Alberts D S, Liu P Y, Hannigan E V, O'Toole R, Williams S D, Young J A, Franklin E W, Clarke-Pearson D L, Malviya V K, DuBeshter B
University of Arizona, Tucson, USA.
N Engl J Med. 1996 Dec 26;335(26):1950-5. doi: 10.1056/NEJM199612263352603.
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.
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.
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 lower 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.
As compared with intravenous cisplatin, intraperitoneal cisplatin significantly improves survival and has significantly fewer toxic effects in patients with stage III ovarian cancer and residual tumor masses of 2 cm or less.
静脉铂类化疗是晚期卵巢癌的标准一线治疗方法。我们开展了一项3期试验，比较腹腔内和顺铂静脉注射对先前未接受治疗的III期上皮性卵巢癌女性患者生存率的影响。
患者接受了初步的探索性剖腹手术，并切除了所有直径大于2 cm的肿瘤块。术后四周内，每三周进行一次，共六个疗程的静脉注射环磷酰胺（每疗程每平方米体表面积600 mg），并联合腹腔内顺铂（每平方米100 mg）或静脉顺铂（每平方米100 mg）。
在654例随机分组的患者中，546例符合研究条件。接受腹腔内顺铂治疗的组估计中位生存期（49个月；95%置信区间为42至56个月）显著长于接受静脉顺铂治疗的组（41个月；95%置信区间为34至47个月）。腹腔内治疗组的死亡风险低于静脉治疗组（风险比为0.76；95%置信区间为0.61至0.96；P = 0.02）。静脉治疗组中，中度至重度耳鸣、临床听力损失和神经肌肉毒性作用明显更为常见。
与静脉注射顺铂相比，腹腔内注射顺铂可显著提高III期卵巢癌且残留肿瘤块为2 cm或更小患者的生存率，并显著减少毒性作用。
