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PMID: 18247017 Published · ppublish English Clinical Trial, Phase III Journal Article Randomized Controlled Trial

Erlotinib/gemcitabine for first-line treatment of locally advanced or metastatic adenocarcinoma of the pancreas.

Oncology (Williston Park, N.Y.) ·Vol. 21 ·No. 14 ·2007-12-00 ·Pages 1696-706; discussion 1706-9, 1712, 1715

Senderowicz AM, Johnson JR, Sridhara R, Zimmerman P, Justice R, Pazdur R

Abstract

Erlotinib (Tarceva) is a human epidermal growth factor receptor type 1/epidermal growth factor receptor (HER1/EGFR) tyrosine kinase inhibitor initially approved by the US Food and Drug Administration for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of at least one prior chemotherapy regimen. In this report, we present the pivotal study that led to the approval of erlotinib in combination with gemcitabine (Gemzar) in patients with locally advanced/metastatic chemonaive pancreatic cancer patients. The combination demonstrated a statistically significant increase in overall survival accompanied by an increase in toxicity. Physicians and patients now have a new option for the treatment of locally advanced/metastatic adenocarcinoma of the pancreas.

MeSH Terms
Adenocarcinoma/drug therapy,secondary Adult Aged Aged, 80 and over Antimetabolites, Antineoplastic/administration & dosage,adverse effects Antineoplastic Combined Chemotherapy Protocols/adverse effects,therapeutic use Cohort Studies Deoxycytidine/administration & dosage,adverse effects,analogs & derivatives Double-Blind Method ErbB Receptors/antagonists & inhibitors Erlotinib Hydrochloride Female Humans Male Middle Aged Pancreatic Neoplasms/drug therapy,pathology Protein Kinase Inhibitors/administration & dosage,adverse effects Quinazolines/administration & dosage,adverse effects Survival Analysis
Chemicals
Antimetabolites, Antineoplastic Protein Kinase Inhibitors Quinazolines Deoxycytidine gemcitabine Erlotinib Hydrochloride ErbB Receptors
Authors & Affiliations
6 authors, click to expand affiliations / ORCID
Senderowicz Adrian M
Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA. adrian.senderowicz@fda.gov
Johnson John R
Sridhara Rajeshwari
Zimmerman Paul
Justice Robert
Pazdur Richard
Article Info
Journal
Oncology (Williston Park, N.Y.)
Abbr.
Oncology (Williston Park)
ISSN
0890-9091
Published
2007-12-00
Pages
1696-706; discussion 1706-9, 1712, 1715
Language
English
Region
United States
NLM ID
8712059
Subset
IM
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