Erschienen in:
01.01.2013 | Original Article
Two-year adjuvant imatinib mesylate after complete resection of localized, high-risk GIST with KIT exon 11 mutation
verfasst von:
Yoon-Koo Kang, Byung Woog Kang, Seock-Ah Im, Jae-Lyun Lee, Sook Ryun Park, Won Ki Kang, Heung Moon Chang, Tae Won Kim, Do-Youn Oh, Kyung Hae Jung, Min-Hee Ryu
Erschienen in:
Cancer Chemotherapy and Pharmacology
|
Ausgabe 1/2013
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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.