Publications by authors named "M Libertini"
Background: In clinical trials, the assessment of safety is traditionally focused on the overall rate of high-grade and serious adverse events (AEs). A new approach to AEs evaluation, taking into account chronic low-grade AEs, single patient's perspective, and time-related information, such as ToxT analysis, should be considered especially for less intense but potentially long-lasting treatments, such as maintenance strategies in metastatic colorectal cancer (mCRC).
Patients And Methods: We applied ToxT (Toxicity over Time) evaluation to a large cohort of mCRC patients enroled in randomised TRIBE, TRIBE2, and VALENTINO studies, in order to longitudinally describe AEs throughout the whole treatment duration and to compare AEs evolution over cycles between induction and maintenance strategies, providing numerical and graphical results overall and per single patient.
Article Synopsis
- Genomics is transforming cancer treatment, but solid, clinical-grade genomic biomarkers for chemotherapy are still needed.
- A study with 37 patients found KRAS mutations linked to resistance against the chemotherapy trifluridine/tipiracil (FTD/TPI), and a larger real-world analysis with 960 patients confirmed that these mutations correspond to lower survival rates.
- Data from a phase 3 trial with 800 patients showed that those with KRAS mutations did not benefit from FTD/TPI, indicating that identifying these mutations could guide treatment decisions for around 28% of metastatic colorectal cancer patients.
Pandemic Phase-Adjusted Analysis of COVID-19 Outcomes Reveals Reduced Intrinsic Vulnerability and Substantial Vaccine Protection From Severe Acute Respiratory Syndrome Coronavirus 2 in Patients With Breast Cancer.
J Clin Oncol
May 2023
Purpose: Although representing the majority of newly diagnosed cancers, patients with breast cancer appear less vulnerable to COVID-19 mortality compared with other malignancies. In the absence of patients on active cancer therapy included in vaccination trials, a contemporary real-world evaluation of outcomes during the various pandemic phases, as well as of the impact of vaccination, is needed to better inform clinical practice.
Methods: We compared COVID-19 morbidity and mortality among patients with breast cancer across prevaccination (February 27, 2020-November 30, 2020), Alpha-Delta (December 1, 2020-December 14, 2021), and Omicron (December 15, 2021-January 31, 2022) phases using OnCovid registry participants (ClinicalTrials.
Background: Encorafenib plus cetuximab with or without binimetinib showed increased objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) compared with chemotherapy plus anti-EGFR in previously treated patients with BRAF V600E-mutated (mut) metastatic colorectal cancer (mCRC). Although no formal comparison was planned, addition of binimetinib to encorafenib plus cetuximab did not provide significant efficacy advantage.
Patients And Methods: This real-life study was aimed at evaluating safety, activity, and efficacy of encorafenib plus cetuximab with or without binimetinib in patients with BRAF V600E-mut mCRC treated at 21 Italian centers within a nominal use program launched in May 2019.
Article Synopsis
- The study investigates the impact of the omicron variant of SARS-CoV-2 on patients with cancer compared to earlier waves (prevaccination, alpha, and delta), focusing on COVID-19 outcomes in Europe.
- It is a retrospective analysis using data from the OnCovid Registry, including patients with a history of cancer from various European countries, monitoring their COVID-19 complications and mortality.
- Findings from 3820 patients reveal trends in hospitalization, complications, and mortality rates related to COVID-19 across different time periods, with adjustments for various factors.