Abdollah, Firas

Keeley, Jacob

Menon, Mani

English

Henry Ford Health System Scholarly Commons

Henry Ford Health Henry Ford Health Scholarly Commons Urology Articles Urology 2-21-2019 Minimally Invasive or Abdominal Radical Hysterectomy for Cervical Cancer. Firas Abdollah Henry Ford Health, FABDOLL1@hfhs.org Jacob Keeley Henry Ford Health, JKeeley2@hfhs.org Mani Menon Henry Ford Health, MMENON1@hfhs.org Follow this and additional works at: https://scholarlycommons.henryford.com/urology_articles Recommended Citation Abdollah F, Keeley J, Menon M. Minimally Invasive or Abdominal Radical Hysterectomy for Cervical Cancer.. New England Journal of Medicine 2019; 380(8):793. This Article is brought to you for free and open access by the Urology at Henry Ford Health Scholarly Commons. It has been accepted for inclusion in Urology Articles by an authorized administrator of Henry Ford Health Scholarly Commons. Correspondencen engl j med 380;8 nejm.org February 21, 2019 793We thank Jean Turner for editorial support with the supple-mentary material.1. World Health Organization. WHO publishes list of bacteria for which new antibiotics are urgently needed. February 27, 2017 (http://www .who .int/ mediacentre/ news/ releases/ 2017/ bacteria - antibiotics - needed/ en/ ).2. Hauck C, Cober E, Richter SS, et al. Spectrum of excess mor-tality due to carbapenem-resistant Klebsiella pneumoniae infec-tions. Clin Microbiol Infect 2016; 22: 513-9.3. Guidance for industry: antibacterial therapies for patients with an unmet medical need for the treatment of serious bacte-rial diseases. Silver Spring, MD: Food and Drug Administration, Center for Drug Evaluation and Research, 2013.4. Waikar SS, Bonventre JV. Creatinine kinetics and the defini-tion of acute kidney injury. J Am Soc Nephrol 2009; 20: 672-9.5. Wagenlehner FME, Cloutier DJ, Komirenko AS, et al. Once-daily plazomicin for complicated urinary tract infections. N Engl J Med 2019; 380: 729-40.DOI: 10.1056/NEJMc1807634Minimally Invasive or Abdominal Radical Hysterectomy  for Cervical CancerTo the Editor: In the trial reported by Ramirez et al. (Nov. 15 issue),1 the authors observed lower survival rates among women with early-stage cervical cancer who underwent minimally inva-sive surgery than among those who underwent open surgery. These results suggest that factors such as CO2 gas insufflation might cause early spread of tumor cells, which in turn compromis-es outcomes. Similar findings were observed in the accompanying retrospective study conducted by Melamed et al.2We tested the replicability of these findings in patients with other pelvic cancers, using selec-tion criteria and methods similar to those used by Melamed et al. Our inverse probability of treatment–weighted analysis (involving 3928 pa-tients with data in the National Cancer Database in the period 2010–2011) showed that patients who underwent cystectomy by means of mini-mally invasive surgery had similar 4-year mor-tality as their counterparts who underwent open surgery (45.7% and 45.9%, respectively; P = 0.07). Likewise, our interrupted time-series analysis (with the use of data from the Surveillance, Epi-demiology, and End Results [SEER] 18-registry database for the 2000–2010 period) showed no significant change in trend in 4-year relative survival among patients who underwent cystec-tomy before the adoption of minimally invasive surgery (i.e., in years 2000–2003; −0.3%; 95% confidence interval [CI], −2.5 to 1.2)3 as com-pared with those who underwent surgery after 2003 (1.5%; 95% CI, 0.6 to 2.4) (P = 0.20 for trend). Similar results were observed in patients who underwent prostatectomy (data not shown), which suggests that the findings reported re-garding cervical cancer may not be generalizable to all pelvic cancers.Firas Abdollah, M.D. Jacob Keeley, B.S. Mani Menon, M.D.Henry Ford Health System Detroit, MI firas . abdollah@ gmail . comDr. Abdollah reports receiving consulting fees and advisory fees from GenomeDx Biosciences. No other potential conflict of interest relevant to this letter was reported.1. Ramirez PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med 2018; 379: 1895-904.2. Melamed A, Margul DJ, Chen L, et al. Survival after mini-mally invasive radical hysterectomy for early-stage cervical can-cer. N Engl J Med 2018; 379: 1905-14.3. Leow J, Chung B, Chang S. Trends in surgical approach and outcomes for radical cystectomy: a contemporary population-based analysis. J Urol 2017; 197(4): e725.DOI: 10.1056/NEJMc1816590To the Editor: The unexpected results of the trial conducted by Ramirez et al. have brought a great debate within the academic arena. Under the umbrella of the European Society of Gyneco-logical Oncology (ESGO), we recently conducted a survey entitled “after LACC [Laparoscopic Ap-proach to Cervical Cancer] trial,” which had 400 responses. We found that 83% of the survey re-spondents did not anticipate these trial results. Respondents attributed the outcomes in the min-imally invasive surgery group to several factors, such as a less radical technique than with open surgery, incorrect manipulation, and spread of the tumor because of CO2 gas insufflation. A to-tal of 57% of the ESGO members who responded to the survey have changed their approach to open surgery, and 50% consider minimally inva-sive surgery to be appropriate only for small tu-mors. Almost 90% of the respondents reported that they intend to share this article with every The New England Journal of Medicine Downloaded from nejm.org at HENRY FORD HOSPITAL on December 5, 2019. For personal use only. No other uses without permission.  Copyright © 2019 Massachusetts Medical Society. All rights reserved. T h e  n e w  e ngl a nd  j o u r na l  o f  m e dic i n en engl j med 380;8 nejm.org February 21, 2019794patient, and 75% consider it unethical not to dis-cuss the trial results with surgical candidates.The results of this trial are now on the table, but the final conclusions regarding its effect have to be elucidated. It is time to discover why mini-mally invasive surgery has done so poorly and, if possible, how to improve it.Luis Chiva, M.D., Ph.D.Clinica Universidad de Navarra Madrid, Spain lchiva@ unav . esDavid Cibula, M.D., Ph.D.Charles University Hospital Prague, Czech RepublicDenis Querleu, M.D., Ph.D.Institut Bergonié Cancer Center Bordeaux, FranceNo potential conflict of interest relevant to this letter was re-ported.DOI: 10.1056/NEJMc1816590To the Editor: On the basis of the results of the LACC trial conducted by Ramirez et al. and the National Cancer Database report from Melamed et al., we performed a subanalysis of our recently published results,1 including only the population with the highest risk of recurrence (stages IB1 through IIA1, according to the FIGO [Interna-tional Federation of Gynecology and Obstetrics] 2009 criteria, with tumors measuring 2 to 4 cm in the greatest dimension), and the data are pre-sented here. No uterine manipulators were rou-tinely used. Instead, a vaginal probe was used to delineate the vaginal fornices.Of 111 patients, 57 underwent minimally in-vasive surgery (laparoscopic or robotic) and 54 underwent laparotomy. The rates of lymphovas-cular invasion (46% and 45%, respectively) and positive nodes (16% and 18%) were similar in the two groups. With a median follow-up of 8.6 years, there were no differences between the minimally invasive surgery group and the lapa-rotomy group in rates of recurrence (14% and 17%, respectively; P = 0.69), cancer-specific sur-vival (calculated from the date of surgery to the date of death from cervical cancer or last follow-up; 88% and 87%, P = 0.77), disease-free survival (calculated from the date of surgery to the date of first recurrence or last follow-up in patients without relapse; 86% and 77%, P = 0.34), and overall survival (88% and 78%, P = 0.20).We found similar results for the same sub-group of patients when we used the tumor–node–metastasis classification. Whether the use of a uterine manipulator is a factor for recur-rence remains to be determined.Antonio Gil-Moreno, M.D., Ph.D.Vall d’Hebron Hospital Barcelona, Spain antonioimma@ yahoo . esJavier F. Magrina, M.D.Mayo Clinic Arizona Phoenix, AZNo potential conflict of interest relevant to this letter was re-ported.1. Gil-Moreno A, Carbonell-Socias M, Salicrú S, et al. Radical hysterectomy: efficacy and safety in the dawn of minimally in-vasive techniques. J Minim Invasive Gynecol 2018 June 13 (Epub ahead of print).DOI: 10.1056/NEJMc1816590Drs. Ramirez and Obermair reply: Chiva et al. comment on the ESGO survey that was conduct-ed after the results of our randomized trial were presented at the Society of Gynecologic Oncology meeting in March 2018. It should be highlighted that this survey was conducted before the final publication of our article. Nevertheless, they found on the basis of preliminary data that 57% of the respondents had switched from minimally invasive to open radical hysterectomy. The re-spondents attributed outcomes in the minimally invasive surgery group to less radical technique and incorrect uterine manipulation. In our trial, the open-surgery group and the minimally inva-sive surgery group were balanced for histologic subtype, grade, stage, tumor size, and lymph-node status. In addition, there was no significant difference in parametrial involvement or vaginal margins, which thus argues against inadequate radicality in the minimally invasive surgery group.The survey also pointed to the issue of incor-rect uterine manipulation. Clearly, this is a sub-jective observation and more a commentary than a scientific fact, given that there are no data as to what defines adequate uterine manipulation. Pertaining to tumor dissemination and effect of CO2 gas insufflation on tumor implantation, we agree with this hypothesis1 and discuss it in our article. We are encouraged to learn that 90% of the respondents planned on sharing the results of our trial with patients. It would be interesting The New England Journal of Medicine Downloaded from nejm.org at HENRY FORD HOSPITAL on December 5, 2019. For personal use only. No other uses without permission.  Copyright © 2019 Massachusetts Medical Society. All rights reserved. Correspondencen engl j med 380;8 nejm.org February 21, 2019 795to see results from this same survey being con-ducted after the final publication of the article.In response to Gil-Moreno and Magrina: our prospective, randomized trial was not designed to determine the cause of the inferior outcomes observed in the minimally invasive surgery group. The concept that a uterine manipulator is a po-tential factor that may increase the risk of recur-rence is speculative. The results presented by their group in this correspondence are based on a retrospective comparison of a very small cohort of patients.2 Such comparisons highlight the f laws of retrospective sequential comparisons with limited numbers of patients. The groups that were compared may not be balanced with regard to selection of the patients, risk factors, adjuvant therapy, surveillance strategies, or docu-mentation and confirmation of recurrences. In addition, in retrospective data, the duration of follow-up ought to be evaluated for each group, given that there is usually shorter follow-up in the minimally invasive surgery group than in the open-surgery group, thus leading to a lower like-lihood of time allowed for the manifestation of recurrent events. The reported recurrence rate of 14% in their minimally invasive surgery group far exceeds that of the same approach in our prospective trial (8.4%).Pedro T. Ramirez, M.D.M.D. Anderson Cancer Center Houston, TX peramire@ mdanderson . orgAndreas Obermair, M.D.Queensland Centre for Gynaecological Cancer Research Brisbane, QLD, AustraliaSince publication of their article, the authors report no fur-ther potential conflict of interest.1. Lin F, Pan L, Li L, Li D, Mo L. Effects of a simulated CO2 pneumoperitoneum environment on the proliferation, apoptosis, and metastasis of cervical cancer cells in vitro. Med Sci Monit 2014; 20: 2497-503.2. Gil-Moreno A, Carbonell-Socias M, Salicrú S, et al. Radical hysterectomy: efficacy and safety in the dawn of minimally in-vasive techniques. J Minim Invasive Gynecol 2018 June 13 (Epub ahead of print).DOI: 10.1056/NEJMc1816590Dr. Melamed and coauthors reply: Abdollah and colleagues note that the increased risk of death related to minimally invasive radical hyster-ectomy that was observed in our study may not be generalizable to other operations for pelvic cancers. Two randomized trials have shown the oncologic safety of minimally invasive hysterec-tomy for endometrial carcinoma.1,2 Furthermore, our observational study3 showed that minimally invasive staging surgery for epithelial ovarian cancer was not associated with shorter survival than laparotomy. The safety and effectiveness of minimally invasive surgery must be evaluated in-dependently for specific oncologic indications whenever feasible. Extrapolation of study find-ings across anatomical locations, histologic types, and tumor stages should be undertaken with ex-treme caution.The comments of Gil-Moreno and Magrina present an opportunity to address the limita-tions of small, retrospective studies that com-pare the risk of recurrence and death between minimally invasive surgery and open radical hysterectomy for cervical cancer. With only 111 patients and a recurrence rate of approximately 16%, the progression-free survival estimates re-ported by Gil-Moreno and Magrina are based on no more than 17 recurrences. As such, their study is severely underpowered. Furthermore, the small number of events makes adjustment for multiple confounders challenging. The absence of a sig-nificant difference in rates of recurrence and survival reported by Gil-Moreno and Magrina, and in studies of similar design, is likely to be due to the limitations inherent to the study de-sign. Interpreting these findings as strong evi-dence in support of the safety of minimally in-vasive radical hysterectomy for cervical cancer is imprudent.Alexander Melamed, M.D., M.P.H.Massachusetts General Hospital Boston, MAJason D. Wright, M.D.Columbia University College of Physicians and Surgeons New York, NYJ. Alejandro Rauh-Hain, M.D., M.P.H.M.D. Anderson Cancer Center Houston, TXSince publication of their article, the authors report no fur-ther potential conflict of interest.1. Walker JL, Piedmonte MR, Spirtos NM, et al. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol 2009; 27: 5331-6.2. Janda M, Gebski V, Davies LC, et al. Effect of total laparo-scopic hysterectomy vs total abdominal hysterectomy on disease-free survival among women with stage I endometrial cancer: a randomized clinical trial. JAMA 2017; 317: 1224-33.3. Melamed A, Keating NL, Clemmer JT, et al. Laparoscopic staging for apparent stage I epithelial ovarian cancer. Am J Ob-stet Gynecol 2017; 216(1): 50.e1-50.e12.DOI: 10.1056/NEJMc1816590The New England Journal of Medicine Downloaded from nejm.org at HENRY FORD HOSPITAL on December 5, 2019. For personal use only. No other uses without permission.  Copyright © 2019 Massachusetts Medical Society. All rights reserved. 

Minimally Invasive or Abdominal Radical Hysterectomy for Cervical Cancer.

https://scholarlycommons.henryford.com/cgi/viewcontent.cgi?article=1008&context=urology_articles

Minimally Invasive or Abdominal Radical Hysterectomy for Cervical Cancer.

Abstract

Similar works

Full text

Available Versions

Henry Ford Health System Scholarly Commons