title: Treatment outcomes for older patients with relapsed/refractory aggressive lymphoma receiving salvage chemotherapy and autologous stem cell transplantation are similar to younger patients: a subgroup analysis from the phase III CCTG LY.12 trial.
abstract: High-dose therapy and autologous stem cell transplantation (ASCT) is often considered for older patients (age >60 years) with relapsed/refractory aggressive lymphomas. Although registry data support the safety and potential efficacy of this approach, there are no prospective trials evaluating outcomes of ASCT in older patients. We evaluated the result of second-line chemotherapy and ASCT in older versus younger patients in the CCTG randomized LY.12 trial.
  
  
  
  From August 2003 to November 2011, 619 patients with relapsed/refractory aggressive lymphoma were randomized to gemcitabine, dexamethasone, cisplatin (GDP) or dexamethasone, cytarabine, cisplatin (DHAP); 177 patients (28.6%) enrolled were >60.0 years of age (range, 60-74) and 442 were ≤60.0 years of age. After two to three cycles, responding patients proceeded to ASCT. Intention-to-treat analysis was used to compare response rate, transplantation rate, event-free survival (EFS) and overall survival (OS) between patients aged ≤60.0 and >60.0 years.
  
  
  
  Patient characteristics were comparable between the two cohorts, except a larger proportion of older patients had high International Prognostic Index risk scores. Response to salvage therapy was 48.6% for patients aged  >60.0 versus 43.0% for those aged  ≤60.0 (P = 0.21). Transplantation rates were also similar: 50.3% versus 49.8% (P = 0.87) for older versus younger patients. Rates of febrile neutropenia and adverse events requiring hospitalization were comparable for older and younger patients (30.5% versus 22.9% and 37.9% versus 32.1%, respectively). With a median follow-up of 53 months, there was no difference in 4-year OS (36% and 40% for patients aged >60.0 and ≤60.0 years, P = 0.42), or 4-year EFS (20% versus 28%, P = 0.43). Mortality from salvage therapy was 8/174 (4.60%) and 5/436 (1.15%), and 100-day mortality post-ASCT was 7/88 (8.06%) and 4/219 (1.85%).
  
  
  
  This subgroup analysis suggests that older patients derive similar benefit from salvage therapy and ASCT to younger patients, with acceptable toxicity.
  
  
  
  NCT00078949.
authors.affiliation: Division of Hematology, Department of Medicine, Royal Victoria Hospital, McGill University Health Centre, Montreal, Canada.
authors.forename: K
authors.initials: K
authors.lastname: Davison
authors.affiliation: Canadian Cancer Trials Group, Queen's University, Kingston, Canada.
authors.forename: B E
authors.initials: BE
authors.lastname: Chen
authors.affiliation: Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.
authors.forename: V
authors.initials: V
authors.lastname: Kukreti
authors.affiliation: Division of Hematology, Department of Medicine, Queen Elizabeth II Health Sciences Centre, Halifax, Canada.
authors.forename: S
authors.initials: S
authors.lastname: Couban
authors.affiliation: Division of Malignant Hematology, Department of Oncology, Juravinski Cancer Centre, Hamilton, Canada.
authors.forename: A
authors.initials: A
authors.lastname: Benger
authors.affiliation: Department of Medicine, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.
authors.forename: N L
authors.initials: NL
authors.lastname: Berinstein
authors.affiliation: Division of Oncology, Department of Medicine, Credit Valley Hospital, Mississauga, Canada.
authors.forename: L
authors.initials: L
authors.lastname: Kaizer
authors.affiliation: Division of Hematology, Department of Medicine, Hôpital Charles LeMoyne, Longueuil, Canada.
authors.forename: P
authors.initials: P
authors.lastname: Desjardins
authors.affiliation: Division of Hematology, Department of Medicine, London Health Sciences Centre, London, Canada.
authors.forename: J
authors.initials: J
authors.lastname: Mangel
authors.affiliation: Canadian Cancer Trials Group, Queen's University, Kingston, Canada.
authors.forename: L
authors.initials: L
authors.lastname: Zhu
authors.affiliation: Canadian Cancer Trials Group, Queen's University, Kingston, Canada.
authors.forename: M S
authors.initials: MS
authors.lastname: Djurfeldt
authors.affiliation: Canadian Cancer Trials Group, Queen's University, Kingston, Canada.
authors.forename: A E
authors.initials: AE
authors.lastname: Hay
authors.affiliation: Canadian Cancer Trials Group, Queen's University, Kingston, Canada.
authors.forename: L E
authors.initials: LE
authors.lastname: Shepherd
authors.affiliation: Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.
authors.forename: M
authors.initials: M
authors.lastname: Crump
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D002945:Cisplatin / Q000008:administration & dosage; D003561:Cytarabine / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects; D006801:Humans; D008223:Lymphoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D016879:Salvage Therapy / Q000009:adverse effects*; D033581:Stem Cell Transplantation / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D003561:Cytarabine; D003907:Dexamethasone; D002945:Cisplatin
keywords: Non-Hodgkin lymphoma; autologous transplant; elderly; relapse; salvage chemotherapy