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High-dose intravenous melphalan and autologous stem cell transplantation as initial therapy or following two cycles of oral chemotherapy for the treatment of AL amyloidosis: results of a prospective randomized trial
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High-dose intravenous melphalan and autologous stem cell transplantation as initial therapy or following two cycles of oral chemotherapy for the treatment of AL amyloidosis: results of a prospective randomized trial
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High-dose intravenous melphalan and autologous stem cell transplantation as initial therapy or following two cycles of oral chemotherapy for the treatment of AL amyloidosis: results of a prospective randomized trial
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Journal Article
High-dose intravenous melphalan and autologous stem cell transplantation as initial therapy or following two cycles of oral chemotherapy for the treatment of AL amyloidosis: results of a prospective randomized trial
2004
Overview
A prospective randomized trial was conducted to study the timing of high-dose intravenous melphalan and autologous stem cell transplantation (HDM/SCT) in AL amyloidosis. In all, 100 newly diagnosed patients were randomized to receive HDM/SCT, either as initial therapy (Arm-1) or following two cycles of oral melphalan and prednisone (Arm-2). The objectives of the trial were to compare survival and hematologic and clinical responses. With a median follow-up of 45 months (range 24-70), the overall survival was not significantly different between the two treatment arms (P=0.39). The hematologic response and organ system improvements after treatment did not differ between the two groups. Fewer patients received HDM/SCT in Arm-2 because of disease progression during the oral chemotherapy phase of the study, rendering them ineligible for subsequent high-dose therapy. This affected patients with cardiac involvement particularly, and led to a trend for an early survival disadvantage in Arm-2. Hence, newly diagnosed patients with AL amyloidosis eligible for HDM/SCT did not benefit from initial treatment with oral melphalan and prednisone, and there was a survival disadvantage for patients with cardiac involvement if HDM/SCT was delayed by initial oral chemotherapy.
Publisher
Nature Publishing Group
Subject
/ Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
/ Antineoplastic Agents, Alkylating - administration & dosage
/ Antineoplastic Agents, Alkylating - toxicity
/ Antineoplastic Combined Chemotherapy Protocols - administration & dosage
/ Antineoplastic Combined Chemotherapy Protocols - toxicity
/ Biological and medical sciences
/ Bone marrow, stem cells transplantation. Graft versus host reaction
/ Female
/ Heart
/ Hematopoietic Stem Cell Transplantation - methods
/ Hematopoietic Stem Cell Transplantation - mortality
/ Humans
/ Male
/ Melphalan - administration & dosage
/ Patients
/ Prednisone - administration & dosage
/ Survival
/ Transfusions. Complications. Transfusion reactions. Cell and gene therapy
