Phase III Studies and Guideline Recommendations*
* In Hong Kong, TS-ONE ® is indicated for post operative adjuvant chemotherapy for locally advanced (stage II (excluding T1), IIIA or IIIB) gastric cancer
Gastric Cancer
- Kodera Y. et al., 2023. Addition of docetaxel to S‑1 results in significantly superior 5‑year survival outcomes in Stage III gastric cancer: a final report of the JACCRO GC‑07 study. Gastric Cancer (2023).
- Japanese Gastric Cancer Association. Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition). Gastric Cancer. 2023 Jan;26(1), pp. 1-25.
- Kang Y.K. et al., 2021. PRODIGY: A Phase III Study of Neoadjuvant Docetaxel, Oxaliplatin, and S-1 Plus Surgery and Adjuvant S-1 Versus Surgery and Adjuvant S-1 for Resectable Advanced Gastric Cancer. J Clin Oncol. 2021 Sep 10;39(26), pp. 2903-2913.
- Terashima M et al., 2019. Randomized Phase III Trial of Gastrectomy with Or Without Neoadjuvant S-1 Plus Cisplatin for Type 4 Or Large Type 3 Gastric Cancer, The Short-Term Safety and Surgical Results: Japan Clinical Oncology Group Study (JCOG0501).
Gastric Cancer, 22(5), pp.1044-1052. - Yoshida K et al., 2019. Addition of Docetaxel to Oral Fluoropyrimidine Improves Efficacy in Patients with Stage III Gastric Cancer: Interim Analysis of JACCRO GC-07, a Randomized Controlled Trial.
J Clin Oncol., 37(15), pp.1296-1304. - Ishigami H et al., 2018. Phase III Trial Comparing Intraperitoneal and Intravenous Paclitaxel Plus S-1 Versus Cisplatin Plus S-1 in Patients with Gastric Cancer with Peritoneal metastasis: PHOENIX- GC Trial.
J Clin Oncol., 36(19), pp.1922-1929. - Muro K. et al., 2018. Pan-Asian adapted ESMO Clinical Practice Guidelines for the management of patients with metastatic gastric cancer; a JSMO-ESMO initiative endorsed by CSCO, KSMO, MOS, SSO and TOS.
Annal of Oncology, 30, pp.19–33. - Yamada Y et al., 2015. Phase III Study Comparing Oxaliplatin Plus S-1 with Cisplatin Plus S-1 In Chemotherapy-Naïve Patients with Advanced Gastric Cancer.
Ann Oncol., 26(1), pp.141-148 -
Ryu M. et al. 2015. Comparison of two different S-1 plus cisplatin dosing schedules as first-line chemotherapy for metastatic and/ or recurrent gastric cancer: a multicenter, randomized phase III trial (SOS).
Ann Oncol., 26(10), pp.2097-2101 - Sasako M et al., 2011. Five-Year Outcomes of a Randomized Phase III Trial Comparing Adjuvant Chemotherapy With S-1 Versus Surgery Alone in Stage II or III Gastric Cancer.
J Clin Oncol., 29(33), pp.4387-4393. -
Ajani J et al. 2010. Multicenter Phase III Comparison of Cisplatin/ S-1 with Cisplatin/ Infusional Fluorouracil in Advanced Gastric or Gastroesophageal Adenocarcinoma Study: The FLAGS Trial.
J Clin Oncol, 28(9), pp.1547-1553 - Boku N et al., 2009. Fluorouracil Versus Combination of Irinotecan Plus Cisplatin Versus S-1 In Metastatic Gastric Cancer: A Randomised Phase 3 Study.
Lancet Oncol., 10(11), pp.1063-1069. - Koizumi W et al., 2008. S-1 Plus Cisplatin Versus S-1 Alone for First-Line Treatment of Advanced Gastric Cancer (SPIRITS Trial): A Phase III Trial.
Lancet Oncol., 9(3), pp.215-221. - Sakuramoto S et al., 2007 Adjuvant Chemotherapy for Gastric Cancer with S-1, an Oral Fluoropyrimidine.
N Eng J Med. 357(18), pp.1810-1820
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