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Efficacy and safety profile of imatinib mesylate (ST1571) in Japanese patients with advanced gastrointestinal stromal tumors: a phase II study (STI571B1202)

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Abstract

Background

Imatinib mesylate, an inhibitor of KIT, ABL protein, and platelet-derived growth factor receptor α (PDGFRα) tyrosine kinase, has recently been found to have a dramatic antitumor effect on gastrointestinal stromal tumor (GIST). The aim of this study was to assess the efficacy and safety of imatinib mesylate in Japanese patients with advanced GIST.

Methods

Patients with measurable lesions were enrolled between April 1, 2002, and September 20, 2002, using a design based on previous phase II studies in the United States and the European Union. The diagnosis of GIST was proven histologically with positive immunostaining for KIT (CD117). Imatinib mesylate was administered at a dose of either 400 mg or 600 mg once a day. Pharmacokinetic parameters and mutation analysis of c-kit were also assessed in a subgroup of patients.

Results

A total of 74 patients (28 receiving imatinib mesylate at 400 mg/day; 46 receiving 600 mg/day); median age, 56.0 years, were enrolled. No patient had a complete response, 51 patients (69%) had a partial response, and 19 patients (26%) had stable disease. The median progression-free survival time was 96 weeks. The estimated 3-year overall survival (Kaplan-Meier) rate for all patients was 73.6%. The most frequent adverse effects related to the drug were nausea (78%), diarrhea (70%), dermatitis (62%), facial edema (61%), edema of the lower limbs (58%), vomiting (54%), and eyelid edema (51%). Most of the adverse effects were mild and manageable.

Conclusion

Imatinib mesylate is generally safe and has significant activity in the treatment of advanced GIST in Japanese patients.

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Authors and Affiliations

  1. Department of Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan

    Toshirou Nishida

  2. Department of Medical Oncology, National Cancer Center Hospital, Tokyo, Japan

    Kuniaki Shirao

  3. Department of Gastroenterology, Aichi Cancer Center Hospital, Aichi, Japan

    Akira Sawaki

  4. Department of Surgery, National Hospital Organization Kure Medical Center, Hiroshima, Japan

    Masato Koseki

  5. Department of Gastroenterological Surgery, National Kyushu Cancer Center, Fukuoka, Japan

    Takeshi Okamura

  6. Division of Gastrointestinal Oncology/Digestive Endoscopy, National Cancer Center Hospital East, Chiba, Japan

    Atsushi Ohtsu

  7. Department of Gastroenterology, Hokkaido University Graduate School of Medicine, Hokkaido, Japan

    Toshiro Sugiyama

  8. Diagnostic Radiology Division, National Cancer Center Hospital, Tokyo, Japan

    Kunihisa Miyakawa

  9. Department of Surgical Pathology, Hyogo College of Medicine, Hyogo, Japan

    Seiichi Hirota

Authors
  1. Toshirou Nishida
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  2. Kuniaki Shirao
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  3. Akira Sawaki
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  4. Masato Koseki
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  5. Takeshi Okamura
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  6. Atsushi Ohtsu
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  7. Toshiro Sugiyama
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  8. Kunihisa Miyakawa
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  9. Seiichi Hirota
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Corresponding author

Correspondence to Toshirou Nishida.

Additional information

Japanese Study Group on GIST

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Nishida, T., Shirao, K., Sawaki, A. et al. Efficacy and safety profile of imatinib mesylate (ST1571) in Japanese patients with advanced gastrointestinal stromal tumors: a phase II study (STI571B1202). Int J Clin Oncol 13, 244–251 (2008). https://doi.org/10.1007/s10147-007-0746-y

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  • DOI: https://doi.org/10.1007/s10147-007-0746-y

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