Health-related quality of life data from a phase 3, international, randomized, open-label, multicenter study in patients with previously treated mantle cell lymphoma treated with ibrutinib versus temsirolimus

Abstract

Mantle cell lymphoma (MCL) is a rare, aggressive, incurable B-cell malignancy. Ibrutinib has been shown to be highly active for patients with relapsed/refractory (R/R) MCL. The RAY trial (MCL3001) was a phase 3, randomized, open-label, multicenter study that compared ibrutinib with temsirolimus in patients with R/R MCL. Active disease is frequently associated with impaired functional status and reduced well-being. Therefore, the current study employed two patient-reported outcome instruments, the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) and the EQ-5D-5L, to assess symptoms, well-being, health status, and health-related quality of life of patients on treatment within the RAY trial. We found that patients on ibrutinib had substantial improvement in FACT-Lym subscale and total scores, and had improvement in EQ-5D-5L utility and VAS scores compared with temsirolimus patients, indicating a superior well-being. These improvements in well-being correlated with clinical response, indicating that better health-related quality of life was associated with decreased disease burden.

Keywords:

• Bruton’s tyrosine kinase inhibitor
• EQ-5D-5L
• FACT-Lym
• ibrutinib
• mantle cell lymphoma
• patient-reported outcomes

Acknowledgments

This study was funded by Janssen Research and Development. Writing assistance was provided by Michelle Olsher, PhD (PAREXEL, Hackensack, NJ) and was funded by Janssen Global Services, LLC. The authors thank the patients who participated in this trial, their families, and the investigators and coordinators at each of the clinical sites.

Potential conflict of interest

Disclosure forms provided by the authors are available with the full text of this article online at https://doi.org/10.1080/10428194.2017.1326034.

Additional information

Funding

This study was funded by Janssen Research and Development. Writing assistance was provided by Michelle Olsher, PhD (PAREXEL, Hackensack, NJ) and was funded by Janssen Global Services, LLC.