Background: Thrombocytopenia is a significant problem in the treatment of cancer.
Objective: To assess the clinical safety of therapy with recombinant human thrombopoietin (rhTPO) and its ability to ameliorate chemotherapy-induced severe thrombocytopenia.
Design: Phase I/II clinical cohort study.
Setting: The University of Texas M.D. Anderson Cancer Center, Houston, Texas.
Patients: 29 patients with gynecologic cancer.
Intervention: Recombinant human thrombopoietin was given before chemotherapy and after a second cycle of carboplatin therapy.
Measurements: Peripheral blood counts and platelet transfusions.
Results: Administration of rhTPO after chemotherapy significantly reduced the degree and duration of thrombocytopenia and enhanced platelet recovery. In patients who received the optimal biological dose of rhTPO (1.2 microg/kg of body weight) in cycle 2 (carboplatin plus rhTPO), the mean platelet count nadir was higher (44x10(9) cells/L and 20x10(9) cells/L; P = 0.002) and the duration of thrombocytopenia was shorter (days with a platelet count <20x10(9) cells/L, 1 and 4 [P = 0.002]; days with a platelet count <50x10(9) cells/L, 4 and 7 [P = 0.006]) than in cycle 1 (carboplatin only). The need for platelet transfusion in this group was reduced from 75% of patients in cycle 1 to 25% of patients in cycle 2 (P = 0.013).
Conclusions: Therapy with rhTPO seems to be safe and may attenuate chemotherapy-induced severe thrombocytopenia and reduce the need for platelet transfusions.