In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 22, No. 13 ( 2004-07-01), p. 2654-2661
Kurzfassung:
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/IgH negativity (CR − ) received no further treatment; those in CR with bcl-2/IgH positivity (CR + ) received rituximab, as did those in partial remission (PR) with bcl-2/IgH 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.
Materialart:
Online-Ressource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2004.07.170
Sprache:
Englisch
Verlag:
American Society of Clinical Oncology (ASCO)
Publikationsdatum:
2004
ZDB Id:
2005181-5