Intensive first-line FIr-C/FOx-C association of triplet chemotherapy plus cetuximab in
FIr-C/FOx-C triplet chemotherapy plus cetuximab
RAS wildtype
first line
metastatic colorectal cancer
phase II study
Journal
Therapeutic advances in medical oncology
ISSN: 1758-8340
Titre abrégé: Ther Adv Med Oncol
Pays: England
ID NLM: 101510808
Informations de publication
Date de publication:
2019
2019
Historique:
received:
18
07
2018
accepted:
13
03
2019
entrez:
18
6
2019
pubmed:
18
6
2019
medline:
18
6
2019
Statut:
epublish
Résumé
Intensive triplet chemotherapy/bevacizumab significantly increased metastatic colorectal cancer (MCRC) outcome. This phase II study investigated the safety/activity of FIr-C/FOx-C triplet/cetuximab (CET) in first-line A Simon two-step design was used: p0 70%, p1 85%, power 80%, α5%, β20%; projected objective response rate (ORR) I step 14/19. FIr-C/FOx-C: 5-fluorouracil (5-FU) 12h-timed flat infusion 900 mg/m A total of 29 patients <75 years, with a primary/intermediate Cumulative Index Rating Scale were enrolled; the median age was 59 years; there were 7 young-elderly (yE; 24%). Recommended CPT-11/5-FU doses were 120/750 mg/m FIr-C/FOx-C is highly active and tolerable at recommended doses in non-elderly The trial was registered at Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali (OsSC) Agenzia Italiana del Farmaco (AIFA) Numero EudraCT 2009-016793-32.
Sections du résumé
BACKGROUND
BACKGROUND
Intensive triplet chemotherapy/bevacizumab significantly increased metastatic colorectal cancer (MCRC) outcome. This phase II study investigated the safety/activity of FIr-C/FOx-C triplet/cetuximab (CET) in first-line
METHODS
METHODS
A Simon two-step design was used: p0 70%, p1 85%, power 80%, α5%, β20%; projected objective response rate (ORR) I step 14/19. FIr-C/FOx-C: 5-fluorouracil (5-FU) 12h-timed flat infusion 900 mg/m
RESULTS
RESULTS
A total of 29 patients <75 years, with a primary/intermediate Cumulative Index Rating Scale were enrolled; the median age was 59 years; there were 7 young-elderly (yE; 24%). Recommended CPT-11/5-FU doses were 120/750 mg/m
CONCLUSIONS
CONCLUSIONS
FIr-C/FOx-C is highly active and tolerable at recommended doses in non-elderly
TRIAL REGISTRATION
BACKGROUND
The trial was registered at Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali (OsSC) Agenzia Italiana del Farmaco (AIFA) Numero EudraCT 2009-016793-32.
Identifiants
pubmed: 31205502
doi: 10.1177/1758835919846421
pii: 10.1177_1758835919846421
pmc: PMC6535746
doi:
Types de publication
Journal Article
Langues
eng
Pagination
1758835919846421Déclaration de conflit d'intérêts
Conflict of interest statement: The authors declare that there is no conflict of interest.
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