Efficacy and safety results from OCTAVIA, a single-arm phase II study evaluating front-line bevacizumab, carboplatin and weekly paclitaxel for ovarian cancer

Improving outcomes for older women with gynaecological malignancies

“…The median PFS was 20.5 months in the ≥65s (n=37) compared to 24.4 months in the <65 group (n=152) (95% CI 17.8-20.1 months) [51]. The incidence of grade ≥3 bleeding was higher in older patients (3% vs. 0%, respectively) [50]. In keeping with the AURELIA subgroup analysis, hypertension at baseline and on treatment was higher in the ≥65s [52].…”

“…In addition, hypertension at baseline prior to trial therapy was also more frequent in patients ≥ 65 than <65 years (46% vs. 13%) [49]. The OCTAVIA [50] trial, a single-arm study which evaluated the addition of bevacizumab to 3 weekly carboplatin and weekly paclitaxel (80mg/m2), included 20% and 9% of patients over the age of 65 and 70 respectively. The median PFS was 20.5 months in the ≥65s (n=37) compared to 24.4 months in the <65 group (n=152) (95% CI 17.8-20.1 months) [51].…”

Incorporation of anti-angiogenesis therapy in the management of advanced ovarian carcinoma—Mechanistics, review of phase III randomized clinical trials, and regulatory implications

“…These changes are hypothesized to result in improved delivery of oxygen, nutrients, and cytotoxic chemotherapy to the tumor [43]. Table 1 details notable phase 2 studies of anti-angiogenesis therapy in EOC [44][45][46][47][48][49][50][51][52][53][54]. Of the 6 molecules studied, 5 have been advanced to the phase 3 arena.…”

“…The single arm phase II OCTAVIA study evaluated weekly paclitaxel with q21-day carboplatin and bevacizumab (7.5 mg/kg) in newly diagnosed ovarian cancer. For 189 enrolled patients, median PFS was 23.7 months with 90% completing at least six cycles of therapy (Table 1) [48]. GOG 252 (NCT00951496), a phase 3 randomized 3-arm trial for optimally cytoreduced patients, included bevacizumab (15 mg/kg) in all three arms while testing the efficacy of intraperitoneal carboplatin and weekly, metronomic paclitaxel.…”

Antiangiogenic Therapy in Epithelial Ovarian Cancer

“…The combination of bevacizumab with intense-dose chemotherapy was studied in the OCTA-VIA phase II clinical trial [23]. The primary objective was PFS according to RECIST criteria; the secondary objectives included the overall response rate, response duration in responder patients, OS, progression defined by CA-125, safety, and tolerability.…”