Originally published by 2 Minute Medicine® (view original article). Reused on AccessMedicine with permission.

1. 36-month overall survival was significantly greater in the pembrolizumab-chemoradiotherapy group compared to placebo-chemoradiotherapy.

2. Grade 3 or higher adverse events were more common in the pembrolizumab group.

Evidence Rating Level: 1 (Excellent)

Study Rundown:

Cervical cancer is the fourth most common cancer affecting women worldwide. Previous trials have shown that adding pembrolizumab, an anti-PD1 antibody, to chemoradiotherapy may improve progression-free survival in patients with locally advanced cancer. This randomized controlled trial aimed to evaluate whether pembrolizumab plus chemoradiotherapy could improve survival outcomes in newly diagnosed cervical cancer. The primary outcome of this study was overall survival, while key secondary outcomes included safety and progression-free survival. According to study results, pembrolizumab plus chemoradiotherapy significantly improved overall survival compared to placebo but had a greater rate of adverse events. Although this study was well done, it was limited by a relatively short follow-up period, as median overall survival was not yet reached in either group.

In-depth [randomized-controlled trial]:

Between Jun 9, 2020, and Dec 15, 2022, 1562 patients were screened for eligibility across 176 sites in 30 countries. Included were patients with newly diagnosed, high-risk, histologically confirmed, locally advanced cervical cancer (FIGO 2014 node-positive stage IB2-IIB or III-IVA without nodal status). Altogether, 1060 patients (529 in pembrolizumab–chemoradiotherapy and 531 in placebo–chemoradiotherapy) were included in the final analysis. The primary outcome of 36-month overall survival was significantly greater in the pembrolizumab group compared to placebo (82.6% vs. 74.8%, hazard ratio [HR] 0.67, 95% confidence interval [CI] 0.50-0.90, p=0.0040). The secondary safety outcome followed a similar trend, with 78% in the pembrolizumab group and 70% in the placebo group experiencing ≥ grade 3 adverse events. Findings from this study suggest that adding pembrolizumab to chemoradiotherapy improves survival in patients with locally advanced cervical cancer.

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