25th Europian Society of Medical Oncology (Hamburg, German)
Phase II/III Clinical Trial of Interleukin-11 (rhIL-11: YM294) Treatment for Thrombocytopenia During Chemotherapy of Small Cell Lung Cancer (SCLC)F rhIL-11 Study Group (SCLC)
Toshiyuki Sawa1, Yoshihiko Segawa2, Kiyoshi Mori3, Masaaki Kawahara4, Yasuo Ohhashi5 and Kiyoyuki Furuse6
1Gifu Municipal Hosp.,Gifu JP;2National Shikoku Cancer Center Hosp.,Ehime JP;3Tochigi Cancer Center,Tochigi JP;4National Kinki Central Hosp. for Chest Disease,Osaka JP;5Tokyo Univ.,Tokyo JP;6Osaka Central Hosp.,Osaka JP
@@We conducted clinical trials to investigate efficacy and safety of rhIL-11 administration as the treatment for thrombocytopenia caused by SCLC chemotherapy, using placebo as a control in a double blind, between-groups comparison method testing. SCLC patients were administered Carboplatin (day 1) and Etoposide (day 1-3) . For those cases of patient whose platelet count decreased to <50,000/mm3, 25 mg/kg/day (IL25), 50 m g/kg/day (IL50) of rhIL-11, or placebo (P) were administered subcutaneously during the following course of the same chemotherapy on day 4 to 17. Analysis was conducted on 100 cases that were subjects for Full Analysis Set, out of 105 cases officially enrolled.
@@The up-lifting increase in minimum platelet count was 13,300*15,070/mm3 for P, though 18,800*26,450/mm3 for IL25 and 16,600*17,420/mm3 for IL50. No statistically significant difference was observed between P and either of rhIL-11 treatment groups. On the other hand, the number of days required to recover the platelet count of 50,000/mm3 were significantly shortened in IL25 (p=0.0159) and IL50 (p=0.0005), compared to P. Moreover, the days required to recover 100,000/mm3 were also significantly shortened in IL25 (p=0.0292) and IL50 (p=0.0019), compared to P (generalized Wilcoxon test). The incidences of adverse reaction were 21.2% for P, 36.4% for IL25, and 41. 2% for IL50. However, most of the adverse reaction were either Grade 1 or 2, and reversible; also, all were regarded within the manageable range.
@@Conclusion: We consider rhIL-11 is an effective agent in treating thrombocytopenia caused by chemotherapy for the patients of SCLC.
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