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Survival Outcomes Associated With 3 Years vs 1 Year of Adjuvant Imatinib for Patients With High-Risk Gastrointestinal Stromal Tumors

医学 主旨 随机化 内科学 临床终点 甲磺酸伊马替尼 伊马替尼 人口 临床试验 随机对照试验 队列研究 佐剂 队列 外科 间质细胞 环境卫生 髓系白血病
作者
Heikki Joensuu,Mikael Eriksson,Kirsten Sundby Hall,Annette Reichardt,Bárbara Hermes,J. Schütte,Silke Cameron,Peter Hohenberger,Philipp J. Jost,Salah‐Eddin Al‐Batran,Lars H. Lindner,Sebastian Bauer,Eva Wardelmann,Bengt Nilsson,Raija Kallio,Panu Jaakkola,Jouni Junnila,Thor Alvegård,Peter Reichardt
出处
期刊:JAMA Oncology [American Medical Association]
卷期号:6 (8): 1241-1241 被引量:150
标识
DOI:10.1001/jamaoncol.2020.2091
摘要

Importance

Adjuvant imatinib is associated with improved recurrence-free survival (RFS) when administered after surgery to patients with operable gastrointestinal stromal tumor (GIST), but its influence on overall survival (OS) has remained uncertain.

Objective

To evaluate the effect of adjuvant imatinib on OS of patients who have a high estimated risk for GIST recurrence after macroscopically complete surgery.

Design, Setting, and Participants

In this open-label, randomized (1:1), multicenter phase 3 clinical trial conducted in Finland, Germany, Norway, and Sweden, 400 patients who had undergone macroscopically complete surgery for GIST with a high estimated risk for recurrence according to the modified National Institutes of Health Consensus Criteria were enrolled between February 2004 and September 2008. Data for this follow-up analysis were analyzed from September to November, 2019.

Interventions

Imatinib 400 mg/d administered orally for either 12 months or 36 months after surgery.

Main Outcomes And Measures

The primary end point was RFS; the secondary objectives included OS and treatment safety.

Results

The intention-to-treat cohort consisted of 397 patients (12-month group, 199; 36-month group, 198; 201 men and 196 women; median [IQR] age, 62 (51-69) years and 60 (51-67) years, during a median follow-up time of 119 months after the date of randomization, 194 RFS events and 96 OS events were recorded in the intention-to-treat population. Five-year and 10-year RFS was 71.4% and 52.5%, respectively, in the 36-month group and 53.0% and 41.8% in the 12-month group (hazard ratio [HR], 0.66; 95% CI, 0.49-0.87;P = .003). In the 36-month group, 5-year OS and 10-year OS rates were 92.0% and 79.0%, respectively, and in the 12-month group 85.5% and 65.3% (HR, 0.55; 95% CI, 0.37-0.83;P = .004). The results were similar in the efficacy population, from which 15 patients who did not have GIST in central pathology review and 24 patients who had intra-abdominal metastases removed at surgery were excluded (36-month group, 10-year OS 81.6%; 12-month group, 66.8%; HR, 0.50; 95% CI, 0.32-0.80;P = .003). No new safety signals were detected.

Conclusions and Relevance

Three years of adjuvant imatinib is superior in efficacy compared with 1 year of imatinib. Approximately 50% of deaths may be avoided during the first 10 years of follow-up after surgery with longer adjuvant imatinib treatment.

Trial Registration

ClinicalTrials.gov Identifier:NCT00116935
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