Phase II clinical trial of bevacizumab with albumin-bound paclitaxel in patients with recurrent, platinum-resistant primary epithelial ovarian or primary peritoneal carcinoma

• Published in: Gynecologic oncology Vol. 128; no. 2; pp. 221 - 228
• Main Authors: Tillmanns, Todd D, Lowe, M. Patrick, Walker, Mark S, Stepanski, Edward J, Schwartzberg, Lee S
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-02-2013
• Subjects: Adult; Aged; Aged, 80 and over; Albumin-Bound Paclitaxel; Albumins - administration & dosage; Albumins - adverse effects; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Bevacizumab; Carcinoma, Ovarian Epithelial; Disease-Free Survival; Drug Resistance, Neoplasm; Epithelial ovarian cancer; Female; Hematology, Oncology and Palliative Medicine; Humans; Middle Aged; Neoplasm Recurrence, Local - drug therapy; Neoplasms, Glandular and Epithelial - drug therapy; Obstetrics and Gynecology; Organoplatinum Compounds - pharmacology; Ovarian Neoplasms - drug therapy; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Peritoneal Neoplasms - drug therapy; Platinum‐resistant; Primary peritoneal cancer; Survival Rate; Toxicities; Treatment Outcome; Primary peritoneal cancer; Toxicities; Albumin-bound paclitaxel; Epithelial ovarian cancer; Platinum‐resistant; Bevacizumab
• ISSN: 0090-8258; 1095-6859
• DOI: 10.1016/j.ygyno.2012.08.039

Abstract Objective We examined the safety and efficacy of combining bevacizumab with albumin-bound (ab-) paclitaxel to treat patients with recurrent, platinum-resistant primary epithelial ovarian or peritoneal carcinoma. Methods Patients had measurable disease per RECIST guidelines, progressing within 6 months after a prior course of platinum-based treatment. Patients received ab-paclitaxel 100 mg/m2 given by intravenous infusion over 30 min on days 1, 8, and 15 of a 28-day cycle with bevacizumab 10 mg/kg given on days 1 and 15. Results Forty-eight patients with an average 1.8 prior lines of treatment participated. The overall response rate was 50% (24/48) (95% CI, 34.8% – 65.1%), with 4 complete and 20 partial responses. Fourteen patients (29%) had stable disease, whereas eight (17%) had progressive disease, and two (4%) were not evaluable. Patients received a median of 6 treatment cycles (range, 1 – 31 cycles). The median progression-free survival was 8.08 months (95% CI, 5.78 – 10.15 months); 6 month progression-free rate was 62.5% (95% CI, 47.8%–77.2%); median overall survival was 17.15 months (95% CI, 13.57 – 23.82 months). Grade 3–4 adverse events included gastrointestinal disorders (18.8%), neutropenia (8.3%), and hypertension (6.3%). Conclusions Ab-paclitaxel with bevacizumab clearly demonstrates antitumor activity and manageable toxicity profile in patients with recurrent, platinum-resistant ovarian carcinoma. This regimen should be evaluated in a larger randomized trial.