中国循证医学杂志

中国循证医学杂志

根治性同步放化疗联合手术治疗局部晚期宫颈癌的随机对照试验

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目的 比较根治性同步放化疗联合手术与单纯根治性同步放化疗治疗局部晚期宫颈癌的疗效并对患者预后进行多因素分析。 方法 2012 年 6 月–2016 年 12 月期间,在福建医科大学附属第二医院收治的 130 例局部晚期宫颈癌患者使用随机数字生成器随机分为试验组和对照组。对照组单纯采用以铂类为基础的根治性同步放化疗;试验组在对照组的基础上,采用联合广泛性全子宫切除术及盆腔淋巴结清扫术,宫旁和阴道组织各切除 3 cm。计数资料采用卡方检验,等级计数资料采用 Kendall’s tau-b 等级资料卡方检验。采用 Kaplan-Meier 法、Log-rank 检验、Cox 比例风险模型等方法对患者的生存情况进行比较和影响因素分析。对失访患者采用意向性治疗分析(ITT 分析)。 结果 本文为该随机对照试验的终期报告。试验组纳入 68 例患者,对照组纳入 62 例患者。试验组术后病理资料显示无癌残留率为 83.8%(57/68),癌残留率为 2.9%(2/68)。试验组和对照组 3 年(65.6%vs. 59.6%)和 4 年(52.5% vs. 56.3%)无进展生存率(PFS)的差异无统计学意义(χ2=0.008,P=0.928)。试验组和对照组 3 年(80.3% vs. 74.6%)和 4 年(77.6%vs. 64.9%)总生存率(OS)的差异也无统计学意义(χ2=0.361,P=0.548)。多因素分析显示,只有肿瘤大小和是否存在宫旁侵犯是显著影响 PFS 的预后因子(P<0.05);是否存在宫旁侵犯是影响 OS 的预后因子(P=0.078)。 结论 是否存在宫旁侵犯是影响局部晚期宫颈癌总生存率的重要因素。因采用根治性同步放化疗联合手术与单纯根治性同步放化疗比较治疗局部晚期宫颈癌不能显著提高 PFS 率和 OS 率,患者获益并未增加,故目前需选择性并谨慎应用该治疗方法。

Objective To explore the efficacy of simultaneous chemoradiotherapy combined with surgery for locally advanced cervical patients and perform multivariable analysis. Methods A total of 130 cases of patients with locally advanced cervical cancer who were admitted to the Second Affiliated Hospital of Fujian Medical University from June 2012 to December 2016 were randomly divided into case group and control group. The patients in the control group were treated with platinum-based radical concurrent chemoradiation. In the case group, patients received both treatment in the control group and extensive hysterectomy and pelvic lymph node dissection. The short-term efficacy and survival outcomes of the two groups were compared. Results The present study was the final report of this randomized controlled trial. 68 patients were randomly enrolled into the case group and 50 patients into control group. The non-microscopic residual tumor (non-MRT) rates were 83.8% (57/68) and microscopic residual tumor (MRT) rates were 2.9% (2/68) in the experimental group. There was no significant difference between two groups (χ2=0.008, P=0.928) in 3-year progression-free survival rate (65.6%vs. 59.6%) and 4-year progression-free survival rate (52.5% vs. 56.3%). And there was no significant difference between two groups (χ2=0.361, P=0.548) in 3-year overall survival rate (80.3%vs. 74.6%) and 4-year overall survival rate (77.6% vs. 64.9%). Multivariable analysis showed that only tumor size and parametrial invasion were significant prognostic factors of PFS (P<0.05). And only parametrial invasion was a potential prognostic indicator affecting OS (P=0.078). Conclusion Parametrial invasion is an important prognostic factor. Radical concurrent chemoradiotherapy combined with surgical treatment of locally advanced cervical cancer has not significantly improved progression-free survival and overall survival. The treatment regimen should be applied with caution and selectivity.

关键词: 宫颈癌; 化学治疗; 放射治疗; 手术切除; 随机对照试验

Key words: Uterine cervical neoplasm; Chemotherapy; Radiotherapy; Surgery; Randomized controlled trial

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1. Chereau E, DE LA Hosseraye C, Ballester M, et al. The role of completion surgery after concurrent radiochemotherapy in locally advanced stages IB2-IIB cervical cancer. Anticancer Res, 2013, 33(4): 1661-1666.
2. Alhosainy AM, Hefzi N, Abdeldayem HM, et al. The impact of concurrent chemo-irradiation followed by surgery for locally advanced cervical carcinoma. Cancer Bio, 2015, 5(4): 113-123.
3. 郑建清, 黄碧芬, 周云清, 等. 根治性同步放化疗+手术治疗局部晚期宫颈癌:一项随机对照试验的中期结果分析. 中国循证医学杂志, 2017, 17(1): 1-6.
4. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer, 2009, 45(2): 228-247.
5. Trimble E, Gius D, Harlan LC. Impact of NCI announcement upon use of chemoradiation for women with cervical cancer. J Clin Oncol, 2007, (25): 283s.
6. Morris M, Eifel PJ, Lu J, et al. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med, 1999, 340(15): 1137-1143.
7. Rose PG, Bundy BN, Watkins EB, et al. Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer. N Engl J Med, 1999, 340(15): 1144-1153.
8. Whitney CW, Sause W, Bundy BN, et al. Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes: a Gynecologic Oncology Group and Southwest Oncology Group study. J Clin Oncol, 1999, 17(5): 1339-1348.
9. 黄碧芬, 郑建清, 李文渊, 等. 热疗辅助治疗宫颈癌疗效和安全性的系统评价. 中国循证医学杂志, 2015, 15(2): 201-205.
10. Keys HM, Bundy BN, Stehman FB, et al. Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma. N Engl J Med, 1999, 340(15): 1154-1161.
11. Trimble T. Global strategies for cervical cancer control in the 21st century. Gynecol Oncol, 2005, 99(3 Suppl 1): S245.
12. 杨宇星, 程晓伟, 俞小元. 宫颈癌根治性放射治疗后再手术22例临床分析. 上海医学, 2007, 30(2): 137-138.
13. 薛惠英. 中晚期子宫颈癌根治性放疗后再手术28例临床分析. 医学信息(手术学分册), 2008, 21(7): 645-646.
14. 殷向平, 赵新. 中晚期子宫颈癌放疗后再手术29例疗效分析. 中医临床研究, 2011, 3(7): 32-33.
15. 李瑞莲, 盛修贵, 董佚美. 子宫颈癌根治性放疗后再手术192例疗效观察. 中国冶金工业医学杂志, 2009, 26(5): 543-544.
16. Ferrandina G, Margariti PA, Smaniotto D, et al. Long-term analysis of clinical outcome and complications in locally advanced cervical cancer patients administered concomitant chemoradiation followed by radical surgery. Gynecol Oncol, 2010, 119(3): 404-410.
17. Keys HM, Bundy BN, Stehman FB, et al. Radiation therapy with and without extrafascial hysterectomy for bulky stage IB cervical carcinoma: a randomized trial of the gynecologic oncology group. Gynecol Oncol, 2003, 89(3): 343-353.
18. Motton S, Houvenaeghel G, Delannes M, et al. Results of surgery after concurrent chemoradiotherapy in advanced cervical cancer: comparison of extended hysterectomy and extrafascial hysterectomy. Int J Gynecol Cancer, 2010, 20(2): 268-275.
19. Leguevaque P, Motton S, Delannes M, et al. Completion surgery or not after concurrent chemoradiotherapy for locally advanced cervical cancer? Eur J Obstet Gynecol Reprod Biol, 2011, 155(2): 188-192.
20. Landoni F, Bocciolone L, Perego P, et al. Cancer of the cervix, FIGO stages IB and IIA: patterns of local growth and paracervical extension. Int J Gynecol Cancer, 1995, 5(5): 329-334.