Phase II trial of neoadjuvant/adjuvant imatinib mesylate (IM) for advanced primary and metastatic/recurrent operable gastrointestinal stromal tumor (GIST): Early results of RTOG 0132/ACRIN 6665

Background Therapy for gastrointestinal stromal tumors (GIST) has changed significantly with the use of imatinib mesylate (IM). Despite the success of this drug in metastatic GIST, disease progression remains a perplexing clinical issue suggesting the need for multimodality management. There have be...

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Published in:Journal of surgical oncology 2009-01, Vol.99 (1), p.42-47
Main Authors: Eisenberg, Burton L., Harris, Jonathan, Blanke, Charles D., Demetri, George D., Heinrich, Michael C., Watson, James C., Hoffman, John P., Okuno, Scott, Kane, John M., von Mehren, Margaret
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Antineoplastic Agents - administration & dosage
Antineoplastic Agents - adverse effects
Benzamides
Combined Modality Therapy
Female
Gastrointestinal Stromal Tumors - drug therapy
Gastrointestinal Stromal Tumors - pathology
Gastrointestinal Stromal Tumors - secondary
Gastrointestinal Stromal Tumors - surgery
GIST
Humans
Imatinib Mesylate
locally advanced GIST
Male
metastatic GIST
Middle Aged
neoadjuvant imatinib
Piperazines - administration & dosage
Piperazines - adverse effects
Prospective Studies
Pyrimidines - administration & dosage
Pyrimidines - adverse effects
Survival Analysis
Treatment Outcome
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Summary:Background Therapy for gastrointestinal stromal tumors (GIST) has changed significantly with the use of imatinib mesylate (IM). Despite the success of this drug in metastatic GIST, disease progression remains a perplexing clinical issue suggesting the need for multimodality management. There have been no prospective studies either evaluating the neoadjuvant use of IM in primary GIST or as a preoperative cytoreduction agent for metastatic GIST. Methods RTOG 0132/ACRIN 6665 was a prospective phase II study evaluating safety and efficacy of neoadjuvant IM (600 mg/day) for patients with primary GIST or the preop use of IM in patients with operable metastatic GIST. The trial continued postop IM for 2 years. Results Sixty‐three patients were entered (52 analyzable), 30 patients with primary GIST (Group A) and 22 with recurrent metastatic GIST (Group B). Response (RECIST) in Group A was (7% partial, 83% stable, 10% unknown), in Group B (4.5% partial, 91% stable, 4.5% progression). Two‐year progression free survival (Group A 83%, Group B 77%). Estimated overall survival (Group A 93%, Group B 91%). Complications of surgery and IM toxicity were minimal. Conclusion This trial represents the first prospective report of preop IM in GIST. This approach is feasible, requires multidisciplinary consultations, and is not associated with notable postop complications. J. Surg. Oncol. 2009;99:42–47. © 2008 Wiley‐Liss, Inc.
ISSN:0022-4790
1096-9098
DOI:10.1002/jso.21160