A Randomized Noninferiority Trial of Intravenous Iron Isomaltoside versus Oral Iron Sulfate in Patients with Nonmyeloid Malignancies and Anemia Receiving Chemotherapy: The PROFOUND Trial.

ABSTRACT:

Study objective

A safe alternative to erythropoiesis-stimulating agents to treat anemia is warranted in patients with cancer and anemia; thus the objective of this trial was to compare the efficacy and safety of intravenous (IV) iron isomaltoside with oral iron in patients with cancer and anemia by testing the noninferiority of IV versus oral iron.

Design

Phase III, prospective, open-label, comparative, randomized, noninferiority, multicenter trial.

Setting

Forty-seven hospitals or private cancer clinics in Asia, the United States, and Europe.

Patients

A total of 350 patients with cancer and anemia.

Intervention

Patients were randomized in a 2:1 ratio to either intravenous iron isomaltoside or oral iron sulfate. Patients in the iron isomaltoside group we

SUBMITTER: Birgegard G 

PROVIDER: S-EPMC5071650 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature