Tepler, I., Elias, L., Hussein, M., Rosen, G., Chang, A.Y., Moore, J.O., . . . Kaye, J. A. (1996). A randomized placebo-controlled trial of recombinant human interleukin-11 in cancer patients with severe thrombocytopenia due to chemotherapy. Blood, 87, 3607–3614.

Placebo or interleukin-11 (IL-11) 25 mcg/kg or 50 mcg/kg subcutaneous (SC) daily beginning at day one (after completion of chemotherapy) and continued for 14–21 days or until platelet count of greater than or equal to 100K
Study during one cycle of chemotherapy. Platelet checked three times per week (nonconsecutive days); repeated daily if platelet count less than or equal to 50K. Platelets were transfused if the count was less than or equal to 20K.
Had to start with platelet count greater than or equal to 100K
Single donor and pooled donor platelets given
Done as outpatient from December 1993–February 1995

N = 93
AGE: 17–73 years
KEY DISEASE CHARACTERISTICS: Solid tumors of lymphoma, excluded radiotherapy-induced thrombocytopenia or chemotherapy given less than five days prior
OTHER KEY SAMPLE CHARACTERISTICS: Patients who already had been transfused with platelets at least once (during the chemotherapy cycle immediately preceding the study) for severe thrombocytopenia related to chemotherapy (nadir counts less than or equal to 20K). Chemotherapy regimen was continued (same agent, doses, and schedule).

Determine whether patients required any platelet transfusions during the study cycle
Successful outcome was no transfusion.

Dose of 50 mcg = 30% did not require transfusion versus 4% with placebo (p < .05)
Dose of 25 mcg = 18% did not require transfusion (p = .23)
Side effects were fatigue and cardiovascular symptoms (e.g., atrial fibrillation, syncope).
Five patients were discontinued before receiving any study drug; 82 patients were evaluable, and six patients were not evaluable.
Median number of platelet transfusions was one with the 50 mcg group, two with the 25 mcg group, and three with the placebo group. Forty-one percent of patients who did not require transfusion were those with shorter chemotherapy times and the 50 mcg dose.
Median duration of platelet count with 25 mcg and 50 mcg dosing was two days at less than 20K, seven days at less than 50K, 13 days at less than 100K, versus with placebo of five days at less than 20K, 10 days at less than 50K, and 14 days at less than 100K.
Ecchymosis appeared in 21% at 50 mcg dose, 24% at 25 mcg dose, and 35% with placebo.

Patients already had received platelet transfusions during chemotherapy cycle prior to study
Studied during only one cycle of chemotherapy
Chemotherapy (single and combo agents) cycles were less than five days.
Started with platelet counts greater than 100K
Variety of cancers (e.g., breast, lung, Hodgkin and non-Hodgkin, ovarian, and “other”)