Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer

Summary

Primary Objective: \- To compare the 3-year progression free survival (PFS) in the two treatment arms. Secondary Objectives: * Overall survival (OS). * Postoperative pathological stage and R0 (complete) resection rate. * Safety: Toxicities associated with neoadjuvant chemotherapy, surgery, morbidity/mortality, toxicity of adjuvant chemotherapy.

Timeline

Start

2011-12-30

Primary completion

2019-01-21

Completion

2021-12-13

Outcome

Met primary endpoint

registry analysis (superiority test); Surgery + Adjuvant Chemotherapy (SC) vs Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC); p = 0.0152 NCT01515748 ↗

paper CSC improved PFS versus SC (adjusted hazard ratio, 0.70; 95% CI, 0.52 to 0.95; stratified log-rank P = .023). PMID 34133211 ↗

Publications

• Kang YK, Kim HD, Yook JH, Park YK, Lee JS, Kim YW, Kim JY, Ryu MH, Rha SY, Chung IJ, Kim IH, Oh SC, Park YS, Cheong JH, Jeong O, Heo MH, Kim HK, Park C, Yoo CH, Kang SY, Zang DY, Jang YJ, Sul JY, Kim JG, Kim BS, Beom SH, Hwang JE, Ryu SW, Kook MC, Ryoo BY, Kim H, Yoo MW, Lee NS, Lee SH, Noh SH. Neoadjuvant Docetaxel, Oxaliplatin, and S-1 Plus Surgery and Adjuvant S-1 for Resectable Advanced Gastric Cancer: Updated Overall Survival Outcomes From Phase III PRODIGY. J Clin Oncol. 2024 Sep 1;42(25):2961-2965. doi: 10.1200/JCO.23.02167. Epub 2024 Jul 12.
• Kang YK, Yook JH, Park YK, Lee JS, Kim YW, Kim JY, Ryu MH, Rha SY, Chung IJ, Kim IH, Oh SC, Park YS, Son T, Jung MR, Heo MH, Kim HK, Park C, Yoo CH, Choi JH, Zang DY, Jang YJ, Sul JY, Kim JG, Kim BS, Beom SH, Cho SH, Ryu SW, Kook MC, Ryoo BY, Kim HK, Yoo MW, Lee NS, Lee SH, Kim G, Lee Y, Lee JH, Noh SH. 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):2903-2913. doi: 10.1200/JCO.20.02914. Epub 2021 Jun 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	50 mg/m2	Intravenous
Subject	Oxaliplatin	Small molecule	100 mg/m2	Intravenous
Subject	S-1	Small molecule	40 mg/m2	Oral

Indications