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- Title
Nivolumab as Second-Line Therapy Improves Survival in Patients with Unresectable Hepatocellular Carcinoma.
- Authors
Sanai, Faisal M.; Odah, Hassan O.; Alshammari, Kanan; Alzanbagi, Adnan; Alsubhi, Murooj; Tamim, Hani; Alolayan, Ashwaq; Alshehri, Ahmed; Alqahtani, Saleh A.
- Abstract
Simple Summary: The current options for second-line therapy in unresectable liver cancer are limited, with an evolving role for immunotherapeutic regimens. This study examines the role of nivolumab as a second-line treatment option in 42 patients with liver cancer who had failed first-line therapy with sorafenib and compared outcomes in another 38 patients who were maintained on sorafenib therapy. Our results show that nivolumab prolongs survival in such patients compared to those who were continued on sorafenib therapy. This study adds to the growing body of research that nivolumab may be an effective treatment option in patients with unresectable and advanced liver cancer. Background: Limited data exists for the efficacy and outcomes of nivolumab as a second-line treatment for unresectable hepatocellular carcinoma (uHCC). We aimed to assess the efficacy and safety of nivolumab in patients with uHCC who experienced disease progression during sorafenib treatment. Methods: In this retrospective, observational, multicenter study, adult Child-Turcotte-Pugh A/7B patients with uHCC who tolerated sorafenib therapy but showed disease progression switched to second-line intravenous nivolumab (n = 42). A similar number of consecutive, unselected patients who were maintained on sorafenib therapy, regardless of tumoral response or progression, served as historical controls (n = 38). The primary endpoint was overall survival (OS, defined as the time from starting sorafenib in either group up to death due to any cause) and analyzed by intention-to-treat. Results: The mean age of the overall cohort was 72.4 ± 10.1 years, of whom 87.5% were males and 58.8% had underlying viral etiology. Patients in the two cohorts were similar, except those who received nivolumab had more co-morbidities (70.0% vs. 15.4%), ECOG-2 status (21.4% vs. 15.8%), BCLC stage C (81.0% vs. 47.4%), and extravascular invasion (54.4% vs. 21.8%) (p < 0.05 for all). More patients in the nivolumab arm were Child-Turcotte-Pugh B (35.7% vs. 21.1%, p = 0.15). Median OS was 22.2 months (95% CI: 8.9–49.8) on second-line nivolumab and 11.0 months (95% CI: 3.6–18.4) on sorafenib alone (HR 1.93; 95% CI: 1.1–3.3, p = 0.014). Median OS after starting nivolumab was 10.2 months, and time-to-progression was 4.9 months (95% CI: 3.2–6.3). Conclusion: Nivolumab is an effective second-line treatment option in patients with uHCC who progress on sorafenib, with significantly improved OS. These early real-life data offer encouraging results, similar to those shown in Phase I/IIa clinical trials. Further investigations are warranted for the use of nivolumab as a monotherapy.
- Subjects
THERAPEUTIC use of antineoplastic agents; LIVER tumors; PATIENT safety; RESEARCH funding; SCIENTIFIC observation; TREATMENT effectiveness; RETROSPECTIVE studies; DESCRIPTIVE statistics; RESEARCH; NIVOLUMAB; SURVIVAL analysis (Biometry); CANCER patient psychology; COMPARATIVE studies; CONFIDENCE intervals; HEPATOCELLULAR carcinoma; OVERALL survival; EVALUATION
- Publication
Cancers, 2024, Vol 16, Issue 12, p2196
- ISSN
2072-6694
- Publication type
Article
- DOI
10.3390/cancers16122196