Le Chevalier T, Arriagada R, Baldeyrou P, Martin M, Ruffié P, Duroux P, Tarayre M, Rouesse J
Bull Cancer. 1985;72(1):25-9.
Thirty three evaluable patients with locally advanced squamous cell carcinoma of the lung were entered in a Phase II study combining chemotherapy (Vindesine 1.5 mg/m2 dl; CCNU 50 mg/m2 d2, 25 mg/m2 d3; Cis-Platinum 100 mg/m2 d3; Cyclophosphamide 200 mg/m2 d3, 4, 5) (VCPC) and radical radiotherapy to the primary tumor, mediastinum and supraclavicular nodes. Responders to chemotherapy resumed four additional cycles following radiation therapy. Fourteen patients (42%) presented an objective response to the first two cycles of VCPC. On final evaluation, 18 patients (54.5%) obtained a complete remission and 6 patients (18%) a partial remission. Median survival of all patients was 15.9 months and toxicity was acceptable. We conclude that our results justify a phase III study comparing combined treatment versus radiotherapy alone.
33例可评估的局部晚期肺鳞状细胞癌患者进入一项II期研究,该研究将化疗(长春地辛1.5mg/m²第1天;洛莫司汀50mg/m²第2天,25mg/m²第3天;顺铂100mg/m²第3天;环磷酰胺200mg/m²第3、4、5天)(VCPC)与对原发肿瘤、纵隔和锁骨上淋巴结进行的根治性放疗相结合。化疗有反应者在放疗后继续进行四个额外周期的化疗。14例患者(42%)对VCPC的前两个周期有客观反应。最终评估时,18例患者(54.5%)获得完全缓解,6例患者(18%)获得部分缓解。所有患者的中位生存期为15.9个月,毒性可接受。我们得出结论,我们的结果证明有必要进行一项III期研究,比较联合治疗与单纯放疗的效果。