1. Progression-free survival at 24 months was higher in the pembrolizumab versus placebo-controlled group.
2. The pembrolizumab-chemoradiotherapy group reported slightly higher rates of grade 3 or higher adverse events compared to the placebo-chemoradiotherapy group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Pembrolizumab has demonstrated efficacy in advanced cervical cancer, prompting an investigation into its potential synergy with chemoradiotherapy. This randomized controlled trial aimed to assess the safety and efficacy of adding pembrolizumab to chemoradiotherapy for the treatment of locally advanced cervical cancer. The primary outcome of this study was progression-free survival, evaluated by Response Evaluation Criteria in Solid Tumours version 1.1, while a key secondary outcome was overall survival. According to study results, the pembrolizumab-chemoradiotherapy group demonstrated a significant improvement in progression-free survival compared to placebo-chemoradiotherapy but there were no differences in overall survival. However, rates of grade 3 or worse adverse events were more common in the pembrolizumab group. Although this study was well done, given the increased rate of adverse events, quality of life outcomes may provide a more robust perspective between treatment groups.
Click to read the study in The Lancet
In-depth [randomized controlled trial]: Between Jun 9, 2020, and Dec 15, 2022, 1562 patients were screened for eligibility across 176 medical centers in 30 countries. Included were patients ≥ 18 years old with high-risk, locally advanced cervical cancer. Altogether, 1060 patients (529 in pembrolizumab-chemoradiotherapy and 531 in placebo-chemoradiotherapy) were included in the final analysis. The primary outcome of progression-free survival at 24 months was 68% in pembrolizumab versus 57% in placebo (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.55-0.89, p=0.0020) while overall survival was also higher in the intervention group versus control (87% vs. 81%, HR 0.73, 95% CI 0.49-1.07). Overall, findings from this study suggest that adding pembrolizumab to chemoradiotherapy may improve progression-free survival in patients with newly diagnosed, high-risk cervical cancer.
Image: PD
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