Rachel Kupets1, Gillian M Thomas, Allan Covens. 1. Department of Radiation Oncology, Division of Gynecologic Oncology, University of Toronto, Toronto, Ontario, M5G 2M9, Canada. r.kupets@yahoo.com
Abstract
OBJECTIVE: The purpose of this study is to determine if a survival advantage exists from surgical debulking of enlarged pelvic lymph nodes in advanced cervical cancer. METHODS: Using information from studies published on the topic of debulking lymph nodes in locally advanced cervical cancer along with baseline control rates of standard treatment and patterns of failure, an estimate of how many patients with bulky pelvic lymph node disease would benefit from this procedure was calculated. The design and feasibility of a randomized trial to test this intervention is also discussed. RESULTS: Based on our calculations 1, 2, and 4% of stage IB, IIB, and IIIB patients, respectively, would benefit from a debulking procedure. Based on our calculations with such small differences in survival along with other inclusion and exclusion criteria, a randomized trial, which would compare chemoradiation to chemoradiation and surgery, would require anywhere from 10,000-30,000 patients per arm. CONCLUSIONS: A very small fraction of patients would benefit from a surgical debulking procedure of pelvic nodes. A randomized controlled trial to test this research question is not feasible. A subset population is identified which may benefit from a debulking approach.
RCT Entities:
OBJECTIVE: The purpose of this study is to determine if a survival advantage exists from surgical debulking of enlarged pelvic lymph nodes in advanced cervical cancer. METHODS: Using information from studies published on the topic of debulking lymph nodes in locally advanced cervical cancer along with baseline control rates of standard treatment and patterns of failure, an estimate of how many patients with bulky pelvic lymph node disease would benefit from this procedure was calculated. The design and feasibility of a randomized trial to test this intervention is also discussed. RESULTS: Based on our calculations 1, 2, and 4% of stage IB, IIB, and IIIB patients, respectively, would benefit from a debulking procedure. Based on our calculations with such small differences in survival along with other inclusion and exclusion criteria, a randomized trial, which would compare chemoradiation to chemoradiation and surgery, would require anywhere from 10,000-30,000 patients per arm. CONCLUSIONS: A very small fraction of patients would benefit from a surgical debulking procedure of pelvic nodes. A randomized controlled trial to test this research question is not feasible. A subset population is identified which may benefit from a debulking approach.
Authors: Michael Frumovitz; Pedro T Ramirez; Homer A Macapinlac; Ann H Klopp; Alpa M Nick; Lois M Ramondetta; Anuja Jhingran Journal: Int J Gynecol Cancer Date: 2012-09 Impact factor: 3.437