To assess survival, use of subsequent anticancer therapy, and safety outcomes from the TOPAZ-1 trial at the final data cutoff, approximately 4 years after randomization.
Approach:
Study Design: The TOPAZ-1 trial randomized 685 participants to durvalumab plus gemcitabine and cisplatin (GemCis) or placebo plus GemCis, with a 1:1 ratio.
Data Collection: Final analysis was conducted approximately 48 months after randomization, focusing on overall survival (OS), safety, and subsequent therapy.
Statistical Analysis: OS was evaluated using log-rank tests and Cox proportional hazards models, with median follow-up calculated using the reverse Kaplan-Meier method.
Key Findings:
Median OS was 13.0 months for durvalumab plus GemCis versus 11.4 months for placebo plus GemCis (HR, 0.75; 95% CI, 0.64-0.88).
At 48 months, OS rates were 11.8% for durvalumab plus GemCis and 4.3% for placebo plus GemCis (OS rate ratio, 2.74).
Subsequent anticancer therapy use was comparable between groups, with 3.8% of the durvalumab group receiving subsequent immunotherapy.
Limitations:
Progression-free survival data were not included in the 4-year analysis as it had matured at the primary data cutoff.
The analysis is based on a post hoc evaluation, which may introduce biases.
