Both chemotherapy and pembrolizumab monotherapy maintained health-related quality of life (HRQOL) in patients with advanced esophageal cancer on the KEYNOTE-181 trial, according to research published in the Journal of Clinical Oncology.1
HRQOL was similar with both second-line treatments in patients with squamous cell carcinoma (SCC), those with a PD-L1 combined positive score (CPS) ≥10, and patients with SCC and a CPS ≥10.
In the phase 3 KEYNOTE-181 trial (ClinicalTrials.gov Identifier: NCT02564263), researchers compared pembrolizumab monotherapy to investigator’s choice of paclitaxel, docetaxel, or irinotecan in patients with advanced esophageal or gastroesophageal junction carcinoma that had progressed after first-line therapy. Previously published results showed that pembrolizumab prolonged overall survival for patients with a PD-L1 CPS ≥ 10.2
In the current analysis, researchers measured HRQOL using 3 questionnaires. The analysis included 568 patients in total, 387 patients with SCC, 218 patients with a CPS ≥ 10, and 166 patients with SCC and a CPS ≥10. All patients received more than 1 dose of study treatment and had completed at least 1 HRQOL questionnaire by the data cutoff (October 15, 2018).
Patients completed the questionnaires electronically at baseline, at several time points between weeks 2 and 45, at the end of treatment, and at the 30-day safety follow-up visit. For all 3 questionnaires, compliance and completion rates were similar in both treatment groups at baseline and at the prespecified week 9 endpoint.
The researchers observed no “clinically meaningful” differences between the pembrolizumab and chemotherapy arms for the change in global health status/quality of life (GHS/QOL) scores from baseline to week 9 in any of the subgroups.
In the SCC group, mean GHS/QOL scores decreased to a lesser degree in the pembrolizumab arm than in the chemotherapy arm (least-squares mean [LSM] difference, 2.80; 95% CI, -1.48 to 7.08). There were similar patterns in the CPS ≥ 10 group (LSM difference, 3.68; 95% CI, -2.28 to 9.64) and the CPS ≥ 10 SCC group (LSM difference, 6.55; 95% CI, 0.01 to 13.10).
“Descriptive analyses of mean score change from baseline demonstrated that GHS/QOL scores were stable compared with baseline at each time point through week 45 across both treatment groups and all 3 subgroups,” the researchers wrote.
In the SCC subgroup, the time to deterioration was similar between the treatment arms for pain (hazard ratio [HR], 1.22; 95% CI, 0.79-1.89), reflux (HR, 2.38; 95% CI, 1.33-4.25), and dysphagia (HR, 1.53; 95% CI, 1.02-2.31). Similar trends were observed in the CPS ≥ 10 and CPS ≥ 10 SCC subgroups.
The researchers concluded that pembrolizumab maintained HRQOL in all subgroups and the overall population.
“Given the limited HRQOL data in patients with advanced EC [esophageal cancer] receiving second-line treatment, the current analysis from KEYNOTE-181 helps address the unmet need for therapies that maintain or improve HRQOL in addition to providing a survival benefit,” the researchers wrote.
Disclosures: This research was supported by Merck Sharp & Dohme Corp. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
- Adenis A, Kulkarni AS, Girotto GC, et al. Impact of pembrolizumab versus chemotherapy as second-Line therapy for advanced esophageal cancer on health-related quality of life in KEYNOTE-181. J Clin Oncol. Published online November 03, 2021 doi:10.1200/JCO.21.00601
- Kojima T, Shah MA, Muro K, et al. Randomized phase III KEYNOTE-181 study of pembrolizumab versus chemotherapy in advanced esophageal cancer. J Clin Oncol. 2020;38(35):4138-4148. doi:10.1200/JCO.20.01888