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Haematology and Oncology

Regorafenib in hepatocellular carcinoma: latest evidence and clinical implications

Authors: Nicola Personeni MD, Tiziana Pressiani MD, Armando Santoro MD, Lorenza Rimassa MD

Over the past ten years, sorafenib has been the only systemic agent approved for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC) and in a second-line setting, most investigational drugs have failed to provide better survival outcomes than placebo. However, in 2016, data from the RESORCE trial, a phase 3 study evaluating regorafenib in HCC patients who experience disease progression after first-line treatment with sorafenib, have shown a 2.8-month median survival benefit over placebo (10.6 versus 7.8 months).

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Immunotherapy in renal cell carcinoma: latest evidence and clinical implications

Authors: Matteo Santoni MD, Francesco Massari MD, Vincenzo Di Nunno MD, Alessandro Conti MD, Alessia Cimadamore MD, Marina Scarpelli MD, Rodolfo Montironi PhD, Liang Cheng PhD, Nicola Battelli MD, Antonio Lopez-Beltran PhD

This editorial describes the results of the most recent clinical trials on the use of immunotherapies in renal cell carcinoma and research for reliable biomarkers of tumour response in this setting, as well as the role of the gut microbiome and tumour microenvironment in the development of future therapeutic strategies.

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Treatment with combined dabrafenib and trametinib in BRAFV600E-mutated metastatic malignant melanoma: a case of long-term complete response after treatment cessation

Authors: Sonia Brugnara, Mariacristina Sicher, Elena Maria Bonandini, Davide Donner, Franca Chierichetti, Mattia Barbareschi, Carlo Renè Girardelli, Orazio Caffo

The case report discusses a patient, diagnosed with BRAFV600E-mutated metastatic malignant melanoma M1a, who achieved a complete metabolic response after 7 months of treatment with the combination of dabrafenib and trametinib.

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Harnessing the immune system in the battle against breast cancer

Authors: Elizabeth S Nakasone MD, PhD, Sara A Hurvitz MD, Kelly E McCann MD, PhD

This article examines the major approaches to immunotherapy in breast cancers, both successes and failures, as well as new therapies on the horizon.

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Approving cancer treatments based on endpoints other than overall survival: an analysis of historical data using the PACE Continuous Innovation Indicators™ (CII)

Authors: Neon Brooks, Mario Campone, Silvia Paddock, Scott Shortenhaus, David Grainger, Jacqueline Zummo, Samuel Thomas, Rose Li

This article examines the relationship between U.S. Food and Drug Administration (FDA) approval and the publication of OS evidence to understand better the risks and benefits of delaying approval until OS evidence is available.

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