Vitolo.
Methods | Randomised controlled trial Number of centres: not clarified Location: Italy Years: January 1997 ‐ September 2000 Target reached Sponsorship: Amgen, majority of funding industrial, main reports and database completed and held independently from sponsor Number of withdrawals: Central pathology review: no Definition of complete response: WHO criteria | |
Participants | Number of patients randomised: 130 (126 analysed) Our analysis: 126 Patients untreated: yes INCLUDED: Histology: diffuse large cell, peripheral T‐cell, anaplastic large cell lymphoma (REAL classification) IPI: age‐adjusted: intermediate‐high or high risk; OR patients with bone marrow involvement regardless of IPI score Age: <60 years EXCLUDED: non‐advanced stage; abnormal renal, liver function; cardiac ejection <50%, inadequate bone marrow function (neutrophils < 1,5 x 1000000000/l, platelets < 50 x 1000000000/l); CNS involvement; performance status >2; neoplasia in the last 5 years; life expectancy < 3 months; HbsAg+, hepatitis C, HIV | |
Interventions | Control group: MegaCEOP 6 to 8 cycles Experimental group: APO 1 to 2 cycles followed by high‐dose therapy and ASCT Patients in experimental arm with bone marrow involvement received 2 cycles APO, others 1 course Randomization upfront | |
Outcomes | Overall survival Disease‐free survival Failure‐free survival Response rates | |
Notes | source: abstract and personal communication 4 patients excluded from the analysis due to major violations | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
Patients untreated means: no lymphoma related treatment before study entry, according to inclusion and exclusion criteria: only stated criteria are mentioned (especially important for abstract as source, Randomisation upfront=before treatment