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
Collaborazione Corriere della Sera – AIOM
Web-app
Una nuova web-app gratuita, in otto lingue, per computer, tablet e smartphone sul tumore dell’ovaio è disponibile sul sito del Corriere della Sera in collaborazione con l’Associazione Italiana di Oncologia Medica (leggi e scarica). Strumento interattivo in due versioni, per tablet/computer e smartphone, è il sesto della serie di 6 su altrettanti tipi di tumori per aiutare i cittadini a capire come si può prevenire e diagnosticare in tempo la malattia.
Oggi in Oncologia
Alcohol and Cancer: A Statement of the American Society of Clinical Oncology
Alcohol drinking is an established risk factor for several malignancies, and it is a potentially modifiable risk factor for cancer. The Cancer Prevention Committee of the American Society of Clinical Oncology (ASCO) believes that a proactive stance by the Society to minimize excessive exposure to alcohol has important implications for cancer prevention. In addition, the role of alcohol drinking on outcomes in patients with cancer is in its formative stages, and ASCO can … (leggi tutto)
Negli ultimi anni, si è fatto molto per sensibilizzare l’opinione pubblica sui danni e sui rischi oncologici del fumo di sigaretta, forse si è fatto meno a proposito di altri fattori di rischio. L’ASCO pubblica un importante documento relativo al consumo di alcool come fattore di rischio per numerose neoplasie. La società scientifica sottolinea che un coinvolgimento proattivo della comunità oncologica nel sensibilizzare sui rischi associati al consumo eccessivo di alcool può avere importanti implicazioni per la prevenzione. I dati di letteratura che documentano l’aumentato rischio di numerosi tumori, non solo del tratto gastrointestinale, sono solidi. In verità, meno solidi i dati relativi all’associazione tra consumo di alcool e outcome dei pazienti dopo la diagnosi di tumore e l’ASCO sottolinea quindi che va incoraggiata la ricerca e la produzione di dati su questo aspetto altrettanto importante. Gli obiettivi del documento sono quelli di: promuovere l’educazione pubblica sui rischi dell’abuso di alcool; supportare sforzi di prevenzione primaria basati su strategie di riduzione del consumo di alcool; informare gli oncologi a proposito dell’associazione tra uso di alcool e rischi legati alle complicanze di malattia e agli effetti collaterali dei trattamenti; identificare aree di ricerca sui suddetti temi.
OV21/PETROC: A randomized Gynecologic Cancer Intergroup phase II study of intraperitoneal versus intravenous chemotherapy following neoadjuvant chemotherapy and optimal debulking surgery in epithelial ovarian cancer
The purpose of this multistage, adaptively, designed randomized phase II study was to evaluate the role of intraperitoneal (IP) chemotherapy following neoadjuvant chemotherapy (NACT) and optimal debulking surgery in women with epithelialovarian cancer (EOC). We performed a multicentre, 2 stage, phase II trial. Eligible patients with stage IIB-IVA EOC treated with platinum-based intravenous (IV) NACT followed by optimal (<1cm) debulking surgery were … (leggi tutto)
Lo studio randomizzato da fase II ha comparato la chemioterapia standard endovenosa con due regimi di terapia endoperitoneale (cisplatino-paclitaxel i.p. e carboplatino-paclitaxel i.p.). Il braccio con il cisplatino non ha superato la prima analisi ad interim per efficacia e tossicità ed è stato chiuso precocemente. Il confronto finale è stato effettuato tra la terapia endovenosa standard e il braccio di carbo-taxolo i.p. L’endpoint originario dello studio era la sopravvivenza libera da progressione (PFS) ma lo studio è stato cambiato in corso di svolgimento inserendo la PFS a 9 mesi come endpoint primario. Con questa modifica la PFS è risultata migliore nel braccio i.p. senza alcun segnale per la PFS e sopravvivenza globale a vantaggio del braccio i.p. Questo studio riporta l’ennesimo dato dibattuto sul ruolo della chemioterapia intraperitoneale nel trattamento del tumore ovarico. Potenzialmente la strategia ha una sua validità biologica e dati di letteratura la supportano, ma l’incoerenza dei dati di letteratura, che non vanno tutti nella stessa direzione, i problemi metodologici di questo studio e le problematiche di tossicità del trattamento, non ne fanno una opzione standard per tutte le pazienti, ma certamente una buona opportunità che centri con esperienza possono offrire a pazienti senza residuo di malattia.
Seizure Rates in Enzalutamide-Treated Men With Metastatic Castration-Resistant Prostate Cancer and Risk of Seizure The UPWARD Study
The androgen receptor inhibitor enzalutamide prolongs survival in men with metastatic castration-resistant prostate cancer (mCRPC). In controlled clinical studies, 0.5% (10 of 2051) of patients experienced seizure, but patients with a history of or risk factors for seizure were excluded. Men with mCRPC and seizure risk factors have an estimated seizure rate of 2.8 per 100 patient-years without enzalutamide exposure. To assess seizure incidence in patients with seizure … (leggi tutto)
Un evento avverso raro che è stato descritto in pazienti trattati con enzalutamide sono le crisi epilettiche. Questo effetto sembrerebbe dovuto all’inibizione dei canali del cloro mediati dal neurotrasmettitore acido gamma-aminobutirrico (GABA) da parte di enzalutamide, con conseguente abbassamento della soglia epilettogena. Negli studi di fase I/II tale evento avverso è stato riportato nel 2% dei pazienti trattati con un dosaggio di enzalutamide superiore a 360 mg al giorno. Per questo motivo gli studi clinici successivi di fase III prevedevano l’esclusione dei pazienti con storia di epilessia o fattori predisponenti l’insorgenza di crisi epilettiche. La sicurezza di enzalutamide in questo sottogruppo di pazienti è stata indagata per la prima volta nello studio UPWARD, uno studio prospettico a singolo braccio, multicentrico (73 centri), nel quale 423 pazienti affetti da carcinoma prostatico metastatico resistente alla castrazione sono stati trattati con enzalutamide al dosaggio standard di 160 mg al giorno. Tutti i pazienti presentavano fattori predisponenti l’insorgenza di epilessia (trattamento con farmaci che riducono la soglia epilettogena, eventi cerebro-vascolari in anamnesi o precedenti episodi di crisi epilettiche). Quattro dei 366 pazienti inclusi nell’analisi (1,1%) hanno presentato almeno un episodio di epilessia nel corso dei primi 4 mesi di trattamento e 3/366 (0,8%) nei 4 mesi successivi. L’incidenza complessiva di epilessia è stata 2,6 per 100 pazienti/anno. Il rischio di crisi epilettica in pazienti con fattori di rischio noti per epilessia trattati con enzalutamide è risultata sostanzialmente sovrapponibile a quella dei pazienti con le medesime caratteristiche inclusi in un grosso studio retrospettivo condotto negli Stati Uniti non trattati con enzalutamide (2,8 per 100 pazienti/anno). La presenza in anamnesi di fattori predisponenti l’epilessia è sempre stato nella pratica clinica uno dei criteri tenuti in considerazione nella scelta tra le terapie ormonali di nuova generazione. Lo studio UPWARD suggerisce invece come il trattamento con enzalutamide non incrementi il rischio di epilessia e possa pertanto essere preso in considerazione anche in questo sottogruppo di pazienti.
Cabozantinib, a New Standard of Care for Patients With Advanced Renal Cell Carcinoma and Bone Metastases? Subgroup Analysis of the METEOR Trial
Cabozantinib, an inhibitor of tyrosine kinases including MET, vascular endothelial growth factor receptors, and AXL, increased progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) in patients with advanced renal cell carcinoma (RCC) after previous vascular endothelial growth factor receptor-targeted therapy in the phase III METEOR trial. Because bone metastases are associated with increased morbidity in patients with RCC … (leggi tutto)
La presenza di secondarismi ossei costituisce un fattore prognostico sfavorevole indipendente nel carcinoma renale avanzato. Inoltre, l’efficacia dei vari inibitori dell’angiogenesi validati nella patologia renale è meno valida sulle metastasi ossee rispetto ad altre sedi. Lo studio METEOR ha dimostrato la superiorità in tutte le variabili cliniche di efficacia di cabozantinib rispetto ad everolimus dopo terapia con inibitore dell’angiogenesi. L’analisi di sottogruppo presentata da Escudier mostra come, in presenza di malattia ossea, cabozantinib sia superiore in sopravvivenza libera da progressione, sopravvivenza globale e ORR rispetto ad everolimus. Tale differenza è statisticamente significativa e clinicamente rilevante. Il messaggio chiaro è che, anche in presenza di interessamento secondario osseo, cabozantinib è da considerarsi valida opzione di trattamento dopo fallimento della terapia con inibitore dell’angiogenesi.
In Europa
Frontline Alectinib Approved in Europe for ALK-Positive NSCLC
December 22, 2017 – The European Commission (EC) has approved alectinib for the frontline treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC), according to Roche, the manufacturer of the second-generation ALK inhibitor. The approval, which follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use, is based on findings from the phase III ALEX trial … (leggi tutto)
Regulatory information – adjusted fees for pharmacovigilance applications to EMA from January 2018
December 22, 2017 – The European Medicines Agency reminds applicants and marketing authorisation holders that adjusted fees for pharmacovigilance applications are expected to come into effect in mid-January 2018. The European CommissionExternal link icon adopted a regulation adjusting the pharmacovigilance fees payable to the Agency on 18 October 2017. Following a two-month consultation with the Council and Parliament, the amended … (leggi tutto)
NICE Recommends Approval for Ribociclib, Palbociclib for HR+/ HER2- Advanced Breast Cancer
December 21, 2017 – The United Kingdom’s National Institute for Health and Care Excellence (NICE) has issued guidance supporting approval for ribociclib and palbociclib for patients with hormone receptor-positive/HER2¬-negative locally advanced or secondary breast cancer. Both CDK4/6 inhibitors are indicated for use with an aromatase inhibitor (AI). If approved for routine National Health Service (NHS) use, about 8000 newly diagnosed patients in the … (leggi tutto)
End of year message from EMA’s Executive Director
December 21, 2017 – As we approach the end of 2017 I would like to take a moment to thank all our partners and stakeholders for their support during this year. It was not always easy to stay focused on our core tasks with the uncertainty of relocation hanging over us, nonetheless we did everything we could to deliver on EMA’s mission to promote and protect public health as European citizens – rightly – expect from us. We also did our best to break new … (leggi tutto)
Orphan medicines in the EU – leaving no-one behind
December 21, 2017 – There are over 6,000 rare diseases and it is estimated that around 30 million people in the European Union (EU) suffer from one of them. Treating these patients can be very difficult, because there are only few medicines available. This represents a huge unmet medical need and a significant public health challenge. The EU’s orphan designation programme was launched in the year 2000 to encourage companies to research and develop … (leggi tutto)
NICE Recommends Ixazomib for Multiple Myeloma Through CDF
December 19, 2017 – The United Kingdom’s National Institute for Health and Care Excellence (NICE) has issued guidance recommending ixazomib in for patients with relapsed/refractory multiple myeloma. The proteasome inhibitor developed by Takeda is indicated for use in combination with lenalidomide and dexamethasone for patients who have already undergone 2 or 3 prior lines of therapy. The drug would be made available through the Cancer Drugs Fund (CDF) … (leggi tutto)
CHMP Issues Positive Opinion on CT-P6 for HER2+ Breast, Gastric Cancers
December 18, 2017 – The European Union’s Committee for Medicinal Products for Human Use (CHMP) has delivered a positive opinion for CT-P6, a trastuzumab biosimilar, for the treatment of patients with HER2-positive early breast cancer, metastatic breast cancer, or metastatic gastric cancer. The CHMP’s opinion will now go to the European Commission (EC) for final review. South Korea-based Celltrion, developer of the monoclonal antibody, announced the CHMP’s … (leggi tutto)
Ipilimumab Approaches EU Approval for Pediatric Melanoma
December 18, 2017 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of ipilimumab for the treatment of pediatric patients aged 12 years and older with unresectable or metastatic melanoma, according to Bristol-Myers Squibb (BMS), the manufacturer of the CTLA-4 inhibitor. The application is based on data across 2 trials in which objective responses were observed in 2 of 17 patients aged … (leggi tutto)
Dall’FDA
FDA Approves Denosumab for Multiple Myeloma
January 5, 2018 – The FDA has approved denosumab for the prevention of skeletal-related events (SREs) in patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor. The approval is based on data from the phase III 482 study, which were presented at the 16th International Myeloma Workshop in New Delhi. In the trial, denosumab demonstrated noninferiority to zoledronic acid at delaying the time to the first SRE in patients with … (leggi tutto)
FDA Grants Frontline Eltrombopag Breakthrough Designation for Severe Aplastic Anemia
January 4, 2018 – The FDA has granted a breakthrough therapy designation to eltrombopag for use in combination with standard immunosuppressive therapy as a first-line treatment for patients with severe aplastic anemia (SAA). The small molecule thrombopoietin receptor agonist is already approved in the United State for the treatment of patients with SAA who have had an insufficient response to immunosuppressive therapy. The breakthrough designation will … (leggi tutto)
FDA Grants Ribociclib Breakthrough Designation for HR+/HER2- Premenopausal Breast Cancer
January 3, 2018 – The FDA has granted ribociclib a breakthrough therapy designation for use in combination with tamoxifen or an aromatase inhibitor (AI) as frontline treatment for pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer. The CDK4/6 inhibitor received the designation based on the phase III MONALEESA-7 trial. In the study, the median progression-free survival (PFS) was 23.8 months for women … (leggi tutto)
FDA Grants Priority Review to Frontline Brentuximab Vedotin for Hodgkin Lymphoma
January 2, 2018 – The FDA has granted a priority review to a supplemental biologics license application (sBLA) for brentuximab vedotin in combination with Adriamycin, vinblastine, and dacarbazine (AVD) as a frontline treatment for advanced classical Hodgkin lymphoma, according to a statement from the company developing the CD30-targeted antibody-drug conjugate, Seattle Genetics. The sBLA is based on findings from the phase III … (leggi tutto)
FDA Grants Priority Review to Novel Iobenguane I-131 Agent for Rare Neuroendocrine Tumors
December 29, 2017 – The FDA has granted a priority review designation to a novel version of the radiopharmaceutical iobenguane I-131 for patients with malignant or recurrent pheochromocytoma or paraganglioma (PPGL), according to a statement from Progenics Pharmaceuticals, the company developing the novel iodine-131 metaiodobenzylguanidine (MIBG). The new drug application (NDA) for iobenguane I-131 was based on findings from a phase … (leggi tutto)
FDA Approval Sought for Ivosidenib in IDH1+ AML
December 26, 2017 – A new drug application (NDA) has been submitted for ivosidenib (AG-120) for patients with relapsed/refractory IDH1-mutant acute myeloid leukemia (AML), according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy. The NDA was based on findings from a phase I trial, which was presented at the 2017 ASH Annual Meeting. In the single-arm trial, patients treated with the dose of ivosidenib being … (leggi tutto)
FDA Updates Nilotinib CML Label With Discontinuation Provision
December 22, 2017 – The FDA has updated the label for nilotinib with a provision stipulating that patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) who have received the BCR-ABL tyrosine kinase inhibitor for at least 3 years and have achieved specific predetermined criteria may be eligible to stop treatment. Specifically, the label states that to discontinue treatment, patients must achieve a sustained … (leggi tutto)
FDA Approves Stereotactic Radiotherapy System for Breast Cancer
December 22, 2017 – The FDA has approved a novel breast-specific stereotactic body radiotherapy (SBRT) device known as GammaPod as a treatment for patients with early breast cancer, based on findings from a 17-patient study. In the small clinical trial, GammaPod was effectively used to deliver a single “boost” radiation dose of 8 Gy directly to the tumor, while only eliciting grade 1 adverse events (AEs). The system uses a vacuum-assisted breast cup guided by … (leggi tutto)
FDA Grants Adjuvant Dabrafenib/Trametinib Priority Review for BRAF+ Melanoma
December 22, 2017 – The FDA has granted a priority review to a supplemental new drug application (sNDA) for the use of dabrafenib combined with trametinib as an adjuvant treatment for patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection. The sNDA is based on findings from the phase III COMBI-AD study, in which adjuvant treatment with dabrafenib and trametinib reduced the risk of relapse or death by 53% … (leggi tutto)
FDA Grants Frontline Avelumab/Axitinib Breakthrough Designation for RCC
December 21, 2017 – The FDA has granted the PD-L1 inhibitor avelumab a breakthrough therapy designation for use in combination with the VEGF inhibitor axitinib in treatment-naïve patients with advanced renal cell carcinoma (RCC). The designation, which will expedite the development and review of this combination, is based on findings from the phase Ib JAVELIN Renal 100 trial. In the study, frontline avelumab/axitinib induced a response rate of … (leggi tutto)
FDA Grants Apalutamide Priority Review for Nonmetastatic CRPC
December 21, 2017 – The FDA has granted a priority review to a new drug application (NDA) for apalutamide (ARN-509) for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to Janssen Biotech, the manufacturer of the next-generation oral androgen receptor inhibitor. The NDA is based on data from the phase III SPARTAN trial (ARN-509-003), which evaluated the safety and efficacy of apalutamide versus … (leggi tutto)
FDA Approves Adjuvant Pertuzumab Regimen for HER2+ Breast Cancer
December 20, 2017 – The FDA has approved pertuzumab in combination with trastuzumab and chemotherapy as an adjuvant treatment for patients with HER2-positive early breast cancer at high risk for recurrence, based on findings from the APHINITY trial. In the phase III trial, adjuvant treatment with pertuzumab, trastuzumab, and chemotherapy demonstrated a 3-year invasive disease-free survival (iDFS) rate of 94.1% versus 93.2% for those who received … (leggi tutto)
FDA Approves Adjuvant Nivolumab for Melanoma
December 20, 2017 – The FDA has approved nivolumab as an adjuvant treatment for patients with completely resected melanoma with lymph node involvement or metastatic disease, based on findings from the phase III CheckMate-238 trial. In the randomized trial, the recurrence-free survival (RFS) rate at 18 months with nivolumab was 66.4% (95% CI, 61.8%-70.6%) compared with 52.7% (95% CI, 47.8%-57.4%) for ipilimumab (Yervoy) in patients with stage IIIB/C or … (leggi tutto)
FDA Approves Bosutinib for Newly-Diagnosed Ph+ CML
December 19, 2017 – The FDA has approved bosutinib as a first-line treatment for patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), based on findings from the phase III BFORE trial. In the open-label study, the major molecular response (MMR) at 12 months was 47.2% with bosutinib (95% CI, 40.9-53.4) compared with 36.9% (95% CI, 30.8-43.0) for imatinib (P = .02). The complete cytogenetic response (CCyR) rate by 12 … (leggi tutto)
FDA Approves Frontline Cabozantinib for Advanced RCC
December 19, 2017 – The FDA has approved cabozantinib for previously untreated patients with advanced renal cell carcinoma (RCC), based on a meaningful improvement in progression-free survival (PFS) versus sunitinib in the CABOSUN trial. In the phase II study, first-line treatment with cabozantinib reduced the risk of progression or death by 52% compared with sunitinib for patients with advanced RCC. The median PFS was 8.6 months with cabozantinib versus … (leggi tutto)
FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs
December 18, 2017 – Today, the U.S. Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to … (leggi tutto)
FDA Grants Frontline Osimertinib Priority Review for NSCLC
December 18, 2017 – The FDA has granted a priority review to a supplemental new drug application (sNDA) for the use of osimertinib as a first-line treatment for patients with non–small cell lung cancer (NSCLC) whose tumors harbor EGFR mutations (exon 19 deletions or exon 21 [L858R] substitution mutations). The sNDA is based on the phase III FLAURA study, in which frontline osimertinib reduced the risk of progression or death by 54% versus standard TKI … (leggi tutto)
Dall’ASCO
Sexual Problems and Cancer: ASCO Clinical Practice Guideline Adaptation of CCO Guideline
December 21, 2017 – As reported in the Journal of Clinical Oncology by Jeanne Carter, PhD, of Memorial Sloan Kettering Cancer Center, and colleagues, ASCO has issued a clinical practice guideline adaptation of the Cancer Care Ontario (CCO) guideline on interventions to address sexual problems in people with cancer. ASCO staff reviewed the CCO 2016 guideline and updated the relevant literature search. An ASCO expert panel reviewed guideline content … (leggi tutto)
Howard A. ‘Skip’ Burris III, MD, FACP, FASCO, Elected ASCO President for 2019–2020 Term
December 19, 2017 – Howard A. “Skip” Burris III, MD, FACP, FASCO, a long-time member and volunteer, has been elected to serve as the President of ASCO for the term beginning in June 2019. He will take office as President-Elect during the ASCO Annual Meeting in Chicago in June 2018. Additionally, five members were elected to open seats on the ASCO Board of Directors, as well as two members to the ASCO Nominating Committee. “It is a tremendous honor … (leggi tutto)
Dal mondo
Japan Approves Pembrolizumab for Urothelial Carcinoma
January 2, 2018 – The Japanese Ministry of Health, Labor and Welfare has approved the use of pembrolizumab for the treatment of patients with radically unresectable urothelial carcinoma who progressed after cancer chemotherapy, according to Merck, the manufacturer of the PD-1 inhibitor. The approval is based on the phase III KEYNOTE-045 study, in which single-agent pembrolizumab reduced the risk of death by 27% compared with chemotherapy … (leggi tutto)
Pillole dall’Aifa
2 gennaio 2018 – Epatite C: l’eradicazione in un percorso chiaro e progressivo
ENGAGEMENT E PATIENT ADVOCACY Il ruolo delle associazioni nella medicina partecipativa Corso di Alta Formazione #Engage2Advocate I Edizione
Milano, 15 febbraio – 15 novembre 2018 Evento patrocinato da AIOM Iscrizioni entro l’1 febbraio; informazioni al link: milano.unicatt.it/formazionepermanente
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