Title |
Adjuvant Imatinib for High-Risk GI Stromal Tumor: Analysis of a Randomized Trial
|
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Published in |
Journal of Clinical Oncology, November 2015
|
DOI | 10.1200/jco.2015.62.9170 |
Pubmed ID | |
Authors |
Heikki Joensuu, Mikael Eriksson, Kirsten Sundby Hall, Annette Reichardt, Jörg T Hartmann, Daniel Pink, Giuliano Ramadori, Peter Hohenberger, Salah-Eddin Al-Batran, Marcus Schlemmer, Sebastian Bauer, Eva Wardelmann, Bengt Nilsson, Harri Sihto, Petri Bono, Raija Kallio, Jouni Junnila, Thor Alvegård, Peter Reichardt |
Abstract |
Three years of adjuvant imatinib therapy are recommended for patients with GI stromal tumor (GIST) with high-risk features, according to survival findings in the Scandinavian Sarcoma Group XVIII/AIO (Arbeitsgemeinschaft Internistische Onkologie) trial. To investigate whether the survival benefits have persisted, we performed the second planned analysis of the trial. Eligible patients had macroscopically completely excised, KIT-positive GIST with a high risk of recurrence, as determined by using the modified National Institutes of Health criteria. After surgery, the patients were randomly assigned to receive imatinib for either 1 or 3 years. The primary objective was recurrence-free survival (RFS), and the secondary objectives included survival. A total of 400 patients were entered onto this open-label study between February 4, 2004, and September 29, 2008. During a median follow-up of 90 months, 171 recurrences and 69 deaths were detected. Patients assigned to the 3-year group had longer RFS than those assigned to the 1- year group; 5-year RFS was 71.1% versus 52.3%, respectively (hazard ratio [HR], 0.60; 95% CI 0.44 to 0.81; P < .001), and survival was 91.9% versus 85.3% (HR, 0.60; 95% CI, 0.37 to 0.97; P = .036). Patients in the 3-year group survived longer in the subset with centrally confirmed GIST and without macroscopic metastases at study entry (93.4% v 86.8%; HR, 0.53; 95% CI, 0.30 to 0.93; P = .024). Similar numbers of cardiac events and second cancers were recorded in the groups. Three years of adjuvant imatinib therapy results in longer survival than 1 year of imatinib. High 5-year survival rates are achievable in patient populations with high-risk GIST. |
X Demographics
Geographical breakdown
Country | Count | As % |
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Spain | 3 | 19% |
United States | 2 | 13% |
United Kingdom | 1 | 6% |
Unknown | 10 | 63% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Practitioners (doctors, other healthcare professionals) | 6 | 38% |
Members of the public | 6 | 38% |
Scientists | 2 | 13% |
Science communicators (journalists, bloggers, editors) | 2 | 13% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Finland | 1 | <1% |
United States | 1 | <1% |
Italy | 1 | <1% |
Germany | 1 | <1% |
Unknown | 125 | 97% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 22 | 17% |
Other | 14 | 11% |
Student > Doctoral Student | 13 | 10% |
Student > Bachelor | 11 | 9% |
Student > Master | 10 | 8% |
Other | 29 | 22% |
Unknown | 30 | 23% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 74 | 57% |
Biochemistry, Genetics and Molecular Biology | 9 | 7% |
Pharmacology, Toxicology and Pharmaceutical Science | 4 | 3% |
Agricultural and Biological Sciences | 3 | 2% |
Nursing and Health Professions | 2 | 2% |
Other | 6 | 5% |
Unknown | 31 | 24% |