Weekly nedaplatin <i>versus</i> weekly cisplatin as postoperative concurrent chemoradiotherapy after radical surgery for cervical cancer: a randomized controlled trial_Chinese Journal of Evidence-Based Medicine

Authors：

XIAO Lihua ¹ , HUANG Bifen ² ,  ZHENG Jianqing ¹ , CHEN Mingfen ¹ , SU Jingjing ¹ , WU Min ¹

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;

Corresponding author：

ZHENG Jianqing, Email: 18060108268@189.cn

Keywords：

Uterine cervical neoplasm; Chemotherapy; Nedaplatin; Randomized controlled trial

DOI：

10.7507/1672-2531.201807055

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Objectives To compare the efficacy and safety of weekly nedaplatin compared with weekly cisplatin as postoperative concurrent chemoradiotherapy scheme for cervical cancer patients.Methods This trial was performed in the Department of Radiation Oncology in the Second Affiliated Hospital of Fujian Medical University from June 2016 to January 2017. A total of 200 patients with stage ⅠB1-ⅡB cervical cancer were randomly assigned to the nedaplatin group and the cisplatin group after signing informed content. The dose of nedaplatin or cisplatin ranged 35 to 40 mg/m², once a week for 5 weeks. Intensity-modulated radiation therapy or three-dimensional conformal radiation therapy were used for patients. The progression-free survival, overall survival and adverse reactions were compared between two groups. Statistical analysis was performed by SPSS 24.0 software.Results A total of 105 patients were enrolled in the nedaplatin group, and 95 patients were in cisplatin group. The three-year progression-free survival rate was 80.5% vs. 79.5% in the nedaplatin group and the cisplatin group, respectively; and no statistical significant difference was found (χ²=0.198, P=0.656) between two groups. The 3-year overall survival rates were 72.5% and 69.9% for the nedaplatin group and the cisplatin group, respectively, and there was no significant difference between the two groups (χ²=0.261, P=0.609). The incidence of grade 3/4 nausea and vomiting in the nedaplatin group was 6.67%, which was significantly lower than that of 15.79% in the cisplatin group, and statistical significant difference was found (χ²=2.555, P=0.011); however, the incidence of grade 3/4 thrombocytopenia in the nedaplatin group was 9.52%, which was significantly higher than that in the cisplatin group (3.15%); and the difference was statistically significant (χ²=1.985, P=0.047). There was no difference in the incidence of adverse reactions such as anemia, neutropenia, and radiological proctitis in both groups.Conclusions Nedaplatin-based concurrent chemoradiotherapy has similar efficacy compared to cisplatin-based concurrent chemoradiotherapy, and it could significantly reduce the digestive tract reaction, which can be used as an alternative to cisplatin.

Citation： XIAO Lihua, HUANG Bifen, ZHENG Jianqing, CHEN Mingfen, SU Jingjing, WU Min. Weekly nedaplatin versus weekly cisplatin as postoperative concurrent chemoradiotherapy after radical surgery for cervical cancer: a randomized controlled trial. Chinese Journal of Evidence-Based Medicine, 2019, 19(4): 381-386. doi: 10.7507/1672-2531.201807055 Copy

1.	Shimada M, Itamochi H, Kigawa J. Nedaplatin: a cisplatin derivative in cancer chemotherapy. Cancer Manag Res, 2013, 5(default): 67-76.
2.	Kodama J, Takemoto M, Seki N, et al. Phase I study of weekly nedaplatin and concurrent pelvic radiotherapy as adjuvant therapy after radical surgery for cervical cancer. Int J Gynecol Cancer, 2008, 18(5): 1037-1041.
3.	Niibe Y, Tsunoda S, Jobo T, et al. Phase II study of radiation therapy combined with weekly nedaplatin in locally advanced uterine cervical carcinoma (LAUCC): Kitasato Gynecologic Radiation Oncology Group (KGROG 0501)-initial analysis. Eur J Gynaecol Oncol, 2008, 29(3): 222-224.
4.	Yuan G, Wu L, Huang M, et al. A phase II study of concurrent chemo-radiotherapy with weekly nedaplatin in advanced squamous cell carcinoma of the uterine cervix. Radiat Oncol, 2014, 9(default): 55.
5.	Kobayashi Y, Ohara T, Wada Y, et al. Concurrent chemoradiotherapy with nedaplatin after radical hysterectomy in patients with stage IB and II cervical cancer. J Obstet Gynaecol Res, 2009, 35(3): 490-494.
6.	周晖, 卢淮武, 彭永排, 等. 《2015年NCCN宫颈癌临床实践指南》解读. 中国实用妇科与产科杂志, 2015, 30(3): 185-191.
7.	Takeshita S, Kita T, Motoike Y, et al. Postoperative concurrent chemoradiotherapy for the high-risk uterine cervical cancer. J Obstet Gynaecol Res, 2010, 36(5): 1009-1014.
8.	Colombo N, Carinelli S, Colombo A, et al. Cervical cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol, 2012, 23 Suppl 7(suppl_5): vii27.
9.	郑建清, 黄碧芬. 宫颈癌术后紫杉醇联合顺铂同步放化疗的临床研究. 中国实用医药, 2015, 10(1): 11-13.
10.	叶伟军, 徐敏, 曹新平, 等. 奈达铂同期放化疗治疗中晚期宫颈癌前瞻性临床研究. 国际肿瘤学杂志, 2014, 41(6): 476-479.
11.	Kagabu M, Shoji T, Murakami K, et al. Clinical efficacy of nedaplatin-based concurrent chemoradiotherapy for uterine cervical cancer: a Tohoku Gynecologic Cancer Unit Study. Int J Clin Oncol, 2016, 21(4): 735-740.
12.	Mabuchi S, Morishige K, Isohashi F, et al. Postoperative concurrent nedaplatin-based chemoradiotherapy improves survival in early-stage cervical cancer patients with adverse risk factors. Gynecol Oncol, 2009, 115(3): 482-487.
13.	Isohashi F, Mabuchi S, Yoshioka Y, et al. Intensity-modulated radiation therapy versus three-dimensional conformal radiation therapy with concurrent nedaplatin-based chemotherapy after radical hysterectomy for uterine cervical cancer: comparison of outcomes, complications, and dose-volume histogram parameters. Radiat Oncol, 2015, 10(default): 180.
14.	谢忆山, 唐甜, 李长虎, 等. 宫颈癌术后奈达铂同步调强放疗的临床研究. 安徽医学, 2013, 34(12): 1813-1815.

1. Shimada M, Itamochi H, Kigawa J. Nedaplatin: a cisplatin derivative in cancer chemotherapy. Cancer Manag Res, 2013, 5(default): 67-76.
2. Kodama J, Takemoto M, Seki N, et al. Phase I study of weekly nedaplatin and concurrent pelvic radiotherapy as adjuvant therapy after radical surgery for cervical cancer. Int J Gynecol Cancer, 2008, 18(5): 1037-1041.
3. Niibe Y, Tsunoda S, Jobo T, et al. Phase II study of radiation therapy combined with weekly nedaplatin in locally advanced uterine cervical carcinoma (LAUCC): Kitasato Gynecologic Radiation Oncology Group (KGROG 0501)-initial analysis. Eur J Gynaecol Oncol, 2008, 29(3): 222-224.
4. Yuan G, Wu L, Huang M, et al. A phase II study of concurrent chemo-radiotherapy with weekly nedaplatin in advanced squamous cell carcinoma of the uterine cervix. Radiat Oncol, 2014, 9(default): 55.
5. Kobayashi Y, Ohara T, Wada Y, et al. Concurrent chemoradiotherapy with nedaplatin after radical hysterectomy in patients with stage IB and II cervical cancer. J Obstet Gynaecol Res, 2009, 35(3): 490-494.
6. 周晖, 卢淮武, 彭永排, 等. 《2015年NCCN宫颈癌临床实践指南》解读. 中国实用妇科与产科杂志, 2015, 30(3): 185-191.
7. Takeshita S, Kita T, Motoike Y, et al. Postoperative concurrent chemoradiotherapy for the high-risk uterine cervical cancer. J Obstet Gynaecol Res, 2010, 36(5): 1009-1014.
8. Colombo N, Carinelli S, Colombo A, et al. Cervical cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol, 2012, 23 Suppl 7(suppl_5): vii27.
9. 郑建清, 黄碧芬. 宫颈癌术后紫杉醇联合顺铂同步放化疗的临床研究. 中国实用医药, 2015, 10(1): 11-13.
10. 叶伟军, 徐敏, 曹新平, 等. 奈达铂同期放化疗治疗中晚期宫颈癌前瞻性临床研究. 国际肿瘤学杂志, 2014, 41(6): 476-479.
11. Kagabu M, Shoji T, Murakami K, et al. Clinical efficacy of nedaplatin-based concurrent chemoradiotherapy for uterine cervical cancer: a Tohoku Gynecologic Cancer Unit Study. Int J Clin Oncol, 2016, 21(4): 735-740.
12. Mabuchi S, Morishige K, Isohashi F, et al. Postoperative concurrent nedaplatin-based chemoradiotherapy improves survival in early-stage cervical cancer patients with adverse risk factors. Gynecol Oncol, 2009, 115(3): 482-487.
13. Isohashi F, Mabuchi S, Yoshioka Y, et al. Intensity-modulated radiation therapy versus three-dimensional conformal radiation therapy with concurrent nedaplatin-based chemotherapy after radical hysterectomy for uterine cervical cancer: comparison of outcomes, complications, and dose-volume histogram parameters. Radiat Oncol, 2015, 10(default): 180.
14. 谢忆山, 唐甜, 李长虎, 等. 宫颈癌术后奈达铂同步调强放疗的临床研究. 安徽医学, 2013, 34(12): 1813-1815.

Chinese Journal of Evidence-Based Medicine

Weekly nedaplatin versus weekly cisplatin as postoperative concurrent chemoradiotherapy after radical surgery for cervical cancer: a randomized controlled trial

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