Outcomes in patients (pts) who had received sorafenib (S) as the only prior systemic therapy in the phase 3 CELESTIAL trial of cabozantinib (C) versus placebo (P) in advanced hepatocellular carcinoma (HCC).

4088 Background: C inhibits tyrosine kinases including MET, VEGFR, and AXL. In the CELESTIAL trial, C improved overall survival (OS) and progression-free survival (PFS) compared with P in pts with advanced HCC after 1 or 2 prior lines of systemic therapy including S. Overall, median OS was 10.2 mo for C vs 8.0 mo for P (HR 0.76, 95% CI 0.63–0.92; p = 0.0049), and median PFS was 5.2 mo for C vs 1.9 mo for P (HR 0.44, 95% CI 0.36–0.52; p < 0.0001). Here, outcomes were analyzed for pts who had received S as the only prior systemic therapy. Methods: In the overall study, 707 pts were randomized 2:1 to receive C (60 mg qd) or P stratified by disease etiology, geographic region, and extent of disease. Eligible pts had pathologic diagnosis of HCC, Child-Pugh score A, and ECOG PS ≤1. Pts must have received prior S and could have received up to two lines of prior systemic therapy for HCC. Outcomes were analyzed for pts who received only prior S based on duration of prior S ( < 3 mo, 3 to < 6 mo, and ≥6 mo). Results: Out of the 495 pts who received only prior S, 136 (27%) received prior S for < 3 mo, 141 (28%) for 3 to < 6 mo, and 217 (44%) for ≥6 mo. OS and PFS were improved for C vs P in pts who had received only prior S; median OS was 11.3 mo for C vs 7.2 mo for P (HR 0.70), and median PFS was 5.5 mo for C vs 1.9 mo for P (HR 0.40). Results for OS and PFS also favored C for subgroups based on duration of prior S (Table). Median OS was generally longer for pts who received prior S for longer durations in both treatment arms. Grade 3/4 adverse events in subgroups were similar to those observed in the overall population in both arms. Conclusions: C improved OS and PFS vs P in pts with advanced HCC who had received S as the only prior systemic therapy irrespective of the duration of prior S treatment. Clinical trial information: NCT01908426. Prior S Only Duration of Prior S < 3 mo 3 to < 6 mo ≥6 mo C (N = 331) P (N = 164) C (N = 89) P (N = 47) C (N = 98) P (N = 43) C (N = 143) P (N = 74) Median OS, mo 11.3 7.2 8.9 6.9 11.5 6.5 12.3 9.2 OS HR (95% CI) 0.70 (0.55–0.88)* 0.72 (0.47–1.10) 0.65 (0.43–1.00) 0.82 (0.58–1.16) Median PFS, mo 5.5 1.9 3.8 1.8 5.4 1.9 5.7 1.9 PFS HR (95% CI) 0.40 (0.32–0.50)* 0.35 (0.23–0.52) 0.37 (0.25–0.56) 0.48 (0.35–0.67) *Stratified; all other HRs are unstratified.

Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.