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Poster Display session 2

3006 - Nal-iri/lv5-fu versus paclitaxel as second-line therapy in patients with metastatic esophageal squamous cell carcinoma (OESIRI-PRODIGE 62): A FFCD multicenter, randomized, phase II study.

Date

29 Sep 2019

Session

Poster Display session 2

Presenters

Violaine Randrian

Citation

Annals of Oncology (2019) 30 (suppl_5): v253-v324. 10.1093/annonc/mdz247

Authors

V. Randrian1, A. Adenis2, J. Desrame3, E. Barbier4, F. Di Fiore5, A. Lievre6, L. Dahan7, P. Laurent-Puig8, L. Mineur9, G. Breysacher10, G. Roquin11, S. Louafi12, A. Lopez13, C. Louvet14, C. Borg15, J. Metges16, R. Faroux17, L. Gaba18, S. Manfredi19, D. Tougeron20

Author affiliations

  • 1 Gastroenterology, CHU Estaing, 63003 - Clermont-Ferrand/FR
  • 2 Medical Oncology, Institut de Cancérologie de Montpellier, Montpellier/FR
  • 3 Medical Oncology, Hôpital privé Jean Mermoz, 69373 - Lyon/FR
  • 4 Biostatistics, FFCD-, 21079 - Dijon/FR
  • 5 Medical Oncology, Centre Henri Becquerel, 76038 - Rouen Cedex /FR
  • 6 Gastroenterology, CHU de Pontchaillou, 35033 - Rennes/FR
  • 7 Digestive Oncology, AP-HM - CHU La Timone Enfants, 13385 - Marseille/FR
  • 8 Biology, Paris Descartes University, 75006 - Paris/FR
  • 9 Radiotherapy And Oncology Gi And Liver, Institut Ste Catherine, Avignon/FR
  • 10 Gastroenterology, Hôpitaux Civils de Colmar, 68000 - Colmar/FR
  • 11 Gastroenterology, CHU Angers, 49933 - Angers/FR
  • 12 Gastroenterology, Centre Hospitalier de Longjumeau, 91161 - Longjumeau/FR
  • 13 Gastroenterology And Hepatology, CHU Brabois, 54500 - Vandoeuvre les Nancy/FR
  • 14 Medical Oncology, Institute Mutualiste Montsouris, 75014 - Paris/FR
  • 15 Medical Oncology, CHU Besançon, Hôpital Jean Minjoz, 25030 - Besançon/FR
  • 16 Medical Oncology, CHU Morvan - Institut de Cancerologie et d'Hematologie, 29200 - Brest/FR
  • 17 Gastroenterology And Hepatology, CHD Vendee - Hopital Les Oudairies, 85925 - La Roche sur Yon/FR
  • 18 U1231, UFR des Sciences de Santé, 21079 - Dijon/FR
  • 19 Gastroenterology And Hepatology, CHU de Dijon, 21000 - Dijon/FR
  • 20 Gastroenterology And Hepatology, CHU Poitiers, Jean Bernard Hôpital, 86021 - Poitiers/FR
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Resources

Abstract 3006

Background

Half of patients newly diagnosed with esophagus squamous cell cancer (ESCC) has a metastatic ESCC (mESCC) and half of patients with initial loco-regional disease presents disease recurrence after surgery and/or chemoradiation. Although not validated by a phase III trial, first-line palliative chemotherapy combines fluoropyrimidine with platinum salt. Patients with disease progression after platinum-based chemotherapy and good performance status may benefit from a second-line chemotherapy. Based on phase I/II trials or retrospective studies, the most commonly used regimens in second-line setting of mESCC are paclitaxel monotherapy or irinotecan monotherapy or combined with 5FU (FOLFIRI). Up to now, there is no randomized trial available.

Trial design

OESIRI is a multicenter, open-label, randomized phase II trial designed to evaluate efficacy and safety of nanoliposomal irinotecan (NalIRI) plus 5FU versus paclitaxel as second-line therapy in mESCC. Main inclusion criteria are histologically proven mESCC after failure of first-line platinum-based chemotherapy and WHO performance status ≤ 2. Patients initially treated by surgery and chemotherapy or definitive chemoradiation are eligible if relapse occurred less than 6 months after the end of the treatment. In the experimental arm, patients will receive, every 14 days, intravenous (IV) infusion of NalIRI (80 mg/m2) followed by 5FU (2400 mg/m2 over 46 h). In the control arm, patients will receive at days 1, 8 and 14 of a 28 days-cycle, an IV infusion of paclitaxel (80 mg/m2). The primary objective is to evaluate the percentage of patients alive 9 months after randomisation. The clinical hypotheses are to extent the 9-months survival rate from 40% to 60%. With a one-sided type one error α of 5%, a power of 85%, a 5% rate of patients lost to follow-up, 53 patients per arm (n = 106) will be randomized. Secondary endpoints are progression-free survival, overall survival, response rate, safety and quality of life. Circulating tumor DNA will be monitored to assess its predictive value of response to treatment. Inclusions started in January 2019 and theoretical end of recruitment is January 2022.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Fédération Française de Cancérologie Digestive.

Funding

Servier.

Disclosure

All authors have declared no conflicts of interest.

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