Salvage therapy with mitomycin and ifosfamide in patients with gemcitabine-resistant metastatic pancreatic cancer: A phase II trial

Stefano Cereda, Michele Reni, Alessia Rognone, Clara Fugazza, Michele Ghidini, Domenica Ceraulo, Matteo Brioschi, Roberto Nicoletti, Eugenio Villa

Research output: Contribution to journalArticle

Abstract

Background: At the time of upfront treatment failure, over half of the patients with advanced pancreatic cancer are candidates for further treatment. Methods: Patients with metastatic gemcitabine-resistant pancreatic cancer were treated with mitomycin 8 mg/m2 on day 1, ifosfamide 2,500 mg/m 2 and mesna 3,000 mg/m2 on days 1-3 every 28 days until progressive disease. A positive responder was defined as a patient who was progression free at 6 months from trial enrolment. According to the Fleming design, a sample size of 34 patients was estimated assuming p0 = 0.05 and p1 = 0.20. Results: Between May 2006 and December 2007, 21 patients (median age 56 years; median Karnofsky performance score 80) were enrolled. One patient died before receiving any treatment. Eighteen patients interrupted chemotherapy due to progressive disease (n = 15), toxicity (n = 2) or refusal (n = 1). Grade >2 toxicity consisted of neutropenia in 80% of patients, thrombocytopenia and fatigue in 20% and anemia in 10%. Only 1 patient was progression free at 6 months (5%). One patient had a partial response (5%) and 2 patients had stable disease (10%). Median survival was 3.7 months. Conclusion: Based on the poor outcome observed and on the high level of grade 3-4 toxicity, the trial was prematurely stopped and the mitomycin and ifosfamide regimen was considered insufficiently active in gemcitabine-pretreated advanced pancreatic cancer.

Original languageEnglish
Pages (from-to)156-161
Number of pages6
JournalChemotherapy
Volume57
Issue number2
DOIs
Publication statusPublished - Apr 2011

Keywords

  • Gemcitabine resistance
  • Mitomycin/ifosfamide therapy
  • Pancreatic cancer

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Oncology
  • Infectious Diseases
  • Pharmacology
  • Drug Discovery

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    Cereda, S., Reni, M., Rognone, A., Fugazza, C., Ghidini, M., Ceraulo, D., Brioschi, M., Nicoletti, R., & Villa, E. (2011). Salvage therapy with mitomycin and ifosfamide in patients with gemcitabine-resistant metastatic pancreatic cancer: A phase II trial. Chemotherapy, 57(2), 156-161. https://doi.org/10.1159/000324865