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- Title
Salvage Therapy with Mitomycin and Ifosfamide in Patients with Gemcitabine-Resistant Metastatic Pancreatic Cancer: A Phase II Trial.
- Authors
Cereda, Stefano; Reni, Michele; Rognone, Alessia; Fugazza, Clara; Ghidini, Michele; Ceraulo, Domenica; Brioschi, Matteo; Nicoletti, Roberto; Villa, Eugenio
- 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/m2 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. Copyright © 2011 S. Karger AG, Basel
- Subjects
PANCREATIC cancer treatment; MITOMYCIN C; METASTASIS; CANCER patients; DRUG resistance in cancer cells; CLINICAL trials; HEALTH outcome assessment; DRUG toxicity
- Publication
Chemotherapy (0009-3157), 2011, Vol 57, Issue 2, p156
- ISSN
0009-3157
- Publication type
Article
- DOI
10.1159/000324865