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Phase II Study of Bevacizumab in Patients With Platinum-Resistant Ovarian Cancer or Peritoneal Serous Cancer

Stephen A. Cannistra, Ursula A. Matulonis, Richard T. Penson, Julie Hambleton, Jakob Dupont, Howard Mackey, Jeffrey Douglas, Robert A. Burger, Deborah Armstrong, Robert Wenham, William McGuire

From the Beth Israel Deaconess Medical Center; Dana-Farber Cancer Institute; Massachusetts General Hospital, Boston, MA; Genentech Inc, South San Francisco; University of California at Irvine, Orange, CA; The Johns Hopkins Kimmel Cancer Center; Franklin Square Hospital, Baltimore, MD; and Moffitt Cancer Center, Tampa, FL

Address reprint requests to Stephen A. Cannistra, MD, Beth Israel Deaconess Medical Center, East Campus KS158, 330 Brookline Ave, Boston, MA 02215; e-mail: scannist{at}bidmc.harvard.edu

Purpose We evaluated the efficacy and safety of bevacizumab in patients with platinum-resistant epithelial ovarian carcinoma (EOC) or peritoneal serous carcinoma (PSC) who had experienced disease progression during, or within 3 months of discontinuing, topotecan or liposomal doxorubicin.

Patients and Methods No more than three prior treatment regimens were allowed. Patients received single-agent bevacizumab 15 mg/kg intravenously every 3 weeks. Response was assessed by computed tomography (CT) scan every 6 weeks using Response Evaluation Criteria in Solid Tumors (RECIST).

Results Of 44 patients treated, 83.7% were primarily platinum resistant, 59.1% had received liposomal doxorubicin, 25% topotecan, 15.9% both agents, and 47.7% had received three prior chemotherapy regimens. A median of five (range, two to 16) bevacizumab doses were administered. Partial responses were observed in seven patients (15.9%). Median progression-free survival was 4.4 months (95% CI, 3.1 to 5.5 months), with a median survival duration of 10.7 months at study termination. Bevacizumab-associated grade 3 to 4 events included hypertension (9.1%), proteinuria (15.9%), bleeding (2.3%), and wound-healing complications (2.3%). The incidence of GI perforation (GIP; 11.4%) was higher than reported in bevacizumab trials of other tumor types. GIP occurred in 23.8% of patients receiving three prior chemotherapy regimens, compared with 0% of patients receiving two prior chemotherapy regimens (P < .01). A trend toward higher risk of GIP was observed for patients with bowel wall thickening or bowel obstruction on CT scan. Arterial thromboembolic events occurred in three patients (6.8%). Three deaths were related to bevacizumab treatment.

Conclusion Bevacizumab has single-agent activity in patients with platinum-resistant EOC or PSC. A higher than expected incidence of GIP was noted in these heavily pretreated patients.

Supported by Genentech Inc.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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