title: Feasibility, efficacy and safety of CHOP-14 in elderly patients with very high-risk diffuse large B-cell lymphoma.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Hematology, Rigshospitalet, Copenhagen, Denmark. dt@dadlnet.dk
authors.forename: Dorte
authors.initials: D
authors.lastname: Tholstrup
authors.forename: Peter
authors.initials: P
authors.lastname: de Nully Brown
authors.forename: Jesper
authors.initials: J
authors.lastname: Jurlander
authors.forename: Mads
authors.initials: M
authors.lastname: Hansen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D003520:Cyclophosphamide / Q000009:adverse effects / Q000627:therapeutic use; D004317:Doxorubicin / Q000009:adverse effects / Q000627:therapeutic use; D064420:Drug-Related Side Effects and Adverse Reactions; D005240:Feasibility Studies; D006801:Humans; D016393:Lymphoma, B-Cell / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology*; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology*; D008875:Middle Aged; D011241:Prednisone / Q000009:adverse effects / Q000627:therapeutic use; D012307:Risk Factors; D015996:Survival Rate; D013997:Time Factors; D014750:Vincristine / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone