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What is the appropriate duration of adjuvant imatinib mesylate treatment for primary gastrointestinal stromal tumors classified according to the strict definition of tumor rupture?

ABSTRACT: In gastrointestinal stromal tumors (GISTs), rupture is a high-risk feature; however, "tumor rupture" is inconsistently defined, and its prognostic value remains controversial.Six hundred ninety-one patients undergoing surgery for primary nonmetastatic GISTs from 2003 to 2015 at our institution were enrolled. The strict definitions of "tumor rupture" according to the Kinki GIST Study Group (KGSG) were used.The median follow-up time was 64 months. The 5-year recurrence-free survival (RFS) and overall survival (OS) rates in the entire group were 79.3% and 84.1%, respectively. According to the KGSG's definition, tumor rupture occurred only in 24 (3.5%) of 691 patients. For all 691 patients, multivariable analysis showed that tumor rupture, according to KGSG's definition, is one of the independently prognostic factors for both RFS and OS. Twenty-four patients with tumor rupture were further analyzed. Receiving IM for more than 3 years was significantly associated with improved RFS and OS in GISTs patients with tumor rupture.Tumor rupture according to KGSG's definition was an independent predictive factor associated with GIST patient prognosis. More importantly, for GISTs with tumor rupture according to the KGSG's strict definition, receiving IM treatment for ≥3 years should be considered.

SUBMITTER: Lu J

PROVIDER: S-EPMC6370173 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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What is the appropriate duration of adjuvant imatinib mesylate treatment for primary gastrointestinal stromal tumors classified according to the strict definition of tumor rupture?

Lu Jun J Dai Yun Y Zheng Hua-Long HL Xie Jian-Wei JW Wang Jia-Bin JB Lin Jian-Xian JX Chen Qi-Yue QY Cao Long-Long LL Lin Mi M Tu Ru-Hong RH Huang Ze-Ning ZN Lin Ju-Li JL Li Ping P Huang Chang-Ming CM Zheng Chao-Hui CH

Medicine 20190101 3

In gastrointestinal stromal tumors (GISTs), rupture is a high-risk feature; however, "tumor rupture" is inconsistently defined, and its prognostic value remains controversial.Six hundred ninety-one patients undergoing surgery for primary nonmetastatic GISTs from 2003 to 2015 at our institution were enrolled. The strict definitions of "tumor rupture" according to the Kinki GIST Study Group (KGSG) were used.The median follow-up time was 64 months. The 5-year recurrence-free survival (RFS) and over ...[more]

PMID: 30653164

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Project description:BackgroundGastrointestinal stromal tumour is the most common sarcoma of the intestinal tract. Imatinib mesylate is a small molecule that inhibits activation of the KIT and platelet-derived growth factor receptor alpha proteins, and is effective in first-line treatment of metastatic gastrointestinal stromal tumour. We postulated that adjuvant treatment with imatinib would improve recurrence-free survival compared with placebo after resection of localised, primary gastrointestinal stromal tumour.MethodsWe undertook a randomised phase III, double-blind, placebo-controlled, multicentre trial. Eligible patients had complete gross resection of a primary gastrointestinal stromal tumour at least 3 cm in size and positive for the KIT protein by immunohistochemistry. Patients were randomly assigned, by a stratified biased coin design, to imatinib 400 mg (n=359) or to placebo (n=354) daily for 1 year after surgical resection. Patients and investigators were blinded to the treatment group. Patients assigned to placebo were eligible to crossover to imatinib treatment in the event of tumour recurrence. The primary endpoint was recurrence-free survival, and analysis was by intention to treat. Accrual was stopped early because the trial results crossed the interim analysis efficacy boundary for recurrence-free survival. This study is registered with ClinicalTrials.gov, number NCT00041197.FindingsAll randomised patients were included in the analysis. At median follow-up of 19.7 months (minimum-maximum 0-56.4), 30 (8%) patients in the imatinib group and 70 (20%) in the placebo group had had tumour recurrence or had died. Imatinib significantly improved recurrence-free survival compared with placebo (98% [95% CI 96-100] vs 83% [78-88] at 1 year; hazard ratio [HR] 0.35 [0.22-0.53]; one-sided p<0.0001). Adjuvant imatinib was well tolerated, with the most common serious events being dermatitis (11 [3%] vs 0), abdominal pain (12 [3%] vs six [1%]), and diarrhoea (ten [2%] vs five [1%]) in the imatinib group and hyperglycaemia (two [<1%] vs seven [2%]) in the placebo group.InterpretationAdjuvant imatinib therapy is safe and seems to improve recurrence-free survival compared with placebo after the resection of primary gastrointestinal stromal tumour.FundingUS National Institutes of Health and Novartis Pharmaceuticals.

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What is the appropriate duration of adjuvant imatinib mesylate treatment for primary gastrointestinal stromal tumors classified according to the strict definition of tumor rupture?

Publications

What is the appropriate duration of adjuvant imatinib mesylate treatment for primary gastrointestinal stromal tumors classified according to the strict definition of tumor rupture?

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