| Methods |
Randomised controlled trial
Number of centres: not stated
Location: Italy
Years: 1987 ‐ not stated
Final Analysis
Sponsorship: Sandoz and Schering‐Plough; Consiglio Nazionale delle Ricerche, Rome; Associazone Italiana per la Ricerca sul Cancro, Milan
Central pathology review: not stated
Definition of Complete Response: ECOG criteria |
| Participants |
Number of patients randomised: 101 (98 patients analysed)
Our analysis: 98
Patients untreated: yes
INCLUDED:
Histology: groups G and H (Working Formulation)
IPI: no restriction
Age: 17‐60 years
EXCLUDED:
stage I non‐bulky; lymphoma cell infiltration of bone marrow; T‐cell immunophenotype; follicular component in biopsy; abnormal cardiac, pulmonary, renal, and hepatic function; HIV, hepatitis B and C |
| Interventions |
Control group: MACOP‐B 12 weeks
Experimental group: High‐dose sequential therapy and PBSC or ABMT,
consolidation radiotherapy allowed,
cross‐over allowed if tumour reduction was 80% or less (patients received respectively MACOP‐B and high‐dose sequential therapy as salvage)
Randomisation upfront |
| Outcomes |
Freedom from disease progression
Overall survival
Event‐free survival
Freedom from relapse
Response rates |
| Notes |
source: paper
3 patients excluded from the analysis due to concomitant liver disease |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
