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Table of Contents
Vol. 72, No. 5-6, 2007
Issue release date: February 2008
Section title: Clinical Study
Oncology 2007;72:279–284
(DOI:10.1159/000113039)

Irinotecan plus Gemcitabine and 5-Fluorouracil in Advanced Pancreatic Cancer: A Phase II Study

Endlicher E. · Troppmann M. · Kullmann A. · Gölder S. · Herold T. · Herfarth H. · Grossmann J. · Schlottmann K. · Kullmann F.
aDepartment of Internal Medicine I and bInstitute of Radiology, University of Regensburg, Regensburg, Germany

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Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Received: 1/30/2007
Accepted: 7/19/2007
Published online: 1/11/2008

Number of Print Pages: 6
Number of Figures: 1
Number of Tables: 2

ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)

For additional information: http://www.karger.com/OCL

Abstract

Aims: The aim of the present study was to evaluate the 6-month survival rate of patients with inoperable or metastatic pancreatic cancer treated with irinotecan and gemcitabine plus 5-fluorouracil. Secondary efficacy end points included response rate, time to progression (TTP), overall survival (OS) and toxicity. Patients and Methods: 30 patients with histologically proven pancreatic carcinoma and at least one bidimensionally measurable lesion were enrolled. Of the patients, 83% had metastatic and 17% locally advanced disease. One cycle, lasting 21 days, comprised treatment on days 1 and 8 consisting of 75 mg/m2 irinotecan i.v. for 90 min, 1,000 mg/m2 gemcitabine i.v. for 30 min and 2,000 mg/m2 fluorouracil (5-FU) for 24 h. A total of six cycles was planned for each patient. Results: 28 patients competed at least one treatment cycle and were therefore assessable for efficacy, and 75% of them achieved the primary end point of the study (survival after 6 months). One-year survival was 25%. Stabilization (partial response and stable disease) was observed in 35.7% (10/28) and partial remission in 7.1% (2/28). The objective response rate was 7.1% (2/28) after completion of the six cycles. Median TTP was 3.4 months (1.2–11.5), and median OS was 8.3 months (2.1–36.2). Regarding severe hematological toxicities, only neutropenia was observed (grade 3 20.7%, 6/29, and grade 4 3.5%, 1/29). In spite of anti-emetic supportive care, nausea affected most of the patients: 79.3% (23/29). Grade 3 vomiting was observed in 4 of the 29 patients (13.8%) and grade 4 in 1 patient (3.5%). Only 1 patient experienced diarrhea grade 3 (3.5%) and 1 patient (3.5%) suffered from a grade 3 peroneal nerve enervation. Conclusions: A combination of irinotecan, gemcitabine and 5-FU is feasible and shows considerable efficacy in patients with inoperable or metastatic pancreatic cancer. Due to its low toxicity, this combination might be an interesting cytotoxic regimen in addition to targeted therapies.


  

Author Contacts

F. Kullmann, MD
University of Regensburg
DE–93042 Regensburg (Germany)
Tel. +49 941 9447 003, Fax +49 941 9447 004
E-Mail frank.kullmann@klinik.uni-regensburg.de

  

Article Information

Received: January 30, 2007
Accepted after revision: July 19, 2007
Published online: January 11, 2008
Number of Print Pages : 6
Number of Figures : 1, Number of Tables : 2, Number of References : 21

  

Publication Details

Oncology (International Journal of Cancer Research and Treatment)

Vol. 72, No. 5-6, Year 2007 (Cover Date: February 2008)

Journal Editor: Markman, M. (Houston, Tex.)
ISSN: 0030–2414 (Print), eISSN: 1423–0232 (Online)

For additional information: http://www.karger.com/OCL


Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Received: 1/30/2007
Accepted: 7/19/2007
Published online: 1/11/2008

Number of Print Pages: 6
Number of Figures: 1
Number of Tables: 2

ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)

For additional information: http://www.karger.com/OCL


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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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