Despite the advances in the treatment, chronic lymphocytic leukemia (CLL) remains an incurable disease. Patient-reported outcomes like quality of life (QoL) analyses are increasingly incorporated into clinical trials. This is important where therapies that do not affect overall survival but differ by an anticipated gain in QoL are compared. 1 Besides, this also strengthens the physician-patient relationship. 2 Formal QoL analyses in CLL outside of clinical trials have been few. The most extensive international study done in 2007 was using the older QoL assessment questionnaires British Fatigue Inventory (BFI) and Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaires. 3 Other studies using the more universally validated European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires were limited to regional analyses. 4-6 These studies have shown contradictory findings from compromised to better QoL in CLL patients than the
To report the efficacy, safety, and quality of life (QoL) on generic and innovator ibrutinib in Indian CLL patients. This was a single centre, prospective study of treatment-naive (TN), and relapsed/refractory (R/R) CLL patients receiving ibrutinib in India. The choice of innovator or generic ibrutinib was as per patient discretion. Response and adverse events were recorded as per the 2018 iwCLL guidelines and CTCAEv4.0. QoL was assessed using the EORTC QLQ-C30 and CLL17 questionnaires. A total of 32 CLL patients (TN, n = 7 and R/R, n = 25) received ibrutinib from 2016-2019. The median age was 60 years (37-84). All TN patients attained partial response without any grade 3/4 adverse events (AE). Ibrutinib was less tolerated in the R/R setting, with 52% patients developing grade 3/4 AE and required dose reduction. Eleven patients (44%) died during follow-up. Grade 3-5 infections were seen in 44% of R/R CLL patients. Generic ibrutinib (n = 8) was comparable to innovator ibrutinib (n = 17) in terms of efficacy, safety, and QoL. Ibrutinib is less well tolerated in Indian R/R CLL patients. Infections are a common cause of morbidity and mortality. This study affirms the safety and efficacy of generic ibrutinib.
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