Oggi in Oncologia
Axillary Treatment and Chronic Breast Cancer-Related Lymphedema: Implications for Prospective Surveillance and Intervention From a Randomized Controlled Trial
Purpose: The PREVENT randomized trial assessed progression to chronic breast cancer-related lymphedema (cBCRL) after intervention triggered by bioimpedance spectroscopy (BIS) or tape measurement (TM). This secondary analysis identifies cBCRL risk factors on the basis of axillary treatment. Methods: Between June 2014 and September 2018, 881 patients received sentinel node biopsy (SNB; n = 651), SNB + regional node irradiation (RNI; n = 58) … (leggi tutto)
Il tasso di linfedema correlato al carcinoma mammario oscilla tra il 5% con la biopsia del linfonodo sentinella al 20-50% con la dissezione dei linfonodi del cavo ascellare e il trattamento radioterapico consecutivo. Boyages et al hanno recentemente pubblicato sul Journal of Clinical Oncology i risultati del loro studio sui fattori di rischio per l’insorgenza del linfedema correlato al carcinoma mammario alla base del trattamento del cavo ascellare.
Da giugno 2014 a settembre 2018, sono stati arruolati 881 pazienti, di cui 651 pazienti sono stati sottoposti a biopsia del linfonodo sentinella, 58 alla biopsia e al trattamento radioterapico, 85 pazienti alla dissezione del cavo ascellare, mentre 87 alla dissezione + trattamento radioterapico.
L’outcome primario era il tasso a 3 anni del linfedema correlato al carcinoma mammario con necessità di trattamento fisioterapico decongestionante. Dopo un follow-up mediano di 32.8 mesi, 69/881 pazienti hanno sviluppato il linfedema. Il rischio a tre anni del linfedema correlato al carcinoma mammario era il 4.4% (95% CI, 2.7-6.1), 4.2% (95% CI, 0-9.8), 25.8% (95% CI, 15.8-35.8), e 26% (95% CI, 15.3-36.7), rispettivamente nei diversi gruppi. In particolare, il rischio è apparso aumentato in tutti i gruppi per i pazienti residenti in zone rurali. Per il primo gruppo di pazienti che erano state sottoposte alla biopsia del linfonodo sentinella non c’è stato aumento del rischio né a seguito di trattamento radioterapico, né a seguito di trattamento chemioterapico a base di taxani, mentre il rischio si è mostrato aumentato del 6.3% per i pazienti con un BMI maggiore di 30. Per il gruppo di pazienti sottoposti a biopsia del linfonodo sentinella + trattamento radioterapico, l’utilizzo dei taxani e del trattamento radioterapico della regione sovraclavicolare ha mostrato un aumento del rischio rispettivamente del 5.7% e 5%. Nei pazienti sottoposti a dissezione del cavo ascellare, un aumento del rischio si è verificato a seguito dell’impiego dei taxani e con un BMI superiore a 25. Infine, per i pazienti sottoposti a dissezione del cavo ascellare + trattamento radioterapico non si sono evidenziati ulteriori fattori di rischio.
L’estensione del trattamento ascellare è un fattore di rischio significativo per l’insorgenza del linfedema correlato al carcinoma mammario. Ciò potrebbe essere usato nel prossimo futuro per l’avvio di programmi di screening e trattamento precoce.
Atezolizumab for Advanced Alveolar Soft Part Sarcoma
Background: Alveolar soft part sarcoma (ASPS) is a rare soft-tissue sarcoma with a poor prognosis and no established therapy. Recently, encouraging responses to immune checkpoint inhibitors have been reported. Methods: We conducted an investigator-initiated, multicenter, single-group, phase 2 study of the anti-programmed death ligand 1 (PD-L1) … (leggi tutto)
Il sarcoma alveolare dei tessuti molli (ASPS) è una rara entità con prognosi sfavorevole e nessuna terapia standardizzata. Recentemente, sono state evidenziate risposte incoraggianti ai trattamenti con immune checkpoint inhibitors. Chen et al hanno pubblicato sul NEJM i risultati del loro trial multicentrico a braccio singolo di fase II, che ha esaminato l’attività di atezolizumab, anti PD-L1, in pazienti adulti e pediatrici affetti da ASPS avanzato. Atezolizumab è stato somministrato per via endovenosa ad un dosaggio di 1200 mg nei pazienti adulti e al dosaggio di 15 mg / Kg nei pazienti pediatrici, ogni 21 giorni. Gli endpoint comprendevano la proporzione di risposte obiettive, la durata della risposta, e la sopravvivenza libera da progressione (PFS).
Un totale di 52 pazienti è stato arruolato, e in 19/52 (37%) è stata evidenziata una risposta obiettiva, con 1 risposta completa e 18 risposte parziali. Il tempo mediano alla risposta è stato di 3.6 mesi, la durata della risposta mediana è stata di 24.7 mesi, e la PFS mediana è stata di 20.8 mesi. In particolare, 7/52 pazienti hanno interrotto il trattamento dopo due anni di terapia, e la loro risposta si è mantenuta fino al data cut-off.
Non si sono evidenziati eventi avversi di grado 4 o 5, e la risposta è stata evidenziata a prescindere dall’espressione del PD-L1/PD-1.
In conclusione, atezolizumab ha mostrato efficacia in circa un terzo dei pazienti con ASPS avanzato.
Cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy in patients with advanced ovarian cancer (OVHIPEC-1): final survival analysis of a randomised, controlled, phase 3 trial
Background: The OVHIPEC-1 trial previously showed that the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery resulted in improved progression-free and overall survival compared with cytoreductive surgery alone at 4·7 years of follow-up in patients with stage III epithelial ovarian cancer who were ineligible for primary cytoreduction. We report the final survival outcomes after 10 years of follow-up … (leggi tutto)
Il clinical trial OVHIPEC-1 aveva già dimostrato che l’aggiunta dell’HIPEC (chemioterapia intraperitoneale ipertermica) all’intervallo della chirurgica citoriduttiva migliora la sopravvivenza libera da progressione (PFS) e la sopravvivenza globale (OS) in confronto alla sola chirurgia, in un follow up di 4,7 anni in pazienti affette da carcinoma ovarico in stadio III non elegibili per citoriduzione primaria.
Recentemente sono stati pubblicati su Lancet gli outcome di sopravvivenza a 10 anni di follow up.
In questo studio di fase III open-label, randomizzato e controllato, pazienti con cancro ovarico in stadio III sono state arruolate in otto diversi centri tra Belgio e Olanda. Le pazienti eleggibili avevano un’età compresa tra i 18 e i 76 anni, non avevano mostrato una progressione dopo almeno 3 cicli di chemioterapia neoadiuvante a base di platino e paclitaxel, performance status tra 0 e 2, emocromo nei limiti, e una funzionalità renale nella norma. Le pazienti sono state randomizzate 1:1 a chirurgia citoriduttiva da sola o chirurgia + HIPEC con cisplatino a 100 mg/m2.
Endpoint primario era la PFS e l’endpoint secondario era l’OS. Tra Aprile 2007 ed Aprile 2016, circa 245 pazienti sono state oggetto di studio e con un follow up mediano di 10,1 anni (95% CI 8,4–12,9) nel gruppo sottoposto alla sola chirurgia (N=123), e 10,4 anni (95% CI 9,5–13,3) nel gruppo HIPEC (N=122).
Nel gruppo sottoposto alla sola chirurgia, il 93% delle pazienti ha avuto progressione o recidiva con un mPFS di 10,7 mesi (95% CI 9,6–12), contro 109 pazienti nel gruppo HIPEC 14,3 mesi (12,0–18,5); HR 0,63 (95% CI 0,48–0,83). Il decesso si è verificato in 108 donne del gruppo sottoposto alla sola chirurgia mOS 33,3 mesi (95%CI 29,0-39,1) e in 100 pazienti del gruppo HIPEC (44,9 mesi 95%CI 38,6-55,1) con un HR 0,70 (95%CI 0,53-0,92).
Tali risultati confermano il beneficio dell’utilizzo di HIPEC nelle pazienti con carcinoma ovarico in stadio III sottoposte a chirurgia citoriduttiva.
In Europa
Perioperative Durvalumab Plus Neoadjuvant Chemotherapy Results in Greater EFS and pCR in Patients with Resectable NSCLC Than Neoadjuvant Chemotherapy Alone
Nov 06, 2023 – In patients with resectable non-small cell lung cancer (NSCLC), perioperative durvalumab plus neoadjuvant chemotherapy, as compared with neoadjuvant chemotherapy alone, was associated with significantly better results with regard to the two primary endpoints of event-free survival (EFS) and pathological complete response (pCR), with a safety profile that was consistent with the individual agents, and had no detrimental effect … (leggi tutto)
Erdafitinib Prolongs Survival in Patients with Metastatic Urothelial Carcinoma and FGFR Alterations After Previous Anti–PD1(-L1) Treatment
Nov 03, 2023 – In a Cohort 1 of the phase III THOR study, treatment with erdafitinib resulted in significantly longer median overall survival (OS) than chemotherapy among patients with locally advanced or metastatic urothelial carcinoma with FGFR alterations after previous treatment with anti–PD1 or anti–PD-L1 therapy. Erdafitinib was also associated with a significantly longer median progression-free survival (PFS) and a greater likelihood of objective response than chemotherapy … (leggi tutto)
EMA encourages companies to submit type I variations for 2023 in November 2023
Nov 03, 2023 – EMA is advising marketing authorisation holders to submit type IA and type IAIN variations for 2023 no later than Thursday, 30 November 2023. This will enable EMA to acknowledge the validity of the submissions before the Agency’s closure between 25 December 2023 and 3 January 2024 and within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) … (leggi tutto)
Call for expressions of interest for patients’ organisations representatives to join Committee for Orphan Medicinal Products (COMP)
Nov 03, 2023 – The European Commission has launched a call for expressions of interest to represent patients’ organisations in EMA’s Committee for Orphan Medicinal Products (COMP). The call aims to fill three positions for COMP members nominated by the European Commission to represent patient organisations. The three members will be appointed for a term of three years from 1 July 2024 ... (leggi tutto)
Call for expression of interest for independent scientific experts to participate in the work of EMA’s Safety Committee
Nov 03, 2023 – The European Commission is launching a selection procedure to appoint independent scientific experts to EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). Six experts will be appointed for a three-year mandate starting on 2 July 2024. The deadline for submission of applications expires at 12:00, CET, on 7 December 2023. Current members may re-apply. … (leggi tutto)
EMA Recommends Extending Indications for Zanubrutinib to Include Treatment of Patients with Follicular Lymphoma
Nov 02, 2023 – On 12 October 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 zanubrutinib (Brukinsa). The marketing authorisation holder for this medicinal product is … (leggi tutto)
Tarlatamab Shows Promise in Patients with Previously Treated Small-Cell Lung Cancer
Oct 31, 2023 – In a phase II DeLLphi-301 study, tarlatamab had durable antitumour activity in patients with heavily pretreated small-cell lung cancer (SCLC). The study was designed to compare two active doses, which is consistent with the US Food and Drug Administration Project Optimus initiative to reform the dose-optimisation and dose-selection paradigm in the development of drugs in oncology ... (leggi tutto)
Dall’FDA
FDA Roundup: November 3, 2023
Nov 03, 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 announced that its Center for Devices and Radiological Health (CDRH) is seeking input from the public on advancing health equity and facilitating access to digital health technologies for detecting prediabetes and type 2 diabetes, particularly in racial and ethnic minorities. … (leggi tutto)
FDA Places Partial Clinical Hold on Phase 1 Trial of NX-2127 in R/R B-Cell Malignancies
Nov 02, 2023 – The FDA has placed a partial clinical hold on the phase 1 NX-2127-001 trial (NCT04830137) investigating the novel BTK degrader NX-2127 in patients with relapsed/refractory B-cell malignancies, according to an announcement from Nurix Therapeutics, Inc. The FDA’s decision follows Nurix’s communication of its intention to improve its manufacturing process … (leggi tutto)
FDA Approves Pembrolizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Biliary Tract Cancer
Nov 01, 2023 – The FDA has approved pembrolizumab (Keytruda) plus gemcitabine and cisplatin for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer. The decision is supported by findings from the phase 3 KEYNOTE-966 trial (NCT04003636), in which the chemoimmunotherapy combination significantly improved overall survival (OS) vs chemotherapy alone in this population … (leggi tutto)
FDA Grants Fast Track Designation to SLS009 for Relapsed/Refractory PTCL
Oct 31, 2023 – The FDA has granted a fast track designation to SLS009 (formerly GFH009) for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL), according to an announcement from SELLAS Life Sciences Group. The fast track designation … (leggi tutto)
FDA Lifts Clinical Hold on Phase 1 Trial Evaluating XMT-2056 in HER2-Expressing Solid Tumors
Oct 31, 2023 – The FDA has lifted the clinical hold placed on a phase 1 trial (NCT05514717) evaluating the HER2-directed, Immunosynthen STING agonist antibody-drug conjugate XMT-2056 as monotherapy in patients with HER2-high or -low advanced or recurrent solid tumors. On March 13, 2023, the FDA placed a clinical hold on the phase 1 trial following the voluntary suspension … (leggi tutto)
FDA Grants Breakthrough Therapy Designation to Furmonertinib for EGFR Exon 20 Insertion+ NSCLC
Oct 31, 2023 – The FDA has granted breakthrough therapy designation to furmonertinib (AST2818) for use as a potential therapeutic option in patients with previously untreated, locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. The decision is based on interim data from the phase 1b FAVOUR trial (NCT04858958) in which the agent elicited a confirmed objective response rate … (leggi tutto)
FDA Roundup: October 31, 2023
Oct 31, 2023 – Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA provided an update from our ongoing postmarket evaluation of Essure by posting interim results from the postmarket surveillance study, after all patients have completed three years of follow up. Five-year follow-up of patients in the study is ongoing … (leggi tutto)
Dall’ASCO
Solutions, Guidance for Oncologists During the Platinum Shortage
Nov 02, 2023 – Drug shortages have led to the abrupt discontinuation of patients receiving platinum-based chemotherapy and the increased use of alternative therapies.
Professional societies have joined together to provide clinical guidance for physicians treating patients with platinum-based therapies. Many academic institutions have created a comprehensive, streamlined approach, forming a committee to evaluate and provide solutions to the shortage. … (leggi tutto)
Early-Career Awards Gave Dr. Adam S. Feldman the Confidence to Continue
Nov 02, 2023 – The ASCO Genitourinary Cancers Symposium is a highlight of the year for Adam S. Feldman, MD, MPH, of Massachusetts General Hospital, and it has been for 2 decades. Dr. Feldman was among the group of multidisciplinary health care practitioners who attended the meeting in its inaugural year in 2005—then called the Multidisciplinary Prostate Cancer Symposium—where he was the recipient of a Merit Award for … (leggi tutto)
Understanding ADC Treatment Combinations for Gynecologic Cancer: What Oncologists Need to Know
Nov 01, 2023 – Combination antibody-drug conjugate (ADC) treatment involves combining an antibody that targets the surface receptor on malignant cells with an agent that delivers a cytotoxic payload directly to the cancerous tissue. Although ADCs have been approved for noninvestigative use in several cancers, including cervical and ovarian, their potential additive effects—whether beneficial or adverse—when combined with cytotoxic agents are only just beginning to be explored in the gynecologic cancer space … (leggi tutto)
Multicancer Detection Assays Promise to Improve Cancer Screening. But Do They Work?
Nov 01, 2023 – Multicancer detection (MCD) tests are available despite limited evidence on their clinical benefit, and none have received marketing authorization from the U.S. Food and Drug Administration (FDA). Clinicians faced with managing a positive MCD result currently have no roadmap for conducting a diagnostic work-up. To address these evidence gaps, the National Cancer Institute (NCI) … (leggi tutto)
Person-Centered Collaborative Care Reduces Disruptions in Cancer Care and Psychiatric Illness Severity in Patents With Serious Mental Illness
Nov 01, 2023 – Patients with serious mental illness and cancer are less likely to receive guideline-concordant care and have worse cancer outcomes than those without mental illness. The BRIDGE study found that a person-centered collaborative care model decreased cancer treatment disruptions and improved psychiatric illness severity and anxiety in patients with serious mental illness as compared with enhanced usual care … (leggi tutto)
Lazertinib Demonstrates Significant PFS Improvement in Advanced EGFR-Mutated NSCLC
Nov 01, 2023 – In LASER-301, lazertinib significantly improved progression-free survival (PFS) compared with gefitinib in the first-line treatment of EGFR-mutant advanced non–small cell lung cancer (NSCLC). Median PFS was 20.6 vs 9.7 months and median duration of response was 19.4 vs 8.3 months for lazertinib and gefitinib, respectively. Paresthesia occurred in 39% of patients who received lazertinib but was mostly grade 1 or 2 and … (leggi tutto)
Pillole dall’AIFA
03 novembre 2023 – Aggiornamento “Diario di bordo sulla Trasparenza”
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03 novembre 2023 – Attivazione web e pubblicazione schede di monitoraggio – Registro BLINCYTO (LLA Ph+)
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02 novembre 2023 – Topiramato: nuove restrizioni per prevenire l’esposizione durante la gravidanza
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02 novembre 2023 – Nota Informativa Importante su Integrilin (eptifibatide)
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31 ottobre 2023 – Elenco dei farmaci innovativi: AIFA pubblica l’aggiornamento di ottobre 2023
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31 ottobre 2023 – “From Theory to Practice: Implementing the EU Health Technology Assessment Regulation”
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31 ottobre 2023 – Attivazione web e pubblicazione schede di monitoraggio – Registro EQUINGAM
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31 ottobre 2023 – Nota Informativa Importante su Nadololo Cheplapharm
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