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.
Resources from the same session
5203 - Novel fusion genes identified from matched primary and recurred breast cancers by RNA-sequencing
Presenter: Soojeong Choi
Session: Poster Display session 2
Resources:
Abstract
5873 - Association between PIK3CA mutation status and development of brain metastases in HR+/HER2- metastatic breast cancer
Presenter: Donna Fitzgerald
Session: Poster Display session 2
Resources:
Abstract
3588 - The role of AXL as mechanism of resistance to trastuzumab and a prognostic factor in breast cancer HER2 positive: a translational approach.
Presenter: Anna Adam-Artigues
Session: Poster Display session 2
Resources:
Abstract
5640 - Untargeted assessment of tumor fractions in plasma for monitoring and prognostication from metastatic breast cancer patients undergoing systemic treatment
Presenter: Marija Balic
Session: Poster Display session 2
Resources:
Abstract
2616 - Clinical application of mutational analysis in breast cancer patients: the relevance of PIK3CA analysis for precision medicine.
Presenter: Juan Miguel Cejalvo
Session: Poster Display session 2
Resources:
Abstract
3870 - A retrospective gene expression analysis of surgically-removed Breast Cancer Brain Metastasis (BCBM)
Presenter: Meritxell Mallafré-Larrosa
Session: Poster Display session 2
Resources:
Abstract
1240 - Endocrine therapy alone versus targeted combination strategy as first line treatment in elderly patients with hormone receptor-positive advanced breast cancer: meta-analysis of Phase II and III randomized clinical trials
Presenter: Claudia Omarini
Session: Poster Display session 2
Resources:
Abstract
5535 - Alpelisib (ALP) + fulvestrant (FUL) for patients with hormone receptor–positive (HR+), HER2− advanced breast cancer (ABC): management and time course of key adverse events of special interest (AESIs) in SOLAR-1
Presenter: Hope Rugo
Session: Poster Display session 2
Resources:
Abstract
3093 - Changes in Hormone-Receptor status in Luminal breast cancers between primary tumor and metastases: results of the observational cohort GIM-13 AMBRA Study
Presenter: Marina Cazzaniga
Session: Poster Display session 2
Resources:
Abstract
1378 - MONARCH 3: Updated time to chemotherapy and disease progression following abemaciclib plus aromatase inhibitor (AI) in HR+, HER2- advanced breast cancer (ABC)
Presenter: Miguel Martín
Session: Poster Display session 2
Resources:
Abstract