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A Phase II Trial of Irinotecan in Patients with Previously Untreated Advanced Esophageal and Gastric Adenocarcinoma

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Abstract

Chemotherapy options for esophagogastric adenocarcinoma remain limited. Irinotecan has demonstrated broad activity in a variety of epithelial malignancies. Forty-six patients with previously untreated, measurable, unresectable, or metastatic esophagogastric adenocarcinoma were enrolled. Patients received irinotecan (125 mg/m2intravenously over 90 min weekly) for 4 consecutive weeks followed by a 2-week rest. Forty-three patients received at least one treatment and were evaluable for response and toxicity. One complete and five partial responses were observed, for an overall response rate of 14% (95% CI, 4–24%). Median survival for all 43 patients was 6.4 months (95% CI, 4.6–8.2 months). Grade 3 to 4 toxicity included 10 patients (23%) with neutropenia, 13 patients (30%) with late diarrhea, 6 patients (14%) with vomiting, and 6 patients (14%) with fatigue. We conclude that although single-agent irinotecan is an active agent for esophagogastric adenocarcinoma, the schedule utilized in this trial is associated with moderate toxicity. When used as a single-agent, a triweekly schedule may be preferable for this patient population.

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Authors and Affiliations

  1. Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA

    Peter C. Enzinger MD, Matthew H. Kulke MD, Craig C. Earle MSc, MD, Michele M. Vincitore BA, Ann L. Michelini RN, MSN, Robert J. Mayer MD & Charles S. Fuchs MD, MPH

  2. Department of Biostatistics, Dana-Farber Cancer Institute, Boston, Massachusetts, USA

    Haesook Kim PhD

  3. Division of Hematology/Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA

    Jeffrey W. Clark MD & David P. Ryan MD

  4. Department of Channing Laboratory, Brigham and Women's Hospital, Boston, Massachusetts, USA

    Charles S. Fuchs MD, MPH

  5. Dana-Farber Cancer Institute, 44 Binney Street, Boston, Massachusetts, 02115, USA

    Peter C. Enzinger MD

Authors
  1. Peter C. Enzinger MD
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  2. Matthew H. Kulke MD
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  3. Jeffrey W. Clark MD
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  4. David P. Ryan MD
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  5. Haesook Kim PhD
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  6. Craig C. Earle MSc, MD
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  7. Michele M. Vincitore BA
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  8. Ann L. Michelini RN, MSN
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  9. Robert J. Mayer MD
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  10. Charles S. Fuchs MD, MPH
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Corresponding author

Correspondence to Peter C. Enzinger MD.

Additional information

This study was supported by Pfizer Oncology, Inc.

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Enzinger, P.C., Kulke, M.H., Clark, J.W. et al. A Phase II Trial of Irinotecan in Patients with Previously Untreated Advanced Esophageal and Gastric Adenocarcinoma. Dig Dis Sci 50, 2218–2223 (2005). https://doi.org/10.1007/s10620-005-3038-2

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  • DOI: https://doi.org/10.1007/s10620-005-3038-2

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