| Methods |
Randomised controlled trial
Number of centres: multi‐centre
Location: France and Belgium
Years: March 1993 ‐ September 1995
Preclosure due to significantly lower event‐free survival in experimental arm
Sponsorship: Ministere de la Sante France, Assistance Publique Hopitaux Paris, Amgen‐Roche Neuilly sur Seine, Asta‐Mediac Merignac
Number of withdrawals: not stated
Central pathology review: yes (70% of patients)
Definition of Complete Response: disappearance of all clinical evidence of disease and normalization of all laboratory values, radiographs, and biopsies from sites that had initially been abnormal. Pts. with persistent CT abnormalities but >75% regression of the initial tumour were considered to be unconfirmed CR (CRu) if in CR on all other parameters |
| Participants |
Number of patients randomised: 397 (370 patients analysed)
Our analysis: 370
Patients untreated: yes
INCLUDED:
Histology: aggressive lymphoma (Kiel and WHO classification)
IPI: age‐adjusted: at least 2 factors
Age: 15‐60 years
EXCLUDED:
lymphoblastic or Burkitt lymphoma with meningeal or bone marrow involvement, primary cerebral lymphoma; concomitant or previous cancer; congestive heart failure, liver or kidney failure; HIV |
| Interventions |
Control group: ACVBP 4 cycles followed by sequential consolidation
Experimental group: shortened induction (CEOP 1 cycle and ECVBP 2 cycles) followed by BEAM and PSCT or ABMT
Randomization upfront |
| Outcomes |
Event‐free survival
Overall survival
Disease‐free survival
Response rates |
| Notes |
source: paper
27 patients excluded from the analysis due to ineligibility (15x incorrect histology, 1x Burkitt with bone marrow involvement, 1x HIV, 10x missing data) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
