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目的探索含高危因素宫颈癌根治性术后紫杉醇联合顺铂同步放化疗的疗效及毒性。方法 180例宫颈癌患者均行根治性手术,术后病理证实具有高危因素,并于术后3~4周行辅助同步放化疗。治疗方案:研究组(TP组)为紫杉醇135~150 mg/m2 d1+顺铂25~30 mg/m2 d1~3,每3周1次同步化疗。对照组(P组)为顺铂35~40 mg/m2,每周1次同步化疗。全组病例采用相同放疗方案:总放疗剂量45~59 Gy,1.8~2.2 Gy/次,4~5次/周。主要研究内容为5年无局部复发生存率(LRFS)、5年无瘤生存率(DFS)、5年无远处转移生存率(FDMS)、5年总生存率(OS)以及毒性反应。结果全组中位随访期33个月(1~84个月),未能观察到研究组较对照组可以提高无瘤生存期、无局部复发生存期和总生存期。研究组和对照组5年无远处转移生存率分别为95.4%和82.6%,差异具有统计学意义(P=0.034<0.05)。而研究组治疗期间37.8%的患者出现了3/4级白细胞下降,44.4%的患者出现严重骨髓抑制。结论与顺铂相比,紫杉醇联合顺铂辅助同步放化疗未能提高含高危因素的宫颈癌术后患者的总生存率,但它具有提高无远处转移生存率的优势,而且除了血液学毒性外,其毒副作用整体可接受。
Objective To explore the curative effect and toxicity of paclitaxel combined with cisplatin concurrent chemoradiotherapy after radical surgery for cervical cancer with high risk factors. Methods 180 cases of cervical cancer patients underwent radical surgery, postoperative pathology confirmed with high risk factors, and 3 to 4 weeks after adjuvant radiotherapy and chemotherapy. Treatment: The study group (TP group) was paclitaxel 135 ~ 150 mg / m2 d1 + cisplatin 25 ~ 30 mg / m2 d1 ~ 3, once every 3 weeks, a synchronous chemotherapy. The control group (P group) was cisplatin 35 ~ 40 mg / m2, once a week, synchronous chemotherapy. The same group of patients with the same radiotherapy program: total radiation dose 45 ~ 59 Gy, 1.8 ~ 2.2 Gy / time, 4 ~ 5 times / week. The main research contents include 5 year LRFS, 5 year DFS, 5 year FDMS, 5 year OS, and toxicity. Results The median follow-up period was 33 months (range, 1 to 84 months). The failure to observe the progression-free survival, local recurrence-free survival and overall survival of the study group compared with the control group was not observed. The 5-year distant metastasis-free survival rates of the study group and the control group were 95.4% and 82.6% respectively, with statistical significance (P = 0.034 <0.05). In the study group, 37.8% of the patients had grade 3/4 leukopenia and 44.4% of patients had severe myelosuppression. Conclusion Compared with cisplatin, paclitaxel and cisplatin-assisted concurrent chemoradiotherapy failed to improve the overall survival rate of postoperative patients with high-risk cervical cancer, but it has the advantage of improving the survival rate without distant metastasis, and in addition to hematological toxicity In addition, its toxic side effects are generally acceptable.