Herold 2006.
| Methods | Allocation generation: unclear Allocation concealment: unclear Blinding: no ITT: no Number of dropouts: 2/164 Median follow‐up: 44 months | |
| Participants | 164 randomised, 162 evaluable, adult patients
Type of lymphoma: follicular, mantle cell, lymphoplasmacytic lymphoma
Stage: III/IV Previous treatment: no Mean age: 58 years WHO Performance status: < 2 |
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| Interventions | Investigational intervention: Bendamustine 60 mg/m2 on days 1 to 5, vincristine 2 mg on day 1 and prednisone 100 mg/m2 on days 1 to 5; every 3 weeks, for 8 cycles Comparator intervention: Cyclophosphamide 400 mg/m2 on days 1 to 5, vincristine 2 mg on day 1 and prednisone 100 mg/m2 on days 1 to 5; every 3 weeks, for 8 cycles |
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| Outcomes | Survival time was defined as time from the start of therapy until death Time to progression was defined as the time from the start of therapy until progression or disease‐related death, and was reported in responding patients Time to treatment failure was defined as the time from the start of therapy until treatment failure (objective progression, change of randomised therapy, intolerable toxicity or death for any reason). Rates of treatment failure in each group are described, but time to treatment failure is reported only in responding patients CR, PR Adverse events |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 2 patients (1%) were not evaluable and not included in the analysis. Reasons and allocation were not specified |
| Selective reporting (reporting bias) | Unclear risk | The trial's protocol was not available to evaluate selective reporting Time to progression and time to treatment failure were reported only in responding patients |
| Other bias | Unclear risk | Funded by Ribosepharm GmbH, Clinical Research, Munich |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were not blinded to allocated treatment |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |