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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

Authors
 Yoon-Koo Kang  ;  Jeong Hwan Yook  ;  Young-Kyu Park  ;  Jong Seok Lee  ;  Young-Woo Kim  ;  Jin Young Kim  ;  Min-Hee Ryu  ;  Sun Young Rha  ;  Ik Joo Chung  ;  In-Ho Kim  ;  Sang Cheul Oh  ;  Young Soo Park  ;  Taeil Son  ;  Mi Ran Jung  ;  Mi Hwa Heo  ;  Hark Kyun Kim  ;  ChoHyun Park  ;  Chang Hak Yoo  ;  Jin-Hyuk Choi  ;  Dae Young Zang  ;  You Jin Jang  ;  Ji Young Sul  ;  Jong Gwang Kim  ;  Beom Su Kim  ;  Seung-Hoon Beom  ;  Sang Hee Cho  ;  Seung Wan Ryu  ;  Myeong-Cherl Kook  ;  Baek-Yeol Ryoo  ;  Hyun Ki Kim  ;  Moon-Won Yoo  ;  Nam Su Lee  ;  Sang Ho Lee  ;  Gyunji Kim  ;  YeonJu Lee  ;  Jee Hyun Lee  ;  Sung Hoon Noh 
Citation
 JOURNAL OF CLINICAL ONCOLOGY, Vol.39(26) : 2903-2913, 2021-09 
Journal Title
JOURNAL OF CLINICAL ONCOLOGY
ISSN
 0732-183X 
Issue Date
2021-09
MeSH
Adenocarcinoma / mortality ; Adenocarcinoma / pathology ; Adenocarcinoma / therapy* ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols / adverse effects ; Antineoplastic Combined Chemotherapy Protocols / therapeutic use* ; Chemotherapy, Adjuvant ; Docetaxel / adverse effects ; Docetaxel / therapeutic use* ; Drug Combinations ; Esophagogastric Junction / drug effects* ; Esophagogastric Junction / pathology ; Esophagogastric Junction / surgery* ; Female ; Gastrectomy* / adverse effects ; Gastrectomy* / mortality ; Humans ; Male ; Middle Aged ; Neoadjuvant Therapy* / adverse effects ; Neoadjuvant Therapy* / mortality ; Neoplasm Staging ; Oxaliplatin / adverse effects ; Oxaliplatin / therapeutic use* ; Oxonic Acid / adverse effects ; Oxonic Acid / therapeutic use* ; Progression-Free Survival ; Republic of Korea ; Stomach Neoplasms / mortality ; Stomach Neoplasms / pathology ; Stomach Neoplasms / therapy* ; Tegafur / adverse effects ; Tegafur / therapeutic use* ; Time Factors ; Young Adult
Abstract
Purpose: Adjuvant chemotherapy after D2 gastrectomy is standard for resectable locally advanced gastric cancer (LAGC) in Asia. Based on positive findings for perioperative chemotherapy in European phase III studies, the phase III PRODIGY study (ClinicalTrials.gov identifier: NCT01515748) investigated whether neoadjuvant docetaxel, oxaliplatin, and S-1 (DOS) followed by surgery and adjuvant S-1 could improve outcomes versus standard treatment in Korean patients with resectable LAGC.

Patients and methods: Patients 20-75 years of age, with Eastern Cooperative Oncology Group performance status 0-1, and with histologically confirmed primary gastric or gastroesophageal junction adenocarcinoma (clinical TNM staging: T2-3N+ or T4Nany) were randomly assigned to D2 surgery followed by adjuvant S-1 (40-60 mg orally twice a day, days 1-28 every 6 weeks for eight cycles; SC group) or neoadjuvant DOS (docetaxel 50 mg/m2, oxaliplatin 100 mg/m2 intravenously day 1, S-1 40 mg/m2 orally twice a day, days 1-14 every 3 weeks for three cycles) before D2 surgery, followed by adjuvant S-1 (CSC group). The primary objective was progression-free survival (PFS) with CSC versus SC. Two sensitivity analyses were performed: intent-to-treat and landmark PFS analysis.

Results: Between January 18, 2012, and January 2, 2017, 266 patients were randomly assigned to CSC and 264 to SC at 18 Korean study sites; 238 and 246 patients, respectively, were treated (full analysis set). Follow-up was ongoing in 176 patients at data cutoff (January 21, 2019; median follow-up 38.6 months [interquartile range, 23.5-62.1]). CSC improved PFS versus SC (adjusted hazard ratio, 0.70; 95% CI, 0.52 to 0.95; stratified log-rank P = .023). Sensitivity analyses confirmed these findings. Treatments were well tolerated. Two grade 5 adverse events (febrile neutropenia and dyspnea) occurred during neoadjuvant treatment.

Conclusion: PRODIGY showed that neoadjuvant DOS chemotherapy, as part of perioperative chemotherapy, is effective and tolerable in Korean patients with LAGC.
Full Text
https://ascopubs.org/doi/full/10.1200/JCO.20.02914
DOI
10.1200/JCO.20.02914
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Hyunki(김현기) ORCID logo https://orcid.org/0000-0003-2292-5584
Noh, Sung Hoon(노성훈) ORCID logo https://orcid.org/0000-0003-4386-6886
Rha, Sun Young(라선영) ORCID logo https://orcid.org/0000-0002-2512-4531
Son, Tae Il(손태일) ORCID logo https://orcid.org/0000-0002-0327-5224
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/190513
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