宫颈癌紫杉醇联合洛铂或顺铂新辅助序贯洛铂或顺铂同步化放疗多中心随机临床研究

Randomized clinical study of short term efficacy and safety of paclitaxel combined with lobaplatin compared to paclitaxel combine with cisplatin in chemoradiotherapy of locally advanced cervical cancer

目的对于局部晚期宫颈癌（locally advanced cervical cancer，LACC）患者，新辅助化疗（neoadjuvant chemotherapy，NACT）已被广泛应用，但尚无标准化疗方案，国内外学者倾向于以铂类为基础的联合化疗为最佳方案。本研究评价紫杉醇联合洛铂与紫杉醇联合顺铂在LACCNACT序贯同步．化放疗的近期疗效与安全性。方法2011-11—28-2013-11-1l贵州医科大学附属肿瘤医院·贵州省肿瘤医院（65例）、贵州省人民医院（20例）和遵义医学院附属肿瘤医院（5例）3家肿瘤治疗中心入组ⅠB2～ⅣA期宫颈癌患者共90例，随机数字表法分为试验组50例（紫杉醇联合洛铂＋单药洛铂）和对照组40例（紫杉醇联合顺铂＋单药顺铂），观察2组的近期疗效及毒副作用，计数资料采用x2检验或非参数检验，不良反应率的比较采用非参数检验，Kaplan-Meier法进行生存分析。结果90例患者随访至2015-03—30，随访率100％，死亡20例，生存70例，中住随访时间39个月，1、2和3年总生存（overall survival，OS）率分别为91％、82％和62％。试验组与对照组1年OS率分别为92％和90％，2年分别为80％和85％，3年为66％和55％；中位随访时间分别为39和36个月，差异无统计学意义，x2=0．086，P=0．769。90例患者中NACT后CR3例，PR64例，有效率为74．4％。试验组CR3例，PR34例，有效率为74．0％；对照组PR30例，有效率为75．0％；差异无统计学意义，x2=1．143，P=0．288。90例患者行NACT后，无治疗相关性死亡，主要表现为Ⅱ～Ⅲ度不良反应。试验组在化疗引起的厌食明显好于对照组，P〈0．001；恶心、呕吐明显好于对照组，P=0．008；疼痛明显好于对照组，P〈0．001；而在血小板抑制方面试验组劣于对照组，P=0．045。3例患者因自身原因未行同步化放疗。87例患者同步化放疗后CR34例，PR51例，有效率为97．7％。试验组cR19例，PR28例，有效率为97．9％；对照组CR15例，PR23例，有效率为97．4％；差异无统计学意义，x2=0．002，P=0．967。结论与紫衫醇联合顺铂及序贯同步化放疗相比，紫杉醇联合洛铂序贯洛铂同步化放疗方案治疗LACC疗效相当，毒副作用可耐受，是临床上可选的治疗方案。

OBJECTIVE The optimal chemotherapy for locally advanced cervical cancer has no uniform standards. This article aimed to evaluate the short-term efficacy and safety of paclitaxel combined with lobaplatin and paelitaxel combined with cisplatin in neoadjuvant chemotherapy of locally advanced cervical cancer. METHODS From November 28,2011 to November 11,2013,90 cases （65cases from Cancer Hospital Affiliated to Guizhou Medical University/Guizhou Cancer Hospital, 20 cases from Guizhou People Hospital, 5cases from Cancer Hospital Affiliated to Zunyi Medical College） of ⅠB2--ⅣA cervical cancer from three cancer treatment centers in Guizhou province were treated and the patients were randomly divided into the experimental group （50 cases） and the control group （40 cases） for observing the efficacy and toxicity of the two groups. Adverse reaction rates of the two groups were compared using 2 test and survival analysis was performed by Kaplan Meier method. RESULTS To March 30,2015,the follow-up rate was 100% . Twenty cases of death and 70 cases of survival. The median follow- up time was 39 months, 1,2,3 years of OS respectively 91 % and 82 %, 62%, in experimental group. In control group, the 1,2, 3 years of OS and the median follow-up time respectively were 92% and 90%, 80% and 85 %, 66 % and 55% , 39 months and 36 month. The difference between the two groups had no statistical significance （X2=0. 086,P=0. 769）. In experimental group 3 cases were CR and 34 patients were PR, the efficient was 74. 0%. In control group 30 patients were PR, the efficient was 75.0% ,the difference between the two groups had no significance （X2 = 1. 143, P= 0. 288）. After neoadjuvant chemotherapy, there were no treatment related death. The adverse reactions mainly were Ⅱ-Ⅲ degree. Compared to patients in two groups,in experimental group,the chemotherapy-induced anorexia （P〈0. 001） nausea/vomiting （P=0. 008） and pain （P〈0. 001） were significantly better than those of the control group, and the platelet inhibition in the experimental group is inferior than that of the control group （P=0. 045）. CONCLUSION Compared with paclitaxel and cisplatin,paclitaxel combined with lobaplatin as a new adjuvant chemotherapy regimen for treatment of locally advanced cervical cancer is effective with mild adverse reactions, which is one of the clinical treatment options.