PMID- 21737652
OWN - NLM
STAT- MEDLINE
DCOM- 20111019
LR  - 20181201
IS  - 1791-7530 (Electronic)
IS  - 0250-7005 (Linking)
VI  - 31
IP  - 6
DP  - 2011 Jun
TI  - Phase II trial of weekly alternating sequential BIBF 1120 and afatinib for 
      advanced colorectal cancer.
PG  - 2271-81
AB  - AIM: The feasibility of an alternating regimen of BIBF 1120, a potent, oral, 
      triple angiokinase inhibitor, and afatinib (BIBW 2992), a potent ErbB family 
      blocker, was explored in patients with advanced pretreated colorectal cancer 
      (CRC). PATIENTS AND METHODS: Patients received repeated courses of alternating 
      7-day treatment periods, first with BIBF 1120 250 mg twice daily and then 
      afatinib 50 mg once daily. The primary endpoint was the objective response rate; 
      the incidence/severity of adverse events (AEs) and pharmacokinetics (PK) were 
      determined. RESULTS: Forty-six patients (>/=4 prior lines, most anti-VEGF and/or 
      -EGFR pretreated) received BIBF 1120 and afatinib. No objective responses were 
      observed; the best response was stable disease in 20 patients (43.5%). Seven 
      patients (15.2%) remained progression-free for >/=16 weeks. Median progression-free 
      survival was 1.9 months; median overall survival was 5.5 months. The most 
      frequent drug-related AEs were diarrhoea (80.4%), asthenia (47.8%), nausea 
      (43.5%) and rash (41.3%). PK assessments did not show obvious alterations for 
      either drug. CONCLUSION: Weekly alternating administration of BIBF 1120 and 
      afatinib is feasible; however, its efficacy was limited in this highly palliative 
      patient population.
FAU - Bouche, Olivier
AU  - Bouche O
AD  - CHU Reims, Reims, France. obouche@chu-reims.fr
FAU - Maindrault-Goebel, Frederique
AU  - Maindrault-Goebel F
FAU - Ducreux, Michel
AU  - Ducreux M
FAU - Lledo, Gerard
AU  - Lledo G
FAU - Andre, Thierry
AU  - Andre T
FAU - Stopfer, Peter
AU  - Stopfer P
FAU - Amellal, Nadia
AU  - Amellal N
FAU - Merger, Michael
AU  - Merger M
FAU - De Gramont, Aimery
AU  - De Gramont A
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - Greece
TA  - Anticancer Res
JT  - Anticancer research
JID - 8102988
RN  - 0 (Indoles)
RN  - 0 (Quinazolines)
RN  - 41UD74L59M (Afatinib)
RN  - G6HRD2P839 (nintedanib)
SB  - IM
MH  - Afatinib
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse 
      effects/pharmacokinetics
MH  - Colorectal Neoplasms/*drug therapy/metabolism
MH  - Disease-Free Survival
MH  - Drug Administration Schedule
MH  - Humans
MH  - Indoles/administration & dosage/adverse effects/pharmacokinetics
MH  - Male
MH  - Middle Aged
MH  - Quinazolines/administration & dosage/adverse effects/pharmacokinetics
MH  - Survival Rate
EDAT- 2011/07/09 06:00
MHDA- 2011/10/20 06:00
CRDT- 2011/07/09 06:00
PHST- 2011/07/09 06:00 [entrez]
PHST- 2011/07/09 06:00 [pubmed]
PHST- 2011/10/20 06:00 [medline]
AID - 31/6/2271 [pii]
PST - ppublish
SO  - Anticancer Res. 2011 Jun;31(6):2271-81.