Suzumiya Junji, Suzushima Hitoshi, Maeda Kouichi, Okamura Seiichi, Utsunomiya Atae, Shibuya Tunefumi, Tamura Kazuo
Department of Internal Medicine, Fukuoka University, School of Medicine, Nanakuma 7-45-1, Jonan-ku, Fukuoka 814-0180, Japan.
Int J Hematol. 2004 Apr;79(3):266-70. doi: 10.1532/ijh97.03071.
A phase I study of irinotecan hydrochloride (CPT-11), carboplatin, and dexamethasone treatment in 7 patients with relapsed lymphoma and 7 patients with refractory lymphoma was conducted to evaluate the maximal tolerated dose. The 6 female and 8 male patients had a median age of 63 years (range, 45-73 years), a median performance status of 0 (range, 0-2), and a median disease stage of IV. This study included patients with diffuse large B-cell lymphoma (n = 5), adult T-cell leukemia/lymphoma (n = 2), mantle cell lymphoma (n = 2), follicular lymphoma (n = 2), angioimmunoblastic T-cell lymphoma (n = 1), anaplastic large cell lymphoma (n = 1), and Hodgkin's lymphoma (n = 1). All patients had received anthracycline-containing combination chemotherapy prior to this therapy. The starting dosage of CPT-11 was 15 mg/m2 per day (days 1-3 and 8-10), and dosage-escalation increments of 5 mg/m2 per day were planned, with fixed dosages of carboplatin (250 mg/m2 per day, day 1) and dexamethasone (40 mg/body, days 1-3 and days 8-10). Five patients were enrolled at level 1, 3 at level 2, 4 at level 3, and 2 at level 4. Ten patients (71%) and 11 patients (79%) experienced grade 3 or 4 hematologic toxicities of leukocytopenia and neutropenia, respectively. Three patients (29%) and 9 patients (64%) experienced grade 3 or 4 thrombocytopenia and anemia, respectively. Two patients who received 30 mg/m2 (level 4) of CPT-11 developed sepsis. We concluded that the recommended dose of CPT-11 with carboplatin and dexamethasone is 25 mg/m2. No deaths were related to this chemotherapy, and no patient developed liver dysfunction. The overall response rate was 36%. We conclude that the combination therapy of CPT-11, carboplatin, and dexamthasone is effective as salvage therapy but that the duration of response is too short.
对7例复发淋巴瘤患者和7例难治性淋巴瘤患者进行了盐酸伊立替康（CPT - 11）、卡铂和地塞米松治疗的I期研究，以评估最大耐受剂量。6名女性和8名男性患者的中位年龄为63岁（范围45 - 73岁），中位体能状态为0（范围0 - 2），中位疾病分期为IV期。本研究纳入弥漫性大B细胞淋巴瘤患者5例、成人T细胞白血病/淋巴瘤患者2例、套细胞淋巴瘤患者2例、滤泡性淋巴瘤患者2例、血管免疫母细胞性T细胞淋巴瘤患者1例、间变性大细胞淋巴瘤患者1例和霍奇金淋巴瘤患者1例。所有患者在此次治疗前均接受过含蒽环类药物的联合化疗。CPT - 11的起始剂量为每日15mg/m²（第1至3天和第8至10天），计划剂量递增幅度为每日5mg/m²，卡铂（每日250mg/m²，第1天）和地塞米松（40mg/体，第1至3天和第8至10天）剂量固定。1级入组5例患者，2级入组3例患者，3级入组4例患者，4级入组2例患者。分别有10例（71%）和11例（79%）患者发生3级或4级白细胞减少和中性粒细胞减少血液学毒性。分别有3例（29%）和9例（64%）患者发生3级或4级血小板减少和贫血。2例接受30mg/m²（4级）CPT - 11的患者发生败血症。我们得出结论，CPT - 11联合卡铂和地塞米松的推荐剂量为25mg/m²。无死亡与该化疗相关，且无患者发生肝功能障碍。总缓解率为36%。我们得出结论，CPT - 11、卡铂和地塞米松联合治疗作为挽救治疗是有效的，但缓解持续时间太短。
