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2016年6月3-7日,一年一度的美国临床肿瘤学会(American Society of Clinical Oncology,ASCO)年会在芝加哥举办。6月4日上午的消化系统(非结直肠)肿瘤壁报专场上,复旦大学附属中山医院的王研教授呈现了一项摘要号为4047的中国研究,该研究在最初不能手术切除的局部晚期胃腺癌患者中比较了术前化疗方案卡培他滨+奥沙利铂(XELOX)或者联合表柔比星的疗效,医脉通整理如下:
对于最初不能手术切除的局部晚期胃癌来说,术前化疗被认为可以缩减根治性切除时的肿瘤,同时延长生存期,但是目前没有最佳的推荐方案。研究人员将EOX(卡培他滨,奥沙利铂和表柔比星)与XELOX(卡培他滨和奥沙利铂)作为最初不能手术切除局部晚期胃癌的术前化疗方案,并对它们的疗效性进行比较评估。
这是一项前瞻性观察研究。该试验在Clinical Trials.gov(NCT02192983)登记注册。不能切除的局部晚期胃癌患者由研究人员决定是接受EOX方案还是XELOX方案。他们每2个周期接受CT(计算机断层扫描)扫描以评估治疗回应情况。在4个周期后,由一个多学科小组重新评估可切除性。如果病变变为可切除,根治性手术将在最后治疗周期后的4-6周内开展。主要终点是回应率。次要终点包括R0切除率,生存期和不良事件。
从2008年11月到2015年5月,242例患者被入组;其中112例被分配给EOX方案,130例分配接受XELOX方案。在EOX组和XELOX组的回应率分别为33.0%和33.8%(P=0.997)。4个周期的化疗后,EOX组有63例(56.3%)患者,XELOX组的81例(62.3%)患者接受了根治性手术(P=0.408)。在这两组之间,无进展生存期(PFS,12.0个月 vs 15.4个月,P=0.925)和总生存期(OS,25.7个月 vs 29.0个月,P=0.783)没有显著差异。此外,EOX组会发生更多的不良反应,例如白细胞减少(22.3% vs 10.0%,P=0.014),中性粒细胞减少(23.2% vs 11.5%,P=0.025),乏力(11.6% vs 3.8%,P=0.041)和呕吐(10.7% vs 2.3%,P=0.015)。
对于不能切除的局部晚期胃癌患者来说,XELOX方案在回应率,根治性切除率和生存获益上表现出相似的效果,但是该方案的毒性反应更低。
会议专题》》》2016年ASCO年会专题报道
原文摘要:
Efficacy of preoperative chemotherapy regimens in patients with initially unresectable locally advanced gastric adenocarcinoma: Capecitabine and oxaliplatin (XELOX) or with epirubicin (EOX).(Abstract4047)
Authors:Yan Wang, Yiyi Yu, Rongyuan Zhuang,et al
Session Type:Poster Session
Background: Preoperative chemotherapy for initially unresectable locally advanced gastric cancer is thought to downsize tumors for curative resection and there upon prolong survival, but there is no best recommended regimen. We assessed the effectiveness of EOX (capecitabine, oxaliplatin and epirubicin) compared with XELOX (capecitabine and oxaliplatin) as preoperative chemotherapy for initially unresectable locally advanced gastric cancer.
Methods: This is a prospective observational study. The trial was registered on ClinicalTrials.gov (NCT02192983). Patients with unresectable locally advanced gastric cancer were performed EOX regimen or XELOX regimen at the discretion of the investigators. They were assessed for response every 2 cycles by CT (computed tomography) scan. A multidisciplinary team reassessed resectability after 4 cycles. If disease became resectable, radical surgery would be performed within 4-6 weeks after the last treatment cycle. The primary endpoint was the response rate. Secondary end points included the R0 resection rate, survival and adverse events.
Results: From November 2008 to May 2015, 242 patients were enrolled; 112 of them were assigned to EOX regimen and 130 to XELOX regimen. The response rates were 33.0% and 33.8% respectively in EOX group and XELOX group (P= 0.997). After 4 cycles of chemotherapy, 63 patients (56.3%) in EOX group and 81 patients (62.3%) in XELOX group received radical operation (P= 0.408). There was no significant difference in progress-free survival (PFS, 12.0m vs. 15.4m, P= 0.925) and overall survival (OS, 25.7m vs. 29.0m, P= 0.783) in two groups. In addition, more adverse effects occurred in EOX group, such as more leucopenia (22.3% vs. 10.0%, P= 0.014), neutropenia (23.2% vs. 11.5%, P= 0.025), fatigue (11.6% vs. 3.8%, P= 0.041) and vomiting (10.7% vs. 2.3%, P= 0.015).
Conclusions: For unresectable locally advanced gastric cancer patients, XELOX regimen showed similar effects in response rate, radical resection rate and survival benefits, but with less toxicity effects.
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