Objectives: The dose-dense CHOP-14 regimen is efficient and safe in elderly patients with diffuse large B-cell lymphoma (DLBCL). However, no clinical data regarding very high-risk patients [age >75 yr and/or performance status (PS) >3] are available. The objective of this study was to evaluate the feasibility, efficacy and safety of CHOP-14 in these patients not eligible for clinical trials.
Methods: We analyzed 65 patients treated with CHOP-14. Patients were stratified into two cohorts; A: very high-risk (age 60-75 with PS = 4 or age >75; n = 24) and B: standard risk (age 60-75 with PS < or =3 or age <60; n = 41).
Results: Fifty eight percent in cohort A achieved complete response (CR) compared with 80% in cohort B (P = 0.054). The 3-yr event free survival (EFS) was 40% vs. 52% (ns), 3-yr overall survival (OAS) 44% vs. 68% (P = 0.017). Median schedule-erosion was 14 (0-67) (A) vs. 8 (0-44) (B) days (ns) and dose-erosion was confined to vincristine-reduction in both cohorts. Therapy-associated deaths did not differ. However, a significant increase in hospital admission was found in cohort A, where 88% required hospitalization (median 47 d) compared with 68% (median 9 d) in cohort B (P = 0.003). The patients presented with a combination of opportunistic infections, malnutrition and decreasing PS.
Conclusions: Although the 3-yr OAS in very high-risk DLBCL is encouraging, the high frequency of severe toxicity with infections and malnutrition responsible for increased morbidity during treatment, warrants for careful attention to these very high-risk patients.