Oggi in Oncologia 

Pain is one of the most complex and prevalent symptoms in the cancer population. Despite the protective role of acute cancer-related pain, it is also an important predictor for the likelihood of developing chronic pain after cancer treatment. Since the last systematic review on pain prevalence rates during cancer treatment dates already from 2016, the aim of the present systematic review was to provide an overview of pain prevalence rates during cancer treatment … (leggi tutto)

Scopo del lavoro è stato la valutazione della prevalenza del dolore nei pazienti in trattamento attivo.
Sono stati valutati 9.052 studi – pubblicati dal 2014 al 2020 – che avevano come obiettivo la valutazione della prevalenza del dolore durante o entro 3 mesi dal termine di una terapia con intento curativo.
Per la meta-analisi sono stati selezionati 12 studi, 10 su pazienti con neoplasie della mammella e 2 con neoplasie del polmone.
I dati sono stati confrontati con quelli di uno studio analogo pubblicato nel 2016, che rappresentava l’ultima review pubblicata sull’argomento.
Il dolore è stato riscontrato nel 40% dei pazienti con una significativa eterogeneità, riconducibile alle metodiche di valutazione.
In conclusione, la prevalenza del dolore nei pazienti in trattamento attivo rimane significativa.

Il dolore non è un sintomo esclusivo dei pazienti in fase avanzata. Pertanto, va valutato e trattato tempestivamente nei pazienti in trattamento attivo.


 

 

Systemic therapies for preventing or treating aromatase inhibitor-induced musculoskeletal symptoms in early breast cancer

Adjuvant aromatase inhibitors (AI) improve survival compared to tamoxifen in postmenopausal women with hormone receptor-positive stage I to III breast cancer. In approximately half of these women, AI are associated with aromatase inhibitor-induced musculoskeletal symptoms (AIMSS), often described as symmetrical pain and soreness in the joints, musculoskeletal pain and joint stiffness. AIMSS may have significant and prolonged impact on women’s quality of life ... (leggi tutto)

Circa metà delle pazienti in post-menopausa, sottoposte a terapia con inibitori dell’aromatasi, presenta dolore muscolo-scheletrico (AIMSS). L’AIMSS ha un impatto sulla qualità della vita ed è associato a ridotta compliance con un potenziale effetto negativo sull’outcome.
Una meta-analisi ha valutato dell’efficacia e la sicurezza di diverse terapie sistemiche (farmacologiche, nutrizionali, complementari o alternative) sulla prevenzione ed il trattamento dell’AIMSS.
Sono stati presi in considerazione 17 studi controllati e randomizzati, con un gruppo di controllo costituito da placebo o standard di cura o entrambi, per un totale di 2034 pazienti.
Nella revisione viene sottolineata la bassa qualità degli studi presi in esame, dovuta al basso numero di pazienti, all’eterogeneità delle terapie, alla metodologia utilizzata ed il conseguente rischio di bias.
Gli autori concludono che non ci sono evidenze sulla sicurezza e sull’impatto di terapie sistemiche nella prevenzione ed il trattamento dell’AIMSS, sulla qualità della vita delle pazienti e sulla compliance al trattamento con inibitori dell’aromatasi.

Il dolore muscolo-scheletrico è presente in un’elevata percentuale di pazienti in trattamento con inibitori dell’aromatasi. Al momento, non ci sono evidenze che supportino trattamenti specifici.

Incidence and Predictors of Persistent Opioid Use in Survivors of Head and Neck Cancer Treated With Curative Radiation

We sought to characterize the incidence of chronic opioid dependence among head and neck cancer survivors treated by radiation, as well as to identify patient and treatment factors associated with persistent use. The medical records of patients with head and neck cancer who received radiation therapy from January 2012 to July 2016 were reviewed. All patients received 60 to 70 Gy with curative intent. Patients who progressed or died within 1 year were intentionally excluded. ... (leggi tutto)

Sono stati studiati 261 pazienti che erano stati sottoposti ad una radioterapia per neoplasie testa-collo (60-70 Gy con intento curativo).
Durante il trattamento, 211 pazienti (80%) avevano assunto oppioidi per il controllo del dolore (dose mediana di morfina/24 ore 73.8 mg, range 5-561 mg).
A sei mesi, un anno e due anni dal trattamento il 41.8%, il 30.1% ed il 26.0% – rispettivamente – continuava ad assumere oppioidi.
Ad un’analisi multivariata, l’uso di oppioidi pre-radioterapia era correlato ad un uso persistente a tutti gli step di follow up.

I pazienti con neoplasie testa-collo presentano un elevato rischio di utilizzo improprio degli oppioidi. Questi pazienti andrebbero valutati per il rischio all’inizio della terapia e monitorati periodicamente.

Cancro, 10 anni di immunoterapia. Come è cambiata la lotta ai tumori, fra successi, speranze e nuovi sfide

“Cancro, 10 anni di immunoterapia” è il libro scritto da Paolo Marchetti e Mauro Boldrini che racconta la straordinaria avventura scientifica iniziata dieci anni fa con la scoperta della prima molecola immunoterapica. Un volume per comprendere le ricerche, i progressi e le prospettive aperte da queste rivoluzionarie terapie. Ma anche storie di pazienti che hanno ricevuto, tra fasi di scoraggiamento e di rinascita, questi trattamenti innovativi, grazie ai quali oggi possono affermare di aver superato la malattia.
Un bilancio di dieci anni di lotta al cancro, duri, complessi ma entusiasmanti che hanno permesso a centinaia di migliaia di persone di guardare al futuro con maggiore serenità. E ai ricercatori di aprire nuove strade impensabili, partendo da un’idea apparentemente semplice: stimolare il sistema immunitario per renderlo più forte contro le neoplasie.
Una storia affascinante, ancora in gran parte da scrivere, ma che merita di essere raccontata nel decimo anniversario dall’approvazione della prima molecola. Era il 2011, prima la FDA e poi EMA approvavano ipilimumab, nel trattamento del melanoma metastatico. L’immunoterapia diventava così una nuova arma contro il cancro e ipilimumab, frutto della ricerca di Bristol Myers Squibb, rappresentava la prima molecola autorizzata in oncologia. Da allora, anno dopo anno, l’immunoterapia si è ritagliata uno spazio sempre più rilevante non solo nel melanoma, ma anche in altre neoplasie e gli studi proseguono a ritmo serrato. Dal 2011 sono state approvate altre molecole e centinaia di migliaia di persone nel mondo sono tornate ad una esistenza normale con buona qualità di vita e con tassi di sopravvivenza impensabili fino a poco tempo fa. Le prospettive sono sempre più stimolanti, soprattutto grazie alle combinazioni di più molecole e terapie.
Il volume, reso possibile grazie a un contributo non condizionato di Bristol Myers Squibb, analizza tumore per tumore, i numeri, i fattori di rischio, la diagnosi, il ruolo della prevenzione. I proventi della vendita del libro “Cancro, 10 anni di immunoterapia” (ed. Cairo) saranno devoluti a progetti di ricerca della Fondazione per la Medicina Personalizzata.

In Europa

Adding Darolutamide to ADT and Docetaxel Prolongs Overall Survival in Patients with Metastatic, Hormone-Sensitive Prostate Cancer

Mar 01, 2022 – In an international, randomised, double-blind, placebo-controlled, phase III ARASENS study that involved patients with metastatic, hormone-sensitive prostate cancer, overall survival (OS) was significantly longer among patients who received darolutamide plus androgen-deprivation therapy (ADT) and docetaxel than among those who received placebo plus ADT and docetaxel. … (leggi tutto)

Higher Risk of Major Adverse Cardiovascular Events and Cancers with Tofacitinib

Feb 28, 2022 – The European Medicines Agency (EMA) announced on 11 February 2022 that its Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of the safety of Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders, in particular rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, ulcerative colitis and atopic dermatitis … (leggi tutto)

New medicine for rare type of eye cancer

Feb 25, 2022 – EMA has recommended granting a marketing authorisation in the European Union (EU) for Kimmtrak (tebentafusp), a monotherapy for the treatment of adult patients with uveal melanoma, a rare type of eye cancer. Uveal melanoma is a rare and aggressive disease in which cancer cells form in the tissues of the eye. Signs of uveal melanoma include blurred vision or a dark spot on the iris. … (leggi tutto)

Cancer Mortality Predictions for the 10 Major Causes of Cancer Mortality and Total Cancer in 2022 in the European Union

Feb 25, 2022 – A report published in March 2022 issue of the Annals of Oncology by Prof. Carlo La Vecchia of the Department of Clinical Sciences and Community Health, Università degli Studi di Milano in Milan, Italy and colleagues confirms predicted declining mortality rates for most major cancers and total cancers in both sexes in European Union (EU) estimated at 6% for men and 4% for women over the past 5 years. Pancreatic cancer is becoming … (leggi tutto)

In NeoTRIP, Atezolizumab with Neoadjuvant Carboplatin/Nab-Paclitaxel was Feasible in TNBC, but Led to Non-Significant pCR Increase

Feb 24, 2022 – The first analysis of NeoTRIP study supports the notion that pathologic complete response (pCR) may not be the most appropriate surrogate endpoint to measure the role of immune checkpoint inhibitors (ICIs) in early triple-negative breast cancer (TNBC). Atezolizumab with neoadjuvant carboplatin/nab-paclitaxel was feasible in patients with high-risk early TNBC without limiting immune-related side effects … (leggi tutto)

EMA recommends authorisation of booster doses of Comirnaty from 12 years of age

Feb 24, 2022 – EMA’s human medicines committee (CHMP) has recommended that a booster dose of the COVID-19 vaccine Comirnaty may be given where appropriate to adolescents from 12 years of age. Comirnaty is already authorised in the EU as a 2-dose primary course in adolescents (as well as adults and children from 5 years of age) and a booster dose is currently authorised from 18 years of age. … (leggi tutto)

EMA recommends approval of Spikevax for children aged 6 to 11

Feb 24, 2022 – EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Spikevax to include use in children aged 6 to 11. The vaccine, developed by Moderna, is already approved for use in adults and children aged 12 and above. The dose of Spikevax in children from 6 to 11 years of age will be lower than that used in people aged 12 and above (50 µg compared with 100 µg) … (leggi tutto)

Late Breast Cancer Recurrence Less Aggressive and Associated with Better Prognosis Compared to Early Recurrence

Feb 23, 2022 – In a first large population-based cohort study to investigate the impact of late breast cancer recurrence on mortality, to evaluate prognostic factors, and to compare survival after late recurrence with survival after early recurrence, women who developed late recurrence had better prognosis compared with those with early recurrence. It was illustrated by lower hazard ratio (HR) of breast cancer-specific …(leggi tutto)

Dall’FDA

FDA Approves Pacritinib for Intermediate- or High-Risk Myelofibrosis With Severe Thrombocytopenia

Mar 1, 2022 – The FDA has granted an accelerated approval to pacritinib (Vonjo) for the treatment of adult patients with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. The decision was based on findings from the phase 3 PERSIST-1 (NCT01773187) and PERSIST-2 (NCT02055781) trials, as well as findings from the phase 2 PAC203 trial … (leggi tutto)

FDA Approves Cilta-Cel for Relapsed/Refractory Multiple Myeloma

Mar 1, 2022 – The FDA has approved ciltacabtagene autoleucel (cilta-cel; Carvykti) for the treatment of adult patients with relapsed and/or refractory multiple myeloma. In November 2021, the FDA had extended the Prescription Drug User Fee Act target date for the biologics license application (BLA) seeking the approval of cilta-cel for use in adult patients with relapsed and/or refractory multiple myeloma. … (leggi tutto)

FDA Approval Sought for Ibrutinib in Pediatric Chronic Graft-Versus-Host Disease

Feb 28, 2022 – A supplemental new drug application (sNDA) has been submitted to the FDA seeking the approval of ibrutinib (Imbruvica) for the treatment of pediatric and adolescent patients aged 1 year and older with chronic graft-vs-host disease (cGVHD) following failure of 1 or more lines of systemic therapy. A new drug application (NDA) has also been submitted for an oral suspension formulation of ibrutinib to serve as an alternative administration option for pediatric patients. … (leggi tutto)

FDA Approves Treatment for Wider Range of Patients with Heart Failure

Feb 24, 2022 – Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Jardiance was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes. Jardiance is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established … (leggi tutto)

FDA Accepts sNDA for Zanubrutinib in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Feb 23, 2022 – The FDA has accepted for review a supplemental new drug application (sNDA) for zanubrutinib (Brukinsa) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The application is supported by findings from 2 phase 3 trials, ALPINE (NCT03734016) and SEQUOIA (NCT03336333), which showed that zanubrutinib produced superior response and progression-free survival (PFS) rates vs ibrutinib … (leggi tutto)

Dall’ASCO

Older Patients With Cancer and High-Risk Geriatric Profiles at Greater Risk for Death and Other Adverse Sequelae of COVID-19

Feb 24, 2022 – In a large study of 5,671 older adults with COVID-19 and cancer, performed by the COVID-19 and Cancer Consortium (CCC19), the CCC19 geriatric risk index was associated with poorer outcomes, including clinical complications, hospitalization, and mortality. A higher CCC19 geriatric risk index was significantly associated with higher COVID-19 severity and 30-day all-cause mortality after adjustment of major prognostic … (leggi tutto)

How to Incorporate Tucatinib Into HER2-Positive Metastatic Breast Cancer Treatment

Feb 23, 2022 – Because the HER2 selectivity of tucatinib decreases the potential for EGFR-associated toxicities such as diarrhea and skin rash, combination therapies using tucatinib are of interest as tolerable and effective tools in the treatment of breast cancer. Tucatinib, trastuzumab, and capecitabine combination therapy is recommended in National Comprehensive Cancer Center and ASCO guidelines for HER2-positive metastatic breast cancer  … (leggi tutto)

Adjuvant Therapy in Non–Small Cell Lung Cancer: Closer to Cure or Just Delaying Progression?

Feb 23, 2022 – Adjuvant platinum-based chemotherapy has been the standard-of-care treatment for resected stage IB to III lung cancer with a modest survival benefit. There has been a remarkable development in the field of nonmetastatic lung cancer treatment with recent trials showing benefit from adjuvant targeted therapy and immunotherapy bringing these treatments in the frontline as standard-of-care regimens. … (leggi tutto)

Chemoimmunotherapy: Still the Standard of Care for Metastatic Triple-Negative Breast Cancer

Feb 23, 2022 – In August 2021, the FDA’s accelerated approval of atezolizumab and nab-paclitaxel for patients with metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1 was voluntarily withdrawn. Contrary to the results of the IMpassion130 trial, IMpassion131 did not meet its primary endpoint; progression-free survival was not improved when atezolizumab was added to paclitaxel for treatment of mTNBC … (leggi tutto)

T-Cell Responses May Help Predict Protection Against SARS–CoV-2 Infection in Individuals With and Without Cancer

Feb 23, 2022 – T-cell responses directed against the receptor-binding domain of the SARS–CoV-2 spike protein were associated with protection from SARS–CoV-2 infection in vaccinated individuals with or without cancer, with lower T-cell responses observed in patients with blood cancers, according to results from a study published by Fahrner et al in Cancer Discovery.  … (leggi tutto)

Pillole dall’AIFA


28 febbraio 2022 – Farmaci biosimilari in Italia: report AIFA aggiornati a settembre 2021
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25 febbraio 2022 – Monitoraggio antivirali per COVID-19: pubblicato il quinto report
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25 febbraio 2022 – Raccomandata la sospensione dal mercato delle soluzioni a base di amido idrossietilico per infusione
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24 febbraio 2022 – Monitoraggio anticorpi monoclonali per COVID-19: pubblicato il quarantaseiesimo report
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23 febbraio 2022 – Valutazioni Economiche – Report di Monitoraggio 2021
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