Multicenter phase-II trial of irinotecan plus oxaliplatin [IROX regimen] in patients with poor-prognosis cancer of unknown primary: a hellenic cooperative oncology group study.

Abstract

BACKGROUND:

Cancer of unknown primary (CUP) lacks established therapy although it affects 3% of cancer patients. We evaluated the irinotecan-oxaliplatin combination (IROX regimen) in previously untreated patients with non-favorable subsets of unknown primary carcinomas.

METHODS:

This was a multicenter phase-II trial. Protocol treatment consisted of oxaliplatin 80 mg/m(2) followed by irinotecan 160 mg/m(2) administered every 3 weeks. The primary end points were response rate and toxicity, and secondary end points were time to progression and survival.

RESULTS:

Forty-seven patients with liver, bone or multiple visceral metastases entered into the trial and received a median 6 chemotherapy cycles (1-11). The regimen was very well tolerated with one febrile neutropenia case and six cases with diarrhea grade 3 (16%). In intent-to-treat analysis the tumor response rate was 13% (95% CI = 4.8-25.7%) and 12 patients (27%, 95%CI 13.9-40.4%) had at least 4 months' duration of disease stabilization. The median time to progression was 2.7 months and the median survival was 9.5 months, with 40% of patients alive at 1 year.

CONCLUSIONS:

The IROX regimen demonstrated similar efficacy and a favorable toxicity profile compared to other more toxic chemotherapy combinations in patients with poor-prognosis CUP.

• Authors: E Briasoulis, G Fountzilas, A Bamias, M A Dimopoulos, N Xiros, G Aravantinos, E Samantas, H Kalofonos, T Makatsoris, N Mylonakis, P Papakostas, D Skarlos, I Varthalitis, N Pavlidis
• Journal: Cancer chemotherapy and pharmacology (Cancer Chemother Pharmacol) Vol. 62 Issue 2 Pg. 277-84 (Jul 2008) ISSN: 0344-5704 [Print] Germany
• PMID: 17901952 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Organoplatinum Compounds
• Oxaliplatin
• Irinotecan
• Camptothecin

Topics

• Adenocarcinoma (drug therapy, mortality, secondary)
• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Camptothecin (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Disease-Free Survival
• Drug Administration Schedule
• Female
• Humans
• Irinotecan
• Male
• Middle Aged
• Neoplasms, Unknown Primary (drug therapy, mortality)
• Organoplatinum Compounds (administration & dosage, adverse effects, therapeutic use)
• Oxaliplatin