Interpretation and Implications of LACC Trial
- 8 Downloads
LACC trial is a multicentre randomized controlled noninferiority trial. It evaluated the oncological outcomes after minimally invasive surgery and open abdominal radical hysterectomy among women with early-stage cervical cancer. The results showed lower disease-free survival (DFS) and overall survival (OS) in the minimally invasive surgery (MIS) arm.
The results of the LACC trial were surprising and contrary to the outcomes in various other retrospective studies which compared outcomes in MIS and open arms for carcinoma cervix. We write this review article to rebut the LACC trial and point out few shortcomings of the trial. These may explain the outcomes.
The surgeon proficiency criteria for MIS RH in the trial are inadequate. Surgeons were required to submit two unedited operative videos of MIS radical hysterectomy and outcomes of at least ten cases. The routine use of a uterine manipulator causes tumour fragmentation and is against the norms of oncosurgery. Missing histopathological data in almost a third of cases and inadequate follow-up data add to the lacunae. We think the inferior oncological outcomes in MIS arm are not due to MIS per se but due to these factors. Great caution is required in interpreting the results of the LACC trial.
The authors of LACC trial mention that the results cannot be generalized to low-risk patients who still can undergo laparoscopic surgery. We recommend further trials to address the issue of safety of minimal access surgery in the treatment of early-stage carcinoma cervix. MIS radical hysterectomy can still be considered an oncologically safe treatment option in trained hands.
KeywordsLACC trail Lacunae The road ahead
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
- 2.Obermair A, Gebski V, Frumovitz M, Soliman PT, Schmeler KM, Levenback C, Ramirez PT. A phase III randomized clinical trial comparing laparoscopic or robotic radical hysterectomy with abdominal radical hysterectomy in patients with early stage cervical cancer. J Minim Invasive Gynecol. 2008;15(5):584–8.CrossRefGoogle Scholar
- 3.Takeda N, Sakuragi N, Takeda M, Okamoto K, Kuwabara M, Negishi H, Oikawa M, Yamamoto R, Yamada H, Fujimoto S. Multivariate analysis of histopathologic prognostic factors for invasive cervical cancer treated with radical hysterectomy and systematic retroperitoneal lymphadenectomy. Acta Obstet Gynecol Scand. 2002;81(12):1144–51.CrossRefGoogle Scholar
- 18.Chong GO, Park NY, Hong DG, Cho YL, Park IS, Lee YS. Learning curve of laparoscopic radical hysterectomy with pelvic and/or para-aortic lymphadenectomy in the early and locally advanced cervical cancer: comparison of the first 50 and second 50 cases. Int J Gynecol Cancer. 2009;19(8):1459–64.CrossRefGoogle Scholar
- 21.Lim S, Kim HS, Lee KB, Yoo CW, Park SY, Seo SS. Does the use of a uterine manipulator with an intrauterine balloon in total laparoscopic hysterectomy facilitate tumor cell spillage into the peritoneal cavity in patients with endometrial cancer? Int J Gynecol Cancer. 2008;18:1145–9.CrossRefGoogle Scholar
- 25.Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Spiegel G, Barakat R, Pearl ML, Sharma SK. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009;27(32):5331–6.CrossRefGoogle Scholar
- 28.Hillemanns P, Brucker S, Holthaus B, et al. Comment on the LACC trial investigating Early stage Cervical Cancer by the Uterus Commission of the Study Group for Gynecologic Oncology (AGO) and the Study Group for Gynecologic Endoscopy (AGE) of the German Society for Gynecology and Obstetrics (DGGG). Geburtshilfe Frauenheilkd. 2018;78(8):766–7.CrossRefGoogle Scholar