Currently, therapeutic combinations of immune checkpoint inhibitors (ICIs) with anti-angiogenic agents have shown promising outcomes and have the potential to establish a new standard of care. The efficacy and safety of the first-line combination of envafolimab (an ICI) and lenvatinib (an anti-tumor angiogenesis drug) for the treatment of patients with inoperable hepatocellular carcinoma (HCC) have not been demonstrated. Unresectable HCC patients with an Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 1 and a Child-Pugh score ≤ 7 who had not received systemic therapy were included in this single-arm, exploratory, multicentre phase II clinical study. All patients were required to meet the criteria of being at least 18 years of age, having no history of other malignancies, and existing at least one measurable lesion. The patients were treated with envafolimab (150 mg, QW, subcutaneous) in combination with lenvatinib (12 mg for patients weighing over 60 kg, 8 mg for patients weighing under 60 kg). The co-primary endpoint of the study was overall survival (OS), while surrogate endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety. Between March 2022 and April 2023, 36 patients were enrolled, 30 of whom were treated with envafolimab plus lenvatinib. At data cutoff, the median follow-up duration was 20 months (95% CI 18.9-21.1). Among the 30 assessable patients (patients treated according to the trial protocol), the median overall survival (mOS) and median progression-free survival (mPFS) for the therapy comprising envafolimab alongside lenvatinib were 18.5 months (95% CI 13.2-23.8) and 9.4 months (95% CI 1.6-15.6), respectively. The ORR and the DCR (evaluated according to mRECIST criteria) reached 40% and 80%, respectively. In terms of safety, 23 patients (76.7%) experienced at least one treatment-related adverse event (TRAE), of which the most common was elevated aspartate aminotransferase (AST, 23.3%). Furthermore, grade 3 and higher TRAEs occurred in 30%. This study demonstrates that envafolimab in combination with lenvatinib exhibits favourable anti-cancer activity and a manageable safety profile for the first-line treatment of patients with unresectable HCC.
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http://dx.doi.org/10.1007/s10637-024-01468-6 | DOI Listing |
Lung Cancer
December 2024
State Key Laboratory of Oncology in South China, Guangzhou, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, China; Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address:
Background: Primary pulmonary lymphoepithelioma-like carcinoma (PLELC) is a rare subtype of non-small-cell lung cancer. This study aims to compare the efficacy and safety of perioperative PD-1/PD-L1 inhibitor plus chemotherapy versus chemotherapy alone in stage II-IIIB PLELC patients.
Patients And Methods: This retrospective study included stage II-IIIB PLELC patients.
Clin Transl Oncol
December 2024
Dr Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital, Health Sciences University, Ankara, Turkey.
Background: In triple-negative breast cancer (TNBC) patients receiving adjuvant capecitabine, the impact of HER2 expression on survival outcomes is unclear.
Methods: Between June 2017 and December 2023, 112 patients with TNBC who received adjuvant capecitabine due to residual masses after neoadjuvant chemotherapy (NACT) in three hospitals were identified. HER2 is analyzed through immunohistochemistry (IHC) and/or in situ hybridization in the core biopsy and/or post-surgical histopathologies.
AIDS Res Ther
December 2024
Veterans Affairs (VA) Connecticut Healthcare System Cooperative Studies Program Clinical Epidemiology Research Center (CSP-CERC), 950 Campbell Avenue, West Haven, CT, 06516-2770, USA.
Background: Real-world data on treatment patterns and clinical outcomes for newer drugs, including integrase strand transfer inhibitors, among older people with human immunodeficiency virus (PWH) are limited.
Methods: This cohort study included PWH enrolled in the Veterans Aging Cohort Study (VACS) who were prescribed a standard 3-drug antiretroviral therapy (ART) regimen containing dolutegravir (DTG), bictegravir (BIC), cobicistat boosted elvitegravir (EVG), raltegravir (RAL), or darunavir/ritonavir (DRV) plus 2 nucleoside reverse transcriptase inhibitors between January 1, 2014, and March 31, 2020, and who were ≥50 years at regimen initiation. The association between regimen and virologic effectiveness or discontinuation was assessed using logistic regression models with inverse probability of treatment weights.
J Craniomaxillofac Surg
December 2024
School of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain; IDIBELL Institute, Barcelona, Spain.
Real-time surgical navigation systems (dynamic computer-aided surgery, d-CAIS) and static guided surgery (static computer-aided surgery, s-CAIS) have been shown to enhance the accuracy of zygomatic implant (ZI) placement. The objective of this systematic review was to evaluate and compare the accuracy and risk of complications associated with d-CAIS and s-CAIS in ZI placement. A systematic review of published studies involving more than 4 patients was conducted to assess and compare the accuracy of d-CAIS and s-CAIS in zygomatic implant placement.
View Article and Find Full Text PDFBackground: Recovery after severe injury may be impacted by a range of psychological factors. This multi-site study investigated the prevalence and impact of anxiety and depression at one year after trauma critical care admission.
Methods: Adult trauma patients admitted to four Level 1 Critical Care Units were prospectively enrolled over 18 months.
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