Objective: To investigate the efficacy and side effect of paclitaxel liposome for neoadjuvant chemotherapy (NACT) in locally advanced cervical cancer. Methods: This study were included 265 cervical cancer patients staging Ⅰb2 and Ⅱa2 who underwent paclitaxel-platinum NACT followed by radical surgery from June 2008 to December 2016 in the Cancer Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences. All patients were classified into two groups with 106 patients in paclitaxel liposome group and 159 patients in traditional paclitaxel group. The difference in clinicopathologic characteristics, efficacy and side effect were analyzed retrospectively between the two groups. Results: (1) Clinicopathologic characteristics: there were no significant difference in clinicopathologic characteristics between the two groups, including age, body mass index, clinical stage, pathological histology, cycles of NACT, combined platinum regimen, lymph-vascular space invasion, lymph node metastasis, deep stromal invasion, and postoperative adjuvant therapy (all P>0.05). (2) Efficacy: after NACT, the overall response occurred in 90 (15 complete response plus 75 partial response) of 106 cases in the paclitaxel liposome group versus 131 (21 complete response plus 110 partial response) of 159 cases in the traditional paclitaxel group without statistical significance (84.9% vs 82.4%; χ(2)=0.291, P=0.590). A total of 248 patients received surgery after NACT and were evaluable in survival. The 5-year recurrence-free survival (RFS) rate and 5-year overall survival (OS) rate of these patients was 85.1% and 88.2%. The 5-year RFS rate in the paclitaxel liposome group was 85.9% compared with 85.2% in the traditional paclitaxel group, while the corresponding 5-year OS rate was 88.5% and 88.7%, respectively. There was no statistically significant difference in efficacy between the two groups (P=0.968, P=0.797). (3) Side effect: the incidence of allergic reaction between the paclitaxel liposome group and the traditional paclitaxel group was 0 versus 1.9% (3/159) without statistical significance (P=0.277). But the incidence of neurotoxicity in the paclitaxel liposome group significantly decreased compared with the traditional paclitaxel group (6.6% vs 15.7%, P<0.05), as well as the incidence of alopecia (67.9% vs 79.2%, P<0.05) and myalgia (17.9% vs 28.9%, P<0.05). However, significant differences were not found in terms of hematological toxicity, gastrointestinal reaction, and hepatic function damage (P>0.05). Conclusion: In paclitaxel-platinum NACT of local advanced cervical cancer, paclitaxel liposome can achieve similar efficacy compared with traditional paclitaxel, but paclitaxel liposome is helpful in decreasing the toxicity of neurotoxicity, alopecia and myalgia.
目的： 探讨紫杉醇脂质体用于局部晚期子宫颈癌新辅助化疗的疗效及副反应。 方法： 收集2008年6月—2016年12月在中国医学科学院北京协和医学院肿瘤医院接受紫杉醇联合铂类药物方案新辅助化疗（NACT）后手术治疗的Ⅰb2和Ⅱa2期子宫颈癌患者共265例，其中NACT方案为紫杉醇脂质体联合铂类药物者106例（紫杉醇脂质体组），紫杉醇联合铂类药物者159例（紫杉醇组），回顾性分析两组患者的临床病理特征、疗效及NACT副反应的差异。 结果： （1）临床病理特征：紫杉醇脂质体组、紫杉醇组患者的年龄、体质指数、临床分期、病理类型、NACT疗程数、铂类药物种类、有无淋巴脉管间隙浸润（LVSI）、有无淋巴结转移、间质浸润深度、术后辅助治疗分别比较，差异均无统计学意义（P均>0.05）。（2）疗效：接受NACT后，紫杉醇脂质体组（106例）完全缓解15例，部分缓解75例，有效率为84.9%（90/106）；紫杉醇组（159例）完全缓解21例，部分缓解110例，有效率为82.4%（131/159）；两组有效率比较，差异无统计学意义（χ(2)=0.291，P=0.590）。局部晚期子宫颈癌患者的5年无复发生存（RFS）率及总生存（OS）率分别为85.1%及88.2%；其中，紫杉醇脂质体组与紫杉醇组患者的5年RFS率（分别为85.9%、85.2%）、5年OS率（分别为88.5%、88.7%）分别比较，差异均无统计学意义（P=0.968，P=0.797）。（3）NACT副反应：紫杉醇脂质体组无一例发生过敏反应（0），而紫杉醇组过敏反应的发生率为1.9%（3/159），但两组比较无显著差异（P=0.277）；与紫杉醇组比较，紫杉醇脂质体组的神经毒性（分别为15.7%、6.6%）、脱发（分别为79.2%、67.9%）、关节肌肉疼痛（分别为28.9%、17.9%）的发生率均显著降低（P均<0.05）；而两组的血液学毒性、胃肠道反应、肝功能受损的发生率比较均无显著差异（P>0.05）。 结论： 紫杉醇脂质体与普通紫杉醇在局部晚期子宫颈癌NACT中的近期疗效和远期预后相当，但紫杉醇脂质体对于减少神经毒性、关节肌肉疼痛、脱发等副反应的发生有一定帮助。.
Keywords: Chemotherapy, adjuvant; Liposomes; Paclitaxel; Prognosis; Uterine cervical neoplasms.