在2013年美国临床肿瘤学会（ASCO）年会上，中山大学肿瘤医院徐瑞华教授的关于S-1和顺铂对比氟尿嘧啶和顺铂治疗胃癌的研究入选了本次的壁报讨论，医脉通的编辑有幸在专场上采访了徐教授。徐教授对这项研究进行了简介，并谈了自己的参会感受，详细内容如下：
徐瑞华教授接受医脉通的采访
医脉通：徐教授，感谢您接受医脉通在ASCO对您的专访，恭喜您关于S-1和顺铂对比氟尿嘧啶和顺铂的这项研究入选了本次CSCO大会的壁报讨论，请您给我们介绍一下这项研究的基本情况，以及这项研究结果对临床实践会有怎样的改变？
徐瑞华教授：十分感谢医脉通的邀请，有机会在美国接受采访。这个研究是我们中国国内的一个多中心的胃癌的临床研究，我们设计的是一个新药S-1+顺铂，这个药是我们国产的一个企业注册的临床研究，对比的是顺铂加上5-FU，这是一个传统的方案。在这项研究中我们看到S-1 +顺铂取得的疗效和有效率，PFS和OS与传统的方案是差不多的。疗效是没有统计学差异，不良反应方面两者具有可比性，但是S-1为口服药，应用相对方便。我们研究设计里对照组5-Fu是静脉用药，要连续滴注5天，这个在临床工作当中是很不方便的，S-1可以口服，所以它的毒性可以接受。这个研究对我们进一步地去运用顺铂+口服的5-FU制剂S-1作为一线治疗，可以进一步确定它在临床治疗当中的地位。
医脉通：本次大会中，在消化道肿瘤治疗领域内有没有比较新的临床试验的结果呢？请您为我们简单介绍一下。
徐瑞华教授：消化道肿瘤这两天也是比较热闹的，也有一些大的临床研究，在肠癌这块来讲主要是靶向药物，是爱必妥（西妥昔单抗）和安维汀（贝伐单抗）一个是抗VEGF通路的，还一个是抗EGFR通路。今年有几个研究，涉及维持治疗的问题，发现安维汀（贝伐单抗）联合希罗达维持治疗肠癌，可以认为是标准治疗方法之一。另外，还有一个研究就是头对头的对比，FOLFIRI联合安维汀（贝伐单抗）对比FOLFIRI联合爱必妥（西妥昔单抗），这项研究的终点，在有效率方面是差不多的，但是在生存期方面爱必妥（西妥昔单抗）组具有统计学差异，但这个研究还有很多信息是我们没完全明了的，进一步解读的话还需要获得更多的信息。总之看到这个病的治疗生存期都还是比较长的。
在胃癌领域，今天上午已经做了口头报告，非常吸引眼球的研究还没有，其中，二线治疗中有一个就是多西他赛的治疗，可以进一步确立胃癌二线治疗的地位，就是胃癌需要做二线治疗。在这之前还是存在争议的，需不需要做二线治疗，二线治疗到底有没有意义，越来越多的证据证明了它的存在和意义。另外的一个研究是一个失败的研究，是关于拉帕替尼抗HER2+这条通路的研究，是个阴性的结果。在这项研究中，中国也录了很多病人，但没有达到研究终点，就是说抗HER2+的这样一个小分子药物联合化疗没有达到研究终点，这个还是会让人有点失望。其他的也没有更多的一些在胃癌方面的新突破。
医脉通：请问这是您第几次参加ASCO大会了呢？有什么样的感受？
徐瑞华教授：已经很多次了，我自己都没数过，最近这几年，基本上我每年都会参加。感触很深的就是ASCO本身的信息量就非常大，是国际的最高学术交流平台，中国的医生早年更多的是作为听众，来参与这个会议的学习。今天我们也看到好多中国的医生已经拿着自己的材料、数据在这里交流，也就是说真正的从一个学习的角度慢慢地开始走向为医学进步或者说为癌症治疗的进步提供自己的证据的这样一个时代，中国医生慢慢走入这个国际大家庭，也逐步地发挥它的一个学术引领的作用。
医脉通：最后再次恭喜您和您的团队取得非常好的成果，也感谢您接受我们医脉通的采访。
徐瑞华教授站在壁报前
背景阅读:徐瑞华教授在ASCO会议上的壁报摘要
A phase III study of S-1 plus cisplatin versus fluorouracil plus cisplatin in patients with advanced gastric or gastroesophageal junction adenocarcinoma.
Author(s): Rui-hua Xu, Guo-ping Sun, Hui-shan Lu, Liu Yun Peng, Jian-ming Xu, Mei-zuo Zhong, He-long Zhang, Shi-ying Yu, Wei Li, Xiao-hua Hu, Jie Jun Wang, Ying Cheng, Jun-tian Zhou, Zeng-qing Guo, Zhongzhen Guan; Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China; Department of Oncology, The First Affiliated Hospital of An Hui Medical University, Hefei, China; Department of Surgical Oncology, Fujian Medical University union Hospital, Shanghai, China; First Hospital of China Medical University, Shenyang, China; Department of Oncology, Chinese People's Liberation Army 307 Hospital, Beijing, China; Department of Oncology, Xiangya Hospital Central-South University, Changsha, China; Department of Oncology, Tangdu Hospital of the Fourth Liberation Army University, Xi-an, China; Department of Oncology, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China; Department of Oncology, The First Affiliated Hospital to Jilin University, Jilin, China; Department of Oncology, The Guangxi Zhuang Autonomous Region Tumor Hospital, Nanning, China; Shanghai Chong Zhen Hospital, Shanghai, China; Jilin Provincial Cancer Hospital, Changchun, China; Department of Oncology, Tumor Hospital of Hunan Province, Changsha, China; Department of Oncology, Tumor Hospital of Fujian Province, Fuzhou, China; State Key Laboratory of Oncology in South China, Cancer Center of Sun Yat-sen University, Guangzhou, China
【Abstract】
Background: A combination of S-1 and cisplatin (DDP) has been shown to be effective and safe for the first-line treatment of advanced gastric cancer in Japan. This is the first randomized phase III trial to compare S-1 plus DDP with 5-fluorouracil (5-Fu) plus DDP in Asia.
Methods: This is an open-label, multicenter, phase 3, randomized controlled study. Patients with gastric or gastro-oesophageal junction adenocarcinoma were eligible for inclusion. Patients were randomly assigned in a 1:1 ratio to receive S-1 plus DDP (experiment group) or 5-Fu plus DDP (control group) for 6 cycles. In the experiment group, the dose of S-1 was 80 mg/m2/day, po, twice daily on day 1-21 and DDP was 20mg/m2 iv on day 1-4, repeat every 5 weeks. In the control group, 5-Fu was given as 0.8g/m2/d CI 120h ,and the dose of DDP was the same with the experiment group, while repeat every 4 weeks. Allocation was by block randomization stratified by Eastern Cooperative Oncology Group performance status, sites of metastasis and prior gastrectomy. The primary endpoint was time to progression (TTP). Secondary end points included time to failure (TTF), overall survival (OS), and quality of life.
Results: Totally 255 patients were enrolled into the study, of whom 236 were included in the analysis (n=120; n=116). Median TTP was 5.51 months (95% CI 4.59-6.26) in those assigned to experiment group compared with 4.62 months (95% CI 4.00-6.33) in the control group (hazard ratio [HR] 1.03; 95%CI 0.76-1.39, p=0.86). In the experiment and control groups, response rates were 22.5% vs 21.5%; P=0.86. Median OS was 10.00 months (95% CI 8.59-14.52) in the experiment group compared with 10.46 months (8.92-13.84) in the control group (HR 1.05; 95%CI 0.71-1.54, p=0.82). The most common adverse events in both groups were anemia (S-1 plus cisplatin, 80.17% vs 5-Fu plus cisplatin, 71.19%), leukopenia (71.90% vs 62.71%), neutropenia (68.60% vs 55.93%), nausea (50.41% vs 60.17%), thrombocytopenia (44.63% vs 26.27%), vomiting (42.98% vs 42.37%) and anorexia (38.02% vs 41.53%).
Conclusions: S-1 plus DDP is an effective and tolerable option for patients with advanced gastric or gastro-oesophageal junction adenocarcinoma.
Clinical trial information: NCT01198392.
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