Dataset Information

Lymphadenectomy in ovarian cancers: a meta-analysis of hazard ratios from randomized clinical trials.

ABSTRACT:

Background

The debate surrounding systematic lymphadenectomy in the epithelial cancers of the ovary (EOC) was temporarily put to rest by the LION trial. However, there was a glaring disparity between the number of patients registered and the number of patients randomized suggesting inadvertent selection. A subsequent meta-analysis after this trial included all types of studies in the literature (randomized, non-randomized, case series, and, retrospective cohort), thus diluting the results.

Methods

We conducted a meta-analysis of hazard ratios of randomized controlled trials, to study the role of systematic para-aortic and pelvic lymph node dissection in the EOC. A detailed search of MEDLINE, Cochrane, and Embase databases was done to look for the published randomized controlled trials (RCT) comparing lymphadenectomy versus no lymphadenectomy in EOC. A meta-analysis of hazard ratios (HR) was performed for overall survival (OS) and progression-free survival (PFS) using fixed and random effect models. The quality of the RCTs was evaluated on Jadad's score, and the risk of bias was estimated by the Cochrane tool.

Results

A total of 1342 patients with EOC were included for quantitative analysis. On meta-analysis, HR for PFS was 0.9 (95% CI 0.79-1.04) favoring lymphadenectomy. HR for OS was 1 (95% CI 0.84-1.18) signifying no benefit of systematic lymphadenectomy.

Conclusion

The results show a trend towards increased PFS which did not reach statistical significance nor translate into any meaningful benefit in OS. There is still a need for a greater number of well-conducted, suitably powered trials to convincingly answer this question.

SUBMITTER: Purwar R

PROVIDER: S-EPMC9682714 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Lymphadenectomy in ovarian cancers: a meta-analysis of hazard ratios from randomized clinical trials.

Purwar Roli R Ranjan Rakesh R Soni Kishan K Pandey Manoj M Upadhyay Satyanshu K SK Pai Esha E Kumar Tarun T

World journal of surgical oncology 20221122 1

<h4>Background</h4>The debate surrounding systematic lymphadenectomy in the epithelial cancers of the ovary (EOC) was temporarily put to rest by the LION trial. However, there was a glaring disparity between the number of patients registered and the number of patients randomized suggesting inadvertent selection. A subsequent meta-analysis after this trial included all types of studies in the literature (randomized, non-randomized, case series, and, retrospective cohort), thus diluting the result ...[more]

PMID: 36419077

Similar Datasets

Project description:ImportanceGroup sequential designs allow potential early trial termination at the interim analysis, before study completion. Traditional maximum likelihood estimate is commonly used to quantify the treatment effect in group sequential design trials; however, in published clinical trials, a bias-adjusted estimator has rarely been reported.ObjectiveTo emphasize the need for considering overestimation of treatment effect by applying 2 bias-adjusted estimators to previously published, early-terminated oncology clinical trials.Evidence reviewTrials published from 2013 to 2017 were identified by searching MEDLINE and Embase on February 23, 2018. This review was restricted to oncology clinical trials using group sequential designs with a single preplanned interim analysis as well as 2-arm randomized clinical trials that were subsequently stopped for efficacy reasons. Each article was independently reviewed by 3 biostatisticians during text screening, and differences in opinion were resolved by discussion. This report presents the unadjusted hazard ratio (HR) of an experimental arm to a reference arm and 2 bias-adjusted HRs calculated by using the conditional mean-adjusted estimator (CMAE) and weighted CMAE (WCMAE).FindingsIn total, 198 abstracts were screened for eligibility, of which, 19 eligible clinical trials were identified as applicable to the bias-adjusted estimators. Unadjusted HRs ranged from 0.203 (95% CI, 0.150-0.276) to 0.71 (95% CI, 0.60-0.84), number of events at the interim analysis from 58 to 540, and information time from 48% to 82%. In each study, the HRs adjusted by CMAE and WCMAE were higher than the unadjusted HR. Bias-adjusted estimates in large trials (243 and 414 events at the interim analysis) were similar to the unadjusted HR. However, in small trials (eg, with 58 events at the interim analysis), bias-adjusted estimates were highly disparate from the unadjusted HR. In trials with large treatment effects (eg, HRs of 0.20 and 0.22), the difference between unadjusted and bias-adjusted HRs was small even though the number of events at the interim analysis was small; larger differences were observed when the unadjusted HR was greater than 0.5.Conclusions and relevanceIn this systematic review of oncology clinical trials that were stopped for efficacy at the interim analysis, relatively large differences were noted between the unadjusted and adjusted HRs when the number of events at the interim analysis was small or when the unadjusted HR was close to the boundaries. These findings suggest presenting the 2 bias-adjusted HRs along with the unadjusted HR in the data monitoring committee meeting.

Dataset Information

Lymphadenectomy in ovarian cancers: a meta-analysis of hazard ratios from randomized clinical trials.

Background

Methods

Results

Conclusion

Publications

Lymphadenectomy in ovarian cancers: a meta-analysis of hazard ratios from randomized clinical trials.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets