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Adjuvant Systemic Immunotherapies for Resected Stage III Melanoma: A Single-Centre Retrospective Clinical Practice Review.
Int J Mol Sci
January 2025
Department of Oncology, The Royal Surrey Hospital NHS Foundation Trust, Egerton Road, Guildford GU2 7XX, UK.
Melanoma poses significant challenges due to its resistance to conventional therapies and increasing incidence rates. Stage III melanoma, characterised by regional lymph node involvement, has a high risk of recurrence despite surgical resection. Adjuvant immunotherapy, particularly using the PD-1 inhibitors pembrolizumab and nivolumab, has shown promising results in improving recurrence-free survival (RFS) and overall survival (OS) in Stage III melanoma patients.
View Article and Find Full Text PDF[Translated article] The relevance of therapeutic positioning in the post-approval evaluation of new drugs.
Farm Hosp
January 2025
Servicio de Farmacia, Hospital Universitario Puerto Real, Cádiz, Spain.
The objective of regulatory authorities is to ensure a favourable risk-benefit balance for medicines in their licenced indication, without seeking to establish their place in the therapeutic armamentarium beyond that. The licenced indication covers heterogeneous subpopulations and often does not sufficiently specify the characteristics of the patients who may benefit. The regulatory information does not always show the benefit over the standard treatment(s); moreover, it only reacts to the conditions specified in the developer's application, and lacks an assessment of the clinical relevance of the benefit and its uncertainties.
View Article and Find Full Text PDFPembrolizumab and chemotherapy in high-risk, early-stage, ER/HER2 breast cancer: a randomized phase 3 trial.
Nat Med
January 2025
University of California Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.
Addition of pembrolizumab to neoadjuvant chemotherapy followed by adjuvant pembrolizumab improved outcomes in patients with high-risk, early-stage, triple-negative breast cancer. However, whether the addition of neoadjuvant pembrolizumab to chemotherapy would improve outcomes in high-risk, early-stage, estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER/HER2) breast cancer remains unclear. We conducted a double-blind, placebo-controlled phase 3 study (KEYNOTE-756) in which patients with previously untreated ER/HER2 grade 3 high-risk invasive breast cancer (T1c-2 (≥2 cm), cN1-2 or T3-4, cN0-2) were randomly assigned (1:1) to neoadjuvant pembrolizumab 200 mg or placebo Q3W given with paclitaxel QW for 12 weeks, followed by four cycles of doxorubicin or epirubicin plus cyclophosphamide Q2W or Q3W.
View Article and Find Full Text PDFYAU renal cancer spotlight: how should cost-effectiveness affect decision-making regarding adjuvant pembrolizumab for clear cell renal cell carcinoma?
Minerva Urol Nephrol
December 2024
European Association of Urology (EAU), Young Academic Urologists (YAU) Renal Cancer Working Group, Arnhem, the Netherlands.
Anti-PD-1 and anti-PD-L1 antibodies for glioma.
Cochrane Database Syst Rev
January 2025
Saúde Baseada em Evidências, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil.
Background: Glioblastoma multiforme (GBM) is the most common and aggressive adult glioma (16-month median survival). Its immunosuppressive microenvironment limits the efficacy of immune checkpoint inhibitors (ICIs).
Objectives: To assess the effects of the ICIs antibodies anti-programmed cell death 1 (anti-PD-1) and anti-programmed cell death ligand 1 (anti-PD-L1) in treating adults with diffuse glioma.
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