Table 2.

Summary of efficacy

VariableTwice daily dose
Total (N = 103)
10 mg (n = 51)100 mg (n = 52)
Best response (RECIST criteria)
    CR2 (4)0 (0)2 (2)
    PR0 (0)2 (4)*2 (2)
    SD28 (55)24 (46)52 (50)
    PD18 (35)24 (46)42 (41)
    Incomplete data3 (6)2 (4)5 (5)
ORR% (90% CI)3.92 (0.70-11.83)0.01.94 (0.35-5.99)
PFS
    Median PFS, mo4.23.3NA
    Observed 4-mo PFS% (90% CI)54 (42-66)41 (30-53)48 (39-56)
    Observed 6-mo PFS% (90% CI)39 (27-51)32 (21-43)35 (27-43)
Overall survival
    Median survival, mo27.826.126.1
  • NOTE: There were no statistically significant differences in ORR (P = 0.243, Fisher's exact test), PFS (P = 0.803, log-rank test), or overall survival (P = 0.588, log-rank test) between groups. Values in table expressed as n (%).

    Abbreviations: RECIST, Response Evaluation Criteria in Solid Tumors; 90% CI, 90% confidence interval; NA, not available.

  • * The two partial responses were not confirmed by a second tumor assessment within 60 days of the initial observation of the response. For this reason, they were not included in the calculation of the ORR.