Comitato scientifico editoriale: Giuseppe Aprile, Consuelo Buttigliero, Paolo Carlini, Maria Vittoria Dieci, Massimo Di Maio, Raffaele Giusti, Sara Lonardi, Domenica Lorusso, Cristina Masini, Laura Noto, Silvia Novello, Filippo Pietrantonio, Giuseppe Procopio, Daniele Santini Editore: Intermedia – Direttore Responsabile: Mauro Boldrini
Oggi in Oncologia
Trabectedin and olaparib in patients with advanced and non-resectable bone and soft-tissue sarcomas (TOMAS): an open-label, phase 1b study from the Italian Sarcoma Group
Trabectedin is an alkylating drug with a unique mechanism of action causing single-strand and double-strand DNA breaks that activate DNA damage-response pathways. Based on our preclinical data, we hypothesised that poly(ADP-ribose) polymerase 1 (PARP1) inhibitors might be an ideal partner of trabectedin and aimed to assess the safety, identify the recommended phase 2 dose, and explore preliminary signs of activity of trabectedin and olaparib … (leggi tutto)
Lo studio ha arruolato 50 pazienti, 28 nella fase di dose escalation e 22 nella fase di espansione con sarcomi non resecabili dei tessuti molli e dell’osso. Sono state testate dosi scalari di olaparin e trabectedina in un classico disegno 3+ 3 ed è stata identificata una dose massima tollerata (MTD) ad un livello di trabectedina pari a 1,1 mg/m2 q 21 e olaparib 150 mg due volte al giorno. L’importanza dello studio sta a mio avviso nel razionale della combinazione (sono due farmaci che agiscono su pazienti con un malfunzionamento del sistema di ricombinazione omologa HRD, Homologous Recombination Deficient, e come tali si potenziano) e sull’essere riusciti a combinare una chemioterapia con un PARP inibitore (olaparib), combinazione fallita in passato in diversi studi clinici per la importante tossicità midollare del PARP inibitore. La stessa combinazione è attualmente oggetto di uno studio clinico randomizzato nelle pazienti BRCA mutate o fenotipo BRCAness con tumore ovarico.
Gender-related challenges facing oncologists: the results of the ESMO Women for Oncology Committee survey
Although women account for a growing proportion of the oncology workforce, there is evidence they are under-represented in leadership roles. To gain further insights into this issue and extend understanding of gender challenges, the European Society for Medical Oncology Women for Oncology (W4O) Committee undertook a survey of female and male oncologists in 2016. The 2016 W4O questionnaire included questions on (1) Demographics and professional … (leggi tutto)
Report on the status of women occupying leadership roles in oncology
While the global workforce is approaching gender parity, women occupy a small number of management level positions across most professions, including healthcare. Although the inclusion of women into the membership of many oncology societies has increased, the under-representation of women in leadership roles within international and national oncology societies remains relatively consistent. Moreover, the exact status of women participating as board … (leggi tutto)
Le due pubblicazioni di ESMO Open, a cura del gruppo di lavoro Women for Oncology dell’ESMO, sollevano l’importante tema della parità di genere tra gli oncologi. In molte realtà, il numero di donne tra il personale medico dell’oncologia ha superato quello degli uomini, ma i risultati della survey, condotta nel 2016, documentano che le donne occupano più raramente posizioni di leadership rispetto ai colleghi maschi, e soprattutto questi ultimi percepiscono un miglioramento del problema nel tempo molto maggiore di quanto non sia effettivamente percepito dalle donne. Interessante anche l’analisi della presenza di oncologhe nel board delle società nazionali e nella faculty dei più importanti congressi oncologici: a questa analisi hanno contribuito i dati di numerose società scientifiche nazionali, tra cui AIOM. Anche questi dati documentano una presenza di donne inferiore agli uomini. Come concludono gli autori, nonostante varie società scientifiche abbiano promosso programmi per migliorare la disparità, il “gender gap” è ancora presente, e l’argomento va portato all’attenzione di tutta la comunità oncologica.
Prospective Study of Psychosocial Outcomes of Having Contralateral Prophylactic Mastectomy Among Women With Nonhereditary Breast Cancer
The incidence of contralateral prophylactic mastectomy (CPM) has continued to increase. We prospectively examined psychosocial outcomes before and up to 18 months after surgery in women who did or did not have CPM. Women with unilateral, nonhereditary breast cancer completed questionnaires before and 1, 6, 12, and 18 months after surgery. Primary psychosocial measures were cancer worry and cancer-specific distress. Secondary measures were body … (leggi tutto)
Interessante studio prospettico di coorte relativo ad aspetti psicosociali in pazienti con carcinoma mammario sporadico in funzione dell’esecuzione di mastectomia controlaterale profilattica. Nonostante sia noto che la mastectomia controlaterale profilattica non abbia alcun impatto sulla sopravvivenza, tale pratica chirurgica è in crescente aumento, spesso come conseguenza di un desiderio della paziente motivato dalla preoccupazione di incorrere in una seconda diagnosi in futuro. Questo studio prospettico, seppur di dimensioni limitate, offre degli spunti interessanti e utili nella discussione multidisciplinare e con la paziente. Viene infatti dimostrato come, al baseline, le donne che si sottopongono alla mastectomia controlaterale presentino un maggiore grado di distress e preoccupazione legati alla diagnosi di carcinoma ed una peggiore immagine corporea rispetto alle donne sottoposte ad intervento solo a carico della mammella affetta. Sebbene le donne trattate con mastectomia controlaterale vedano un progressivo miglioramento delle preoccupazioni legate alla diagnosi di tumore, si osserva anche una riduzione della qualità di vita e dell’immagine corporea, che, nei 18 mesi successivi all’intervento risulta peggiore rispetto alle donne non sottoposte a mastectomia controlaterale.
Incidence of secondary myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with ovarian or breast cancer in a real-world setting in the United States
Real-world data on patients with cancer developing secondary malignancies such as myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) are lacking. This study assessed the incidence and impact of select DNA-damaging therapy exposure on risk of secondary MDS and AML in patients with ovarian cancer (OC) or breast cancer (BC). Adults with a first observed OC or BC diagnosis (index date) between 1/1/2000 and 6/30/2014 were identified from … (leggi tutto)
Lo studio fa una fotografia del mondo reale sul rischio di sviluppare una sindrome mielodisplastica secondaria e leucemia mieloide acuta in una popolazione di 23.862 pazienti con carcinoma ovarico e 281.473 pazienti con carcinoma della mammella e riporta un rischio rispettivamente di 2,77 e 1,44 per 1.000 pazienti/anno. Il rischio è aumentato nelle pazienti che ricevono alchilanti del DNA, come il platino, rispetto a quelle che non lo ricevono e sembra risentire della sua durata di utilizzo. Questo dato è particolarmente importante alla luce di una nuova categoria di farmaci che stanno entrando in clinica che sono gli inibitori di PARP che si accompagnano ad un rischio < 2% di analoghe sindromi mieloproliferative e mielodisplastiche andando ulteriormente ad aumentare il rischio in queste pazienti la cui sopravvivenza mediana sta progressivamente aumentado e in cui questi effetti secondari dei trattamenti rischiano di diventare un challenge clinico.
In Europa
Regulatory information – adjusted fees for pharmacovigilance applications from 18 October 2018
September 28, 2018 – The European Medicines Agency (EMA) would like to inform applicants and marketing authorisation holders that adjusted fees for pharmacovigilance applications are expected to come into effect as of 18 October 2018. The European Commission has adopted a regulation adjusting the pharmacovigilance fees payable to the Agency with reference to the inflation rate in the European Union for the previous year. The 2017 inflation rate was 1.7%. Following a … (leggi tutto)
Harnessing the potential of real world data through a ‘learning healthcare system’
September 27, 2018 – Real world data (RWD) hold the promise to substantially increase the effectiveness and efficiency of all processes in the development and utilisation of medicines, from research and development, to regulatory decision-making, pricing and reimbursement decisions to use in medical practice. However, to realise the full potential of RWD requires a ‘learning healthcare system’, write the European Medicines Agency’s (EMA) Executive Director … (leggi tutto)
EMA launches new corporate website
September 27, 2018 – The European Medicines Agency (EMA) has launched a new version of its corporate website (www.ema.europa.eu) today. The website has a number of new features to improve user experience, including: an improved search, allowing users to find content easily and to filter their search results. EMA plans to further refine this functionality in the future; a ‘responsive’ design for cleaner display on mobile devices; simpler URLs based on the location … (leggi tutto)
Companies stepping up efforts to ensure medicine supply post Brexit
September 24, 2018 – The European Medicines Agency (EMA) has revised the number of centrally authorised medicines (CAPs) for which, based on current knowledge, there are concerns of Brexit-related supply disruptions from 108 to 39. This revision results from EMA’s follow-up activities with the marketing authorisation holders of the 108 medicines that were identified as deemed to be at risk of supply shortages once the United Kingdom (UK) leaves the European … (leggi tutto)
Dall’FDA
FDA Approves Cemiplimab for CSCC
September 28, 2018 – The FDA has approved the PD-1 inhibitor cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for curative surgery or curative radiation. The approval is based on a combined analysis of data from the phase II EMPOWER-CSCC-1 (Study 1540) trial and 2 advanced CSCC expansion cohorts from a phase I trial (Study 1423). The … (leggi tutto)
FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma
September 28, 2018 – Today the U.S. Food and Drug Administration permitted marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a measure of the amount of cancer cells remaining in a person’s bone marrow. “At the FDA, we’re continuing to maximize opportunities for innovation that can improve patient outcomes,” said … (leggi tutto)
FDA Approves Dacomitinib for Frontline EGFR+ NSCLC
September 28, 2018 – The FDA has approved dacomitinib for the frontline treatment of patients with metastatic non–small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 L858R substitution mutations, according to Pfizer, the manufacturer of the pan-human EGFR tyrosine kinase inhibitor (TKI). The approval is based on the phase III ARCHER 1050 trial, in which dacomitinib reduced the risk of disease progression or death by more than 40% and resulted in … (leggi tutto)
Statement by FDA Commissioner Scott Gottlieb, M.D., on preparations for the upcoming flu season and vaccinations
September 27, 2018 – This week marks the official start of “flu season” for 2018-2019. The FDA, along with its partners across the Department of Health and Human Services, has been working throughout the year to prepare the development of a safe, effective flu vaccine for the season. I got my flu shot this week at an event in Washingtondisclaimer icon, along with the U.S. Surgeon General Jerome M. Adams. With the severity of last year’s flu season, I know that there are … (leggi tutto)
FDA Approves Duvelisib for CLL and Follicular Lymphoma
September 24, 2018 – The FDA has approved duvelisib for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or relapsed/refractory follicular lymphoma. The CLL/SLL indication is a standard approval and the follicular lymphoma indication is an accelerated approval contingent on the results of a confirmatory trial. Both indications are for the treatment of patients who have received at least … (leggi tutto)
FDA Lifts Partial Clinical Hold on Tazemetostat Trials
September 24, 2018 – The FDA has lifted a partial clinical hold on tazemetostat trials, reopening enrollment to clinical studies examining the EZH2 inhibitor in patients with various solid tumors and hematologic malignancies. The federal agency had placed the hold on the tazemetostat program after Epizyme, the manufacturer of the drug, provided a safety update detailing a pediatric patient with advanced poorly differentiated chordoma enrolled in a phase I … (leggi tutto)
FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare disease
September 24, 2018 – The U.S. Food and Drug Administration today announced that it has awarded 12 new clinical trial research grants totaling more than $18 million over the next four years to enhance the development of medical products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry across the country. “Developing a treatment for a rare disease can be especially challenging. Given the often small … (leggi tutto)
Dall’ASCO
ASCO Praises Congress for Continuing to Invest in Federal Research
September 27, 2018 – ASCO applauds Congress for passing a $2 billion increase in funding for the National Institutes of Health (NIH), which will bring NIH’s budget to a total of $39.1 billion and the National Cancer Institute’s to a total of $6.147 billion. We are grateful for the strong Congressional leadership and bipartisan support of federal funding for biomedical research that made passage of this appropriations bill a reality. We especially applaud the tireless … (leggi tutto)
Dr. Ray Page Named ASCO 2017 Advocate of the Year
September 25, 2018 – The American Society of Clinical Oncology (ASCO) presented its 2017 Advocate of the Year Award to Ray D. Page, DO, PhD, FACOI, for his exceptional advocacy efforts on behalf of individuals living with cancer and their cancer care teams. As a member of the Government Relations Committee and in other roles, Dr. Page has provided distinguished leadership in the society’s policy and advocacy efforts. As a member of ASCO’s Delegation to the … (leggi tutto)
Three Studies Reveal Cancer Patients Face Serious Financial Hardship, Do Not Discuss Treatment Costs With Physicians
September 24, 2018 – New studies released today reveal the financial difficulties that people living with cancer currently face. The research looks at financial distress, also known as “financial toxicity,” among patients with metastatic breast cancer and older patients, as well as conversations about cost of care that women with breast cancer are having with their physicians. Authors will present their findings at the American Society of Clinical Oncology’s (ASCO) upcoming … (leggi tutto)
Pillole dall’Aifa
28 settembre 2018 – Comunicazione EMA su valsartan
Dal Soroptimist International Club Genova a favore delle ragazze STEM
Il Premio, del valore di 2.000 Euro, sarà attribuito ad una Tesi di Laurea Magistrale in campo Emato-Oncologico, discussa da una studentessa dell’Università degli Studi di Genova negli anni accademici 2016-17 o 2017-18, in una delle seguenti discipline: Medicina e Chirurgia – Scienze infermieristiche e ostetriche, Scienze riabilitative delle professioni sanitarie – Psicologia – Biologia – Scienze chimiche – Fisica – Farmaci e farmacia industriale – Biotecnologie mediche, veterinarie e farmaceutiche – Ingegneria biomedica.
Le domande dovranno essere inviate entro il 31 marzo 2019 ed il Premio sarà assegnato a giugno 2019.
Per scaricare il Bando e la Scheda di Partecipazione, vai al sito web.
Preserva la tua fertilità
Scheda informativa condivisa da ISS, PMA, AIMAC e AIOM
Suggerimenti semplici su come preservare la fertilità prima dei trattamenti antitumorali, firmate da Istituto Superiore di Sanità (ISS), Registro Nazionale di Procreazione Medicalmente Assistita (PMA), Associazione Italiana Malati di Cancro, parenti e amici (AIMaC) e Associazione Italiana di Oncologia Medica (AIOM), sono state incluse in una locandina. Contiene consigli e tecniche utilizzate in donne, uomini e bambini, in forma sintetica. Ulteriori informazioni sono disponibili ai siti web di ISS, AIMaC e AIOM oppure al numero verde AIMaC 840503579.
CORSO AIRO-LAM Le sfide della Radioterapia: Problematiche, Novità e Terapie Integrate 1° Incontro. Radioterapia nel Paziente con CIED (Linee Guida e Pratica Clinica)
PDTA: QUESTA S…CONOSCIUTA 4° Convegno Infermieristico della Rete Oncologica del Piemonte e della Valle D’Aosta Gli Infermieri per la Rete, la Rete per gli Infermieri
Torino, 19 ottobre 2018 Patrocinio concesso dalla Sezione Regionale AIOM Piemonte e Valle D’Aosta
LA RICERCA IN ONCOLOGIA CLINICA 2018 Radiotherapy cures cancer today XXVIII Congresso Nazionale AIRO, XXXI Congresso Nazionale AIRB, X Congresso Nazionale AIRO Giovani
Rimini, 2 -4 novembre 2018 Evento patrocinato da AIOM
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