The efficacy and safety of treatment with cabozantinib in combination with nivolumab and ipilimumab in patients with previously untreated advanced renal-cell carcinoma are unknown. In this phase 3, double-blind trial, we enrolled patients with advanced clear-cell renal-cell carcinoma who had not previously received treatment and had intermediate or poor prognostic risk according to the International Metastatic Renal-Cell Carcinoma Database Consortium categories … (leggi tutto)

L’efficacia e la sicurezza della combinazione nivolumab più ipilimumab nei pazienti affetti da carcinoma renale a cellule chiare metastatico (RCC) è sconosciuta.
Motzer et al. hanno recentemente pubblicato uno studio sul NEJM col fine di valutare questo particolare setting di pazienti. Lo studio COSMIC-313 è uno trial di fase 3 randomizzato in doppio cieco che ha coinvolto pazienti con RCC avanzato naïve al trattamento e con rischio intermedio\sfavorevole secondo i criteri dell’International Metastatic Renal-Cell Carcinoma Database Consortium. I pazienti sono stati randomizzati a ricevere cabozantinib 40 mg con nivolumab e ipilimumab q21 per 4 settimane oppure placebo con la doppietta di immunoterapici.
Successivamente i pazienti hanno ricevuto nivolumab in mantenimento a dose flat di 480 mg q28 fino a due anni. Endpoint primario era la PFS, endpoint secondari l’OS.
Un totale di 855 pazienti è stato arruolato, di cui 428 sono stati assegnati al gruppo sperimentale e 427 al gruppo di controllo. La PFS a 12 mesi è stata 0,57 nel gruppo sperimentale e 0,49 nel braccio di controllo (HR 0.73; 95%CI, 0.57-0.94; P = 0.01). È stata evidenziata una risposta nel 43% dei pazienti del gruppo sperimentale e nel 36% dei pazienti del braccio di controllo. Eventi avversi di grado 3 e 4 sono stati riscontrati nel 79% dei pazienti del braccio sperimentale e nel 56% del gruppo placebo. Il follow up per l’OS è ancora in corso.
Pertanto nei pazienti con RCC avanzato naïve al trattamento e con rischio intermedio\sfavorevole il trattamento con cabozantinib e nivolumab+ipilimumab hanno dimostrato una PFS aumentata rispetto alla sola doppietta di inibitori degli ImmunoCheckpoint.

Interrupting Endocrine Therapy to Attempt Pregnancy after Breast Cancer

Prospective data on the risk of recurrence among women with hormone receptor-positive early breast cancer who temporarily discontinue endocrine therapy to attempt pregnancy are lacking. We conducted a single-group trial in which we evaluated the temporary interruption of adjuvant endocrine therapy to attempt pregnancy in young women with previous breast cancer … (leggi tutto)

Sono presenti pochi dati in letteratura riguardo la gravidanza in donne con anamnesi di carcinoma mammario ormonoresponsivo che devono pertanto interrompere la terapia ormonale adiuvante. Pagani et al hanno pubblicato recentemente i dati dello studio POSITIVE (Pregnancy Outcome and Safety of Interrupting Therapy for Women with Endocrine Responsive Breast Cancer) sul NEJM. Si tratta di uno studio a braccio singolo che ha valutato l’interruzione temporanea della terapia ormonale in donne che desideravano una gravidanza e avevano anamnesi positiva per carcinoma mammario. I criteri di inclusione comprendevano età inferiore ai 42 anni, stadio 1-3di malattia, aver ricevuto ormonoterapia dai 18 ai 36 mesi, e il desiderio di una gravidanza. End point primario era il numero di eventi correlati al tumore, definita come una recidiva locale o a distanza o controlaterale di carcinoma mammario invasivo durante il follow-up.
La coorte comprendeva 516 donne con età media pari a 37 anni, il tempo mediano dalla diagnosi oncologica all’arruolamento è stato di 29 mesi, e il 93,4% aveva avuto uno stadio I-II di cancro mammario. Tra le 497 donne che sono state seguite per lo stato di gravidanza, 368 (74,0%) hanno avuto almeno una gravidanza e 317 di loro (63,8%) hanno avuto almeno un parto con neonato in vita. Complessivamente il numero di nati vivi è stato pari a 365. Il follow-up mediano è stato di 41 mesi, 44 pazienti hanno avuto un evento correlato al tumore, e l’incidenza a tre anni (di eventi: ca mammario) è stata del 8.9% (95% CI, 6.3-11.6) nel gruppo sperimentale e del 9.2% (95% CI, 7.6-10.8) nel gruppo di controllo.
In conclusione, l’interruzione dell’ormonoterapia adiuvante per portare a termine il desiderio di maternità non ha dimostrato un aumento del rischio a breve termine di recidiva di malattia.
Un follow up più lungo è comunque necessario per valutare i risultati a lungo termine.

In Europa

Significant PFS Benefit in Patients with HR-positive, HER2-negative MBC Who Switched Endocrine Treatment and Received Ribociclib After Previous CDK4/6 Inhibitor and Different Endocrine Therapy

May 26, 2023 – MAINTAIN is the first randomised, placebo-controlled study to show the benefit of switching endocrine treatment and subsequent cyclin-dependent kinase 4/6 (CDK4/6) inhibitor after CDK4/6 inhibitor progression among patients with hormone receptor-positive, HER2-negative metastatic breast cancer (MBC). There was a 43% risk reduction in the hazard of progression or death with ribociclib in the … (leggi tutto)

Use of Immune Checkpoint Inhibitors is Safe and Effective in Patients with Cancer and HIV Even in Those on Antiretroviral Therapy

May 26, 2023 – In a retrospective study conducted by the Cancer Therapy Using Checkpoint Inhibitors in People Living With HIV-International (CATCH-IT) Consortium, 390 patients with cancer and HIV received immune checkpoint inhibitors (ICIs) while on antiretroviral therapy, including 30% of patients with baseline CD4-positive T-cell counts <200 cells/µL. ICIs were deemed safe and had differential activity across tumour types … (leggi tutto)

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 May 2023

May 26, 2023 – EMA’s human medicines committee (CHMP) recommended two medicines for approval at its May 2023 meeting. The committee recommended granting a marketing authorisation for Pylclari (piflufolastat (18F)), intended for the diagnosis of prostate cancer. The benefit of this medicinal product is its potential to diagnose prostate cancer during primary staging of patients at high risk and in the staging of patients with a suspected recurrence … (leggi tutto)

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 – 26 April 2023

May 26, 2023 – EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its April 2023 meeting. The CHMP recommended granting a marketing authorisation for Arexvy (recombinant, adjuvanted), the first vaccine for active immunisation to protect adults aged 60 years and older against lower respiratory tract disease caused by respiratory syncytial virus (RSV). RSV is a common respiratory virus that usually causes mild ... (leggi tutto)

Pralsetinib: Measures to Minimise Increased Risk for Tuberculosis

May 25, 2023 – Meeting highlights from the European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee held from 10 to 12 May 2023 consist of a direct healthcare professional communication (DHPC) that aims to inform healthcare professionals of the increased risk of tuberculosis and measures to minimise this risk, which was identified following a post-marketing review of pralsetinib (Gavreto) … (leggi tutto)

 


Patient-Reported Outcomes Support the Overall Benefit of Trastuzumab Deruxtecan for Patients with HER2-positive Metastatic Breast Cancer

May 24, 2023 – Patient-reported outcomes (PROs) data from the progression-free survival (PFS) analysis of DESTINY-Breast03 suggest that health-related quality-of-life (HRQoL) was sustained with trastuzumab deruxtecan across prespecified global measures and cancer-specific subscales, in accordance with its efficacy benefit in patients with HER2-positive metastatic breast cancer. In a phase III DESTINY-Breast03 study ... (leggi tutto)

Dall’FDA

FDA Roundup: May 26, 2023

May 26, 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 issued warning letters to firms responsible for two popular flavored, disposable e-cigarette products—Shenzen Innokin Technology Co. Ltd., who make Esco Bars products, and Breeze Smoke LLC, who import and distribute Breeze products. The e-cigarette firms that received warning letters today make … (leggi tutto)

FDA Grants Priority Review to Fruquintinib for Previously Treated mCRC

May 25, 2023 – he FDA has granted priority review to the new drug application (NDA) seeking the approval of fruquintinib (HMPL-013) for use in the treatment of adult patients with previously treated metastatic colorectal cancer (mCRC). The application was supported by findings from the phase 3 FRESCO-2 trial (NCT04322539)—conducted in the United States, Europe, Japan, and Australia—and the phase 3 FRESCO trial (NCT02314819), which was conducted in China … (leggi tutto)

FDA Grants Priority Review to Lumisight Optical Imaging Agent for Breast Cancer Detection

May 23, 2023 – The FDA has granted priority review to a new drug application seeking the approval of the optical imaging agent Lumisight (pegulicianine) for use in patients with breast cancer, according to an announcement from Lumicell, Inc.1 The agency also accepted a premarket approval application for the Lumicell Direct Visualization System (DVS) … (leggi tutto)

Dall’ASCO

Exploring Stereotactic Body Radiation Therapy for Patients With Oligorecurrent Prostate Cancer

May 26, 2023 – Parallel advances in radiation delivery techniques (stereotactic body radiation therapy [SBRT]) and molecular PET imaging have set the stage for evaluating the role of metastasis-directed therapy (MDT) with SBRT in oligorecurrent metastatic castrate-sensitive prostate cancer. Two landmark randomized phase 2 trials demonstrate the progression-free survival and androgen deprivation therapy (ADT)-free survival benefits of MDT in this setting … (leggi tutto)

Despite Challenges, HAI Is Beneficial in Colorectal Cancer at High Risk for Hepatic Recurrence

May 25, 2023 – A total of 99 patients underwent curative-intent surgery for 4 or more colorectal liver metastases and were treated with either HAI with oxaliplatin plus adjuvant IV fluorouracil/leucovorin or IV chemotherapy alone. With a median follow-up of 56 months, the median h-RFS was 25 months in the HAI-IV arm compared with 12 months in the IV chemotherapy arm. Approximately 58% of patients assigned to HAI-IV experienced grade 3/4 adverse events compared … (leggi tutto)

American College of Surgeons Evaluates the Impact of COVID-19 Pandemic on National Cancer Database Reporting

May 25, 2023 – New research from the American College of Surgeons (ACS) outlines significant ways that the COVID-19 pandemic destabilized usual patterns of cancer care, as reported in the National Cancer Database (NCDB). The NCDB is one of the largest cancer registries in the world and is used by thousands of hospitals and centers around the United States to inform and improve the quality of cancer care … (leggi tutto)

Lerociclib/Fulvestrant May Reduce Risk of Disease Progression in Advanced HR-Positive/HER2-Negative Breast Cancer

May 25, 2023 – LEONARDA-1 data indicate significantly greater progression-free survival with lerociclib/fulvestrant versus fulvestrant/placebo (HR 0.451; P < .001) in patients with HR-positive/HER2-negative advanced breast cancer. Most patients had at least 1 prior line of chemotherapy containing taxanes, anthracycline, or cyclophosphamide; 29.1% had received first-line chemotherapy in the recurrent and metastatic stage … (leggi tutto)

Survival Benefit of Tumor-Treating Fields in Newly Diagnosed Glioblastoma Confirmed in the Real-World Setting

May 25, 2023 – TTFields is a noninvasive therapeutic modality that delivers low-intensity electric fields of intermediate frequency to the treated area where a tumor grows. A meta-analysis of several studies assessed if there was a consistent survival benefit of TTFields in glioma in the real-world setting. The pooled median OS was 22.2 months for patients who received TTFields compared to 17.3 months for patients who did not receive TTFields … (leggi tutto)

TAPUR Study: Talazoparib May Have Antitumor Activity in Range of Solid Tumors With BRCA1/2 Mutations

May 25, 2023 – This study involved 1 cohort of TAPUR (28 patients). Patients had 16 types of solid tumors and somatic mutations in BRCA1 (9 patients), BRCA2 (16 patients), or both (3 patients), and some had mutations in other genes as well. Treatment with talazoparib resulted in a complete response for 1 patient and a partial response for 9 patients. Six patients had stable disease for at least 16 weeks. Median PFS in the cohort was 24 weeks, and the median … (leggi tutto)

Significant Survival Benefit Seen With IO-Based Regimens for Sarcomatoid and/or Rhabdoid Metastatic Non–Clear Cell RCC

May 25, 2023 – Sarcomatoid and rhabdoid (S/R) differentiation can occur across most RCC histologic subtypes, is found in approximately 10% to 15% of cases, and is usually associated with a poor prognosis. In a retrospective analysis of the IMDC database, first-line IO-based regimens were associated with significantly improved clinical outcomes compared with first-line VEGF-targeted therapy among patients with non–clear cell RCC with S/R differentiation  … (leggi tutto)

Pillole dall’AIFA

26 maggio 2023 – Aggiornamento “Diario di bordo sulla Trasparenza”
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26 maggio 2023 – EMA raccomanda la revoca dell’autorizzazione all’immissione in commercio di Adakveo
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26 maggio 2023 – Modifica Registro BRAFTOVI in associazione a MEKTOVI (melanoma)
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24 maggio 2023 – CdA AIFA chiede approfondimenti su rimborsabilità pillola anticoncezionale
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