Long-term results of the CHOP regimen in stage C chronic lymphocytic leukaemia. French Cooperative Group on Chronic Lymphocytic Leukaemia.

This paper reports the results of the third interim analysis of a randomized clinical trial in poor prognosis chronic lymphocytic leukaemia (stage C). From May 1980 to February 1985, 70 stage C patients were randomized between the two polychemotherapies COP and CHOP (COP+doxorubicin). At the reference date of 1 June 1987 used for this analysis, the mean follow-up was 58 months, 46 deaths were observed, 27 in the COP group and 19 in the CHOP group. Overall survival was significantly improved in the CHOP group (P = 0.0005). The 3-year survival rates were 71% in the CHOP group and 28% in the COP group and the median survival times were 62 months in the CHOP group as compared to 22 months in the COP group. This benefit with CHOP was confirmed when adjusting treatment comparison for nine parameters (P = 0.001) and when considering other endpoints than survival, namely 9-month status and stage. This third interim analysis confirms the results of the first interim analysis that led to an early stopping of this clinical trial and clearly indicates the beneficial effect of low doses of doxorubicin in advanced chronic lymphocytic leukaemia.

RCT Entities:   Population Interventions Outcomes