Annals of Oncology : Official Journal of the European Society for Medical Oncology

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Radiotheranostics is a field of rapid growth with some approved treatments including 131 I for thyroid cancer, 223 Ra for osseous metastases, 177 Lu-Dotatate for neuroendocrine tumors, and 177 Lu-PSMA for prostate cancer, and several more under investigation. In this review, we will cover the fundamentals of radiotheranostics, the key clinical studies that have led to current success, future developments with new targets, radionuclides and platforms, challenges with logistics and reimbursement and, lastly, forthcoming considerations regarding dosimetry, identifying the right line of therapy, artificial intelligence and more...

BACKGROUND: Combination of a BRAF inhibitor (BRAFi) and an anti-EGFR, with or without a MEK inhibitor (MEKi) improves survival in BRAF-V600E-mutant metastatic colorectal cancer (mCRC) over standard chemotherapy. However, responses are heterogeneous and there are no available biomarkers to assess patient prognosis or guide doublet or triplet-based regimes. In order to better characterize the clinical heterogeneity observed, we assessed the prognostic and predictive role of the plasmatic BRAF allele fraction (AF) for these combinations...

BACKGROUND: The APPLE trial aimed to evaluate the feasibility of longitudinal plasma EGFR T790M monitoring for the best sequencing strategy of gefitinib and osimertinib. METHODS: APPLE is a randomized, non-comparative, phase II study in patients with common EGFR-mutant, treatment-naïve NSCLC including 3-arms: Arm A (osimertinib upfront until RECIST progression, PD), Arm B (gefitinib until emergence of circulating tumor DNA EGFR T790M mutation by cobas EGFR Test v2 or RECIST PD) and Arm C (gefitinib until RECIST PD), and then switch to osimertinib in both arms...

BACKGROUND: The intestinal microbiome has been associated with response to immune checkpoint inhibitors (ICI) in humans, and causally implicated in ICI responsiveness in animal models. Two recent human trials demonstrated that fecal microbiota transplant (FMT) from ICI responders can rescue ICI responses in refractory melanoma, but FMT has specific limitations to scaled use. PATIENTS AND METHODS: We conducted an early phase clinical trial of a cultivated, orally-delivered 30-species microbial consortium (Microbial Ecosystem Therapeutic-4, MET4) designed for co-administration with ICIs as an alternative to FMT and assessed safety, tolerability and ecological responses in patients with advanced solid tumors...

BACKGROUND: The first interim analysis of the phase III, randomized, double-blind, placebo-controlled, multinational TITAN study demonstrated improved overall survival (OS) and radiographic progression-free survival (rPFS) with apalutamide added to ongoing androgen deprivation therapy (ADT) in patients with metastatic castration-sensitive prostate cancer (mCSPC). The final analysis confirmed improvement in OS and other long-term outcomes. We evaluated prostate-specific antigen (PSA) kinetics and the association between PSA decline and outcomes in patients with mCSPC from TITAN...

BACKGROUND: Early detection of cancer offers the opportunity to identify candidates when curative treatments are achievable. The THUNDER study (THe UNintrusive Detection of EaRly-stage cancers, NCT04820868) aimed to evaluate the performance of ELSA-seq, a previously described cfDNA methylation-based technology, in the early detection and localization of six types of cancers in the colorectum, esophagus, liver, lung, ovary and pancreas. PATIENTS AND METHODS: A customized panel of 161,984 CpG sites was constructed and validated by public and in-house (cancer: n=249; non-cancer: n=288) methylome data, respectively...

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BACKGROUND: We aimed to predict cancer mortality figures for 2023 for the European Union (EU-27), its five most populous countries, and the UK. We focused on mortality from lung cancer. MATERIALS AND METHODS: Using cancer death certifications and population data from the World Health Organization and EUROSTAT databases for 1970-2018 we predicted numbers of deaths and age-standardized rates (ASR) for 2023 for all cancers combined and the ten most common cancer sites...

BACKGROUND: Very young premenopausal women diagnosed with hormone receptor-positive, HER2-negative (HR+HER2-) early breast cancer (EBC) have higher rates of recurrence and death for reasons that remain largely unexplained. PATIENTS AND METHODS: Genomic sequencing was applied to HR+HER2- tumours from patients enrolled in the SOFT clinical trial to determine genomic drivers that are enriched in young premenopausal women. Genomic alterations were characterised using next-generation sequencing from a subset of 1,276 patients (deep targeted sequencing, N=1258; whole-exome sequencing in a young-age, case-control subsample, N=82)...

BACKGROUND: Circulating tumor DNA (ctDNA) sequencing is a promising approach for tailoring therapy in cancer patients. We report hereby the results from a prospective study where we investigated the impact of comprehensive molecular profiling of ctDNA in patients with advanced solid tumors. METHODS: Genomic analysis was performed using the Foundation One Liquid CDx Assay (324 genes, tumor mutational burden [TMB], microsatellite instability status). Each individual genomic report was reviewed and discussed weekly by a multidisciplinary tumor board (MTB)...

BACKGROUND: We evaluated whether tissue tumor mutational burden (tTMB) and STK11, KEAP1, and KRAS mutations have clinical utility as biomarkers for pembrolizumab monotherapy versus platinum-based chemotherapy in patients with programmed death ligand- 1 (PD-L1)-positive (tumor proportion score ≥1%) advanced/metastatic non-small-cell lung cancer (NSCLC) without EGFR/ALK alterations in the phase III KEYNOTE-042 trial. PATIENTS AND METHODS: This retrospective exploratory analysis assessed prevalence of tTMB and STK11, KEAP1, and KRAS mutations determined by whole-exome sequencing of tumor tissue and matched normal DNA and their associations with outcomes in KEYNOTE-042...

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