Sarcopenia in Patients With Gastrointestinal Stromal Tumours

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-10-31

Brief Summary

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The treatment of advanced gastrointestinal stromal tumours (GIST) has shifted since the arrival of targeted therapies. Imatinib is an active multikinase inhibitor that mainly targets C-kit tyrosine-kinase receptors and the platelet-derived growth factor receptor. Imatinib use has been validated for adjuvant and palliative therapy settings. Imatinib is generally well-tolerated and known to improve performance status but up to 16% grades 3-4 toxicities, leading to at least 40% withdrawals, have been reported.

Recently, in oncology, sarcopenia was shown to be a predictor of severe toxicity patients included in phase 1 trials, suggesting that it should be considered an inclusion criterion for such studies. Sarcopenic patients had low performance status, shorter survival, more chemotherapy toxicities and post-operative infections, and longer post-operative hospitalization times. In addition, exposure to tyrosine-kinase inhibitors (e.g. sorafenib or sunitinib) has been associated with dose-limiting toxicity (DLT) in patients with renal cell or hepatocellular carcinomas.

Computed tomography (CT) scans acquired during routine care have been validated as an accurate and robust imaging technique to evaluate sarcopenia in cancer patients.

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Detailed Description

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Aims of the study were:

* to assess the influence of imatinib on sarcopenia patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST)
* to compare imatinib-induced toxicities between patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST) with pre-treatment sarcopenia and patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST) without pre-treatment sarcopenia

Conditions

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Gastrointestinal Stromal Tumours

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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gastrointestinal stromal tumours

Patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST) .

Computed tomography

Intervention Type OTHER

Interventions

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Computed tomography

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST)
* Patients treated with imatinib prescribed at a fixed dose of 400 mg/day from 1 January 2005 to 31 December 2013
* Aged \> 18 years