title: Multicenter, randomized study of genetically modified recombinant human interleukin-11 to prevent chemotherapy-induced thrombocytopenia in cancer patients receiving chemotherapy.
abstract: OBJECTIVE
  The aim of this study is to evaluate the efficacy and safety of genetically modified recombinant human IL-11 (mIL-11), using original IL-11 as an active control, in a multicenter randomized trial involving 88 cancer patients undergoing chemotherapy
  
  
  METHODS
  Eighty-eight subjects who had platelets ≤ 75 × 10(9)/L during the prior chemotherapy were randomized to the MR or RM group. Cohort MR consists of subcutaneous injection of mIL-11 (7.5 μg/kg/day) for 10 days, beginning 72 h after chemotherapy for a 21-day chemotherapy cycle (cycle-1) followed by that of recombinant human interleukin-11 (rhIL-11) (25 μg/kg/day) for another 10 days (cycle-2). Cohort RM represents the reverse sequence. Intent-to-treat populations of mIL-11 (n = 73) or rhIL-11 (n = 80) were analyzed to evaluate the safety.
  
  
  RESULTS
  The incidence of drug-related adverse events of mIL-11 (32.9%) was lower than that of rhIL-11 (51.3%) (p = 0.033). There were no unexpected ≥ grade-3 adverse events, and no subject developed antibodies to the mIL-11 protein. Sixty-two subjects were analyzed for efficacy by measuring average platelet levels. Both mIL-11 and rhIL-11 increased nadir platelet levels (62.6 ± 34.9 × 10(9)/L for mIL-11 vs. 60.2 ± 31.7 × 10(9)/L for rhIL-11) as compared with the untreated control group (41.2 ± 17.7 × 10(9)/L) (p < 0.0001). There was no statistical difference in average platelet levels and platelet recovery rate between mIL-11 and rhIL-11.
  
  
  CONCLUSIONS
  This study shows that mIL-11 is well tolerated and has thrombopoietic activity equivalent to one third of the clinical dose of rhIL-11, indicating the potential of mIL-11 for use in the treatment of CIT.
authors: Cancer Center, 307 Hospital of PLA, No. 8 Dongda Street, Fengtai District, Beijing, China.
authors: Shikai
authors: S
authors: Wu
authors: Yang
authors: Y
authors: Zhang
authors: Liyan
authors: L
authors: Xu
authors: Yun
authors: Y
authors: Dai
authors: Yuee
authors: Y
authors: Teng
authors: Shanshan
authors: S
authors: Ma
authors: Seong-Hyun
authors: SH
authors: Ho
authors: Jong-Mook
authors: JM
authors: Kim
authors: Seung Shin
authors: SS
authors: Yu
authors: Sunyoung
authors: S
authors: Kim
authors: Santai
authors: S
authors: Song
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001803:Blood Transfusion / Q000706:statistics & numerical data; D016009:Chi-Square Distribution; D002681:China; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D017370:Interleukin-11 / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000627:therapeutic use*; D013921:Thrombocytopenia / Q000139:chemically induced* / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D017370:Interleukin-11; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor