Hanno curato la selezione degli articoli scientifici e i commenti di questo numero: Oronzo Brunetti, Nicola Silvestris (Università degli Studi di Bari, Istituto Tumori “Giovanni Paolo II”, Bari)
Coordinatori: Massimo Di Maio, Silvia Novello
Editore: Intermedia – Direttore Responsabile: Mauro Boldrini
Oggi in Oncologia
The Treatment and Outcome of a Lung Cancer Patient Infected with SARS-CoV-2
Since December 2019, an outbreak of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from Wuhan, China has spread around the world, causing great concern. Currently, there is no specific treatment against this disease. A previous study has demonstrated that patients with cancer are at increased risks of severe infections. Concerning deteriorating infection, most patients with cancer were recommended to withdraw cancer … (leggi tutto)
Nell’epoca del COVID-19, diventa importante il focus sui pazienti con tumori del polmone, essendo spesso pazienti con comorbidità (anche a carattere respiratorio) e sapendo che questo li mette nella condizione di esser maggiormente a rischio.
Lo studio in oggetto è un case report di un paziente con adenocarcinoma polmonare EGFR-mutato in trattamento di seconda linea con osimertinib: quadro di sostanziale stabilità di malattia ed una sopravvivenza di circa 3 anni. La sintomatologia d’esordio comprendeva: febbre, tosse, lieve dispnea, mialgia e diarrea. Alcuni di questi sono indubbiamente sintomi spesso presenti nei pazienti con malattia polmonare, tuttavia le indagini radiologiche hanno rilevato un quadro di polmonite suggestivo, pertanto il paziente è stato posto a tampone per SARS-CoV-2, che è risultato positivo. Non manifestando un quadro acclarato di insufficienza respiratoria, il paziente ha proseguito l’osimertinib associando terapia retrovirale con lopinavir/ritonavir e copertura antibiotica. Questo caso è utile (seppur nella sua unicità) per capire che in alcuni casi i pazienti oncologici potrebbero continuare le terapie target.
A parte questi case report indubbiamente interessanti, molti sono i quesiti aperti in ambito oncologico in emergenza COVID-19 di tipo diagnostico (triage dedicato), terapeutico (tutte le terapie vanno considerate alla stessa stregua? Quale atteggiamento avere nei confronti dei trattamenti immunoterapici da soli e/o combinati? …).
Cancer care during the spread of coronavirus disease 2019 (COVID-19) in Italy: young oncologists’ perspective
At the end of 2019, a novel severe acute respiratory syndrome (SARS) coronavirus (CoV), named SARS-CoV-2 or 2019-nCoV, has been identified as the microbial agent causing viral pneumonia in several patients epidemiologically linked to a seafood market in Wuhan (Hubei province, China). Since then, the spread of coronavirus disease 2019 (COVID-19) has progressively involved countries outside China leading the World Health Organization … (leggi tutto)
In questi giorni di emergenza sanitaria determinata dalla pandemia di COVID-19, tutti noi oncologi stiamo vivendo quotidianamente le enormi difficoltà derivanti dalla necessità di proseguire una parte dell’attività, garantendo la prosecuzione delle terapie e delle visite necessarie, e al tempo stesso provando a minimizzare i rischi di contagio per i pazienti e per gli operatori.
In questi giorni, la letteratura si sta rapidamente affollando di esperienze, comunicati, raccomandazioni. È stata pubblicata il 29 marzo su ESMO Open la prospettiva di un gruppo di giovani oncologi italiani, che provano a descrivere l’impatto del virus sull’attività oncologica italiana.
L’articolo richiama le indicazioni divulgate qualche settimana fa da AIOM in collaborazione con il CIPOMO e con COMU, e declinate / integrate a livello delle singole realtà lavorative. Il messaggio operativo è stato sintetizzato nell’acronimo Y-O-P (che non sta solo per Young Oncologist Perspective), ma anche per “Yourself“: proteggi te stesso e la tua famiglia, con attenzione costante ai dispositivi di protezione individuale e al rispetto delle raccomandazioni; “Oncological care“: proteggi la cura dei tuoi pazienti oncologici, rinviando quello che può essere rinviato ma provando, nei limiti del possibile, a contenere l’impatto dell’emergenza sullo standard di cura; “Patients“: proteggi i pazienti stessi dall’infezione, facendo ogni possibile sforzo per minimizzare i loro rischi.
In Europa
Scagliotti Speaks to Italy’s Response to COVID-19 Outbreak
March 29, 2020 – Despite significant restrictive measures being put in place, Italy remains the country hardest hit by the novel coronavirus 2019 (COVID-19) pandemic, with hundreds of individuals dying from the virus per day. “I can easily say that when this pandemic started in Italy, there was some level of underestimation of the risks associated with COVID-19,” said Giorgio Vittorio Scagliotti, MD, PhD, chief of the Medical Oncology Division at the S. Luigi … (leggi tutto)
Isatuximab Nears European Approval for Relapsed/Refractory Myeloma
March 27, 2020 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended isatuximab in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with relapsed/refractory multiple myeloma who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. The recommendation … (leggi tutto)
No change to product information for breast cancer medicine Lapatinib following re-assessment of data
March 27, 2020 – The product information for Lapatinib (Novartis), a breast cancer medicine, will continue to state that no data are available on the effectiveness of Tyverb used together with an aromatase inhibitor compared with trastuzumab used with an aromatase inhibitor in patients previously treated with trastuzumab. In July 2018, results of a study involving women with ‘HR+/HER2+’ breast cancer and whose disease had worsened despite previous treatment … (leggi tutto)
Restrictions in use of cyproterone due to meningioma risk
March 27, 2020 – On 13 February 2020, EMA’s safety committee (PRAC) recommended that medicines with daily doses of 10 mg or more of cyproterone should only be used for androgen-dependent conditions such as hirsutism (excessive hair growth), alopecia (hair loss), acne and seborrhoea (excessively oily skin) once other treatment options, including treatment with lower doses, have failed. Once higher doses have started working, the dose should be … (leggi tutto)
No change is needed in use of direct oral anticoagulants following EMA-funded study
March 27, 2020 – No change to the conditions of use of the direct oral anticoagulants apixaban, dabigatran etexilate and rivaroxaban is needed following a review of the results of a European study of real-world data for these medicines. The study, commissioned by EMA and using real-world data from Denmark, France, Germany, Spain, the Netherlands and the United Kingdom, assessed the risk of serious bleeding with these 3 medicines when used to prevent … (leggi tutto)
Recommendations to restrict use of fosfomycin antibiotics
March 27, 2020 – EMA has recommended that fosfomycin medicines given by infusion (drip) into a vein should only be used to treat serious infections when other antibiotic treatments are not suitable. Fosfomycin medicines given by mouth can continue to be used to treat uncomplicated bladder infections in women and adolescent girls. They can also be used to prevent infection in men who undergo a procedure whereby a tissue sample is taken from … (leggi tutto)
Global regulators map out data requirements for phase 1 COVID-19 vaccine trials
March 24, 2020 – Global regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The meeting report provides an overview of regulatory considerations related to COVID-19 vaccine development and data required for regulatory decision-making on two key points: Pre-clinical … (leggi tutto)
EMA Starts Review of Handling Errors with Depot Formulations of Leuprorelin Medicines
March 24, 2020 – The European Medicines Agency (EMA) announced that it has started a review of leuprorelin medicines after reports indicated that handling errors with the products during preparation and administration can cause some patients to receive insufficient amounts of their medicine, thus reducing the benefits of treatment. This review covers depot formulations which are given by injection under the skin or into a muscle and release the … (leggi tutto)
Selumetinib Shows Durable Tumour Shrinkage and Clinical Benefit in Neurofibromatosis
March 23, 2020 – Selumetinib resulted in sustained neurofibroma shrinkage in the majority of patients and provided clinically meaningful benefit in a phase II trial in children and adolescents with neurofibromatosis type 1 and symptomatic plexiform neurofibroma. The toxicity level and absence of cumulative toxic effects permit long-term treatment according to investigators from the US National Cancer Institute (NCI). Neurofibromatosis type 1 is an … (leggi tutto)
Dall’FDA
Melflufen Continues to Impress in Heavily Pretreated Myeloma, FDA Submission Coming Soon
March 26, 2020 – Melflufen in combination with dexamethasone induced a 26% overall response rate (ORR) in patients with triple-class refractory multiple myeloma, according to final topline results from the pivotal phase II HORIZON study announced by Oncopeptides AB, the developer of the first-in-class anticancer peptide-drug conjugate. Triple-class refractory is defined as the patient being refractory to immunomodulatory drugs (IMiDs), proteasome … (leggi tutto)
FDA Grants IPI-549 Fast Track Designation in Urothelial Carcinoma
March 25, 2020 – The FDA has granted a Fast Track Designation to IPI-549 for use in combination with nivolumab for the treatment of patients with advanced urothelial cancer, according to Infinity Pharmaceuticals, Inc., the manufacturer of the PI3K-gamma inhibitor. The designation will expedite the development and review of IPI-549 in this setting. Infinity is collaborating with Bristol Myers Squibb on the phase II MARIO-275 trial, which is currently … (leggi tutto)
FDA Approves New Dose of Trastuzumab Biosimilar Ontruzant
March 24, 2020 – The FDA has approved a 420-mg multidose vile of trastuzumab-dttb (SB3), according to Samsung Bioepis Co., Ltd., the manufacturer of the trastuzumab biosimilar. SB3 was initially approved in January 2019 as a 150-mg single-dose vile for the treatment of patients with HER2-overexpressing breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma. The approval was based on data sets from 7 clinical trials, which … (leggi tutto)
FDA OKs Launch of Phase III Tocilizumab Trial for COVID-19 Pneumonia
March 23, 2020 – The FDA has approved the initiation of a double-blind, randomized phase III clinical trial of the oncology supportive care drug tocilizumab for use in combination with standard of care for the treatment of hospitalized adult patients with severe COVID-19 pneumonia, according to Genentech (Roche), the manufacturer of the interleukin-6 receptor antagonist. Genentech is collaborating with the Biomedical Advanced Research and Development … (leggi tutto)
Dall’ASCO
The Blind Leading the Blind: COVID-19, Cancer, and the Need for More Data
March 27, 2020 – In the novel Blindness, Portuguese author José Saramago describes an epidemic that quickly and inexorably causes nearly all inhabitants of an unnamed city to lose their sight. The Nobel Laureate writes in long uninterrupted sentences, making the reader experience the fears and anxieties of the characters, with food shortages and interruption of everyday life certainties leading to social disruption, panic, and despair. Today … (leggi tutto)
American College of Surgeons Issues COVID-19 Guidelines for Triage of Patients Undergoing Cancer Surgery
March 27, 2020 – This week, the American College of Surgeons issued guidelines on triage of patients undergoing elective cancer surgery during the COVID-19 pandemic. During the current COVID-19 pandemic, hospital leadership and individual providers are facing increasingly difficult decisions about how to conserve critical resources, such as hospital and intensive care unit (ICU) beds, respirators, and transfusion capacity, as well as protective gear (PPE) that is … (leggi tutto)
Trends in Global Rates of Liver Cancer From 1990 to 2017
March 27, 2020 – New research published by Liu et al in the journal Cancer has revealed rising rates of liver cancer around the world, despite advances aimed at preventing the disease; however, some steps towards alleviation have been made due to control of hepatitis. To obtain trends and estimates of liver cancer by age, sex, region, and cause, Xingdong Chen, MD, PhD, of Fudan University in China, and colleagues examined data from 1990 to 2017 from the … (leggi tutto)
Practicing Oncology in the Era of COVID-19
March 26, 2020 – The coronavirus-related pandemic has affected nearly every corner of the globe. What originated in one country is on course to likely affect every country in the world. In a few countries, the disease has peaked and is on the downward trend. In some, including the United States, the disease is on the ascent, with hope for an abbreviated peak and accelerated decline. In many others, it is too early to make an educated guess of the effects of … (leggi tutto)
Oncologists on the Front Lines of COVID19. A Conversation With John Cole, MD
March 24, 2020 – Coronavirus disease 2019 (COVID-19) is dramatically affecting health-care systems. This is the first in a series of interviews The ASCO Post will conduct with oncologists, to learn what they and their cancer centers are doing to deal with the crisis. In this article, we talk with John Cole, MD, a breast cancer specialist and Head of Clinical Oncology Research at Ochsner Health in New Orleans, Louisiana’s largest nonprofit health-care system. Protecting … (leggi tutto)
ASCO Meeting Goes Virtual Due to COVID-19
March 24, 2020 – Due to COVID-19 (coronavirus), the American Society of Clinical Oncology (ASCO) Annual Meeting will now occur using a virtual format instead of the in-person meeting that had been scheduled to take place in Chicago from May 29 to June 2, according to a press release from the organization. “Our mission is as important as ever. That is why we still intend to deliver the latest cancer science to the global community during the Annual Meeting timeframe … (leggi tutto)
Dal mondo
Avapritinib Approval Sought in Taiwan for PDGFRA Exon 18+ GIST
March 27, 2020 – A new drug application has been submitted to the Taiwan Food and Drug Administration for avapritinib for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring PDGFRA exon 18 mutations, including PDGFRA D842V mutations, according to CStone Pharmaceuticals, a partner of Blueprint Medicines. The application is based on data showing that avapritinib induced an overall response rate (ORR) of … (leggi tutto)
Trastuzumab Deruxtecan Approved in Japan for HER2+ Metastatic Breast Cancer
March 25, 2020 – The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved trastuzumab deruxtecan for the treatment of patients with HER2-positive unresectable or recurrent breast cancer who have had prior chemotherapy and are refractory or intolerant to standard treatments. The approval is based on findings from the phase II DESTINY-Breast01 trial, in which the antibody-drug conjugate (ADC) trastuzumab deruxtecan induced a confirmed objective … (leggi tutto)
Tepotinib Approved in Japan for MET-Positive NSCLC
March 25, 2020 – The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved tepotinib for the treatment of patients with unresectable, advanced or recurrent non–small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping alterations. The MHLW based its decision on data from the ongoing, single-arm phase II VISION study (NCT02864992), in which the MET inhibitor tepotinib induced an overall response rate (ORR) of … (leggi tutto)
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XXII CONGRESSO NAZIONALE AIOM 2020
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