4. Outcomes
The primary endpoint was 16-week CR rate. Secondary endpoints were 32-week CR rate, treatment-related adverse events, recurrent rate and pregnancy rate. Safety assessment was assessed and graded following the National Cancer Institute Common Toxicity Criteria version 4.0 at baseline (prior to treatment), during treatment, and at completion of treatment. Serious adverse events would be reported within 24 hours. The maximum extent of weight change during treatment was also measured.