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
Effectiveness of postoperative chemotherapy for stage IC mucinous ovarian cancer
To examine the association between postoperative chemotherapy and survival of women with stage IC mucinous ovarian cancer (MOC). Comprehensive nationwide tumor registry data from the Commission on Cancer-accredited facilities in the United States from 2004 to 2014 were retrospectively examined. Women with stage IC MOC who underwent primary surgery followed by postoperative chemotherapy were compared to those who did not receive. Clinico-pathological factors … (leggi tutto)
Lo studio riporta una analisi retrospettiva di circa 900 pazienti con carcinoma ovarico mucinoso trattate tra il 2004 e il 2014 e registrate nel registro nazionale tumori degli Stati Uniti per valutare se la chemioterapia adiuvante nel tumore mucinoso ovarico stadio IC impatti sulla prognosi. Sono state analizzate 532 pazienti che hanno ricevuto la chemioterapia con 377 che non l’hanno ricevuta, e, sebbene le prime avessero più tumori G2-G3 e di maggiori dimensioni, l’utilizzo della chemioterapia adiuvante non ha impattato sulla sopravvivenza delle pazienti. Lo studio, anche se retrospettivo, è molto interessante e fornisce uno strumento utile nel counseling perché il tumore mucinoso ovarico rappresenta il 2-3% dei tumori ovarici e 900 pazienti sono un numero ragguardevole sul quale derivare conclusioni da condividere con la pazienti nel decision making.
Development and validation of a prognostic nomogram for overall survival in patients with platinum-resistant ovarian cancer treated with chemotherapy
Platinum-resistant ovarian cancer (PROC) is associated with a variable prognosis and unpredictable survival times. We have developed and validated a prognostic nomogram with the objective of improving the prediction of overall survival (OS) in patients treated with chemotherapy. The nomogram was developed using data from a training cohort of patients from two trials, including the chemotherapy-only arm in AURELIA and all randomised patients in CARTAXHY. Multivariable … (leggi tutto)
La recidiva platino-resistente di carcinoma ovarico rappresenta un challenge clinico per la cattiva prognosi delle pazienti e perché dati clinici riportano che il 30% di loro riceve una chemioterapia nel mese precedente la morte per l’incapacità dei clinici di prevedere l’outcome a breve termine. Lo studio descrive uno strumento semplice e di grande applicabilità clinica che consiedera 6 parametri clinici facilmente valutabili che quando applicato distingue la popolazione di pazienti platino-resistenti in 3 differenti gruppi con differente prognosi. In particolare quello a scarsa prognosi ha una aspettativa di vita che varia da 5 a 10 mesi rispetto ai 25 mesi del gruppo a prognosi favorevole a significare che all’interno della definizione di platino-resistenza ci sono categorizzazioni cliniche completamente differenti di cui il clinico deve tenere conto nel decision making della scelta della terapia.
Pembrolizumab in men with heavily treated metastatic castrate-resistant prostate cancer
Pembrolizumab is approved for patients with metastatic, microsatellite instability (MSI)-high or mismatch repair-deficient (dMMR) solid tumors. However, very few men with prostate cancer were included in these initial studies. We performed a single institution retrospective review of men with metastatic castrate-resistant prostate cancer (mCRPC) who were treated with pembrolizumab. The primary objective was to describe the clinical efficacy of pembrolizumab … (leggi tutto)
Nonostante si tratti di un piccolo studio retrospettivo, i risultati ottenuti con pembrolizumab in monoterapia o in combinazione con enzalutamide, in pazienti con tumore della prostata resistente alla castrazione fortemente pre-trattati (> 3 linee di terapia), per i quali ad oggi non vi siano alternative terapeutiche, sono assai incoraggianti; tutto questo con un costo in termini di tossicità di minima rilevanza (prevalentemente tossicità di G1-2). Particolarmente interessante in questo studio è la valutazione effettuata mediante la profilazione genomica con il test FoundationOne per definire se esistono altri fattori che possano predire un beneficio clinico a tale trattamento. Sebbene attualmente solo FDA abbia approvato il farmaco per i pazienti con elevata instabilità dei microsatelliti o difetto dei geni del mismatch repair, questo studio mette in luce come la presenza di mutazione a carico di LRP1b (lowdensity lipoprotein receptorrelated protein 1b) possa essere un ulteriore potenziale marker per la risposta al trattamento insieme al TMB (tumor mutational burden).
In Europa
EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers
July 12, 2019 – With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories. “We welcome the implementation of this agreement, which means authorities on both sides of the Atlantic will now be able to rely on each other’s inspection results. This …. (leggi tutto)
PRAC recommends new measures to avoid dosing errors with methotrexate
July 12, 2019 – EMA’s safety committee (PRAC) is recommending new measures to avoid dosing errors that have led to some patients incorrectly taking methotrexate-containing medicines daily instead of weekly. The new measures include restricting who can prescribe these medicines, making warnings on the packaging more prominent and providing educational materials for patients and healthcare professionals. In addition, to help patients follow the once-weekly dosing … (leggi tutto)
Guido Rasi elected chair of International Coalition of Medicines Regulatory Authorities (ICMRA)
July 8, 2019 – The International Coalition of Medicines Regulatory Authorities (ICMRA) has elected EMA’s Executive Director Guido Rasi as its new chair. ICMRA brings together the leaders of regulatory authorities around the world to provide strategic directions for enhanced cooperation on common scientific, regulatory or safety challenges, improved communication and information sharing between its members and effective global crisis response mechanisms. “It is a great … (leggi tutto)
Dall’FDA
FDA Approval Sought for Subcutaneous Daratumumab in Multiple Myeloma
July 12, 2019 – A supplemental biologics license application (sBLA) has been submitted to the FDA for a new subcutaneous formulation of daratumumab for the treatment of patients with multiple myeloma. The sBLA is based on findings from the phase III COLUMBA (MMY3012) study, which demonstrated noninferiority in terms of efficacy compared with the intravenous (IV) formulation of the CD38-targeted monoclonal antibody. Data also demonstrated that the subcutaneous … (leggi tutto)
FDA Grants Durvalumab Orphan Drug Status in Small Cell Lung Cancer
July 12, 2019 – The FDA has granted an Orphan Drug Designation to durvalumab for the treatment of patients with small cell lung cancer (SCLC), according to AstraZeneca, the developer of the PD-L1 inhibitor. The designation follows the announcement of the phase III CASPIAN trial data, in which the combination of durvalumab and standard etoposide and platinum-based chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival … (leggi tutto)
FDA Grants Fast Track Designation to CLR 131 for DLBCL
July 11, 2019 – The FDA has granted a fast track designation to CLR 131 for use as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The designation is based on findings from a DLBCL cohort that is part of the ongoing phase II CLOVER-1 study, which is investigating CLR 131 in patients with relapsed/refractory B-cell lymphomas (NCT02952508). “We are pleased to receive FDA’s fast track designation for CLR 131 … (leggi tutto)
FDA Reviewing Isatuximab for Multiple Myeloma
July 10, 2019 – The FDA has accepted a Biologics License Application (BLA) for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma, according to Sanofi, the manufacturer of the anti-CD38 monoclonal antibody. The BLA is based on the phase III ICARIA-MM trial, in which adding isatuximab to pomalidomide and low-dose dexamethasone led to a greater than 40% reduction in the risk of disease progression or death compared with pomalidomide and … (leggi tutto)
FDA Approval Sought for Extended Pembrolizumab Dosing Schedule for Select Indications
July 9, 2019 – The FDA has accepted 6 supplemental biologics license applications (sBLAs) for review to update the dosing schedule for pembrolizumab to include an every-6-weeks option at 400 mg over 30-minute infusions. The new dosage would be applicable for the PD-1 inhibitor’s following indications: melanoma, Merkel cell carcinoma, gastric cancer, hepatocellular carcinoma, classical Hodgkin lymphoma, and primary mediastinal large B-cell lymphoma. If approved … (leggi tutto)
Dall’ASCO
Medicaid Patients Need Clinical Trial Access, Coalition Tells Congress
July 10, 2019 – Today, organizations representing patients, providers, medical researchers, survivors, and their families joined together to call on Congress to improve access to clinical trials for patients with life-threatening diseases. The coalition, which is made up of 86 supporting organizations, is urging Congress to pass the bipartisan CLINICAL TREATMENT Act (H.R. 913), which would guarantee coverage of the routine care costs of clinical trial participation for Medicaid … (leggi tutto)
Pillole dall’Aifa
13 luglio 2019 – Farmaci falsificati: AIFA, in Italia nessuna segnalazione
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