PMID- 23108949
OWN - NLM
STAT- MEDLINE
DCOM- 20130730
LR  - 20200206
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Linking)
VI  - 24
IP  - 3
DP  - 2013 Mar
TI  - A phase II trial of dacomitinib, an oral pan-human EGF receptor (HER) inhibitor, 
      as first-line treatment in recurrent and/or metastatic squamous-cell carcinoma of 
      the head and neck.
PG  - 761-9
LID - 10.1093/annonc/mds503 [doi]
AB  - BACKGROUND: An open-label, multicenter, single-arm phase II trial was conducted 
      to investigate the clinical activity of dacomitinib in recurrent/metastatic 
      squamous-cell carcinoma of the head and neck (RM-SCCHN). PATIENTS AND METHODS: 
      Eligible patients were administered dacomitinib at 45 mg orally daily, in 21-day 
      cycles. Primary end point was objective response rate. RESULTS: Sixty-nine 
      patients were enrolled with a median age of 62 years. Among response-evaluable 
      patients, 8 [12.7%, 95% confidence interval (CI) 5.6% to 23.5%] achieved a 
      partial response and 36 (57.1%) had stable disease, lasting >/=24 weeks in 9 
      patients (14.3%). The median progression-free survival (PFS) was 12.1 weeks and 
      the median overall survival (OS) was 34.6 weeks. Most adverse events (AEs) were 
      tolerable. The most common grade 3 or higher treatment-related AEs were diarrhea 
      (15.9%), acneiform dermatitis (8.7%), and fatigue (8.7%). Treatment-related AEs 
      led to at least one dose interruption in 28 (40.6%) patients and dose reductions 
      in 26 (37.7%). Permanent treatment discontinuation occurred in 8 (11.6%) patients 
      due to treatment-related AEs. CONCLUSIONS: Dacomitinib demonstrated clinical 
      activity in RM-SCCHN, and the primary end point of this study was met. The 
      toxicity profile of this agent was generally manageable with dose interruptions 
      and adjustments.
FAU - Abdul Razak, A R
AU  - Abdul Razak AR
AD  - Department of Medical Oncology, Princess Margaret Hospital, University of 
      Toronto, Toronto.
FAU - Soulieres, D
AU  - Soulieres D
FAU - Laurie, S A
AU  - Laurie SA
FAU - Hotte, S J
AU  - Hotte SJ
FAU - Singh, S
AU  - Singh S
FAU - Winquist, E
AU  - Winquist E
FAU - Chia, S
AU  - Chia S
FAU - Le Tourneau, C
AU  - Le Tourneau C
FAU - Nguyen-Tan, P-F
AU  - Nguyen-Tan PF
FAU - Chen, E X
AU  - Chen EX
FAU - Chan, K K
AU  - Chan KK
FAU - Wang, T
AU  - Wang T
FAU - Giri, N
AU  - Giri N
FAU - Mormont, C
AU  - Mormont C
FAU - Quinn, S
AU  - Quinn S
FAU - Siu, L L
AU  - Siu LL
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20121028
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Quinazolinones)
RN  - 5092U85G58 (dacomitinib)
RN  - EC 2.7.10.1 (ErbB Receptors)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*administration & dosage/adverse effects/pharmacokinetics
MH  - Carcinoma, Squamous Cell/*drug therapy/mortality/secondary
MH  - Diarrhea/chemically induced
MH  - ErbB Receptors/*antagonists & inhibitors
MH  - Female
MH  - Head and Neck Neoplasms/*drug therapy/mortality/pathology
MH  - Humans
MH  - Induction Chemotherapy
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local/*drug therapy/mortality
MH  - Quinazolinones/*administration & dosage/adverse effects/pharmacokinetics
MH  - Treatment Outcome
EDAT- 2012/10/31 06:00
MHDA- 2013/07/31 06:00
CRDT- 2012/10/31 06:00
PHST- 2012/10/31 06:00 [entrez]
PHST- 2012/10/31 06:00 [pubmed]
PHST- 2013/07/31 06:00 [medline]
AID - S0923-7534(19)37131-5 [pii]
AID - 10.1093/annonc/mds503 [doi]
PST - ppublish
SO  - Ann Oncol. 2013 Mar;24(3):761-9. doi: 10.1093/annonc/mds503. Epub 2012 Oct 28.