Mandelli F, Amadori S, Giona F, Antonietta M, Spiriti A, Pastore S, Meloni G, Paolucci G
Leuk Res. 1982;6(5):649-52. doi: 10.1016/0145-2126(82)90080-7.
A phase II evaluation of vindesine (VDS) was carried out in 46 patients with hematologic malignancies refractory to conventional chemotherapy. Two VDS schedules were employed (at random): (A) a weekly bolus (5 mg/m2 i.v. X 4); (B) fractionated daily injections (0.5 mg/m2 i.v. q.12 h X 10, course to be repeated after 10-15 days). Complete and partial remissions were observed in acute lymphocytic leukemia (3/14 patients), acute non-lymphocytic leukemia (2/12 patients), chronic myelocytic leukemia in blastic crisis (4/12 patients) and non-Hodgkin's lymphoma (4/8 patients). Responses were seen with higher frequency in patients treated with the weekly bolus (42.8 vs 16%). Myelosuppression was the most relevant side effect in both schedules. Neurotoxicity occurred infrequently and was generally mild in degree. Further trials with VDS in combination with other drugs are recommended in hematologic malignancies.
对46例对传统化疗耐药的血液系统恶性肿瘤患者进行了长春地辛(VDS)的II期评估。采用了两种VDS给药方案(随机分组):(A)每周大剂量给药(5mg/m²静脉注射×4次);(B)每日分次注射(0.5mg/m²静脉注射,每12小时1次×10次,10 - 15天后重复疗程)。在急性淋巴细胞白血病(14例患者中的3例)、急性非淋巴细胞白血病(12例患者中的2例)、慢性粒细胞白血病急变期(12例患者中的4例)和非霍奇金淋巴瘤(8例患者中的4例)中观察到完全缓解和部分缓解。每周大剂量给药治疗的患者缓解频率更高(42.8%对16%)。两种给药方案中,骨髓抑制都是最主要的副作用。神经毒性发生率低,程度一般较轻。建议在血液系统恶性肿瘤中进一步开展VDS与其他药物联合应用的试验。