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]

Characterization of the Early Years of Bevacizumab Use for First-Line Treatment of Ovarian Cancer in the United States

“…In addition to yearly rates, we also calculated BEV utilization during successive periods flanked by the dates of key events (new research findings or guideline change). These key events were the publication of the first phase II trial of BEV for frontline and maintenance treatment of OC in the United States (May 2009), 15 the presentation of GOG-218 at ASCO annual meeting (June 2010), 16 the presentation of ICON-7 at the European Society of Medical Oncology annual congress (October 2010), 17 the publication of GOG-218 and ICON-7 in the same issue of the New England Journal of Medicine (December 2011), 18,19 the inclusion of BEV as a category 3 recommendation for the upfront treatment of OC by the NCCN (November 2012), 10 and the publication of the final OS data for ICON7 (August 2015). 9…”

Targeted Agents in Ovarian Cancer

“…No GIP or wound complications were observed, and grade 3 hypertension was observed in only 10% of the study subjects. More recently, the preliminary results of a Phase II study of a novel chemotherapeutic regimen of oxaliplatin and docetaxel plus bevacizumab followed by maintenance bevacizumab every 3 weeks for a total of 12 months of therapy after debulking surgery for ovarian, primary peritoneal or fallopian tube cancer has been reported [32]. A total of 110 subjects were included in the toxicity analysis; 55 patients had measurable disease and 61% of patients were optimally debulked.…”