Speyer J L, Beller U, Colombo N, Sorich J, Wernz J C, Hochster H, Green M, Porges R, Muggia F M, Canetta R
Rita and Stanley H. Kaplan Cancer Center, Department of Medicine, New York University Medical Center.
J Clin Oncol. 1990 Aug;8(8):1335-41. doi: 10.1200/JCO.1990.8.8.1335.
From August 1985 to November 1989 we conducted a trial of intraperitoneal (IP) carboplatin including a dose-escalation design in 25 women with advanced gynecologic malignancies. All had extensive prior therapy with cisplatin (median cumulative dose, 525 mg/m2). Carboplatin was administered IP in 2 L of 1.5% dextrose with a 4-hour dwell time every 4 weeks for six cycles at a starting dose of 200 mg/m2. Patients with reduced creatinine clearance (30 to 60 cc/min) were escalated more slowly than those with high (greater than 60 cc/min) clearance. Thrombocytopenia was dose-limiting and often more severe in patients with compromised renal function; there was no local drug toxicity. The median time of follow-up is 25 months. Complete responses (CRs) were documented in six of 23 assessable patients (26%) by repeat laparotomy, and an additional 11 patients (48%) had no disease evident by noninvasive restaging. Five of the CRs and six of the patients with no clinically evident disease have relapsed from 3 to 40 months after therapy. Six patients (26%) are alive and free of disease 8 to 47 (median, 20) months after therapy. IP carboplatin is effective against relapsed ovarian cancer, even after prior cisplatin therapy.
1985年8月至1989年11月，我们对25例晚期妇科恶性肿瘤患者进行了腹腔内（IP）卡铂试验，包括剂量递增设计。所有患者此前均接受过大量顺铂治疗（中位累积剂量为525mg/m²）。卡铂以200mg/m²的起始剂量，每4周在2L 1.5%葡萄糖溶液中腹腔内给药，保留4小时，共六个周期。肌酐清除率降低（30至60cc/min）的患者剂量递增速度比肌酐清除率高（大于60cc/min）的患者慢。血小板减少是剂量限制性的，在肾功能受损的患者中往往更严重；无局部药物毒性。中位随访时间为25个月。通过重复剖腹术，23例可评估患者中有6例（26%）记录为完全缓解（CR），另有11例患者（48%）通过非侵入性分期未发现疾病。6例CR患者中的5例以及11例无临床明显疾病的患者中有6例在治疗后3至40个月复发。6例患者（26%）在治疗后8至47个月（中位时间20个月）存活且无疾病。腹腔内卡铂对复发性卵巢癌有效，即使在先前接受过顺铂治疗之后。
