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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
Kang, Yoon-KooYook, Jeong HwanPark, Young-KyuLee, Jong SeokKim, Young-WooKim, Jin YoungRyu, Min-HeeRha, Sun YoungChung, Ik JooKim, In-HoOh, Sang CheulPark, Young SooSon, TaeilJung, Mi RanHeo, Mi HwaKim, Hark KyunPark, ChoHyunYoo, Chang HakChoi, Jin-HyukZang, Dae YoungJang, You JinSul, Ji YoungKim, Jong GwangKim, Beom SuBeom, Seung-HoonCho, Sang HeeRyu, Seung WanKook, Myeong-CherlRyoo, Baek-YeolKim, Hyun KiYoo, Moon-WonLee, Nam SuLee, Sang HoKim, GyunjiLee, YeonJuLee, Jee HyunNoh, Sung Hoon
Issue Date
10-9월-2021
Publisher
LIPPINCOTT WILLIAMS & WILKINS
Citation
JOURNAL OF CLINICAL ONCOLOGY, v.39, no.26, pp.2903 - +
Indexed
SCIE
SCOPUS
Journal Title
JOURNAL OF CLINICAL ONCOLOGY
Volume
39
Number
26
Start Page
2903
End Page
+
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/136369
DOI
10.1200/JCO.20.02914
ISSN
0732-183X
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/m(2), oxaliplatin 100 mg/m(2) intravenously day 1, S-1 40 mg/m(2) 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 = 5.023). 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. (C) 2021 by American Society of Clinical Oncology
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