Comitato scientifico editoriale: Giuseppe Aprile, Consuelo Buttigliero, Paolo Carlini, Maria Vittoria Dieci, Massimo Di Maio, Raffaele Giusti, Domenica Lorusso, Cristina Masini, Laura Noto, Silvia Novello, Giuseppe Procopio, Daniele Santini Editore: Intermedia – Direttore Responsabile: Mauro Boldrini
Oggi in Oncologia
Efficacy and safety results from GEICO 1205, a randomized phase II trial of neoadjuvant chemotherapy with or without bevacizumab for advanced epithelial ovarian cancer
Bevacizumab is an approved treatment after primary debulking surgery for ovarian cancer. However, there is limited information on bevacizumab added to neoadjuvant chemotherapy before interval debulking surgery. To evaluate neoadjuvant bevacizumab in a randomized phase II trial. Patients with newly diagnosed stage III/IV high-grade serous/endometrioid ovarian cancer were randomized to receive four cycles of neoadjuvant chemotherapy with or without ≥3 cycles of … (leggi tutto)
L’articolo riporta i risultati di uno studio randomizzato di fase 2 che ha voluto testare efficacia e sicurezza del bevacizumab in combinazione alla chemioterapia con carbotaxolo nel setting neoadiuvante nel carcinoma dell’ovaio avanzato. L’endpoint principale dello studio era il tasso di risposta macroscopica completa alla chirurgia di intervallo e non è stato raggiunto, come non sono emerse differenze in termini di tasso di citoriduzione tra i due gruppi e sopravvivenza libera da progressione. Lo studio ha di contro dimostrato che non ci sono eventi avversi aggiuntivi nel gruppo di pazienti trattate con il bevacizumab in neoadiuvante a significare che il trattamento è fattibile in termini di safety ma non sembra aggiungere niente alla chemioterapia in termini di efficacia. Il mancato raggiungimento dell’endpoint primario potrebbe essere correlato al basso numero di pazienti arruolate, anche in considerazione del fatto che gli studi di seconda linea documentano un aumento del tasso di risposta del 20% quando bevacizumab viene combinato alla chemioterapia rispetto alla chemioterapia da sola. Ciononostante ad oggi non abbiamo evidenze scientifiche a supporto dell’uso del bevacizumab in neoadiuvante nel tumore ovarico avanzato.
Has the Quality of Patient-Provider Communication About Survivorship Care Improved?
The aim of the current study was to assess whether the quality of patient–provider communication on key elements of cancer survivorship care changed between 2011 and 2016. Participating survivors completed the 2011 or 2016 Medical Expenditure Panel Survey Experiences with Cancer Surveys (N = 2,266). Participants reported whether any clinician ever discussed different aspects of survivorship care. Responses ranged from “Did not discuss at all” to “Discussed it with me in … (leggi tutto)
I dati documentano che, per fortuna, il numero di pazienti che vivono a lungo dopo una diagnosi di cancro (spesso definiti con il termine “survivors” nella letteratura anglosassone) è in continuo aumento, grazie alle diagnosi precoci e al miglioramento delle terapie disponibili. Gli argomenti che è opportuno siano oggetto di adeguata comunicazione tra i clinici e tali pazienti sono molteplici, dalle implicazioni sociali ed emotive all’eventuale gestione della tossicità a lungo termine, alle raccomandazioni di stili di vita e comportamenti salutari, solo per citarne alcuni. C’è il rischio, però, che a fronte di una intensiva comunicazione sui temi legati alla gestione “acuta” della malattia e del suo trattamento, ci sia meno spazio per la comunicazione su questi temi di grande importanza per chi vivrà molta parte della sua vita essendosi lasciato alle spalle la fase acuta della diagnosi e del trattamento. Gli autori della recente pubblicazione del Journal of Oncology Practice presentano i risultati di un’interessante survey, condotta negli Stati Uniti, e ripetuta a distanza di 5 anni (nel 2011 e nel 2016), consentendo così di descrivere anche eventuali cambiamenti (auspicabilmente in positivo) nella comunicazione su questi temi. Ebbene, i risultati sono largamente deludenti, in quanto una elevata percentuale di soggetti rispondeva, sia nel 2011 che nel 2016, di aver parlato molto brevemente (o di non aver discusso affatto) a proposito di uno o più dei temi suddetti. In particolare, il 35% dei “survivors” dichiarava, nel 2011, di non aver ricevuto informazioni dettagliate sul follow-up, il 54% sulle tossicità a lungo termine, il 59% sulle raccomandazioni relative agli stili di vita e il 69% a proposito delle problematiche sociali ed emotive. Nel 2016, le percentuali rimanevano simili (rispettivamente il 35%, il 56%, il 58% ed il 68%). Soltanto il 24% dei rispondenti nel 2011 e il 22% dei rispondenti nel 2016 dichiarava di aver potuto discutere tutti i suddetti argomenti. Si tratta, naturalmente, di una indagine condotta negli Stati Uniti, ma utile per riflettere sui margini di miglioramento necessari anche nella nostra pratica quotidiana.
Fear of Cancer Recurrence: A Model Examination of Physical Symptoms, Emotional Distress, and Health Behavior Change
Fear of cancer recurrence is highly prevalent among adult survivors of cancer. The role of fear of recurrence in the emotional distress of survivors of cancer, as well as health behaviors that may directly affect their health, remains unclear. To advance oncology practice, this study sought to examine the extent to which fear of recurrence stemming from physical symptoms accounts for emotional distress in a large sample of adult survivors of cancer and to extend the … (leggi tutto)
Il lavoro deve essere interpretato nel panorama internazionale, nel quale il numero di lungosopravviventi e pazienti potenzialmente guariti dalla malattia oncologica sta progressivamente aumentando. Lo studio americano punta i riflettori sulla valutazione oggettiva della paura della recidiva di malattia dei pazienti che hanno completato l’iter chirurgico e le successive terapie adiuvanti, suggerendo di integrare tale valutazione nel survivorship care plan. Infatti, la paura della recidiva non solo può causare distress emotivo ma anche condizionare i futuri comportamenti del soggetto, correlandosi a un significativo incremento del consumo alcolico e a una diminuzione della attività fisica quotidiana. Gli autori lasciano intendere che potrebbe essere utile, in pazienti con elevato livello di ansia e timore, una valutazione psicologica per eventualmente organizzare un intervento specifico: in altri contesti sono stati avviati progetti ad hoc che prevedono un approccio vis-a-vis (programma CALM praticato al Princess Margaret Cancer Centre di Toronto e programma Conquer the fear presentato all’ASCO) o in remoto con interazione on-line medico-paziente (programma STREAM). Per un approfondimento si suggerisce la lettura di Butow P, et al. “Fear of Cancer Recurrence: A Practical Guide for Clinicians” Oncology 2018 Jan 15;32(1):32 (leggi testo integrale).
In Europa
First ‘histology-independent’ treatment for solid tumours with a specific gene mutation
July 26, 2019 – EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for larotrectinib for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. Treatment with larotrectinib is recommended for patients whose disease has spread or cannot be surgically removed, and who have no other satisfactory treatment options. Larotrectinib … (leggi tutto)
TAS-102 Nears EU Approval for Gastric Cancer
July 26, 2019 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has backed approval of TAS-102 (trifluridine/tipiracil) for the treatment of adult patients with metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction (GEJ), following treatment with at least 2 prior systemic regimens for advanced disease. The CHMP based its positive opinion on the phase III TAGS trial, in which TAS-102 … (leggi tutto)
Paediatric Committee elects Koenraad Norga as its new chair
July 24 2019 – At its July 2019 meeting, EMA’s paediatric committee (PDCO) elected Koenraad Norga from Belgium as its new chair, for a three-year mandate starting in September. Professor Norga will replace Dr Dirk Mentzer who is retiring as PDCO Chair, having served the maximum of two three-year mandates. Professor Norga was nominated to the PDCO by the Federal Agency for Medicines and Health Products (FAMHP) in Belgium and is head of paediatric oncology at … (leggi tutto)
Dall’FDA
FDA Grants Priority Review to Tazemetostat for Epithelioid Sarcoma
July 25, 2019 – The FDA has granted a priority review to a new drug application (NDA) for tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery, according to Epizyme, the manufacturer of the EZH2 inhibitor. The NDA is based on data from the epithelioid sarcoma cohort of a phase II trial (NCT02601950) that were presented at the 2019 ASCO Annual Meeting. Among 62 patients with … (leggi tutto)
CAR T-Cell Therapy MB-102 Granted FDA Orphan Drug Designation for AML
July 24, 2019 – The CAR T-Cell therapy MB-102 has been granted an Orphan Drug Designation by the FDA, according to Mustang Bio, Inc, the manufacturer of the investigational treatment. MB-102, which targets CD123, previously received Orphan Drug status for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The designation incentivizes the development of novel therapies for rare diseases (<200,000 US cases) or diseases for … (leggi tutto)
FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market
July 24, 2019 – The U.S. Food and Drug Administration today took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL. Following the agency’s request, Allergan has notified the FDA that it is moving forward with a worldwide … (leggi tutto)
FDA Approves Rituximab Biosimilar for CD20+ B-Cell Non-Hodgkin Lymphoma and CLL
July 23, 2019 – The FDA has approved PF-05280586 (rituximab-pvvr), a biosimilar for rituximab, for the treatment of adult patients with CD20-positive B-cell non-Hodgkin lymphoma as a single agent or in combination with chemotherapy, or for patients with CD20-positive chronic lymphocytic leukemia (CLL) in combination with chemotherapy. Additionally, this is the first biosimilar approved to treat patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangitis … (leggi tutto)
FDA Grants Breakthrough Designation to Frontline Pembrolizumab/Lenvatinib for HCC
July 23, 2019 – The FDA has granted a breakthrough therapy designation to the combination of pembrolizumab and lenvatinib for the first-line treatment of patients with advanced unresectable hepatocellular carcinoma (HCC) that is not amenable to locoregional therapy. The designation is based on updated interim findings from the phase Ib KEYNOTE-524/Study 116 trial. Earlier interim data, which were presented at the 2019 AACR Annual Meeting, showed that the combination … (leggi tutto)
FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety
July 23, 2019 – Today, the U.S. Food and Drug Administration announced that it has issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases. “As we examine potential regulatory pathways for the lawful marketing of products containing … (leggi tutto)
FDA Updates Durvalumab NSCLC Label to Include OS Data
July 22, 2019 – The FDA has updated the label for durvalumab for patients with unresectable, stage III non–small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemoradiation to include overall survival (OS) data from the phase III PACIFIC trial. In results of the primary OS analysis, the PD-1 inhibitor demonstrated a 32% reduction in the risk of death compared with placebo, which was a significant and clinically … (leggi tutto)
Searching for Novel Agents to Augment Atezolizumab Approval in Small Cell Lung Cancer
July 22, 2019 – Despite the integration of frontline immunotherapy into routine practice for patients with extensive-stage small cell lung cancer (SCLC), researchers are still searching for agents with a high clinical impact that do more than fill a space of unmet need, explained Stephen V. Liu, MD. “The only study we have that has shown a survival benefit is the IMpower133 trial, which tested the addition of atezolizumab to standard carboplatin and etoposide followed by atezolizumab … (leggi tutto)
FDA launches its first youth e-cigarette prevention TV ads, plans new educational resources as agency approaches one-year anniversary of public education campaign
July 22, 2019 – Today, the U.S. Food and Drug Administration is announcing the launch of its first e-cigarette prevention TV ads educating kids about the dangers of e-cigarette use. The FDA also plans to provide new posters for high schools and educational materials for middle schools across the U.S. as part of “The Real Cost” Youth E-Cigarette Prevention Campaign. The public education effort was first launched in September 2018 with hard-hitting advertising on … (leggi tutto)
Dall’ASCO
No Man Is an Island: Reflections From an ASCO IDEA Recipient
July 25, 2019 – IT WAS a chilly Chicago morning, and I was sitting at the lobby of my hotel when I saw a smiling gentleman cheerfully waving at me from his car. It was Lawrence H. Einhorn, MD, picking me up for our drive to Indiana. I was one of the recipients of the ASCO International Development and Education Award (ASCO-IDEA) Program. The IDEA provides support for early-career oncologists in low- and middle-income countries to be able to attend the ASCO Annual … (leggi tutto)
How the ASCO Breakthrough Global Summit Is Bringing Together Innovators to Transform Cancer Care
July 25, 2019 – Earlier this year, ASCO announced plans for its first-ever international meeting, ASCO Breakthrough: A Global Summit for Oncology Innovators, which will be held October 11–13, 2019, in Bangkok, Thailand. The meeting is a joint effort by ASCO and the Thai Society of Clinical Oncology to bring together leaders in a variety of fields, including information and computer science, artificial intelligence (AI), basic and translational research, social media, and … (leggi tutto)
Statistics Show Increase in US Cancer Survivors
July 22, 2019 – The growth and aging of the population combined with advances in the early detection and treatment of cancer have resulted in a growing population of survivors across the nation, according to a study from the American Cancer Society and the National Cancer Institute. In addition, cancer rates are declining in men and stabilizing in women. The report indicates that more than 16.9 million Americans with a history of cancer were alive as of January 1, 2019. It projects that … (leggi tutto)
Pillole dall’Aifa
26 luglio 2019 – Sunset Clause – Warning di prossima decadenza del 26 luglio 2019
Editore: Intermedia s.r.l. – Via Malta 12/b, 25124 Brescia – tel. 030 226105 fax 030 2420472 – Reg. Trib. di Brescia n. 35/2001 del 2/7/2001 Per contattare la redazione e commentare le notizie clicca qui: redazione Per consultare i numeri arretrati della newsletter clicca qui: archivio Per sospendere la ricezione di questa newsletter clicca qui: AIOM news RIMUOVI