title: Salvage therapy with mitomycin and ifosfamide in patients with gemcitabine-resistant metastatic pancreatic cancer: a phase II trial.
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/m(2) on day 1, ifosfamide 2,500 mg/m(2) and mesna 3,000 mg/m(2) 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 enrollment. 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.
  
  
  CONCLUSIONS
  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.
authors: Department of Oncology, S. Raffaele Scientific Institute, Milan, Italy.
authors: Stefano
authors: S
authors: Cereda
authors: Michele
authors: M
authors: Reni
authors: Alessia
authors: A
authors: Rognone
authors: Clara
authors: C
authors: Fugazza
authors: Michele
authors: M
authors: Ghidini
authors: Domenica
authors: D
authors: Ceraulo
authors: Matteo
authors: M
authors: Brioschi
authors: Roberto
authors: R
authors: Nicoletti
authors: Eugenio
authors: E
authors: Villa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000494:pharmacology; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D016879:Salvage Therapy / Q000379:methods; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D016685:Mitomycin; D007069:Ifosfamide; D000093542:Gemcitabine