J Cancer 2018; 9(24):4718-4725. doi:10.7150/jca.26690

Research Paper

A Randomized Controlled Study of rhTPO and rhIL-11 for the Prophylactic Treatment of Chemotherapy-Induced Thrombocytopenia in Non-Small Cell Lung Cancer

Yunhua Xu1, Xia Song2, Fangmin Du3, Qiong Zhao4, Li Liu5, Zhiyong Ma6, Shun Lu1✉

1. Department of Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241West Huaihai Road, Shanghai, P. R. China.
2. Shanxi Cancer Hospital, No.309 West Yanta Road, Shanxi, P. R. China.
3. Dongyang people's Hospital of Zhejiang Province, No.60 West Wuning Road, Dongyang, P. R. China.
4. The First Affiliated Hospital of Zhejiang University, No. 79 Qingchun Road, Hangzhou, P. R. China
5. The Affilicated Wuhan Union Hospital of Huazhong University of Science and Technology, No.1277 Liberation Avenue, Wuhan, P. R. China.
6. Henan Cancer Hospital, No.127 Dongming Road, Zhengzhou, P. R. China.

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Xu Y, Song X, Du F, Zhao Q, Liu L, Ma Z, Lu S. A Randomized Controlled Study of rhTPO and rhIL-11 for the Prophylactic Treatment of Chemotherapy-Induced Thrombocytopenia in Non-Small Cell Lung Cancer. J Cancer 2018; 9(24):4718-4725. doi:10.7150/jca.26690. Available from http://www.jcancer.org/v09p4718.htm

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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 × 109/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 × 109/L in the study arm, values higher than those measured in the control arm 52.8 ± 36.8 × 109/L (P = 1.044). Platelet counts < 50 × 109/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.

Keywords: thrombocytopenia, rhTPO, rhIL-11, prophylactic administration, NSCLC