Procedures
toxicity, metabolic tumor, Tumor
DISEASE PROGRESSION, ADVERSE EVENT, TUMOR
Regorafenib was given orally at the approved schedule, 160 mg on days 1-21 in q28 treatment cycles. The study protocol allowed dose reductions and interruptions due to AEs. Two dose reductions were permitted, up to a dose of 80 mg. In case of simultaneous treatment-related AEs leading to different dose modifications, the lowest dose level was indicated as per protocol. If the AEs requiring dose reduction returned to baseline grades after a full cycle of therapy, dose re-escalation was allowed. Guidance on toxicity management is detailed in the protocol (Treatment was continued until disease progression, occurrence of an AE requiring treatment cessation, withdrawal of consent, or motivated investigator decision to terminate treatment. Safety was assessed and graded with the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Patients who received at least one dose of study drug were considered assessable for safety assessment.Tumor assessments were carried out in accordance with RECIST version 1.1 by expert radiologists at baseline, within 28 days before initiation of study treatment, at weeks 6 and 12, and every 3 months thereafter, until disease progression.For exploratory objectives, an [For each lesion, the following PET-derived parameters have been calculated: Highest maximum standardized uptake value (SUVmax), defined as the highest SUVmax among all evaluable lesions; total SUVmax, defined as the sum of the SUVmax of all evaluable lesions; highest total lesion glycolysis (TLG), defined as the highest TLG among all evaluable lesions. Among these parameters, the SUVmax (the maximum pixel value measured in the visualized lesion) and the TLG) (the average SUVs in the regions of interest × metabolic tumor volume) were evaluated.