Tejaswi V, Lad Deepesh P, Jindal Nishant, Prakash Gaurav, Malhotra Pankaj, Khadwal Alka, Jain Arihant, Sreedharanunni Sreejesh, Sachdeva Manupdesh Singh, Naseem Shano, Varma Neelam, Varma Subhash
Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Department of Hematology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
JCO Glob Oncol. 2020 Jun;6:866-872. doi: 10.1200/GO.20.00032.
Chronic lymphocytic leukemia (CLL) is uncommon in India. There are limited studies on CLL from the Indian subcontinent.
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/m) 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.
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 ( = .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 ( = .25).
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.
慢性淋巴细胞白血病（CLL）在印度并不常见。来自印度次大陆的关于CLL的研究有限。
这是一项在单一中心对连续诊断的CLL患者进行的前瞻性研究（2011 - 2017年）。根据慢性淋巴细胞白血病国际研讨会指南记录诊断、预后、治疗指征、反应标准和不良事件。所有疗程均采用生物类似药利妥昔单抗固定剂量（375 mg/m）。下次治疗时间（TTNT）定义为从一线治疗开始到下次治疗或因任何原因死亡的时间。总生存期（OS）定义为从治疗开始到因任何原因死亡的时间。
在研究期间共纳入409例CLL患者。中位随访时间为32个月（范围2 - 135个月）。中位年龄为61岁，31.8%的CLL患者年龄≤55岁；43.3%的患者累积疾病评定量表评分≥3。53.3%的患者有预后荧光原位杂交数据。苯丁酸氮芥（94/180；52.2%）和苯达莫司汀 + 利妥昔单抗（BR；57/180；31.6%）是最常用的一线治疗方案。一线治疗后的总体缓解率分别为74.4%和91.2%。TTNT分别为33个月和未达到（P = 0.001）。接受BR治疗的患者中，52.6%出现3/4级中性粒细胞减少，38.5%出现感染。两种治疗方案的中位OS均未达到（P = 0.25）。
印度CLL患者实际年龄较轻，但发病负担较高。生物类似药固定剂量BR的治疗效果与文献报道相当。鉴于疾病和治疗的经济负担，苯丁酸氮芥仍是一个有效的选择。
