Safety, toxicity, and adverse events
dysarthria, muscle weakness, death, myocardial infarction, urinary tract infections, urosepsis, pneumonia, stroke, both).Treatment emergent, SAEs, atrial fibrillation, sepsis, cerebral ischemia
MUSCLE WEAKNESS, MYOCARDIAL INFARCTION, URINARY TRACT INFECTIONS, PNEUMONIA, UROSEPSIS, STROKE, EVENT, EVENTS, ATRIAL FIBRILLATION, SEPSIS, CEREBRAL ISCHEMIA
SAEs occurred in four of the nineteen enrolled patients (21.1%). Events of grade ≥3 were experienced by 73.7% of patients on the study. Three of the SAEs that occurred were a cerebral ischemia event (stroke) in one patient that also caused right‐sided muscle weakness and dysarthria (all grade 4) which were all considered possibly related to sunitinib and resulted in this patient coming off the study. Another patient experienced grade 2 atrial fibrillation considered possibly related to sunitinib which resolved after a day and the patient remained on study. One death occurred while a patient was on cycle 2 of study treatment which was not considered related to either drug. This was a suspected myocardial infarction but there was no autopsy performed that would have confirmed this. One patient experienced grade 3 urosepsis requiring hospitalization for 2 days. The patient had a history of urinary tract infections and the urosepsis was not related to either drug. Two years later, the same patient experienced grade 3 pneumonia with sepsis requiring hospitalization for 6 days, considered likely related to temsirolimus. Following each of these SAEs, this patient recovered and was continued on treatment.Treatment‐emergent AEs were any AEs considered possibly, probably or definitely related to either drug. Treatment‐emergent AEs of some grade occurred in all patients. AEs were consistent with those expected for sunitinib or temsirolimus alone. Treatment‐emergent AEs experienced by >10% of patients are detailed in Table Detailed table of treatment‐related AEs which were observed in >10% patients, their grade, and relationship to drug (S = sunitinib; T = temsirolimus; B = both).Treatment emergent AEs > 10% of patients(i.e., more than one patient)