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Three versus five years of adjuvant Imatinib as treatment for patients with operable gastrointestinal stromal tumour (GIST) with a high risk for recurrence: SSGXXII: A Randomised phase III study

ABSTRACT: Interventions: Following completion of 35-38 months of standard of care Imatinib treatment (defined as 200-800mg daily oral tablet), patients will be enrolled and randomised to receive continued Imatinib oral tablets at 400 mg/day for 24 months, or to receive no further imatinib treatment. Pharmacy teams will monitor returned imatinib packaging to ensure adherence to the oral medication. Primary outcome(s): Recurrence-free survival Defined as the time from the date of randomisation to GIST recurrence or death. Assessed by CT/MRI scans and patient follow-up.[Scans every 6 months for 5 years, then every 12 months to 10 years.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel

DISEASE(S): Cancer-bowel-small Bowel (duodenum And Ileum),Cancer-bowel-anal,Cancer-stomach,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Cancer-oesophageal (gullet),Gastrointestinal Stromal Tumour (gist)

PROVIDER: 2473347 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Background and aims: Liver transplantation (LT) is the most radical treatment for hepatocellular carcinoma (HCC) with high rates of long-term survival, but tumor recurrence after LT is an unresolved problem. The aim of our study was to identify predictive markers for tumor recurrence after liver transplantation. Methods: In a retrospective single-center study, we included all patients with LT for HCC in our institution (01/2007-12/2012). Beside demographic data, we analyzed course, bridging therapies, Serum-AFP, time point of tumor recurrence, as well as the correlation of imaging and histopathology of our recipients. Additionally, we performed a microarray analysis to identify different miRNA profiles of patients with and without HCC recurrence after LT. Single assay stem-loop real-time PCR (Q-RT-PCR) was used for validation of the results. Results: During the study period, we performed 92 LT in patients with HCC (22 women, 70 men). Twenty-two (23.9%) patients developed a recurrent HCC after LT. Our subgroup with tumor recurrence after LT, presented with a mean disease-free survival of 10 months (3-55 months) and an overall survival of 25.5 months (4-77 months). Milan criteria, AFP levels and pathologic grading had an influence on the tumor recurrence. Performing miRNA analysis, we could identify significant upregulation of 8 miRNAs and downregulation of another 5 miRNAs in patients with tumor recurrence. Consecutively, array data were successfully validated using Q-RT-PCR. Multivariate Cox regression, ROC analysis and Kaplan-Meier showed that a score consisting of two miRNAs and Milan criteria are an independent predictor for tumor recurrence-free survival. Conclusions: Despite careful selection of patients, an early recurrence of HCC after LT cannot be avoided completely. Reliable prognostic markers related to tumor biology are still missing. Analysis and validation of specific miRNAs combined with radiological parameters might lead to a promising strategy for the prediction of tumor recurrence, but prospective studies have to follow. 8 macrodissected hepatocellular carcinoma (recurrent HCC) and 10 macrodissected hepatocellular carcinoma (non-recurrent HCC).

Dataset Information

Three versus five years of adjuvant Imatinib as treatment for patients with operable gastrointestinal stromal tumour (GIST) with a high risk for recurrence: SSGXXII: A Randomised phase III study

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