Quality-of-Life Outcomes for Pembrolizumab Compared With Standard of Care in Head and Neck Cancer

CHICAGO―Pembrolizumab may lead to improved health-related quality-of-life (HRQOL) outcomes among patients with recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) compared with methotrexate, docetaxel, or cetuximab, according to a poster presentation at the American Society of Clinical Oncology 2018 Annual Meeting on Saturday, June 2.¹

The KEYNOTE-040 (ClinicalTrials.gov Identifier: NCT02252042) study previously demonstrated that treatment with pembrolizumab 200 mg every 3 weeks for 2 years prolonged overall survival (OS) compared with standard of care (SOC) among patients with R/M HNSCC, but the effects on HRQOL require further elucidation.

In this analysis, researchers had 469 patients complete the EORTC QLQ-C30, EORTC QLQ-H&N35, and EQ-5D QOL surveys at baseline, week 3, week 6, week 9, and then every 6 weeks for up to 1 year or end of therapy, and at a 30-day safety follow-up visit. Evaluable patients received at least 1 dose of the study drug and completed 1 or more HRQOL assessments.

Of the study patients, 241 received pembrolizumab and 228 were assigned to SOC (methotrexate, docetaxel, cetuximab) arms. Compliance at week 15 was 75.3% and 74.6% in the pembrolizumab arm and SOC arms, respectively.

Results showed that from baseline to week 15, global health status (GHS)/QOL scores were steady for patients receiving pembrolizumab (least-squares [LS] mean, 0.39; 95% CI, -3.00 to 3.78), but decreased among patients receiving SOC (LS mean, –5.86; 95% CI, -9.6 8 to -2.04). The GHS/QoL score remained stable through week 51 in the pembrolizumab arm.

When analyzed according to SOC agent, the difference in mean GHS/QOL score was greater between pembrolizumab versus docetaxel (10.23), compared with pembrolizumab versus methotrexate (6.21) or cetuximab (-1.44).

The median time-to-deterioration of GHS/QOL in pembrolizumab versus SOC was 4.8 months and 2.8 months, respectively (hazard ratio [HR], 0.79; 95% CI, 0.59-1.05; P = .048).

The authors concluded that “additional HRQoL analyses by SOC choice will further assess trends. Along with previously presented efficacy and safety results, these data support the clinically meaningful benefit of pembrolizumab in R/M HNSCC.”

Read more of Cancer Therapy Advisor‘s coverage of the American Society of Clinical Oncology (ASCO) 2018 meeting by visiting the conference page.

Reference

1. Cohen EEW, Soulieres D, Le Tourneau C, et al. Health-related quality of life (HRQoL) of pembrolizumab (pembro) vs standard of care (SOC) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in KEYNOTE-040. Poster presentation at: 2018 ASCO Annual Meeting; June 1-5, 2018; Chicago, IL.