Abstract
Background: Early-stage cervical cancer (CC) is the second leading malignant tumour in China and remains a major public health burden in developing countries. We aimed to determine the long-term oncological outcomes between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in the era of big data and real-world settings. Methods: We conducted a multicentre, retrospective, case-control study of 37 hospitals in mainland China. All consecutive early-stage CC patients with FIGO 2009 stage between IA1 (LVSI-positive), IA2 and IB1 who were treated by LRH or ARH between 2004 and 2016 were included. We compared the overall survival (OS) and disease-free survival (DFS) of the two surgical approaches in real-world and 1:1 case-control matched settings based on prognosis-related factors. Findings: We selected 8630 of 46313 patients from our database. In the real-world setting, the 5-year OS of patients who received LRH (n=2842) and ARH (n=5518) was similar, but LRH was associated with significantly poorer 5-year DFS (LRH 90·3%, ARH 87·8%, p=0·001; HR=1·392). After matching (n=1619/1619), we found that LRH was associated with significantly worse 5-year DFS (LRH 88·1%, ARH 91·2%, p=0·011; HR=1·392). In the subgroup analysis, in non-high-risk patients (n=1205/1205) who did not receive postoperative adjunct therapy (PAT) with LRH, both 5-year OS and 5-year DFS were significantly worse (5-OS: LRH 95·0%, ARH 97·8%, p=0·027; 5-DFS: LRH 95·6%, ARH 90·3%, p<0·001). However, such differences in 5-year OS and 5-year DFS were no longer significant in patients with high-risk factors who received PAT. Interpretation: This strictly matched retrospective cohort study revealed that in early-stage CC patients, LRH was associated with significantly poorer DFS but not OS. However, further subgroup analysis demonstrated that patients with high-risk factors who received standard PAT might be an indication for LRH. Funding: The National Science and Technology Support Program of China (2014BAI05B03), the National Natural Science Fund of Guangdong (2015A030311024), the Science and Technology Plan of Guangzhou (158100075). Declaration of Interest: All authors have no conflicts of interest to disclose. Ethical Approval: This retrospective study was approved by the Ethics Committee of Nanfang Hospital, Southern Medical University (ethical number NEEC-2017-135, clinical trial number CHiCTR1800017778 (International Clinical Trials Registry Platform Search Port).
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