AiomNews N. 921, 5 Settembre 2023

Oggi in Oncologia

Is Acetaminophen Beneficial in Patients With Cancer Pain Who are on Strong Opioids? A Randomized Controlled Trial

Pain is common among cancer patients. The evidence recommends using strong opioids in moderate to severe cancer pain. No conclusive evidence supports the effectiveness of adding acetaminophen to patients with cancer pain who are already using this regime. To assess the analgesic efficacy of acetaminophen in hospitalized cancer patients with moderate to severe pain receiving strong opioids … (leggi tutto)

Scopo dello studio randomizzato è stata la valutazione dell’efficacia dell’acetaminofene (paracetamolo) nel migliorare l’efficacia analgesica degli oppiacei forti nei pazienti con dolore da cancro moderato-severo (> 4 in una scala 0-10).
Sono stati randomizzati 112 pazienti (56 trattati con placebo e 56 trattati con acetaminofene). Obiettivo primario era la valutazione dell’efficacia dell’acetaminofene nel controllo del dolore a 48 ore. Obiettivi secondari la riduzione della dose di morfina giornaliera somministrata e la percezione della qualità del controllo del dolore riferita dai pazienti.
L’acetaminofene non ha mostrato vantaggi rispetto al placebo per quanto riguarda 1) l’efficacia nel controllo del dolore valutata a 48 ore 2) la dose media di morfina somministrata nelle 24 ore 3) l’efficacia del controllo del dolore percepita dai pazienti.
In conclusione, associare l’acetaminofene (paracetamolo) agli oppiacei non migliora l’analgesia né riduce la dose giornaliera di morfina somministrata.
Diversi lavori hanno dimostrato che l’aggiunta di “adiuvanti” (paracetamolo, FANS, gabapentinoidi) non migliora l’analgesia indotta da oppiacei.
Eppure, è esperienza comune che taluni pazienti riferiscano di essere particolarmente “sensibili” a questi farmaci.
Come possiamo comportarci nella pratica clinica? Partiamo da un presupposto: tutti gli studi sull’efficacia di “adiuvanti” non prevedevano alcuna selezione dei pazienti. Potremmo ipotizzare che esiste una percentuale di pazienti che potrebbero giovarsi dell’associazione oppiacei “adiuvanti”, ma non siamo in grado di individuarli tramite marker specifici.
Una possibile soluzione? Basarsi su un criterio clinico, iniziando la terapia con oppiacei ed eventualmente aggiungendo un “adiuvante” in quei pazienti con un’analgesia non del tutto soddisfacente che mostrano una particolare sensibilità a questi farmaci.
Una strategia “add on” piuttosto che “tutto e subito a tutti” in maniera indiscriminata.

Cancer-related breathlessness: opioids other than morphine – comprehensive literature review

Although there is low-quality evidence, there has been an increase in publications on the experience of evaluating and managing cancer-related breathlessness using opioids other than morphine. The author conducted a non-systematic literature review in the PubMed/Medline and Embase until 4 October 2022. Eligible studies have evaluated the efficacy of opioids other than morphine for cancer-related breathlessness … (leggi tutto)

Scopo della revisione della letteratura è stato valutare se ci sono dati a supporto dell’impiego di oppiacei – diversi dalla morfina – nella dispnea correlata al cancro.
Sono stati considerati eleggibili per la revisione 23 studi per un totale di 469 pazienti.
Di questi 223 trattati con fentanyl, 171 con ossicodone e 75 con idromorfone.
Il fentanyl ha mostrato di essere “promettente” nel trattamento della dispnea indotta dal movimento.
I dati disponibili in letteratura sull’impiego di oppiacei diversi dalla morfina per il trattamento della dispnea indotta da cancro sono molto scarsi.
La morfina rimane il farmaco di prima scelta nel trattamento della dispnea.
Come comportarsi nella pratica clinica? Iniziare il trattamento con morfina quanto più precocemente possibile, ricordando che nei pazienti opioid-naive sono efficaci basse dosi di morfina.
Nei pazienti in trattamento con altri oppiacei? Abbiamo due opzioni: 1) ruotare a dosi equivalenti di morfina (da preferire) 2) associare basse dosi di morfina se il trattamento della dispnea non è soddisfacente (unico caso in cui può essere presa in considerazione l’associazione di due oppiacei).

Exercise regimens for improved sleep quality in adult breast cancer survivors: systematic review and network meta-analysis

The relative efficacy of exercise regimens for improving sleep quality in adult breast cancer survivors remains unknown. This network meta-analysis aimed to compare the efficacy of various exercise regimens for improving sleep quality in adult breast cancer survivors … (leggi tutto)

Sono stati esaminati i dati di 35 trials randomizzati, per complessive 3.374 pazienti survivors con neoplasie della mammella, allo scopo di valutare l’efficacia dell’attività fisica sulla qualità del sonno.
La combinazione di attività “endurance” e attività “resistance” si è rivelata più efficace nel migliorare la qualità del sonno.
I disturbi del sonno sono molto frequenti nelle donne con pregresse neoplasie della mammella.
Questa metanalisi conferma l’efficacia dell’attività fisica sulla qualità del sonno in queste pazienti ed entra nello specifico del “tipo” di attività da suggerire.
Cosa suggerire per la pratica clinica? Innanzitutto, andare a “cercare” i sintomi delle pazienti in follow up, usando un questionario specifico, ad esempio il BreSAS (Giusti R et al. Clinical and psychometric validation of the BreSAS questionnaire module for symptom assessment among breast cancer survivors. Support Care Cancer. 2020). Secondo, suggerendo di praticare un’attività fisica regolare.
Per le pazienti più motivate, un programma di attività fisica che combini forza e resistenza può essere considerato ottimale.

Encouraging Single-Agent Antitumour Activity of Divarasib Across KRAS G12C-positive Tumours

Sept 05, 2023 – Divarasib (GDC-6036) is a covalent KRAS G12C inhibitor designed to exhibit high potency and selectivity. It is 5 to 20 times as potent and up to 50 times as selective in vitro as sotorasib and adagrasib. In an ongoing phase I study that is evaluating divarasib as a single agent and in combination with other anticancer treatments in patients with advanced or metastatic solid tumours with a KRAS G12C mutation ... (leggi tutto)

Binimetinib Contributes to the Efficacy and Safety Outcomes Observed with Encorafenib Plus Binimetinib Combination Therapy in Patients with BRAFV600-mutated Melanoma

Sept 04, 2023 – COLUMBUS consists of two parts: part 1 compared encorafenib 450 mg once daily plus binimetinib 45 mg twice a day (COMBO450), encorafenib 300 mg once daily (ENCO300), and 960 mg vemurafenib arms, and part 2 compared encorafenib 300 mg once daily plus binimetinib 45 mg twice daily (COMBO300) and ENCO300 arms. Results from part 1 demonstrated that COMBO450 improved progression-free survival (PFS) versus vemurafenib … (leggi tutto)

PRAC recommends new measures to avoid topiramate exposure in pregnancy

Sept 01, 2023 – EMA’s safety committee (PRAC) recommends new measures to avoid exposure of children to topiramate-containing medicines in the womb, because the medicine may increase the risk of neurodevelopmental problems after exposure during pregnancy. Topiramate is already known to cause serious birth defects when used during pregnancy. Topiramate‑containing medicines are used in the EU for the treatment ... (leggi tutto)

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 August 2023

Sept 01, 2023 – EMA’s safety committee (PRAC) recommends new measures to avoid exposure of children to topiramate-containing medicines in the womb, because the medicine may increase the risk of neurodevelopmental problems after exposure during pregnancy. Topiramate is already known to cause serious birth defects when used during pregnancy … (leggi tutto)

EMA Recommends Granting a Marketing Authorisation for Decitabine / Cedazuridine

Aug 31, 2023 – On 20 July 2023, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product decitabine / cedazuridine (Inaqovi), intended for the treatment of acute myeloid leukaemia (AML). The applicant for this medicinal product is ... (leggi tutto)

Activity and Safety of Atezolizumab Combined with Carboplatin and Pemetrexed in Patients with Untreated Brain Metastases from Non-squamous NSCLC

Aug 30, 2023 – The results of a phase II Atezo-Brain study show that patients with treatment-naïve advanced non-squamous non-small cell lung cancer (NSCLC) with untreated brain metastases can benefit from initiating systemic treatment with atezolizumab combined with carboplatin and pemetrexed. It is the first study centred on this special population that evaluates the activity and safety of a PD-L1 inhibitor combined with platinum-based chemotherapy in patients with NSCLC … (leggi tutto)

A Combination of Durvalumab-Tremelimumab with mFOLFOX6 Is Tolerable with Promising Activity in Patients with Microsatellite Stable Metastatic Colorectal Cancer

Aug 29, 2023 – A single-arm, phase Ib/II MEDITREME study evaluated clinical and biological response with first-line chemo-immunotherapy combination of modified FOLFOX6 (mFOLFOX6) regimen combined with durvalumab and tremelimumab as induction therapy, followed by maintenance therapy with durvalumab until progression for RAS-mutated metastatic colorectal cancer (mCRC). The study reached its primary objective, with 3-month progression-free survival ... (leggi tutto)

Efficacy and Safety of Elranatamab, BCMA-CD3 Bispecific Antibody, in Patients with Relapsed or Refractory Multiple Myeloma

Aug 28, 2023 – In a phase II MagnetisMM-3 study conducted in heavily pretreated patients with relapsed or refractory multiple myeloma, elranatamab demonstrated a high rate of deep and durable responses, including in patients who achieved at least complete response (CR), with a manageable safety profile. Administration of a two step-up priming dose regimen successfully mitigated the rate and severity of cytokine release syndrome (CRS) with a predictable profile supporting ... (leggi tutto)

EMA Adopts a Positive Opinion for a New Indication for Pembrolizumab

Aug 24, 2023 – On 20 July 2023, 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 pembrolizumab (Keytruda). The marketing authorisation holder for this medicinal product is … (leggi tutto)

First Prospective Description of Familial EGFR-mutated Lung Cancer

Aug 23, 2023 – In a prospective cohort study, entitled Investigating HEreditary RIsk from T790M (INHERIT) and published on 14 August 2023 in the JCO, Prof. Geoffrey R. Oxnard of the Dana-Farber Cancer Institute in Boston, MA, US, and colleagues report on 77 individuals from 39 kindreds carrying pathogenic germline variants in EGFR. The data confirms the existence of an underappreciated syndrome of familial EGFR-mutated ... (leggi tutto)

Sept 01, 2023 – Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA cleared for marketing the updated 23andMe Personal Genome Service (PGS) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). It is a direct-to-consumer (DTC) test that reports selected BRCA1/BRCA2 genetic variants from human saliva collected … (leggi tutto)

FDA Grants Breakthrough Therapy Designations to Trastuzumab Deruxtecan for HER2+ Solid Tumors, Including mCRC

Aug 31, 2023 – The FDA has granted 2 breakthrough therapy designations to fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of patients with unresectable or metastatic HER2-positive solid tumors that have progressed after prior treatment and who have no satisfactory alternative treatment options, and for those with HER2-positive metastatic colorectal cancer (mCRC) who have received at least 2 prior lines of therapy. Both designations require HER2 positivity … (leggi tutto)

FDA Approval Sought for Erdafitinib in Locally Advanced or Metastatic FGFR3+ Urothelial Carcinoma

Aug 29, 2023 – A supplemental new drug application (sNDA) seeking the full approval of erdafitinib (Balversa) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations who progressed during or following at least 1 line of a PD-1/PD-L1 inhibitor in the locally advanced or metastatic setting or within 12 months of neoadjuvant or adjuvant therapy, has been submitted to the FDA … (leggi tutto)

FDA Approves Luspatercept for First-line Treatment of Anemia in Lower-Risk MDS

Aug 28, 2023 – The FDA has approved luspatercept-aamt (Reblozyl) for the treatment of anemia without prior erythropoiesis-stimulating agent (ESA) use in adult patients with very low– to intermediate-risk myelodysplastic syndrome (MDS) who may require regular red blood cell (RBC) transfusions.The regulatory decision is supported by interim findings from the phase 3 COMMANDS trial (NCT03682536), in which luspatercept … (leggi tutto)

New Data Link Exercise With Improvements in All-Cause Mortality in Pan-Cancer Population

Sept 01, 2023 – Researchers found among the pan-cancer group, patients classified as exercisers had a 5-year benefit in median OS versus those classified as nonexercisers. In the cancer-specific groups, exercise consistent with national guidelines was associated with improved mortality in 2 cancer types: head and neck cancers and renal cell carcinoma. An analysis of data from more than 11,000 patients representing … (leggi tutto)

Aug 31, 2023 – Presented here are some brief summaries of novel therapies under study from the 2023 ASCO Breakthrough meeting in Yokohama, Japan. The subjects range from new observations about a HER2-directed bispecific antibody and systemic treatment of gastric cancer to an option for treating hand-foot syndrome in patients on capecitabine. In addition, dexamethasone premedication may reduce the immunogenicity of COVID-19 vaccinations in patients with solid … (leggi tutto)

Aug 30, 2023 – Ruxolitinib, the first of three JAK inhibitors approved for the treatment of myelofibrosis, provides therapeutic benefits for many patients; however, it can be associated with cytopenias, and response may be suboptimal or not durable. When ruxolitinib is not effective, fedratinib and pacritinib are two options with similar side effect profiles. Fedratinib is preferred for patients with platelet counts of greater than 50 and pacritinib … (leggi tutto)

Risky Business: Examining the Challenge With Defining High-Risk and Ultra High–Risk Multiple Myeloma

Aug 30, 2023 – Many risk classifications exist for newly diagnosed multiple myeloma, largely focusing on serum biomarkers (β2-microglobulin, albumin, and LDH) and cytogenetics. High-risk gene expression profiles and clinical factors at diagnosis such as circulating plasma cells, plasma cell leukemia, and extramedullary disease are also associated with poor outcomes. Identifying optimal strategies for the treatment of patients with high-risk multiple myeloma is a key unmet need … (leggi tutto)

HIMALAYA and IMbrave-150 for Hepatocellular Carcinoma: A Critical Comparison

Aug 30, 2023 – HIMALAYA and IMbrave-150 were open-label, phase 3 trials investigating different treatment regimens in patients with hepatocellular carcinoma (HCC).
Both trials demonstrated the superiority of an immunotherapy-based combination approach over sorafenib to improve survival in patients with advanced HCC in the frontline setting. Atezolizumab plus bevacizumab … (leggi tutto)

Pillole dall’AIFA

01 settembre 2023 – Aggiornamento “Diario di bordo sulla Trasparenza”
Leggi tutto

01 settembre 2023 – Il PRAC raccomanda nuove misure per evitare l’esposizione del topiramato in gravidanza
Leggi tutto

01 settembre 2023 – Elenco dei farmaci innovativi: AIFA pubblica l’aggiornamento di agosto 2023
Leggi tutto

30 agosto 2023 – Comirnaty: EMA raccomanda l’approvazione del vaccino COVID-19 adattato contro Omicron XBB.1.5
Leggi tutto

Dedicato ai Soci

Opportunità di lavoro in Oncologia

Consulta le posizioni disponibili nella vetrina riservata ai Soci AIOM o scarica il modulo per richiedere la pubblicazione di annunci

Appuntamenti

NELL’AGENDA DISPONIBILE SUL SITO DELL’ASSOCIAZIONE TUTTE LE INFORMAZIONI SUGLI EVENTI AIOM NAZIONALI, REGIONALI e ALTRI APPUNTAMENTI PATROCINATI DA AIOM