Concomitant chemoradiation followed by radical surgery for locally advanced cervical cancer patients: preliminary results from a randomized, controlled trial_Chinese Journal of Evidence-Based Medicine

Authors：

ZHENG Jianqing ¹ ,  HUANG Bifen ² , ZHOU Yunqing ³ , HUANG Shuangying ³ , CHEN Shaorong ³ , LI Luhong ³

1. Department of Radiation Oncology, the Second Affiliated Hospital of Fujian Medical University, Quanzhou, 362000, P.R.China;
2. Department of Obstetrics and Gynecology, Quanzhou Medical College People’s Hospital Affiliated, Quanzhou, 362000, P.R.China;
3. Department of Obstetrics and Gynecology, the Second Affiliated Hospital of Fujian Medical University, Quanzhou, 362000, P.R.China;

Corresponding author：

HUANG Bifen, Email: 408933537@qq.com

Keywords：

Uterine cervical neoplasm; Chemotherapy; Radiotherapy; Operation; Randomized controlled trial

DOI：

10.7507/1672-2531.201602012

Video：

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Objective To evaluate the radical chemoradiotherapy plus surgery for locally advanced cervical patients. Methods 102 cases of patients with locally advanced cervical cancer were randomly divided into a trial group and a control group. In the control group, patients received radical chemoradiotherapy only, with chemotherapy consisted of cisplatin 35-40 mg/m², one times a week. In the trial group, patients received both treatment in the control group and extensive hysterectomy and pelvic lymph node dissection. Results Fifty-two patients were randomly enrolled into the trial group and 50 patients into the control group. The microscopic residual tumor (MRT) rate was 5.8% (3/52) and non-microscopic residual tumor (NMRT) rate was 82.7% (43/52) in the trial group. Progression-free survival time was 3-40 months with a median survival time of 23 months, and the 3-year progression-free survival rate was 73.1% in the trial group, and progression-free survival time was 5–41 months with a median survival time of 22 months, and the 3-year progression-free survival rate was 64.8% in the control group; while the difference was not statistically significant (χ²=0.092,P=0.761). Overall survival time was 6–40 months with median overall survival time of 23 months, and the 3-year overall survival rate was 82.7% in the trial group, and overall survival time was 5-41 months with a median survival time of 22.5 months, and the 3-year overall survival rate was 81.8%; while the difference was not statistically significant (χ²=0.338,P=0.561). Conclusion Concomitant chemoradiation followed by radical surgery could not significantly improve progression-free survival and overall survival in patients with locally advanced cervical cancer. The treatment regimen should be applied with caution and selectivity.

Citation： ZHENG Jianqing, HUANG Bifen, ZHOU Yunqing, HUANG Shuangying, CHEN Shaorong, LI Luhong. Concomitant chemoradiation followed by radical surgery for locally advanced cervical cancer patients: preliminary results from a randomized, controlled trial. Chinese Journal of Evidence-Based Medicine, 2017, 17(1): 1-6. doi: 10.7507/1672-2531.201602012 Copy

1.	Waggoner SE. Cervical cancer. Lancet, 2003, 361(9376): 2217-2225.
2.	Look KY, Brunetto VL, Clarke-Pearson DL,et al. An analysis of cell type in patients with surgically staged stage IB carcinoma of the cervix: a Gynecologic Oncology Group study. Gynecol Oncol, 1996, 63(3): 304-311.
3.	Trimble T. Global strategies for cervical cancer control in the 21st century. Gynecol Oncol, 2005, 99(3 Suppl 1): S245.
4.	孔为民, 孙建衡. 宫颈癌的放射治疗及进展. 中国实用妇科与产科杂志, 2003, 19(3): 146-148.
5.	钟亚娟. 宫颈癌筛查进展. 中华实用诊断与治疗杂志, 2011, 25(8): 731-733.
6.	Zhao YB, Wang JH, Chen XX,et al. Values of three different preoperative regimens in comprehensive treatment for young patients with stage Ib2 cervical cancer. Asian Pac J Cancer Prev, 2012, 13(4): 1487-1489.
7.	NCCN. NCCN clinical practice guidelines in oncology (NCCN Guidelines ) cervical cancer version 3.2013. Avaliable at: http://wwwnccnorg/professionals/physician_gls/pdf/cervicalpdf, 2013, MS-7.
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.	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.
10.	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.
11.	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.
12.	Peters WA, Lui PY, Barrett R. Cisplatin, 5-fluorouracil plus radiation therapy are superior to radiation therapy as adjunctive therapy in high-risk, early stage carcinoma of the cervix after radical hysterectomy and pelvic lymphadenectomy: report of a phase III intergroup study. Presented at the 30th Annual Society of Gynecologic Oncology meeting in San Francisco, 1999.
13.	Trimble E, Gius D, Harlan LC. Impact of NCI announcement upon use of chemoradiation for women with cervical cancer. J Clin Oncol, 2007, 25: S283.
14.	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.
15.	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.
16.	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.
17.	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.
18.	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.
19.	Motton S, Houvenaeghel G, Delannes M,et al. Results of Surgery After Concurrent Chemoradiotherapy in Advanced Cervical Cancer. Int J Gynecol Cancer, 2010, 20(2): 268-275.
20.	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.

1. Waggoner SE. Cervical cancer. Lancet, 2003, 361(9376): 2217-2225.
2. Look KY, Brunetto VL, Clarke-Pearson DL,et al. An analysis of cell type in patients with surgically staged stage IB carcinoma of the cervix: a Gynecologic Oncology Group study. Gynecol Oncol, 1996, 63(3): 304-311.
3. Trimble T. Global strategies for cervical cancer control in the 21st century. Gynecol Oncol, 2005, 99(3 Suppl 1): S245.
4. 孔为民, 孙建衡. 宫颈癌的放射治疗及进展. 中国实用妇科与产科杂志, 2003, 19(3): 146-148.
5. 钟亚娟. 宫颈癌筛查进展. 中华实用诊断与治疗杂志, 2011, 25(8): 731-733.
6. Zhao YB, Wang JH, Chen XX,et al. Values of three different preoperative regimens in comprehensive treatment for young patients with stage Ib2 cervical cancer. Asian Pac J Cancer Prev, 2012, 13(4): 1487-1489.
7. NCCN. NCCN clinical practice guidelines in oncology (NCCN Guidelines ) cervical cancer version 3.2013. Avaliable at: http://wwwnccnorg/professionals/physician_gls/pdf/cervicalpdf, 2013, MS-7.
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. 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.
10. 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.
11. 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.
12. Peters WA, Lui PY, Barrett R. Cisplatin, 5-fluorouracil plus radiation therapy are superior to radiation therapy as adjunctive therapy in high-risk, early stage carcinoma of the cervix after radical hysterectomy and pelvic lymphadenectomy: report of a phase III intergroup study. Presented at the 30th Annual Society of Gynecologic Oncology meeting in San Francisco, 1999.
13. Trimble E, Gius D, Harlan LC. Impact of NCI announcement upon use of chemoradiation for women with cervical cancer. J Clin Oncol, 2007, 25: S283.
14. 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.
15. 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.
16. 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.
17. 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.
18. 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.
19. Motton S, Houvenaeghel G, Delannes M,et al. Results of Surgery After Concurrent Chemoradiotherapy in Advanced Cervical Cancer. Int J Gynecol Cancer, 2010, 20(2): 268-275.
20. 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.

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Concomitant chemoradiation followed by radical surgery for locally advanced cervical cancer patients: preliminary results from a randomized, controlled trial

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