Nakano H, Tsuchiya S, Takei Y, Minato K, Watanabe S, Makimoto T, Naruse I, Nomoto T, Ishihara S, Takise A, Ezawa K, Fueki N, Hoshino H, Saito R, Mori M
Department of Internal Medicine, National Nishi-Gunma Hospital, Shibukawa, Japan.
Am J Clin Oncol. 1996 Jun;19(3):245-8. doi: 10.1097/00000421-199606000-00007.
Cisplatin (CDDP)-containing chemotherapy has become the mainstay of clinical trials in unresectable non-small-cell lung cancer (NSCLC), but the role of chemotherapy in the routine management of NSCLC remains controversial. We conducted a phase I study with the combination carboplatin (CBDCA), CDDP, and etoposide (Etop) in unresectable NSCLC. CBDCA, at a starting dose of 80 mg/m2, on day 1, was combined with a fixed dose of CDDP (80 mg/m2, day 1) and Etop (80 mg/m2, days 1-3). Escalation was performed after four patients entered at each dose level. If no World Health Organization (WHO) grade 4 toxicity developed after the first cycle in more than half of the patients or WHO grade 3/4 toxicity in more than two thirds, the dose was escalated. The maximum tolerated dose was established at 300 mg/m2 for CBDCA. Thrombocytopenia and leukopenia were the dose-limiting toxicities. No grade 3/4 nonhematologic toxicities were seen. The recommended dose of CBDCA to be combined with CDDP (80 mg/m2, day 1) and Etop (80 mg/m2, days 1-3) is 280 mg/m2. This trial suggests that our combination chemotherapy may be effective in patients with advanced NSCLC. A multicenter phase II study based on these findings is now under way.
含顺铂（CDDP）的化疗已成为不可切除非小细胞肺癌（NSCLC）临床试验的主要手段，但化疗在NSCLC常规治疗中的作用仍存在争议。我们对不可切除的NSCLC患者进行了一项卡铂（CBDCA）、顺铂和依托泊苷（Etop）联合的I期研究。CBDCA起始剂量为80mg/m²，于第1天给药，与固定剂量的顺铂（80mg/m²，第1天）和依托泊苷（80mg/m²，第1 - 3天）联合使用。每个剂量水平纳入4例患者后进行剂量递增。如果在第一个周期后超过半数患者未出现世界卫生组织（WHO）4级毒性，或超过三分之二患者未出现WHO 3/4级毒性，则增加剂量。CBDCA的最大耐受剂量确定为300mg/m²。血小板减少和白细胞减少是剂量限制性毒性。未观察到3/4级非血液学毒性。与顺铂（80mg/m²，第1天）和依托泊苷（80mg/m²，第1 - 3天）联合使用时，CBDCA的推荐剂量为280mg/m²。该试验表明我们的联合化疗可能对晚期NSCLC患者有效。基于这些发现的多中心II期研究正在进行中。
