Fludarabine plus mitoxantrone with and without rituximab versus CHOP with and without rituximab as front-line treatment for patients with follicular lymphoma

Pier Luigi Zinzani, Alessandro Pulsoni, Alessio Perrotti, Simona Soverini, Francesco Zaja, Amalia De Renzo, Sergio Storti, Vito Michele Lauta, Luciano Guardigni, Patrizia Gentilini, Alessandra Tucci, Anna Lia Molinari, Marco Gobbi, Brunangelo Falini, Pier Paolo Fattori, Fabrizio Ciccone, Lapo Alinari, Maurizio Martelli, Stefano Pileri, Sante Tura & 1 others Michele Baccarani

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Abstract

Purpose: Promising new therapeutic options for follicular lymphoma (FL) include fludarabine plus mitoxantrone (FM) and the mouse/human anti-CD20 antibody, rituximab. We performed a randomized comparative trial of FM with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) front-line chemotherapy with and without sequential rituximab. Patients and Methods: All previously untreated CD20+ FL patients presenting in 15 Italian cooperative institutions from October 1999 were randomly allocated to FM or CHOP. Following clinical or molecular restaging, patients in complete remission (CR) with bcl-2/lgH negativity (CR-) received no further treatment; those in CR with bcl-2/lgH positivity (CR+) received rituximab, as did those in partial remission (PR) with bcl-2/lgH negativity (PR-) or positivity (PR+); nonresponders (NR subgroup) were off study. Results: After chemotherapy, the FM arm achieved higher rates of CR (68% [49 of 72 patients] v 42% [29 of 68 patients]; P = .003) and CR- (39% [28 of 72 patients] v 13 of 68 patients [19%]; P = .001). Rituximab elicited CR - in 55 of 95 treated patients (58%). The final CR- rate was higher in the FM arm(71% [51 of 72 patients] v 51% [35 of 68 patients]; P = .01). However, with a median follow-up of 19 months (range, 9 to 37 months), no statistically significant difference was found among the various study arms in terms of both progression-free (PFS) and overall survival (OS). Conclusion: These results indicate that FM is superior to CHOP for front-line treatment of FL and that rituximab is an effective sequential treatment option. However, they also confirm that this superiority is unlikely to translate into either better PFS or OS.

Original languageEnglish
Pages (from-to)2654-2661
Number of pages8
JournalJournal of Clinical Oncology
Volume22
Issue number13
DOIs
Publication statusPublished - 2004

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Mitoxantrone
Follicular Lymphoma
Therapeutics
fludarabine
Rituximab
Drug Therapy
Survival
Vincristine
Prednisone
Doxorubicin
Cyclophosphamide
Anti-Idiotypic Antibodies

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Fludarabine plus mitoxantrone with and without rituximab versus CHOP with and without rituximab as front-line treatment for patients with follicular lymphoma. / Zinzani, Pier Luigi; Pulsoni, Alessandro; Perrotti, Alessio; Soverini, Simona; Zaja, Francesco; De Renzo, Amalia; Storti, Sergio; Lauta, Vito Michele; Guardigni, Luciano; Gentilini, Patrizia; Tucci, Alessandra; Molinari, Anna Lia; Gobbi, Marco; Falini, Brunangelo; Fattori, Pier Paolo; Ciccone, Fabrizio; Alinari, Lapo; Martelli, Maurizio; Pileri, Stefano; Tura, Sante; Baccarani, Michele.

In: Journal of Clinical Oncology, Vol. 22, No. 13, 2004, p. 2654-2661.

Research output: Contribution to journalArticle

Zinzani, PL, Pulsoni, A, Perrotti, A, Soverini, S, Zaja, F, De Renzo, A, Storti, S, Lauta, VM, Guardigni, L, Gentilini, P, Tucci, A, Molinari, AL, Gobbi, M, Falini, B, Fattori, PP, Ciccone, F, Alinari, L, Martelli, M, Pileri, S, Tura, S & Baccarani, M 2004, 'Fludarabine plus mitoxantrone with and without rituximab versus CHOP with and without rituximab as front-line treatment for patients with follicular lymphoma', Journal of Clinical Oncology, vol. 22, no. 13, pp. 2654-2661. https://doi.org/10.1200/JCO.2004.07.170
Zinzani, Pier Luigi ; Pulsoni, Alessandro ; Perrotti, Alessio ; Soverini, Simona ; Zaja, Francesco ; De Renzo, Amalia ; Storti, Sergio ; Lauta, Vito Michele ; Guardigni, Luciano ; Gentilini, Patrizia ; Tucci, Alessandra ; Molinari, Anna Lia ; Gobbi, Marco ; Falini, Brunangelo ; Fattori, Pier Paolo ; Ciccone, Fabrizio ; Alinari, Lapo ; Martelli, Maurizio ; Pileri, Stefano ; Tura, Sante ; Baccarani, Michele. / Fludarabine plus mitoxantrone with and without rituximab versus CHOP with and without rituximab as front-line treatment for patients with follicular lymphoma. In: Journal of Clinical Oncology. 2004 ; Vol. 22, No. 13. pp. 2654-2661.
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abstract = "Purpose: Promising new therapeutic options for follicular lymphoma (FL) include fludarabine plus mitoxantrone (FM) and the mouse/human anti-CD20 antibody, rituximab. We performed a randomized comparative trial of FM with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) front-line chemotherapy with and without sequential rituximab. Patients and Methods: All previously untreated CD20+ FL patients presenting in 15 Italian cooperative institutions from October 1999 were randomly allocated to FM or CHOP. Following clinical or molecular restaging, patients in complete remission (CR) with bcl-2/lgH negativity (CR-) received no further treatment; those in CR with bcl-2/lgH positivity (CR+) received rituximab, as did those in partial remission (PR) with bcl-2/lgH negativity (PR-) or positivity (PR+); nonresponders (NR subgroup) were off study. Results: After chemotherapy, the FM arm achieved higher rates of CR (68{\%} [49 of 72 patients] v 42{\%} [29 of 68 patients]; P = .003) and CR- (39{\%} [28 of 72 patients] v 13 of 68 patients [19{\%}]; P = .001). Rituximab elicited CR - in 55 of 95 treated patients (58{\%}). The final CR- rate was higher in the FM arm(71{\%} [51 of 72 patients] v 51{\%} [35 of 68 patients]; P = .01). However, with a median follow-up of 19 months (range, 9 to 37 months), no statistically significant difference was found among the various study arms in terms of both progression-free (PFS) and overall survival (OS). Conclusion: These results indicate that FM is superior to CHOP for front-line treatment of FL and that rituximab is an effective sequential treatment option. However, they also confirm that this superiority is unlikely to translate into either better PFS or OS.",
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T1 - Fludarabine plus mitoxantrone with and without rituximab versus CHOP with and without rituximab as front-line treatment for patients with follicular lymphoma

AU - Zinzani, Pier Luigi

AU - Pulsoni, Alessandro

AU - Perrotti, Alessio

AU - Soverini, Simona

AU - Zaja, Francesco

AU - De Renzo, Amalia

AU - Storti, Sergio

AU - Lauta, Vito Michele

AU - Guardigni, Luciano

AU - Gentilini, Patrizia

AU - Tucci, Alessandra

AU - Molinari, Anna Lia

AU - Gobbi, Marco

AU - Falini, Brunangelo

AU - Fattori, Pier Paolo

AU - Ciccone, Fabrizio

AU - Alinari, Lapo

AU - Martelli, Maurizio

AU - Pileri, Stefano

AU - Tura, Sante

AU - Baccarani, Michele

PY - 2004

Y1 - 2004

N2 - Purpose: Promising new therapeutic options for follicular lymphoma (FL) include fludarabine plus mitoxantrone (FM) and the mouse/human anti-CD20 antibody, rituximab. We performed a randomized comparative trial of FM with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) front-line chemotherapy with and without sequential rituximab. Patients and Methods: All previously untreated CD20+ FL patients presenting in 15 Italian cooperative institutions from October 1999 were randomly allocated to FM or CHOP. Following clinical or molecular restaging, patients in complete remission (CR) with bcl-2/lgH negativity (CR-) received no further treatment; those in CR with bcl-2/lgH positivity (CR+) received rituximab, as did those in partial remission (PR) with bcl-2/lgH negativity (PR-) or positivity (PR+); nonresponders (NR subgroup) were off study. Results: After chemotherapy, the FM arm achieved higher rates of CR (68% [49 of 72 patients] v 42% [29 of 68 patients]; P = .003) and CR- (39% [28 of 72 patients] v 13 of 68 patients [19%]; P = .001). Rituximab elicited CR - in 55 of 95 treated patients (58%). The final CR- rate was higher in the FM arm(71% [51 of 72 patients] v 51% [35 of 68 patients]; P = .01). However, with a median follow-up of 19 months (range, 9 to 37 months), no statistically significant difference was found among the various study arms in terms of both progression-free (PFS) and overall survival (OS). Conclusion: These results indicate that FM is superior to CHOP for front-line treatment of FL and that rituximab is an effective sequential treatment option. However, they also confirm that this superiority is unlikely to translate into either better PFS or OS.

AB - Purpose: Promising new therapeutic options for follicular lymphoma (FL) include fludarabine plus mitoxantrone (FM) and the mouse/human anti-CD20 antibody, rituximab. We performed a randomized comparative trial of FM with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) front-line chemotherapy with and without sequential rituximab. Patients and Methods: All previously untreated CD20+ FL patients presenting in 15 Italian cooperative institutions from October 1999 were randomly allocated to FM or CHOP. Following clinical or molecular restaging, patients in complete remission (CR) with bcl-2/lgH negativity (CR-) received no further treatment; those in CR with bcl-2/lgH positivity (CR+) received rituximab, as did those in partial remission (PR) with bcl-2/lgH negativity (PR-) or positivity (PR+); nonresponders (NR subgroup) were off study. Results: After chemotherapy, the FM arm achieved higher rates of CR (68% [49 of 72 patients] v 42% [29 of 68 patients]; P = .003) and CR- (39% [28 of 72 patients] v 13 of 68 patients [19%]; P = .001). Rituximab elicited CR - in 55 of 95 treated patients (58%). The final CR- rate was higher in the FM arm(71% [51 of 72 patients] v 51% [35 of 68 patients]; P = .01). However, with a median follow-up of 19 months (range, 9 to 37 months), no statistically significant difference was found among the various study arms in terms of both progression-free (PFS) and overall survival (OS). Conclusion: These results indicate that FM is superior to CHOP for front-line treatment of FL and that rituximab is an effective sequential treatment option. However, they also confirm that this superiority is unlikely to translate into either better PFS or OS.

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DO - 10.1200/JCO.2004.07.170

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