Com mon AEs reported in patients treated with everolimus Escape From
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PTC124 Totally included stomatitis, infections, asthenia, fatigue, and diarrhea. common laboratory abnormalities included de creased hemoglobin, increased glucose, and increased cholesterol and triglycerides. pneumonitis occurred in 14% of patients. A phase 1 study investigated everolimus 5 mg and 10 mg daily in Chinese patients with different tumor types, results of which confirmed the safety of everolimus in Chinese patients. Most AEs were grade 1 or 2, and the most common were hypergly cemia, fatigue, and anemia. Based on clinical results, guidelines for the appropriate management of AEs related to everolimus treatment have been developed.
In this study, expected known class effect toxicities re lated to mTOR inhibitor therapy were observed, including anemia, hypertriglyceridemia, hyperglycemia, hypercholes terolemia, pulmonary events, and stomatitis. Most of the AEs were grade 1 2 in severity. Although anemia occurred in 64% of the patients, only 16% and 5% of patients experi enced grade 3 or 4 events, respectively. It is important to note that a large portion of the study population had abnormal hematologic values at baseline, including grades 1 2 decreased hemoglobin in 52% of patients. Many pa tients also had abnormal biochemistry values at baseline, including 44% with increased triglycerides and 28% with increased glucose. Non infectious pneumonitis events occurred in 31% of patients in this study.
Although this percentage was higher than in the overall RECORD 1 population based on blinded investigator assessment, it was similar to the incidence reported based on prospective, blinded independent review of CT scans from patients in the RECORD 1 trial in whom a diagnosis of clinical pneu monitis was not made but who experienced radio graphic changes while receiving everolimus. Additionally, our results were consistent with the incidence of noninfectious pneumonitis reported in the Japanese subpopulation of RECORD 1. In the current study, most pulmonary events were grade 1 or 2. only 6% of patients experienced a grade 3 pulmonary event. In the overall population of RECORD 1, 4% of pa tients experienced a grade 3 pulmonary event and there were no grade 4 events. in the Japanese subpopulation of RECORD 1 there were no grade 3 events. Efficacy outcomes in this study are comparable to those from RECORD 1.
The confirmed objective tumor response rate was 5% in this study versus 1. 8% in RECORD 1. DCR was 66%, which was also comparable to the 69% of patients who achieved PR or SD in RECORD 1. In RECORD 1, everolimus 10 mg daily provided clinical benefit to patients with mRCC whose disease had progressed despite VEGFr TKI ther apy. In comparison, the median PFS asso ciated with everolimus in Chinese patients refractory to previous VEGFr TKI therapy in this single arm study was 6. 9 months.