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    There are some study limitations, due to the secondary analysis of an original trial in patients who were selected for the presence of BTcP. Thus, we do not have information about the prevalence of this phe-nomenon in patients with H&N cancer. Moreover, no specific treatment was given, as treatment was based on local policy. However, data were collected from centers with experienced personnel for the management of background pain and BTcP. Indeed, this data reflects the real world, giving a picture of the characteristics of such patients, as well as the most common analgesic treatments employed for this kind of patients either for background pain or BTcP. The sample was sufficiently num-bered to provide preliminary but solid data. The descriptors for the study AZD-2281 refer only to “H&N cancer”, which is a broad term that refers to an anatomically complex region of the body afflicted with a wide variety of histologies and stages of cancer. Additional information regarding anatomic subsite (oropharynx, parotid gland, larynx, etc), histology (squamous cell, salivary, thyroid, etc), and stages (I, II, III, IV) would enhance the external generalizability of these findings. A better characterization in terms of anticancer intervention could provide more specific data. Thus, a specific study with a larger sample of patients may provide further information about factors influencing background and BTcP presentation.
    In conclusion, BTcP in patients with H&N cancer has its own pe-culiarities, including a larger number of episodes/day and the pre-dictability, particularly with ingestion of food. Transdermal prepara-tions and nasal fentanyl preparations were more likely to be prescribed for background pain and BTcP, respectively, possibly to avoid inter-ference with swallowing or local mucosal damage. Future studies should be performed to analyze the prevalence of BTcP in this popu-lation as well as the optimal management strategy for H&N cancer pain and BTcP.
    The study was sponsored by Molteni, Italy. Data were independently managed by authors.
    Declaration of Competing Interest
    No conflict of interest to be declared.
    The paper is dedicated to prof. Alessandro Sabato and Prof. Antonio Gatti who died during the project.
    Data availability
    The datasets generated during/and or analyzed during the current  Oral Oncology 95 (2019) 87–90
    study are available from the corresponding author on request
    Appendix A. Supplementary material
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