Kyung Kim1, Reena Jha2, Petra A Prins1,3, Hongkun Wang1,4, Monica Chacha1, Marion L Hartley1,3, Aiwu Ruth He5,6,7. 1. Georgetown University Hospital, 3800 Reservoir Road, N.W., Washington, DC, 20007, USA. 2. Department of Radiology, Georgetown University Hospital, CCC Building, 3800 Reservoir Road, N.W., Washington, DC, 20007, USA. 3. The Ruesch Center for the Cure of Gastrointestinal Cancers, 3800 Reservoir Road, Washington, DC, 20007, USA. 4. Department of Biostatistics, Bioinformatics, and Biomathematics, 4000 Reservoir Road, N.W., Washington, DC, 20057, USA. 5. Georgetown University Hospital, 3800 Reservoir Road, N.W., Washington, DC, 20007, USA. Aiwu.R.He@gunet.georgetown.edu. 6. The Ruesch Center for the Cure of Gastrointestinal Cancers, 3800 Reservoir Road, Washington, DC, 20007, USA. Aiwu.R.He@gunet.georgetown.edu. 7. Georgetown Lombardi Comprehensive Cancer Center, 3800 Reservoir Road, N.W., Washington, DC, 20057, USA. Aiwu.R.He@gunet.georgetown.edu.
Abstract
PURPOSE: We report our institutional observations of ten patients with advanced hepatocellular carcinoma (HCC) (seven and three were Child-Pugh class A and B, respectively) who received compassionate regorafenib therapy between June 2016 and January 2017. These patients did not fit the rigid criteria of a clinical trial and represented the use of regorafenib in an everyday clinic situation. METHODS: Regorafenib (160 mg P.O. daily) was administered to patients on a 4-week cycle (3 weeks on, 1 week off) until disease progression (assessed using mRECIST criteria) or discontinuation secondary to toxicity (assessed using CTCAE criteria). Relevant clinical data were abstracted from patient medical records and reviewed retrospectively. RESULTS: The median duration of patient treatment was 6.6 weeks, and the median time to disease progression was 12.5 weeks. Most common treatment emergent adverse events were fatigue, diarrhea, and hand-foot skin reaction. Elevated AST and ALT were the most commonly observed laboratory-assessed adverse events, which reached grade 3 status in the Child-Pugh class B patients only. We observed intolerance to regorafenib treatment in one patient who had previously received a liver transplant. We also saw lithium toxicity in one patient receiving long-term lithium treatment, suggesting a potential and unexpected drug-drug interaction with regorafenib. CONCLUSIONS: Taken together, our observations indicate that regorafenib is beneficial in the treatment of patients with advanced HCC who progressed on or demonstrated intolerance to sorafenib therapy; however, careful selection and close monitoring of patients is necessary to maximize the benefit while minimizing the toxicities of regorafenib treatment.
PURPOSE: We report our institutional observations of ten patients with advanced hepatocellular carcinoma (HCC) (seven and three were Child-Pugh class A and B, respectively) who received compassionate regorafenib therapy between June 2016 and January 2017. These patients did not fit the rigid criteria of a clinical trial and represented the use of regorafenib in an everyday clinic situation. METHODS:Regorafenib (160 mg P.O. daily) was administered to patients on a 4-week cycle (3 weeks on, 1 week off) until disease progression (assessed using mRECIST criteria) or discontinuation secondary to toxicity (assessed using CTCAE criteria). Relevant clinical data were abstracted from patient medical records and reviewed retrospectively. RESULTS: The median duration of patient treatment was 6.6 weeks, and the median time to disease progression was 12.5 weeks. Most common treatment emergent adverse events were fatigue, diarrhea, and hand-foot skin reaction. Elevated AST and ALT were the most commonly observed laboratory-assessed adverse events, which reached grade 3 status in the Child-Pugh class B patients only. We observed intolerance to regorafenib treatment in one patient who had previously received a liver transplant. We also saw lithiumtoxicity in one patient receiving long-term lithium treatment, suggesting a potential and unexpected drug-drug interaction with regorafenib. CONCLUSIONS: Taken together, our observations indicate that regorafenib is beneficial in the treatment of patients with advanced HCC who progressed on or demonstrated intolerance to sorafenib therapy; however, careful selection and close monitoring of patients is necessary to maximize the benefit while minimizing the toxicities of regorafenib treatment.
Authors: Ahmed M Khalaf; David Fuentes; Ali I Morshid; Mata R Burke; Ahmed O Kaseb; Manal Hassan; John D Hazle; Khaled M Elsayes Journal: J Hepatocell Carcinoma Date: 2018-06-27