A RANDOMIZED PLACEBO-CONTROLLED TRIAL OF RECOMBINANT HUMAN INTERLEUKIN-11 IN CANCER-PATIENTS WITH SEVERE THROMBOCYTOPENIA DUE TO CHEMOTHERAPY

Thrombocytopenia is a complication of cancer treatment that can limit dose intensity. Interleukin-11 (IL-11) is a growth factor that increas es platelet production. We conducted a multicenter, randomized, placeb o-controlled trial of recombinant human IL-11 (rhIL-11) in 93 patients with cancer who had already been transfused platelets for severe thro mbocytopenia resulting from chemotherapy. The patients had received pl atelet transfusions for nadir platelet counts of less than or equal to 20,000/mu L during the chemotherapy cycle immediately preceding study entry, Chemotherapy was continued during the study without dose reduc tion. Patients were randomized to receive placebo or rhIL-11 at 50 or 25 mu g/kg subcutaneously once daily for 14 to 21 days beginning 1 day after chemotherapy. Eight of 27 (30%) evaluable patients treated with rhIL-11 at a dose of 50 mu g/kg did not require platelet transfusions versus 1 of 27 (4%) patients who received placebo (P < .05). Five of 28 (18%) patients treated with rhIL-11 at 25 mu g/kg avoided platelet transfusions (P = .23). Side effects were fatigue and cardiovascular s ymptoms, including a low incidence of atrial arrhythmias and syncope. There were no differences among treatment groups in the incidence of n eutropenic fever, days of hospitalization, or number of red blood cell transfusions. This study shows that rhIL-11 treatment at a dose of 50 mu g/kg significantly increases the likelihood that patients who have already been transfused platelets for severe chemotherapy-induced thr ombocytopenia will not require platelet transfusions during a subseque nt chemotherapy cycle. (C) 1996 by The American Society of Hematology.