芬蘭赫爾辛基市赫爾辛基大學(xué)研究人員在3月28日出版的《美國醫(yī)學(xué)會雜志》上發(fā)表的一項研究成果顯示,，在胃腸道間質(zhì)瘤手術(shù)切除后具有復(fù)發(fā)高風(fēng)險的患者中,，那些接受伊馬替尼（治療某些癌癥的一種藥物）達(dá)3年而不是1年時間的患者的無復(fù)發(fā)存活率和總體存活率有所改善。
根據(jù)文章的背景資料：“胃腸道間質(zhì)瘤（GIST）通常被發(fā)現(xiàn)存在于胃或小腸中,，但它可發(fā)生在胃腸道的任何部位,，可它罕見于腹腔內(nèi)的其它部位。GIST的惡性潛質(zhì)可從微觀的胃腸道間質(zhì)瘤到侵略性癌癥不等,。”在手術(shù)后給予12個月的伊馬替尼治療提高了無復(fù)發(fā)存活率（RFS）,，盡管GIST的復(fù)發(fā)在停止治療后的第一年中是常見的；這提示,，為期12個月的給藥可能時間太短,。
芬蘭赫爾辛基市赫爾辛基大學(xué)中心醫(yī)院的Heikki Joensuu, M.D.及其同事對給予那些被認(rèn)為具有GIST復(fù)發(fā)高風(fēng)險的患者輔助性（手術(shù)后）伊馬替尼治療3年以上是否會比治療1年的結(jié)果更好進(jìn)行了檢查。該隨機(jī)化試驗包括了在手術(shù)時切除了KIT（一種基因）陽性GIST的患者,，他們是在2004年2月至2008年9月間加入該項研究的,。有200位病人被分配至一個治療12個月的小組,，有200位病人則被分配到治療36個月的小組；這些病人來自芬蘭,、德國,、挪威和瑞典的24個醫(yī)療中心。病人在手術(shù)后12周內(nèi)開始隨機(jī)性地每日口服400毫克的伊馬替尼,，時間或是12個月或是36個月,。
研究人員發(fā)現(xiàn)，服藥36個月小組中的患者的無復(fù)發(fā)存活時間比服藥12個月小組的患者的無復(fù)發(fā)存活時間更長（5年RFS 為 65.6% vs. 47.9%）,。被分配至服用伊馬替尼36個月的小組中的病人在隨訪期間死亡的人數(shù)比那些服藥12個月小組中的人在隨訪期間的死亡人數(shù)要少（分別為12人 vs. 25人）,，而36個月小組患者的總體存活時間也更長（5年存活率分別為92.0% vs. 81.7%）。
文章的作者還發(fā)現(xiàn),，服藥36個月組的病人與服藥12個月組的病人相比,，前者有較大比例因為與GIST復(fù)發(fā)無關(guān)的原因而停止服用伊馬替尼（分別為51人[25.8%] vs. 25人[12.6%]；其停藥的原因有不良反應(yīng),、病人的偏好,、腫瘤組織學(xué)不是GIST及其它不明的原因）。幾乎所有參與研究的患者至少有一個記錄在案的不良反應(yīng)事件,；大多數(shù)的事件在嚴(yán)重程度上被評為輕度,。
研究人員補充說，對總體存活率的影響是基于一個相當(dāng)小的死亡數(shù)字,，這些參與研究的患者將繼續(xù)被追蹤以確認(rèn)對總體存活率方面的裨益,。由于GIST常常會在停止服用輔助性伊馬替尼后復(fù)發(fā)，因此有必要開展更長時間治療的評估研究,，以及那些使用新的制劑及其組合的研究,。（生物谷 bioon.com）
doi:10.1001/jama.2012.347
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One vs Three Years of Adjuvant Imatinib for Operable Gastrointestinal Stromal Tumor
Heikki Joensuu, MD; Mikael Eriksson, MD; Kirsten Sundby Hall, MD; Jrg T. Hartmann, MD; Daniel Pink, MD; Jochen Schütte, MD; Giuliano Ramadori, MD; Peter Hohenberger, MD; Justus Duyster, MD; Salah-Eddin Al-Batran, MD; Marcus Schlemmer, MD; Sebastian Bauer, MD; Eva Wardelmann, MD; Maarit Sarlomo-Rikala, MD; Bengt Nilsson, MD; Harri Sihto, MSc; Odd R. Monge, MD; Petri Bono, MD; Raija Kallio, MD; Aki Vehtari, DSc; Mika Leinonen, MSc; Thor Alvegrd, MD; Peter Reichardt, MD
Context Adjuvant imatinib administered for 12 months after surgery has improved recurrence-free survival (RFS) of patients with operable gastrointestinal stromal tumor (GIST) compared with placebo. Objective To investigate the role of imatinib administration duration as adjuvant treatment of patients who have a high estimated risk for GIST recurrence after surgery. Design, Setting, and Patients Patients with KIT-positive GIST removed at surgery were entered between February 2004 and September 2008 to this randomized, open-label phase 3 study conducted in 24 hospitals in Finland, Germany, Norway, and Sweden. The risk of GIST recurrence was estimated using the modified National Institutes of Health Consensus Criteria. Intervention Imatinib, 400 mg per day, orally for either 12 months or 36 months, started within 12 weeks of surgery. Main Outcome Measures The primary end point was RFS; the secondary end points included overall survival and treatment safety. Results Two hundred patients were allocated to each group. The median follow-up time after randomization was 54 months in December 2010. Diagnosis of GIST was confirmed in 382 of 397 patients (96%) in the intention-to-treat population at a central pathology review. KIT or PDGFRA mutation was detected in 333 of 366 tumors (91%) available for testing. Patients assigned for 36 months of imatinib had longer RFS compared with those assigned for 12 months (hazard ratio [HR], 0.46; 95% CI, 0.32-0.65; P < .001; 5-year RFS, 65.6% vs 47.9%, respectively) and longer overall survival (HR, 0.45; 95% CI, 0.22-0.89; P = .02; 5-year survival, 92.0% vs 81.7%). Imatinib was generally well tolerated, but 12.6% and 25.8% of patients assigned to the 12- and 36-month groups, respectively, discontinued imatinib for a reason other than GIST recurrence. Conclusion Compared with 12 months of adjuvant imatinib, 36 months of imatinib improved RFS and overall survival of GIST patients with a high risk of GIST recurrence
