PMID- 21104328
OWN - NLM
STAT- MEDLINE
DCOM- 20110721
LR  - 20221207
IS  - 1534-4681 (Electronic)
IS  - 1068-9265 (Linking)
VI  - 18
IP  - 4
DP  - 2011 Apr
TI  - Phase II study of gemcitabine and erlotinib as adjuvant therapy for patients with 
      resected pancreatic cancer.
PG  - 1122-9
LID - 10.1245/s10434-010-1401-9 [doi]
AB  - BACKGROUND: There is currently no consensus about the most effective adjuvant 
      therapy for adenocarcinoma of the pancreas. Both gemcitabine and erlotinib have 
      been demonstrated to improve survival in patients with metastatic disease. This 
      study was designed to evaluate the efficacy of gemcitabine and erlotinib as 
      adjuvant therapy, and to explore potential biomarkers associated with response. 
      METHODS: An institutional review board-approved single-center phase II trial of 
      adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m(2)) and daily erlotinib 
      (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 
      8 months was initiated. Primary end point was recurrence-free survival (RFS). 
      Epidermal growth factor receptor (EGFR) expression in the resected tumors was 
      assessed by fluorescence in situ hybridization (FISH) and immunohistochemistry 
      (IHC). RESULTS: The study completed planned accrual of 25 patients. Median 
      follow-up was 18.2 (range 11.6-23.5) months. Recurrences were observed in 17 
      subjects (68%). Median RFS was 14.0 months (95% confidence interval [95% CI], 
      8.2-24.5) with 1-year and 2-year RFS of 56% (95% CI, 35-73) and 26% (95% CI, 
      6-52), respectively. Median overall survival was not reached. Estimated 1-year 
      and 2-year overall survival was 84% (95% CI, 63-94) and 53% (95% CI, 22-76), 
      respectively. Nine patients (36%) had a grade 3 event and only 1 (4%) had a grade 
      4 (neutropenia). Most toxicities were dermatologic, gastrointestinal, and 
      constitutional. There were nonsignificant trends to longer RFS and lower 
      recurrence rates while receiving therapy in subjects with fluorescence in situ 
      hybridization-positive tumors and greater immunohistochemistry expression. 
      CONCLUSIONS: Our phase II results suggest that adjuvant gemcitabine and erlotinib 
      is a promising regimen that merits further investigation.
FAU - Bao, Philip Q
AU  - Bao PQ
AD  - Department of Surgery, Stony Brook University Hospital, Stony Brook, NY, USA.
FAU - Ramanathan, Ramesh K
AU  - Ramanathan RK
FAU - Krasinkas, Alyssa
AU  - Krasinkas A
FAU - Bahary, Nathan
AU  - Bahary N
FAU - Lembersky, Barry C
AU  - Lembersky BC
FAU - Bartlett, David L
AU  - Bartlett DL
FAU - Hughes, Steven J
AU  - Hughes SJ
FAU - Lee, Kenneth K
AU  - Lee KK
FAU - Moser, A James
AU  - Moser AJ
FAU - Zeh, Herbert J 3rd
AU  - Zeh HJ 3rd
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20101123
PL  - United States
TA  - Ann Surg Oncol
JT  - Annals of surgical oncology
JID - 9420840
RN  - 0 (Quinazolines)
RN  - 0W860991D6 (Deoxycytidine)
RN  - DA87705X9K (Erlotinib Hydrochloride)
RN  - EC 2.7.10.1 (EGFR protein, human)
RN  - EC 2.7.10.1 (ErbB Receptors)
RN  - 0 (Gemcitabine)
SB  - IM
EIN - Ann Surg Oncol. 2011 Dec;18 Suppl 3:S323
CIN - Ann Surg Oncol. 2011 Dec;18 Suppl 3:S246-7. PMID: 21630121
MH  - Adenocarcinoma/*drug therapy/secondary/surgery
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Chemotherapy, Adjuvant
MH  - Deoxycytidine/administration & dosage/analogs & derivatives
MH  - ErbB Receptors/antagonists & inhibitors/genetics/metabolism
MH  - Erlotinib Hydrochloride
MH  - Female
MH  - Humans
MH  - Immunoenzyme Techniques
MH  - In Situ Hybridization, Fluorescence
MH  - Male
MH  - Middle Aged
MH  - Pancreatectomy
MH  - Pancreatic Neoplasms/*drug therapy/pathology/surgery
MH  - Quinazolines/administration & dosage
MH  - Survival Rate
MH  - Treatment Outcome
MH  - Gemcitabine
EDAT- 2010/11/26 06:00
MHDA- 2011/07/22 06:00
CRDT- 2010/11/25 06:00
PHST- 2010/05/07 00:00 [received]
PHST- 2010/11/25 06:00 [entrez]
PHST- 2010/11/26 06:00 [pubmed]
PHST- 2011/07/22 06:00 [medline]
AID - 10.1245/s10434-010-1401-9 [doi]
PST - ppublish
SO  - Ann Surg Oncol. 2011 Apr;18(4):1122-9. doi: 10.1245/s10434-010-1401-9. Epub 2010 
      Nov 23.