Rosso R, Ardizzoni A, Salvati F, Gallo-Curcio C, Rubagotti A, Fusco V, Brunetti I, DePalma M, Crucsiani A R, Portalone L
Forza Operativa Nazionale per il Cancro del Polmone (FONICAP), Italy.
Semin Oncol. 1988 Dec;15(6 Suppl 7):49-51.
A multicenter Italian Cooperative Study Group (FONICAP) conducted a prospective, randomized trial comparing cisplatin and etoposide (VP-16) with single-agent etoposide. The national study accrued 216 patients with measurable or evaluable non-small cell lung cancer (NSCLC) with either unresectable stage III, or distant metastasis (stage IV). One hundred patients were evaluable for response in the single-agent arm, and 93 in the two-drug combination arm. The overall response rates for the etoposide group and cisplatin/etoposide (VP-16) group were 7% and 26%, respectively (P less than 0.005). Five patients (5.6%) in the combination arm and 1 (1%) in the single agent arm had a complete response. The overall median survival was 236 days for the two-drug arm and 178 days on the single-drug arm (P = 0.2). Treatment-related toxicity (nausea and vomiting, leukopenia, anemia, hearing-loss, peripheral neuropathy, serum creatinine elevation) was significantly more pronounced in the combined arm. The addition of cisplatin to etoposide gave a small non-statistically significant improvement in terms of performance status and thoracic symptoms.
一个意大利多中心合作研究小组（FONICAP）开展了一项前瞻性随机试验，比较顺铂和依托泊苷（VP - 16）联合用药与单药依托泊苷的疗效。这项全国性研究纳入了216例患有可测量或可评估的非小细胞肺癌（NSCLC）患者，这些患者处于不可切除的III期或远处转移（IV期）。单药治疗组有100例患者可评估疗效，联合用药组有93例。依托泊苷组和顺铂/依托泊苷（VP - 16）组的总缓解率分别为7%和26%（P < 0.005）。联合用药组有5例患者（5.6%）完全缓解，单药治疗组有1例（1%）完全缓解。联合用药组的总中位生存期为236天，单药治疗组为178天（P = 0.2）。联合用药组与治疗相关的毒性反应（恶心、呕吐、白细胞减少、贫血、听力丧失、周围神经病变、血清肌酐升高）更为明显。在体能状态和胸部症状方面，顺铂与依托泊苷联合使用有微小但无统计学意义的改善。
