Experiencing pain and insufficient relief can be devastating and negatively affect a patient’s quality of life. Developments in oncology such as new treatments and adjusted pain management guidelines may have influenced the prevalence of cancer pain and severity in patients. This review aims to provide an overview of the prevalence and severity of pain in cancer patients in the 2014-2021 literature period. A systematic literature search was performed … (leggi tutto)

Questa revisione della letteratura ha avuto come oggetto la prevalenza del dolore nel periodo 2014-2020, ovvero nella fase di massima espansione dell’immunoterapia e delle altre terapie innovative.
Il 30% dei pazienti riferisce un dolore moderato-severo; questo valore è inferiore a quanto riportato in precedenza.
Facendo riferimento alle fasi di malattia di maggiore interesse per l’oncologo la prevalenza del dolore – di qualunque entità – è:
• 40.3% alla diagnosi
• I47.8% in trattamento in curativo
• 55.2% nella transizione fra oncologia e cure palliative
• I35.8% in follow-up
Per quanto riguarda il dolore moderato-severo (> 4 in una scala numerica 0-10) la prevalenza è:
• 33.1% alla diagnosi
• 27.8% in trattamento in curativo
• 43.3% nella transizione fra oncologia e cure palliative
• 22.8% in follow-up
La prevalenza del dolore sembra essere in discesa rispetto al passato, pur rimanendo uno dei sintomi più frequentemente riportato dai pazienti oncologici, indipendentemente dalla fase di malattia.
Questo lavoro apre ad una serie di riflessioni.
La prima: prendiamo ad esempio un giovane oncologo con una prospettiva di 30 anni di professione, con 200 giorni lavorativi/anno. Lavorerà 6.000 giorni. Assumendo che si confronterà con 10 pazienti/giorno, avrà 3 pazienti/giorno con dolore moderato-severo (prevalenza del dolore 30%). Totale: nella sua carriera un giovane oncologo vedrà 18.000 pazienti con dolore moderato-severo.
Seconda: la prevalenza del dolore è significativa non solo nei pazienti nella fase di transizione tra oncologia-cure palliative, ma anche nei pazienti alla diagnosi e in terapia curativa.
Terza: il dolore è prevalente in maniera significativa anche nei pazienti in follow-up.
In conclusione, gli oncologi devono riservare una grande attenzione alla valutazione ed alla terapia del dolore, preparandosi ed aggiornandosi di conseguenza.

 

In Europa

Clinical and Biological Activity of Patritumab Deruxtecan in Patients with HR-positive, HER2-negative Primary Operable Early Breast Cancer

Jun 05, 2023 – In SOLTI-1805 TOT-HER3 study, conducted among patients with operable hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer, a HER3-directed antibody-drug conjugate, patritumab deruxtecan (HER3-DXd) increased immune infiltration, suppressed proliferation, and switched tumours to a less proliferative phenotype. It showed clinical and biological activity independently of baseline … (leggi tutto)

Adding Capivasertib to Fulvestrant Results in Longer PFS in Patients with HR-positive, HER2-negative ABC Whose Disease Had Progressed to Previous AI With or Without a CDK4/6 Inhibitor

Jun 05, 2023 – A double-blind, phase III, randomised CAPItello-291 study showed that the addition of AKT inhibitor capivasertib to fulvestrant resulted in a significant improvement in progression-free survival (PFS) among patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer (ABC) that had progressed during previous aromatase inhibitor (AI) therapy with or without a CDK4/6 inhibitor. Randomisation was not stratified according to AKT ... (leggi tutto)

EMA Recommends Granting a Marketing Authorisation for Piflufolastat (18F)

Jun 01, 2023 – On 25 May 2023, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product piflufolastat (18F), Pylclari, intended for the diagnosis of prostate cancer. The applicant for this medicinal product is Curium Pet France … (leggi tutto)

 


Olaparib Plus Bevacizumab Provides Clinically Meaningful OS Improvement for Newly Diagnosed Patients with Homologous Recombination Deficiency-Positive Advanced Ovarian Cancer

May 31, 2023 – The PAOLA-1/ENGOT-ov25 is the first study with PARP inhibitor to show a clinically meaningful overall survival (OS) benefit in newly diagnosed patients with homologous recombination deficiency (HRD)-positive advanced ovarian cancer, irrespective of BRCA mutation. 5-year OS rate in patients with HRD-positive tumours was 66% with olaparib plus bevacizumab versus 48% with placebo plus bevacizumab ... (leggi tutto)

Dall’FDA

FDA Announces Additional Steps to Modernize Clinical Trials

Jun 06, 2023 – Today, the U.S. Food and Drug Administration is announcing the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections.The updates are intended to help pave the way for more efficient clinical trials to facilitate the development of medical products … (leggi tutto)

FDA Grants Priority Review to Dostarlimab Plus Chemo for dMMR/MSI-H Endometrial Cancer

Jun 06, 2023 – The FDA has accepted and granted priority review to a supplemental biologics license application (sBLA) seeking the approval of dostarlimab (Jemperli) plus chemotherapy for use in adult patients with mismatch repair–deficient (dMMR)/microsatellite instability–high (MSI-H) primary advanced or recurrent endometrial cancer … (leggi tutto)

 


FDA Roundup: June 2, 2023

Jun 02, 2023 – Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA provided an update on medical device reports it received that are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021 … (leggi tutto)

FDA Approves Olaparib/Abiraterone Combo for BRCA+ Metastatic Castration-Resistant Prostate Cancer

May 31, 2023 – The FDA has approved olaparib (Lynparza) plus abiraterone and prednisone or prednisolone for the treatment of patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test. The regulatory decision is supported by findings from the phase 3 PROpel trial (NCT03732820) in which the olaparib regimen significantly improved … (leggi tutto)

FDA Grants Priority Review to Lifileucel in Advanced Melanoma

May 30, 2023 – The FDA has granted priority review to the biologics license application (BLA) for the tumor infiltrating lymphocyte (TIL) therapy lifileucel (LN-144) for the treatment of patients with advanced melanoma who progressed on or after prior anti–PD-1/PD-L1 therapy and targeted therapy. The BLA was supported by data from cohort 2 (n = 66) and cohort 4 (n = 87) of the phase 2 C-144-01 trial (NCT02360579) … (leggi tutto)

FDA Grants Priority Review to Repotrectinib for ROS1+ NSCLC

May 30, 2023 – The FDA has granted priority review to repotrectinib (TPX-0005) for the treatment of patients with ROS1-positive locally advanced or metastatic non–small cell lung cancer (NSCLC). The designation is based on data from the registrational phase 1/2 TRIDENT-1 trial (NCT03093116), which will inform the FDA’s decision regarding the agent’s approval by November 27, 2023, under the Prescription Drug User Fee Act. … (leggi tutto)

FDA Proposes New, Easy-to-Read Medication Guide for Patients, Patient Medication Information

May 30, 2023 – Providing people with accurate and timely information to help them take their prescription medications safely and effectively is an important priority for the U.S. Food and Drug Administration. Evidence suggests that more easy-to-read information can help patients reduce preventable adverse drug reactions and improve health outcomes … (leggi tutto)

FDA Approves First Radiohybrid PSMA-targeted PET Imaging Agent for Prostate Cancer

May 30, 2023 – The FDA has approved flotufolastat F 18 injection (Posluma; formerly ¹⁸F-rhPSMA-7.3) for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)–positive lesions in men with prostate cancer with suspected metastasis who are eligible for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen level … (leggi tutto)

Dall’ASCO

Pembro Plus Chemo Fails to Show Efficacy Benefit in TKI-Resistant, EGFR-Mutated, Metastatic Nonsquamous NSCLC

Jun 06, 2023 – KEYNOTE-789 did not show a significant improvement in PFS or OS with the addition of pembrolizumab to chemotherapy in patients with TKI-resistant EGFR-mutated metastatic nonsquamous NSCLC. There remains a need for more effective treatment strategies for patients with EGFR-mutated NSCLC. An analysis from the randomized, phase 3 KEYNOTE-789 trial did not show a significant efficacy benefit with the addition … (leggi tutto)

ADC With Novel SEZ6 Target Well-Tolerated With Preliminary Efficacy in Small Cell Lung Cancer Phase 1 Trial

Jun 05, 2023 – ABBV-011, an ADC targeting SEZ6, was well-tolerated and demonstrated antitumor activity in a first-in-human, phase 1 trial of patients with relapsed/refractory small cell lung cancer. ABBV-011 at 1 mg/kg Q3W showed encouraging efficacy with an overall response rate of 25% and a duration of response of 4.2 months. 78% of patients who received ABBV-011 at 1 mg/kg in the dose-expansion cohort experienced TEAEs, including … (leggi tutto)

THOR: Survival Benefit Seen With Erdafitinib in Advanced Urothelial Carcinoma

Jun 05, 2023 – The phase 3 randomized THOR trial was launched to investigate the efficacy of erdafitinib versus investigator’s choice of chemotherapy (docetaxel or vinflunine) in patients with advanced urothelial cancer with FGFR2/3 aberrations whose disease previously failed to respond on 1 or 2 prior lines of treatment. Results from the trial’s primary and secondary endpoints indicated median OS, PFS, and ORR were all significantly improved with erdafitinib … (leggi tutto)

CLEAR Study: First-Line Lenvatinib Plus Pembrolizumab Maintains Advantage Over Sunitinib in Advanced RCC at Long-Term Follow-up

Jun 05, 2023 – With extended 4-year follow-up data, the combination of lenvatinib plus pembrolizumab remains superior to sunitinib on clinical outcomes as first-line treatment for advanced renal cell carcinoma. The updated results from CLEAR reaffirmed current practice of frontline combination immunotherapy/TKI. No new safety signals were evident. With a median follow-up of 4 years, the immunotherapy/tyrosine kinase inhibitor (IO-TKI) lenvatinib … (leggi tutto)

RELATIVITY-047 Update: Nivolumab/Relatlimab Provides PFS Benefit in Previously Untreated Advanced Melanoma

Jun 05, 2023 – An updated analysis from RELATIVITY-047 after a median follow-up of 25.3 months continues to show a significant PFS benefit for the nivolumab/relatlimab combination over nivolumab alone in the first-line treatment of patients with unresectable or metastatic melanoma while no new safety findings were noted. Although investigators observed improvements in melanoma-specific survival and OS, these did not meet the prespecified bar … (leggi tutto)

DESTINY-PanTumor-02: Trastuzumab Deruxtecan Has Activity Against a Range of HER2-Expressing Solid Tumors

Jun 05, 2023 – Interim results of the phase 2 trial DESTINY-PanTumor-02 show that T-DXd has broad activity across tumor types and a toxicity profile consistent with previous studies. T-DXd had the lowest activity in pancreatic cancer, and this cohort was stopped early. Responses were especially high among patients who had cervical, endometrial, and ovarian cancers. The interim results of the phase 2 trial DESTINY-PanTumor-02, a tumor-agnostic study including … (leggi tutto)

INDIGO: Vorasidenib Offers Patients With IDH-Mutant Low-Grade Glioma a Means to Delay Chemotherapy and Radiotherapy

Jun 04, 2023 – INDIGO is the first randomized phase 3 study of a targeted therapy in grade 2 IDH1/2-mutated glioma. The results showed that vorasidenib led to a 61% reduction in the risk of tumor progression or death and significantly delayed the need for more toxic therapy when compared with placebo. Vorasidenib demonstrated a manageable safety profile; only transaminase elevations and diarrhea occurred more frequently compared with placebo… (leggi tutto)

Pillole dall’AIFA

06 giugno 2023 – Tabelle farmaci di classe A e H al 15/12/2022
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06 giugno 2023 – Ordine del giorno Riunione Commissione Tecnico Scientifica (CTS)
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05 giugno 2023 – Chiusura del Registro di monitoraggio ERLEADA
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05 giugno 2023 – Chiusura del Registro DINUTUXIMAB BETA secondo legge 648/96
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05 giugno 2023 – Progetto pilota per favorire la partecipazione di oncologi ed emato-oncologi alle attività regolatorie in ambito farmaceutico
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01 giugno 2023 – Aggiornamento “Diario di bordo sulla Trasparenza”
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01 giugno 2023 – Farmaci biosimilari in Italia: report AIFA aggiornati a dicembre 2022
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01 giugno 2023 – Esiti della riunione del Comitato Prezzi e Rimborso (CPR)
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31 maggio 2023 – Indicazioni operative per il censimento dei Comitati etici territoriali (CET) in Clinical Trials Information System (CTIS)
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31 maggio 2023 – Elenco dei farmaci innovativi: AIFA pubblica l’aggiornamento di maggio 2023
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30 maggio 2023 – Procedura semplificata per domande di AIC di medicinali con base giuridica “generic/hybrid application”
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30 maggio 2023 – Procedura semplificata per la modifica del regime di fornitura e per l’autorizzazione di una nuova confezione di un medicinale autorizzato a seguito di una variazione
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30 maggio 2023 – AIFA pubblica il monitoraggio delle estensioni di indicazione e posologia approvate da EMA
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