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Short Communication

Regorafenib in patients with refractory metastatic pancreatic cancer: a Phase II study (RESOUND)

    Silvia Bozzarelli

    Medical Oncology & Hematology Unit, Humanitas Cancer Center, Humanitas Clinical & Research Center, IRCCS, Rozzano, Milan, 20089, Italy

    ,
    Lorenza Rimassa

    *Author for correspondence: Tel.: +39 028 224 4573;

    E-mail Address: lorenza.rimassa@hunimed.eu

    Medical Oncology & Hematology Unit, Humanitas Cancer Center, Humanitas Clinical & Research Center, IRCCS, Rozzano, Milan, 20089, Italy

    Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, 20090, Italy

    ,
    Laura Giordano

    Biostatistics Unit, Humanitas Cancer Center, Humanitas Clinical & Research Center, IRCCS, Rozzano, Milan, 20089, Italy

    ,
    Simona Sala

    Medical Oncology & Hematology Unit, Humanitas Cancer Center, Humanitas Clinical & Research Center, IRCCS, Rozzano, Milan, 20089, Italy

    ,
    Maria Chiara Tronconi

    Medical Oncology & Hematology Unit, Humanitas Cancer Center, Humanitas Clinical & Research Center, IRCCS, Rozzano, Milan, 20089, Italy

    ,
    Tiziana Pressiani

    Medical Oncology & Hematology Unit, Humanitas Cancer Center, Humanitas Clinical & Research Center, IRCCS, Rozzano, Milan, 20089, Italy

    ,
    Valeria Smiroldo

    Medical Oncology & Hematology Unit, Humanitas Cancer Center, Humanitas Clinical & Research Center, IRCCS, Rozzano, Milan, 20089, Italy

    ,
    Maria G Prete

    Medical Oncology & Hematology Unit, Humanitas Cancer Center, Humanitas Clinical & Research Center, IRCCS, Rozzano, Milan, 20089, Italy

    ,
    Paola Spaggiari

    Anatomic Pathology Unit, Humanitas Clinical & Research Center, IRCCS, Rozzano, Milan, 20089, Italy

    ,
    Nicola Personeni

    Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, 20090, Italy

    &
    Armando Santoro

    Medical Oncology & Hematology Unit, Humanitas Cancer Center, Humanitas Clinical & Research Center, IRCCS, Rozzano, Milan, 20089, Italy

    Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, 20090, Italy

    Published Online:https://doi.org/10.2217/fon-2019-0480

    Aim: Regorafenib may be active in different cancer types. This Phase II trial included patients with various refractory cancer types treated with regorafenib. Here, we report the results of the pancreatic adenocarcinoma cohort. Methods: The primary end point was progression-free survival (PFS) rate at 8 weeks; further investigation of regorafenib would be warranted with a PFS rate ≥50%. Results: A total of 20 patients were enrolled. The best response was stable disease in four patients (20%). The 8-week PFS rate was 25% with a median PFS of 1.7 months (95% CI: 1.5–2.0). A total of 13 patients (65%) experienced grade 3–4 treatment-related adverse events. Conclusion: The study did not meet its primary end point. Further investigation of regorafenib monotherapy in this setting is not recommended.

    Clinical Trial Registration: NCT02307500

    Papers of special note have been highlighted as: • of interest; •• of considerable interest

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