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

Burton L. Eisenberg, Jonathan Harris, Charles Blanke, George D. Demetri, Michael Heinrich, James C. Watson, John P. Hoffman, Scott Okuno, John M. Kane, Margaret Von Mehren

    Research output: Contribution to journalArticle

    257 Citations (Scopus)

    Abstract

    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.

    Original languageEnglish (US)
    Pages (from-to)42-47
    Number of pages6
    JournalJournal of Surgical Oncology
    Volume99
    Issue number1
    DOIs
    StatePublished - Jan 1 2009

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    Gastrointestinal Stromal Tumors
    Imatinib Mesylate
    Disease-Free Survival
    Disease Progression
    Referral and Consultation
    Prospective Studies
    Safety
    Survival

    Keywords

    • GIST
    • Locally advanced GIST
    • Metastatic GIST
    • Neoadjuvant imatinib

    ASJC Scopus subject areas

    • Surgery
    • Oncology

    Cite this

    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. / Eisenberg, Burton L.; Harris, Jonathan; Blanke, Charles; Demetri, George D.; Heinrich, Michael; Watson, James C.; Hoffman, John P.; Okuno, Scott; Kane, John M.; Von Mehren, Margaret.

    In: Journal of Surgical Oncology, Vol. 99, No. 1, 01.01.2009, p. 42-47.

    Research output: Contribution to journalArticle

    Eisenberg, Burton L. ; Harris, Jonathan ; Blanke, Charles ; Demetri, George D. ; Heinrich, Michael ; Watson, James C. ; Hoffman, John P. ; Okuno, Scott ; Kane, John M. ; Von Mehren, Margaret. / 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. In: Journal of Surgical Oncology. 2009 ; Vol. 99, No. 1. pp. 42-47.
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    abstract = "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.",
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    T1 - Phase II trial of neoadjuvant/adjuvant imatinib mesylate (IM) for advanced primary and metastatic/recurrent operable gastrointestinal stromal tumor (GIST)

    T2 - Early results of RTOG 0132/ACRIN 6665

    AU - Eisenberg, Burton L.

    AU - Harris, Jonathan

    AU - Blanke, Charles

    AU - Demetri, George D.

    AU - Heinrich, Michael

    AU - Watson, James C.

    AU - Hoffman, John P.

    AU - Okuno, Scott

    AU - Kane, John M.

    AU - Von Mehren, Margaret

    PY - 2009/1/1

    Y1 - 2009/1/1

    N2 - 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.

    AB - 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.

    KW - GIST

    KW - Locally advanced GIST

    KW - Metastatic GIST

    KW - Neoadjuvant imatinib

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