Prognostic factors in patients treated with second-line chemotherapy for advanced gastric cancer: results from the randomized prospective phase III FFCD-0307 trial

  • Y. TouchefeuEmail author
  • R. Guimbaud
  • C. Louvet
  • L. Dahan
  • E. Samalin
  • E. Barbier
  • K. Le Malicot
  • R. Cohen
  • J. M. Gornet
  • T. Aparicio
  • S. Nguyen
  • A. Azzedine
  • P. L. Etienne
  • J. M. Phelip
  • P. Hammel
  • N. Chapelle
  • D. Sefrioui
  • L. Mineur
  • C. Lepage
  • O. Bouche
Original Article



The aim of this study was to determine prognostic factors in patients treated with second-line therapy (L2) for locally advanced or metastatic gastric and gastro-esophageal junction (GEJ) adenocarcinoma in a randomized phase III study with predefined L2.


In the FFCD-0307 study, patients were randomly assigned to receive in L1 either epirubicin, cisplatin, and capecitabine (ECX arm) or fluorouracil, leucovorin, and irinotecan (FOLFIRI arm). L2 treatment was predefined (FOLFIRI for the ECX arm and ECX for the FOLFIRI arm). Chi square tests were used to compare the characteristics of patients treated in L2 with those of patients who did not receive L2. Prognostic factors in L2 for progression-free survival (PFS) and overall survival (OS) were analyzed using a Cox model.


Among 416 patients included, 101/209 (48.3%) patients in the ECX arm received FOLFIRI in L2, and 81/207 (39.1%) patients in the FOLFIRI arm received ECX in L2. Patients treated in L2, compared with those who only received L1 had : a better ECOG score (0–1: 90.4% versus 79.7%; p = 0.0002), more frequent GEJ localization (40.8% versus 27.6%; p = 0.005), and lower platelet count (median: 298000 versus 335000/mm3; p = 0.02). In multivariate analyses, age < 60 years at diagnosis (HR 1.49, 95% CI 1.09–2.03, p = 0.013) and ECOG score 2 before L2 (HR 2.62, 95% CI 1.41–4.84, p = 0.005) were the only significant poor prognostic factors for OS.


Age ≥ 60 years at diagnosis and ECOG score 0/1 before L2 were the only favorable prognostic factors for OS.


Gastric neoplasm Survival Prognosis Second-line chemotherapy 


Compliance with ethical standards

Conflict of interest

The authors have no conflict of interest to declare.

Ethical approval

All participants gave their written informed consent before inclusion in the FFCD-0307 trial. The study was approved by relevant ethics committees.


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Copyright information

© The International Gastric Cancer Association and The Japanese Gastric Cancer Association 2018

Authors and Affiliations

  • Y. Touchefeu
    • 1
    Email author
  • R. Guimbaud
    • 2
  • C. Louvet
    • 3
  • L. Dahan
    • 4
  • E. Samalin
    • 5
  • E. Barbier
    • 6
  • K. Le Malicot
    • 6
  • R. Cohen
    • 7
  • J. M. Gornet
    • 8
  • T. Aparicio
    • 9
  • S. Nguyen
    • 3
  • A. Azzedine
    • 10
  • P. L. Etienne
    • 11
  • J. M. Phelip
    • 12
  • P. Hammel
    • 13
  • N. Chapelle
    • 1
  • D. Sefrioui
    • 14
  • L. Mineur
    • 15
  • C. Lepage
    • 16
  • O. Bouche
    • 17
  1. 1.Gastrointestinal Oncology UnitInstitut des Maladies de l’Appareil Digestif, University HospitalNantes Cedex 1France
  2. 2.Digestive Medical Oncology IUCT RangueilCHU de ToulouseToulouseFrance
  3. 3.Oncology Multidisciplinary Research Group (GERCOR)ParisFrance
  4. 4.Digestive Oncology Unit, AP-HMLa Timone Hospital, Aix-Marseille UniversitéMarseilleFrance
  5. 5.Digestive Oncology DepartmentInstitut du Cancer de MontpellierMontpellierFrance
  6. 6.Fédération Francophone de Cancérologie Digestive-EPICAD INSERM LNC-UMR 1231University of Burgundy and Franche ComtéDijonFrance
  7. 7.Department of OncologySorbonne Université, AP-HP, hôpital Saint-AntoineParisFrance
  8. 8.Department of GastroenterologyAP-HP Hôpital Saint LouisParisFrance
  9. 9.Department of Gastroenterology and Digestive OncologySaint Louis Hospital, APHP, University Denis Diderot, Sorbonne Paris CitéParisFrance
  10. 10.Department of oncologyCH MontélimarMontélimarFrance
  11. 11.Oncology DepartmentCARIO, HPCAPlérinFrance
  12. 12.Service HGE et Oncologie Digestive, CHU de Saint EtienneUnité HESPER EA-7425 Université Jean Monnet/Claude Bernard Lyon 1VilleurbanneFrance
  13. 13.Digestive Oncology Unit, Beaujon HospitalAssistance Publique-Hôpitaux de ParisClichyFrance
  14. 14.Digestive Oncology Unit, Department of Hepato-Gastroenterology, Rouen University Hospital, UNIROUEN, Inserm U1245, IRON groupNormandie UniversityRouenFrance
  15. 15.Institut Sainte CatherineAvignonFrance
  16. 16.Gastroenterology Department, INSERM UMR1231, CHU de DijonUniversity Bourgogne Franche-ComtéDijonFrance
  17. 17.Digestive OncologyCHU REIMSReimsFrance

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