Front-Line Chemo-Immunotherapy Rituximab-FC + Rituximab Maintenance in Patients with Untreated Advanced Stage Non Follicular Lymphoma (INFL): Preliminary Results of a Prospective Study of the Intergruppo Italiano Linfomi and Roche (ML18324).

Luca Baldini1,*, Alessandro Pulsoni2,*, Giuseppe Rossi3,*, Umberto Vitolo4,*, Enrica Morra5,*, Barbara Olivero6,*, Elena Cavalieri2,*, Francesco Merli7,*, Luigi Rigacci8,*, Francesco Nobile9,*, Lorella Orsucci10,*, Maura Brugiatelli11,*, Pellegrino M

Author address: 

1 UO Ematologia 1-CTMO, Fondazione Policlinico MaRe, IRCCS, Universita’ degli Studi, Milano, Italy, 2 Dipartimento Biotecnologie Cellulari ed Ematologia, Universita’ La Sapienza, Roma, Italy, 3 Department of Hematology, Spedali Civili, Brescia, Italy


Fludarabine in combination with cyclophosphamide (FC) plus rituximab (R) is an effective treatment for newly diagnosed as well as relapsed low-grade non-Hodgin’s lymphoma (NHL), including chronic lymphocytic leukemia (TAM 2006 and 2008, Keating 2005, Sacchi 2007). Maintenance treatment with R improves overall and progression-free survival in patients both with and without rituximab during induction, with relapsed/resistant follicular NHL (Van Oers 2006). We investigated efficacy and safety of the chemo-immunotherapy FCR followed by rituximab maintenance treatment in patients with advanced untreated indolent B-cell non follicular lymphomas (INFL). Patients and methods: from July 2005 to May 2007, 47 pts whit untreated advanced stage INFL (23 lymphocytic, 20 limphoplasmacytic and 4 nodal marginal zone NHL) were enrolled in an open label, single arm, multicenter phase II study, consisting with 6 courses of FC (Fludarabine, 25 mg/m2 i.v. plus Cyclophosphamide, 250 mg/m2, days 24) plus 8 doses of R (375 mg/m2, day 1 every FC cycle and day 14 of cycles 4 and 5) followed by R maintenance (375 mg/m2 every two months for 4 doses). Prophylactic antibiotic treatment with cotrimoxazole (two tablets three times a week) and antifungal profilaxis with itraconazole was planned from the beginning of chemotherapy to three months later or until normalization of CD4 count. The primary endpoint of this study is the percentage of failure free patients after two years from the treatment start. Results: 46/47 pts were evaluable for therapeutic response: median age 59 years (3168), M/F ratio 28/18; stage III/ IV 44; B symptoms and splenomegaly 11 and 14 pts respectively; FLIPI scores were: 01, 16 pts (34.8%), score 2, 19 pts (41.3%) and score 3, 11 pts (23.9%). Forty-five patients received all the 6 courses of treatment and 1 patient 3 courses only. The ORR was 96% (44/46 pts) with 28 complete (61%) and 16 (35%) partial responses; 2 pts were in MR/SD. A total of 274 courses of FRC were given to 47 patients. The most frequent serious toxicity (NCI-CTC grade 34) was neutropenia that was reported in 55% of the courses. Three cases of Herpes zoster infection were reported. All the patients are still alive. Conclusions: in a series of INFL at diagnosis, FCR regimen is safe and effective with a very high CR rate. The whole study will provide insights on the role of R maintenance after R-chemotherapy in a particular subset of low-grade NHLs. Footnotes Corresponding author Disclosures: Vitolo: Roche: Membership on an entity’s Board of Directors or advisory committees. Morra: Roche: Honoraria, Speakers Bureau. Gamba: Roche: Employment. Off Label Use: Rituximab Fludarabine

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Full conference title: 

50th American Society of Haematologists Annual Meeting
    • ASH 50th (2008)