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Phase II trial of bevacizumab and pemetrexed for recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
J Clin Oncol 30, 2012 (suppl; abstr 5013)
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Background: This phase II clinical trial evaluated the efficacy and safety of the combination of bevacizumab, a VEGF inhibitor, and pemetrexed, a multi-targeted antifolate agent inhibiting thymidylate synthase, for recurrent or persistent epithelial ovarian, fallopian tube (FT) or primary peritoneal (PP) cancer. Methods: Patients with measurable recurrent/persistent epithelial ovarian, FT or PP cancer after at least one prior platinum- and taxane-containing regimen were eligible. Patients might have received < 2 prior cytotoxic chemotherapy regimens but no prior bevacizumab. Pemetrexed 500 mg/m2 IV and bevacizumab 15 mg/kg IV were given every 3 weeks until progression, unacceptable adverse effects, or patient/physician choice. 32 patients were needed to have 90% power to detect the primary endpoint of 6-month PFS ≥ 40% with a two-sided 0.05 significance. Secondary endpoints included toxicity and response by RECIST and CA-125 criteria. Results: Thirty-four patients received a median of 7 treatment cycles (range, 2-26). Twenty-eight patients (82%, 95% CI: 66-92) were platinum-sensitive. Median follow-up was 17.1 months (range, 2.7-31.2). The 6-month PFS was 58.2% (95%CI: 40-73) for all patients and 50% (19-81) for platinum-resistant patients. Objective response rates by RECIST criteria included (%; 95%CI): 0 CR, 14 PR (41%; 25-59), 18 SD (53%; 35-70) and 2 PD (6%; 1-20). Of 27 patients evaluable by CA-125, levels declined ≥50% in 17 (62%; 44-79), and ≥75% in 8 (30%; 16-49). 12-month OS was 88% (95%CI: 71-95) and median PFS was 7.8 months (95%CI: 4.7-10.7). Of the 34 patients, grade 3-4 hematologic toxicities occurred in 53% (neutropenia 50%, leukopenia 26%, thrombocytopenia 12%, anemia 9%). Other grade 3-4 toxicities included metabolic (29%), constitutional (18%), pain (18%) and gastrointestinal (15%). No bowel perforations occurred. Conclusions: Combined bevacizumab/pemetrexed is well tolerated and highly active for the treatment of recurrent ovarian cancer. The dose and schedule tested here warrant further investigation in phase III trials.
Abstracts by Andrea R. Hagemann:
Presentations by Andrea R. Hagemann:
Phase II trial of bevacizumab and pemetrexed for recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer.Session: Gynecologic Cancer (Poster Discussion Session)