Tamura T, Shinkai T, Eguchi K, Sasaki Y, Fujiwara Y, Fukuda M, Ohe Y, Nakagawa K, Minato K, Saijo N
Department of Internal Medicine, National Cancer Center Hospital, Tokyo.
Jpn J Clin Oncol. 1989 Mar;19(1):51-5.
Forty four patients with advanced non-small cell lung cancer (NSCLC) were treated with carboplatin (CBDCA; cis-diammine-1, 1-cyclobutane dicarboxylate platinum II) at a dose of 400-450 mg/m2 intravenously every four weeks in a phase II study. Forty three patients were evaluated for response and toxicity. Two patients achieved responses resulting in an overall response rate of 4.7% (95% confidence limits: 0.6-15.8%); one of these had not been treated previously and the other had been treated previously with vinblastine. The durations of their responses were 5 and 7 months, respectively. The response rate in 28 previously untreated patients was 3.6% (1/28; 95% confidence limits: 0.1-18.3%). Myelosuppression was the most commonly found toxicity, and thrombocytopenia especially was dose-limiting. Thrombocytopenia (less than 75,000/mm3) was observed in 12 patients (28%). Leukopenia (less than 3,000/mm3) was observed in 14 patients (33%). No serious infection or bleeding occurred, however. Treatment with 400-450 mg CBDCA/m2 was well tolerated in the good risk patients in this study. Mild to moderate emesis was observed in 28 patients (65%). No renal toxicity, neurotoxicity or ototoxicity was seen. It was demonstrated that CBDCA had little efficacy in NSCLC at the dose and schedule given in the present study.
在一项II期研究中，44例晚期非小细胞肺癌（NSCLC）患者接受了卡铂（CBDCA；顺-二胺-1,1-环丁烷二羧酸铂II）治疗，剂量为400 - 450mg/m²，每四周静脉注射一次。对43例患者进行了疗效和毒性评估。2例患者获得缓解，总缓解率为4.7%（95%置信区间：0.6 - 15.8%）；其中1例患者此前未接受过治疗，另1例患者此前接受过长春碱治疗。他们的缓解持续时间分别为5个月和7个月。28例此前未接受过治疗的患者的缓解率为3.6%（1/28；95%置信区间：0.1 - 18.3%）。骨髓抑制是最常见的毒性反应，尤其是血小板减少是剂量限制性毒性。12例患者（28%）出现血小板减少（低于75,000/mm³）。14例患者（33%）出现白细胞减少（低于3,000/mm³）。然而，未发生严重感染或出血。在本研究中，风险状况良好的患者对400 - 450mg CBDCA/m²的治疗耐受性良好。28例患者（65%）出现轻度至中度呕吐。未观察到肾毒性、神经毒性或耳毒性。结果表明，在本研究给出的剂量和给药方案下，卡铂对非小细胞肺癌疗效甚微。
