奈达铂治疗晚期头颈癌的临床疗效观察

目的：通过随机对照试验试图准确地评价奈达铂联合长春瑞滨治疗晚期头颈癌的疗效以及耐受性。方法：42例患者被随机分到奈达铂联合长春瑞滨治疗组（A组）,或顺铂联合长春瑞滨治疗组（B组）。两个治疗组均用药至6个疗程,除非肿瘤进展或毒性不能耐受。客观缓解率的评价采用WHO的疗效标准,毒性评价采用NCI第2版的毒性标准。结果：两组患者基线资料具有可比性。A组的客观缓解率为76.2%,B组为52.4%,两组的差异无统计学意义,P=0.107。两组的治疗相关毒性都比较轻。两组在贫血、中性粒细胞减少、神经毒性和肾毒性方面均无差异。A组的恶心/呕吐发生率显著低于B组（14.3%vs47.6%,P=0.019）,且B组中有2例因严重的呕吐而终止治疗。但A组的血小板减少发生率显著高于B组（57.1%vs23.8%,P=0.028）。结论：奈达铂治疗晚期头颈鳞癌疗效略高于顺铂,不良反应较低,值得进一步的研究观察。

Clinical effect of nedaplatin in treatment of advanced head and neck cancer

OBJECTIVE:In order to explore the therapeutic potential and tolerance of combination chemotherapy with nedaplatin and vinorelbine for advanced head and neck cancer more precisely,the present randomized controlled trial was initiated.METHODS:We prospectively randomized 42 patients in treatment with nedaplatin plus vinorelbine(arm A),or the treatment with cisplatin plus vinorelbine(arm B).In both arms,chemotherapy was administered for 6 cycles unless there was prior evidence of progressive disease or intolerant toxicity.The objective response rate of the two treatment arms was evaluated according to WHO standard criteria,and the toxicity was analyzed by NCI common toxicity criteria(Version 2.0).RESULTS:No significant difference was detected in the characteristics of the patients between the two arms.The overall objective response rate among the 21 patients in arm A was 76.2% compared with 11/21(52.4%)among those in arm B,but there was no significant difference between these in the two arms,P=0.107.Drug-related symptomatic toxicity was generally mild in both the arms.There was no significant difference between both the arms in terms of anemia,neutropenia,neurotoxicity and nephrotoxicity.The incidence rate of nausea/vomiting was lower in the arm A than in the arm B significantly(14.3% vs 47.6%,P=0.019),and 2 paitents in the arm B dropped out because of severe vomiting.However,the incidence rate of thrombocytopenia was higher in the arm A than in the arm B significantly(57.1% vs 23.8%,P=0.028).CONCLUSION:Results of this trial suggest a fairly good therapeutic index for nedaplatin in the treatment of head and neck cancer as compared with cisplatin,and it wonld like to be further studied.