STUDY DESIGN

For over 2 decades, locally advanced cervical cancer (LACC) has been treated with external beam radiotherapy (EBRT) and concurrent chemotherapy, followed by brachytherapy.¹ However, the toxicity associated with these treatments along with the burden of the disease itself have led to a decreased health-related quality of life (HRQoL) for patients.¹ Studies conducted in both the clinical and preclinical settings have suggested the enhancing effect of immunotherapy on chemoradiotherapy (CCRT).¹ Specifically, pembrolizumab, a programmed cell death protein 1 (PD-1)  inhibitor has previously shown its efficacy and manageable safety profile in patients with cervical cancer.¹ In the phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 study, the efficacy, safety and HRQoL patient-reported outcomes (PROs) of pembrolizumab and concurrent CCRT in patients with high-risk LACC had been reported.¹

In the study, treatment-naïve LACC patients (n=1,060) with Federation of Gynecology and Obstetrics (FIGO) 2014 stages IB2-IIB node+ disease, or stage III-IVA disease regardless of measurable disease were included.¹ They were randomized 1:1 to receive pembrolizumab 200mg Q3W or a matching placebo in addition to cisplatin 40mg/m2 weekly for a total of 5 cycles + EBRT followed by brachytherapy.¹ Pembrolizumab 400mg Q6W or a matching placebo was continued for 15 cycles after that.¹ The dual primary endpoints of the study were progression-free survival (PFS) per investigator review and overall survival (OS).¹

In this presentation, the HRQoL PRO endpoints in terms of change from baseline and overall improvement or stability were reported at week 36.¹ PROs were assessed at every treatment cycle before any treatment at follow-up until disease progression.¹ However, no formal hypothesis testing was conducted for PRO analysis.¹ They were assessed using prespecified questionnaires including the European Organization for Research and Treatment of  Cancer (EORTC) Core Quality of Life questionnaire (QLQ-C30), EORTC cervical cancer-specific quality of life questionnaire (QLQ-CX24), and the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)  visual analogue scale (VAS).¹

FINDINGS

“These data support pembrolizumab + CCRT as a new SoC for patients
with newly diagnosed,previously untreated, high-risk LACC”

_{Dr. Sandro Pignata
IRCCS National Cancer Institute "Fondazione G. Pascale",}
^{Naples, Italy}