Paridaens R, Clarysse A, Rozencweig M, Rotmensz N, Heuson J C
Eur J Cancer Clin Oncol. 1985 May;21(5):595-9. doi: 10.1016/0277-5379(85)90087-2.
This phase II clinical trial was conducted in a series of patients with advanced breast cancer, refractory to conventional chemotherapy. The therapeutic regimen consisted of a combination of cisplatin 100 mg/m2, given as a 24-hr infusion on day 1 and vindesine (VDS) 2 mg/m2, i.v. bolus on days 1 and 8. VDS injection was omitted on day 8 in patients with poor bone marrow reserves (prior extensive irradiation). Courses were repeated at 4-week intervals until documented disease progression. Among 46 evaluable patients, there were two complete and seven partial remissions for an overall response rate of 20%. These responses lasted for a median of 21 weeks (range 8-89 weeks). Remission rates according to the predominant metastatic site were as follows: soft tissue, 3/8 (38%); bone, 0/6 (0%); viscera, 6/32 (19%). Transient myelosuppression and gastrointestinal intolerance were almost universal. Renal function impairment and neurologic manifestations were frequently encountered but these adverse reactions were generally mild. Significant antineoplastic activity in far-advanced and heavily pretreated patients warrants further evaluation of this regimen at an earlier stage of the disease.
这项II期临床试验针对一系列对传统化疗耐药的晚期乳腺癌患者开展。治疗方案包括顺铂100 mg/m²，于第1天静脉滴注24小时，长春地辛（VDS）2 mg/m²，于第1天和第8天静脉推注。对于骨髓储备差（既往接受过广泛放疗）的患者，第8天省略VDS注射。每4周重复疗程，直至记录到疾病进展。在46例可评估患者中，有2例完全缓解和7例部分缓解，总缓解率为20%。这些缓解持续的中位时间为21周（范围8 - 89周）。根据主要转移部位的缓解率如下：软组织，3/8（38%）；骨，0/6（0%）；内脏，6/32（19%）。短暂的骨髓抑制和胃肠道不耐受几乎普遍存在。肾功能损害和神经学表现经常出现，但这些不良反应通常较轻。在晚期和经过大量预处理的患者中显著的抗肿瘤活性值得在疾病的更早阶段对该方案进行进一步评估。
