Department of Hematology, Toranomon Hospital, Tokyo, Japan.
Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.
Jpn J Clin Oncol. 2021 Mar 3;51(3):408-415. doi: 10.1093/jjco/hyaa215.
Fludarabine, cyclophosphamide and rituximab (FCR) is the standard regimen for fit patients with untreated CD20-positive chronic lymphocytic leukemia (CLL). However, this combination is unavailable in Japan because rituximab is not approved for CLL. We investigated the efficacy and safety of FCR in this single-arm, multicenter study designed as a bridging study to the CLL8 study by the German CLL Study Group.
The study enrolled previously untreated patients with CLL of Binet stage B or C with active disease. Patients with a Cumulative Illness Rating Scale score of ≤6 and creatinine clearance of ≥70 ml/min were eligible. Patients received 6 cycles of FCR every 28 days and were followed for up to 1 year.
Seven patients were enrolled. The best overall response rate according to the 1996 NCI-WG Guidelines, the primary endpoint of the study, was 71.4% (95% confidence interval, 29.0-96.3%), with one patient achieving complete response. No deaths or progression occurred during follow-up. The main adverse event was hematotoxicity. CD4-positive T-cell count decreased in all patients; most patients showed no reduction in serum immunoglobulin G.
Although the number of patients was limited, FCR appears to be effective with manageable toxicity for treatment-naïve fit Japanese patients with CD20-positive CLL.
JapicCTI-132285.
氟达拉滨、环磷酰胺和利妥昔单抗（FCR）是未经治疗的 CD20 阳性慢性淋巴细胞白血病（CLL）患者的标准治疗方案。然而，由于利妥昔单抗未被批准用于 CLL，该组合在日本无法使用。我们在这项单臂、多中心研究中调查了 FCR 的疗效和安全性，该研究设计为德国 CLL 研究组的 CLL8 研究的桥接研究。
该研究招募了未经治疗的 Binet 期 B 或 C 期伴有活动性疾病的 CLL 患者。符合条件的患者Cumulative Illness Rating Scale 评分≤6 且肌酐清除率≥70ml/min。患者每 28 天接受 6 个周期的 FCR 治疗，并随访长达 1 年。
共招募了 7 名患者。根据 1996 年 NCI-WG 指南，即该研究的主要终点，最佳总体缓解率为 71.4%（95%置信区间，29.0-96.3%），1 名患者达到完全缓解。随访期间无死亡或进展。主要不良事件为血液毒性。所有患者的 CD4 阳性 T 细胞计数均下降；大多数患者的血清免疫球蛋白 G 无减少。
尽管患者人数有限，但 FCR 似乎对未经治疗的适合日本 CD20 阳性 CLL 患者有效，且毒性可管理。
JapicCTI-132285。
