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Cited by 980

The DOI matches its Crossref record; 22 of the 22 references it cites were found in a registry or an index.

One vs Three Years of Adjuvant Imatinib for Operable Gastrointestinal Stromal Tumor: A Randomized Trial

Joensuu, Heikki, Eriksson, Mikael, Sundby Hall, Kirsten, Hartmann, Jörg T., Pink, Daniel, Schütte, Jochen, Ramadori, Giuliano, Hohenberger, Peter, Duyster, Justus, Al-Batran, Salah-Eddin, Schlemmer, Marcus, Bauer, Sebastian, Wardelmann, Eva, Sarlomo-Rikala, Maarit, Nilsson, Bengt, Sihto, Harri, Monge, Odd R., Bono, Petri, Kallio, Raija, Vehtari, Aki, Leinonen, Mika, Alvegård, Thor, Reichardt, Peter·2012·JAMA

Abstract

CONTEXT: Adjuvant imatinib administered for 12 months after surgery has improved recurrence-free survival (RFS) of patients with operable gastrointestinal stromal tumor (GIST) compared with placebo. OBJECTIVE: To investigate the role of imatinib administration duration as adjuvant treatment of patients who have a high estimated risk for GIST recurrence after surgery. DESIGN, SETTING, AND PATIENTS: Patients with KIT-positive GIST removed at surgery were entered between February 2004 and September 2008 to this randomized, open-label phase 3 study conducted in 24 hospitals in Finland, Germany, Norway, and Sweden. The risk of GIST recurrence was estimated using the modified National Institutes of Health Consensus Criteria. INTERVENTION: Imatinib, 400 mg per day, orally for either 12 months or 36 months, started within 12 weeks of surgery. MAIN OUTCOME MEASURES: The primary end point was RFS; the secondary end points included overall survival and treatment safety. RESULTS: Two hundred patients were allocated to each group. The median follow-up time after randomization was 54 months in December 2010. Diagnosis of GIST was confirmed in 382 of 397 patients (96%) in the intention-to-treat population at a central pathology review. KIT or PDGFRA mutation was detected in 333 of 366 tumors (91%) available for testing. Patients assigned for 36 months of imatinib had longer RFS compared with those assigned for 12 months (hazard ratio [HR], 0.46; 95% CI, 0.32-0.65; P < .001; 5-year RFS, 65.6% vs 47.9%, respectively) and longer overall survival (HR, 0.45; 95% CI, 0.22-0.89; P = .02; 5-year survival, 92.0% vs 81.7%). Imatinib was generally well tolerated, but 12.6% and 25.8% of patients assigned to the 12- and 36-month groups, respectively, discontinued imatinib for a reason other than GIST recurrence. CONCLUSION: Compared with 12 months of adjuvant imatinib, 36 months of imatinib improved RFS and overall survival of GIST patients with a high risk of GIST recurrence. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00116935.

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Metadata

Authors
Joensuu, H., Eriksson, M., Sundby Hall, K., Hartmann, J. T., Pink, D., Schütte, J., Ramadori, G., Hohenberger, P., Duyster, J., Al-Batran, S.-E., Schlemmer, M., Bauer, S., Wardelmann, E., Sarlomo-Rikala, M., Nilsson, B., Sihto, H., Monge, O. R., Bono, P., Kallio, R., Vehtari, A., Leinonen, M., Alvegård, T., & Reichardt, P.
Venue
JAMA
Published
2012-03-28
Volume
307
Issue
12
Pages
1265
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
OpenAlex
W1970687736
Cited by
980
References
22
FWCI
93.61
Type
journal article
Language
en
Open access
closed

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Joensuu, H., Eriksson, M., Sundby Hall, K., Hartmann, J. T., Pink, D., Schütte, J., Ramadori, G., Hohenberger, P., Duyster, J., Al-Batran, S.-E., Schlemmer, M., Bauer, S., Wardelmann, E., Sarlomo-Rikala, M., Nilsson, B., Sihto, H., Monge, O. R., Bono, P., Kallio, R., . . . Reichardt, P. (2012). One vs Three Years of Adjuvant Imatinib for Operable Gastrointestinal Stromal Tumor: A Randomized Trial. JAMA. https://doi.org/10.1001/jama.2012.347

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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