Thomas P, Kleisbauer J P, Robinet G, Clavier J, Poirier R, Vernenegre A, Bonnaud F, Taytard A, Paillotin D, Pommier De Santi P, Barriere J R, Pignon T
Service d'oncologie respiratoire, Hopital Sainte-Marguerite, Marseille, France.
Lung Cancer. 1997 Aug;18(1):71-81. doi: 10.1016/s0169-5002(97)00047-0.
A Phase I trial of carboplatin therapy was performed on patients with locally advanced non-small cell lung cancer who had been previously treated with cisplatin, mitomycin and a vinca aklaloïd. This was administered as a daily bolus infusion or as a continuous infusion for 6 weeks with concurrent daily thoracic radiation. All patients had to be objective responders or to show no change after chemotherapy. The carboplatin was started at 10 mg/m2 per day, and increased to 15 mg/m2 per day and 20 mg/m2 per day, if treatment was feasible in successive cohorts of at least six patients. The radiation therapy consisted of 62-66 Gray on the tumor and the ipsilateral mediastinal nodes, 50 Gray on the mediastinum and 40-45 Gray on the supraclavicular lymph nodes. Twenty-nine patients took part in this study. Thrombocytopenia was the principal dose-limiting toxicity, with 15 mg/m2 per day of bolus or continuous infusion. Other toxicities included a fall in haemoglobin level, a fall in white-blood cell count, nausea and vomiting. The median survival time was 12 months, but the response rate cannot be determined among patients selected on the basis of response to chemotherapy. The recommended Phase II dose for patients previously treated with cisplatin containing chemotherapy, is 10 mg/m2 per day of either a bolus or continuous infusion.
对先前接受过顺铂、丝裂霉素和长春花生物碱治疗的局部晚期非小细胞肺癌患者进行了卡铂治疗的I期试验。以每日大剂量输注或持续输注的方式给药6周，同时每日进行胸部放疗。所有患者必须是客观缓解者或化疗后无变化。卡铂起始剂量为每天10mg/m²，若在至少6名患者的连续队列中治疗可行，则剂量增加至每天15mg/m²和20mg/m²。放射治疗包括对肿瘤和同侧纵隔淋巴结给予62 - 66格雷，对纵隔给予50格雷，对锁骨上淋巴结给予40 - 45格雷。29名患者参与了这项研究。血小板减少是主要的剂量限制性毒性，大剂量或持续输注每天15mg/m²时出现。其他毒性包括血红蛋白水平下降、白细胞计数下降、恶心和呕吐。中位生存时间为12个月，但在根据化疗反应选择的患者中无法确定缓解率。对于先前接受过含顺铂化疗的患者，推荐的II期剂量为每天10mg/m²，采用大剂量或持续输注。
