Miller V A
Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
Semin Oncol. 1997 Aug;24(4 Suppl 14):S14-15-S14-17.
We undertook a phase I/II study of the combination of docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) and vinorelbine in the treatment of unresectable or metastatic non-small cell lung cancer (NSCLC). Nineteen patients with unresectable NSCLC received a combination of docetaxel 50 mg/m2 and vinorelbine 15 to 45 mg/m2 every 2 weeks. All patients received prophylactic granulocyte-colony stimulating factor 5 microg/kg/d and corticosteroids. The incidence of hematologic toxicity with this dosing schedule was low; only 2.5% of treatment cycles were complicated by febrile neutropenia. The maximum tolerated dose has not been reached. It is concluded that using this schedule, a combination of docetaxel and vinorelbine can be administered in combination, together with granulocyte-colony stimulating factor, with a low risk of associated hematologic toxicity. Further dose escalation is needed to determine the maximum tolerated dose of the combination. A partial response was observed in five patients (26%; 95% confidence interval, 15% to 57%), and nine (47%) patients showed stable disease. Based on these preliminary results, the combination of these two drugs appears to have antitumor activity against NSCLC and warrants continued study.
我们开展了一项多西他赛（泰索帝；法国罗纳普朗克-乐安公司，安东尼）与长春瑞滨联合治疗不可切除或转移性非小细胞肺癌（NSCLC）的I/II期研究。19例不可切除的NSCLC患者每2周接受一次多西他赛50 mg/m²与长春瑞滨15至45 mg/m²的联合治疗。所有患者均接受5 μg/kg/d的预防性粒细胞集落刺激因子和皮质类固醇治疗。该给药方案的血液学毒性发生率较低；仅2.5%的治疗周期出现发热性中性粒细胞减少并发症。尚未达到最大耐受剂量。结论是，采用该方案，多西他赛与长春瑞滨可联合给药，并联合粒细胞集落刺激因子，相关血液学毒性风险较低。需要进一步提高剂量以确定该联合用药的最大耐受剂量。5例患者（26%；95%置信区间，15%至57%）观察到部分缓解，9例（47%）患者病情稳定。基于这些初步结果，这两种药物的联合似乎对NSCLC具有抗肿瘤活性，值得继续研究。
