First-Line Treatment with R-Chop/21 for Patients with Disseminated Diffuse Large B-Cell Lymphoma (DLCL). Results of a Prospective Series of 128 Patients.

Purpose: to analize the response rate and survival of a series of patients with disseminated large B-cell lymphoma treated with R-CHOP/21 x 8 cycles and to evaluate the prognostic factors and the prognostic value of gallium-67 imaging.

Patients and Methods: 128 patients with DLCL have been prospectively treated with R-CHOP/21 from March 2002 to March 2004, ages between 18 and 85 years. Survival curves were expressed as Kaplan-Meier plots. Prognostic factors were evaluated by the Chi-square test. Survival curves were compared by the Log-rank test.

Results: the median age was 65 years (limits: 27–83), 31% older than 70 years. 59 (54%) patients were males. Gallium imaging was positive at diagnosis in 91%. Clinical presentation of DLCL was: bulky disease: 40%, extra-nodal disease: 66% (³ 2 sites: 33%), B symptoms: 41%, ECOG ³ 2: 53%, LDH>N: 67%, IPI ³ 3: 60%. Chemotherapy cycles received were: <6: 20%; 6: 34%; 8: 46%. The intention-to-treat response was: CR 72%, PR 11%, failures 11%, not evaluable: 6%. Survival, with a median follow-up of 13 months, was: OS: 74%, and EFS: 70%. There are no differences between patients who have been treated with 6 or 8 cycles. EFS of patients with normal gallium imaging at the end of treatment was 90% (p=0.03). EFS was not different between patients older or younger than 70 years. EFS of patients with age adjusted IPI 0 was 100%, IPI 1:70%; IPI 3: 82% and IPI 4: 48%. Three (5%) patients relapsed. Prognostic factors for OS and EFS were: LDH > Normal (p=0.01 y p=0.005 respectively) and ECOG ³ 2 (p=0.0008 y p=0.02).

Conclusion: Rituximab associated with CHOP improves the results of historical series treated with CHOP for patients of all ages, but in patients with age-adjusted IPI=3 results have to be improved with other therapeutic strategies. Normalization of gallium-67 imaging at the end of treatment is predictive of a significantly better EFS. Age is not a prognostic factor in patients who receive the same treatment. For patients with disseminated disease, LDH and ECOG are the only significant prognostic factors.