Oggi in Oncologia

Duration of palliative care involvement and immunotherapy treatment near the end of life among patients with cancer who died in-hospital

 Immune checkpoint inhibitors (ICIs) have revolutionised cancer treatment, but their use near the end of life in patients with advanced cancer is poorly documented. This study investigated the association between administration of ICI therapy in the last month of life and the duration of involvement of the palliative care (PC) team, among patients with advanced cancer who died in-hospital. In a retrospective, multicentre study, we included all patients who died in 2018 of melanoma, head and neck carcinoma  … (leggi tutto)

In pazienti morti in ospedale – affetti da melanoma, NSCLC e neoplasie renali – è stata valutata l’associazione tra la somministrazione di immunoterapia nell’ultimo mese di vita e la durata delle cure palliative. Su 350 pazienti morti nel 2018, 133 (38%) avevano ricevuto terapia “attiva” nell’ultimo mese di vita; di questi, 71/133 (53%) erano stati sottoposti ad immunoterapia. È stata riscontrata un’associazione tra inizio dell’immunoterapia nell’ultimo mese di vita e la breve durata delle cure palliative.
Gli autori auspicano una più stretta collaborazione tra oncologi e palliativisti per migliorare il percorso di cura dei pazienti.
La somministrazione di terapie “attive”, in particolare immunoterapia, è molto frequente in pazienti in fase avanzata. Spesso si tratta di pazienti con performance status scaduto, alto carico di malattia, comorbidità, età avanzata. Solo una simultanea attivazione delle cure palliative può garantire ai pazienti l’accesso a terapie innovative e al migliore trattamento dei sintomi.

Administration of Immune Checkpoint Inhibitors Near the End of Life

Recent literature suggests an increasing use of systemic treatment in patients with advanced cancer near the end of life (EOL), partially driven by the increasing adoption of immune checkpoint inhibitors (ICIs). While studies have identified this trend, additional variables associated with ICI use at EOL are limited. Our aim was to characterize a population of patients who received a dose of ICI in the last 30 days of life. We performed a manual retrospective chart review of patients ≥ 18 years who died within 30 days of receiving a dose of ICI ... (leggi tutto)

Lo studio retrospettivo ha valutato il follow up di pazienti sottoposti ad immunoterapia nell’ultimo mese di vita. Il 60% di questi pazienti è stato ospedalizzato, il 65% ha avuto accesso a servizi di emergenza, il 20% è stato ricoverato in unità di terapia intensiva ed il 25% è morto in ospedale. Per inciso, il 50% dei pazienti aveva un ECOG PS > 2.
La somministrazione di terapie innovative in pazienti in fase avanzata comporta un elevato utilizzo delle risorse ospedaliere. Questo comporta un incremento dei costi per i sistemi sanitari e, nello stesso tempo, un peggioramento della qualità della vita dei pazienti.
Come nel commento allo studio precedente, l’integrazione precoce tra oncologia e cure palliative potrebbe permettere non solo la migliore qualità della vita per i pazienti ma anche un consistente risparmio di risorse.

Alleviating breathlessness in patients with cancer with dexamethasone (ABCD): A parallel-group, double-blind, randomized clinical trial

Systemic corticosteroids are commonly prescribed for palliation of dyspnea in patients with cancer; however, evidence to support their use is limited. A small RCT suggested that dexamethasone may be efficacious. In this confirmatory RCT, we compared the effect of high dose dexamethasone and placebo on dyspnea in patients with cancer. This NCI-funded, multi-site, double-blind, parallel group RCT enrolled ambulatory patients with cancer, age ≥18, dyspnea ≥4/10 and randomly... (leggi tutto)

I corticosteroidi vengono spesso prescritti ai pazienti oncologici affetti da dispnea, sebbene ci siano scarse evidenze sulla loro efficacia.
Lo studio ha randomizzato i pazienti in due gruppi: A) desametasone 16 mg/24 ore per 7 giorni seguiti da 8 mg/24 ore per 7 giorni B) placebo.
La somministrazione di desametasone non ha mostrato vantaggi rispetto al placebo e lo studio è stato interrotto per futilità.
I pazienti trattati con desametasone hanno mostrato maggiore incidenza di ansia, depressione ed effetti collaterali (insonnia, vampate di calore, singhiozzo, edema). Inoltre, questi pazienti sono stati più frequentemente ricoverati in ospedale.
Il desametasone o, più in generale, i corticosteroidi, sono prescritti con grande facilità nei pazienti che riferiscono dispnea. Secondo i risultati dello studio, il desametasone non sembra offrire vantaggi nel trattamento della dispnea. Pertanto, andrebbe prescritto con cautela, in pazienti selezionati e per brevi periodi.

In Europa



Patients with Advanced Hodgkin’s Lymphoma Treated with Brentuximab Vedotin Plus AVD Have a Survival Advantage Over Those Who Received ABVD Regimen

Jul 19, 2022 – In the ECHELON-1 study that involved patients with previously untreated stage III or IV Hodgkin’s lymphoma, treatment with a CD30-directed antibody–drug conjugate, brentuximab vedotin, plus doxorubicin, vinblastine, and dacarbazine (AVD), resulted in a risk of death that was significantly lower than that observed with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) regimen. This result translated to an overall difference in mortality of 4.5% in favour of brentuximab vedotin plus AVD … (leggi tutto)

Only a Quarter of Phase III Studies Demonstrated Improved QoL in Advanced Cancer Setting

Jul 18, 2022 – In an analysis that evaluated the outcomes of anticancer drug studies in advanced disease setting with regards to patients’ quality of life (QoL), improved QoL outcomes were associated with improved overall survival (OS), but not with improved progression-free survival (PFS). Almost half of the anticancer drug studies that demonstrated improved PFS showed no improvements in OS or QoL. Some publications summarised QoL findings by statements  … (leggi tutto)

EMA Recommends Extension of Therapeutic Indications for Ibrutinib

Jul 15, 2022 – On 23 June 2022, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product ibrutinib (Imbruvica). The marketing authorisation holder for this medicinal product is Janssen-Cilag International N.V. The CHMP adopted an extension to an existing indication to include its use in combination with venetoclax. For information, the full indications for Imbruvica will therefore be as follows … (leggi tutto)

Trastuzumab Deruxtecan Leads to Longer PFS and OS Compared with Chemotherapy in Previously Treated HER2-Low Unresectable or Metastatic Breast Cancer

Jul 14, 2022 – Findings from randomised, phase III DESTINY-Breast04 study show significantly longer progression-free survival (PFS) and overall survival (OS) with trastuzumab deruxtecan than with the physician’s choice of chemotherapy among patients with previously treated HER2-low unresectable or metastatic breast cancer, regardless of hormone receptor (HR) status. These results have the potential to improve the treatment outcome for more than half of patients historically categorised as having HER2-negative … (leggi tutto)

Dall’FDA

Alpelisib/Fulvestrant Combination Wins Philippine Approval for PIK3CA-Mutated, HR+/HER2– Metastatic Breast Cancer

Jul 18, 2022 – The Philippine FDA has granted approval to alpelisib (Vijoice) in combination with fulvestrant (Faslodex) for the treatment of patients with PIK3CA-mutated, hormone receptor (HR)–positive, HER2-negative advanced or metastatic breast cancer who have disease progression following an endocrine-containing regimen. The approval is based on findings from the phase 3 SOLAR-1 trial (NCT02437318), which showed alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared with placebo  … (leggi tutto)

FDA Grants Orphan Drug Designation to NT-I7 for Glioblastoma Multiforme

Jul 16, 2022 – The FDA has granted an orphan drug designation (ODD) to NT-I7 (efineptakin alfa; rhIL-7-hyFc; GX-I7) for the treatment of patients with glioblastoma multiforme, according to an announcement from NeoImmunTech. NT-I7 is a novel, long-acting human IL-7 being developed in oncologic and immunologic indications. IL-7 is a fundamental cytokine for the development of naïve and memory T cells and for prolonging immune response to chronic or foreign antigens  … (leggi tutto)

FDA Approves Crizotinib for ALK+ Inflammatory Myofibroblastic Tumors

Jul 14, 2022 – The FDA has approved crizotinib (Xalkori) for adult and pediatric patients aged 1 year and older with unresectable, recurrent, or refractory inflammatory ALK-positive myofibroblastic tumors (IMT). The safety and efficacy of the agent were examined in the following 2 multicenter, single-arm, open-label trials: ADVL0912 (NCT00939770), which enrolled 14 pediatric patients, and A8081013 (NCT01121588), which enrolled 7 adult patients. All patients had unresectable, recurrent, or refractory ALK-positive IMT …  (leggi tutto)

FDA Defers Action on BLA for Tislelizumab in Second-Line Esophageal Squamous Cell Carcinoma

Jul 14, 2022 – The FDA has deferred action on the biologics license application (BLA) seeking the approval of tislelizumab (BGB-A317) as a second-line treatment in patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC), citing the inability to conduct required inspections in China because of travel restrictions associated with COVID-19. Action on the application will be deferred until those inspections are completed, according to a press release issued by BeiGene. Although a new anticipated  … (leggi tutto)

FDA Grants Orphan Drug, Fast Track Designations to CV-01 in Recurrent Glioblastoma

Jul 13, 2022 – CV-01, Alpheus Medical’s novel sonodynamic therapy (SDT) delivery platform, has received orphan drug and fast track designations from the FDA for the treatment of patients with recurrent glioblastoma (GBM), according to a news release from Alpheus. SDT offers the possibility of non-invasively eradicating solid tumors in a site-directed manner through the sensitization of target tissues with a non-toxic sensitizing chemical agent and subsequent exposure of the sensitized tissues to relatively low-intensity ultrasound … (leggi tutto)

Dall’ASCO



ASCO Updated Guideline of Biomarkers in Metastatic Breast Cancer Supports PIK3CA, BRCA1/2, PD-L1 Testing

Jul 15, 2022 – ASCO has issued a new practice guideline update on the use of biomarkers in the management of metastatic breast cancer. The updated guideline makes a total of 11 recommendations, including in cases in which the Expert Panel found insufficient evidence to recommend routine testing for specific biomarkers. The Expert Panel found the strongest support for widespread testing for PIK3CA somatic variants, germline BRCA1/2 mutations, and PD-L1 expression … (leggi tutto)

ctDNA Analysis Finds MRD in 10% of Patients With HR-Positive Breast Cancer at Least 5 Years Beyond Diagnosis

Jul 15, 2022 – Detection of minimal residual disease (MRD) via circulating tumor DNA (ctDNA) is correlated with distant metastatic recurrence more than 5 years postdiagnosis in high-risk, hormone receptor (HR)–positive, HER2-negative breast cancer. A recent study found that, among 83 patients with high-risk stage II/III HR-positive breast cancer who underwent successful whole exome sequencing of primary tumor tissue, 10% were MRD-positive more than 5 years from diagnosis … (leggi tutto)

ASCO22 Professional Development Research Highlights Persistent Gender Disparities and Explores EDI Efforts in Oncology

Jul 14, 2022 – Several abstracts within the professional development track at this year’s ASCO Annual Meeting focused on the persistent disparities and challenges facing women professionals, underlining inequities in the authorship of clinical trials and research payments, and inadequacy of lactation facilities; abstracts also explored equity, diversity, and inclusion (EDI) efforts and strategies, and their expansion into the community setting. An analysis of 227 publications and 231 clinical trials revealed  … (leggi tutto)

PARP Inhibitors As Single Agents or Combination Therapy in Melanoma: Where Do We Stand?

Jul 14, 2022 – Novel therapies are needed to improve outcomes in patients with advanced refractory melanoma, and continued evaluation of novel treatment strategies is of critical importance. PARP inhibitors (PARPis) as single agents, or in combination with immunotherapy have shown promising early results in HRR-DDR deficient advanced melanoma in clinical trials. Although the clinical data remain limited at this time, ongoing trials will yield important data regarding the clinical utility of PARPis in patients with HRR-DDR deficient advanced melanoma ... (leggi tutto)

Pillole dall’AIFA

13 luglio 2022 – Esiti della riunione della Commissione Tecnico Scientifica (CTS)
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13 luglio 2022 – Ordine del giorno riunione Comitato Prezzi e Rimborso (CPR)
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12 luglio 2022 – Definizione dei criteri per l’inserimento in lista di trasparenza dei medicinali
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11 luglio 2022 – Aggiornamento delle raccomandazioni ECDC-EMA sulle dosi di richiamo aggiuntive dei vaccini a mRNA anti-COVID-19
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11 luglio 2022 – COVID-19: estensione della platea dei destinatari della seconda dose di richiamo
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