| Methods |
Randomised controlled trial
Number of centres: 35
Location: France and Belgium
Years: October 1987 ‐ February 1993
Final analysis
Sponsorship: Delegation a la Recherche Clinique de l'Assistance Publique‐Hopitaux de Paris, Fondation contre la Leucemie Paris, Laboratoires: Roger Bellon Neuilly sur Seine, Wyeth‐Lederle Nanterre, Asta Medica Oncology, Merignac
Central pathology review: yes (87% of patients)
Definition of complete response (evaluated after induction): disappearance of all clinical evidence of disease; normalization of all laboratory values, radiographs, and biopsies; patients with persistent computed tomographic abnormalities but regression greater than 75% of initial tumour |
| Participants |
Number of patients randomised: 541 (subgroup analysis on 236 patients with age‐adjusted high‐intermediate and high‐risk IPI patients)
Our analysis: 541 for overall results, 236 for IPI subgroup analysis
Patients untreated: yes
INCLUDED:
Histology: intermediate or high‐grade NHL (Working Formulation)
IPI: no restriction (setting before 1993)
Age: 16‐55 years
Presentation of at least one of the following adverse factors: ECOG performance status >1, extranodal sites >1, tumour burden 10cm or more, bone marrow or CNS involvement, Burkitt or lymphoblastic subtype (latter two without bone marrow or CNS involvement)
EXCLUDED:
concomitant or previous cancer; congestive heart failure, recent myocardial infarction or conduction abnormalities, uncontrolled diabetes mellitus, liver or kidney failure; HIV |
| Interventions |
Control group: ACVB or NCVB followed by sequential consolidation regimen
Experimental group: ACVB or NCVB followed by intensive consolidation and ABMT
Randomization of patients in complete remission after induction therapy with ACVB or NCVB
ACVB compared to NCVB as first randomisation (NCVB arm stopped 1991 due to significant advantage of ACVB) |
| Outcomes |
Disease‐free survival
Overall survival |
| Notes |
source: paper (1994, 1997, 2000)
1043 patients enrolled, 127 of them considered ineligible, so 916 patients received induction chemotherapy, 614 achieved a complete response, of these 541 patients were randomisedN =, 268 patients of these 541 had high‐intermediate or high risk IPI |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
