Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Interventional Therapy, Peking University Cancer Hospital & Institute, Beijing, China
Shaoxing Liu , Song Gao , Jianhai Guo , Fuxin Kou , Xin Zhang , Baojiang Liu , Aiwei Feng , Xiaodong Wang , Hui Chen , Xu Zhu
Background: Regorafenib is a guideline-recommended second-line systemic drug, and its combination with transarterial chemoembolization (TACE) for the treatment of advanced liver cancer after first-line therapy has been gradually recognized by clinicians. We investigated the efficacy and safety of TACE combined with regorafenib with or without anti-PD-1 immunotherapy as a second line choice for advanced hepatocellular carcinoma (HCC). Methods: In this retrospective study, we retrieved patients with advanced liver cancer who had failed first-line therapy in our center from January 2019 to December 2021, and screened out patients who received TACE combined with regorafenib as second-line therapy. The data of objective response rate (ORR), progression-free survival (PFS) and adverse reactions (ARs) of treatment in these patients were analyzed and summarized. Subgroup analysis of patients with and without PD-1 inhibitors was also performed. Results: A total of 43 eligible patients were screened and treated with TACE in combination with regorafenib in second-line therapy, including 29 patients treated with PD-1 inhibitors. In all patients, one patient had complete response (CR) and 11 patients had partial response (PR), with ORR of 27.91% (12/43) and 24 patients had stable disease (SD), with disease control rate (DCR) of 83.72% (36/43). The median PFS was 10.0 months for all patients in survival follow-up, with PFS rates of 77.65% and 37.17% at 6 and 12 months follow-ups, respectively. Overall survival (OS) rates were 90.49%, 67.03%, and 58.65% at 12, 18, and 24 months, respectively. In subgroup analysis, there was no statistical difference in median PFS between the groups with or without PD-1 inhibitors (11.0 months vs 8.0 months, p=0.229), but there was a trend toward survival benefit in the combined group (hazard ratio/HR 0.62). The incidence of treatment-related ARs in all treated patients was 81.40% (35/43), all grade 1-2. Among ARs, hand-foot syndrome (27.91%), loss of appetite (20.93%), and elevated transaminases (16.28%) were predominant. Conclusions: This study verified the efficacy and safety of TACE combined with regorafenib as second-line therapy for the treatment of advanced HCC after failure of first-line therapy, and the results need to be further justified in future prospective studies with larger sample sizes.
Groups | Total (N=43) | ||
---|---|---|---|
Mono (N=14) | Comb (N=29) | ||
ORR*, n(%) | 2(14.29%) | 10(34.48%) | 12(27.91%) |
P | 0.279 | - | |
DCR *, n(%) | 10(71.43%) | 26(89.66%) | 36(83.72%) |
P | 0.190 | - | |
mPFS(months) | 8.0 11.0 | 10.0 | |
P | 0.229 | ||
Hazard Ratio* | 0.62(0.27-1.42) | ||
OS rate(%) | |||
12-month, 95%CI | 83.33 92.35 | 90.49 | |
18-month, 95%CI | 83.33 62.25 | 67.03 | |
24-month, 95%CI | 83.33 49.80 | 58.65 |
Mono: TACE with regorafenib. Comb: TACE with regorafenib and PD-1 inhibitors. ORR: objective response rate, DCR: disease control rate, PFS: progression-free survival, OS: overall survival. CI: confidence interval.
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