Randomized trial of fludarabine versus fludarabine and idarubicin as frontline treatment in patients with indolent or mantle-cell lymphoma

Pier Luigi Zinzani, Massimo Magagnoli, Luciano Moretti, Amalia De Renzo, Raffaele Battista, Alfonso Zaccaria, Luciano Guardigni, Patrizio Mazza, Roberto Marra, Fioravante Ronconi, Vito Michele Lauta, Maurizio Bendandi, Filippo Gherlinzoni, Patrizia Gentilini, Fabrizio Ciccone, Claudia Cellini, Vittorio Stefoni, Francesco Ricciuti, Marco Gobbi, Sante Tura

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Abstract

Purpose: A first comparative trial of fludarabine (FLU) alone versus FLU plus idarubicin (FLU-ID) for indolent or mantle-cell lymphomas. Patients and Methods: From September 1995 to July 1998, 199 patients aged 25 to 65 years (median, 54 years) with newly diagnosed stages II to IV indolent or mantle- cell lymphomas (standard risk according to the International Prognostic Index) were enrolled onto a multicenter, 1:1 randomized study. Of the 199 patients who were able to be assessed, 101 were assigned to the FLU group (six monthly cycles of FLU 25 mg/m2/d on days 1 through 5) and 98 to the FLU-ID group (six monthly cycles of FLU 25 mg/m2/d on days 1 through 3 and idarubicin 12 mg/m2 on day 1). Results: In the FLU group, complete response (CR) and partial response rates were 47% and 37%, respectively, whereas in the FLU-ID group, they were 39% and 42%, respectively. In-depth analysis of the CR rate with respect to histologic type showed that FLU seemed to be superior to FLU-ID in treating follicular lymphomas (60% v 40%, respectively), whereas FLU-ID seemed to be more effective than FLU in treating nonfollicular lymphomas (small lymphocytic, 43% v 29%, respectively; immunocytoma, 38% v 23%, respectively; P = not significant), excluding the mantle-cell subset (in which there was no difference between the two groups). No striking differences were observed between the two protocols in terms of overall response or toxicity, which was generally mild. However, with a median follow-up of 19 months, only 29 patients (62%) who received FLU alone have maintained their initial CR, compared with 32 (84%) of those who received FLU-ID therapy (P = .021). Conclusion: Although the FLU-ID regimen may not significantly improve the induction of CR in most indolent-lymphoma patients, our preliminary data do suggest that, with respect to FLU alone, it may be capable of conferring a longer-lasting CR and that it might be superior in terms of CR rate in small lymphocytic and immunocytoma subtypes. (C) 2000 American Society of Clinical Oncology.

Original languageEnglish
Pages (from-to)773-779
Number of pages7
JournalJournal of Clinical Oncology
Volume18
Issue number4
Publication statusPublished - Feb 2000

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Idarubicin
Mantle-Cell Lymphoma
Therapeutics
fludarabine
Follicular Lymphoma

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Zinzani, P. L., Magagnoli, M., Moretti, L., De Renzo, A., Battista, R., Zaccaria, A., ... Tura, S. (2000). Randomized trial of fludarabine versus fludarabine and idarubicin as frontline treatment in patients with indolent or mantle-cell lymphoma. Journal of Clinical Oncology, 18(4), 773-779.

Randomized trial of fludarabine versus fludarabine and idarubicin as frontline treatment in patients with indolent or mantle-cell lymphoma. / Zinzani, Pier Luigi; Magagnoli, Massimo; Moretti, Luciano; De Renzo, Amalia; Battista, Raffaele; Zaccaria, Alfonso; Guardigni, Luciano; Mazza, Patrizio; Marra, Roberto; Ronconi, Fioravante; Lauta, Vito Michele; Bendandi, Maurizio; Gherlinzoni, Filippo; Gentilini, Patrizia; Ciccone, Fabrizio; Cellini, Claudia; Stefoni, Vittorio; Ricciuti, Francesco; Gobbi, Marco; Tura, Sante.

In: Journal of Clinical Oncology, Vol. 18, No. 4, 02.2000, p. 773-779.

Research output: Contribution to journalArticle

Zinzani, PL, Magagnoli, M, Moretti, L, De Renzo, A, Battista, R, Zaccaria, A, Guardigni, L, Mazza, P, Marra, R, Ronconi, F, Lauta, VM, Bendandi, M, Gherlinzoni, F, Gentilini, P, Ciccone, F, Cellini, C, Stefoni, V, Ricciuti, F, Gobbi, M & Tura, S 2000, 'Randomized trial of fludarabine versus fludarabine and idarubicin as frontline treatment in patients with indolent or mantle-cell lymphoma', Journal of Clinical Oncology, vol. 18, no. 4, pp. 773-779.
Zinzani, Pier Luigi ; Magagnoli, Massimo ; Moretti, Luciano ; De Renzo, Amalia ; Battista, Raffaele ; Zaccaria, Alfonso ; Guardigni, Luciano ; Mazza, Patrizio ; Marra, Roberto ; Ronconi, Fioravante ; Lauta, Vito Michele ; Bendandi, Maurizio ; Gherlinzoni, Filippo ; Gentilini, Patrizia ; Ciccone, Fabrizio ; Cellini, Claudia ; Stefoni, Vittorio ; Ricciuti, Francesco ; Gobbi, Marco ; Tura, Sante. / Randomized trial of fludarabine versus fludarabine and idarubicin as frontline treatment in patients with indolent or mantle-cell lymphoma. In: Journal of Clinical Oncology. 2000 ; Vol. 18, No. 4. pp. 773-779.
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abstract = "Purpose: A first comparative trial of fludarabine (FLU) alone versus FLU plus idarubicin (FLU-ID) for indolent or mantle-cell lymphomas. Patients and Methods: From September 1995 to July 1998, 199 patients aged 25 to 65 years (median, 54 years) with newly diagnosed stages II to IV indolent or mantle- cell lymphomas (standard risk according to the International Prognostic Index) were enrolled onto a multicenter, 1:1 randomized study. Of the 199 patients who were able to be assessed, 101 were assigned to the FLU group (six monthly cycles of FLU 25 mg/m2/d on days 1 through 5) and 98 to the FLU-ID group (six monthly cycles of FLU 25 mg/m2/d on days 1 through 3 and idarubicin 12 mg/m2 on day 1). Results: In the FLU group, complete response (CR) and partial response rates were 47{\%} and 37{\%}, respectively, whereas in the FLU-ID group, they were 39{\%} and 42{\%}, respectively. In-depth analysis of the CR rate with respect to histologic type showed that FLU seemed to be superior to FLU-ID in treating follicular lymphomas (60{\%} v 40{\%}, respectively), whereas FLU-ID seemed to be more effective than FLU in treating nonfollicular lymphomas (small lymphocytic, 43{\%} v 29{\%}, respectively; immunocytoma, 38{\%} v 23{\%}, respectively; P = not significant), excluding the mantle-cell subset (in which there was no difference between the two groups). No striking differences were observed between the two protocols in terms of overall response or toxicity, which was generally mild. However, with a median follow-up of 19 months, only 29 patients (62{\%}) who received FLU alone have maintained their initial CR, compared with 32 (84{\%}) of those who received FLU-ID therapy (P = .021). Conclusion: Although the FLU-ID regimen may not significantly improve the induction of CR in most indolent-lymphoma patients, our preliminary data do suggest that, with respect to FLU alone, it may be capable of conferring a longer-lasting CR and that it might be superior in terms of CR rate in small lymphocytic and immunocytoma subtypes. (C) 2000 American Society of Clinical Oncology.",
author = "Zinzani, {Pier Luigi} and Massimo Magagnoli and Luciano Moretti and {De Renzo}, Amalia and Raffaele Battista and Alfonso Zaccaria and Luciano Guardigni and Patrizio Mazza and Roberto Marra and Fioravante Ronconi and Lauta, {Vito Michele} and Maurizio Bendandi and Filippo Gherlinzoni and Patrizia Gentilini and Fabrizio Ciccone and Claudia Cellini and Vittorio Stefoni and Francesco Ricciuti and Marco Gobbi and Sante Tura",
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T1 - Randomized trial of fludarabine versus fludarabine and idarubicin as frontline treatment in patients with indolent or mantle-cell lymphoma

AU - Zinzani, Pier Luigi

AU - Magagnoli, Massimo

AU - Moretti, Luciano

AU - De Renzo, Amalia

AU - Battista, Raffaele

AU - Zaccaria, Alfonso

AU - Guardigni, Luciano

AU - Mazza, Patrizio

AU - Marra, Roberto

AU - Ronconi, Fioravante

AU - Lauta, Vito Michele

AU - Bendandi, Maurizio

AU - Gherlinzoni, Filippo

AU - Gentilini, Patrizia

AU - Ciccone, Fabrizio

AU - Cellini, Claudia

AU - Stefoni, Vittorio

AU - Ricciuti, Francesco

AU - Gobbi, Marco

AU - Tura, Sante

PY - 2000/2

Y1 - 2000/2

N2 - Purpose: A first comparative trial of fludarabine (FLU) alone versus FLU plus idarubicin (FLU-ID) for indolent or mantle-cell lymphomas. Patients and Methods: From September 1995 to July 1998, 199 patients aged 25 to 65 years (median, 54 years) with newly diagnosed stages II to IV indolent or mantle- cell lymphomas (standard risk according to the International Prognostic Index) were enrolled onto a multicenter, 1:1 randomized study. Of the 199 patients who were able to be assessed, 101 were assigned to the FLU group (six monthly cycles of FLU 25 mg/m2/d on days 1 through 5) and 98 to the FLU-ID group (six monthly cycles of FLU 25 mg/m2/d on days 1 through 3 and idarubicin 12 mg/m2 on day 1). Results: In the FLU group, complete response (CR) and partial response rates were 47% and 37%, respectively, whereas in the FLU-ID group, they were 39% and 42%, respectively. In-depth analysis of the CR rate with respect to histologic type showed that FLU seemed to be superior to FLU-ID in treating follicular lymphomas (60% v 40%, respectively), whereas FLU-ID seemed to be more effective than FLU in treating nonfollicular lymphomas (small lymphocytic, 43% v 29%, respectively; immunocytoma, 38% v 23%, respectively; P = not significant), excluding the mantle-cell subset (in which there was no difference between the two groups). No striking differences were observed between the two protocols in terms of overall response or toxicity, which was generally mild. However, with a median follow-up of 19 months, only 29 patients (62%) who received FLU alone have maintained their initial CR, compared with 32 (84%) of those who received FLU-ID therapy (P = .021). Conclusion: Although the FLU-ID regimen may not significantly improve the induction of CR in most indolent-lymphoma patients, our preliminary data do suggest that, with respect to FLU alone, it may be capable of conferring a longer-lasting CR and that it might be superior in terms of CR rate in small lymphocytic and immunocytoma subtypes. (C) 2000 American Society of Clinical Oncology.

AB - Purpose: A first comparative trial of fludarabine (FLU) alone versus FLU plus idarubicin (FLU-ID) for indolent or mantle-cell lymphomas. Patients and Methods: From September 1995 to July 1998, 199 patients aged 25 to 65 years (median, 54 years) with newly diagnosed stages II to IV indolent or mantle- cell lymphomas (standard risk according to the International Prognostic Index) were enrolled onto a multicenter, 1:1 randomized study. Of the 199 patients who were able to be assessed, 101 were assigned to the FLU group (six monthly cycles of FLU 25 mg/m2/d on days 1 through 5) and 98 to the FLU-ID group (six monthly cycles of FLU 25 mg/m2/d on days 1 through 3 and idarubicin 12 mg/m2 on day 1). Results: In the FLU group, complete response (CR) and partial response rates were 47% and 37%, respectively, whereas in the FLU-ID group, they were 39% and 42%, respectively. In-depth analysis of the CR rate with respect to histologic type showed that FLU seemed to be superior to FLU-ID in treating follicular lymphomas (60% v 40%, respectively), whereas FLU-ID seemed to be more effective than FLU in treating nonfollicular lymphomas (small lymphocytic, 43% v 29%, respectively; immunocytoma, 38% v 23%, respectively; P = not significant), excluding the mantle-cell subset (in which there was no difference between the two groups). No striking differences were observed between the two protocols in terms of overall response or toxicity, which was generally mild. However, with a median follow-up of 19 months, only 29 patients (62%) who received FLU alone have maintained their initial CR, compared with 32 (84%) of those who received FLU-ID therapy (P = .021). Conclusion: Although the FLU-ID regimen may not significantly improve the induction of CR in most indolent-lymphoma patients, our preliminary data do suggest that, with respect to FLU alone, it may be capable of conferring a longer-lasting CR and that it might be superior in terms of CR rate in small lymphocytic and immunocytoma subtypes. (C) 2000 American Society of Clinical Oncology.

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