Introduction: Some studies have shown that patients with aggressive lymphoma may benefit from dose intensified schedules as CHOP-14. The addition of rituximab ® improves response rate and survival. The support with G-CSF in dose intensification regimes may provide a good complementation of courses and advantage compared with schedules standard-dose as R-CHOP.

Purpose: To evaluate the efficacy of R-CHOP-14 in naïve patients with diffuse B- large cell lymphoma (DBLC) (REAL classification).

Design: observational, prospective and multicentric in a consecutive and previously untreated patients diagnosed of DBLC CD20+. Exclusion criteria: HIV positive, other malignancies and CNS involvement.

Patients and methods: Since June 2003 to June 2006, 56 patients were included in an R-CHOP regimen administered every 14 days (8 courses). At baseline assessment: clinical and physical exam, blood counts, serum and urine biochemistry, albumin, β2-microglobuline and LDH level, body scan, bone marrow biopsy. Patients were classified according ECOG, clinical stage and IPI. All patients have received prophylaxis with G-CSF. Re-staging studies were performed every 4 cycles. Responses were classified as complete remission (CR), partial remission (PR), and non response (NR).

Statistical analysis: Overall survival (OS), relapsed free survival (RFS). Survival analysis was performed using Kaplan-Meier and Cox regression.

Results: Mean age 50.13 years (20–78), 19M/37V. ECOG 0(24), 1(18), 2(3), 3(11). B symptoms 30 patients (53.5%). IPI score 0–1(21), 2(12), 3(8), 3 4 (15), stage I(4), II(9), III(13), IV(30). Extranodal location 33 (59%): bone marrow 13, lung 8, liver 6, CNS 4. After 4 cycle: 50 evaluable patients; response: 50 (91%), 15 CR (27%), 35 PR (64%), 5 NR. After 8 cycle: 40 valuables patients, 38 CR (95%), 2 PR. 5 patients have relapsed and 12 died (progression 6, infection 6: 5> 70 years). Adverse events 187 episodes: neutropenia III-IV 107 (72%), thrombocytopenia III-IV 21(16%), infection 22 (11.7%): pneumonia 8(4.3%), neutropenia febrile 5(2.7%), gastrointestinal 5 (2.7%). Mean OS was 34.3 months and mean RFS 38.9 months.

Conclusions: A high response rate to R-CHOP 14 in adult’s naïve DBLC patients was observed in this study with acceptable toxicity. No differences in response were observed according to age groups but higher myelotoxicity and adverse events was present in older than seventy

This study is partially sponsored by a grant from FEHHA.

Disclosure: No relevant conflicts of interest to declare.

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