Author(s)
Sharman J1, Barrientos JC2, Ghosh N3, Brander D4, Gutierrez M5, Wu L6, Panjabi S7, Upasani S8, Jermain M8, Naganuma M9, Mato A10
1Willamette Valley Cancer Institute/US Oncology, Eugene, OR, USA, 2Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, NY, USA, 3Levine Cancer Institute, Atrium Health, Charlotte, NC, USA, 4Duke Cancer Institute, Duke University Medical Center, Durham, NC, USA, 5Lymphoma Research Foundation, New York, NY, USA, 6Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA, 7Janssen Pharmaceutical Companies of Johnson & Johnson, San Francisco, CA, USA, 8Pharmacyclics LLC, an AbbVie Company, South San Francisco, CA, USA, 9Pharmacyclics LLC, an AbbVie Company, Oreland, PA, USA, 10Memorial Sloan Kettering Cancer Center, New York, NY, USA
Objectives: We evaluated PROs in the real-world setting for patients in the informCLL registry receiving treatment for CLL/SLL. Methods: Eligible patients were enrolled from 178 sites (10/2015-06/2019). PROs were assessed using the FACT-G questionnaire (score range, 0-108; higher scores indicate better QoL; minimally important difference for change in FACT-G total score: 5 points). Scores at baseline and at 6 and 12 months on study were assessed by line of therapy (LOT) and treatment. Data were analyzed using descriptive statistics and a generalized linear model. Results: Of 1462 patients enrolled, baseline FACT-G data were available for 1423 patients (previously untreated [first-line], 834 [59%]; relapsed/refractory, 589 [41%]). Median age was 71 (range: 34-95) years and median Charlson Comorbidity Index score was 1 (range: 0-11). The most common therapies across LOT were ibrutinib (46%), chemoimmunotherapy (33%), and immunotherapy (13%). Median baseline FACT-G score was 87 for the first-line cohort (ibrutinib, 88; chemoimmunotherapy, 86) and 86 for the relapsed/refractory cohort (ibrutinib, 88; chemoimmunotherapy, 85). In multivariate analyses, factors significantly associated with lower baseline FACT-G scores across LOT were younger age, poorer ECOG performance status, and higher comorbidity burden; additional factors for the first-line cohort were shorter time from diagnosis to treatment initiation, non-White race, and non-private health insurance. At months 6 and 12, FACT-G scores for the first-line cohort were available for 559/834 (67%) and 432/834 (52%) patients, respectively; for the relapsed/refractory cohort, corresponding values were 387/589 (66%) and 280/589 (48%). At both months 6 and 12, the median changes in FACT-G scores (≤2 points) from baseline were not clinically meaningful changes for first-line or relapsed/refractory cohorts (nor for subsets of ibrutinib or chemoimmunotherapy cohorts). Conclusion: In this real-world analysis of patients treated for CLL/SLL, QoL scores remained stable over the first 12 months on the registry across LOT and treatment type.
Conference/Value in Health Info
2022-05, ISPOR 2022, Washington, DC, USA
Value in Health, Volume 25, Issue 6, S1 (June 2022)
Code
PCR123
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Drugs
