The value of augmented preparative regimens combined with an autologous bone marrow transplant for the management of relapsed or XXXX : a Southwest Oncology Group phase II trial.

@entity1 @entity66 @entity3012 @entity786 @entity797 @entity2590 @entity2879 @entity3600 @entity358 @entity978 @entity204
Several single-institution pilot studies have suggested that augmented preparative regimens, including those containing total body irradiation combined with an autologous bone marrow transplantation, are superior to standard regimens for the treatment of relapsed or @entity978 . On the basis of these data, we undertook, in the cooperative group setting, a phase II trial of augmented preparative regimens for @entity1 experiencing treatment failure with conventional chemotherapy. Eighty-one @entity1 with either sensitive or refractory (induction failures or chemoresistant) relapse received @entity2879 (60 mg/kg), @entity786 (100 mg/kg), and either total body irradiation (12 Gy) or, if previously irradiated, @entity3600 (15 mg/kg), followed by an autologous bone marrow transplantation. Progression-free (PFS) and overall ( @entity3012 ) survival were estimated, and a @entity797 regression model was used to assess potential prognostic variables. The 5-year PFS and @entity3012 for the 74 eligible @entity1 treated at 20 Southwest Oncology Group centers were 41% (95% confidence interval [CI], 29%-53%) and 54% (95% CI, 43%-65%), respectively, despite a median remission after initial chemotherapy of only 6 months. The 3-year @entity3012 for those whose induction therapy failed was 72% (95% CI, 52%-93%). There was 1 (1.4%) early treatment-related @entity204 , 2 late deaths due to @entity358 , and only 1 @entity204 due to @entity2590 . There were no differences in PFS or @entity3012 on the basis of regimen or chemosensitivity. A @entity797 prognostic factor analysis determined that >2 prior regimens, relapse in a radiated field, and @entity66 were adverse prognostic factors. Among the 46 @entity1 who received prior radiotherapy, the 5-year @entity3012 was 38% (95% CI, 14%-61%) for @entity1 with 2 or 3 adverse factors, versus 60% (95% CI, 42%-78%) for those with 0 factors or 1 adverse factor. Augmented preparative regimens seem promising for the treatment of relapsed or @entity978 , without an increase in regimen-related mortality. A poor-prognosis group was identified that should be treated with novel therapies.
