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Two-year adjuvant imatinib mesylate after complete resection of localized, high-risk GIST with KIT exon 11 mutation

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An Erratum to this article was published on 13 January 2013

Abstract

Purpose

To evaluate the efficacy and safety of 2-year adjuvant imatinib for patients at high risk of recurrence after complete resection of localized gastrointestinal stromal tumor with KIT exon 11 mutation.

Methods

Imatinib 400 mg/d was administered until disease recurrence, intolerable toxicities, or for 2 years. The primary end point was recurrence-free survival.

Results

Patients (n = 47) from 4 centers in Korea were enrolled. Treatment was well tolerated. Grade 3–4 toxicities included neutropenia (27.7 %), skin rash (8.5 %), anorexia (4.3 %), and constipation (2.1 %). At a median follow-up of 56.7 months, 19 patients had recurrences. Median recurrence-free survival was 58.9 months, which was significantly longer than 22.7 months from historical data of 27 patients in the pre-imatinib era (P < 0.0001). Imatinib was rechallenged for 15 patients with recurrence after completion of adjuvant imatinib. Thirteen patients had partial response, and two had stable disease. There was only one death so far.

Conclusions

Postoperative adjuvant imatinib for 2 years was safe and could prolong the recurrence-free survival in patients with a high risk of recurrence after complete resection of localized KIT exon 11 mutated gastrointestinal stromal tumor. Reintroduction of imatinib after recurrence appears to be effective if the recurrence develops after completion of adjuvant imatinib.

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Acknowledgments

We thank Novartis Korea Ltd. (Seoul, Korea), which provided imatinib mesylate and partial funding for this study. All authors reviewed and approved the paper. Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals. We thank Jinling Wu, MD, PhD, for her medical editorial assistance with this manuscript.

Author information

Author notes

  1. Byung Woog Kang

    Present address: Department of Hematology/Oncology, Kyungpook National University School of Medicine, Kyungpook National University Hospital, 474, Hakjeongdong, Buk-gu, Daegu, 702-210, Korea

  2. Kyung Hae Jung

    Present address: Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 138-736, Korea

Authors and Affiliations

  1. Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 138-736, Korea

    Yoon-Koo Kang, Byung Woog Kang, Jae-Lyun Lee, Heung Moon Chang, Tae Won Kim & Min-Hee Ryu

  2. Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 28 Yongon-Dong, Chongno-Gu, Seoul, 110-744, Korea

    Seock-Ah Im & Do-Youn Oh

  3. Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center, 809 Madu1-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, 411-769, Korea

    Sook Ryun Park

  4. Department of Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Center, 50 Irwon-dong, Kangnam-gu, Seoul, 135-710, Korea

    Won Ki Kang

  5. Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, 809 Madu1-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, 411-769, Korea

    Kyung Hae Jung

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  1. Yoon-Koo Kang
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Correspondence to Yoon-Koo Kang.

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Kang, YK., Kang, B.W., Im, SA. et al. Two-year adjuvant imatinib mesylate after complete resection of localized, high-risk GIST with KIT exon 11 mutation. Cancer Chemother Pharmacol 71, 43–51 (2013). https://doi.org/10.1007/s00280-012-1970-3

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