Title :

Activity and safety of palbociclib in patients with advanced gastrointestinal stromal tumors refractory to imatinib and sunitinib: a biomarker-driven phase 2 study

Author(s) :

Toulmonde, Maud [Auteur]
Bellera, Carine A. [Auteur]
Blay, Jean-Yves [Auteur]
Bouche, Olivier [Auteur]
Mir, Olivier [Auteur]
Penel, Nicolas [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Isambert, Nicolas [Auteur]
Duffaud, Florence [Auteur]
Esnaud, Thomas [Auteur]
Boidot, Romain [Auteur]
Geneste, Damien [Auteur]
Ghiringhelli, François [Auteur]
Lucchesi, Carlo [Auteur]
Le Loarer, François [Auteur]
Italiano, Antoine [Auteur]

Journal title :

Clinical cancer research . an official journal of the American Association for Cancer Research

Abbreviated title :

Clin. Cancer Res.

Publication date :

2019-04-12

ISSN :

1078-0432

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

OBJECTIVE: CDKN2A METHODS: This is a multicenter single-arm phase II clinical trial assessing safety and efficacy of palbociclib in patients with advanced GIST bearing CDKN2ACDKN2A RESULTS: As of May 2017, 71 patients had ...
Show more >OBJECTIVE: CDKN2A METHODS: This is a multicenter single-arm phase II clinical trial assessing safety and efficacy of palbociclib in patients with advanced GIST bearing CDKN2ACDKN2A RESULTS: As of May 2017, 71 patients had been included in the study, and 29 patients (40.3%) met the molecular eligibility requirement. Twenty-five patients (86.2%) had grade 1-2 adverse events (AEs) and 12 patients (41.4%) grade 3-4 AEs possibly related to the drug. The planned interim statistical analysis performed after central histologic and radiological review showed that 19 (86.4%) out of the first 22 evaluable patients had PD at 4 months. CDKN2ACCNE1CDKN1A/P21LRRC3B CONCLUSIONS: Palbociclib has no significant clinical activity as a single agent in P16/CDKN2A-Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

CHU Lille
Université de Lille

Collections :

• METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694

Submission date :

2019-12-09T16:49:44Z