Newsletter settimanale Aiom
Anno XXI - Numero 901 - 28 marzo 2023

Hanno curato la selezione degli articoli scientifici e i commenti di questo numero: Giampiero Porzio (Associazione Tumori Toscana, Firenze), Vittorina Zagonel (Istituto Oncologico Veneto IRCCS, Padova)

Coordinatori: Massimo Di Maio, Silvia Novello
Editore: Intermedia - Direttore Responsabile: Mauro Boldrini

Oggi in Oncologia

An international, open-label, randomised trial comparing a two-step approach versus the standard three-step approach of the WHO analgesic ladder in patients with cancer

Worldwide, cancer pain management follows the World Health Organization (WHO) three-step analgesic ladder. Using weak opioids (e.g. codeine) at step 2 is debatable with low-dose strong opioids being potentially better, particularly in low- and middle-income countries where weak opioids are expensive. We wanted to assess the efficiency, safety and cost of omitting step 2 of the WHO ladder … (leggi tutto)

153 pazienti oncologici con dolore > 4 in una scala numerica 0-10, sono stati randomizzati per ricevere oppiacei deboli (tramadolo o codeina -gruppo di controllo) verso oppiacei “orti (morfina o ossicodone – gruppo sperimentale).
Obiettivo primario dello studio era il tempo necessario per ottenere un ottimale controllo del dolore (3 giorni consecutivi con dolore < 3. Obiettivi secondari: distress, effetti collaterali e costi del trattamento.
Non sono state evidenziate differenze fra i due gruppi per quanto riguarda il tempo per ottenere il controllo del dolore.
Il 58% dei pazienti in trattamento con oppiacei deboli ha avuto necessità di passare ad oppiacei forti a causa dell’inefficacia della terapia.
I pazienti del gruppo sperimentale hanno avuto meno effetti collaterali e la terapia è risultata meno costosa.

Il lavoro presenta una serie di limitazioni. Gli stessi Autori lo definiscono “underpowered”. In una visione “oncologica” del problema del trattamento del dolore è possibile fare alcuni commenti.
1. Più del 50% dei pazienti in trattamento con tramadolo o codeina è dovuto passare ad oppiacei forti a causa dell’inefficacia del trattamento
2. Gli oppiacei deboli hanno mostrato più effetti collaterali e sono risultati più costosi
3. I risultati contrastano con quanto in precedenza pubblicato in un lavoro italiano che mostrava una chiara superiorità degli oppiacei forti a basse dosi nell’ottenere un efficace, rapido controllo del dolore rispetto agli oppiacei deboli, a parità di effetti collaterali.
Riteniamo gli oppiacei fori a basse dosi il miglio trattamento per pazienti opioid-naive che presentano dolore di intensità moderata-severa (NRS > 4)

Medical oncologists and supportive/palliative care education: prevention of fragmented care

The integration between oncology and palliative care is a pivotal issue of oncological practice. Among the various integration models proposed, one of the best known, widely cited in the literature, is the one developed by Hui and Bruera. Bruera represents the most effective model as a cube in whose surface the team dedicated to oncological therapies and the one dedicated to the integration of supportive and palliative care … (leggi tutto)

Vengono analizzati i dati – resi noti recentemente – inerenti il numero degli specializzandi in cure palliative.
Di 100 posti disponibili, 59 non sono stati assegnati; due specializzandi hanno abbandonato il corso durante il primo anno. Attualmente risultano frequentare regolarmente 39 specializzandi in cure palliative.
In una proiezione a 5 anni, esaminando anche i dati relativi alla scuola di specializzazione in oncologia, ci saranno 195 specialisti in cure palliative ogni 2.800 oncologi.
Questi dati portano alla valutazione di almeno due possibili scenari:
– Grandi ospedali, in cui il numero degli specialisti in cure palliative sarà insufficiente per seguire tutti i pazienti con sintomi di entità severa
– Piccoli ospedali, in cui i palliativisti saranno assenti o presenti solo part-time.
È pertanto necessario che i giovani oncologi acquisiscano una solida esperienza nel trattamento dei sintomi più comuni per garantire l’obiettivo di una reale simultaneous care.


In Europa

Prognostic Role of Plasmatic BRAF Allele Fraction for Survival in Patients with BRAF V600E-mutated mCRC Treated with BRAF Inhibitor-Based Combination Therapies

Mar 27, 2023 – In a research work that aimed to evaluate whether plasmatic BRAF allele fraction determined by droplet digital polymerase chain reaction (ddPCR) can be used to improve understanding of the prognosis in patients with BRAF V600E-mutated metastatic colorectal cancer (mCRC) treated with BRAF inhibitor-based combination therapy, Spanish and Italian investigators showed that plasmatic BRAF allele fraction determined by ddPCR is a reliable (leggi tutto)


Neoadjuvant Treatment with Dual Immune Checkpoint Inhibitors Plus Chemotherapy Produces Numerically Higher Major Pathologic Response Rate in Operable NSCLC

Mar 23, 2023 – In the NEOSTAR phase II platform study that evaluated neoadjuvant nivolumab plus chemotherapy and ipilimumab plus nivolumab plus chemotherapy primary endpoint is met in both treatment arms, which exceeded the historical conservative major pathologic response (MPR) rate of approximately 15% produced by neoadjuvant chemotherapy in patients with operable non-small cell lung cancer (NSCLC) ... (leggi tutto)

Similarity of Molecular Portraits in Synchronous Bilateral Breast Cancers Could be Influenced by Common Environmental Factors

Mar 22, 2023 – A large comprehensive overview of synchronous bilateral breast cancers that integrated clinical and pathological data with immune infiltration and genomic profiles generated using modern whole exome sequencing and RNA sequencing technologies provides important insights to understand the relationships among tumour, host, immunity and response to treatment. The findings indicate that synchronous bilateral breast cancers represent two distinct … (leggi tutto)

Advancing regulatory science in the EU – mid-point report published

Mar 22, 2023 – EMA has published a PDF icon report summarising the mid-term achievements of its Regulatory Science Strategy (RSS) to 2025. The report provides an overview of the main deliverables achieved between March 2020 and December 2022 across the human and veterinary areas. “The achievements highlighted in this report demonstrate that we have made considerable progress in advancing regulatory  (leggi tutto)


FDA Issues Draft Guidance Aimed at Improving Oncology Clinical Trials for Accelerated Approval

Mar 24, 2023 – Today, the U.S. Food and Drug Administration issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support accelerated approval applications. The accelerated approval pathway is commonly used for approval of oncology drugs in part due to the serious and life-threatening nature of cancer and because of available intermediate clinical endpoints … (leggi tutto)



FDA Roundup: March 24, 2023

Mar 24, 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 finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations … (leggi tutto)


FDA Approves Retifanlimab for Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma

Mar 22, 2023 – The FDA has granted accelerated approval to retifanlimab-dlwr (Zynyz) for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). The regulatory decision is supported by data from the phase 2 POD1UM-201 trial (NCT03599713), in which retifanlimab elicited an objective response rate (ORR) of 52% (95% CI, 40%-65%) by independent central review (ICR) and RECIST v1.1 … (leggi tutto)


FDA Grants Orphan Drug Designation to FORE8394 for Primary Brain and CNS Malignancies

Mar 21, 2023 – The FDA has granted an orphan drug designation to FORE8394 for the treatment of primary brain and central nervous system (CNS) malignancies, according to an announcement from Fore Biotherapeutics. FORE8394 is an investigational, novel, small-molecule, next-generation, oral, selective BRAF inhibitor that is designed to target a range of BRAF mutations and spare RAF wild-type. … (leggi tutto)




Emerging Clinical Decision-Making Tools in Clinical Stage I and IIA/B Germ Cell Tumors—What Are the Targets?

Mar 23, 2023 – Nearly all patients who are in clinical stage I and clinical stage IIA/B germ cell malignancies receiving care in developed countries are eventually cured.
Treatment decision-making for patients with early-stage germ cell malignancies should focus on quality of life and survivorship. Highly accurate liquid molecular biomarkers are under global investigative development that should translate to less overtreatment with chemotherapy for these patients. … (leggi tutto)


TAPUR Confirms Olaparib Activity in BRCA 1/2–Mutated Metastatic Castration-Resistant Prostate Cancer

Mar 23, 2023 – Treatment with olaparib yielded a disease control rate of 69% and an objective response rate of 58% in patients with mCRPC. Fifteen of the 18 patients with objective response had BRCA2 mutations. The response rates seen in TAPUR are comparable with responses seen in the trial leading to olaparib’s regulatory approval. Researchers are exploring the combination of PARP inhibition with immunotherapy for prostate cancer. … (leggi tutto)


Zolbetuximab Succeeds Yet Again in CLDN18.2-Positive Advanced Gastric/Gastroesophageal Junction Cancer in First-Line Phase 3 GLOW Trial

Mar 22, 2023 – Zolbetuximab is a novel monoclonal antibody targeting CLDN18.2, a protein expressed in gastric mucosa. Zolbetuximab improved both PFS and OS when added to capecitabine and oxaliplatin in patients with CLDN18.2-positive, HER2-negative advanced G/GEJ adenocarcinoma in the phase 3 GLOW trial. This is the second positive phase 3 trial for zolbetuximab in the first-line setting following SPOTLIGHT … (leggi tutto)

New Developments in Antibody-Drug Conjugates for the Treatment of Ovarian and Urothelial Carcinomas

Mar 22, 2023 – Antibody-drug conjugates (ADCs) allow for targeted drug delivery to the tumor cell and thus less toxicity than standard chemotherapy.
Recent work has focused on expanding ADCs for solid tumors. There are multiple ongoing trials of ADCs in ovarian cancer, including ones in the platinum-sensitive setting and ones that target TROP2, mesothelin, and HER2. Exploring the application of ADCs in RCC has also gained traction, with several early-phase clinical trials underway. … (leggi tutto)

Bispecific Antibodies in Refractory Multiple Myeloma: Basics and Unanswered Questions

Mar 22, 2023 – Bispecific antibodies have yielded promising outcomes for patients with advanced multiple myeloma. In particular, teclistamab, which targets BCMA, has been approved by the FDA for the treatment of relapsed myeloma after 4 lines of therapy. Side effects of bispecific antibodies include cytokine release syndrome, immune effector cell–associated neurotoxicity syndrome, cytopenias, and infections, which can be managed by supportive care. … (leggi tutto)

Trust in Cancer Information May Have Declined Among Black Individuals During COVID-19 Pandemic

Mar 20, 2023 – Investigators have found that Black individuals’ trust in information provided by the government on cancer fell by almost 50% during the COVID-19 pandemic, according to a new study published by Bispo et al in the Journal of Health Communication. The investigators stressed the need to assess whether this mistrust has persisted beyond the pandemic and whether it could potentially cause an upsurge … (leggi tutto)

Pillole dall’AIFA

27 marzo 2023 – Aggiornamento Registro Multifarmaco PPP per i farmaci sottoposti a programma di prevenzione della gravidanza (inserimento ERIVEDGE)
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27 marzo 2023 – Ordine del giorno Riunione straordinaria Commissione Tecnico Scientifica (CTS)
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24 marzo 2023 – FAQ sui DM attuativi della Legge 3/2018 sulla sperimentazione clinica
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24 marzo 2023 – Esiti della riunione del Comitato Prezzi e Rimborso (CPR)
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23 marzo 2023 – Aggiornamenti in merito all’applicazione delle quote di spettanza all’interno dei provvedimenti AIFA di P&R
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22 marzo 2023 – Monitoraggio della spesa farmaceutica (gennaio – novembre 2022)
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21 marzo 2023 – Attivazione web e pubblicazione schede di monitoraggio – Registro FETCROJA
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