Jones W G, Fosså S D, Denis L, Coninx P, Glashan R W, Akdas A, De Pauw M
Eur J Cancer Clin Oncol. 1983 May;19(5):583-8. doi: 10.1016/0277-5379(83)90172-4.
In a phase II study of vindesine in patients with bi-dimensionally measurable primary or metastatic prostate cancer, 27 patients (given 3 mg/m2 weekly for at least 4 treatment cycles) were evaluable for response 6 weeks from the start of treatment. Dose escalation to 4 mg/m2 weekly was attempted. Five patients (19%) achieved a partial remission of short duration, 11 patients (41%) showed no change and 11 patients (41%) showed progression. Thirty-one patients were evaluable for toxicity. Neurotoxicity occurred in 58% (severe in 23%) and was apparently cumulative dose-dependent, although there was variable individual sensitivity. Haematological toxicity was evidenced by lack of dose escalation in 32% of patients, dose delay in 71% and some degree of anaemia in 48%. Alopecia occurred in 55%. Other toxicities were few and minor. Vindesine shows marginal activity in prostatic cancer but at this dose schedule causes appreciable toxicity.
在一项针对二维可测量的原发性或转移性前列腺癌患者的长春地辛II期研究中,27例患者(每周给予3mg/m²,至少进行4个治疗周期)在治疗开始6周后可评估疗效。尝试将剂量增至每周4mg/m²。5例患者(19%)实现了短期部分缓解,11例患者(41%)无变化,11例患者(41%)病情进展。31例患者可评估毒性。58%的患者出现神经毒性(23%为严重神经毒性),尽管个体敏感性存在差异,但神经毒性显然与累积剂量相关。32%的患者因血液学毒性而未增加剂量,71%的患者出现剂量延迟,48%的患者有一定程度的贫血。55%的患者出现脱发。其他毒性较少且轻微。长春地辛在前列腺癌中显示出一定活性,但按此剂量方案会导致明显毒性。