Efficacy and safety of sequential therapy with sorafenib and regorafenib for advanced hepatocellular carcinoma: a two-center study in China.
J Gastrointest Oncol
; 13(3): 1266-1277, 2022 Jun.
Article
in En
| MEDLINE
| ID: mdl-35837206
ABSTRACT
Background:
Regorafenib is a standard 2nd-line treatment for patients with advanced hepatocellular carcinoma (HCC), but the efficacy and safety of sequential therapy with sorafenib and regorafenib among advanced HCC patients in China is not clear.Methods:
This was a retrospective, two-center, cohort study of advanced HCC patients who received sequential therapy of sorafenib and regorafenib from October 2018 to April 2020 at 2 Chinese institutions. The patients were converted directly to regorafenib after failing to respond to sorafenib monotherapy. The patients underwent evaluations every 4-6 weeks to determine the efficacy and safety of the treatment according to physiological, laboratory, and radiological results. A radiological evaluation using computed tomography or magnetic resonance imaging scans was conducted. The outcomes included overall survival (OS) and progression-free survival (PFS).Results:
A total of 43 patients received regorafenib as a 2nd-line treatment after sorafenib progression. Of these patients, 26 (60.5%) and 17 (39.5%) were diagnosed with Barcelona Clinic Liver Cancer (BCLC) stages B and C, respectively. The median PFS was 11.0 [95% confidence interval (CI) 5.8-16.2] months, and the median OS was 17.0 (95% CI 12.8-21.2) months. Conversely, the most common toxicities were hand-foot skin reaction (48.8%), diarrhea (32.6%), and hypertension (14%). The most common grade 3-4 toxicities were hypoalbuminemia (4.7%), anemia (4.7%), and thrombocytopenia (4.7%). Alpha-fetoprotein (AFP) ≥400, alanine transaminase (ALT) ≥60 IU/L, and aspartate aminotransferase (AST) ≥60 IU/L before 2nd-line treatment were associated with PFS in the univariable analyses. The Cox proportional-hazards regression analysis showed that AFP [hazard ratio (HR) =0.225; 95% CI 0.073-0.688; P=0.009], ALT (HR =0.195; 95% CI 0.051-0.741; P=0.016), AST (HR =0.209; 95% CI 0.063-0.697; P=0.011), and presence of extrahepatic metastasis (HR =0.074; 95% CI 0.009-0.608; P=0.015) before 2nd-line treatment were independently associated with PFS.Conclusions:
The sequential therapy of sorafenib and regorafenib is well-tolerated and effective in advanced HCC patients after sorafenib progression based on our two-center real-world data. Patients with good liver function reserve and a high level of AFP before 2nd-line treatment may benefit from sequential treatment. These results still need further validation.
Full text:
1
Collection:
01-internacional
Health context:
3_ND
Database:
MEDLINE
Type of study:
Observational_studies
/
Risk_factors_studies
Language:
En
Journal:
J Gastrointest Oncol
Year:
2022
Document type:
Article