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
Emerging Role of Combination Immunotherapy in the First-line Treatment of Advanced Renal Cell Carcinoma: A Review
Novel immunotherapies, notably the immune checkpoint inhibitors, have been shown to be efficacious in patients with advanced renal cell carcinoma, but innate or adaptive resistance is observed with single-agent immunotherapy. New combination treatment strategies are needed that can improve efficacy in a broader patient population, without exacerbating the toxic effects. Numerous late-phase trials are ongoing to investigate (1) dual immune checkpoint … (leggi tutto)
La strategia terapeutica del carcinoma renale avanzato evolve verso combinazioni terapeutiche includenti inibitori del checkpoint immunitario. Studi clinici hanno già rilevato come alcune di queste combinazioni quali nivolumab + ipilimumab, avelumab + axitinib, pembrolizumab + axitinib e bevacizumab + atezolizumab siano più attive rispetto alla monoterapia con l’inibitore dell’angiogenesi. Rimangono però alcune criticità aperte quali: 1) l’assenza di fattori predittivi in grado di individuare i pazienti da candidare alla combinazione rispetto alla monoterapia; 2) il profilo di tollerabilità delle combinazioni spesso più impegnativo da gestire per il clinico; 3) la rilevanza clinica della maggior attività (un vantaggio in sopravvivenza libera da progressione non necessariamente equivale ad un vantaggio per il paziente). Ulteriori studi prospettici sono in corso per rispondere ai quesiti aperti.
BRCA Reversion Mutations in Circulating Tumor DNA Predict Primary and Acquired Resistance to the PARP Inhibitor Rucaparib in High-Grade Ovarian Carcinoma
A key resistance mechanism to platinum-based chemotherapies and PARP inhibitors in BRCA-mutant cancers is the acquisition of BRCA reversion mutations that restore protein function. To estimate the prevalence of BRCA reversion mutations in high-gradeovarian carcinoma (HGOC), we performed targeted next-generation sequencing of circulating cell-free DNA (cfDNA) extracted from pretreatment and postprogression plasma in patients with deleterious … (leggi tutto)
Lo studio risponde ad uno dei quesiti più caldi del momento e cioè quali siano i meccanismi di resistenza ai PARP inibitori. Altrettanto interessante la possibilità di acquisire l’informazione sul DNA circolante perché molto spesso non è possibile, vista la diffusione prevalentemente peritoneale del tumore ovarico, acquisire una nuova biopsia al momento della progressione al trattamento. Lo studio dimostra come l’acquisizione di mutazioni repertanti di BRCA sia presente nel 18% dei tumori ovarici che ricorrono come resistenti e nel 13% dei tumori platino-refrattari e solo nel 2% dei tumori platino-sensibili. Le pazienti senza mutazione repertante del BRCA presentano una più lunga risposta al PARP inibitore rucaparib (9 vs 1,8 mesi). Mutazioni acquisite durante trattamento con rucaparib e condizionanti la progressione allo stesso sono state inoltre identificate nel 10% delle pazienti. Sebbene i meccanismi di resistenza ai PARP inibitori siano per la maggior parte sconosciuti, questo studio dimostra che almeno nel 10% delle pazienti intervengono mutazioni ex novo del BRCA che ne ristorano l’attività e creano resistenza ai PARP inibitori.
A Subset of Mesotheliomas With Improved Survival Occurring in Carriers of BAP1 and Other Germline Mutations
We hypothesized that four criteria could help identify malignant mesotheliomas (MMs) most likely linked to germline mutations of BAP1 or of other genes: family history of MM, BAP1-associated cancers, or multiple malignancies; or age younger than 50 years. Over the course of 7 years, 79 patients with MM met the four criteria; 22 of the 79 (28%) reported possible asbestos exposure. They were screened for germline BAP1 mutations by Sanger sequencing … (leggi tutto)
Lo studio ha screenato, nell’arco di 7 anni, un totale di 79 pazienti affetti da mesotelioma maligno con determinate caratteristiche cliniche (storia familiare di mesotelioma o altri tumori, diagnosi di multiple neoplasie, età inferiore a 50 anni) sospette per essere associate alla presenza di mutazioni germinali del gene BAP1 o di altri geni. Nel 72% dei pazienti portatori dell’alterazione genetica non vi era alcuna esposizione all’asbesto, inoltre una buona parte di questi pazienti presentava parenti di primo o secondo grado con storia di mesotelioma, tumore renale o melanoma uveale, tutte neoplasie correlate con mutazioni germinali di BAP1. In generale, la sopravvivenza dei pazienti affetti da mesotelioma con caratteristiche cliniche sospette per una sindrome ereditaria è nettamente superiore rispetto a quella dei pazienti con mesotelioma classico sporadico (9-10 anni rispetto a 1 anno appena), suggerendo una diversa biologia associata ad una migliore prognosi. Sulla base di questi dati i pazienti che rispecchiano queste caratteristiche dovrebbero essere sottoposti a test genetico per la ricerca di eventuali alterazioni suscettibili di terapie mirate nell’ambito di studi clinici nonché per il ruolo prognostico positivo emerso.
In Europa
Revised guideline to assess risk of human medicines for the environment
November 30, 2018 – EMA has published a revision of its guideline on the environmental risk assessment (ERA) of human medicines for a six-month public consultation. Stakeholders are invited to send their comments by 30 June 2019 to era_dg@ema.europa.eu using the Microsoft Office document template provided. The presence of biologically-active pharmaceuticals in the environment is a growing concern, because some of these substances have … (leggi tutto)
Meeting highlights from EMA’s safety committee (PRAC) 26-29 November 2018
November 30, 2018 – At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of signals, risk management plans, periodic safety update reports and post-authorisation safety studies. The Committee did not start or conclude any referral procedures. More information on all safety reviews currently under evaluation is provided in the … (leggi tutto)
Human medicine European public assessment report (EPAR): Topotecan Hospira (Pfizer)
November 30, 2018 – This Human medicine European public assessment report (EPAR) was updated. Leggi tutto
Human medicine European public assessment report (EPAR): Encorafenib (Pierre Fabre)
November 30, 2018 – This Human medicine European public assessment report (EPAR) was updated. Leggi tutto
Human medicine European public assessment report (EPAR): Osimertinib (AstraZeneca)
November 30, 2018 – This Human medicine European public assessment report (EPAR) was updated. Leggi tutto
Five additional countries to benefit from EU-US mutual recognition agreement for inspections
November 29, 2018 – In November 2018, the US Food and Drug Administration (FDA) confirmed the capability of five additional EU Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). Belgium, Denmark, Finland and Latvia were included into the mutual recognition agreement between the European Union (EU) and the United States (US) on 16 November and Estonia on 28 November … (leggi tutto)
Human medicine European public assessment report (EPAR): Bortezomib (Sun)
November 29, 2018 – This Human medicine European public assessment report (EPAR) was updated. Leggi tutto
Human medicine European public assessment report (EPAR): Bevacizumab (Amgen)
November 29, 2018 – This Human medicine European public assessment report (EPAR) was updated. Leggi tutto
Human medicine European public assessment report (EPAR): Pegaspargase (Baxalta)
November 28, 2018 – This Human medicine European public assessment report (EPAR) was updated. Leggi tutto
Human medicine European public assessment report (EPAR): Trastuzumab (Samsung)
November 28, 2018 – This Human medicine European public assessment report (EPAR) was updated. Leggi tutto
Human medicine European public assessment report (EPAR): Bosutinib (Pfizer)
November 28, 2018 – This Human medicine European public assessment report (EPAR) was updated. Leggi tutto
Pegfilgrastim Biosimilar Approved in Europe
November 27, 2018 – The European Commission has granted approval to the biosimilar LA-EP2006, a biosimilar for pegfilgrastim, as a treatment to reduce the duration of neutropenia and incidence of febrile neutropenia that is associated with anticancer chemotherapy, according to Sandoz, the developer of the agent. LA-EP2006 is now authorized for use in the same proposed indications as reference pegfilgrastim, which is to prevent febrile neutropenia in patients … (leggi tutto)
Brigatinib Approved in Europe for ALK+ NSCLC
November 27, 2018 – The European Commission has approved brigatinib for the treatment of adult patients with ALK-positive non–small cell lung cancer (NSCLC) who were previously treated with crizotinib, according to Takeda Pharmaceutical Company, the developer of the ALK inhibitor. The approval follows a positive opinion granted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in September … (leggi tutto)
Human medicine European public assessment report (EPAR): Rolapitant (Tesaro)
November 26, 2018 – This Human medicine European public assessment report (EPAR) was updated. Leggi tutto
Human medicine European public assessment report (EPAR): Brigatinib (Takeda)
November 26, 2018 – This Human medicine European public assessment report (EPAR) was updated. Leggi tutto
Dall’FDA
FDA Approves Gilteritinib for FLT3+ AML
November 28, 2018 – The FDA has approved gilteritinib for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia (AML). The approval of the FLT3 inhibitor was based on data from the ADMIRAL study, in which 138 adult patients with FLT3-positive relapsed/refractory AML received gilteritinib orally at 120 mg daily. The rate of complete remission (CR) or CR with partial hematologic recovery … (leggi tutto)
FDA Approves First Biosimilar for Non-Hodgkin Lymphoma
November 28, 2018 – The FDA has approved the first rituximab biosimilar, CT-P10 (rituximab-abbs), for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) as a single agent or in combination with chemotherapy. This is the first biosimilar approved by the FDA for the treatment of patients with NHL. CT-P10, which is developed by Celltrion and Teva Pharmaceutical Industries, has approved indications that are … (leggi tutto)
FDA Approves Larotrectinib for NTRK+ Cancers
November 26, 2018 – The FDA has granted an accelerated approval to larotrectinib for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. The approval is based on findings from patients with TRK-positive … (leggi tutto)
Dall’ASCO
ASCO and Friends of Cancer Research Applaud NCI’s Expansion of Clinical Trial Eligibility Criteria
November 29, 2018 – The American Society of Clinical Oncology, Inc. (ASCO) and Friends of Cancer Research (Friends) applaud the National Cancer Institute’s (NCI) recent revision of its clinical trial protocol template to broaden eligibility criteria for cancer clinical trials. The protocol template was expanded to help increase the opportunity for participation in NCI-funded clinical trials for patients with certain health care conditions, as well as to provide an opportunity for … (leggi tutto)
Compromising Patient Protections to Lower Drug Costs Could Harm People with Cancer
November 27, 2018 – “While ASCO supports efforts to control drug prices, we are keenly aware that optimal cancer care requires patient access to the most medically appropriate drug, at the most opportune time, based on the highest quality evidence. Therefore, ASCO has significant concerns about the Centers for Medicare & Medicaid Services’ (CMS) proposed rule to reduce the number of prescription drugs that must be made available to Medicare beneficiaries … (leggi tutto)
Pillole dall’Aifa
30 novembre 2018 – Modifica alle regole per l’inserimento delle schede di rivalutazione per i Registri Pemetrexed (Eli Lilly), Aflibercept (Sanofi-Aventis) e Ivacaftor (Vertex)
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, cofirmati 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 stati inclusi 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 II Sessione. Integrazione tra RT e nuovi farmaci; Efficacia e Tossicità
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