奥先达联合紫杉醇或卡铂联合紫杉醇治疗卵巢上皮癌的多中心随机对照初步研究

Nedaplatin combined with paclitaxel or carboplatin with paclitaxel for the treatment of epithelial ovarian cancer:a randomized,multicenter,parallel-controlled clinical trial

目的:比较奥先达联合紫杉醇或卡铂联合紫杉醇治疗卵巢上皮癌的疗效和安全性。方法:2010年8月到2012年4月入组了Ⅱ期以上行满意的肿瘤细胞减灭术的卵巢上皮癌患者182例。术后将患者随机分为奥先达组(92例)和卡铂组(90例),分别采用奥先达或卡铂联合紫杉醇方案治疗。奥先达剂量80mg/m2,或卡铂AUC=5,第2天给药;紫杉醇135mg/m2,第1天给药,21天1个疗程。研究两组患者治疗的近期疗效和药物安全性。结果:奥先达组、卡铂组患者完成的治疗周期数分别为5.02±1.63和5.39±1.30。奥先达组化疗第3、6个周期结束时,CA125下降到正常水平的比率分别为80.00%和86.36%,卡铂组为72.88%和86.00%,两组比较均无统计学差异;治疗后两组患者的KPS、QOL评分均明显改善,但两组间比较无统计学差异。奥先达组恶心呕吐发生率为3.26%,卡铂组为5.56%;奥先达组和卡铂的Ⅲ～Ⅳ度白细胞减少的发生率分别为10.87%和23.33%,两组差异有统计学意义(P<0.05);两组的其他毒性反应发生率无统计学差异(P>0.05)。结论:奥先达联合紫杉醇治疗卵巢上皮癌近期疗效与卡铂方案相似,但其毒副反应较轻,患者耐受性好。

Objective： To compare the efficacy and safety profile of a nedaplatin/paclitaxel combination and a carboplatin/palitaxel combination in the treatment of epithelial ovarian cancer. Methods：Eighty patients receiving satisfying surgical resection for epithelial ovarian cancer （stage Ⅱ or above） during a period between Aug. 2010 and Apr. 2012 were randomly assigned to a nedaplatin/paclitaxel group （ n = 92 ） or a carboplatin/palitaxel group （ n = 90 ）. The chemotherapy started at 5 -7 days after the surgery,and repeated every 21 days per cycle. Paclitaxel was given at a dose of 135mg/m^2/d. Nedaplatin and carboplatin were given at a dosage of 80mg/m^2 and AUC = 5, respecticely, starting from the second day of the cycle. The efficacy of the treatment and the safety were evaluated. Results：The cycles of chemotherapy conducted were 5.02±1.63 and 5.39 ± 1.30 for nedaplatin/paclitaxel and carboplatin/paclitaxel protocol, respectively. By the end of the third course of chemotherapy, the rate of decrease in CA125 to a normal level was 80.00% and 72.88% in the nedaplatin/paclitaxel and carboplatin/paclitaxel groups. However, there was no statistically significant difference between the two groups. By the end of the sixth cycle of chemotherapy,the rate decrease in CA125 to a normalvalue was 86.36% and 86.00% in the nedaplatin/paclitaxel and carboplatin/paclitaxel proto- col, respectively. However, there was no statistically significant difference between the two groups. KPS and QOL scores were significantly improved after the treatment in each group. But, there was no significant difference between the two treatment groups. The rate of nausea and vomiting was significantly lower in the nedaplatin/paclitaxel protocol group than that in the carboplatin/paclitaxel protocol （3.26% vs 5.56% , P = 0, 4943 ）. The rate of grade Ⅲ-Ⅳ neutropenia was also significantly lower in the nedaplatin/paclitaxel group than that in the carboplatin/paclitaxel group（10.87% vs 23.33% ,P=0. 0303）. There was no difference between the two groups in other toxic effects. Conclusions：The nedaplatin/paclitaxel combination treatment is equivalent to the carboplatin/paclitaxel in terms of short-term efficacy for epithelial ovarian cancer, but is better tolerated, The nedaplatin/paclitaxel produced lesser side effects.