Isaacs, C., Robert, N.J., Bailey, F.A., Schuster, M.W., Overmoyer, B., Graham, M., . . . Kaye, J.A. (1997). Randomized placebo-controlled study of recombinant human interleukin-11 to prevent chemotherapy-induced thrombocytopenia in patients with breast cancer receiving dose-intensive cyclophosphamide and doxorubicin. Journal of Clinical Oncology, 15, 3368–3377.
Patients were assigned randomly to receive either placebo or interleukin-11 (IL-11) 50 mcg/kg/day subcutaneous (SC). The study drug was blinded. Randomization was stratified by investigative site and also by whether patients had received any prior chemotherapy. SC administration began on day two and was given for a minimum of 10 days after the first cycle of chemotherapy.
Sixty-seven patients were assessable. Sixty-eight percent of patients in the IL-11 group did not receive transfusions, versus 41% in the placebo group (p = .04). The IL-11 group had a decreased total number of platelet transfusions (p = .03) and time to platelet recovery to greater than 50K in the second cycle (p = .01). Side effects in the IL-11 group (p < .05) were peripheral edema (68%), dyspnea (48%), pleural effusion (18%), and conjunctival infection (25%).