Extended follow-up of High-dose Melphalan and autologous SCT after Vincristine, Doxorubicin, Dexamethasone induction in AL amyloidosis of the prospective phase II HOVON-41 study by the Dutch-Belgian Cooperative Trial Group for Hematology Oncology
Hazenberg, Bouke P C × Croockewit, Alexandra van der Holt, Bronno Zweegman, Sonja Bos, Gerard M J Delforge, Michel Raymakers, Reinier A P Sonneveld, Pieter Vellenga, Edo Wijermans, Pierre W von dem Borne, Peter A van Oers, Marinus H de Weerdt, Okke Spoelstra, Fokje M Lokhorst, Henk M #
Il Pensiero Scientifico
Haematologica vol:100 issue:5 pages:677-82
In a prospective multicenter phase II study, we evaluated the effect of three courses of vincristine, doxorubicin and dexamethasone followed by High-dose melphalan and autologous stem cell transplantation on an intention to treat basis. Sixty-nine newly diagnosed patients with AL amyloidosis were included between November 2000 and January 2006: 37 men and 32 women with a median age of 56 years, including 46% of patients with cardiac and 22% of patients with involvement of 3 or 4 organs. Initial results presented in 2008 (New England Journal of Medicine 358;1) showed a 4-year overall survival rate of 62 % among all the patients, while the 4-year survival rate after transplantation was 78%. Here we report the long term follow up data after median follow-up of 115 months of the patients still alive. Median survival of all patients was 96 months from registration and for the transplanted patients 10 years from the date of transplantation. Twelve (12%) of patients died during induction therapy with vincristine, doxorubicin and dexamethasone including 8 patients (12%) due to treatment related mortality. Two patients died within 1 month following High-dose melphalan. We conclude that vincristine, doxorubicin and dexamethasone should not be applied as induction therapy for intensification in AL amyloidosis. However a 2-step approach consisting of a non-intensive less toxic induction therapy followed by High-dose melphalan and autologous stem cell transplantation may result in extended survival in newly diagnosed patients with AL amyloidosis. (ISRCTN01207094).