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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

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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/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.

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Acknowledgments

The authors wish to thank Georgia Vourli for excellent job in statistical analysis of this study.

Author information

Authors and Affiliations

  1. Ioannina University Hospital, Ioannina, Greece

    E. Briasoulis & N. Pavlidis

  2. Thessaloniki University Hospital “Papageorgiou”, Thessaloniki, Greece

    G. Fountzilas

  3. Athens University Hospital “Alexandra”, Athens, Greece

    A. Bamias & M. A. Dimopoulos

  4. Athens University Hospital “Attikon”, Athens, Greece

    N. Xiros

  5. Agioi Anargyroi Cancer Hospital, Athens, Greece

    G. Aravantinos & E. Samantas

  6. Patras, University Hospital, Rion, Greece

    H. Kalofonos & T. Makatsoris

  7. Metaxa Cancer Hosptital, Piraeus, Greece

    N. Mylonakis

  8. Hippocrateion General Hospital, Athens, Greece

    P. Papakostas

  9. Henry Dunant General Hospital, Athens, Greece

    D. Skarlos

  10. Hania General Hospital, Crete, Greece

    I. Varthalitis

Authors
  1. E. Briasoulis
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  2. G. Fountzilas
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  3. A. Bamias
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  4. M. A. Dimopoulos
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  8. H. Kalofonos
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  13. I. Varthalitis
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  14. N. Pavlidis
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Corresponding author

Correspondence to E. Briasoulis.

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Briasoulis, E., Fountzilas, G., Bamias, A. et al. 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. Cancer Chemother Pharmacol 62, 277–284 (2008). https://doi.org/10.1007/s00280-007-0604-7

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  • DOI: https://doi.org/10.1007/s00280-007-0604-7

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