Is salvage radiotherapy optimal to patients with occult cervical cancer undergoing inadvertent simple hysterectomy? A propensity score-matched analysis of a nationwide clinical oncology database.

OBJECTIVE: We used National Cancer Institute's Surveillance, Epidemiology and End Result database to assess the role of salvage radiotherapy for women with unanticipated cervical cancer after simple hysterectomy. METHODS: Patients with non-metastatic cervical cancer and meeting inclusion criteria were divided into three groups based on treatment strategy: simple hysterectomy, salvage radiotherapy after hysterectomy and radical surgery. Parallel propensity score-matched datasets were established for salvage radiotherapy group vs. simple hysterectomy group (matching ratio 1: 1), and salvage radiotherapy group vs. radical surgery group (matching ratio 1:2). The primary endpoint was the overall survival advantage of salvage radiotherapy over simple hysterectomy or radical surgery within the propensity score-matched datasets. RESULTS: In total, 2682 patients were recruited: 647 in the simple hysterectomy group, 564 in the salvage radiotherapy group and 1471 in the radical surgery group. Age, race, histology, grade, FIGO stage, insured and marital status and chemotherapy were comprised in propensity score-matched. Matching resulted in two comparison groups with neglectable differences in most variables, except for black race, FIGO stage III and chemotherapy in first matching. In the matched analysis for salvage radiotherapy vs. simple hysterectomy, the median follow-up time was 39 versus 32 months. In the matched analysis for salvage radiotherapy vs. radical surgery, the median follow-up time was 39 and 41 months, respectively. Salvage radiotherapy (HR 0.53, P = 0.046) significantly improved overall survival compared with simple hysterectomy, while salvage radiotherapy cannot achieve similar overall survival to radical surgery (HR 1.317, P = 0.045). CONCLUSIONS: This is the largest study of the effect of salvage radiotherapy on overall survival in patients with unanticipated cervical cancer. Salvage radiotherapy can improve overall survival compared with hysterectomy alone, while cannot achieve comparable survival to radical surgery.

Role of locoregional surgery in treating FIGO 2009 stage IVB cervical cancer patients: a population-based study.

OBJECTIVE: We aimed to analyse the clinical value of primary site surgery in improving the cancer-specific survival (CSS) and overall survival (OS) of initial metastatic cervical cancer patients. DESIGN: A population-based retrospective study. SETTING: National Cancer Institute's Surveillance, Epidemiology and End Results database. PARTICIPANTS: We analysed 1390 patients with the International Federation of Gynecology and Obstetrics 2009 stage IVB cervical cancer with complete clinical data treated between 2010 and 2016. INTERVENTIONS: Primary site surgery. MEASURES: Propensity score matching (PSM) with a ratio of 1:2 was used to balance measure covariates of comparison groups. Survival time was calculated using Kaplan-Meier methods and compared by the log-rank test. To eliminate the bias of site-specific metastasis, clinicopathological factors and subsequent therapy on survival analysis, subgroup analyses stratified by metastasis type, clinicopathological factors and subsequent therapy were employed to evaluate the effect of cervical surgery on survival. Combination of directed acyclic graph and change-in-estimate procedures was performed to indentified confounders, and Cox regression was used to assess the survival benefit of cervical surgery for primary metastatic cervical cancer patients. The consistency of our findings was evaluated through sensitivity analysis. RESULTS: Matching resulted in two comparison groups with minor differences in most variables. Pre-and-post-PSM, the median CSS and OS in the surgery group were 1.3 and 1.5, 1.1 and 1.2 times of those in the non-surgery group, respectively. Primary site surgery conferred prognosis superiority for patients with metastases to distant lymph node and other sites rather than organ metastases. After PSM and adjusting confounders, local surgery reduced the cancer related and overall mortality rates by 31% and 30%, respectively. CONCLUSIONS: Surgical procedures could promote survival in patients with primary metastatic cervical cancer and should be considered a therapeutic option for carefully chosen patients.

Multicentre, randomised controlled trial of adjuvant chemotherapy in cervical cancer with residual human papilloma virus DNA following primary radiotherapy or chemoradiotherapy: a study protocol.

INTRODUCTION: The role of adjuvant chemotherapy after radical radiotherapy (RT) or chemoradiotherapy (CRT) in cervical cancer awaits further confirmation. Evidences have shown that persistent human papilloma virus (HPV) DNA in exfoliated cell post-RT is a potential biomarker of subclinical residual disease and thus increases the risk of recurrence. In this prospective, multicentre, randomised controlled trial, we will use HPV DNA in exfoliated cell to identify patients with cervical cancer who received definitive RT or CRT with higher risk of relapse for adjuvant chemotherapy. METHODS AND ANALYSIS: Eligible patients with histologically confirmed cervical cancer stage IIA2 to IVA of the International Federation of Gynaecology and Obstetrics, adequate organ function and no locoregional disease or distant metastasis after completion of primary treatment will be screened for HPV DNA in exfoliated cell at 1 month post-RT. Patients with undetectable HPV DNA will undergo standard surveillance. Patients with detectable HPV DNA will be randomly assigned to either adjuvant chemotherapy with docetaxel and nedaplatin for four cycles (arm 1) or observation (arm 2). Patients will be stratified for primary treatment (RT vs CRT). The primary endpoint is relapse-free survival. ETHICS AND DISSEMINATION: This protocol received a favourable ethical opinion from the Ethics Committee of the Second Affiliated Hospital of Fujian Medical University on 6 February, 2018, (No. 28). The trial results will be published in peer-reviewed journals and presented in conferences. A summary of the findings will be made available to participants. TRIAL REGISTRATION NUMBER: ChiCTR-IIR-17012655; Pre-results.