Overall Survival (OS) Update: 2-year follow-up from the phase-3 RESORCE trial of Regorafenib for patients with hepatocellular carcinoma (HCC) progressing on Sorafenib

Waldschmidt, D.; Granito, Alessandro; Merle, Philippe; Yh, Huang; Bodoky, G.; Yokosuka, Osamu; Rosmorduc, Olivier; Бредер, В. В.; Gerolami, René; Masi, Gianluca; Ross, P.; Quinn, Susan; Song, Tianqiang; Bronowicki, J.-P.; Olivier-Hourmand, I; Kudo, Masatoshi; LeBerre, M.-A.; Baumhauer, Annette; Meinhardt, Gerold; Han, Guorong; Bruix, Jordi

doi:10.1055/s-0039-1695314

Cited by 4 publications

(7 citation statements)

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“…In our study, the median duration of sorafenib sequential regorafenib combined with TACE was 17 and 15 months, respectively, in the two groups (Figure 1). The median OS of first-line sorafenib sequential second-line regorafenib has been reported to reach 26 months (17). While the OS of sorafenib sequential regorafenib combined TACE in our study was not reached, the outcome of OS we foresee may be higher.…”

Section: Discussioncontrasting

confidence: 60%

Study on efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with regorafenib and PD-1 antibody versus continued TACE combined with regorafenib in patients with hepatocellular carcinoma after failed second-line treatment with regorafenib

Wang¹,

Xiao²,

Han³

et al. 2022

J Gastrointest Oncol

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Background: At present, there is no standard for the posterior treatment of hepatocellular carcinoma (HCC). This study isTo evaluate and compare the safety and efficacy of transcatheter arterial chemoembolization (TACE) combined with regorafenib and anti-PD-1 antibody with continued TACE combined with regorafenib in patients with HCC after the failure of second-line treatment with regorafenib. Methods:We enrolled patients with advanced HCC who were treated with sorafenib and sequential regorafenib. All patients were treated with TACE and found to have tumor progression in 2021. After tumor progression, patients were treated with TACE combined with regorafenib and PD-1 antibody or with continued TACE combined with regorafenib according to the wishes of the patient. Efficacy was evaluated after 1 month of treatment. The objective response rate (ORR), disease-control rate (DCR), and safety were evaluated according to adverse reactions of patients.Results: Nine patients were treated with TACE combined with regorafenib and PD-1 antibody, and the 9 patients continued to receive TACE combined with regorafenib. There was no significant difference in baseline data between the 2 groups. In the PD-1 group five patients achieved a partial response (PR), three achieved stable disease (SD), and one patient had progressive disease (PD) after 1 month of treatment.The ORR was 55.6% and the DCR was 88.9%. In the continued TACE-regorafenib group, four patients achieved PR, one achieved SD, and four patients achieved PD after 1 month of treatment, while the ORR was 44.4% and the DCR was 55.6%. There was a significant difference in the DCR between the two groups (P=0.012), while adverse events were similar in both.Conclusions: TACE combined with regorafenib and PD-1 antibody had a higher DCR and was more effective than continued TACE combined with regorafenib in patients with HCC who failed second-line treatment with regorafenib. However, PD-1 antibody therapy might increase the risk of death by causing an uncontrollable immune response. Given the risk of an immune response, patients may choose to continue TACE combined with regorafenib, given the similar ORR of the two treatments.

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Section: Discussioncontrasting

confidence: 60%

Study on efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with regorafenib and PD-1 antibody versus continued TACE combined with regorafenib in patients with hepatocellular carcinoma after failed second-line treatment with regorafenib

Wang¹,

Xiao²,

Han³

et al. 2022

J Gastrointest Oncol

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“…ORR was also significantly better in the regorafenib arm (11% versus 4%; p = 0.0047 (Table 2). Updated OS results are very similar to the primary analysis (HR 0.62; 95% CI 0.50-0.75; p<0.0001) (42). Grade 3/4 toxicity was greater in the regorafenib arm overall (67% versus 39%) including hand-foot skin reaction (13% versus 1%), diarrhea (3% versus 0%), fatigue (9% versus 5%), and hypertension (15% versus 5%).…”

Section: Regorafenib + Best Supportive Care (Bsc) Versus Placebo + Bscsupporting

confidence: 64%

“…One full publication (41) and two abstracts (42,43) of the RESORCE trial were retained. This was a phase III RCT of regorafenib/BSC versus placebo/ BSC.…”

Section: Regorafenib + Best Supportive Care (Bsc) Versus Placebo + Bscmentioning

confidence: 99%

Non-surgical management of advanced hepatocellular carcinoma: A systematic review by Cancer Care Ontario

Meyers

Knox

Cosby

et al. 2021

CanLivJ

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BACKGROUND: Hepatocellular carcinoma (HCC) is a global health problem, accounting for 4.7% of all new cancer cases and 8.2% of all cancer deaths worldwide in 2018. Resection and transplantation are the only modalities that offer a cure for HCC; however, most patients are diagnosed at an advanced stage, precluding these curative treatments. A number of local (ie, ablative therapies) and/or local-regional therapies (ie, chemo-embolization) are used and followed by systemic therapy for advanced or progressive disease. Other treatments are available, but their efficacy compared with these standards is not well known. METHODS: Literature searches (1/2000 to 1/2020 or 1/2005 to 1/2020, depending on the specific systematic review question) were conducted, including MEDLINE, Embase and the Cochrane Database of Systematic Reviews. RESULTS: Over 30,000 articles were identified. In total, 49 studies were included in the systematic review. CONCLUSIONS: There is no evidence to support the addition of sorafenib to any local or regional therapy. First-line systemic therapy options for unresectable or metastatic HCC include sorafenib, lenvatinib, and atezolizumab + bevacizumab. Regorafenib or cabozantinib provide survival benefits when given as second-line treatment.

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“…A total of 1900 titles and abstracts were identified by the screening electronic search strategy, of which 63 met the eligibility for assessment (Figure 1). Fifteen references were identified reporting 8 studies in the first-line setting and 6 in the second-line setting …”

Section: Resultsmentioning

confidence: 99%

“…Seven references reporting 6 trials were identified in the second-line setting . One of the studies (REACH-2) only included pretreated patients with HCC with AFP levels of 400 or higher, therefore, was only included in our subgroup analysis .…”

Section: Resultsmentioning

confidence: 99%

Systemic Therapy and Sequencing Options in Advanced Hepatocellular Carcinoma

et al. 2020

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The treatment landscape for advanced hepatocellular carcinoma (HCC) has recently changed and become relatively confusing. Head-to-head comparisons between most of the available agents have not been performed and are less likely to be examined in a prospective fashion in the future. Therefore, a network meta-analysis (NMA) is helpful to compare different agents from across different trials.OBJECTIVE To evaluate comparative effectiveness of different systemic treatments in advanced patients with HCC across lines of therapy.DATA SOURCES We searched various databases for abstracts and full-text articles published from database inception through March 2020.STUDY SELECTION We included phase 3 trials evaluating different vascular endothelial growth factor inhibitors (VEGFis), checkpoint inhibitors (CPIs), or their combinations in advanced HCC, in the first-line or refractory setting. DATA EXTRACTION AND SYNTHESISThe reporting of this systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. The overall effect was pooled using the random effects model. MAIN OUTCOMES AND MEASURES Outcomes of interest included overall (OS) and progression-free survival (PFS).FINDINGS Fourteen trials (8 in the first-line setting and 6 in the second-line setting) at low risk of bias were included. The 8 trials in the first-line setting encompassed a total of 6290 patients, with an age range of 18 to 89 years. The 5 trials included in the second-line analysis encompassed a total of 2653 patients, with an age range of 18 to 91 years. Network meta-analysis showed the combination of atezolizumab and bevacizumab was superior in patients with HCC treated in the first-line setting compared with lenvatinib (HR, 0.63; 95% CI, 0.44-0.89), sorafenib (HR, 0.58; 95% CI, 0.42-0.80), and nivolumab (HR, 0.68; 95% CI, 0.48-0.98). In the refractory setting, NMA showed that all studied drugs had PFS benefit compared with placebo. However, this only translated into OS benefit with regorafenib (HR, 0.62; 95% CI, 0.51-0.75) and cabozantinib (HR, 0.76; 95% CI, 0.63-0.92) compared with placebo. In the NMA of patients with α-fetoprotein (AFP) levels of 400 ng/mL or greater, regorafenib, cabozantinib, and ramucirumab showed PFS and OS benefit compared with placebo with no superiority of an active drug compared with any others.CONCLUSIONS AND RELEVANCE This systematic review and NMA of 14 trials found that atezolizumab and bevacizumab in combination is now considered the standard of care in the first-line setting in patients with advanced HCC. Regorafenib and cabozantinib are preferred options in refractory patients, with ramucirumab as an additional option in those with levels of AFP of 400 ng/mL or higher. Future trials should focus on other potential combinations and best treatment strategy in patients with prior VEGFi/CPI exposure.

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Overall Survival (OS) Update: 2-year follow-up from the phase-3 RESORCE trial of Regorafenib for patients with hepatocellular carcinoma (HCC) progressing on Sorafenib

Cited by 4 publications

References 0 publications

Study on efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with regorafenib and PD-1 antibody versus continued TACE combined with regorafenib in patients with hepatocellular carcinoma after failed second-line treatment with regorafenib

Study on efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with regorafenib and PD-1 antibody versus continued TACE combined with regorafenib in patients with hepatocellular carcinoma after failed second-line treatment with regorafenib

Non-surgical management of advanced hepatocellular carcinoma: A systematic review by Cancer Care Ontario

Systemic Therapy and Sequencing Options in Advanced Hepatocellular Carcinoma

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