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‍‍‍‍‍医脉通编译，转载请务必注明出处

2015年ASCO年会将于5月29日--6月2日在美国芝加哥召开，5月31日上午的消化系统（非结直肠）肿瘤口头报告专场，将公布前瞻性随机III期研究——CONKO-005试验的结果。吉西他滨（Gem）辅助化疗6个月会显著改善胰腺癌患者生存期。CONKO-005研究旨在评估EGFR-酪氨酸激酶-抑制剂厄洛替尼（Erlo 100mg 每日p.o.）联合Gem（1000mg/m² i.v. 第1，8，15，q29）治疗R0切除后患者24周的附加效应。

研究方法：

在一项开放标签多中心设计中，患者在手术后8周内，随机分配接受GemElro或者Gem；通过淋巴结受累，手术技术，研究中心进行分层。主要终点是无疾病生存期（DFS）。该研究计划在0.05显著水平应用80%P值以检测DFS从14到18个月的改善情况。次要目标是中位总生存期（OS）和治疗安全性。研究分析应用Kaplan-Meier法展开；治疗组生存数据的比较应用log-rank检测。

研究结果：

在2008年4月～2013年7月之间，219例患者随机接受GemErlo治疗，217例患者接受Gem治疗。患者特征保持平衡（GemErlo/Gem）：年龄（中位数63/65岁），肿瘤状态（T3/T4 88/86%），淋巴结状态（N pos 64/66%），分级（G3 33/34%）。

中位随访41个月后（2015年3月），350例（80%）事件发生。在这两组中中位治疗时间是22周。3/4级毒性是（GemErlo/Gem）：皮疹7/0.4，腹泻5/1，恶心2/2，疲劳5/2，高血压3/1，GGT9/9，中性粒细胞减少27/28，血小板减少5/2。

两组的DFS（中位：GemErlo 11.6个月，Gem 11.6个月；HR 0.89，95% CI 0.72～1.10）或0S（中位：GemErlo 24.6个月，Gem 26.5个月；HR 0.90，95% CI 0.71～1.15）没有差异。

在GemErlo组中皮疹级别和改善的DFS之间没有联系（中位：皮疹级别0-1 vs ≥2 12.2 vs 11.0个月；HR 0.91，95% CI 0.66-1.25）。OS曲线显示一个后期散度支持GemErlo（2/3/4/5-年后评估的存活率：54/36/31/28% vs 53/33/22/19%）。

结论：

GemErlo联合治疗24周未能改善DFS或OS。在经GemErlo治疗的患者中有长期生存的趋势。临床试验信息：DRKS00000247。

会议专题》》》2015年ASCO年会专题报道

阅读英文摘要

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CONKO-005: Adjuvant therapy in R0 resected pancreatic cancer patients with gemcitabine plus erlotinib versus gemcitabine for 24 weeks—A prospective randomized phase III study.（Abstract NO:4007）

Authors：Marianne Sinn, Torsten Liersch,et al.‍‍‍‍‍‍

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Session Type：Oral Abstract Session

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Background：Adjuvant chemotherapy with gemcitabine (Gem) for 6 months significantly improves survival of pancreatic cancer patients. CONKO-005 was designed to evaluate an additional effect of the EGFR-tyrosinkinase-inhibitor erlotinib (Erlo 100 mg p.o. daily) in combination with Gem (1000 mg/m² i.v. day 1,8,15, q29) for 24 weeks in pts after R0 resection.

Methods：In an open-label multicenter design, pts were randomised within 8 weeks after operation to receive GemErlo or Gem; stratified by lymph node involvement, operation techniques, study centre. The primary endpoint was disease-free survival (DFS). The study was planned with a power of 80% at a significance level of 0.05 to detect an improvement of DFS from 14 to 18 months. Secondary objectives were median overall survival (OS) and treatment safety. Kaplan-Meier analyses were performed; survival data for the treatment arms compared using log-rank test.

RESULTS：Between April 2008 and July 2013, 219 pts were randomized to GemErlo and 217 to Gem. Pts characteristics are well balanced (GemErlo/Gem): age (median 63/65 years), tumor status (T3/T4 88/86%), nodal status (N pos 64/66%), grading (G3 33/34%). After a median follow up of 41 months (March 2015), 350 events (80%) occurred. Median treatment duration was 22 weeks in both groups. Grade 3/4 toxicities were (GemErlo%/Gem%): rash 7/0.4, diarrhea 5/1, nausea 2/2, fatigue 5/2, hypertension 3/1,GGT 9/9, neutropenia 27/28, thrombopenia 5/2. There was no difference in DFS (median: GemErlo 11.6 months, Gem 11.6 months; HR 0.89, 95%CI 0.72-1.10) or OS (median: GemErlo 24.6 months, Gem 26.5 months; HR 0.90, 95%CI 0.71-1.15). There was no correlation between the grade of rash and an improved DFS in the GemErlo group (median: rash grade 0-1 vs > = grade 2 12.2 vs 11.0 months; HR 0.91, 95%CI 0.66-1.25). OS curves show a late divergence in favour of GemErlo (estimated survival after 2/3/4/5-years: 54/36/31/28% vs 53/33/22/19%).

Conclusion：The combination therapy of GemErlo for 24 weeks did not improve DFS or OS. There is a trend in favour of long-term survival in pts treated with GemErlo. Clinical trial information: DRKS00000247.

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