Abstract
Abstract only
5518
Background: Objectives: Determine safety and estimate efficacy of a novel taxane/platinum chemotherapy (CTX) doublet in conjunction with bevacizumab, as first-line treatment of advanced cancer of the ovary, peritoneum or fallopian tube (FT), after initial debulking surgery. Methods: Treatment: 6 cycles of oxaliplatin (O) (85 mg/m
2
), docetaxel (D) (75 mg/m
2
) and bevacizumab (B) (15 mg/kg) Q3W, followed by maintenance B (15 mg/kg Q3W) to complete one year of therapy. Pts were treated until disease progression, unacceptable toxicity, prolonged treatment delay, death, or refusal to continue on study. The primary efficacy endpoint is PFS at 12 months. Results: As of 30 Nov 06, 59 pts (median age 58) were enrolled. Primary sites of disease included 47 ovary, 7 peritoneum, 4 FT. Tumors were mostly poorly differentiated (70%) with a serous adenocarcinoma initial pathology type (81%). Most pts were stage IIIC (40) or IV (17). 64% of pts. were optimally debulked. GOG PS was 0–1 in 56 pts. 58 pts were treated with at least one cycle of CTX. 22 pts. completed six cycles of CTX + B; 14 of these have begun B maintenance Rx. Safety data in available on a total of 283 patient-cycles. Of the 57 pts. with adverse event (AE) data available, 31 (54%) reported at least one grade 3–4 AE, 9 (16%) at least one serious AE (SAE), 54 at least one AE related to CTX (O or D), and 45 reported at least one AE related to B. There have been 8 SAEs related to CTX (O or D): febrile neutropenia (FN) (2), chest pain (1), dehydration (1), lymphopenia (1), neutropenia (1), peripheral sensory neuropathy (PSN) (1), palpitations (1). There have been 7 SAEs related to B: chest pain, colonic fistula, dehydration, FN, palpitations, PSN, vertigo (1 each). There were no B-associated colonic perforations. Of the 59 subjects, 31 (53%) had measurable disease at baseline. One of 31 patients has confirmed progression of disease. Conclusions: This preliminary data supports feasibility of this novel regimen, with an acceptable safety profile. As of December 2006, 75 patients have been enrolled. Updated safety and preliminary efficacy (RR) data will be presented.
No significant financial relationships to disclose.