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EORTC 55994

Randomized phase III study comparing neoadjuvant chemotherapy followed by surgery versus chemoradiation in stage IB2-IIB cervical cancer (EORTC-55994)

Phase 3N = 626NCT00039338

Population
FIGO stage IB2-IIB cervical carcinoma
Design
Multicentre randomised phase III trial of the European Organisation for Research and Treatment of Cancer Gynecological Cancer Group, May 2002 to January 2014: neoadjuvant chemotherapy followed by surgery versus standard concomitant chemoradiotherapy. 626 patients were randomised (registry lists 686 as estimated enrolment).
Primary endpoint
OS
Arms
  • Neoadjuvant chemotherapy then surgery (experimental, n = 314): Neoadjuvant chemotherapy followed by surgery
  • Concomitant chemoradiotherapy (control, n = 312): Standard concomitant chemoradiotherapy
People
Kenter GG, European Organisation for Research and Treatment of Cancer Gynecological Cancer Group
Δ 60-month OS−4 points
Show the numbers
Results reported for EORTC 55994
EndpointAnalysisNeoadjuvant chemotherapy then surgeryConcomitant chemoradiotherapyEffect
OSRandomised patients (626); the abstract does not name the analysis populationprimarymedian follow-up 8.7 yearsKenter 202372% at 5 y (66–77%)76% at 5 y (70–80%)The abstract states the 5-year overall survival was not significantly different. Short-term adverse events of grade 3 or higher occurred more often with neoadjuvant chemotherapy plus surgery (41% vs 23%) and long-term adverse events of grade 3 or higher more often with chemoradiotherapy (21% vs 15%). Protocol treatment was completed in 223 of 314 (71%) and 257 of 312 (82%).
Results reported for EORTC 55994
EndpointAnalysisNeoadjuvant chemotherapy then surgeryConcomitant chemoradiotherapyEffect
OSRandomised patients (626); the abstract does not name the analysis populationprimarymedian follow-up 8.7 yearsKenter 202372% at 5 y (66–77%)76% at 5 y (70–80%)The abstract states the 5-year overall survival was not significantly different. Short-term adverse events of grade 3 or higher occurred more often with neoadjuvant chemotherapy plus surgery (41% vs 23%) and long-term adverse events of grade 3 or higher more often with chemoradiotherapy (21% vs 15%). Protocol treatment was completed in 223 of 314 (71%) and 257 of 312 (82%).
Primary publication: Kenter GG, Greggi S, Vergote I, Katsaros D, Kobierski J, van Doorn H, et al. Randomized Phase III Study Comparing Neoadjuvant Chemotherapy Followed by Surgery Versus Chemoradiation in Stage IB2-IIB Cervical Cancer: EORTC-55994. J Clin Oncol. 2023;41(32):5035-5043. PubMedDOI

Appears in

Sources

  1. Kenter GG, Greggi S, Vergote I, Katsaros D, Kobierski J, van Doorn H, et al. Randomized Phase III Study Comparing Neoadjuvant Chemotherapy Followed by Surgery Versus Chemoradiation in Stage IB2-IIB Cervical Cancer: EORTC-55994. J Clin Oncol. 2023;41(32):5035-5043.

    PubMedDOI