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Transarterial chemoembolization combined with lenvatinib plus sintilimab was safe and effective for patients with unresectable hepatocellular carcinoma.
Transarterial chemoembolization (TACE) combined with lenvatinib (Lenvima) plus sintilimab was safe and effective for patients with unresectable hepatocellular carcinoma (HCC), according to recent findings presented at the 2022 ASCO Gastrointestinal Cancers Symposium.
Previously, combination therapies for the treatment of this patient population have demonstrated favorable results including PD-1 inhibitors plus lenvatinib and TACE plus lenvatinib. However, the three therapies combined had not yet been investigated for patients with unresectable HCC. The aim of this study was to discover the safety and efficacy of TACE combined with lenvatinib plus sintilimab.
In this single-arm retrospective study, researchers analyzed data from 52 patients diagnosed with HCC who received either 12 mg or 8 mg of lenvatinib — based on body weight — once orally 2 weeks before undergoing TACE. Sintilimab was administered intravenously at 200 mg on day 1 of a 21-day cycle following TACE. The TACE procedure was then repeated 4 to 6 weeks later.
The primary endpoints included objective response rate (ORR) and duration of response (DOR), both of which were assessed using the modified Response Evaluation Criteria in Solid Tumors (mRECIST).
The analysis included data from 52 patients who were diagnosed with Barcelona Clinic Live Cancer (BCLC) stage B (25%) or C (75%) disease. Patients were mostly men (86.4%) aged 65 years or younger (76.7%). In addition, 13.5% of patients had an ECOG performance status of 0 whereas 86.5% had an ECOG performance status of 1.
After a 12.5-month median follow-up (95% CI, 9.1-14.8), patients had an ORR of 46.7% (28/60: complete response, n = 4; partial response, n = 24). Twenty-three patients in this study had stable disease whereas 9 patients had progressive disease. The median DOR for confirmed respondents was 10 months (95% CI, 9.0-11.0).
Additionally, patients had a median progression-free survival was 13.3 months (95% CI, 11.9-14.7) and an overall survival of 23.6 months (95% CI, 22.2-25.0).
Any-grade adverse events occurred in 84.6% (n = 44) of patients, with the most common events related to treatment including fatigue (30.8%), hypertension (25%), diarrhea (19.2%), decreased appetite (23%) and palmar-plantar erythrodysesthesia (21.1%).
“Randomized-controlled trials of TACE combined with lenvatinib plus sintilimab versus lenvatinib plus sintilimab should be performed to confirm the efficacy and safety of this regimen,” the researchers wrote in the poster.