您所在的位置:首頁 > 腫瘤科醫(yī)學進展 > [ASCO2015]OEO5試驗:食管癌新輔助化療周期是否需延長?
2015年ASCO年會于5月29日—6月2日在美國芝加哥召開。5月31日上午的消化系統(tǒng)(非結(jié)直腸)腫瘤口頭報告專場上,來自英國醫(yī)學研究委員會OEO5隨機試驗(ISRCTN 01852072)的研究結(jié)果揭示了可切除食管和交界區(qū)腺癌患者接受新輔助化療的情況。整理如下:
新輔助化療(2個周期順鉑/5-氟尿嘧啶)(CF)序貫手術(shù)治療是局部晚期食管癌的標準治療方案。該項研究探討了增加化療周期數(shù)(4個周期表柔比星/順鉑/卡培他濱(ECX))是否會帶來患者預后的改善。
該項研究是一項多中心隨機III期臨床試驗,將2個周期CF化療與4個周期ECX化療序貫食管切除術(shù)的療效進行比較,其中低位和交界區(qū)腺癌(I型和II型)聯(lián)合了2區(qū)淋巴結(jié)清掃。主要終點是總生存期(OS);預期入組842例患者(677例死亡),預計3年存活率提高至82%(或70%),提升幅度為30%至38%(或37%),檢驗效能為2α=5%.死亡病例累計未達到預期值,但***數(shù)據(jù)監(jiān)測委員會認為該數(shù)據(jù)足夠充分,結(jié)果可以發(fā)布。次要預后包括無病生存期(DFS),無進展生存期(PFS),病理R0切除率,Mandard分級,和生活質(zhì)量。
2005至2011年,英國72個中心入組897例(CF:451例,ECX:446例),按照1:1隨機分配。兩組間的基線特征類似(總體,男性90%,中位年齡62歲[四分位數(shù)間距56-67],60%的PET檢查,分期T3 N0占22%、T3 N1占65%)。CF組96%的患者接受了2個周期化療,ECX組89%的患者接受了3個周期以上化療。
CF組3/4級毒副反應(yīng)的發(fā)生率較低(30% vs 47%,P<0.001)。本研究R0切除率CF組為60%,ECX組為66%;Mandard分級≤3級的發(fā)生率CF組15%,而ECX組可達到32%,其中有3例約11%患者達到完全緩解。兩組術(shù)后并發(fā)癥的發(fā)生率相似(CF:57%,ECX:62%),術(shù)后30天(CF:2%,ECX:2%),術(shù)后90天(CF:4%,ECX:5%)。ECX組在PFS和DFS上更有優(yōu)勢,危險比(HR,95%CI)PFS 0.86(0.74-1.01),DFS 0.88(0.75-1.03)。CF組315例死亡,ECX組298例死亡,兩組OS的HR值為0.92(0.79-1.08,P=0.3017),兩組的3年生存率差異較小CF 39%(35-44%)vs ECX 42%(37-46%)。
通過試驗發(fā)現(xiàn),延長的ECX方案在PFS,DFS和腫瘤消退上有一定優(yōu)勢,但未轉(zhuǎn)化為生存獲益。相比于2個周期CF化療,4個周期ECX化療的總化療毒副反應(yīng)發(fā)生率提高,但手術(shù)并發(fā)癥未見增加。臨床試驗信息:01852072.
閱讀原文摘要
Neoadjuvant chemotherapy for resectable oesophageal and junctional adenocarcinoma: Results from the UK Medical Research Council randomised OEO5 trial (ISRCTN 01852072)。(Abstract 4002)Authors:Derek Alderson, Ruth E Langley,et al.
Session Type:Oral Abstract Session
Background:Neoadjuvant chemotherapy (2 cycles cisplatin/5 fluorouracil) (CF) followed by surgery is a standard of care for locally advanced oesophageal cancer. We investigated whether more chemotherapy (4 cycles epirubicin/cisplatin /capecitabine (ECX)) would improve outcomes.
Methods:A multi-centre, randomised, phase III trial comparing 2 cycles of CF with 4 cycles of ECX followed by oesophagectomy with 2-field lymphadenectomy for lower oesophageal and junctional (Types I and II) adenocarcinoma. Primary outcome was overall survival (OS); 842 patients (677 deaths) would detect an increase in 3-year survival from 30% to 38% (or 37%) with 82% (or 70%) power with 2α = 5%. Deaths accrued more slowly than anticipated but the Independent Data Monitoring Committee considered the data sufficiently robust for release. Secondary outcomes include disease-free (DFS) and progression-free survival (PFS), pathological R0 resection rate, Mandard grade and quality of life.
Results:From 2005-2011, 897 patients (451 CF, 446 ECX) from 72 UK centres were randomly allocated (1:1)。 Baseline characteristics were similar between the groups (overall, male 90%, median age 62 (IQR 56-67), staging included PET 60%, T3 N0 22%, T3 N1 65%)。 96% CF received 2 cycles, 89% ECX > 3 cycles. Grade 3/4 toxicity was lower with CF (30% v 47% p < 0.001.) Of those patients having a resection R0 rates were CF 60%, ECX 66% with a Mandard grade ≤ 3 achieved in CF 15% v ECX 32% with 3 and 11% achieving complete response. Post-operative complications were similar (CF 57%, ECX 62%) as were deaths at 30 (CF 2%, ECX 2%) and 90 days post-surgery (CF 4%, ECX 5%)。 PFS and DFS favoured ECX, hazard ratio (HR, 95% CI) PFS 0.86 (0.74-1.01), DFS 0.88 (0.75-1.03)。 HR for OS was 0.92 (0.79-1.08, p = 0.3017) based on 315 CF and 298 ECX deaths, with similar 3 year survival rates CF 39% (35-44%) vs ECX 42% (37-46%)。
Conclusions:There is some evidence of a benefit from the prolonged ECX regimen, in terms of PFS, DFS and tumour regression at resection, but this does not translate into a survival benefit. Overall chemotherapy toxicity was higher with 4 cycles of ECX compared to 2 cycles of CF but surgical morbidity was not increased. Clinical trial ***rmation: 01852072.
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