洛铂联合紫杉醇新辅助化疗序贯同步化放疗治疗ⅡB~ⅢB期子宫颈鳞癌的临床研究

Clinical study of lobaplatin combined with paclitaxel neoadjuvant chemotherapy followed by concurrent chemoradiotherapy for stageⅡB-ⅢB cervical squamous cell cancer

目的观察洛铂联合紫杉醇新辅助化疗序贯同步化放疗治疗ⅡB~ⅢB期子宫颈鳞癌的近期疗效、安全性及远期生存情况。方法2014年10月至2016年12月贵州省肿瘤医院妇瘤科入组155例全部经病理组织学证实为ⅡB~ⅢB期子宫颈鳞癌患者,接受洛铂联合紫杉醇新辅助化疗(紫杉醇175 mg/m2,d1;洛铂30 mg/m2,d2;21天为1个周期,共2个周期),后序贯洛铂联合紫杉醇同步化放疗(紫杉醇175 mg/m2,d1;洛铂30 mg/m2,d2;28天为1个周期,共2个周期),观察其近期疗效、不良反应、远期生存率及预后影响因素。结果155例患者中153例(98.7%)完成2个周期新辅助化疗,2例(1.3%)因持续出现3~4级血液学不良反应未行第2周期新辅助化疗;129例(83.2%)完成2个周期同步化疗,26例(16.8%)未行第2周期同步化疗;15例(9.7%)患者未完成放射治疗。新辅助化疗的客观有效率(ORR)为70.3%,疾病控制率(DCR)为98.7%;同步放化疗的ORR为96.1%,DCR为99.4%。随访至2020年2月,死亡45例,1、3、5年生存率分别为92.3%、77.4%、69.9%,1、3、5年无进展生存率分别为90.3%、74.2%、63.8%。Cox多因素分析显示FIGO分期、同步化疗周期数、淋巴结转移是影响无进展生存期(PFS)及总生存期(OS)的独立预后因素(P<0.05)。新辅助化疗期间3~4级不良反应发生率为20.0%,18.7%为血液学不良反应,1.3%为非血液学不良反应;同步化放疗期间3~4级不良反应发生率为45.2%,41.9%为血液学不良反应,3.2%为非血液学不良反应。结论洛铂联合紫杉醇新辅助化疗序贯同步化放疗治疗ⅡB~ⅢB期子宫颈鳞癌有效率较高,可提高5年生存率,近期毒副反应可耐受。

Objective To investigate the clinical efficacy,long-term survival as well as toxicity of lobaplatin combined with paclitaxel neoadjuvant chemotherapy followed by concurrent chemoradiotherapy for stageⅡB-ⅢB cervical squamous cell cancer,and analyze the influence of different factors on the prognosis.Methods From October 2014 to December 2016,155 cases of stageⅡB-ⅢB cervical squamous cell carcinoma confirmed by pathologic diagnosis were selected in the Department of Gynecology,Guizhou Cancer Hospital.They received neoadjuvant chemotherapy(paclitaxel 175 mg/m2,ivgtt,d1;lobaplatin 30 mg/m2,ivgtt,d2;for 2 cycles with an interval of 21 days),followed by sequential lobaplatin combined with paclitaxel concurrent chemoradiotherapy(paclitaxel 175 mg/m2,d1;lobaplatin 30 mg/m2,d2;2 cycles with an interval of 28 days).The short-term efficacy,toxicity,long-term survival rate and prognostic factors were observed.Results Among the 155 patients,153(98.7%)completed two cycles of neoadjuvant chemotherapy,2(1.3%)did not complete the second-cycle neoadjuvant chemotherapy due to persistent hematological toxicity of grade 3-4.One hundred and twenty-nine patients(83.2%)completed two cycles during the concurrent chemotherapy,26 patients(16.8%)did not complete the second cycle of concurrent chemotherapy.15 patients(9.7%)did not complete radiation therapy.The objective response rate(ORR)of neoadjuvant chemotherapy was 70.3%,and the disease control rate(DCR)was 98.7%.ORR was 96.1%and DCR was 99.4%after the concurrent chemoradiotherapy.Follow-up to February 2020,the follow-up rate was 98.0%,45 patients died.The general 1-,3-and 5-year overall survival(OS)rates and progression-free survival(PFS)rates of the 155 patients were 92.3%,77.4%,69.9%and 90.3%,74.2%,63.8%,respectively.Multivariate Cox hazards regression analysis illustrated that FIGO clinical stage,concurrent chemotherapy cycles and lymph node metastasis were independent factors affecting OS and PFS(P<0.05).The incidence of grade 3-4 adverse events during neoadjuvant chemotherapy was 20.0%,in which hematological toxicity was 18.7%,and non-hematological adverse reaction was 1.3%.The incidence of grade 3-4 adverse events during concurrent chemotherapy was 45.2%,in which hematological adverse events were 41.9%,and non-hematological adverse reaction were 3.2%.Conclusion Lobaplatin combined with paclitaxel neoadjuvant chemotherapy followed by concurrent chemoradiotherapy is an effective way in treating stageⅡB-ⅢB cervical squamous cell cancer.It has high efficiency,high survival rates in 5 years,and with acceptable recent toxicities.