Preliminary results of a phase II study of oxaliplatin, docetaxel, and bevacizumab as first-line therapy of advanced cancer of the ovary, peritoneum, and fallopian tube

Abstract

5546 Background: Objectives are to estimate efficacy and safety of a novel taxane/platinum chemotherapy doublet in combination with bevacizumab (B), as first-line treatment of advanced cancer of the ovary, peritoneum or fallopian tube (FT), after initial debulking surgery. Methods: Eligibility criteria included histological confirmation of primary disease, previous debulking surgery, and normal renal, hepatic, hematological, and neurological function. Subjects were treated with 6 cycles of oxaliplatin (85 mg/m2), docetaxel (75 mg/m2) and B (15 mg/kg) Q3W, followed by maintenance B (15 mg/kg Q3W) to complete one year of therapy. The primary endpoint is progression-free survival (PFS) of pts with measurable disease at 1 year. Results: A total of 110 subjects are included in safety and 95 in efficacy analyses (55 with measurable disease). Median age was 58 years. Tumors were mostly ovary as primary site (84%), poorly differentiated (65%), serous adenocarcinoma pathology (73%) and FIGO stage IIIC (68.2%) or IV (14.6%). 61% of subjects were optimally debulked. 95 (86%) of subjects had completed the chemotherapy cycles with 87 of the 95 having started on the B-only maintenance cycles. 85 (77%) subjects have stopped study treatment [including 33 completed study treatment, 29 disease progression, 15 adverse event (AE), 8 other reasons]. The most common grade 3–4 AEs were: neutropenia (39%), leukopenia (11%), hypertension (9%), and fatigue (7%) Grade 3–4 peripheral sensory neuropathy (PSN) occurred in 2 patients (1.3%). There was one case of colonic perforation associated with B. Investigator-determined best overall confirmed response rates were: complete response 32.8%; partial response, 29.1%; stable disease 32.7%; and progressive disease (PD), 1.8%. The 1-year PFS probability is 70.1% (95% C.I., 56.8%-83.4%) in the 55 patients with measurable disease. Conclusions: This preliminary data supports feasibility of this novel regimen, with an acceptable safety profile and a low incidence of PSN and colonic perforation. Preliminary 1-year PFS is promising. The trial completed accrual to 132 patients in August 2008. Updated results will be presented. [Table: see text]