| Added by | mollevi |
|---|---|
| Group name | EquipeMY |
| Item Type | Journal Article |
| Title | 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 |
| Creator | Randrian et al. |
| Author | Violaine Randrian |
| Author | Antoine Adenis |
| Author | Jérôme Desrame |
| Author | Emilie Barbier |
| Author | Frédéric Di Fiore |
| Author | Astrid Lièvre |
| Author | Laetitia Dahan |
| Author | Pierre Laurent-Puig |
| Author | Laurent Mineur |
| Author | Gilles Breysacher |
| Author | Guillaume Roquin |
| Author | Samy Louafi |
| Author | Anthony Lopez |
| Author | Christophe Louvet |
| Author | Christophe Borg |
| Author | Jean Philippe Metges |
| Author | Roger Faroux |
| Author | Lila Gaba |
| Author | Sylvain Manfredi |
| Author | David Tougeron |
| 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. |
| Publication | Digestive and Liver Disease: Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver |
| Date | Dec 30, 2019 |
| Journal Abbr | Dig Liver Dis |
| Language | eng |
| DOI | 10.1016/j.dld.2019.11.014 |
| ISSN | 1878-3562 |
| Short Title | Nal-IRI/LV5-FU versus paclitaxel as second-line therapy in patients with metastatic esophageal squamous cell carcinoma (OESIRI)-PRODIGE 62 |
| Library Catalog | PubMed |
| Extra | PMID: 31899122 |
| Tags | Esophageal cancer, Paclitaxel, Squamous cell cancer |
| Date Added | 2020/01/28 - 09:42:47 |
| Date Modified | 2020/01/28 - 09:42:47 |
| Notes and Attachments | PubMed entry (Attachment) |
Institut de Recherche en Cancérologie de
