Gastrectomy with or without neoadjuvant S-1 plus cisplatin for type 4 or large type 3 gastric cancer (JCOG0501): an open-label, phase 3, randomized controlled trial.

Gastric Cancer : Official Journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association
Yoshiaki IwasakiMitsuru Sasako

Abstract

Specific treatment strategies are sorely needed for scirrhous-type gastric cancer still, which has poor prognosis. Based on the promising results of our previous phase II study (JCOG0210), we initiated a phase III study to confirm the efficacy of neoadjuvant chemotherapy (NAC) in type 4 or large type 3 gastric cancer. Patients aged 20-75 years without a macroscopic unresectable factor as confirmed via staging laparoscopy were randomly assigned to surgery followed by adjuvant chemotherapy with S-1 (Arm A) or NAC (S-1plus cisplatin) followed by D2 gastrectomy plus adjuvant chemotherapy with S-1 (Arm B). The primary endpoint was overall survival (OS). Between October 2005 and July 2013, 316 patients were enrolled, allocating 158 patients to each arm. In Arm B, in which NAC was completed in 88% of patients. Significant downstaging based on tumor depth, lymph node metastasis, and peritoneal cytology was observed using NAC. Excluding the initial 16 patients randomized before the first revision of the protocol, 149 and 151 patients in arms A and B, respectively, were included in the primary analysis. The 3-year OS rates were 62.4% [95% confidence interval (CI)  54.1-69.6] in Arm A and 60.9% (95% CI  52.7-68.2) in Arm B. The hazard rat...Continue Reading

References

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Citations

Apr 17, 2021·Annals of Gastroenterological Surgery·Tomoyuki IrinoYuko Kitagawa
May 2, 2021·European Journal of Surgical Oncology : the Journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology·Yosuke KanoSouya Nunobe
Jun 17, 2021·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Yoon-Koo KangSung Hoon Noh
Aug 3, 2021·Annals of Gastroenterological Surgery·Keishi YamashitaNaoki Hiki
Oct 1, 2021·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Dun-Chang MoLin-Jing Ye
Nov 3, 2021·Journal of Gastrointestinal Surgery : Official Journal of the Society for Surgery of the Alimentary Tract·Tomoki KonishiEigo Otsuji

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