A prospective, multicenter, phase 2 study of imatinib mesylate in Korean patients with metastatic or unresectable gastrointestinal stromal tumor

Min Hee Ryu, Won Ki Kang, Yung Jue Bang, Kyung Hee Lee, Dong Bok Shin, Baek Yeol Ryoo, Jae Kyung Roh, Jin Hyoung Kang, Hyoungnam Lee, Tae Won Kim, Heung Moon Chang, Joon Oh Park, Young Suk Park, Taeyou Kim, Min Kyoung Kim, Woon Kee Lee, Hye Jin Kang, Yoon Koo Kang

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Abstract

Objectives: This prospective, multicenter, phase 2 study evaluated the efficacy and safety of imatinib mesylate and assessed KIT and PDGFRA gene mutation status in Korean patients with gastrointestinal stromal tumors (GISTs). Methods: Forty-seven patients with pathologically proven KIT-positive metastatic or unresectable GISTs were accrued from eight institutions in Korea. Imatinib was administered orally at 400 mg once daily. In case of disease progression, the dose was escalated to 600 mg once daily, then 400 mg twice daily. KIT and PDGFRA mutations were analyzed in 29 of the 47 patients. Results: Imatinib produced partial responses in 30 patients (63.8%; 95% confidence interval, 50.1-77.6%) and stable disease in 13 patients (27.7%). The median time to response was 2.6 months (range, 1.0-6.2 months). With a median follow-up of 62 months (range, 32-67 months), 4-year progression-free survival and overall survival rates were 50 and 65%, respectively. The most common adverse events were anemia, neutropenia, edema, and skin rash (predominantly of grade 1-2). There were no treatment-related deaths. In the subset evaluated for mutational status, 24 patients (82.8%) had KIT exon 11 mutations and 1 (3.4%) had a KIT exon 9 mutation. Conclusions: Imatinib is effective and safe in Korean patients with metastatic or unresectable GIST.

Original languageEnglish
Pages (from-to)326-332
Number of pages7
JournalOncology
Volume76
Issue number5
DOIs
StatePublished - 1 Apr 2009

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Gastrointestinal Stromal Tumors
Mutation
Exons
Korea
Imatinib Mesylate
Exanthema
Neutropenia
Disease-Free Survival
Disease Progression
Anemia
Edema
Survival Rate
Confidence Intervals
Safety
Genes

Keywords

  • Gastrointestinal stromal tumor
  • Imatinib
  • KIT

Cite this

Ryu, Min Hee ; Kang, Won Ki ; Bang, Yung Jue ; Lee, Kyung Hee ; Shin, Dong Bok ; Ryoo, Baek Yeol ; Roh, Jae Kyung ; Kang, Jin Hyoung ; Lee, Hyoungnam ; Kim, Tae Won ; Chang, Heung Moon ; Park, Joon Oh ; Park, Young Suk ; Kim, Taeyou ; Kim, Min Kyoung ; Lee, Woon Kee ; Kang, Hye Jin ; Kang, Yoon Koo. / A prospective, multicenter, phase 2 study of imatinib mesylate in Korean patients with metastatic or unresectable gastrointestinal stromal tumor. In: Oncology. 2009 ; Vol. 76, No. 5. pp. 326-332.
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title = "A prospective, multicenter, phase 2 study of imatinib mesylate in Korean patients with metastatic or unresectable gastrointestinal stromal tumor",
abstract = "Objectives: This prospective, multicenter, phase 2 study evaluated the efficacy and safety of imatinib mesylate and assessed KIT and PDGFRA gene mutation status in Korean patients with gastrointestinal stromal tumors (GISTs). Methods: Forty-seven patients with pathologically proven KIT-positive metastatic or unresectable GISTs were accrued from eight institutions in Korea. Imatinib was administered orally at 400 mg once daily. In case of disease progression, the dose was escalated to 600 mg once daily, then 400 mg twice daily. KIT and PDGFRA mutations were analyzed in 29 of the 47 patients. Results: Imatinib produced partial responses in 30 patients (63.8{\%}; 95{\%} confidence interval, 50.1-77.6{\%}) and stable disease in 13 patients (27.7{\%}). The median time to response was 2.6 months (range, 1.0-6.2 months). With a median follow-up of 62 months (range, 32-67 months), 4-year progression-free survival and overall survival rates were 50 and 65{\%}, respectively. The most common adverse events were anemia, neutropenia, edema, and skin rash (predominantly of grade 1-2). There were no treatment-related deaths. In the subset evaluated for mutational status, 24 patients (82.8{\%}) had KIT exon 11 mutations and 1 (3.4{\%}) had a KIT exon 9 mutation. Conclusions: Imatinib is effective and safe in Korean patients with metastatic or unresectable GIST.",
keywords = "Gastrointestinal stromal tumor, Imatinib, KIT",
author = "Ryu, {Min Hee} and Kang, {Won Ki} and Bang, {Yung Jue} and Lee, {Kyung Hee} and Shin, {Dong Bok} and Ryoo, {Baek Yeol} and Roh, {Jae Kyung} and Kang, {Jin Hyoung} and Hyoungnam Lee and Kim, {Tae Won} and Chang, {Heung Moon} and Park, {Joon Oh} and Park, {Young Suk} and Taeyou Kim and Kim, {Min Kyoung} and Lee, {Woon Kee} and Kang, {Hye Jin} and Kang, {Yoon Koo}",
year = "2009",
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Ryu, MH, Kang, WK, Bang, YJ, Lee, KH, Shin, DB, Ryoo, BY, Roh, JK, Kang, JH, Lee, H, Kim, TW, Chang, HM, Park, JO, Park, YS, Kim, T, Kim, MK, Lee, WK, Kang, HJ & Kang, YK 2009, 'A prospective, multicenter, phase 2 study of imatinib mesylate in Korean patients with metastatic or unresectable gastrointestinal stromal tumor', Oncology, vol. 76, no. 5, pp. 326-332. https://doi.org/10.1159/000209384

A prospective, multicenter, phase 2 study of imatinib mesylate in Korean patients with metastatic or unresectable gastrointestinal stromal tumor. / Ryu, Min Hee; Kang, Won Ki; Bang, Yung Jue; Lee, Kyung Hee; Shin, Dong Bok; Ryoo, Baek Yeol; Roh, Jae Kyung; Kang, Jin Hyoung; Lee, Hyoungnam; Kim, Tae Won; Chang, Heung Moon; Park, Joon Oh; Park, Young Suk; Kim, Taeyou; Kim, Min Kyoung; Lee, Woon Kee; Kang, Hye Jin; Kang, Yoon Koo.

In: Oncology, Vol. 76, No. 5, 01.04.2009, p. 326-332.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A prospective, multicenter, phase 2 study of imatinib mesylate in Korean patients with metastatic or unresectable gastrointestinal stromal tumor

AU - Ryu, Min Hee

AU - Kang, Won Ki

AU - Bang, Yung Jue

AU - Lee, Kyung Hee

AU - Shin, Dong Bok

AU - Ryoo, Baek Yeol

AU - Roh, Jae Kyung

AU - Kang, Jin Hyoung

AU - Lee, Hyoungnam

AU - Kim, Tae Won

AU - Chang, Heung Moon

AU - Park, Joon Oh

AU - Park, Young Suk

AU - Kim, Taeyou

AU - Kim, Min Kyoung

AU - Lee, Woon Kee

AU - Kang, Hye Jin

AU - Kang, Yoon Koo

PY - 2009/4/1

Y1 - 2009/4/1

N2 - Objectives: This prospective, multicenter, phase 2 study evaluated the efficacy and safety of imatinib mesylate and assessed KIT and PDGFRA gene mutation status in Korean patients with gastrointestinal stromal tumors (GISTs). Methods: Forty-seven patients with pathologically proven KIT-positive metastatic or unresectable GISTs were accrued from eight institutions in Korea. Imatinib was administered orally at 400 mg once daily. In case of disease progression, the dose was escalated to 600 mg once daily, then 400 mg twice daily. KIT and PDGFRA mutations were analyzed in 29 of the 47 patients. Results: Imatinib produced partial responses in 30 patients (63.8%; 95% confidence interval, 50.1-77.6%) and stable disease in 13 patients (27.7%). The median time to response was 2.6 months (range, 1.0-6.2 months). With a median follow-up of 62 months (range, 32-67 months), 4-year progression-free survival and overall survival rates were 50 and 65%, respectively. The most common adverse events were anemia, neutropenia, edema, and skin rash (predominantly of grade 1-2). There were no treatment-related deaths. In the subset evaluated for mutational status, 24 patients (82.8%) had KIT exon 11 mutations and 1 (3.4%) had a KIT exon 9 mutation. Conclusions: Imatinib is effective and safe in Korean patients with metastatic or unresectable GIST.

AB - Objectives: This prospective, multicenter, phase 2 study evaluated the efficacy and safety of imatinib mesylate and assessed KIT and PDGFRA gene mutation status in Korean patients with gastrointestinal stromal tumors (GISTs). Methods: Forty-seven patients with pathologically proven KIT-positive metastatic or unresectable GISTs were accrued from eight institutions in Korea. Imatinib was administered orally at 400 mg once daily. In case of disease progression, the dose was escalated to 600 mg once daily, then 400 mg twice daily. KIT and PDGFRA mutations were analyzed in 29 of the 47 patients. Results: Imatinib produced partial responses in 30 patients (63.8%; 95% confidence interval, 50.1-77.6%) and stable disease in 13 patients (27.7%). The median time to response was 2.6 months (range, 1.0-6.2 months). With a median follow-up of 62 months (range, 32-67 months), 4-year progression-free survival and overall survival rates were 50 and 65%, respectively. The most common adverse events were anemia, neutropenia, edema, and skin rash (predominantly of grade 1-2). There were no treatment-related deaths. In the subset evaluated for mutational status, 24 patients (82.8%) had KIT exon 11 mutations and 1 (3.4%) had a KIT exon 9 mutation. Conclusions: Imatinib is effective and safe in Korean patients with metastatic or unresectable GIST.

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KW - Imatinib

KW - KIT

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U2 - 10.1159/000209384

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SP - 326

EP - 332

JO - Oncology (Switzerland)

JF - Oncology (Switzerland)

SN - 0030-2414

IS - 5

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