Hanno curato la selezione degli articoli scientifici e i commenti di questo numero: Saverio Cinieri (Divisione di Oncologia & Breast Unit ASL Brindisi, Ospedale Senatore Antonio Perrino)
Coordinatori: Massimo Di Maio, Silvia Novello
Editore: Intermedia – Direttore Responsabile: Mauro Boldrini
Oggi in Oncologia
Pembrolizumab for Early Triple-Negative Breast Cancer
Previous trials showed promising antitumor activity and an acceptable safety profile associated with pembrolizumab in patients with early triple-negative breast cancer. Whether the addition of pembrolizumab to neoadjuvant chemotherapy would significantly increase the percentage of patients with early triple-negative breast cancer who have a pathological complete response (defined as no invasive cancer in the breast and negative nodes) at definitive surgery is unclear. In this … (leggi tutto)
Il trattamento del tumore della mammella tre volte negativo rimane ancor oggi una delle neoplasie più difficili da curare. Una nuova strategia terapeutica arriva da uno studio di di fase 3 pubblicato sul New England Journal of Medicine, a cui hanno preso quasi 1.200 donne di 21 Paesi colpite da un tumore al seno triplo negativo (secondo o terzo stadio). Prima di essere operate, le pazienti sono state sottoposte per sei mesi ad una terapia primaria o neoadiuvante avente l’obbiettivo di ridurre la massa da asportare chirurgicamente ed evitare la diffusione delle cellule neoplastiche verso altri organi.
Come in tutti gli studi randomizzati, ad un gruppo (390 donne) è stata somministrata la chemioterapia standard in aggiunta a un placebo, mentre all’altro gruppo un trattamento con gli stessi chemioterapici con l’aggiunta di un farmaco immunoterapico, pembrolizumab. A seguire l’intervento, la radioterapia e la (ulteriore) somministrazione del pembrolizumab (per 27 settimane) o di un placebo.
Il confronto tra i gruppi è stato compiuto analizzando il tessuto asportato in sala operatoria e lo stato di salute delle pazienti 15 mesi oltre la fine del percorso di cure. In entrambi i casi, i risultati raggiunti dalle donne trattate con l’immunoterapia sono stati migliori: per sopravvivenza complessiva, comparsa di recidive e comparsa di metastasi.
Amount and Intensity of Leisure-Time Physical Activity and Lower Cancer Risk
To determine whether recommended amounts of leisure-time physical activity (ie, 7.5-15 metabolic equivalent task [MET] hours/week) are associated with lower cancer risk, describe the shape of the doseresponse relationship, and explore associations with moderate- and vigorous-intensity physical activity. Data from 9 prospective cohorts with self-reported leisure-time physical activity and follow-up for cancer incidence were pooled. Multivariable Cox regression was … (leggi tutto)
Sicuramente non si tratta di un argomento nuovo, che peraltro ancora una volta sottolinea la necessità di investire in capacità comunicativa fin dal periodo di formazione degli operatori sanitari così come di far fronte alla problematica della scarsità del personale e, di rimando, riduzione dei tempi di visita per il paziente oncologico, cosa che certamente non facilita la comunicazione.
Bevacizumab in Combination With Either FOLFOX-4 or XELOX-2 in First-line Treatment of Patients With Metastatic Colorectal Cancer: A Multicenter Randomized Phase II Trial of the Gruppo Oncologico dell’Italia Meridionale (GOIM 2802)
Biweekly schedule of XELOX-2 (capecitabine plus oxaliplatin) showed interesting results in first-line therapy of patients with metastatic colorectal cancer (mCRC). Bevacizumab plus FOLFOX-4 (oxaliplatin, folinic acid, and infusional 5-fluorouracil) is among standard first-line treatment options in this setting. We performed a phase II randomized trial in order to evaluate the activity of bevacizumab plus either FOLFOX-4 or XELOX-2 in first-line therapy of patients with … (leggi tutto)
Un recente lavoro pubblicato dal GOIM (Gruppo Oncologico Italia Meridionale), condotto nei pazienti candidati a ricevere trattamento di prima linea per un tumore colo-rettale avanzato, ha valutato l’attività di uno schema quattordicinale di XELOX-2 (capecitabina e oxaliplatino) in associazione con il bevacizumab. Lo studio era stato disegnato auspicando che tale schema consentisse un’attività paragonabile alla comune combinazione di FOLFOX-4 e bevacizumab, con una buona tollerabilità.
Disegnato come uno studio di fase II randomizzato, il trial non prevedeva un confronto formalmente comparativo tra i 2 bracci, in quanto il braccio di controllo (FOLFOX-4 + bevacizumab) era impiegato come braccio di calibrazione (allo scopo di interpretare correttamente i risultati ottenuti con il trattamento sperimentale). Il confronto tra i 2 bracci è stato quindi condotto con intento dichiaratamente esploratorio. Endpoint primario dello studio era la proporzione di risposte obiettive, mentre la sopravvivenza libera da progressione, la sopravvivenza globale e la tossicità erano endpoint secondari. Lo studio ha visto la randomizzazione di 45 pazienti nel braccio di controllo e 87 pazienti nel braccio sperimentale, con una risposta obiettiva pari al 55,6% e al 48,3%, rispettivamente. Tale differenza non risulta statisticamente significativa. Anche l’outcome in termini di sopravvivenza globale e di sopravvivenza libera da progressione non ha evidenziato differenze statisticamente significative tra i 2 bracci di trattamento.
Gli autori concludono sottolineando che, in ragione della rassicurante attività e della buona tollerabilità, lo schema XELOX-2 + bevacizumab somministrato ogni 2 settimane potrebbe essere preso in considerazione in particolare in pazienti fragili e/o anziani.
Dall’Europa
Regulatory information – adjusted fees for applications to EMA from 1 April 2020
March 6, 2020 – EMA reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2020. Every year, the European Commission adopts a regulation adjusting the fees payable to the Agency with reference to the inflation rate in the European Union for the previous year. The 2019 inflation rate was 1.6%. EMA will publish full details of the revised fees at the … (leggi tutto)
EORTC Updates QOL Module in Breast Cancer
March 5, 2020 – A group of researchers published in the February 2020 issue of the Annals of Oncology about process of updating and testing of the European Organization for Research and Treatment of Cancer (EORTC) questionnaire to assess quality of life (QoL) in breast cancer patients. The final updated module contains a total of 45 items from which 22 are new. These new items contain two multi-item scales: a target symptom scale and a satisfaction scale … (leggi tutto)
Emiel van Galen elected as chair of the Committee for Herbal Medicinal Products
March 4, 2020 – At its March meeting, EMA’s Committee for Herbal Medicinal Products (HMPC) elected Dr Emiel van Galen as its chair, for a three-year mandate. Dr van Galen is the Head of Department for Botanicals and Novel Foods at the Medicines Evaluation Board (CBG-MEB) in Utrecht, the Netherlands. He served as vice-chair of the HMPC from January 2017 to January 2020 and has been a member of the Committee since 2004. “HMPC has always been an important … (leggi tutto)
Update on nitrosamines in EU medicines
March 3, 2020 – EU and national authorities are continuing their work to prevent and manage the presence of nitrosamine impurities in EU medicines. Nitrosamines are classified as probable human carcinogens (substances that could cause cancer) based on animal studies. They are present in some foods and water supplies and are not expected to cause harm when ingested at very low levels. In the few medicines where they have been found, the risk to patients is … (leggi tutto)
EMA started a review of Trabectedin
March 3, 2020 – European Medicines Agency (EMA) announced on 28 February 2020 that its Committee for Medicinal Products for Human Use (CHMP) has started a review of trabectedin, the cancer medicine used to treat ovarian cancer and soft-tissue sarcoma. The review started after a clinical study OVC-3006, which investigated the use of Yondelis in patients with ovarian cancer, was stopped ahead of time, because an interim analysis of the results showed that, overall … (leggi tutto)
Brigatinib Nears EU Approval for Frontline ALK+ NSCLC
March 2, 2020 – The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for brigatinib for the first-line treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC). The application is based on the phase III ALTA-1L trial, in which treatment with brigatinib demonstrated a 57% reduction in the risk of disease progression or death compared with … (leggi tutto)
EMA organisational changes come into effect
March 2, 2020 – As of today, Monday, 2 March, EMA has implemented changes to its organisational structure. The purpose of the re-organisation is to ensure that the Agency operates as efficiently as possible to deliver high quality outputs for public and animal health. The exercise takes into account the rapidly evolving landscape for pharmaceutical research and development that requires regulators to keep up with advances in science and technology and prepare for future … (leggi tutto)
EMA recommends extension of therapeutic indications for Brigatinib
March 2, 2020 – On 27 February 2020, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product brigatinib. The marketing authorisation holder for this medicinal product is Takeda Pharma A/S. The CHMP adopted a new indication as follows: Brigatinib is indicated as monotherapy for the treatment of adult patients with … (leggi tutto)
Dall’FDA
FDA Grants Umbralisib Orphan Drug Status in Follicular Lymphoma
March 6, 2020 – The FDA has granted an orphan drug designation to umbralisib for the treatment of patients with follicular lymphoma, according to TG Therapeutics, Inc, the developer of the dual inhibitor of PI3K-delta and CK1-epsilon. The designation, which facilitates the develop of treatments for rare diseases or conditions, is based on data from the 118-patient follicular lymphoma cohort of the phase IIb UNITY-NHL trial. TG reported in October 2019 that … (leggi tutto)
FDA Reviewing Bevacizumab Biosimilar
March 5, 2020 – The FDA has accepted a biologics license application for a proposed biosimilar for bevacizumab according to an announcement by Mylan during its fourth quarter 2019 earnings call. The company stated that the application is under review by the FDA, with an action date of December 27, 2020. Mylan and Biocon co-develop the bevacizumab biosimilar MYL-1402O (Abevmy) which was approved by the Drug Controller General of India in November 2017 for … (leggi tutto)
FDA Grants Breakthrough Device Status to Elecsys GALAD Score for HCC
March 4, 2020 – The FDA has granted a breakthrough device designation to the Elecsys GALAD score, an algorithmic score designed to aid in the diagnosis of early-stage hepatocellular carcinoma (HCC). If approved, the Elecsys GALAD score, which is manufactured by Roche, would be the first GALAD score for use in In Vitro Diagnostics. The score is part of the Roche Diagnostics Liver Indication Program, which aims to improve diagnostic workflows throughout … (leggi tutto)
FDA Informs Patients, Providers and Manufacturers About Potential Cybersecurity Vulnerabilities in Certain Medical Devices with Bluetooth Low Energy
March 3, 2020 – Today, the U.S. Food and Drug Administration is informing patients, health care providers and manufacturers about a set of cybersecurity vulnerabilities, referred to as “SweynTooth,” that – if exploited – may introduce risks for certain medical devices. SweynTooth affects the wireless communication technology known as Bluetooth Low Energy (BLE). BLE allows two devices to “pair” and exchange information to perform their intended functions while … (leggi tutto)
FDA Grants Fast Track Designation to Tipifarnib for T-Cell Lymphomas
March 3, 2020 – The FDA has granted a Fast Track Designation to tipifarnib for the treatment of adult patients with relapsed/refractory angioimmunoblastic T-cell lymphoma (AITL), follicular T-cell lymphoma (FTCL), and nodal peripheral T-cell lymphoma with T follicular help (TFH) phenotype. “This important designation from the FDA comes just 2 months after tipifarnib was awarded Fast Track for the treatment of patients with HRAS-mutant head and neck squamous … (leggi tutto)
FDA Approves New Therapy for Patients with Previously Treated Multiple Myeloma
March 2, 2020 – Today, the U.S. Food and Drug Administration approved isatuximab-irfc, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Isatuximab-irfc, administered through intravenous (IV) infusion, is a CD38-directed cytolytic antibody that works by helping certain cells in the immune system attack … (leggi tutto)
FDA Grants Priority Review to Tafasitamab/Lenalidomide Combo for Relapsed/Refractory DLBCL
March 2, 2020 – The FDA has granted a priority review designation to a biologics license application (BLA) for the combination of tafasitamab and lenalidomide for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The application is based partly on findings from a primary analysis of the L-MIND trial, which showed that tafasitamab in combination with lenalidomide elicited an objective response rate (ORR) of 54%, including a … (leggi tutto)
Dall’ASCO
March 11 Capitol Hill Briefing: Improving Access to Clinical Trials for Patients on Medicaid
March 6, 2020 – Clinical trials often provide patients with life-threatening conditions the best – perhaps only – treatment option for their condition. However, unlike Medicare and private and commercial payers, Medicaid is not federally required to cover routine care costs (like physician visits and laboratory studies) for patients on clinical trials. Without the guarantee of coverage, many Medicaid beneficiaries do not have the latest technological and scientific advancements as a treatment … (leggi tutto)
NCCN Postpones 2020 Annual Conference, Citing Precautions Against Potential Patient Exposure to COVID-19
March 5, 2020 – The National Comprehensive Cancer Network® (NCCN) announced today that the organization is postponing the NCCN 2020 Annual Conference and preconference programs that were scheduled for March 19–22 in Orlando. The gathering for more than 1,500 oncology professionals was going to feature more than 30 educational sessions on state-of-the-art practices in cancer care. NCCN officials were compelled to postpone in response to the rapidly evolving … (leggi tutto)
Historic Cancer Center Signs on to Participate in CancerLinQ Platform
March 4, 2020 – Roswell Park Comprehensive Cancer Center of Buffalo, N.Y., has just signed an agreement to use the CancerLinQ® platform. The first cancer center in the U.S., established in 1898, Roswell Park is one of many practices to join the CancerLinQ® family in recent months. Roswell Park was recognized in 1972 as one of the first three National Cancer Institute-Designated Comprehensive Cancer Centers. Today, it is one of 28 National Comprehensive …(leggi tutto)
New Guideline Tackles Rapidly Evolving Imaging Strategies for Advanced Prostate Cancer
March 2, 2020 – Advances in radiology and molecular imaging have the potential to significantly change how clinicians diagnose, stage, and monitor response to therapy in patients with prostate cancer. However, there are limited data comparing these next-generation imaging modalities to each other and to conventional imaging in men with advanced prostate cancer. ASCO recently released a new set of guidelines to provide evidence- and expert-based recommendations for the … (leggi tutto)
Pillole dall’Aifa
6 marzo 2020 – Comunicazione EMA su nitrosammine nei medicinali dell’UE
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