High-dose therapy and autologous peripheral blood stem cell transplantation in XXXX : up-front or rescue treatment? Results of a multicenter sequential randomized clinical trial.

@entity1 @entity632 @entity1667 @entity137 @entity1582 @entity1891 @entity34
Results to date indicate that @entity34 ( @entity34 ) with autologous stem cell support improves survival of @entity1 with symptomatic @entity1582 ( @entity1582 ). We performed a multicenter, sequential, randomized trial designed to assess the optimal timing of @entity34 and autotransplantation. Among 202 enrolled @entity1 who were up to 56 years old, 185 were randomly assigned to receive @entity34 and peripheral blood stem cell (PBSC) autotransplantation (early @entity34 group, n = 91) or a conventional-dose chemotherapy (CCT) regimen (late @entity34 group, n = 94). In the late @entity34 group, @entity34 and transplantation were performed as rescue treament, in case of primary resistance to CCT or at relapse in responders. PBSC were collected before randomization, after mobilization by chemotherapy, and, in the two groups, @entity34 was preceded by three or four treatments with @entity1891 , @entity632 , and @entity1667 . Data were analyzed on an intent-to-treat basis using a sequential design. Within a median follow-up of 58 months, estimated median overall survival (OS) was 64.6 months in the early @entity34 group and 64 months in the late group. Survival curves were not different (P = .92, log-rank test). Median event-free survival (EFS) was 39 months in the early @entity34 group whereas median time between randomization and CCT failure was 13 months in the late group. Average time without symptoms, treatment, and treatment @entity137 (TWiSTT) were 27.8 months (95% confidence interval [CI]; range, 23.8 to 31.8) and 22.3 months (range, 16.0 to 28.6) in the two groups, respectively. @entity34 with PBSC transplantation obtained a median OS exceeding 5 years in young @entity1 with symptomatic @entity1582 , whether performed early, as first-line therapy, or late, as rescue treatment. Early @entity34 may be preferred because it is associated with a shorter period of chemotherapy.
