Everolimus in Daily Clinical Practice Focusing to Oral Mucosa Damage Issues – Single Oncology Centre Experience within the Course of the Year 2016

Summary

Background:
Oral mucositis, mTOR associated stomatitis, is a major complication in everolimus (EVE) treatment with an incidence of 44–64%. The management of it in the daily practice has not been described enough, so far.

Patients and Methods:
Retrospective analysis of patients treated with EVE in 2016 at our center, n = 42 patients (69% female), median age 66 (37–81) years, breast cancer in 20 (48%) and renal cell carcinoma in 22 (52%), starting EVE dose of 10 mg/day in 34 (81%) and 5 mg/day in 8 (19%) patients.

Results:
Discomfort and/or dysgeusia without mucosa defects (grade 1 NCI-CTC) was in 4/34 (12%) patients, mucosal defects without oral intake limitation (grade 2) in 6/34 (17.5%), mucosal defects limiting oral intake (grade 3) in 7/34 (20.5%) patients. Actions taken: in grade 1 EVE dose reduced to 5 mg/day in 1/4 affected patients, in grade 2 locally administered dexamethasone solution recommended in 2/6, reduction of EVE to 5 mg/day in 4/6 (in two cases the reduced dose left because of complications recurrences), in grade 3 locally administered dexamehasone solution recommended in 5/7, transient reduction of EVE to 5 mg/day in 1/7, permanent reduction of EVE in 5/7 (recurrent aphthous lesions), EVE terminated in 1/7. In patients with EVE starting dose of 5 mg/day there was one case (1/8, 12.5%) of grade 2 complication requiring no intervention. The complications developed within 2–20 weeks after EVE initiation (median of 8 weeks).

Conclusion:
The incidence of stomatitis and its severity in this cohort is comparable with published trials data, it confirms the significant incidence of damage affecting the quality of life, oral intake and anti-cancer treatment in daily practice. The interventions used in groups of similarly affected patients appears slightly heterogeneous, influenced by individual physician approach. There is tendency not to interrupt the EVE treatment and keep it either in a dosage of 10 or 5 mg/day if the oral damage is tolerable. Local treatment with dexamethasone is not yet fully exploited.

Key words:
everolimus – stomatitis – mucositis – oral cavity

Supported by the grant of Ministry of Health of the Czech Republic – Conceptual Development of Research Organization (Faculty Hospital in Pilsen – FNPl, 00669806) and National Sustainability Program I (NPU I) No. LO1503 provided by the Ministry of Education Youth and Sports of the Czech Republic.

The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study.

The Editorial Board declares that the manuscript met the ICMJE recommendation for biomedical papers.

Submitted:
27. 2. 2017

Accepted:
26. 3. 2017