Efficacy
In the first-line phase 2 trial (GOG 87L),r 42 women were treated with gemcitabine plus docetaxel until disease progression or unacceptable toxicity. The overall response rate (ORR) was 36%, with an additional 26% stable disease.
In the phase 2 trial (GOG 131G),r 51 patients who had disease progression after first-line treatment (90% had received doxorubicin) received gemcitabine plus docetaxel. The ORR was 27% with an additional 50% stable disease. 52% were progression-free at six months.
In both phase II studies the median number of cycles administered was 6.rr
In the phase III trial of gemcitabine-docetaxel plus bevacizumab or placebo (GOG 0250),r the addition of bevacizumab failed to improve response rate, response duration, progression-free survival (PFS), or overall survival.
Objective responses were observed in 31.5% of patients randomly assigned to gemcitabine- docetaxel plus placebo and 35.8% of patients randomly assigned to gemcitabine-docetaxel plus bevacizumab. Mean duration of response was 8.6 months for gemcitabine-docetaxel plus placebo versus 8.8 months for gemcitabine-docetaxel plus bevacizumab.
After a median follow up of 25 months, the median OS was 26.9 months for gemcitabine-docetaxel plus placebo and 23.3 months for gemcitabine-docetaxel plus bevacizumab (HR, 1.07; 95% CI 0.63 to 1.81, p=0.81). Median PFS was 6.2 months for gemcitabine-docetaxel plus placebo versus 4.2 months for gemcitabine-docetaxel plus bevacizumab (HR, 1.12; p=0.58).
Kaplan Meier curve of progression free survival and overall survivalr
© Journal of Clinical Oncology 2015
© Journal of Clinical Oncology 2015