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RESEARCH PRODUCT
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
Jenna D. GoldbergMartin DreylingCristina JoãoWenjiong ZhouChristopher EnnyShana TrainaSimon RuleMathias Witzens-harigIsabelle Bence-brucklerJessica VermeulenJoris DielsChiun Fang ChiouWojciech JurczakMats JerkemanChiara RusconiSeok-goo ChoCristina TrambitasGeorg HessRodrigo Santucci SilvaDolores Caballerosubject
OncologyAdultMaleCancer Researchmedicine.medical_specialtyLymphoma Mantle-CellMalignancy03 medical and health scienceschemistry.chemical_compound0302 clinical medicineRefractoryQuality of lifePiperidinesInternal medicineAntineoplastic Combined Chemotherapy ProtocolsmedicineHumans030212 general & internal medicineDisease burdenAgedNeoplasm StagingAged 80 and overSirolimusbusiness.industryAdenineCancerHematologyMiddle Agedmedicine.diseaseTemsirolimusSurgeryPyrimidinesTreatment OutcomeOncologychemistryDrug Resistance Neoplasm030220 oncology & carcinogenesisIbrutinibRetreatmentQuality of LifePyrazolesMantle cell lymphomaFemalebusinessmedicine.drugdescription
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.
year | journal | country | edition | language |
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2017-01-01 |