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Annals of Surgical Oncology
Published in: Annals of Surgical Oncology 12/2005

01-12-2005

Docetaxel/Gemcitabine Followed by Gemcitabine and External Beam Radiotherapy in Patients With Pancreatic Adenocarcinoma

Authors: J. Marc Pipas, MD, Richard J. Barth Jr., MD, Bassem Zaki, MD, Michael J. Tsapakos, MD, Arief A. Suriawinata, MD, Michael A. Bettmann, MD, Justin M. Cates, MD, PhD, Gregory H. Ripple, MD, John E. Sutton, MD, Stuart R. Gordon, MD, Carol E. McDonnell, CCRP, Raymond P. Perez, MD, Nancy Redfield, ARNP, Louise P. Meyer, ARNP, John F. Marshall, MD, Bernard F. Cole, PhD, Thomas A. Colacchio, MD

Published in: Annals of Surgical Oncology | Issue 12/2005

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Abstract

Background

Pancreatic cancer remains highly lethal. Previous attempts with neoadjuvant therapy in this disease have been inconclusive, but a potential for benefit exists. We conducted a phase II trial of dose-intense docetaxel and gemcitabine followed by twice-weekly gemcitabine and external beam radiotherapy in patients with pancreatic adenocarcinoma.

Methods

Patients with stage I to III disease were eligible. Docetaxel 65 mg/m2 intravenously over 1 hour and gemcitabine 4000 mg/m2 given intravenously over 30 minutes were given on days 1, 15, and 29. On day 43, radiotherapy was begun at 50.4 Gy with gemcitabine 50 mg/m2 intravenously over 30 minutes twice weekly for 12 doses. After treatment, patients were considered for resection.

Results

Twenty-four assessable patients were recruited onto the trial. All but one patient completed a full 12 weeks of therapy. Grade 3 and 4 hematological and nonhematological toxicities were common but manageable, and neutropenic fever did not occur. No patient had local tumor progression. Twelve patients (50%) responded by Response Evaluation Criteria in Solid Tumors Group (RECIST) criteria, including one radiographic complete response. Seventeen patients underwent resection after therapy. Margin-negative resections were performed in 13 patients, including 9 patients whose disease was borderline or unresectable before treatment. A treatment effect was seen in all resection specimens. There have been no local recurrences of tumor, and several patients remain alive without evidence of disease.

Conclusions

Docetaxel/gemcitabine followed by gemcitabine/radiotherapy is active in the treatment of pancreatic adenocarcinoma, with manageable toxicity. Tumor downstaging occurs in some patients to allow complete resection. Further investigation of this regimen is warranted.
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Metadata
Title
Docetaxel/Gemcitabine Followed by Gemcitabine and External Beam Radiotherapy in Patients With Pancreatic Adenocarcinoma
Authors
J. Marc Pipas, MD
Richard J. Barth Jr., MD
Bassem Zaki, MD
Michael J. Tsapakos, MD
Arief A. Suriawinata, MD
Michael A. Bettmann, MD
Justin M. Cates, MD, PhD
Gregory H. Ripple, MD
John E. Sutton, MD
Stuart R. Gordon, MD
Carol E. McDonnell, CCRP
Raymond P. Perez, MD
Nancy Redfield, ARNP
Louise P. Meyer, ARNP
John F. Marshall, MD
Bernard F. Cole, PhD
Thomas A. Colacchio, MD
Publication date
01-12-2005
Publisher
Springer-Verlag
Published in
Annals of Surgical Oncology / Issue 12/2005
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/ASO.2005.04.503

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