Off-target effects and clinical outcome in metastatic colorectal cancer patients receiving regorafenib: The TRIBUTE analysis.

Autor: Giampieri R; Medical Oncology, University Hospital and Polytechnic University of the Marche, Ancona Italy., Prete MD; Medical Oncology, University Hospital and Polytechnic University of the Marche, Ancona Italy., Prochilo T; Fondazione Poliambulanza Hospital, Brescia, Italy., Puzzoni M; Medical Oncology, University Hospital and University of Cagliari, Cagliari, Italy., Pusceddu V; Medical Oncology, University Hospital and University of Cagliari, Cagliari, Italy., Pani F; Endocrinology Unit, University Hospital and University of Cagliari, Cagliari, Italy., Maccaroni E; Medical Oncology, University Hospital and Polytechnic University of the Marche, Ancona Italy., Mascia R; Medical Oncology, University Hospital and University of Cagliari, Cagliari, Italy., Baleani MG; Medical Oncology, University Hospital and Polytechnic University of the Marche, Ancona Italy., Meletani T; Medical Oncology, University Hospital and Polytechnic University of the Marche, Ancona Italy., Berardi R; Medical Oncology, University Hospital and Polytechnic University of the Marche, Ancona Italy., Lanzillo AM; Medical Oncology, Azienda Ospedaliera 'Brotzu' Cagliari, Italy., Mariotti S; Endocrinology Unit, University Hospital and University of Cagliari, Cagliari, Italy., Zaniboni A; Fondazione Poliambulanza Hospital, Brescia, Italy., Cascinu S; Medical Oncology, University Hospital and University of Modena and Reggio Emilia, Modena, Italy., Scartozzi M; Medical Oncology, University Hospital and University of Cagliari, Cagliari, Italy.
Jazyk: angličtina
Zdroj: Scientific reports [Sci Rep] 2017 Apr 05; Vol. 7, pp. 45703. Date of Electronic Publication: 2017 Apr 05.
DOI: 10.1038/srep45703
Abstrakt: Regorafenib is an orally administered multikinase inhibitor indicated for the treatment of heavily pretreated metastatic colorectal cancer patients with good performance status, albeit less than 50% treated patients achieve disease stabilisation or better at the first radiological evaluation. In addition to that a particularly broad spectrum of toxicities (experienced as G3 or more NCI CTCAE graded by 50% of patients treated) have led to reconsider its widespread use in the majority of patients. We retrospectively collected data about the magnitude of off-target effects experienced during the first 8-weeks of regorafenib monotherapy and analysed their correlation with overall survival, progression free survival and disease control rate. Our findings suggest that skin rash (Exp (B): 0.52, p = 0.0133) or hypothyroidism (Exp (B): 0.11, p = 0.0349) were significantly correlated with improved overall survival at multivariate regression analysis. It was also demonstrated a statistically significant role of diarrhea as predictor of improved survival but its independent prognostic role was lost at multivariate analysis (Exp (B): 0.63, p = 0.162). This is the first analysis showing a potential correlation between the onset of these forms of side effects and regorafenib efficacy, however sample size limitations and the retrospective nature of our analysis prevent us from drawing definitive conclusions.
Databáze: MEDLINE