Chronic Lymphocytic Leukemia: Real-World Data From India

Abstract

PURPOSE Chronic lymphocytic leukemia (CLL) is uncommon in India. There are limited studies on CLL from the Indian subcontinent. METHODS This was a prospective study (2011-2017) of consecutively diagnosed patients with CLL at a single center. The diagnosis, prognosis, treatment indication, response criteria, and adverse events were recorded as per International Workshop on Chronic Lymphocytic Leukemia guidelines. Biosimilar rituximab dosing (375 mg/m2) was fixed for all cycles. Time to next treatment (TTNT) was defined as the time from front-line treatment initiation to next treatment or death from any cause. Overall survival (OS) was defined as the time from treatment initiation until death from any cause. RESULTS A total of 409 patients with CLL were enrolled over the study period. The median follow-up was 32 months (range, 2-135 months). The median age was 61 years, and 31.8% of patients with CLL were ≤ 55 years of age; 43.3% of patients had a cumulative illness rating scale score ≥ 3. Prognostic fluorescence in situ hybridization data were available in 53.3% of patients. Chlorambucil (94/180; 52.2%) and bendamustine + rituximab (BR; 57/180; 31.6%) were the most common regimens used up front. The overall response rates after front-line therapy were 74.4% and 91.2%, respectively. The TTNT was 33 months and not reached, respectively ( P = .001). Grade 3/4 neutropenia and infections were seen in 52.6% and 38.5% of patients receiving BR. The median OS was not reached in both regimens ( P = .25). CONCLUSION Indian patients with CLL are younger in chronological age but have higher morbidity burden. Treatment outcomes with biosimilar fixed-dose BR are comparable to those reported in the literature. Chlorambucil is still a valid option, given the economic burden of the disease and treatment.

Efficacy, safety, and quality of life of generic and innovator ibrutinib in Indian CLL patients

“…Whether clinically indicated dose reductions impact clinical outcomes has been debatable in several recent studies [13,14]. The median PFS in our study (14 months) was much shorter than our historical cohort of patients receiving CIT ([ 30 months) and that reported in the real-world data (35 months) [15]. This was due to a combination of factors related to increased rate of infections, deaths, dose reductions, and probably delay in time to initiating ibrutinib.…”

Quality of life in patients of chronic lymphocytic leukemia using the EORTC QLQ‐C30 and QLQ‐CLL17 questionnaire

“…Only patients of the higher SES could afford the ibrutinib option in our study. This is probably the reason for observed less financial difficulty with ibrutinib than CIT though the cost of 1‐month of ibrutinib is the same as the cost of the entire six cycles of CIT 8 . Previous studies have shown significantly low QoL of actively/previously treated patients with CIT compared to those on W&W 3‐5 .…”

“…This is probably the reason for observed less financial difficulty with ibrutinib than CIT though the cost of 1-month of ibrutinib is the same as the cost of the entire six cycles of CIT. 8 Previous studies have shown significantly low QoL of actively/previously treated patients with CIT compared to those on W&W. [3][4][5] QoL studies on ibrutinib have so far only been reported from clinical trials and abstract forms. 16,17 The differences in the QoL on ibrutinib and CIT could be because of the different modes of action of the drugs, adverse events, higher SES of patients on ibrutinib, and the convenience of administration.…”

“…Indian CLL patients are, however, younger with the disease presenting at least a decade earlier than high‐income countries. Despite the younger age at presentation, Indian CLL patients have a higher morbidity burden as determined by a higher cumulative illness rating scale 8 . This prompted us to look at the hitherto unassessed health‐related quality of life (HR‐QoL) in Indian CLL patients.…”

Emergence of Triazole Resistance in Aspergillus spp. in Latin America

“…(invasive infections) in hematological population is at least 10%. Thus, considering only the worldwide cases of acute myeloid leukemia (around 120.000 new cases in 2017), a conservative estimation would be 12,000, but the real burden is higher since other type of patients are at risk [15][16][17].…”