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
Ημερομηνία
2008Συγγραφέας
Briassoulis, E. ChFountzilas, George
Bamias, A. T.
Dimopoulos, M. A.
Xiros, N.
Aravantinos, Gerasimos
Samantas, E.
Kalofonos, H. P.
Makatsoris, T.
Mylonakis, N.
Papakostas, P.
Skarlos, Dimosthenis V.
Varthalitis, I.
Pavlidis, Nicholas
Source
Cancer chemotherapy and pharmacologyVolume
62Issue
2Pages
277-284Google Scholar check
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Εμφάνιση πλήρους εγγραφήςΕπιτομή
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/m2 followed by irinotecan 160 mg/m2 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. © 2007 Springer-Verlag.
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