PMID- 27232378
OWN - NLM
STAT- MEDLINE
DCOM- 20180209
LR  - 20191101
IS  - 1097-0347 (Electronic)
IS  - 1043-3074 (Print)
IS  - 1043-3074 (Linking)
VI  - 38
IP  - 12
DP  - 2016 Dec
TI  - Phase II trial of everolimus in patients with previously treated recurrent or 
      metastatic head and neck squamous cell carcinoma.
PG  - 1759-1764
LID - 10.1002/hed.24501 [doi]
AB  - BACKGROUND: Patients with recurrent/metastatic head and neck squamous cell 
      carcinoma (HNSCC) demonstrate aberrant activation of the 
      phosphotidylinositol-3-kinase (PI3K)/Akt/mammalian target of rapamycin (mTOR) 
      pathway. We examined the efficacy of everolimus, an mTOR inhibitor, in patients 
      with recurrent or metastatic HNSCC. METHODS: This single-arm phase II study 
      enrolled biomarker-unselected patients with recurrent or metastatic HNSCC who 
      failed at least 1 prior therapy. Everolimus was administered until progressive 
      disease or unacceptable toxicity. Primary endpoint was clinical benefit rate 
      (CBR). Secondary endpoints included progression-free survival (PFS), overall 
      survival (OS), and evaluation of tissue and serum biomarkers related to the 
      PIK3CA pathway. RESULTS: Seven of 9 patients treated in the first stage were 
      evaluable. No objective responses were seen; CBR was 28%. Three patients 
      discontinued everolimus because of toxicity. Median PFS and OS were 1.5 and 4.5 
      months, respectively. No activating PI3K mutations were identified in available 
      tumor tissue. CONCLUSION: Everolimus was not active as monotherapy in unselected 
      patients with recurrent/metastatic HNSCC. (c) 2016 Wiley Periodicals, Inc. Head 
      Neck 38: 1759-1764, 2016.
CI  - (c) 2016 Wiley Periodicals, Inc.
FAU - Geiger, Jessica L
AU  - Geiger JL
AD  - Department of Internal Medicine, Division of Hematology/Oncology, University of 
      Pittsburgh, Pittsburgh, Pennsylvania.
FAU - Bauman, Julie E
AU  - Bauman JE
AD  - Department of Internal Medicine, Division of Hematology/Oncology, University of 
      Pittsburgh, Pittsburgh, Pennsylvania.
FAU - Gibson, Michael K
AU  - Gibson MK
AD  - Department of Internal Medicine, Division of Hematology/Oncology, Case Western 
      University, Cleveland, Ohio.
FAU - Gooding, William E
AU  - Gooding WE
AD  - Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer 
      Institute, Pittsburgh, Pennsylvania.
FAU - Varadarajan, Prakash
AU  - Varadarajan P
AD  - Department of Medicine, Division of Hematology/Oncology, University of Texas 
      Health Science Center at San Antonio, San Antonio, Texas.
FAU - Kotsakis, Athanasios
AU  - Kotsakis A
AD  - School of Medicine, University of Crete, Crete, Greece.
FAU - Martin, Daniel
AU  - Martin D
AD  - National Institute of Dental and Craniofacial Research, Bethesda, Maryland.
FAU - Gutkind, Jorge Silvio
AU  - Gutkind JS
AD  - National Institute of Dental and Craniofacial Research, Bethesda, Maryland.
FAU - Hedberg, Matthew L
AU  - Hedberg ML
AD  - Department of Pharmacology and Chemical Biology, University of Pittsburgh, 
      Pittsburgh, Pennsylvania.
FAU - Grandis, Jennifer R
AU  - Grandis JR
AD  - Department of Otolaryngology, University of California San Francisco, San 
      Francisco, California.
FAU - Argiris, Athanassios
AU  - Argiris A
AD  - Department of Medicine, Division of Hematology/Oncology, University of Texas 
      Health Science Center at San Antonio, San Antonio, Texas.
AD  - Department of Medical Oncology, Hygeia Hospital, Athens, Greece.
LA  - eng
GR  - KL2 TR000143/TR/NCATS NIH HHS/United States
GR  - P30 CA047904/CA/NCI NIH HHS/United States
GR  - F30 CA180235/CA/NCI NIH HHS/United States
GR  - R01 CA077308/CA/NCI NIH HHS/United States
GR  - R01 CA098372/CA/NCI NIH HHS/United States
GR  - P50 CA097190/CA/NCI NIH HHS/United States
GR  - R01 DE023685/DE/NIDCR NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
DEP - 20160527
PL  - United States
TA  - Head Neck
JT  - Head & neck
JID - 8902541
RN  - 9HW64Q8G6G (Everolimus)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Carcinoma, Squamous Cell/*drug therapy/mortality/*pathology
MH  - Disease-Free Survival
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Everolimus/adverse effects/*therapeutic use
MH  - Female
MH  - Head and Neck Neoplasms/*drug therapy/mortality/*pathology
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Neoplasm Invasiveness/pathology
MH  - Neoplasm Recurrence, Local/*drug therapy/mortality/pathology
MH  - Neoplasm Staging
MH  - Prognosis
MH  - Risk Assessment
MH  - Survival Analysis
MH  - Treatment Outcome
PMC - PMC6820341
MID - NIHMS1052977
OTO - NOTNLM
OT  - PIK3CA mutations
OT  - clinical trial
OT  - everolimus
OT  - head and neck squamous cell carcinoma (HNSCC)
OT  - mammalian target of rapamycin (mTOR) inhibitors
EDAT- 2016/05/28 06:00
MHDA- 2018/02/10 06:00
PMCR- 2019/10/30
CRDT- 2016/05/28 06:00
PHST- 2016/04/22 00:00 [accepted]
PHST- 2016/05/28 06:00 [pubmed]
PHST- 2018/02/10 06:00 [medline]
PHST- 2016/05/28 06:00 [entrez]
PHST- 2019/10/30 00:00 [pmc-release]
AID - 10.1002/hed.24501 [doi]
PST - ppublish
SO  - Head Neck. 2016 Dec;38(12):1759-1764. doi: 10.1002/hed.24501. Epub 2016 May 27.