CAJ | 학술논문

目的评估延长伊马替尼辅助治疗时间对中高度复发风险胃肠间质瘤(GIST)患者无复发生存率与安全性的影响.方法回顾性分析北京大学肿瘤医院消化肿瘤内科自2004年3月至2009年5月接受伊马替尼辅助治疗、且随访时间均在3年以上的101例中高度复发风险GIST患者的临床和随访资料.伊马替尼治疗情况:3例因不良反应服药不足1年后停药:24例服药1年后停药;21例患者服药2年后停药:18例患者服药3年后停药;8例患者服药3年余仍继续治疗中;27例患者服药超过4年.结果中位随访时间60个月(95％CI:57.9～62.1个月),19例患者出现肿瘤复发,其中5例于辅助治疗过程中出现复发,14例为终止辅助治疗后出现复发.伊马替尼停药至肿瘤复发的中位时间为12.0个月(95％CI:9.6～14.4个月),再次给予伊马替尼治疗均获得肿瘤控制.53例辅助治疗时间3年或3年以上者5年无复发生存率为93.9％,明显优于不足3年的48例患者(68.0％,P＜0.01).其中,3年以上者与3年者5年无复发生存率分别为97.1％和86.6％,差异无统计学意义(P＞0.05).除乏力发生率有所增加外,辅助治疗时间3年以上者总体不良反应发生率并未明显增加(P＞0.05).结论延长伊马替尼辅助治疗时间超过3年有望进一步延长中高度复发风险GIST术后的无复发生存期,且其不良反应并未显著增多.
목적 평고연장이마체니보조치료시간대중고도복발풍험위장간질류(GIST)환자무복발생존솔여안전성적영향.방법 회고성분석북경대학종류의원소화종류내과자2004년3월지2009년5월접수이마체니보조치료、차수방시간균재3년이상적101례중고도복발풍험GIST환자적림상화수방자료.이마체니치료정황:3례인불량반응복약불족1년후정약:24례복약1년후정약;21례환자복약2년후정약:18례환자복약3년후정약;8례환자복약3년여잉계속치료중;27례환자복약초과4년.결과 중위수방시간60개월(95％CI:57.9～62.1개월),19례환자출현종류복발,기중5례우보조치료과정중출현복발,14례위종지보조치료후출현복발.이마체니정약지종류복발적중위시간위12.0개월(95％CI:9.6～14.4개월),재차급여이마체니치료균획득종류공제.53례보조치료시간3년혹3년이상자5년무복발생존솔위93.9％,명현우우불족3년적48례환자(68.0％,P＜0.01).기중,3년이상자여3년자5년무복발생존솔분별위97.1％화86.6％,차이무통계학의의(P＞0.05).제핍력발생솔유소증가외,보조치료시간3년이상자총체불량반응발생솔병미명현증가(P＞0.05).결론 연장이마체니보조치료시간초과3년유망진일보연장중고도복발풍험GIST술후적무복발생존기,차기불량반응병미현저증다.
Objective To evaluate the recurrence-free survival (RFS) and safety of imatinib adjuvant therapy with longer treatment duration in patients undergoing complete resection of localized primary gastrointestinal stromal tumor (GIST).Methods Clinical and follow-up data of 101 GIST patients between March 2004 and May 2009 with intermediate or high recurrence risk receiving imatinib adjuvant treatment and more than 3 years follow-up time in Peking University Cancer Hospital were retrospectively analyzed.Imatinib adjuvant treatment:3 patients discontinued less than 1 year imatinib treatment because of adverse events; 24,21 and 18 patients discontinued imatinib after 1 year,2 years,and 3 years treatment; 8 patients received 3 years adjuvant treatment and were ongoing; 27 patients received more than 4 years imatinib adjuvant treatment.Results The median follow-up time was 60 months (95％CI:57.9-62.1).Nineteen patients had GIST recurrence,of whom recurrence happened during imatinib adjuvant therapy in 5 patients and after imatinib treatment in 14 patients.The median period from imatinib stopping to recurrence was 12.0 months (95％CI:9.6-14.4).Patients with recurrent GIST achieved tumor control after imatinib resumption.RFS of patients (n=53) with ≥ 3 years imatinib treatment duration was higher than that of patients(n=48) with ＜3 years imatinib duration (93.9％ vs.68.0％,P＜0.01).In addition,prolonged adjuvant imatinib duration did not significantly increase the adverse events related to treatment (P＞0.05).Conclusions Prolonged adjuvant imatinib duration may further improve RFS rate further in patients with intermediate or high risk of recurrence after complete tumor resection without increased adverse events.