rights reserved.
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