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A Threefold Dose Intensity Treatment With Ifosfamide, Carboplatin, and Etoposide for Patients With Small Cell Lung Cancer: A Randomized Trial

Leyvraz, Serge ; Pampallona, Sandro ; Martinelli, Giovanni ; Ploner, Ferdinand ; Perey, Lucien ; Aversa, Savina ; Peters, Solange ; Brunsvig, Paal ; Montes, Ana ; Lange, Andrzej ; Yilmaz, Ugur ; Rosti, Giovanni

In: Journal of the National Cancer Institute, 2008, vol. 100, no. 8, p. 533-541

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    Titel
    • A Threefold Dose Intensity Treatment With Ifosfamide, Carboplatin, and Etoposide for Patients With Small Cell Lung Cancer: A Randomized Trial
    Autor
    • Leyvraz, Serge. Affiliations of authors: Centre Pluridisciplinaire d'Oncologie, University Hospital, Lausanne, Switzerland (SL, LP, S. Peters); ForMed, Evolène, Switzerland (S. Pampallona); Insituto Europeo di Oncologia, Milano, Italy (GM); Medical University, Graz, Austria (FP); Azienda Ospedaliera di Padova, Padova, Italy (SA); The Norwegian Radium Hospital, Oslo, Norway (PB); Institute Catalan of Oncology, Barcelona, Spain, (AM); L. Hirszfeld Institute of Immunology and Experimental Hematology, Wroclaw, Poland (AL); Dokuz Eylül Universitesi, Izmir, Turkey (UY); Ospedale Ca' Foncello, Treviso, Italy (GR)
    • Pampallona, Sandro. Affiliations of authors: Centre Pluridisciplinaire d'Oncologie, University Hospital, Lausanne, Switzerland (SL, LP, S. Peters); ForMed, Evolène, Switzerland (S. Pampallona); Insituto Europeo di Oncologia, Milano, Italy (GM); Medical University, Graz, Austria (FP); Azienda Ospedaliera di Padova, Padova, Italy (SA); The Norwegian Radium Hospital, Oslo, Norway (PB); Institute Catalan of Oncology, Barcelona, Spain, (AM); L. Hirszfeld Institute of Immunology and Experimental Hematology, Wroclaw, Poland (AL); Dokuz Eylül Universitesi, Izmir, Turkey (UY); Ospedale Ca' Foncello, Treviso, Italy (GR)
    • Martinelli, Giovanni. Affiliations of authors: Centre Pluridisciplinaire d'Oncologie, University Hospital, Lausanne, Switzerland (SL, LP, S. Peters); ForMed, Evolène, Switzerland (S. Pampallona); Insituto Europeo di Oncologia, Milano, Italy (GM); Medical University, Graz, Austria (FP); Azienda Ospedaliera di Padova, Padova, Italy (SA); The Norwegian Radium Hospital, Oslo, Norway (PB); Institute Catalan of Oncology, Barcelona, Spain, (AM); L. Hirszfeld Institute of Immunology and Experimental Hematology, Wroclaw, Poland (AL); Dokuz Eylül Universitesi, Izmir, Turkey (UY); Ospedale Ca' Foncello, Treviso, Italy (GR)
    • Ploner, Ferdinand. Affiliations of authors: Centre Pluridisciplinaire d'Oncologie, University Hospital, Lausanne, Switzerland (SL, LP, S. Peters); ForMed, Evolène, Switzerland (S. Pampallona); Insituto Europeo di Oncologia, Milano, Italy (GM); Medical University, Graz, Austria (FP); Azienda Ospedaliera di Padova, Padova, Italy (SA); The Norwegian Radium Hospital, Oslo, Norway (PB); Institute Catalan of Oncology, Barcelona, Spain, (AM); L. Hirszfeld Institute of Immunology and Experimental Hematology, Wroclaw, Poland (AL); Dokuz Eylül Universitesi, Izmir, Turkey (UY); Ospedale Ca' Foncello, Treviso, Italy (GR)
    • Perey, Lucien. Affiliations of authors: Centre Pluridisciplinaire d'Oncologie, University Hospital, Lausanne, Switzerland (SL, LP, S. Peters); ForMed, Evolène, Switzerland (S. Pampallona); Insituto Europeo di Oncologia, Milano, Italy (GM); Medical University, Graz, Austria (FP); Azienda Ospedaliera di Padova, Padova, Italy (SA); The Norwegian Radium Hospital, Oslo, Norway (PB); Institute Catalan of Oncology, Barcelona, Spain, (AM); L. Hirszfeld Institute of Immunology and Experimental Hematology, Wroclaw, Poland (AL); Dokuz Eylül Universitesi, Izmir, Turkey (UY); Ospedale Ca' Foncello, Treviso, Italy (GR)
    • Aversa, Savina. Affiliations of authors: Centre Pluridisciplinaire d'Oncologie, University Hospital, Lausanne, Switzerland (SL, LP, S. Peters); ForMed, Evolène, Switzerland (S. Pampallona); Insituto Europeo di Oncologia, Milano, Italy (GM); Medical University, Graz, Austria (FP); Azienda Ospedaliera di Padova, Padova, Italy (SA); The Norwegian Radium Hospital, Oslo, Norway (PB); Institute Catalan of Oncology, Barcelona, Spain, (AM); L. Hirszfeld Institute of Immunology and Experimental Hematology, Wroclaw, Poland (AL); Dokuz Eylül Universitesi, Izmir, Turkey (UY); Ospedale Ca' Foncello, Treviso, Italy (GR)
    • Peters, Solange. Affiliations of authors: Centre Pluridisciplinaire d'Oncologie, University Hospital, Lausanne, Switzerland (SL, LP, S. Peters); ForMed, Evolène, Switzerland (S. Pampallona); Insituto Europeo di Oncologia, Milano, Italy (GM); Medical University, Graz, Austria (FP); Azienda Ospedaliera di Padova, Padova, Italy (SA); The Norwegian Radium Hospital, Oslo, Norway (PB); Institute Catalan of Oncology, Barcelona, Spain, (AM); L. Hirszfeld Institute of Immunology and Experimental Hematology, Wroclaw, Poland (AL); Dokuz Eylül Universitesi, Izmir, Turkey (UY); Ospedale Ca' Foncello, Treviso, Italy (GR)
    • Brunsvig, Paal. Affiliations of authors: Centre Pluridisciplinaire d'Oncologie, University Hospital, Lausanne, Switzerland (SL, LP, S. Peters); ForMed, Evolène, Switzerland (S. Pampallona); Insituto Europeo di Oncologia, Milano, Italy (GM); Medical University, Graz, Austria (FP); Azienda Ospedaliera di Padova, Padova, Italy (SA); The Norwegian Radium Hospital, Oslo, Norway (PB); Institute Catalan of Oncology, Barcelona, Spain, (AM); L. Hirszfeld Institute of Immunology and Experimental Hematology, Wroclaw, Poland (AL); Dokuz Eylül Universitesi, Izmir, Turkey (UY); Ospedale Ca' Foncello, Treviso, Italy (GR)
    • Montes, Ana. Affiliations of authors: Centre Pluridisciplinaire d'Oncologie, University Hospital, Lausanne, Switzerland (SL, LP, S. Peters); ForMed, Evolène, Switzerland (S. Pampallona); Insituto Europeo di Oncologia, Milano, Italy (GM); Medical University, Graz, Austria (FP); Azienda Ospedaliera di Padova, Padova, Italy (SA); The Norwegian Radium Hospital, Oslo, Norway (PB); Institute Catalan of Oncology, Barcelona, Spain, (AM); L. Hirszfeld Institute of Immunology and Experimental Hematology, Wroclaw, Poland (AL); Dokuz Eylül Universitesi, Izmir, Turkey (UY); Ospedale Ca' Foncello, Treviso, Italy (GR)
    • Lange, Andrzej. Affiliations of authors: Centre Pluridisciplinaire d'Oncologie, University Hospital, Lausanne, Switzerland (SL, LP, S. Peters); ForMed, Evolène, Switzerland (S. Pampallona); Insituto Europeo di Oncologia, Milano, Italy (GM); Medical University, Graz, Austria (FP); Azienda Ospedaliera di Padova, Padova, Italy (SA); The Norwegian Radium Hospital, Oslo, Norway (PB); Institute Catalan of Oncology, Barcelona, Spain, (AM); L. Hirszfeld Institute of Immunology and Experimental Hematology, Wroclaw, Poland (AL); Dokuz Eylül Universitesi, Izmir, Turkey (UY); Ospedale Ca' Foncello, Treviso, Italy (GR)
    • Yilmaz, Ugur. Affiliations of authors: Centre Pluridisciplinaire d'Oncologie, University Hospital, Lausanne, Switzerland (SL, LP, S. Peters); ForMed, Evolène, Switzerland (S. Pampallona); Insituto Europeo di Oncologia, Milano, Italy (GM); Medical University, Graz, Austria (FP); Azienda Ospedaliera di Padova, Padova, Italy (SA); The Norwegian Radium Hospital, Oslo, Norway (PB); Institute Catalan of Oncology, Barcelona, Spain, (AM); L. Hirszfeld Institute of Immunology and Experimental Hematology, Wroclaw, Poland (AL); Dokuz Eylül Universitesi, Izmir, Turkey (UY); Ospedale Ca' Foncello, Treviso, Italy (GR)
    • Rosti, Giovanni. Affiliations of authors: Centre Pluridisciplinaire d'Oncologie, University Hospital, Lausanne, Switzerland (SL, LP, S. Peters); ForMed, Evolène, Switzerland (S. Pampallona); Insituto Europeo di Oncologia, Milano, Italy (GM); Medical University, Graz, Austria (FP); Azienda Ospedaliera di Padova, Padova, Italy (SA); The Norwegian Radium Hospital, Oslo, Norway (PB); Institute Catalan of Oncology, Barcelona, Spain, (AM); L. Hirszfeld Institute of Immunology and Experimental Hematology, Wroclaw, Poland (AL); Dokuz Eylül Universitesi, Izmir, Turkey (UY); Ospedale Ca' Foncello, Treviso, Italy (GR)
    Dokumententyp
    • Postprint
    Sprache
    • Englisch
    Veröffentlicht in
    • Journal of the National Cancer Institute, 2008, vol. 100, no. 8, p. 533-541. Oxford University Press
    Andere elektronische Ausgabe
    Klassifikation
    • Gesundheit
    Schlagwörter
    OAI-PMH-ID
    • oai:doc.rero.ch:293710
    Summary
    Background The dose intensity of chemotherapy can be increased to the highest possible level by early administration of multiple and sequential high-dose cycles supported by transfusion with peripheral blood progenitor cells (PBPCs). A randomized trial was performed to test the impact of such dose intensification on the long-term survival of patients with small cell lung cancer (SCLC). Methods Patients who had limited or extensive SCLC with no more than two metastatic sites were randomly assigned to high-dose (High, n = 69) or standard-dose (Std, n = 71) chemotherapy with ifosfamide, carboplatin, and etoposide (ICE). High-ICE cycles were supported by transfusion with PBPCs that were collected after two cycles of treatment with epidoxorubicin at 150 mg/m2, paclitaxel at 175 mg/m2, and filgrastim. The primary outcome was 3-year survival. Comparisons between response rates and toxic effects within subgroups (limited or extensive disease, liver metastases or no liver metastases, Eastern Cooperative Oncology Group performance status of 0 or 1, normal or abnormal lactate dehydrogenase levels) were also performed. Results Median relative dose intensity in the High-ICE arm was 293% (range = 174%-392%) of that in the Std-ICE arm. The 3-year survival rates were 18% (95% confidence interval [CI] = 10% to 29%) and 19% (95% CI = 11% to 30%) in the High-ICE and Std-ICE arms, respectively. No differences were observed between the High-ICE and Std-ICE arms in overall response (n = 54 [78%, 95% CI = 67% to 87%] and n = 48 [68%, 95% CI = 55% to 78%], respectively) or complete response (n = 27 [39%, 95% CI = 28% to 52%] and n = 24 [34%, 95% CI = 23% to 46%], respectively). Subgroup analyses showed no benefit for any outcome from High-ICE treatment. Hematologic toxicity was substantial in the Std-ICE arm (grade ≥ 3 neutropenia, n = 49 [70%]; anemia, n = 17 [25%]; thrombopenia, n = 17 [25%]), and three patients (4%) died from toxicity. High-ICE treatment was predictably associated with severe myelosuppression, and five patients (8%) died from toxicity. Conclusions The long-term outcome of SCLC was not improved by raising the dose intensity of ICE chemotherapy by threefold