Oggi in Oncologia
Trends and Characteristics of Potentially Preventable Emergency Department Visits Among Patients With Cancer in the US
Importance: An initial step to reducing emergency department (ED) visits among patients with cancer is to identify the characteristics of patients visiting the ED and examine which of those visits could be prevented. Objective: To explore nationwide trends and characteristics of ED visits and examine factors associated with potentially preventable ED visits and unplanned hospitalizations among patients with cancer in the US … (leggi tutto)
Sono stati rivalutati 854.911.106 accessi ai dipartimenti di emergenza (ED) degli USA, tra il Gennaio 2012 ed il Dicembre 2019, allo scopo di identificare quelli “potenzialmente evitabili”.
35.510.014 (4.2%) degli accessi riguardava pazienti oncologici.
18.316.373 (51.6%) degli accessi dei pazienti oncologici sono stati definiti come “potenzialmente evitabili”.
Nel 36.9% degli accessi “potenzialmente evitabili” l’indicazione era il dolore non controllato.
Inoltre, la percentuale degli accessi per dolore non controllato è aumentata del 101.8% dal 2012 al 2019 (1.192.197 vs 2.405.349).
Lo studio offre un’ulteriore dimostrazione della scarsa attenzione degli oncologi per la terapia del dolore e, più in generale, dei sintomi.
Questo provoca – oltre al peggioramento della qualità della vita di pazienti e familiari e, forse, della sopravvivenza – anche un utilizzo improprio delle risorse ospedaliere.
La simultaneous care deve essere parte essenziale nella pratica oncologica.
Impact of Dosing and Duration of Dexamethasone on Serious Corticosteroid-Related Adverse Events
Context: Corticosteroids are commonly prescribed in oncology, but few studies have examined its adverse events (AEs) compared to placebo control. Objectives: Using data from a double-blind, placebo-controlled randomized trial, we evaluated the association between the dose and duration of dexamethasone and serious AEs … (leggi tutto)
Il gruppo dell’MD Anderson aveva già pubblicato i risultati di uno studio randomizzato in doppio cieco, che dimostrava l’inefficacia del desametasone nel trattamento della dispnea nei pazienti in fase avanzata (Hui D. Effect of dexamethasone on dyspnoea in patients with cancer (ABCD): a parallel-group, double-blind, randomised, controlled trial. Lancet Oncol. 2022).
Gli stessi Autori hanno analizzato i dati disponibili per valutare gli effetti collaterali relativi alla somministrazione di desametasone.
I pazienti sottoposti a desametasone hanno avuto una significativa incidenza di insonnia (31%), dispepsia (21%), sintomi neuropsichiatrici (18%), infezioni (17%).
In generale, il 32% dei pazienti ha avuto effetti collaterali di grado 3 ed il 23% è stato ricoverato in ospedale.
Conclusioni: il desametasone risulta inefficace nel trattamento della dispnea e associato a una significativa incidenza di effetti collaterali ed ospedalizzazione.
La somministrazione di corticosteroidi nella dispnea è un “automatismo terapeutico” praticato da molti oncologi.
Ad oggi, non ci sono dati a supporto di questa strategia.
Riteniamo che il desametasone – per il più breve tempo possibile ed alle dosi minime efficaci – possa essere preso in considerazione in pazienti selezionati (ostruzione di bronco principale, linfangite carcinomatosa, sindrome della vena cava superiore). Il farmaco più efficace nel trattamento della dispnea – l’unico – è la morfina; il desametasone va considerato, eventualmente, come un “adiuvante”.
Randomized Double-Blind Placebo-Controlled Study of Olanzapine for Chemotherapy-Related Anorexia in Patients With Locally Advanced or Metastatic Gastric, Hepatopancreaticobiliary, and Lung Cancer
Purpose: Anorexia occurs in 30%-80% of patients with advanced malignancies, which may be worsened with chemotherapy. This trial assessed the efficacy of olanzapine in stimulating appetite and improving weight gain in patients receiving chemotherapy. Methods: Adults (≥18 years) with untreated, locally advanced, or metastatic gastric, hepatopancreaticobiliary (HPB) … (leggi tutto)
In questo studio randomizzato in doppio cieco, 124 pazienti affetti da neoplasie gastriche, epatobiliari e polmonari, in trattamento con chemioterapia, sono stati randomizzati per ricevere olanzapina (2.5 mg al giorno per 12 settimane) o placebo.
Scope dello studio era valutare l’efficacia sull’aumento di almeno il 5% del peso corporeo e dell’appetito.
L’olanzapina ha mostrato di incrementare il peso almeno del 5% nel 60% dei pazienti trattati (9% nel gruppo con placebo) e di migliorare l’appetito nel 43% dei pazienti trattati (placebo 13%).
I pazienti trattati con olanzapina, inoltre, hanno mostrato di avere una migliore qualità della vita.
Gli effetti collaterali si sono rivelati di minima entità.
L’olanzapina può essere presa in considerazione nell’anoressia dei pazienti sottoposti a chemioterapia, soprattutto se presentano anche nausea e vomito.
I risultati di questo studio, essendo stati considerati “practice-changing”, hanno portato ad un update delle Linee Guida ASCO sull’anoressia (Roeland EJ, Bohlke K, Baracos VE, Smith TJ, Loprinzi CL; Cancer Cachexia Expert Panel. Cancer Cachexia: ASCO Guideline Rapid Recommendation Update. J Clin Oncol. 2023 Sep 1;41(25):4178-4179.).
In Europa
Adding Durvalumab to First-Line Platinum-Based Chemotherapy Followed by Maintenance Durvalumab With Or Without Olaparib Improves PFS for Patients with Advanced Or Recurrent Endometrial Cancer
Nov 14, 2023 – In a phase III DUO-E study durvalumab in combination with first-line carboplatin and paclitaxel followed by maintenance durvalumab with or without olaparib resulted in significantly lower risk of disease progression or death than chemotherapy alone among patients with newly diagnosed advanced or recurrent endometrial cancer. It is the first phase III study to examine the combination of immunotherapy and PARP inhibition in endometrial cancer … (leggi tutto)
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2023
Nov 10, 2023 – EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its November 2023 meeting. The CHMP adopted a positive opinion for Omjjara* (momelotinib), for the treatment of myelofibrosis, a rare blood cancer that affects the bone marrow. Rystiggo* (rozanolixizumab), intended for the treatment of generalised myasthenia gravis, received a positive opinion. Myasthenia gravis ... (leggi tutto)
Regional Node Radiotherapy Significantly Reduced Breast Cancer Mortality and All-Cause Mortality in Newer but Not in Older Studies
Nov 10, 2023 – The main aim of an individual patient data meta-analysis of 14324 women included in 16 studies was to assess the effects of regional node radiotherapy on breast cancer recurrence and mortality, reporting separate meta-analyses of the newer and older trials. The trials in this meta-analysis span half a century. During this time, there were major changes in breast cancer radiotherapy, as reflected in findings … (leggi tutto)
First electronic product information (ePI) published for selected human medicines
Nov 08, 2023 – The Heads of Medicines Agencies (HMA), the European Commission (EC) and EMA have published for the first time electronic product information (ePI) for selected human medicines harmonised across the European Union (EU). The product information of a medicine includes its summary of product characteristics, labelling and package leaflet. These documents accompany every medicine authorised in the EU and explain how they should be prescribed and used. … (leggi tutto)
Biweekly Cabazitaxel in Patients 65 Years or Older with mCRPC for Whom the Standard Regimen is Unsuitable
Nov 07, 2023 – The results of the CABASTY phase III randomised study demonstrate that a biweekly schedule of cabazitaxel 16 mg/m2 plus prophylactic granulocyte colony–stimulating factor (G-CSF) at every cycle, significantly reduce the risk of severe neutropenia and/or neutropenic complications compared with the standard regimen of triweekly cabazitaxel 25 mg/m2 plus G-CSF in patients 65 years ... (leggi tutto)
Dall’FDA
FDA Grants Priority Review to Liso-Cel for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Nov 09, 2023 – The FDA has granted priority review to the supplemental biologics license application (sBLA) seeking approval to expand the indication of lisocabtagene maraleucel (liso-cel; Breyanzi) to include patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had prior exposure to a BTK inhibitor and a BCL-2 inhibitor … (leggi tutto)
FDA Restricts Approval for Pembrolizumab Plus Trastuzumab and Chemo to Advanced PD-L1+ Gastric/GEJ Cancer
Nov 09, 2023 – The FDA has updated the current indication for pembrolizumab (Keytruda) plus trastuzumab (Herceptin), fluoropyrimidine, and platinum-containing chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma to those whose tumors express PD-L1 with a combined positive score (CPS) of 1 or more as determined by an FDA-approved test … (leggi tutto)
FDA Approves Fruquintinib for Metastatic Colorectal Cancer
Nov 08, 2023 – The FDA has approved fruquintinib (Fruzaqla) for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. The approval is based on findings from the multi-regional phase 3 FRESCO-2 (NCT04322539) and phase 3 Chinese FRESCO (NCT02314819) trials … (leggi tutto)
FDA Roundup: November 7, 2023
Nov 07, 2023 – Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA issued a Safety Communication warning consumers, health care providers, and health care facilities not to use recalled saline (0.9% sodium chloride) and sterile water medical products manufactured by Nurse Assist, LLC … (leggi tutto)
FDA Grants Orphan Drug Designation to AL102 in Desmoid Tumors
Nov 06, 2023 – The FDA has granted an orphan drug designation to the gamma secretase inhibitor (GSI), AL102, as a potential therapeutic option for patients with desmoid tumors, according to an announcement from Ayala Pharmaceuticals. The small molecule DSI is designed to potently and selectively inhibit NOTCH gene targets by blocking the final cleavage step by the GS required for the activation of NOTCH … (leggi tutto)
Dall’ASCO
TKI, Immunotherapy Trials in Early-Stage Resectable NSCLC Highlight Need for Personalized Treatment
Nov 09, 2023 – Both the potential benefit of combining chemotherapy and tyrosine kinase inhibitors (TKIs) in EGFR-mutated resectable nonsquamous mutated non–small cell lung cancer (NSCLC) and the impact it will have on the standard of care for neoadjuvant therapy remain areas of keen investigational interest. Induction immunotherapy with chemotherapy has shown to be a viable treatment option for early-stage resectable NSCLC … (leggi tutto)
Rapid Guideline Update Reflects Newest PSMA-Targeted Imaging Agent for Determining 177Lu-PSMA-617 Treatment Eligibility in mCRPC
Nov 08, 2023 – The new guideline recommendation update reflects the newest radiotracer approval of flotufolastat F-18 for metastatic castration-resistant prostate cancer (mCRPC). The guideline Expert Panel currently recommends the use of either 68Ga-PSMA-11, piflufolastat F-18, or flotufolastat F-18 as radiotracers to determine treatment eligibility to receive lutetium-177 (177Lu)-PSMA-617. ASCO has released a guideline rapid recommendation … (leggi tutto)
When to Consider a PSMA PET Scan After Radical Prostatectomy and Salvage Radiation for Prostate Cancer
Nov 08, 2023 – There is no consensus as to the optimal prostate-specific antigen (PSA) level at which to consider obtaining a prostate-specific membrane antigen (PSMA) PET scan after radical prostatectomy and salvage radiation. At present, we recommend seeking a PSMA PET scan for most patients at PSA 0.5 to 0.9 ng/mL; for patients eligible to receive metastasis-directed therapy (MDT) … (leggi tutto)
Striving Toward Gender Equity in Oncology: Individual, Institutional, and National Level Efforts Needed for Change
Nov 08, 2023 – Women comprise one-third of oncologists, yet female oncologists consistently receive lower salaries than male oncologists. Evidence demonstrates that a gender-diverse workforce leads to improved patient outcomes and greater collective intelligence. Efforts at the individual, institutional, and national levels are required to address gender inequity, including the wage gap, dearth of advancement opportunities, and leaky pipeline phenomenon … (leggi tutto)
How Bioethics and Health Humanities Training Help Future Oncologists Address Ethical Dilemmas
Nov 08, 2023 – Bioethics provides (1) awareness of common and uncommon conflicts within an encounter, (2) a framework to navigate ethical dilemmas, and (3) a venue for dialogue, education, and research regarding actions taken during clinical or research encounters. Health humanities (1) provides skills to raise awareness, (2) aids in professional identity formation, and (3) fosters well-being … (leggi tutto)
Rapid Guideline Update Reflects Newest PSMA-Targeted Imaging Agent for Determining 177Lu-PSMA-617 Treatment Eligibility in mCRPC
Nov 08, 2023 – The new guideline recommendation update reflects the newest radiotracer approval of flotufolastat F-18 for metastatic castration-resistant prostate cancer (mCRPC). The guideline Expert Panel currently recommends the use of either 68Ga-PSMA-11, piflufolastat F-18, or flotufolastat F-18 as radiotracers to determine treatment eligibility to receive lutetium-177 (177Lu)-PSMA-617 … (leggi tutto)
Dual PD-1 and TIGIT Blockade in Tandem With Chemotherapy Shows Encouraging Efficacy and Safety in Advanced Gastroesophageal Cancer
Nov 07, 2023 – The phase 2 EDGE-Gastric trial is evaluating several novel immunotherapy-based regimens in patients with advanced gastroesophageal cancer, some of which target both PD-1 and TIGIT. Preliminary data showed that treatment-naive patients who received both zimberelimab, a PD-1 inhibitor, and domvanalimab, a TIGIT inhibitor, in combination with FOLFOX had a 59% objective response rate (ORR) and 77% 6-month … (leggi tutto)
Pillole dall’AIFA
13 novembre 2023 – Attivazione web e pubblicazione schede di monitoraggio – Registro YESCARTA (FL)
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13 novembre 2023 – Attivazione web e pubblicazione schede di monitoraggio – Registro YESCARTA (DLBCL-HGBL II linea)
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13 novembre 2023 – Nota Informativa Importante su Ozempic (semaglutide) e Victoza (liraglutide)
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10 novembre 2023 – Aggiornamento “Diario di bordo sulla Trasparenza”
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10 novembre 2023 – Aggiornamento Registri PERJETA e PHESGO (EBC)
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09 novembre 2023 – Comunicazione AIFA su Barbesaclone 25mg
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08 novembre 2023 – Nota Informativa Importante su medicinali a base di esteri etilici degli acidi omega-3
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08 novembre 2023 – Monitoraggio della spesa farmaceutica (gennaio – giugno 2023)
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08 novembre 2023 – EMA raccomanda l’approvazione del vaccino COVID-19 Nuvaxovid adattato contro Omicron XBB.1.5
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07 novembre 2023 – Ordine del giorno Riunione Commissione Tecnico Scientifica (CTS)
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07 novembre 2023 – Avvio del procedimento di Pay-Back convenzionata 1.83% – 1° semestre 2023
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06 novembre 2023 – Esiti della riunione del Comitato Prezzi e Rimborso (CPR)
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