Abstract
Background: rhTPO and rhIL-11 are both recommended for the prophylactic treatment of chemotherapy-induced thrombocytopenia (CIT). However, there has been no head to head comparative study on the prophylactic administration of rhTPO and rhIL-11 to alleviate CIT in non-small cell lung cancer (NSCLC). Methods: In this open-label prospective multi-center phase II clinical trial, 108 NSCLC patients who experienced severe CIT after prior chemotherapy were randomized into study and control arms. Patients in the study arm were prophylactically administered rhTPO on day 2, day 4, day 6 and day 9 of the subsequent chemotherapy cycle, while patients in the control arm accepted prophylactic rhIL-11 from day 9 to day 15 of the subsequent chemotherapy cycle. Results: During the trial, the median time required for recovery of the platelet count to ≥ 75 × 10(9)/L was 3 days (range: 2-4) in the study arm and 4 days (range: 2-6) in the control arm (P = 0.398). The lowest platelet counts were 61.8 ± 39.9 × 10(9)/L in the study arm, values higher than those measured in the control arm 52.8 ± 36.8 × 10(9)/L (P = 1.044). Platelet counts < 50 × 10(9)/L occurred in 46.2% of patients in the study arm vs 58.6% in the control arm (P = 0.368). There were no drug-related adverse reactions in the study arm, but 4 cases (12.9%) in the control arm (P = 0.008), especially cardiotoxicity (P = 0.022). Conclusion: Prophylactic administration of rhTPO helps to alleviate CIT in NSCLC as well as rhIL-11, but is safer to use and more convenient to administer.