Adding Vistusertib to Paclitaxel in Platinum-Resistant Ovarian Cancer
Posted: Thursday, November 14, 2019
The OCTOPUS trial showed an improvement in progression free-survival when the dual mTORC1/mTORC2 inhibitor vistusertib was added to weekly paclitaxel in patients with recurrent platinum-resistant or -refractory ovarian cancer. Susana Banerjee, MBBS, PhD, of the Institute of Cancer Research, London, presented these findings at the European Society for Medical Oncology (ESMO) Congress 2019 (Abstract 993O) and published them in the Annals of Oncology, noting that the progression-free survival benefit was not supported by data in terms of overall survival or response.
This phase II, double-blind trial recruited 140 patients with platinum-resistant or -refractory high-grade serous carcinoma. These patients were randomly assigned to receive either weekly paclitaxel plus oral vistusertib twice daily or weekly paclitaxel plus placebo on days 1 to 3, 8 to 10, and 15 to 17 in a 28-day cycle. The median age of patients was 63; 18% were considered to have platinum-refractory disease; and 54% had failed to respond to three or more prior therapies.
The median progression-free survival was 4.5 months for patients receiving vistusertib compared with 4.2 months for those receiving placebo (hazard ratio = 0.84). The median overall survival was 9.7 months and 11.1 months in the vistusertib and placebo groups, respectively. Response rates were 53% with weekly paclitaxel plus vistusertib and 56% with weekly paclitaxel and placebo.
Grade 3 or 4 adverse events were similar between the two groups, with 24% of patients taking vistusertib and 25% of patients taking the placebo drug experiencing them. In patients taking vistusertib, there was more grade 1 or 2 gastroesophageal reflux (10% vs. 0%), grade 2 or 3 rash (9% vs. 0%), and grade 2 to 4 lymphopenia (47% vs. 31%) than in patients taking the placebo.
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