A randomized trial of amifostine and carmustine-containing chemotherapy to assess lung-protective effects

Roy B Jones; Keith E Stockerl-Goldstein; Jared Klein; James Murphy; Karl G Blume; Roger Dansey; Charles Martinez; Steven Matthes; Yago Nieto

doi:10.1016/j.bbmt.2004.01.001

A randomized trial of amifostine and carmustine-containing chemotherapy to assess lung-protective effects

Biol Blood Marrow Transplant. 2004 Apr;10(4):276-82. doi: 10.1016/j.bbmt.2004.01.001.

Authors

Roy B Jones¹, Keith E Stockerl-Goldstein, Jared Klein, James Murphy, Karl G Blume, Roger Dansey, Charles Martinez, Steven Matthes, Yago Nieto

Affiliation

¹ Department of Blood and Marrow Transplantation, M.D. Anderson Cancer Center, Houston, Texas 77030, USA. [email protected]

PMID: 15077226
DOI: 10.1016/j.bbmt.2004.01.001

Abstract

We conducted a randomized, double blind, placebo-controlled multi-institutional trial to assess the ability of amifostine to protect patients against acute lung injury associated with cyclophosphamide/cisplatin/carmustine (BCNU) (STAMP I), a BCNU-containing high dose chemotherapy regimen used with hematopoietic cell transplantation. Amifostine was administered in a dose of 740 mg/m(2) for 2 doses preceding administration of BCNU, the presumed pulmonary-toxic component of the regimen. The trial was stopped after 79 patients were randomized and a planned interim analysis demonstrated that it was unlikely that pulmonary cytoprotection would be detected with further accrual. We conclude that amifostine, used in the dose and schedule we tested, does not reduce the incidence of acute lung injury produced by STAMP I. Further, we suggest that amifostine use with BCNU in other contexts and with clinically achievable doses is unlikely to protect the lung from BCNU-associated acute injury.

Publication types

Clinical Trial
Multicenter Study
Randomized Controlled Trial

MeSH terms

Adult
Amifostine / administration & dosage*
Antineoplastic Agents, Alkylating / administration & dosage*
Antineoplastic Combined Chemotherapy Protocols / adverse effects*
Antineoplastic Combined Chemotherapy Protocols / therapeutic use
Breast Neoplasms / therapy
Carmustine / administration & dosage*
Carmustine / adverse effects*
Carmustine / therapeutic use
Cisplatin / adverse effects*
Cisplatin / therapeutic use
Cyclophosphamide / adverse effects*
Cyclophosphamide / therapeutic use
Double-Blind Method
Female
Hematopoietic Stem Cell Transplantation
Humans
Middle Aged
Placebos / administration & dosage
Radiation-Protective Agents / administration & dosage*
Respiratory Distress Syndrome / chemically induced
Respiratory Distress Syndrome / diagnosis
Respiratory Distress Syndrome / prevention & control*
Treatment Outcome

Substances

Antineoplastic Agents, Alkylating
Placebos
Radiation-Protective Agents
Cyclophosphamide
Amifostine
Cisplatin
Carmustine

Supplementary concepts

STAMP-I protocol