Nal-IRI/LV5-FU versus paclitaxel as second-line therapy in patients with metastatic esophageal squamous cell carcinoma (OESIRI)-PRODIGE 62: A multicentre, randomised, non-comparative phase II study. Issue 3 (March 2020)

• Record Type: Journal Article
• Authors: Randrian, Violaine; Adenis, Antoine; Desrame, Jérôme; Barbier, Emilie; Di Fiore, Frédéric; Lièvre, Astrid; Dahan, Laetitia; Laurent-Puig, Pierre; Mineur, Laurent; Breysacher, Gilles; Roquin, Guillaume; Louafi, Samy; Lopez, Anthony; Louvet, Christophe; Borg, Christophe; Metges, Jean Philippe; Faroux, Roger; Gaba, Lila; Manfredi, Sylvain; Tougeron, David
• Is Part Of: Digestive and liver disease. Volume 52:Issue 3(2020)
• Page Start: 347
• Page End: 350
• Publication Date: 2020-03
• Subjects: Esophageal cancer -- Irinotecan -- Paclitaxel -- Squamous cell cancer; Digestive organs -- Diseases -- Periodicals; Liver -- Diseases -- Periodicals; 616.33005
• DOI: 10.1016/j.dld.2019.11.014
• Languages: English
• ISSNs: 1590-8658

Abstract

Abstract: Half of patients newly diagnosed with esophageal squamous cell cancer (ESCC) have metastatic disease (mESCC) and therefore a poor prognosis. Furthermore, half of patients with initial loco-regional disease present disease recurrence after surgery and/or chemoradiation. In mESCC, the recommended first-line treatment combines 5-fluorouracil and cisplatin, although this has not been validated by a phase III trial. Patients with disease progression or recurrence after platinum-based chemotherapy and good performance status probably benefit from second-line chemotherapy. Several molecules have been evaluated in phase I/II trials or retrospective studies (docetaxel, paclitaxel and irinotecan) but no randomised studies are available. OESIRI is a multicentre, randomised, open-label phase II trial designed to evaluate efficacy and safety of liposomal irinotecan (nal-IRI) plus 5-FU versus paclitaxel as second-line therapy in patients with mESCC. The main inclusion criteria are histologically proven mESCC in progression after first-line platinum-based chemotherapy. Patients with initial resectable disease can be included if recurrence occurred within 6 months. The primary objective is to evaluate the percentage of patients alive 9 months after randomisation. Secondary endpoints are progression-free survival, overall survival, response rate, safety and quality of life. In addition, circulating tumour DNA will be monitored to assess its prognostic value.