RT Journal Article
T1 Quality of Surgery and Outcome in Localized Gastrointestinal Stromal Tumors Treated Within an International Intergroup Randomized Clinical Trial of Adjuvant Imatinib.
A1 Gronchi, Alessandro
A1 Bonvalot, Sylvie
A1 Poveda Velasco, Andres
A1 Kotasek, Dusan
A1 Rutkowski, Piotr
A1 Hohenberger, Peter
A1 Fumagalli, Elena
A1 Judson, Ian R
A1 Italiano, Antoine
A1 Gelderblom, Hans J
A1 van Coevorden, Frits
A1 Penel, Nicolas
A1 Kopp, Hans-Georg
A1 Duffaud, Florence
A1 Goldstein, David
A1 Broto, Javier Martin
A1 Wardelmann, Eva
A1 Marréaud, Sandrine
A1 Smithers, Mark
A1 Le Cesne, Axel
A1 Zaffaroni, Facundo
A1 Litière, Saskia
A1 Blay, Jean-Yves
A1 Casali, Paolo G
AB The association between quality of surgery and overall survival in patients affected by localized gastrointestinal stromal tumors (GIST) is not completely understood. To assess the risk of death with and without imatinib according to microscopic margins status (R0/R1) using data from a randomized study on adjuvant imatinib. This is a post hoc observational study on patients included in the randomized, open-label, phase III trial, performed between December 2004 and October 2008. Median follow-up was 9.1 years (IQR, 8-10 years). The study was performed at 112 hospitals in 12 countries. Inclusion criteria were diagnosis of primary GIST, with intermediate or high risk of relapse; no evidence of residual disease after surgery; older than 18 years; and no prior malignancies or concurrent severe/uncontrolled medical conditions. Data were analyzed between July 17, 2017, and March 1, 2020. Patients were randomized after surgery to either receive imatinib (400 mg/d) for 2 years or no adjuvant treatment. Randomization was stratified by center, risk category (high vs intermediate), tumor site (gastric vs other), and quality of surgery (R0 vs R1). Tumor rupture was included in the R1 category but also analyzed separately. Primary end point of this substudy was overall survival (OS), estimated using Kaplan-Meier method and compared between R0/R1 using Cox models adjusted for treatment and stratification factors. A total of 908 patients were included; 51.4% were men (465) and 48.6% were women (440), and the median age was 59 years (range, 18-89 years). One hundred sixty-two (17.8%) had an R1 resection, and 97 of 162 (59.9%) had tumor rupture. There was a significant difference in OS for patients undergoing an R1 vs R0 resection, overall (hazard ratio [HR], 2.05; 95% CI, 1.45-2.89) and by treatment arm (HR, 2.65; 95% CI, 1.37-3.75 with adjuvant imatinib and HR, 1.86; 95% CI, 1.16-2.99 without adjuvant imatinib). When tumor rupture was excluded, this difference in OS between R1 and R0 resections disappeared (HR, 1.05; 95% CI, 0.54-2.01). The difference in OS by quality of surgery with or without imatinib was associated with the presence of tumor rupture. When the latter was excluded, the presence of R1 margins was not associated with worse OS. ClinicalTrials.gov Identifier: NCT00103168.
YR 2020
FD 2020-06-17
LK http://hdl.handle.net/10668/15307
UL http://hdl.handle.net/10668/15307
LA en
DS RISalud
RD Apr 17, 2025