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Adverse event management in patients with advanced cancer receiving oral everolimus: focus on breast cancer.

Publication ,  Journal Article
Aapro, M; Andre, F; Blackwell, K; Calvo, E; Jahanzeb, M; Papazisis, K; Porta, C; Pritchard, K; Ravaud, A
Published in: Ann Oncol
April 2014

BACKGROUND: Everolimus, an orally administered rapamycin analogue, inhibits the mammalian target of rapamycin (mTOR), a highly conserved intracellular serine-threonine kinase that is a central node in a network of signaling pathways controlling cellular metabolism, growth, survival, proliferation, angiogenesis, and immune function. Everolimus has demonstrated substantial clinical benefit in randomized, controlled, phase III studies leading to approval for the treatment of advanced renal cell carcinoma, advanced neuroendocrine tumors of pancreatic origin, renal angiomyolipoma and subependymal giant-cell astrocytoma associated with tuberous sclerosis complex, as well as advanced hormone-receptor-positive (HR(+)) and human epidermal growth factor receptor-2-negative advanced breast cancer. MATERIALS AND METHODS: We discuss clinically relevant everolimus-related adverse events from the phase III studies, including stomatitis, noninfectious pneumonitis, rash, selected metabolic abnormalities, and infections, with focus on appropriate clinical management of these events and specific considerations in patients with breast cancer. RESULTS: The majority of adverse events experienced during everolimus therapy are of mild to moderate severity. The safety profile and protocols for toxicity management are well established. The class-effect adverse event profile observed with everolimus plus endocrine therapy in breast cancer is (as expected) distinct from that of endocrine therapy alone, but is similar to that observed with everolimus in other solid tumors. Information gained from the experience in other carcinomas on prompt diagnosis and treatments to optimize drug exposure, treatment outcomes, and patients' quality of life also applies to the patient population with advanced breast cancer. CONCLUSIONS: As with all orally administered agents, education of both physicians and patients in the management of adverse events for patients receiving everolimus is critical to achieving optimal exposure and clinical benefit. Active monitoring for early identification of everolimus-related adverse events combined with aggressive and appropriate intervention should lead to a reduction in the severity and duration of the event.

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Published In

Ann Oncol

DOI

EISSN

1569-8041

Publication Date

April 2014

Volume

25

Issue

4

Start / End Page

763 / 773

Location

England

Related Subject Headings

  • Sirolimus
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Humans
  • Female
  • Everolimus
  • Drug-Related Side Effects and Adverse Reactions
  • Breast Neoplasms
  • Administration, Oral
  • 3211 Oncology and carcinogenesis
 

Citation

APA
Chicago
ICMJE
MLA
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Aapro, M., Andre, F., Blackwell, K., Calvo, E., Jahanzeb, M., Papazisis, K., … Ravaud, A. (2014). Adverse event management in patients with advanced cancer receiving oral everolimus: focus on breast cancer. Ann Oncol, 25(4), 763–773. https://doi.org/10.1093/annonc/mdu021
Aapro, M., F. Andre, K. Blackwell, E. Calvo, M. Jahanzeb, K. Papazisis, C. Porta, K. Pritchard, and A. Ravaud. “Adverse event management in patients with advanced cancer receiving oral everolimus: focus on breast cancer.Ann Oncol 25, no. 4 (April 2014): 763–73. https://doi.org/10.1093/annonc/mdu021.
Aapro M, Andre F, Blackwell K, Calvo E, Jahanzeb M, Papazisis K, et al. Adverse event management in patients with advanced cancer receiving oral everolimus: focus on breast cancer. Ann Oncol. 2014 Apr;25(4):763–73.
Aapro, M., et al. “Adverse event management in patients with advanced cancer receiving oral everolimus: focus on breast cancer.Ann Oncol, vol. 25, no. 4, Apr. 2014, pp. 763–73. Pubmed, doi:10.1093/annonc/mdu021.
Aapro M, Andre F, Blackwell K, Calvo E, Jahanzeb M, Papazisis K, Porta C, Pritchard K, Ravaud A. Adverse event management in patients with advanced cancer receiving oral everolimus: focus on breast cancer. Ann Oncol. 2014 Apr;25(4):763–773.

Published In

Ann Oncol

DOI

EISSN

1569-8041

Publication Date

April 2014

Volume

25

Issue

4

Start / End Page

763 / 773

Location

England

Related Subject Headings

  • Sirolimus
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Humans
  • Female
  • Everolimus
  • Drug-Related Side Effects and Adverse Reactions
  • Breast Neoplasms
  • Administration, Oral
  • 3211 Oncology and carcinogenesis