Patient-reported outcomes in KEYNOTE-087, a phase 2 study of pembrolizumab in patients with classical Hodgkin lymphoma

Abstract

In KEYNOTE-087, pembrolizumab had a 69% overall response rate and acceptable safety in patients with relapsed/refractory classical Hodgkin lymphoma (rrHL). We assessed health-related quality of life (HRQoL) in KEYNOTE-087. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and the EuroQoL Five Dimensions Questionnaire 3-level version (EQ-5D) were administered to 206 patients across three cohorts defined by lymphoma progression after: (1) autologous stem cell transplantation (ASCT) and subsequent brentuximab vedotin (BV) (n = 69); (2) salvage chemotherapy and BV (n = 79); and (3) ASCT without post-transplantation BV (n = 58). Compliance/completion rates were ≥90% at week 12 and ≥70% at week 24. QLQ-C30 global health status/QoL and EQ-5D visual analog scale scores showed mean increases from baseline in overall health at all assessed timepoints. With few exceptions, mean improvements from baseline to weeks 12 and 24 in QLQ-C30 functional and symptom scores occurred in all cohorts.

Clinicaltrials.gov identifier: NCT02453594.

KEYWORDS:

• Classical Hodgkin lymphoma
• health-related quality-of-life
• KEYNOTE-087
• patient-reported outcomes
• pembrolizumab

Acknowledgements

The authors would like to thank Kathryn Fogarty (Clinical Operations), Theresa Mezza (ePRO Data Management), Victoria Fox (Clinical Science), Seth Thompson (statistical consultant), Wei Zhou (PRO consultation), Josephine Norquist (PRO endpoint consultation), and Todd Saretsky (PRO endpoint consultation) of Merck & Co., Inc., Kenilworth, NJ, USA, and Veronika Metterlein and Peter Kaskel from MSD Germany for their contributions in the development of this analysis. Editorial assistance was provided by Christine McCrary Sisk, Michele McColgan, and Jennifer Rotonda of Merck & Co., Inc., Kenilworth, NJ, USA.

Merck & Co., Inc.’s data sharing policy, including restrictions, is available at http://engagezone.msd.com/ds_documentation.php. Requests for access to the clinical study data can be submitted through the EngageZone site or via email to [email protected]. Select data from this manuscript were presented at the 59th Annual Meeting of the American Society of Hematology, December 9–12, 2017 in Atlanta, GA, USA.

Potential conflict of interest

Disclosure forms provided by the authors are available with the full text of this article online at https://doi.org/10.1080/10428194.2019.1602262.

Additional information

Funding

Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Dr. Ardeshna reports support from UCL/UCLH Biomedical Research Centre, outside the submitted work.