PMID- 37656948
OWN - NLM
STAT- MEDLINE
DCOM- 20231109
LR  - 20231109
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 41
IP  - 32
DP  - 2023 Nov 10
TI  - Randomized Phase III Study Comparing Neoadjuvant Chemotherapy Followed by Surgery 
      Versus Chemoradiation in Stage IB2-IIB Cervical Cancer: EORTC-55994.
PG  - 5035-5043
LID - 10.1200/JCO.22.02852 [doi]
AB  - PURPOSE: This multicenter trial by the European Organisation for Research and 
      Treatment of Cancer Gynecological Cancer Group was motivated by conflicting 
      evidence on the value of neoadjuvant chemotherapy before surgery compared with 
      concomitant chemoradiotherapy (CCRT) in stage IB2-IIB cervical carcinoma. 
      METHODS: Between May 2002 and January 2014, 626 patients with International 
      Federation of Gynecology and Obstetrics stage IB2-IIb were randomly assigned 
      between neoadjuvant chemotherapy followed by surgery (NACT-S; n = 314) and 
      standard CCRT (n = 312). The primary end point was 5-year overall survival (OS) 
      rate. Secondary end points were progression-free survival, OS, toxicity, and 
      health-related quality of life (HRQOL). RESULTS: After a median follow-up of 8.7 
      years, 198 patients (31.6%) died. Age, stage, and cell type were balanced in both 
      arms. Protocol treatment was completed in 223 of 314 (71%) patients in NACT-S and 
      257 of 312(82%) in CCRT arms. Main reasons for incomplete protocol treatment were 
      toxicity (30 of 314; 9.6%) and progressive disease (21 of 314; 6.7%) in the 
      NACT-S arm and toxicity (23 of 312; 7.4%) and patient refusal (13 of 312; 4.2%) 
      in the CCRT arm. Additional radiotherapy after completed NACT-S was given to 107 
      patients (48%), and additional surgery to 20 patients (8%) after completed CCRT. 
      Short-term adverse events (AEs) >/=grade 3 occurred more frequently with NACT-S 
      (41% v 23%), and long-term AEs >/=grade 3 more often with CCRT (21% v 15%). The 
      5-year OS was not significantly different between NACT-S (72%; 95% CI, 66 to 77) 
      and CCRT (76%; 95% CI, 70 to 80). CONCLUSION: This trial failed to demonstrate 
      superiority in favor of the NACT-S arm but resulted in acceptable morbidity and 
      HRQOL in both arms.
FAU - Kenter, Gemma G
AU  - Kenter GG
AUID- ORCID: 0000-0002-7284-3918
AD  - Center for Gynaecologic Oncology Amsterdam, Amsterdam University Medical Center, 
      Netherlands Cancer Institute, Amsterdam, the Netherlands.
FAU - Greggi, Stefano
AU  - Greggi S
AD  - Gynaecologic Oncology, Istituto Nazionale Tumori di Napoli IRCCS "Fondazione G. 
      Pascale", Naples, Italy.
FAU - Vergote, Ignace
AU  - Vergote I
AUID- ORCID: 0000-0002-7589-8981
AD  - Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium.
FAU - Katsaros, Dionyssios
AU  - Katsaros D
AD  - Department of Surgical Sciences, AOU Citta della Salute, Gynecologic Oncology, PO 
      SANNA, University of Torino, Torino, Italy.
FAU - Kobierski, Juliusz
AU  - Kobierski J
AD  - Department of Gynecology and Gynecologic Oncology, Medical University of Gdansk, 
      Gdansk, Poland.
FAU - van Doorn, Heleen
AU  - van Doorn H
AUID- ORCID: 0000-0003-1062-4485
AD  - ErasmusMC Cancer Institute, University Medical Center, Rotterdam, the 
      Netherlands.
FAU - Landoni, Fabio
AU  - Landoni F
AD  - Gynecologic Clinic Milano Bicocca University, Ospedale San Gerardo, Monza, Italy.
FAU - van der Velden, Jacobus
AU  - van der Velden J
AUID- ORCID: 0000-0002-5985-1163
AD  - Amsterdam University Medical Center, Amsterdam, the Netherlands.
FAU - Reed, Nicholas
AU  - Reed N
AD  - Medical Oncology, Gartnavel General Hospital, Glasgow, United Kingdom.
FAU - Coens, Corneel
AU  - Coens C
AD  - European Organization on Research and Treatment of Cancer Headquarters, Brussels, 
      Belgium.
FAU - van Luijk, Iske
AU  - van Luijk I
AD  - Haaglanden Medical Center, The Hague, the Netherlands.
FAU - Colombo, Nicoletta
AU  - Colombo N
AUID- ORCID: 0000-0003-2225-715X
AD  - European Institute of Oncology, Milano, Italy.
FAU - Steen-Banasik, Elzbietta van der
AU  - Steen-Banasik EV
AD  - Radiotherapiegroep Arnhem, Amsterdam, the Netherlands.
FAU - Ottevanger, Nelleke
AU  - Ottevanger N
AUID- ORCID: 0000-0001-8209-487X
AD  - Medical Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.
FAU - Casado, Antonio
AU  - Casado A
AD  - Medical Oncology, University Hospital San Carlos, Madrid, Spain.
CN  - EORTC-55994 Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT00039338
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20230901
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
SB  - IM
MH  - Female
MH  - Humans
MH  - *Neoadjuvant Therapy/adverse effects/methods
MH  - *Uterine Cervical Neoplasms/pathology
MH  - Quality of Life
MH  - Chemoradiotherapy/adverse effects/methods
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Neoplasm Staging
MH  - Chemotherapy, Adjuvant/methods
EDAT- 2023/09/01 18:42
MHDA- 2023/11/09 06:42
CRDT- 2023/09/01 16:03
PHST- 2023/11/09 06:42 [medline]
PHST- 2023/09/01 18:42 [pubmed]
PHST- 2023/09/01 16:03 [entrez]
AID - 10.1200/JCO.22.02852 [doi]
PST - ppublish
SO  - J Clin Oncol. 2023 Nov 10;41(32):5035-5043. doi: 10.1200/JCO.22.02852. Epub 2023 
      Sep 1.