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.
Keywords
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Article info
Publication history
Published online: December 30, 2019
Accepted:
November 18,
2019
Received:
October 4,
2019
Identification
Copyright
© 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
