Document Detail

Phase 2 study of erlotinib combined with adjuvant chemoradiation and chemotherapy in patients with resectable pancreatic cancer.
MedLine Citation:
PMID:  23773391     Owner:  NLM     Status:  MEDLINE    
PURPOSE: Long-term survival rates for patients with resected pancreatic ductal adenocarcinoma (PDAC) have stagnated at 20% for more than a decade, demonstrating the need to develop novel adjuvant therapies. Gemcitabine-erlotinib therapy has demonstrated a survival benefit for patients with metastatic PDAC. Here we report the first phase 2 study of erlotinib in combination with adjuvant chemoradiation and chemotherapy for resected PDAC.
METHODS AND MATERIALS: Forty-eight patients with resected PDAC received adjuvant erlotinib (100 mg daily) and capecitabine (800 mg/m(2) twice daily Monday-Friday) concurrently with intensity modulated radiation therapy (IMRT), 50.4 Gy over 28 fractions followed by 4 cycles of gemcitabine (1000 mg/m(2) on days 1, 8, and 15 every 28 days) and erlotinib (100 mg daily). The primary endpoint was recurrence-free survival (RFS).
RESULTS: The median follow-up time was 18.2 months (interquartile range, 13.8-27.1). Lymph nodes were positive in 85% of patients, and margins were positive in 17%. The median RFS was 15.6 months (95% confidence interval [CI], 13.4-17.9), and the median overall survival (OS) was 24.4 months (95% CI, 18.9-29.7). Multivariate analysis with adjustment for known prognostic factors showed that tumor diameter >3 cm was predictive for inferior RFS (hazard ratio, 4.01; P=.001) and OS (HR, 4.98; P=.02), and the development of dermatitis was associated with improved RFS (HR, 0.27; P=.009). During CRT and post-CRT chemotherapy, the rates of grade 3/4 toxicity were 31%/2% and 35%/8%, respectively.
CONCLUSION: Erlotinib can be safely administered with adjuvant IMRT-based CRT and chemotherapy. The efficacy of this regimen appears comparable to that of existing adjuvant regimens. Radiation Therapy Oncology Group 0848 will ultimately determine whether erlotinib produces a survival benefit in patients with resected pancreatic cancer.
Joseph M Herman; Katherine Y Fan; Aaron T Wild; Amy Hacker-Prietz; Laura D Wood; Amanda L Blackford; Susannah Ellsworth; Lei Zheng; Dung T Le; Ana De Jesus-Acosta; Manuel Hidalgo; Ross C Donehower; Richard D Schulick; Barish H Edil; Michael A Choti; Ralph H Hruban; Timothy M Pawlik; John L Cameron; Daniel A Laheru; Christopher L Wolfgang
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  International journal of radiation oncology, biology, physics     Volume:  86     ISSN:  1879-355X     ISO Abbreviation:  Int. J. Radiat. Oncol. Biol. Phys.     Publication Date:  2013 Jul 
Date Detail:
Created Date:  2013-06-18     Completed Date:  2013-08-22     Revised Date:  2014-06-16    
Medline Journal Info:
Nlm Unique ID:  7603616     Medline TA:  Int J Radiat Oncol Biol Phys     Country:  United States    
Other Details:
Languages:  eng     Pagination:  678-85     Citation Subset:  IM    
Copyright Information:
Copyright © 2013 Elsevier Inc. All rights reserved.
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MeSH Terms
Aged, 80 and over
Analysis of Variance
Antineoplastic Agents / administration & dosage,  adverse effects,  therapeutic use*
Antineoplastic Combined Chemotherapy Protocols / therapeutic use
Carcinoma, Pancreatic Ductal / mortality,  pathology,  therapy*
Chemoradiotherapy, Adjuvant / adverse effects,  methods*
Deoxycytidine / administration & dosage,  analogs & derivatives
Dose Fractionation
Drug Eruptions / etiology,  pathology
Fluorouracil / administration & dosage,  analogs & derivatives
Middle Aged
Neoplasm Recurrence, Local
Pancreatic Neoplasms / mortality,  pathology,  therapy*
Quality of Life
Quinazolines / administration & dosage,  adverse effects,  therapeutic use*
Radiotherapy, Intensity-Modulated
Grant Support
K23 CA163672/CA/NCI NIH HHS; P30 CA006973/CA/NCI NIH HHS; P50 CA062924/CA/NCI NIH HHS
Reg. No./Substance:
0/Antineoplastic Agents; 0/Quinazolines; 0W860991D6/Deoxycytidine; 6804DJ8Z9U/capecitabine; B76N6SBZ8R/gemcitabine; J4T82NDH7E/erlotinib; U3P01618RT/Fluorouracil

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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