SOR and REG significantly improved OS versus placebo (PBO) in patients with unresectable HCC: SOR in the first-line setting in both the SHARP (median OS: 10.7 SOR vs 7.9 months PBO, HR 0.69; P
Patients with advanced HCC who received treatment in SHARP (SOR n = 299, PBO n = 303; NCT00105443), AP (SOR n = 150, PBO n = 76; NCT00492752), and RESORCE (REG n = 374, PBO n = 193; NCT01774344) were included in the analysis. Patients were subgrouped according to a baseline platelet count of > 150 × 109/L and ≤150 × 109/L. OS (HR and its 95% CI) was evaluated using a Cox proportional hazards model.
In SHARP, 180 patients (60%) treated with SOR and 199 (66%) receiving PBO had a baseline platelet count of > 150 × 109/L; 84 (56%) with SOR and 46 (61%) with PBO in AP; 163 (44%) with REG and 91 (47%) with PBO in RESORCE. Baseline variables were generally similar between subgroups for AP; in RESORCE, more patients had hepatitis C in the >150 × 109/L platelet count group; in SHARP, the lower platelet count group had more patients with ECOG PS 0 and BCLC B, fewer patients with macrovascular invasion and extrahepatic spread, less tumor burden, and more cases of hepatitis C. In SHARP and AP, a lower platelet count at baseline was associated with improved OS, but this was not observed in RESORCE. Both SOR and REG improved OS over PBO in both subgroups.Table:
|Trial (active drug)||Platelet count||n||Median OS for active drug, days||Median OS PBO, days||HR* (95% CI)|
|SHARP (SOR)||>150 × 109/L||379||290||218||0.81 (0.63, 1.04)|
|≤150 × 109/L||221||442||297||0.60 (0.42, 0.85)|
|AP (SOR)||>150 × 109/L||130||186||119||0.62 (0.42, 0.93)|
|≤150 × 109/L||95||227||166||0.78 (0.47, 1.31)|
|RESORCE (REG)||>150 × 109/L||254||326||230||0.57 (0.41, 0.78)|
|≤150 × 109/L||318||313||241||0.78 (0.58, 1.04)|
The analysis indicates that platelet count may be a prognostic factor for first-line HCC but not for second-line HCC patients. SOR and REG are effective treatment options in HCC regardless of platelet count at baseline.
Clinical trial identification
Legal entity responsible for the study
G. Meinhardt, Y. De Sanctis: Employment and stock ownership: Bayer. M-A. LeBerre: Employment: Bayer. K. Nakajima: Employment and ownership: Bayer.