Currie V E, Wong P P, Krakoff I H, Young C W
Cancer Treat Rep. 1978 Sep;62(9):1333-6.
A phase I evaluation of vindesine was carried out in 69 adult patient with advanced malignancies. Two escalating dose schedules were explored: (a) a single dose every 7--14 days, and (b) daily injections X 5--10 days as tolerated. The main toxic effects were myelosuppression, alopecia, paresthesia, asthenia, myalgia, and hyporeflexia. Antitumor activity was seen during this phase I study in patients with leukemia, lymphoma, and testicular neoplasms. Disease oriented phase II trials of 3--4 mg/m2 every 7--14 days or 1.3--2.0 mg/m2/day X 5--7 days every 3 weeks would be appropriate.
对69例成年晚期恶性肿瘤患者进行了长春地辛的I期评估。探索了两种剂量递增方案:(a)每7 - 14天单次给药,以及(b)耐受情况下每日注射5 - 10天。主要毒性作用为骨髓抑制、脱发、感觉异常、乏力、肌痛和反射减退。在这项I期研究中,白血病、淋巴瘤和睾丸肿瘤患者出现了抗肿瘤活性。每3周给予3 - 4 mg/m² 每7 - 14天或1.3 - 2.0 mg/m²/天×5 - 7天的以疾病为导向的II期试验是合适的。