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Proffered Paper 2 – Gastrointestinal tumours, non-colorectal

2111 - Phase III randomized study of neoadjuvant chemotherapy (CT) with docetaxel(D), oxaliplatin(O) and S-1(S) (DOS) followed by surgery and adjuvant S-1, vs surgery and adjuvant S-1, for resectable advanced gastric cancer (GC) (PRODIGY)

Date

29 Sep 2019

Session

Proffered Paper 2 – Gastrointestinal tumours, non-colorectal

Presenters

Yoon-Koo Kang

Citation

Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394

Authors

Y. Kang1, J.H. Yook2, Y. Park3, Y. Kim4, J. Kim5, M. Ryu6, S.Y. Rha7, I. Chung8, I. Kim9, S.C. Oh10, C. Yoo11, J. Choi12, D.Y. Zang13, G. Kim14, Y. Lee15, S. Noh16

Author affiliations

  • 1 Oncology Dept, Asan Medical Center, University of Ulsan College of Medicine, 05505 - Seoul/KR
  • 2 Department Of Surgery, Asan Medical Center, University of Ulsan, Seoul/KR
  • 3 Department Of Surgery, Chonnam National University Hwasun Hospital, Gwangju/KR
  • 4 Stomach Cancer, National Cancer Center, Goyang/KR
  • 5 Department Of Hematooncology, Keimyung University Dongsan Medical Center, Daegu/KR
  • 6 Department Of Oncology, Asan Medical Center, University of Ulsan, Seoul/KR
  • 7 Medical Oncology, Yonsei University, 03722 - Seoul/KR
  • 8 Medical Oncology, Chonnam National University Hwasun Hospital, 58128 - Jeonnam/KR
  • 9 Department Of Internal Medicine, Seoul St. Mary's Hospital, Seoul/KR
  • 10 Department Of Internal Medicine, Korea University Guro Hospital, Seoul/KR
  • 11 Department Of Surgery, Kangbuk Samsung Hospital, Seoul/KR
  • 12 Hematology-oncology, Ajou University School of Medicine, 443-721 - Suwon/KR
  • 13 Department Of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang/KR
  • 14 ., Sanofi Korea, Seoul/KR
  • 15 R&d Clinical Study Unit, Sanofi Korea, Seoul/KR
  • 16 Department Of Surgery, Yonsei Cancer Center, Yonsei University Health System, Seoul/KR
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Abstract 2111

Background

Adjuvant CT after D2 gastrectomy is standard therapy for resectable advanced GC in Asia. We investigated whether added neoadjuvant (NA) CT can further improve outcomes.

Methods

530 pts with newly diagnosed locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma (cT2,3/N[+]M0 or cT4/N[any]M0, AJCC 7th ed), ECOG PS 0-1, were randomized 1:1 to NA DOS then surgery and adjuvant S-1 (CSC; n = 266), or surgery and adjuvant S-1 (SC; n = 264). NA CT was D 50mg/m2 iv and O 100mg/m2 iv on day 1, S 40mg/m2 twice po on days 1–14 every 3 weeks for 3 cycles. Standard surgery was D2 gastrectomy. Adjuvant CT was S 40mg/m2 twice po on days 1–28 every 6 weeks for 8 cycles. Primary endpoint: 3-year progression free survival (PFS) in full analysis set (FAS).

Results

With 46 pts excluded due to ineligibility or consent withdrawal, FAS was 484 pts (238 in CSC, 246 in SC). Baseline characteristics were balanced. In CSC arm, 214 pts (90.0%) completed 3 cycles of NA DOS. Main ≥grade3 toxicities: neutropenia in 12.6%, febrile neutropenia 9.2%, diarrhea in 5.0%, 1 treatment related death. 222 CSC (93.3%) and 246 SC (100%) pts underwent surgery. R0 resection rates: 96.4% vs 85.8%, p < 0.0001; lower pathologic stage in CSC with pathologic CR 10.4% vs 0%, p < 0.0001. Major surgical complication rates: 6.3% vs 8.5% with 1 surgical mortality in CSC arm. 204 CSC pts started adjuvant S-1, 170 (83.3%) completed 8 cycles; SC arm: 187 started, with completion of 8 cycles in 157 (84.0%). Main ≥grade3 toxicities: neutropenia (6.4% CSC, 5.4% SC), diarrhea (2.9% CSC, 3.2% SC). With median follow up of 37.4 months and 37.8% of PFS events, 3-year PFS rate (FAS) was 66.3% for CSC, 60.2% for SC; hazard ratio (HR) 0.70 (95% CI 0.52–0.95), stratified log-rank p = 0.023. Sensitivity analyses (intent to treat set and landmark analysis) confirmed these results.

Conclusions

Addition of NA DOS to D2 gastrectomy and adjuvant S-1 led to significant tumour downstaging and improved PFS with acceptable safety in PRODIGY study. Neoadjuvant DOS chemotherapy followed by D2 gastrectomy and adjuvant S-1 should be considered as a treatment option for resectable advanced GC.

Clinical trial identification

NCT01515748.

Editorial acknowledgement

Legal entity responsible for the study

Sanofi Korea.

Funding

Sanofi Korea.

Disclosure

Y. Kang: Advisory / Consultancy: Ono; Advisory / Consultancy: BMS; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Merck Serono; Research grant / Funding (institution): Roche; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Daehwa; Advisory / Consultancy: LSKBiopharma; Advisory / Consultancy: Taiho; Advisory / Consultancy: Blueprint; Advisory / Consultancy: Macrogenics; Advisory / Consultancy: Zymeworks; Advisory / Consultancy: Hengrui. G. Kim: Shareholder / Stockholder / Stock options, Full / Part-time employment: Sanofi. Y. Lee: Shareholder / Stockholder / Stock options, Full / Part-time employment: Sanofi. All other authors have declared no conflicts of interest.

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