Summary

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• Afinitor (everolimus) is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole; for the treatment of adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced, or metastatic; for the treatment of adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib; for the treatment of adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery; for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected; and for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures.
• This summary is based on the review of 10 systematic review(s)/meta-analysis(es). ^[1-10]
• Refractory Epilepsy in Tuberous Sclerosis (TS): Everolimus demonstrated a response rate ranging from 28.6% to 100% in controlling refractory epilepsy in pediatric patients with TS.
• Advanced or Metastatic Renal Cell Carcinoma (RCC): Everolimus showed a relatively favorable safety profile but was not the most effective treatment for progression-free survival (PFS). Combination with lenvatinib had worse safety outcomes compared to most other treatments, except lenvatinib alone.
• Cardiac Rhabdomyomas (CRs) in Tuberous Sclerosis Complex (TSC): Everolimus resulted in 90.9% clinical improvement and a 95.1% reduction in CR size in children with TSC.
• Neuroendocrine Tumors (NETs): Everolimus showed varying efficacy depending on combination; alone, it had a PFS hazard ratio (HR) of 0.36 for pancreatic NETs, and when combined with somatostatin analogues, the HR was 0.12 for gastrointestinal NETs.
• Refractory Epilepsy in Tuberous Sclerosis (TS): Adverse effects mostly led to dropouts; however, these effects were primarily of low severity. There is no direct comparison with other drugs.
• Advanced or Metastatic Renal Cell Carcinoma (RCC): Everolimus exhibited the lowest risk for grade ≥3 gastrointestinal and respiratory adverse events, but lenvatinib plus everolimus had a higher risk of renal toxicity.
• Pancreatic Neuroendocrine Tumors (pNETs): Everolimus was associated with higher discontinuation rates and a greater incidence of grade 3/4 hematological and nephrotoxicity compared to Lu-DOTATATE.
• There is no population types or subgroups information available in the reviewed studies.