Journal ArticleDOI
Gastrectomy plus chemotherapy versus chemotherapy alone for advanced gastric cancer with a single non-curable factor (REGATTA): a phase 3, randomised controlled trial
Kazumasa Fujitani,Han-Kwang Yang,Junki Mizusawa,Young-Woo Kim,Masanori Terashima,Sang-Uk Han,Yoshiaki Iwasaki,Woo Jin Hyung,Akinori Takagane,Do Joong Park,Takaki Yoshikawa,Seokyung Hahn,Kenichi Nakamura,Cho Hyun Park,Yukinori Kurokawa,Yung-Jue Bang,Byung Joo Park,Mitsuru Sasako,Toshimasa Tsujinaka +18 more
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TLDR
Since gast rectomy followed by chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced gastric cancer with a single non-curable factor, gastrectomy cannot be justified for treatment of patients with these tumours.Abstract:
Summary Background Chemotherapy is the standard of care for incurable advanced gastric cancer. Whether the addition of gastrectomy to chemotherapy improves survival for patients with advanced gastric cancer with a single non-curable factor remains controversial. We aimed to investigate the superiority of gastrectomy followed by chemotherapy versus chemotherapy alone with respect to overall survival in these patients. Methods We did an open-label, randomised, phase 3 trial at 44 centres or hospitals in Japan, South Korea, and Singapore. Patients aged 20–75 years with advanced gastric cancer with a single non-curable factor confined to either the liver (H1), peritoneum (P1), or para-aortic lymph nodes (16a1/b2) were randomly assigned (1:1) in each country to chemotherapy alone or gastrectomy followed by chemotherapy by a minimisation method with biased-coin assignment to balance the groups according to institution, clinical nodal status, and non-curable factor. Patients, treating physicians, and individuals who assessed outcomes and analysed data were not masked to treatment assignment. Chemotherapy consisted of oral S-1 80 mg/m 2 per day on days 1–21 and cisplatin 60 mg/m 2 on day 8 of every 5-week cycle. Gastrectomy was restricted to D1 lymphadenectomy without any resection of metastatic lesions. The primary endpoint was overall survival, analysed by intention to treat. This study is registered with UMIN-CTR, number UMIN000001012. Findings Between Feb 4, 2008, and Sept 17, 2013, 175 patients were randomly assigned to chemotherapy alone (86 patients) or gastrectomy followed by chemotherapy (89 patients). After the first interim analysis on Sept 14, 2013, the predictive probability of overall survival being significantly higher in the gastrectomy plus chemotherapy group than in the chemotherapy alone group at the final analysis was only 13·2%, so the study was closed on the basis of futility. Overall survival at 2 years for all randomly assigned patients was 31·7% (95% CI 21·7–42·2) for patients assigned to chemotherapy alone compared with 25·1% (16·2–34·9) for those assigned to gastrectomy plus chemotherapy. Median overall survival was 16·6 months (95% CI 13·7–19·8) for patients assigned to chemotherapy alone and 14·3 months (11·8–16·3) for those assigned to gastrectomy plus chemotherapy (hazard ratio 1·09, 95% CI 0·78–1·52; one-sided p=0·70). The incidence of the following grade 3 or 4 chemotherapy-associated adverse events was higher in patients assigned to gastrectomy plus chemotherapy than in those assigned to chemotherapy alone: leucopenia (14 patients [18%] vs two [3%]), anorexia (22 [29%] vs nine [12%]), nausea (11 [15%] vs four [5%]), and hyponatraemia (seven [9%] vs four [5%]). One treatment-related death occurred in a patient assigned to chemotherapy alone (sudden cardiopulmonary arrest of unknown cause during the second cycle of chemotherapy) and one occurred in a patient assigned to chemotherapy plus gastrectomy (rapid growth of peritoneal metastasis after discharge 12 days after surgery). Interpretation Since gastrectomy followed by chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced gastric cancer with a single non-curable factor, gastrectomy cannot be justified for treatment of patients with these tumours. Funding The Ministry of Health, Labour and Welfare of Japan and the Korean Gastric Cancer Association.read more
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Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.
Elizabeth C Smyth,Marcel Verheij,William H. Allum,David Cunningham,Andrés Cervantes,Dirk Arnold +5 more
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The Chinese Society of Clinical Oncology (CSCO): clinical guidelines for the diagnosis and treatment of gastric cancer.
Feng Hua Wang,Lin Shen,Jin Li,Zhiwei Zhou,Han Liang,Xiao Tian Zhang,Lei Tang,Yan Xin,Jing Jin,Yu Jing Zhang,Xiang Lin Yuan,T. Liu,Guoxin Li,Qi Wu,Hui Mian Xu,Jiafu Ji,Yuan Fang Li,Xin Wang,Shan Yu,Hao Liu,Wen Long Guan,Rui-Hua Xu +21 more
TL;DR: This guideline uses tables and is complemented by explanatory and descriptive notes covering the diagnosis, comprehensive treatment, and follow-up visits for gastric cancer in China.
Journal ArticleDOI
Effect of Neoadjuvant Chemotherapy Followed by Surgical Resection on Survival in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Cancer: The AIO-FLOT3 Trial
Salah-Eddin Al-Batran,Nils Homann,Claudia Pauligk,Gerald Illerhaus,Uwe M. Martens,Jan Stoehlmacher,Harald Schmalenberg,Kim Barbara Luley,Nicole Prasnikar,Matthias Egger,Stephan Probst,Helmut Messmann,Markus Moehler,Wolfgang Fischbach,Jörg T. Hartmann,Frank Mayer,Heinz-Gert Höffkes,Michael Koenigsmann,Dirk Arnold,Thomas Kraus,Kersten Grimm,Stefan Berkhoff,Stefan Post,Elke Jäger,Wolf O. Bechstein,Ulrich Ronellenfitsch,Stefan Mönig,Ralf Hofheinz +27 more
TL;DR: Patients with limited metastatic disease who received neoadjuvant chemotherapy and proceeded to surgery showed a favorable survival, and the AIO-FLOT3 trial provides a rationale for further randomized clinical trials.
Journal ArticleDOI
Development and validation of an individualized nomogram to identify occult peritoneal metastasis in patients with advanced gastric cancer.
Di Dong,Lei Tang,Zhemin Li,Mengjie Fang,Jianbo Gao,X H Shan,Xiangji Ying,Yi Sun,Jia Fu,X X Wang,L M Li,Zhenhui Li,D F Zhang,Yan Zhang,Z M Li,Fei Shan,Zhaode Bu,Jie Tian,Jie Tian,Jiafu Ji +19 more
TL;DR: CT phenotypes of both primary tumor and nearby peritoneum are significantly associated with occult PM status, and a nomogram of these CT phenotypes and Lauren type has an excellent prediction ability of occult PM, and may have significant clinical implications on early detection of occultPM for AGC.
Journal ArticleDOI
Pan-Asian adapted ESMO Clinical Practice Guidelines for the management of patients with metastatic oesophageal cancer: a JSMO-ESMO initiative endorsed by CSCO, KSMO, MOS, SSO and TOS.
K. Muro,E. Van Cutsem,Yukiya Narita,Georgios Pentheroudakis,Eishi Baba,Jian Li,Min-Hee Ryu,W.I. Wan Zamaniah,W.P. Yong,K.-H. Yeh,Kyoko Kato,Zhihao Lu,Byoung Chul Cho,I.M. Nor,M. Ng,L.-T. Chen,Takako Eguchi Nakajima,Kohei Shitara,Hisato Kawakami,Takahiro Tsushima,Takayuki Yoshino,Florian Lordick,Erika Martinelli,Elizabeth C Smyth,Dirk Arnold,Hironobu Minami,Josep Tabernero,J.-Y. Douillard +27 more
TL;DR: These guidelines represent the consensus opinions reached by experts in the treatment of patients with metastatic oesophageal cancer representing the oncological societies of Japan (JSMO), China (CSCO), Korea (KSMO), Malaysia (MOS), Singapore (SSO) and Taiwan (TOS).
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S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial.
Wasaburo Koizumi,H. Narahara,Takuo Hara,Akinori Takagane,Toshikazu Akiya,Masakazu Takagi,Kosei Miyashita,Takashi Nishizaki,Osamu Kobayashi,Wataru Takiyama,Yasushi Toh,Takashi Nagaie,Seiichi Takagi,Yoshitaka Yamamura,Kimihiko Yanaoka,Hiroyuki Orita,Masahiro Takeuchi +16 more
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