Comitato scientifico editoriale: Giuseppe Aprile, Consuelo Buttigliero, Paolo Carlini, Maria Vittoria Dieci, Massimo Di Maio, Raffaele Giusti, Sara Lonardi, Domenica Lorusso, Cristina Masini, Laura Noto, Silvia Novello, Filippo Pietrantonio, Giuseppe Procopio, Daniele Santini Editore: Intermedia – Direttore Responsabile: Mauro Boldrini
Oggi in Oncologia
Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial
Late-line treatment options for patients with ovarian cancer are few, with the proportion of patients achieving an overall response typically less than 10%, and median overall survival after third-line therapy of 5-9 months. In this study (QUADRA), we investigated the activity of niraparib monotherapy as the fourth or later line of therapy. QUADRA was a multicentre, open-label, single-arm, phase 2 study that evaluated the safety and activity of niraparib in adult patients … (leggi tutto)
Lo studio descrive l’attività di niraparib come agente singolo in una popolazione di 463 pazienti con tumori ovarici sierosi di alto grado, pretrattate con almeno tre precedenti linee di chemioterapia (mediana 4 nelle pazienti arruolate). Il farmaco ha fatto registrare un tasso di risposta del 28% in una popolazione che per il 33% aveva arruolato pazienti resistenti e per il 35% refrattarie alla chemioterapia a base di platino. L’anemia e la piastrinopenia si confermano le tossicità più frequenti e più gravi del trattamento. Lo studio è l’ulteriore conferma dell’attività dei PARP inibitori non solo nel setting del mantenimento, ma anche quando utilizzati come agenti singoli a potenzialmente rappresentare un cambio di paradigma in un trattamento che sempre più in futuro sarà chemo-free.
Immune Checkpoint Inhibitor Outcomes for Patients With Non-Small-Cell Lung Cancer Receiving Baseline Corticosteroids for Palliative Versus Nonpalliative Indications
Baseline use of corticosteroids is associated with poor outcomes in patients with non-small-cell lung cancer (NSCLC) treated with programmed cell death-1 axis inhibition. To approach the question of causation versus correlation for this association, we examined outcomes in patients treated with immunotherapy depending on whether corticosteroids were administered for cancer-related palliative reasons or cancer-unrelated indications. Clinical outcomes in patients with … (leggi tutto)
Negli ultimi tempi, molta letteratura è stata prodotta sull’associazione tra dose di corticosteroidi eventualmente assunti dal paziente al momento dell’eventuale inizio del trattamento immunoterapico ed efficacia di quest’ultimo. Varie casistiche pubblicate documentano un outcome peggiore per i pazienti che ricevano dose superiore a quella oggi consentita dalle schede tecniche dei farmaci immunoterapici (vale a dire, 10 mg di prednisone al giorno o equivalenti). Gli autori della recente pubblicazione sul Journal of Clinical Oncology si sono chiesti se l’impatto negativo sulla prognosi sia dovuto alla immunosoppressione direttamente determinata dai corticosteroidi (e quindi ad una minore efficacia del trattamento immunoterapico), o se l’associazione non sia in realtà confusa dall’impatto prognostico negativo delle condizioni cliniche per le quali quei corticosteroidi sono somministrati (ad esempio, metastasi cerebrali, problematiche respiratorie, ecc.). Per farlo, hanno preso in considerazione una grossa casistica di pazienti con tumore del polmone NSCLC trattati con immunoterapia, dividendoli sulla base dell’impiego di corticosteroidi basali in 3 gruppi: nessuna assunzione o dose sotto la soglia di 10 mg di prednisone; dose sopra la soglia, per motivi legati alla patologia tumorale; dose sopra la soglia, per motivi indipendenti dalla patologia tumorale (es. per patologie concomitanti). Le analisi di sopravvivenza confermano la peggiore prognosi per i pazienti che ricevono corticosteroidi al basale, ma suggeriscono che l’impatto prognostico negativo sia limitato ai casi che assumono i corticosteroidi per situazioni cliniche legate alla malattia tumorale. Gli autori suggeriscono quindi che l’associazione tra corticosteroidi ed efficacia dell’immunoterapia possa essere confusa dall’impatto prognostico delle condizioni cliniche per le quali il trattamento con steroidi viene impiegato.
In Europa
Talazoparib Approved in Europe for BRCA-Mutant Breast Cancer
June 21, 2019 – The European Commission has approved single-agent talazoparib for the treatment of adult patients with germline BRCA1/2-mutant, HER2-negative locally advanced or metastatic breast cancer. The approval is based on findings from the phase III EMBRACA study, in which talazoparib led to a 46% reduction in the risk of disease progression a median compared with standard chemotherapy in patients with germline BRCA1/2-mutant, HER2-negative … (leggi tutto)
Frontline Maintenance Olaparib Approved in Europe for Ovarian Cancer
June 18, 2019 – The European Commission has approved olaparib as a single agent for the maintenance treatment of adult patients with advanced BRCA1/2-mutated germline and/or somatic high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response (PR) following first-line platinum-based chemotherapy. The approval is based on findings from the double-blind, phase III SOLO-1 trial, in which maintenance olaparib led to … (leggi tutto)
Highlights of Management Board meeting: June 2019
June 17, 2019 – At its 12-13 June meeting, the Board heard an update on EMA’s first three months in its temporary building in Amsterdam Sloterdijk and the preparations for the Agency’s move to its final premises in the Zuidas area of Amsterdam. Construction of the new building is expected to be completed by November 2019 and EMA staff are expected to move in as of 6 January 2020. The Board was also informed about the uncertainty regarding the final number of staff … (leggi tutto)
Dall’FDA
FDA Issues Complete Response Letter for Quizartinib in AML
June 21, 2019 – The FDA has issued a complete response letter to Daiichi Sankyo informing the company that its new drug application (NDA) would not be approved for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia (AML). The final decision follows a May 2019 recommendation from the FDA’s Oncologic Drugs Advisory Committee (ODAC). The panel voted 8 to 3 that the available data did not definitively … (leggi tutto)
Statement on the FDA’s benefit-risk framework for evaluating opioid analgesics
June 20, 2019 – Addressing the crisis of opioid addiction is an issue of great concern for our nation and remains a top public health priority for the FDA. The agency continues to take new steps to confront this crisis, while also paying careful attention to the needs of patients in accessing appropriate pain management. Opioids present unique challenges: they have benefits when used as prescribed yet have very serious risks and can cause enormous harm when misused and abused … (leggi tutto)
Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs
June 18, 2019 – The U.S. Food and Drug Administration is committed to helping facilitate American patients’ access to lower-cost generic medicines by taking steps to enhance and streamline the development and approval process of high-quality generic drugs. The U.S. already has one of the most effective and efficient generic markets in the world. Generic drugs represented 90% of U.S. prescriptions dispensed in 2017, and the FDA approved or tentatively approved … (leggi tutto)
FDA Approves Pembrolizumab for Metastatic SCLC
June 18, 2019 – The FDA has granted an accelerated approval to single-agent pembrolizumab for the treatment of patients with metastatic small cell lung cancer (SCLC) who have disease progression on or after platinum-based chemotherapy and ≥1 other prior line of therapy. The approval is based on pooled results from cohorts of the phase II KEYNOTE-158 and phase Ib KEYNOTE-028 trials, which demonstrated that the PD-1 inhibitor elicited a 19% overall response rate … (leggi tutto)
Dall’ASCO
U.S. Cancer Survivors Numbered Nearly 17 Million at the Start of 2019
June 17, 2019 – There were more than 16.9 million Americans with a history of cancer on January 1, 2019, and that number is projected to reach more than 22.1 million by 2030 based on the growth and aging of the population alone, according to estimates from Cancer Treatment and Survivorship Statistics, 2019. The report is produced every 3 years by the American Cancer Society in collaboration with the National Cancer Institute to help the public health community … (leggi tutto)
Dal mondo
Olaparib Approved in Japan for Frontline Maintenance in Ovarian Cancer
June 19, 2019 – Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approved olaparib as a maintenance treatment for patients with BRCA-mutant ovarian cancer after undergoing first-line chemotherapy. The approval was based on findings from the randomized, double-blinded, phase III SOLO-1 study, in which maintenance olaparib significantly improved progression-free survival (PFS) compared with placebo in this patient population following frontline platinum-based … (leggi tutto)
Quizartinib Receives Japanese Approval in Relapsed/Refractory FLT3+ AML
June 18, 2019 – The Ministry of Health, Labor and Welfare (MHLW) of Japan has approved quizartinib for the treatment of adult patients with relapsed/refractory FTL3-ITD–positive acute myeloid leukemia (AML), as detected by an MHLW-approved assay. The approval of the second-generation FLT3 inhibitor is mostly based on the phase III findings of the QuANTUM-R trial, as well as a phase II study, which demonstrated that oral quizartinib monotherapy showed a statistically significant … (leggi tutto)
Entrectinib Breaks Through With Japanese Approval for NTRK-Positive Tumors
June 18, 2019 – Entrectinib received its first regulatory approval, as Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the drug for the treatment of adult and pediatric patients with NTRK fusion–positive, advanced recurrent solid tumors. The MHLW based its decision on data from the phase II STARTRK-2, phase I STARTRK-1, and phase I ALKA-372-001 trials, as well as findings from the phase I/II STARTRK-NG pediatric study. In STARTRK-2, specifically … (leggi tutto)
Pillole dall’Aifa
21 giugno 2019 – Carenza Procarbazina cloridrato (Leadiant) – modalità di richiesta d’Importazione dall’estero
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