Pilot study of irinotecan/oxalipltin (IROX) combination chemotherapy for patients with gemcitabine- and 5-fluorouracil- refractory pancreatic cancer

Invest New Drugs. 2010 Jun;28(3):343-9. doi: 10.1007/s10637-009-9265-1. Epub 2009 May 15.

Abstract

Background: Gemcitabine- and 5-fluorouracil (5-FU)- based chemotherapy is a commonly used adjuvant or palliative treatment for patients with pancreatic cancer. However, a standard chemotherapy regimen has yet to be developed for patients refractory to gemcitabine and 5-FU treatment. We attempted to evaluate the efficacy and safety of a combination of irinotecan and oxaliplatin (IROX) as a salvage treatment for patients with gemcitabine- and 5-FU- refractory pancreatic cancer.

Patients and methods: Patients with advanced pancreatic cancer who were refractory to prior gemcitabine- and 5-FU- based chemotherapy were enrolled in this study. IROX chemotherapy was administered as follows: Irinotecan, 150 mg/m(2) on day 1; and oxaliplatin, 85 mg/m(2) on day 1 over 90 min every 2 weeks.

Result: From Mar. 2006 to Dec. 2008, a total of 14 patients were administered 50 cycles of chemotherapy. The male-to-female ratio of the patient group was 11:3. These patients ranged in age from 48 to 73 years (median 65.5 years old). 3 patients (21.4%) evidenced partial responses. four patients (28.6%) exhibited stable disease. The median time to progression and overall survival time were 1.4 (95% CI: 1.2-1.6) months and 4.1 (95% CI: 2.0-6.2) months, respectively. Major hematologic toxicities included grade 1-2 anemia (88%), neutropenia (36%), thrombocytopenia (30%), and grade 3-4 neutropenia (10%). The most frequently detected non-hematological toxicities were grade 3 diarrheas (14%).

Conclusion: The IROX regimen appears to constitute a feasible and tolerable salvage therapy in patients with advanced pancreatic cancer who have been previously treated with gemcitabine- and 5-FU-based chemotherapy.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Camptothecin / adverse effects
  • Camptothecin / analogs & derivatives
  • Camptothecin / therapeutic use
  • Deoxycytidine / analogs & derivatives*
  • Deoxycytidine / therapeutic use
  • Disease-Free Survival
  • Dose-Response Relationship, Drug
  • Drug Resistance, Neoplasm / drug effects*
  • Female
  • Fluorouracil / therapeutic use*
  • Gemcitabine
  • Humans
  • Male
  • Middle Aged
  • Organoplatinum Compounds / adverse effects
  • Organoplatinum Compounds / therapeutic use
  • Pancreatic Neoplasms / drug therapy*
  • Pilot Projects
  • Salvage Therapy / adverse effects
  • Salvage Therapy / methods
  • Survival Analysis

Substances

  • Organoplatinum Compounds
  • Deoxycytidine
  • Fluorouracil
  • Camptothecin
  • Gemcitabine

Supplementary concepts

  • IROX protocol