[Clinical study of rhIL-11 for prevention and treatment of chemotherapy-induced thrombocytopenia].
OBJECTIVE
Cancer chemotherapy can induce thrombocytopenia. It is necessory to develop drugs that can prevent and treat thrombocytopenia. The current study was designed to evaluate the efficacy and toxicity of rhIL-11 in prevention and treatment of chemotherapy-induced thrombocytopenia.


METHODS
A total of 109 cancer patients were involved randomly into AB or BA group and every patient received 2 cycles of chemotherapy. IL-11 was administered subcutaneously(50 micrograms/kg/d), beginning 24 hours after completion of chemotherapy for 14 consecutive days or continuing until platelet count was > 400 x 10(9)/L during cycle A. Patients did not received IL-11 during cycle B. Another 41 cases of cancer patients whose platelet were less than 50 x 10(9)/L after chemotherapy entered into open study group. IL-11 administration was the same as above.


RESULTS
Efficacy can be evaluated in 107 cases in controlled study group. Mean platelet count of cycle A was (246.49 +/- 88.64) x 10(9)/L and cycle B was (180.24 +/- 83.34) x 10(9)/L(P = 0.000). Grade III/IV thrombocytopenia in cycle A and cycle B were 7/107(6.5%) and 15/107(14%), respectively (P = 0.04). The minimum platelet counts were (136.46 +/- 74.64) x 10(9)/L and (107.77 +/- 61.33) x 10(9)/L, respectively (P = 0.000). The maximum platelet counts were (381.28 +/- 150.39) x 10(9)/L and (207.44 +/- 113.32) x 10(9)/L, respectively (P = 0.000). For open study group, 32 patients could be evaluated. The platelet count increased from(30.1875 +/- 12.13) x 10(9)/L to (226.25 +/- 163.91) x 10(9)/L after IL-11 administration. Major adverse effects were edema, dizziness, palpitation, etc.


CONCLUSIONS
rhIL-11 can reduce thrombocytopenia induced by chemotherapy and is a safe and effective drug for treatment of thrombocytopenia.
Sun
Xiao-fei
XF
Cancer Center, Sun Yat-sen University, Guangzhou 510060, P. R. China. zsesun@21cn.com
Guan
Zhong-zhen
ZZ
Huang
He
H
Zhou
Qing-hua
QH
Yi
Cheng
C
Zhang
Li-jian
LJ
Zhu
Jun
J
Li
Rong
R
Zhou
Juan
J
Zhang
Mei
M
Guo
Yin
Y
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D004244:Dizziness / Q000139:chemically induced; D004487:Edema / Q000139:chemically induced; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D017370:Interleukin-11 / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000097:blood / Q000188:drug therapy*; D010976:Platelet Count; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D013921:Thrombocytopenia / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D017370:Interleukin-11; D011994:Recombinant Proteins