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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LACC NACT序贯同步化放疗的近期疗效与安全性。方法2011-11-28-2013-11-11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χ~2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,中位随访时间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,χ~2=0.086,P=0.769。90例患者中NACT后CR 3例,PR 64例,有效率为74.4%。试验组CR 3例,PR 34例,有效率为74.0%;对照组PR 30例,有效率为75.0%;差异无统计学意义,χ~2=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CR 34例,PR51例,有效率为97.7%。试验组CR 19例,PR 28例,有效率为97.9%;对照组CR 15例,PR 23例,有效率为97.4%;差异无统计学意义,χ~2=0.002,P=0.967。结论与紫杉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: Neoadjuvant chemotherapy (NACT) has been widely used in patients with locally advanced cervical cancer (LACC), but there is no standard chemotherapy regimen. Domestic and foreign scholars prefer platinum-based combination chemotherapy As the best plan. This study was to evaluate the short-term efficacy and safety of paclitaxel plus lobaplatin plus paclitaxel plus cisplatin in LACC NACT sequential synchronized radiotherapy. Methods 2011-11-28-2013-11-11 Cancer Hospital Affiliated to Guizhou Medical University · Guizhou Cancer Hospital (65 cases), Guizhou Provincial People’s Hospital (20 cases) and Zunyi Medical College Affiliated Tumor Hospital (5 cases) Three tumors A total of 90 patients with cervical cancer from ⅠB2 to ⅣA were enrolled in the treatment center. The random number table was divided into 50 cases in trial group (paclitaxel combined with lobaplatin + monotherapy lobaplatin) and 40 cases in control group (paclitaxel combined with cisplatin + monotherapy Platinum). The curative effect and side effects of two groups were observed. Counting data were tested by χ ~ 2 test or nonparametric test. Adverse reaction rate was compared by nonparametric test and Kaplan-Meier method. Results 90 patients were followed up to 2015-03-30, the follow-up rate was 100%, 20 died, 70 survived, and the median follow-up time was 39 months. The overall survival rates at 1, 2, and 3 years were 91%, 82% and 62%. The 1-year OS rates were 92% and 90% in the trial group and the control group, 80% and 85% in 2 years, 66% and 55% in 3 years, respectively; and the median follow-up time was 39 and 36 months respectively Statistical significance, χ ~ 2 = 0.086, P = 0.769.90 patients after NACT CR 3 cases, PR 64 cases, the effective rate was 74.4%. In the experimental group, 3 cases of CR and 34 cases of PR showed an effective rate of 74.0%. In the control group, PR was 30 cases, with an effective rate of 75.0%. There was no significant difference between the two groups (χ ~ 2 = 1.143, P = 0.288.90) , No treatment-related deaths, mainly manifested as Ⅱ ~ Ⅲ degree adverse reactions. P <0.001; nausea and vomiting were significantly better in the experimental group than in the control group, P = 0.008; pain was significantly better than the control group, P <0.001; while in the platelet inhibition test group was worse than the control group In the control group, P = 0.045.3 patients did not undergo synchronized radiotherapy for their own reasons. Among the 87 patients who underwent CR after radiotherapy, 34 had CR, and 51 had PR. The effective rate was 97.7%. In the control group, 19 cases were CR and 28 cases were PR, the effective rate was 97.9%. In the control group, CR 15 and PR 23 cases, the effective rate was 97.4%. There was no significant difference between the two groups (χ ~ 2 = 0.002, P = 0.967). Conclusions Compared with paclitaxel plus cisplatin and sequential synchronized radiotherapy, paclitaxel combined with lobaplatin sequential lobaplatin synergetic radiotherapy regimen for the treatment of LACC has similar efficacy and tolerability. It is a clinically feasible treatment option.