The integration of pembrolizumab alongside concurrent chemoradiotherapy (CCRT) in the treatment regimen for high-risk, locally advanced cervical cancer (LACC) has shown promising results, as highlighted by the phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 study (NCT04221945). This study aimed to evaluate the efficacy and patient-reported outcomes (PROs) associated with pembrolizumab plus CCRT compared to placebo plus CCRT in this patient population.

Eligible patients were randomized to receive either pembrolizumab plus CCRT or placebo plus CCRT. PRO assessments were conducted using instruments such as the EORTC quality of life core 30, EORTC Cervical Cancer module, and EuroQol EQ-5D-5L visual analog scale (VAS) at each treatment cycle.

A total of 1,008 patients out of the 1,060 patients in the intent-to-treat population were included in PRO analyses. Completion and compliance rates for PRO assessments were similar between the pembrolizumab plus CCRT and placebo plus CCRT groups. Baseline PRO scores were comparable between the two treatment arms.

Analysis of PROs revealed that scores for global health status/quality of life (GHS/QoL), physical functioning (PF), symptom experience, and VAS showed initial decreases at weeks 3 and 6 but improved relative to baseline at week 12 and subsequent weeks in both treatment groups. A similar proportion of patients in both groups reported improved or stable scores for GHS/QoL, PF, symptom experience, and VAS.

There were no clinically meaningful differences between the pembrolizumab plus CCRT and placebo plus CCRT groups in changes in PRO scores from baseline to week 36. These findings suggest that the addition of pembrolizumab to CCRT for high-risk LACC is associated with PRO changes comparable to those observed with CCRT alone.

The improvement in progression-free survival observed with pembrolizumab plus CCRT along with comparable PROs to placebo plus CCRT supports the adoption of pembrolizumab plus CCRT as a new standard of care for patients with high-risk LACC. These results underscore the positive benefit-risk profile of pembrolizumab in combination with CCRT, offering a promising therapeutic approach for improving outcomes and maintaining quality of life in this patient population.

Source:

Randall LM, Sukhin V, Colombo N, et al. Patient-reported outcomes from the phase III, randomized, double-blind, placebo-controlled ENGOT-cx11/GOG-3047/KEYNOTE-A18 Study of pembrolizumab plus concurrent chemoradiotherapy among patients with high-risk, locally advanced cervical cancer. Presented at the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer; March 16-March 18, 2024. San Diego, California.