Ota K, Ohno R, Shirakawa S, Masaoka T, Okada K, Ohashi Y, Taguchi T
Nagoya Memorial Hospital.
Gan To Kagaku Ryoho. 1994 Jun;21(7):1047-55.
A nationwide multi-center cooperative phase II clinical study of irinotecan hydrochloride (CPT-11) was conducted to evaluate its efficacy in intractable malignant lymphoma and acute leukemia. In malignant lymphoma, one course of CPT-11 consisted of intravenous drip infusion at a dose of 40 mg/m2 once daily for 3 consecutive days, performed once a week. In acute leukemia, one course of CPT-11 consisted of intravenous drip infusion at a dose of 15 to 20 mg/m2 a day twice daily for 7 consecutive days (1 cycle), performed every 2 to 4 weeks. Among the 79 patients with malignant lymphoma and 50 patients with acute leukemia enrolled in the study, 66 and 41 patients, respectively, completed treatment. These patients had all undergone chemotherapy prior to treatment. Among the malignant lymphomas, the response rate in non-Hodgkin's lymphoma (NHL), including 9 CRs, was 42% (26/62, 95% CI: 30-54%); of these there was a response rate of 39% (5/13), including 1 CR, in adult T-cell leukemia (ATL) as well. In Hodgkin's disease (HD), on the other hand, there were no cases in which efficacy was demonstrated (0/4). The overall response rate in malignant lymphoma was 39% (26/66), and the response rate even among the recurrent intransigent cases was 42% (16/38). The 50% survival time (MST) in the 74 eligible cases of malignant lymphoma was 153 days. In acute leukemia, on the other hand, partial remission was observed in 2 of 17 cases (12%) of acute lymphocytic leukemia (ALL), but no cases of remission were observed in the 24 patients with acute myelogenous leukemia (AML). The overall remission rate in acute leukemia was 5% (2/41, 95% CI: 1-14%). The principal adverse effects were myelosuppression in malignant lymphoma and gastrointestinal symptoms, including diarrhea, nausea/vomiting, anorexia and abdominal pain, in both malignant lymphoma and acute leukemia, and there was little organ damage to the heart, liver or kidney. Myelosuppression and gastrointestinal adverse effects were severe in some of the patients, so caution is required. Based on the above findings, CPT-11 appears to be efficacious in the treatment of non-Hodgkin's lymphoma.
开展了一项关于盐酸伊立替康（CPT - 11）的全国多中心合作II期临床研究，以评估其在难治性恶性淋巴瘤和急性白血病中的疗效。在恶性淋巴瘤中，CPT - 11的一个疗程包括以40mg/m²的剂量每日静脉滴注1次，连续3天，每周进行1次。在急性白血病中，CPT - 11的一个疗程包括以15至20mg/m²的剂量每天静脉滴注2次，连续7天（1个周期），每2至4周进行1次。在该研究纳入的79例恶性淋巴瘤患者和50例急性白血病患者中，分别有66例和41例患者完成了治疗。这些患者在治疗前均接受过化疗。在恶性淋巴瘤中，非霍奇金淋巴瘤（NHL）的缓解率为42%（26/62，95%CI：30 - 54%），包括9例完全缓解（CR）；其中成人T细胞白血病（ATL）的缓解率为39%（5/13），包括1例CR。另一方面，在霍奇金病（HD）中，未观察到有疗效的病例（0/4）。恶性淋巴瘤的总缓解率为39%（26/66），即使在复发难治性病例中的缓解率也为42%（16/38）。74例符合条件的恶性淋巴瘤患者的50%生存时间（MST）为153天。另一方面，在17例急性淋巴细胞白血病（ALL）患者中有2例（12%）观察到部分缓解，但在24例急性髓细胞白血病（AML）患者中未观察到缓解病例。急性白血病的总缓解率为5%（2/41，95%CI：1 - 14%）。主要不良反应在恶性淋巴瘤中为骨髓抑制，在恶性淋巴瘤和急性白血病中均为胃肠道症状，包括腹泻、恶心/呕吐、厌食和腹痛，对心脏、肝脏或肾脏几乎没有器官损害。部分患者的骨髓抑制和胃肠道不良反应较为严重，因此需要谨慎使用。基于上述发现，CPT - 11似乎对非霍奇金淋巴瘤的治疗有效。
