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Clinical Outcomes and Prognosis Factors of Nivolumab Plus Chemotherapy or Multitarget Tyrosine Kinase Inhibitor in Multi-Line Therapy for Recurrent Hepatitis B Virus-Related Hepatocellular Carcinoma: A Retrospective Analysis.

ABSTRACT: Background: This study investigates the potential predictors of nivolumab plus chemotherapy or multitarget tyrosine kinase inhibitor (TKI) treatment response in patients with recurrent hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC). Methods: Patients with recurrent hepatitis B virus-related HCC who underwent nivolumab plus chemotherapy or TKI treatment between July 2017 and June 2019 at Jinling Hospital in China were retrospectively evaluated and included in this study. These patients also had both complete medical charts and follow-up data available. Overall survival (OS) and progression-free survival (PFS) were calculated from the date of nivolumab initiation. Survival data were compared using log-rank tests, and the associations of patient characteristics with survival were estimated using Cox regression models. Results: A total of 22 HCC patients were included in this cohort and constituted the basis for this analysis. Twenty progressed cases (91%) and 16 deaths (73%) were identified at a median follow-up of 8.8 months (range 1-25). The median OS from the time of nivolumab initiation was 10.7 months (95% CI, 0.8-20.6 months), with a median PFS of 5.1 months (95% CI, 3.1-7.0 months). The patients were divided into two risk groups according to a nomogram built by age, Eastern Cooperative Oncology Group (ECOG) status, hepatectomy status, and transarterial chemoembolization (TACE) use. The median PFS was 8.2 ± 2.8 months in the low-risk group compared with 1.9 ± 0.4 months in the high-risk group (p = 0.0018). The median OS was estimated as 16.8 ± 4.9 months for low-risk patients vs. 8.6 ± 3.5 months for high-risk patients (p = 0.13). Conclusion: Nivolumab combined with chemotherapy or TKI treatment is effective in patients with recurrent hepatitis B virus-related HCC. It is observed that previous TACE treatment is associated with a better PFS, and worse PFS in those patients who received hepatectomy. Prospective studies are warranted to evaluate the effects of nivolumab combined chemotherapy or TKI on recurrent hepatitis B virus-related HCC.

SUBMITTER: Chen C

PROVIDER: S-EPMC7479184 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Clinical Outcomes and Prognosis Factors of Nivolumab Plus Chemotherapy or Multitarget Tyrosine Kinase Inhibitor in Multi-Line Therapy for Recurrent Hepatitis B Virus-Related Hepatocellular Carcinoma: A Retrospective Analysis.

Chen Chao C An Li L Cheng Ying Y Luo Xianwen X Li Zixiong Z Liu Xiufeng X

Frontiers in oncology 20200826

<b>Background:</b> This study investigates the potential predictors of nivolumab plus chemotherapy or multitarget tyrosine kinase inhibitor (TKI) treatment response in patients with recurrent hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC). <b>Methods:</b> Patients with recurrent hepatitis B virus-related HCC who underwent nivolumab plus chemotherapy or TKI treatment between July 2017 and June 2019 at Jinling Hospital in China were retrospectively evaluated and included in this st ...[more]

PMID: 32983970

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Project description:PurposeTherapies that produce deep and durable responses in patients with metastatic melanoma are needed. This phase II cohort from the international, single-arm PIVOT-02 study evaluated the CD122-preferential interleukin-2 pathway agonist bempegaldesleukin (BEMPEG) plus nivolumab (NIVO) in first-line metastatic melanoma.MethodsA total of 41 previously untreated patients with stage III/IV melanoma received BEMPEG 0.006 mg/kg plus NIVO 360 mg once every 3 weeks for ≤ 2 years; 38 were efficacy-evaluable (≥ 1 postbaseline scan). Primary end points were safety and objective response rate (blinded independent central review); other end points included progression-free survival, overall survival (OS), and exploratory biomarkers.ResultsAt 29.0 months' median follow-up, the objective response rate was 52.6% (20 of 38 patients), and the complete response rate was 34.2% (13 of 38 patients). Median change in size of target lesions from baseline was -78.5% (response-evaluable population); 47.4% (18 of 38 patients) experienced complete clearance of target lesions. Median progression-free survival was 30.9 months (95% CI, 5.3 to not estimable). Median OS was not reached; the 24-month OS rate was 77.0% (95% CI, 60.4 to 87.3). Grade 3 and 4 treatment-related and immune-mediated adverse events occurred in 17.1% (7 of 41) and 4.9% (2 of 41) of patients, respectively. Increased polyfunctional responses in CD8+ and CD4+ T cells were seen in blood after treatment, driven by cytokines with effector functions. Early on-treatment blood biomarkers (CD8+ polyfunctional strength difference and eosinophils) correlated with treatment response.ConclusionBEMPEG in combination with NIVO was tolerated, with relatively low rates of grade 3 and 4 treatment-related and immune-mediated adverse events. The combination had encouraging antitumor activity in first-line metastatic melanoma, including an extended median progression-free survival. Exploratory analyses associated noninvasive, on-treatment biomarkers with response, before radiologic evidence was observed.

Project description:BackgroundNeoadjuvant or adjuvant chemotherapy confers a modest benefit over surgery alone for resectable non-small-cell lung cancer (NSCLC). In early-phase trials, nivolumab-based neoadjuvant regimens have shown promising clinical activity; however, data from phase 3 trials are needed to confirm these findings.MethodsIn this open-label, phase 3 trial, we randomly assigned patients with stage IB to IIIA resectable NSCLC to receive nivolumab plus platinum-based chemotherapy or platinum-based chemotherapy alone, followed by resection. The primary end points were event-free survival and pathological complete response (0% viable tumor in resected lung and lymph nodes), both evaluated by blinded independent review. Overall survival was a key secondary end point. Safety was assessed in all treated patients.ResultsThe median event-free survival was 31.6 months (95% confidence interval [CI], 30.2 to not reached) with nivolumab plus chemotherapy and 20.8 months (95% CI, 14.0 to 26.7) with chemotherapy alone (hazard ratio for disease progression, disease recurrence, or death, 0.63; 97.38% CI, 0.43 to 0.91; P = 0.005). The percentage of patients with a pathological complete response was 24.0% (95% CI, 18.0 to 31.0) and 2.2% (95% CI, 0.6 to 5.6), respectively (odds ratio, 13.94; 99% CI, 3.49 to 55.75; P<0.001). Results for event-free survival and pathological complete response across most subgroups favored nivolumab plus chemotherapy over chemotherapy alone. At the first prespecified interim analysis, the hazard ratio for death was 0.57 (99.67% CI, 0.30 to 1.07) and did not meet the criterion for significance. Of the patients who underwent randomization, 83.2% of those in the nivolumab-plus-chemotherapy group and 75.4% of those in the chemotherapy-alone group underwent surgery. Grade 3 or 4 treatment-related adverse events occurred in 33.5% of the patients in the nivolumab-plus-chemotherapy group and in 36.9% of those in the chemotherapy-alone group.ConclusionsIn patients with resectable NSCLC, neoadjuvant nivolumab plus chemotherapy resulted in significantly longer event-free survival and a higher percentage of patients with a pathological complete response than chemotherapy alone. The addition of nivolumab to neoadjuvant chemotherapy did not increase the incidence of adverse events or impede the feasibility of surgery. (Funded by Bristol Myers Squibb; CheckMate 816 ClinicalTrials.gov number, NCT02998528.).

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Dataset Information

Clinical Outcomes and Prognosis Factors of Nivolumab Plus Chemotherapy or Multitarget Tyrosine Kinase Inhibitor in Multi-Line Therapy for Recurrent Hepatitis B Virus-Related Hepatocellular Carcinoma: A Retrospective Analysis.

Publications

Clinical Outcomes and Prognosis Factors of Nivolumab Plus Chemotherapy or Multitarget Tyrosine Kinase Inhibitor in Multi-Line Therapy for Recurrent Hepatitis B Virus-Related Hepatocellular Carcinoma: A Retrospective Analysis.

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