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Frontiers of Medicine

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Front. Med.    2023, Vol. 17 Issue (1) : 93-104    https://doi.org/10.1007/s11684-021-0892-z
RESEARCH ARTICLE
Adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial
Danhui Weng1, Huihua Xiong2, Changkun Zhu3, Xiaoyun Wan3, Yaxia Chen3, Xinyu Wang3, Youzhong Zhang4, Jie Jiang4, Xi Zhang4, Qinglei Gao1, Gang Chen1, Hui Xing5, Changyu Wang1, Kezhen Li1, Yaheng Chen1, Yuyan Mao3, Dongxiao Hu3, Zimin Pan3, Qingqin Chen3, Baoxia Cui4, Kun Song4, Cunjian Yi6, Guangcai Peng6, Xiaobing Han7, Ruifang An7, Liangsheng Fan8, Wei Wang8, Tingchuan Xiong9, Yile Chen10, Zhenzi Tang10, Lin Li5, Xingsheng Yang4(), Xiaodong Cheng3(), Weiguo Lu3(), Hui Wang1,3(), Beihua Kong4(), Xing Xie3(), Ding Ma1()
1. Department of Obstetrics and Gynecology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
2. Department of Oncology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
3. Department of Gynecologic Oncology, Women’s Hospital, School of Medicine, Zhejiang University, Hangzhou 310006, China
4. Department of Obstetrics and Gynecology, Qilu Hospital, Shandong University, Jinan 250012, China
5. Department of Obstetrics and Gynecology, Xiangyang Central Hospital, Hubei University of Arts and Science, Xiangyang 441021, China
6. Department of Obstetrics and Gynecology, The First Affiliated Hospital of Yangtze University, Jingmen 448000, China
7. Department of Obstetrics and Gynecology, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710061, China
8. Department of Obstetrics and Gynecology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China
9. Department of Gynecologic Oncology, Affiliated Tumour Hospital, Xinjiang Medical University, Urumqi 830000, China
10. Department of Gynecologic Oncology, Hunan Province Tumor Hospital, Changsha 410013, China
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Abstract

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.
Keywords chemotherapy      cervical cancer      lymph node metastasis      concurrent chemoradiotherapy      quality of life     
Corresponding Author(s): Xingsheng Yang,Xiaodong Cheng,Weiguo Lu,Hui Wang,Beihua Kong,Xing Xie,Ding Ma   
Just Accepted Date: 19 August 2022   Online First Date: 23 November 2022    Issue Date: 15 March 2023
 Cite this article:   
Danhui Weng,Huihua Xiong,Changkun Zhu, et al. Adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial[J]. Front. Med., 2023, 17(1): 93-104.
 URL:  
https://academic.hep.com.cn/fmd/EN/10.1007/s11684-021-0892-z
https://academic.hep.com.cn/fmd/EN/Y2023/V17/I1/93
VariableAdjuvant CT group (N = 166)Adjuvant CCRT group (N = 171)
Age at randomization (year)
Range24?6427?60
Average45.8 ± 8.546.5 ± 7.5
≤ 40 (n (%))44 (26.5)41 (24.0)
41–50 (n (%))70 (42.2)68 (39.8)
> 50 (n (%))52 (31.3)62 (36.2)
FIGO stage (n (%))
IB183 (50.0)88 (51.5)
IB244 (26.5)46 (26.9)
IIA127 (16.3)26 (15.2)
IIA212 (7.2)11 (6.4)
Deep stromal invasion (n (%))91 (54.8)101 (59.1)
Histopathological grade G2?G3 (n (%))76 (45.8)73 (42.7)
Lymphatic vascular space involvement (n (%))41 (24.7)35 (20.5)
Diameter (mm, average)26.4 ± 11.926.6 ± 12.2
Lymph node metastasis (n (%))30 (18.1)36 (21.1)
Sigle positive node (n)1719
Multiple positive nodes (≥ 2) (n)1317
Positive parametrial invasion (n (%))5 (3.0)4 (2.3)
Single risk factor w/o LNM or PMI (n (%))78 (47.0)76 (44.4)
Multiple risk factors or LNM or PMI (n (%))88 (53.0)95 (55.6)
Ovarian conservation (n (%))66 (39.6)63 (36.8)
Initial SCCA (ng/mL, median)1.521.70
Intention-to-treat population (n (%))165 (99.4)164 (95.9)
Per-protocol population (n (%))152 (91.6)144 (84.2)
Tab.1  Baseline characteristics of 337 patients
Fig.1  CONSORT diagram. CT, chemotherapy; CCRT, concurrent chemoradiotherapy.
Fig.2  Progression-free survival (PFS) and overall survival (OS) in the intent-to-treat population. Kaplan–Meier plots for (A) PFS and (B) OS in the intent-to-treat population by treatment group: adjuvant chemotherapy group and adjuvant CCRT group. The three-year PFS rates were both 91.9%, and the five-year PFS was 90.6% versus 90.0%, respectively in adjuvant chemotherapy and adjuvant CCRT groups. The HR for PFS excluding the predefined non-inferiority boundary of 1.9, demonstrating a significant non-inferiority. Estimated OS was similar to the PFS. Numbers in parentheses represent the number of events (deaths or progressions) between the two time points.
Treatment groupAdjuvant CT group(N = 15)Adjuvant CCRT group(N = 15)P value
Recurrence (n)0.288
Local84
Locoregional66
Distant15
Death (n)1012a
Tab.2  Recurrence and death patterns
Fig.3  Subset analysis by using Cox regression model displayed in a forest plot and plotted on the log scale with 95% CI. (A) Progression-free survival (PFS) and (B) overall survival (OS). Horizontal lines represent hazard ratios (HRs; with 95% CIs). Treatment interaction was assessed using a multivariate Cox proportional model. The HRs are relative to the adjuvant CCRT group and vary at approximately 1.0. The vertical line at 1.0 represents no difference in the HRs; HR < 1 favors adjuvant chemotherapy and HR > 1 favors adjuvant CCRT. The vertical line at 1.9 represents upper bound of the hazard ratio. CT, chemotherapy; CCRT, concurrent chemoradiotherapy; CI, confidence interval; LNM, lymph node metastasis; PMI, positive parametrial invasion. Single risk factor including DSI (deep stromal invasion), G2 to G3 (histopathological grading indicating poor differentiation), LVSI (lymphatic vascular space involvement), bulky tumor (tumor diameter > 4 cm). Multiple risk factors including two or more of the risk factors in single risk factor group.
Fig.4  Progression-free survival (PFS) and overall survival (OS) in subgroups. Kaplan–Meier plots for (A) PFS and (B) OS in the group with lymph node metastasis and/or positive parametrial invasion; no significant differences in PSF and OS were observed between the two treatment groups; log-rank P = 0.390 for PFS; log-rank P = 0.103 for OS. (C) PFS and (D) OS in the group without lymph node metastasis or positive parametrial invasion; no significant differences in PSF and OS were observed between the two treatment groups; log-rank P = 0.644 for PFS; log-rank P = 0.417 for OS. Numbers in parentheses represent the number of events (deaths or progressions) between the two time points. CT, chemotherapy; CCRT, concurrent chemoradiotherapy.
Fig.5  Serum FSH and E2 at 36 months after randomization. Data from 82 patients whose ovarian function were evaluated at 36 months after randomization. Higher FSH level (A) and lower E2 level (B) in adjuvant CCRT group were significantly different from adjuvant chemotherapy group (P = 0.002 for FSH and P = 0.004 for E2). FSH > 25 mIU/mL refers to premature ovarian insufficiency (POI), FSH > 45 mIU/mL refers to menopause. Right panels indicated the median (line in the box), interquartile range (box), 90% confidence intervals (error bar), and all the outliers.
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