Therapeutic Compliance and Efficacy of Dose-Dense R-CHOP-14 Immunochemotherapy Plus Pegfilgrastim for First-Line Treatment of Low Risk Diffuse Large B-Cell Lymphoma Patients: Preliminary Results of An Open-Label Clinical Trial in Spain

• Published in: Blood 2008-11, Vol.112 (11), p.4943-4943
• Main Authors: Gonzalez-Barca, Eva, Canales, Miguel, Salar, Antonio, Ferrer, Secundino, Bargay, Joan, Grande, S., Gardella, Santiago, Vidal, María Jesús, Oriol, Albert, López, A., García, J., Bello, Jl, Tomás, Fj, Briones, Javier, Caballero, Dolores
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V112.11.4943.4943

Diffuse large B-cell lymphoma (DLBCL) is the most prevalent form of non-Hodgkin lymphoma. Three-weekly R-CHOP has become the standard treatment for DLBCL. Dose-dense immunochemotherapy could improve the efficacy of treatment; however these regimens are worse tolerated due to mielotoxicity. We are conducting a prospective, open-label, single arm clinical trial of treatment with dose-dense R-CHOP supported by pegfilgrastim in patients with DLBCL older than 65 with IPI 0–5 or younger than 65 with IPI 0–2. The aim of this sub-analysis was to evaluate the efficacy and treatment compliance in patients with low risk DLBCL (IPI 0–2). Patients received R-CHOP administered every 14 days followed by pegfilgrastim (6 mg per cycle) on day 2. Patients with tumor masses > 10 cm were allowed to receive radiotherapy with 30 Gy, and those at risk of central nervous system infiltration receive prophylactic lyposomal cytarabine. Fifty-eight patients with IPI 0–2 were included in this analysis, median age was 58 years old (range 18–82), 22 (38%) patients were older than 65 yr, and 32 (53%) were male. Characteristics of the patients at diagnosis were as follows: stage III–IV: 29 (50%), bulky disease: 13 (22%), extra nodal involvement: 34 (59%), ³2 extranodal sites: 6 (10%), B symptoms: 10 (17%), ECOG 0–1: 55 (95%), elevated LDH 21 (36%), elevated b2microglobulin: 15 (26%), IPI 0–1 28 (48%). Fifty-four patients completed 6 cycles of treatment and 4 patients were dropped out, 1 due to progression and 3 due to exitus: 1 respiratory insufficiency, 1 bilateral pneumonia and 1 septic shock. Overall, 335 chemotherapy cycles were administered and 23 (6.9%) were delayed due to: neutropenia (3), febrile neutropenia (4), hepatotoxicity (1), fever or infection without neutropenia (11) and other adverse events (4). Doses of myelotoxic drugs were reduced in 8 (2.4%) cycles (3 patients). Most cycles (91.9%) were administered as scheduled. Serious adverse events were reported in 23 (39.7%) patients. Among them, febrile neutropenia episodes were observed in 10 patients (17.3%). Out of 54 evaluated patients for efficacy after 130-days follow-up, 45 (83%) achieved complete remission, 5 (9%) partial remission, 3 (5.5%) stable disease and 1 (1.8%) progressed. In an intention-to-treat analysis among the 58 patients, 46 (79.3%) patients achieved CR, 6 (10.3%) PR and 2 (3.4%) were not evaluable. High remission rates suggest that dose-dense immunochemotherapy with pegfilgrastim support is an efficaciou