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Adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial

We conducted a prospective study to assess the non-inferiority of adjuvant chemotherapy alone versus adjuvant concurrent chemoradiotherapy (CCRT) as an alternative strategy for patients with early-stage (FIGO 2009 stage IB–IIA) cervical cancer having risk factors after surgery. The condition was ass...

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Autores principales: Weng, Danhui, Xiong, Huihua, Zhu, Changkun, Wan, Xiaoyun, Chen, Yaxia, Wang, Xinyu, Zhang, Youzhong, Jiang, Jie, Zhang, Xi, Gao, Qinglei, Chen, Gang, Xing, Hui, Wang, Changyu, Li, Kezhen, Chen, Yaheng, Mao, Yuyan, Hu, Dongxiao, Pan, Zimin, Chen, Qingqin, Cui, Baoxia, Song, Kun, Yi, Cunjian, Peng, Guangcai, Han, Xiaobing, An, Ruifang, Fan, Liangsheng, Wang, Wei, Xiong, Tingchuan, Chen, Yile, Tang, Zhenzi, Li, Lin, Yang, Xingsheng, Cheng, Xiaodong, Lu, Weiguo, Wang, Hui, Kong, Beihua, Xie, Xing, Ma, Ding
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Higher Education Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9686219/
https://www.ncbi.nlm.nih.gov/pubmed/36422763
http://dx.doi.org/10.1007/s11684-021-0892-z
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author Weng, Danhui
Xiong, Huihua
Zhu, Changkun
Wan, Xiaoyun
Chen, Yaxia
Wang, Xinyu
Zhang, Youzhong
Jiang, Jie
Zhang, Xi
Gao, Qinglei
Chen, Gang
Xing, Hui
Wang, Changyu
Li, Kezhen
Chen, Yaheng
Mao, Yuyan
Hu, Dongxiao
Pan, Zimin
Chen, Qingqin
Cui, Baoxia
Song, Kun
Yi, Cunjian
Peng, Guangcai
Han, Xiaobing
An, Ruifang
Fan, Liangsheng
Wang, Wei
Xiong, Tingchuan
Chen, Yile
Tang, Zhenzi
Li, Lin
Yang, Xingsheng
Cheng, Xiaodong
Lu, Weiguo
Wang, Hui
Kong, Beihua
Xie, Xing
Ma, Ding
author_facet Weng, Danhui
Xiong, Huihua
Zhu, Changkun
Wan, Xiaoyun
Chen, Yaxia
Wang, Xinyu
Zhang, Youzhong
Jiang, Jie
Zhang, Xi
Gao, Qinglei
Chen, Gang
Xing, Hui
Wang, Changyu
Li, Kezhen
Chen, Yaheng
Mao, Yuyan
Hu, Dongxiao
Pan, Zimin
Chen, Qingqin
Cui, Baoxia
Song, Kun
Yi, Cunjian
Peng, Guangcai
Han, Xiaobing
An, Ruifang
Fan, Liangsheng
Wang, Wei
Xiong, Tingchuan
Chen, Yile
Tang, Zhenzi
Li, Lin
Yang, Xingsheng
Cheng, Xiaodong
Lu, Weiguo
Wang, Hui
Kong, Beihua
Xie, Xing
Ma, Ding
author_sort Weng, Danhui
collection PubMed
description We conducted a prospective study to assess the non-inferiority of adjuvant chemotherapy alone versus adjuvant concurrent chemoradiotherapy (CCRT) as an alternative strategy for patients with early-stage (FIGO 2009 stage IB–IIA) cervical cancer having risk factors after surgery. The condition was assessed in terms of prognosis, adverse effects, and quality of life. This randomized trial involved nine centers across China. Eligible patients were randomized to receive adjuvant chemotherapy or CCRT after surgery. The primary end-point was progression-free survival (PFS). From December 2012 to December 2014, 337 patients were subjected to randomization. Final analysis included 329 patients, including 165 in the adjuvant chemotherapy group and 164 in the adjuvant CCRT group. The median follow-up was 72.1 months. The three-year PFS rates were both 91.9%, and the five-year OS was 90.6% versus 90.0% in adjuvant chemotherapy and CCRT groups, respectively. No significant differences were observed in the PFS or OS between groups. The adjusted HR for PFS was 0.854 (95% confidence interval 0.415–1.757; P = 0.667) favoring adjuvant chemotherapy, excluding the predefined non-inferiority boundary of 1.9. The chemotherapy group showed a tendency toward good quality of life. In comparison with post-operative adjuvant CCRT, adjuvant chemotherapy treatment showed non-inferior efficacy in patients with early-stage cervical cancer having pathological risk factors. Adjuvant chemotherapy alone is a favorable alternative post-operative treatment. ELECTRONIC SUPPLEMENTARY MATERIAL: Supplementary material is available in the online version of this article at 10.1007/s11684-021-0892-z and is accessible for authorized users.
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spelling pubmed-96862192022-11-28 Adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial Weng, Danhui Xiong, Huihua Zhu, Changkun Wan, Xiaoyun Chen, Yaxia Wang, Xinyu Zhang, Youzhong Jiang, Jie Zhang, Xi Gao, Qinglei Chen, Gang Xing, Hui Wang, Changyu Li, Kezhen Chen, Yaheng Mao, Yuyan Hu, Dongxiao Pan, Zimin Chen, Qingqin Cui, Baoxia Song, Kun Yi, Cunjian Peng, Guangcai Han, Xiaobing An, Ruifang Fan, Liangsheng Wang, Wei Xiong, Tingchuan Chen, Yile Tang, Zhenzi Li, Lin Yang, Xingsheng Cheng, Xiaodong Lu, Weiguo Wang, Hui Kong, Beihua Xie, Xing Ma, Ding Front Med Research Article We conducted a prospective study to assess the non-inferiority of adjuvant chemotherapy alone versus adjuvant concurrent chemoradiotherapy (CCRT) as an alternative strategy for patients with early-stage (FIGO 2009 stage IB–IIA) cervical cancer having risk factors after surgery. The condition was assessed in terms of prognosis, adverse effects, and quality of life. This randomized trial involved nine centers across China. Eligible patients were randomized to receive adjuvant chemotherapy or CCRT after surgery. The primary end-point was progression-free survival (PFS). From December 2012 to December 2014, 337 patients were subjected to randomization. Final analysis included 329 patients, including 165 in the adjuvant chemotherapy group and 164 in the adjuvant CCRT group. The median follow-up was 72.1 months. The three-year PFS rates were both 91.9%, and the five-year OS was 90.6% versus 90.0% in adjuvant chemotherapy and CCRT groups, respectively. No significant differences were observed in the PFS or OS between groups. The adjusted HR for PFS was 0.854 (95% confidence interval 0.415–1.757; P = 0.667) favoring adjuvant chemotherapy, excluding the predefined non-inferiority boundary of 1.9. The chemotherapy group showed a tendency toward good quality of life. In comparison with post-operative adjuvant CCRT, adjuvant chemotherapy treatment showed non-inferior efficacy in patients with early-stage cervical cancer having pathological risk factors. Adjuvant chemotherapy alone is a favorable alternative post-operative treatment. ELECTRONIC SUPPLEMENTARY MATERIAL: Supplementary material is available in the online version of this article at 10.1007/s11684-021-0892-z and is accessible for authorized users. Higher Education Press 2022-11-23 2023 /pmc/articles/PMC9686219/ /pubmed/36422763 http://dx.doi.org/10.1007/s11684-021-0892-z Text en © Higher Education Press 2022 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Research Article
Weng, Danhui
Xiong, Huihua
Zhu, Changkun
Wan, Xiaoyun
Chen, Yaxia
Wang, Xinyu
Zhang, Youzhong
Jiang, Jie
Zhang, Xi
Gao, Qinglei
Chen, Gang
Xing, Hui
Wang, Changyu
Li, Kezhen
Chen, Yaheng
Mao, Yuyan
Hu, Dongxiao
Pan, Zimin
Chen, Qingqin
Cui, Baoxia
Song, Kun
Yi, Cunjian
Peng, Guangcai
Han, Xiaobing
An, Ruifang
Fan, Liangsheng
Wang, Wei
Xiong, Tingchuan
Chen, Yile
Tang, Zhenzi
Li, Lin
Yang, Xingsheng
Cheng, Xiaodong
Lu, Weiguo
Wang, Hui
Kong, Beihua
Xie, Xing
Ma, Ding
Adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial
title Adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial
title_full Adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial
title_fullStr Adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial
title_full_unstemmed Adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial
title_short Adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial
title_sort adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9686219/
https://www.ncbi.nlm.nih.gov/pubmed/36422763
http://dx.doi.org/10.1007/s11684-021-0892-z
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