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Paclitaxel plus pazopanib improved survival in advanced ovarian cancer
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CHICAGO — The addition of daily pazopanib to weekly paclitaxel significantly prolonged PFS and OS in patients with platinum-resistant or refractory advanced ovarian cancer, according to phase 2 data presented at the ASCO Annual Meeting.
“The MITO-11 trial met its’ primary endpoint and found statistically significant prolongation of PFS when adding pazopanib to weekly paclitaxel in patients with resistant or refractory advanced ovarian cancer. These results warrant further study,” Sandro Pignata, MD, PhD, of the Istituto Nazionale Tumori, via Mariano Semmola in Italy, said during a presentation here.
Although few therapies are currently available to treat platinum-resistant or refractory advanced ovarian cancer, data are increasing on the efficacy of antiangiogenic therapies.
The multicenter, comparative, randomized study included 74 patients treated across 11 centers whose disease had progressed during or within 6 months from their last platinum-based chemotherapy; none were previously treated with bevacizumab (Avastin, Genentech). Patient median age was 57 years; about half of patients (46%) received one previous platinum-based therapy. Twenty-four percent were platinum-refractory.
The cohort was randomly assigned to either weekly paclitaxel (80 mg/m²) or weekly paclitaxel plus 800 mg daily pazopanib. PFS served as the primary outcome measure.
After a median follow-up of 12.5 months, researchers observed 66 PFS events and 34 deaths (95% CI, 11.6-16.3). Compared with a median PFS of 3.5 months (95% CI, 2-5.7) for the paclitaxel arm, median PFS was 6.3 months for the combination arm (95% CI, 5.4-11.0).
Median OS was 13.7 months (95% CI, 9.1-NA) for the paclitaxel arm vs. 19.1 months (95% CI, 11.5-NA) for the combination arm (HR=0.60; 95% CI, 0.30-1.21).
Grade 3 to 4 adverse events were more common in the combination arm (54% vs. 22%; Chi-square P=.0052). Neutropenia (P=.0007), hypertension (P<.0001), diarrhea (P=.0002), mucositis (P=.0007), sensory neuropathy (P=.025) and other neurologic events (P=.023) were more common with pazopanib alone.
For more information:
Pignata S. Abstract #5503. Presented at: ASCO Annual Meeting; May 30-June 3, 2014; Chicago.
Disclosure: The researchers report research funding from GlaxoSmithKline and PharmaMar; honoraria from GlaxoSmithKline; and consultant or advisory roles with GlaxoSmithKline, Janssen-Cilag and Roche.