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01-10-2016 | Original Article

Effectiveness of tapentadol prolonged release for the management of painful mucositis in head and neck cancers during intensity modulated radiation therapy

Authors: Mazzola Rosario, Ricchetti Francesco, Fersino Sergio, Giaj Levra Niccolò, Fiorentino Alba, Nicodemo Maurizio, Albanese Sergio, Gori Stefania, Alongi Filippo

Published in: Supportive Care in Cancer | Issue 10/2016

Abstract

Purpose

To evaluate the effectiveness and tolerability profile of tapentadol prolonged release (PR) in a cohort of head and neck cancer (HNC) patients affected by background pain due to painful mucositis during intensity modulated radiation therapy with or without cisplatin with definitive and adjuvant intent.

Materials and methods

Tapentadol PR was administered at the moment of pain onset in opioid-naive patients at the dosage of 50 mg BID. The dosage was increased 50 mg twice a day until the optimal dose of no more than 500 mg/day of tapentadol PR. Primary endpoint of the analysis was the evaluation of improved assessment using the numerical rating scale (NRS). Secondary endpoints were as follows: (1) assessment of the treatment received using the patients’ global impression of change (PGIC) scale; (2) weight increase/stability; (3) sleep quality; and (4) tolerability. The period of observation was 90 days from the start of antineoplastic treatment.

Results

Between September 2014 and May 2015, 30 HNC patients were observed. The average age was 64.9 years (range, 36–80). Twenty-two days after the start of antineoplastic treatment, tapentadol PR was administered to 25 % of patients. This percentage was increased to 50 % after 39 days and to 75 % after 43 days. Considering the efficacy of tapentadol PR on daily pain, there was a reduction of 30 % (95 % C.I. 69.3 ÷ 96.2 %) in the pain score in 26 patients (86.7 %), and a reduction of 50 % (95 % C.I. 57.7 ÷ 90.1 %) in 23 patients (76.7 %).

Conclusion

The use of tapentadol PR is feasible and well tolerated in HNC patients affected by background pain due to painful mucositis during intensity modulated radiotherapy with or without cisplatin. Further studies are needed to enhance current findings.

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Title: Effectiveness of tapentadol prolonged release for the management of painful mucositis in head and neck cancers during intensity modulated radiation therapy
Authors: Mazzola Rosario
Ricchetti Francesco
Fersino Sergio
Giaj Levra Niccolò
Fiorentino Alba
Nicodemo Maurizio
Albanese Sergio
Gori Stefania
Alongi Filippo
Publication date: 01-10-2016
Publisher: Springer Berlin Heidelberg
Published in: Supportive Care in Cancer / Issue 10/2016
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-016-3351-7

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