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 language | English |
|---|---|
| Pages (from-to) | 2654-2661 |
| Number of pages | 8 |
| Journal | Journal of Clinical Oncology |
| Volume | 22 |
| Issue number | 13 |
| DOIs | |
| Publication status | Published - 2004 |
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ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
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 journal › Article
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TY - JOUR
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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U2 - 10.1200/JCO.2004.07.170
DO - 10.1200/JCO.2004.07.170
M3 - Article
VL - 22
SP - 2654
EP - 2661
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 13
ER -