Are the findings of high-quality observational studies consistent with the results of a randomized clinical trial that found that minimally invasive hysterectomy was associated with a higher risk of recurrence and death compared with open surgery?
In this systematic review and meta-analysis of 15 high-quality studies comprising 9499 patients, minimally invasive radical hysterectomy was associated with shorter overall and disease-free survival among women with operable cervical cancer compared with open surgery.
These results provide evidence to support the survival benefit associated with open radical hysterectomy for early-stage cervical cancer; these findings are consistent with a recent randomized clinical trial.
Minimally invasive techniques are increasingly common in cancer surgery. A recent randomized clinical trial has brought into question the safety of minimally invasive radical hysterectomy for cervical cancer.
To quantify the risk of recurrence and death associated with minimally invasive vs open radical hysterectomy for early-stage cervical cancer reported in observational studies optimized to control for confounding.
Ovid MEDLINE, Ovid Embase, PubMed, Scopus, and Web of Science (inception to March 26, 2020) performed in an academic medical setting.
In this systematic review and meta-analysis, observational studies were abstracted that used survival analyses to compare outcomes after minimally invasive (laparoscopic or robot-assisted) and open radical hysterectomy in patients with early-stage (International Federation of Gynecology and Obstetrics 2009 stage IA1-IIA) cervical cancer. Study quality was assessed with the Newcastle-Ottawa Scale and included studies with scores of at least 7 points that controlled for confounding by tumor size or stage.
Data Extraction and Synthesis
The Meta-analysis of Observational Studies in Epidemiology (MOOSE) checklist was used to abstract data independently by multiple observers. Random-effects models were used to pool associations and to analyze the association between surgical approach and oncologic outcomes.
Main Outcomes and Measures
Risk of recurrence or death and risk of all-cause mortality.
Forty-nine studies were identified, of which 15 were included in the meta-analysis. Of 9499 patients who underwent radical hysterectomy, 49% (n = 4684) received minimally invasive surgery; of these, 57% (n = 2675) received robot-assisted laparoscopy. There were 530 recurrences and 451 deaths reported. The pooled hazard of recurrence or death was 71% higher among patients who underwent minimally invasive radical hysterectomy compared with those who underwent open surgery (hazard ratio [HR], 1.71; 95% CI, 1.36-2.15; P < .001), and the hazard of death was 56% higher (HR, 1.56; 95% CI, 1.16-2.11; P = .004). Heterogeneity of associations was low to moderate. No association was found between the prevalence of robot-assisted surgery and the magnitude of association between minimally invasive radical hysterectomy and hazard of recurrence or death (2.0% increase in the HR for each 10-percentage point increase in prevalence of robot-assisted surgery [95% CI, −3.4% to 7.7%]) or all-cause mortality (3.7% increase in the HR for each 10-percentage point increase in prevalence of robot-assisted surgery [95% CI, −4.5% to 12.6%]).
Conclusions and Relevance
This systematic review and meta-analysis of observational studies found that among patients undergoing radical hysterectomy for early-stage cervical cancer, minimally invasive radical hysterectomy was associated with an elevated risk of recurrence and death compared with open surgery.
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: April 8, 2020.
Corresponding Author: Alexander Melamed, MD, MPH, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University Vagelos College of Physicians and Surgeons, 161 Ft Washington Ave, New York, NY 10032 (email@example.com).
Published Online: June 11, 2020. doi:10.1001/jamaoncol.2020.1694
Author Contributions: Dr Melamed had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Rauh-Hain and Melamed are co–senior authors and contributed equally to this work.
Concept and design: Nitecki, Ramirez, Tergas, Rauh-Hain, Wright, Melamed.
Acquisition, analysis, or interpretation of data: Nitecki, Ramirez, Frumovitz, Krause, Rauh-Hain, Wright, Melamed.
Drafting of the manuscript: Nitecki, Ramirez, Krause, Rauh-Hain, Wright, Melamed.
Critical revision of the manuscript for important intellectual content: Nitecki, Ramirez, Frumovitz, Tergas, Rauh-Hain, Melamed.
Statistical analysis: Nitecki, Rauh-Hain, Wright, Melamed.
Administrative, technical, or material support: Ramirez, Krause, Tergas, Rauh-Hain.
Supervision: Frumovitz, Rauh-Hain, Melamed.
Conflict of Interest Disclosures: Dr Ramirez reported receiving honoraria from Johnson & Johnson and receiving research funding from Pacira. Dr Frumovitz reported receiving grants and personal fees from Stryker, grants from AstraZeneca, and personal fees from Genentech. Dr Wright reported serving as a consultant for Clovis Oncology and Tesaro and receiving research funding from Merck.
Funding/Support: This study was supported by a National Cancer Institute Cancer Center Support Grant (P30 48CA016672), a National Institutes of Health T32 grant (5T32 CA101642) (Dr Nitecki), and a National Institutes of Health K grant (K08CA234333) (Dr Rauh-Hain).
Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: Editorial support was provided by Bryan Tutt, MA, in Scientific Publications Services, Research Medical Library, The University of Texas MD Anderson Cancer Center. He was not compensated for his contributions.
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