A phase II Japanese trial of fludarabine, cyclophosphamide and rituximab for previously untreated chronic lymphocytic leukemia.
A phase II Japanese trial of fludarabine, cyclophosphamide and rituximab for previously untreated chronic lymphocytic leukemia.
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DOI：
10.1093/jjco/hyaa215
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发表时间：
2021-03-03
影响因子：
2.4
通讯作者：
Tobinai K
中科院分区：
文献类型：
--
作者：
Izutsu K;Kinoshita T;Takizawa J;Fukuhara S;Yamamoto G;Ohashi Y;Suzumiya J;Tobinai K
氟达拉滨、环磷酰胺和利妥昔单抗（FCR）是治疗未经治疗的CD 20阳性慢性淋巴细胞白血病（CLL）的标准方案。然而，这种组合在日本不可用，因为利妥昔单抗未被批准用于CLL。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CLL 8研究的桥接研究。该研究招募了患有活动性疾病的Binet B或C期CLL的先前未经治疗的患者。累积疾病评定量表评分≤6分且肌酐清除率≥70 ml/min的患者合格。患者每28天接受6个周期的FCR，并随访长达1年。7例患者入组。根据1996年NCI-WG指南，最佳总体缓解率（研究的主要终点）为71.4%（95%置信区间，29.0-96.3%），1例患者达到完全缓解。随访期间未发生死亡或进展。主要不良反应为血液毒性。所有患者的CD 4阳性T细胞计数均降低;大多数患者的血清免疫球蛋白G未降低。虽然患者数量有限，但FCR似乎对初治的日本CD 20阳性CLL患者有效，毒性可管理。JapicCTI-132285。FCR方案对于初治适合的日本CD 20阳性CLL患者是可行的，毒性可控，疗效与CLL 8研究中观察到的结果一致。
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. FCR regimen was feasible with manageable toxicity for treatment-naïve fit Japanese patients with CD20-positive CLL, and the efficacy was in line with that seen in the CLL8 study.
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影响因子：
4
作者：
Muto R;Miyoshi H;Sato K;Furuta T;Muta H;Kawamoto K;Yanagida E;Yamada K;Ohshima K
通讯作者：
Ohshima K
影响因子：
3.6
作者：
Fortin, Martin;Hudon, Catherine;Soubhi, Hassan
通讯作者：
Soubhi, Hassan
影响因子：
20.3
作者：
Tam, Constantine S.;O'Brien, Susan;Keating, Michael J.
通讯作者：
Keating, Michael J.
影响因子：
168.9
作者：
Hallek, M.;Fischer, K.;Stilgenbauer, S.
通讯作者：
Stilgenbauer, S.
影响因子：
11.4
作者：
Ysebaert, L.;Gross, E.;Quillet-Mary, A.
通讯作者：
Quillet-Mary, A.