Intraperitoneal cisplatin plus intravenous cyclophosphamide versus intravenous cisplatin plus intravenous cyclophosphamide for stage III ovarian cancer
Intraperitoneal cisplatin plus intravenous cyclophosphamide versus intravenous cisplatin plus intravenous cyclophosphamide for stage III ovarian cancer
复制标题
DOI：
10.1056/nejm199612263352603
复制
发表时间：
1996-12-26
影响因子：
158.5
通讯作者：
Hoskins, WJ
中科院分区：
文献类型：
--
作者：
Alberts, DS;Liu, PY;Hoskins, WJ
背景：以铂为基础的静脉化疗是晚期卵巢癌的标准主要治疗方法。我们进行了一项3期试验，以比较腹膜内和静脉注射顺铂对未经治疗的III期上皮性卵巢癌患者生存率的影响。术后4周内静脉滴注环磷酰胺(600 mg/m2/疗程)+顺铂(100 mg/m2/m2)或顺铂(100 mg/m2/m2)，间隔3周。结果654例患者中，546例进入研究。接受腹膜腔内顺铂组的估计中位生存期(49个月；95%可信区间，42至56)显著长于静脉注射顺铂组(41个月，95%可信区间，34至47)。腹腔组死亡风险高于静脉组(风险比0.76；95%可信区间0.61~0.96；P=0.02)。静脉注射组中重度耳鸣、临床听力损失和神经肌肉毒性反应发生率明显高于静脉注射顺铂。结论与静脉注射顺铂相比，腹膜腔内注射顺铂可显著提高卵巢癌患者的生存率，且毒性反应明显减少。(C)1996年，马萨诸塞州医学会。
Background Intravenous platinum-based chemotherapy is the standard primary therapy for advanced ovarian cancer. We conducted a phase 3 trial to compare the effects of intraperitoneal and intravenous cisplatin on the survival of women with previously untreated, stage III, epithelial ovarian cancer.Methods The patients underwent an initial exploratory laparotomy and resection of all tumor masses larger than 2 cm. Within four weeks after surgery, six courses of intravenous cyclophosphamide (600 mg per square meter of body-surface area per course) plus either intraperitoneal cisplatin (100 mg per square meter) or intravenous cisplatin (100 mg per square meter) were administered at three-week intervals.Results Of 654 randomized patients, 546 were eligible for the study. The estimated median survival was significantly longer in the group receiving intraperitoneal cisplatin (49 months; 95 percent confidence interval, 42 to 56) than in the group receiving intravenous cisplatin (41 months; 95 percent confidence interval, 34 to 47). The risk of death was tower in the intraperitoneal group than in the intravenous group (hazard ratio, 0.76; 95 percent confidence interval, 0.61 to 0.96; P=0.02). Moderate-to-severe tinnitus, clinical hearing loss, and neuromuscular toxic effects were significantly more frequent in the intravenous group.Conclusions As compared with intravenous cisplatin, intraperitoneal cisplatin significantly improves survival and has significantly fewer toxic effects in patients with stage ill ovarian cancer and residual tumor masses of 2 cm or less. (C) 1996, Massachusetts Medical Society.