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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

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Author(s)
Yoon-Koo KangJeong Hwan YookYoung-Kyu ParkJong Seok LeeYoung-Woo KimJin Young KimMin-Hee RyuSun Young RhaIk Joo ChungIn-Ho KimSang Cheul OhYoung Soo ParkTaeil SonMi Ran JungMi Hwa HeoHark Kyun KimChoHyun ParkChang Hak YooJin-Hyuk ChoiDae Young ZangYou Jin JangJi Young SulJong Gwang KimBeom Su KimSeung-Hoon BeomSang Hee ChoSeung Wan RyuMyeong-Cherl KookBaek-Yeol RyooHyun Ki KimMoon-Won YooNam Su LeeSang Ho LeeGyunji KimYeonJu LeeJee Hyun LeeSung Hoon Noh
Keimyung Author(s)
Kim, Jin YoungHeo, Mi Hwa
Department
Dept. of Internal Medicine (내과학)
Journal Title
J Clin Oncol
Issued Date
2021
Volume
39
Issue
26
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.
Keimyung Author(s)(Kor)
김진영
허미화
Publisher
School of Medicine (의과대학)
Citation
Yoon-Koo Kang 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, 39(26), 2903–2913. doi: 10.1200/JCO.20.02914
Type
Article
ISSN
1527-7755
Source
https://ascopubs.org/doi/10.1200/JCO.20.02914?url_ver=Z39.88-2003
DOI
10.1200/JCO.20.02914
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/43815
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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