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Preoperative radiotherapy plus surgery versus surgery alone for patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicentre, open-label, randomised, phase 3 trial

Authors :
Sandrine Marreaud
Hans Gelderblom
Pierre Meeus
Marco Rastrelli
Antonino De Paoli
Claudia Sangalli
Alessandro Gronchi
Elizabeth H. Baldini
Piotr Rutkowski
Jean-Yves Blay
Chandrajit P. Raut
Frits van Coevorden
Charles Honoré
Marco Fiore
Aisha Miah
Rick L. Haas
Angelo Paolo Dei Tos
Carol Jane Swallow
Dirk C. Strauss
Daphne Hompes
Eberhard Stoeckle
Sylvie Bonvalot
Cécile Le Péchoux
Jean Jacques Stelmes
Saskia Litière
Peter Chung
Stephan Stoldt
Université Paris sciences et lettres (PSL)
Fondazione Ospedale San Camillo [Venezia] (IRCCS)
Département d'hématologie [Gustave Roussy]
Institut Gustave Roussy (IGR)
Département de radiothérapie [Gustave Roussy]
Princess Margaret Hospital
University of Toronto
Centre Léon Bérard [Lyon]
Netherlands Cancer Institute (NKI)
Antoni van Leeuwenhoek Hospital
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology (MCMCC)
Veneto Institute of Oncology IOV-IRCCS [Padua, Italy]
Dana-Farber Cancer Institute [Boston]
Harvard Medical School [Boston] (HMS)
Centro San Giovanni di Dio, Fatebenefratelli, Brescia (IRCCS)
Università degli Studi di Brescia [Brescia]
European Organisation for Research and Treatment of Cancer [Bruxelles] (EORTC)
European Cancer Organisation [Bruxelles] (ECCO)
Leiden University Medical Center (LUMC)
Source :
The Lancet Oncology, 21(10), 1366-1377. ELSEVIER SCIENCE INC, Lancet Oncology, Lancet Oncology, Elsevier, 2020, 21, pp.1366-1377. ⟨10.1016/S1470-2045(20)30446-0⟩
Publication Year :
2020

Abstract

Summary Background Unlike for extremity sarcomas, the efficacy of radiotherapy for retroperitoneal sarcoma is not established. The aim of this study was to evaluate the impact of preoperative radiotherapy plus surgery versus surgery alone on abdominal recurrence-free survival. Methods EORTC-62092 is an open-label, randomised, phase 3 study done in 31 research institutions, hospitals, and cancer centres in 13 countries in Europe and North America. Adults (aged ≥18 years) with histologically documented, localised, primary retroperitoneal sarcoma that was operable and suitable for radiotherapy, who had not been previously treated and had a WHO performance status and American Society of Anesthesiologists score of 2 or lower, were centrally randomly assigned (1:1), using an interactive web response system and a minimisation algorithm, to receive either surgery alone or preoperative radiotherapy followed by surgery. Randomisation was stratified by hospital and performance status. Radiotherapy was delivered as 50·4 Gy (in 28 daily fractions of 1·8 Gy) in either 3D conformal radiotherapy or intensity modulated radiotherapy, and the objective of surgery was a macroscopically complete resection of the tumour mass with en-bloc organ resection as necessary. The primary endpoint was abdominal recurrence-free survival, as assessed by the investigator, and was analysed in the intention-to-treat population. Safety was analysed in all patients who started their allocated treatment. This trial is registered with ClinicalTrials.gov , NCT01344018 . Findings Between Jan 18, 2012 and April 10, 2017, 266 patients were enrolled, of whom 133 were randomly assigned to each group. The median follow-up was 43·1 months (IQR 28·8–59·2). 128 (96%) patients from the surgery alone group had surgery, and 119 (89%) patients in the radiotherapy and surgery group had both radiotherapy and surgery. Median abdominal recurrence-free survival was 4·5 years (95% CI 3·9 to not estimable) in the radiotherapy plus surgery group and 5·0 years (3·4 to not estimable) in the surgery only group (hazard ratio 1·01, 95% CI 0·71–1·44; log rank p=0·95). The most common grade 3–4 adverse events were lymphopenia (98 [77%] of 127 patients in the radiotherapy plus surgery group vs one [1%] of 128 patients in the surgery alone group), anaemia (15 [12%] vs ten [8%]), and hypoalbuminaemia (15 [12%] vs five [4%]). Serious adverse events were reported in 30 (24%) of 127 patients in the radiotherapy plus surgery group, and in 13 (10%) of 128 patients in the surgery alone group. One (1%) of 127 patients in the radiotherapy plus surgery group died due to treatment-related serious adverse events (gastropleural fistula), and no patients in the surgery alone group died due to treatment-related serious adverse events. Interpretation Preoperative radiotherapy should not be considered as standard of care treatment for retroperitoneal sarcoma. Funding European Organisation for Research and Treatment of Cancer, and European Clinical Trials in Rare Sarcomas.

Details

Language :
English
ISSN :
14702045
Database :
OpenAIRE
Journal :
The Lancet Oncology, 21(10), 1366-1377. ELSEVIER SCIENCE INC, Lancet Oncology, Lancet Oncology, Elsevier, 2020, 21, pp.1366-1377. ⟨10.1016/S1470-2045(20)30446-0⟩
Accession number :
edsair.doi.dedup.....062d350f81873fe8d57350264abeb5c4
Full Text :
https://doi.org/10.1016/S1470-2045(20)30446-0⟩