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

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, Cho Hyun Park, Chang Hak Yoo, Jin Hyuk Choi, Dae Young ZangYou 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, Yeon Ju Lee, Jee Hyun Lee, Sung Hoon Noh

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134 Citations (Scopus)

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: T2-3N1 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 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.

Original languageEnglish
Pages (from-to)2903-2913
Number of pages11
JournalJournal of Clinical Oncology
Volume39
Issue number26
DOIs
Publication statusPublished - 2021 Sept 10

Bibliographical note

Publisher Copyright:
Copyright © 2022 American Society of Clinical Oncology. All rights reserved.

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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