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Lohre E.T.,Norwegian University of Science and Technology | Klepstad P.,Norwegian University of Science and Technology | Bennett M.I.,University of Leeds | Brunelli C.,Norwegian University of Science and Technology | And 8 more authors.
Journal of Pain and Symptom Management | Year: 2016

Context Cancer pain can appear with spikes of higher intensity. Breakthrough cancer pain (BTCP) is the most common term for the transient exacerbations of pain, but the ability of the nomenclature to capture relevant pain variations and give treatment guidance is questionable. Objectives To reach consensus on definitions, terminology, and subclassification of transient cancer pain exacerbations. Methods The most frequent authors on BTCP literature were identified using the same search strategy as in a systematic review and invited to participate in a two-round Delphi survey. Topics with a low degree of consensus on BTCP classification were refined into 20 statements. The participants rated their degree of agreement with the statements on a numeric rating scale (0-10). Consensus was defined as a median numeric rating scale score of ≥7 and an interquartile range of ≤3. Results Fifty-two authors had published three or more articles on BTCP over the past 10 years. Twenty-seven responded in the first round and 24 in the second round. Consensus was reached for 13 of 20 statements. Transient cancer pain exacerbations can occur without background pain, when background pain is uncontrolled, and regardless of opioid treatment. There exist cancer pain exacerbations other than BTCP, and the phenomenon could be named "episodic pain." Patient-reported treatment satisfaction is important with respect to assessment. Subclassification according to pain pathophysiology can provide treatment guidance. Conclusion Significant transient cancer pain exacerbations include more than just BTCP. Patient input and pain classification are important factors for tailoring treatment. © 2016 American Academy of Hospice and Palliative Medicine.


Mercadante S.,Pain Relief and Supportive Care Unit | Mercadante S.,University of Palermo
Expert Review of Clinical Pharmacology | Year: 2014

Fentanyl buccal tablet (FBT) (FENTORA) is indicated for the management of breakthrough pain (BTP) in patients with cancer pain and who are tolerant to ≥60 mg of oral morphine equivalents, at least with the current availability of the minimal strength of 100 μg. FBT uses the OraVescent technology to further increase the rate and extent of absorption of fentanyl. Short-term, randomized, controlled, clinical studies of FBT in patients with cancer pain have shown the efficacy of FBT in the management of breakthrough cancer pain. The efficacy was also confirmed in long-term studies on the safety and tolerability of FBT. It has been recommended that administration should be tailored to the patient's individual requirement, through dose titration starting from the lowest dose to find the effective dose. However, recent studies have demonstrated that predictable doses calculated from the basal opioid regimen are safe and more effective than doses achieved after dose titration. © 2015 Informa UK, Ltd.


Mercadante S.,Pain Relief and Supportive Care Unit | Mercadante S.,University of Palermo
Drugs | Year: 2012

Breakthrough pain (BTP) is a transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain.The principal pharmacological treatment of BTP is represented by the administration of opioids as needed. Oral opioids have traditionally been the only available drugs for BTP. However, the onset and duration of action of oral opioids such as morphine or oxycodone may not be suitable for treating many episodes of BTP that are of short onset and duration. Transmucosal administration of lipophilic substances has gained a growing popularity in recent years due to the rapid effect, clinically observable 10-15 minutes after drug administration, and the non-invasive form. Different technologies have been developed to provide fast pain relief with potent opioid drugs such fentanyl, delivered by non-invasive routes (rapid onset opioids, ROOs). All the studies performed with ROOs have recommended that these drugs should be administered to opioid-tolerant patients receiving doses of oral morphine equivalents of at least 60 mg. These preparations, including oral transmucosal fentanyl citrate, fentanyl buccal tablet, sublingual fentanyl, intranasal fentanyl spray, fentanyl-pectin nasal spray and fentanyl buccal soluble film have shown better efficacy than placebo or oral opioids. Long-term studies have confirmed their efficacy and safety. © 2012 Adis Data Information BV. All rights reserved.


Mercadante S.,Pain Relief and Supportive Care Unit | Aielli F.,University of LAquila | Adile C.,Pain Relief and Supportive Care Unit | Valle A.,FARO | And 10 more authors.
Journal of Pain and Symptom Management | Year: 2016

Context Episodic breathlessness is a relevant aspect in patients with advanced cancer. Objectives The aim of this study was to assess the different aspects of this clinical phenomenon. Methods A consecutive sample of patients with advanced cancer admitted to different settings for a period of six months was surveyed. The presence of background breathlessness and episodic breathlessness, their intensity (numerical scale 0-10), and drugs used for treatment were collected. Factors inducing episodic breathlessness and its influence on daily activities were investigated. Results Of 921 patients, 29.3% (n = 269) had breathlessness and 134 patients (49.8%) were receiving drugs for background breathlessness. In the multivariate analysis, the risk of breathlessness increased with chronic obstructive pulmonary disease, although it decreased in patients receiving disease-oriented therapy and patients with gastrointestinal tumors. The prevalence of episodic breathlessness was 70.9% (n = 188), and its mean intensity was 7.1 (SD 1.6). The mean duration of untreated episodic breathlessness was 19.9 minutes (SD 35.3); 41% of these patients were receiving drugs for episodic breathlessness. The majority of episodic breathlessness events (88.2%) were triggered by activity. In the multivariate analysis, higher Karnofsky Performance Status levels were significantly related to episodic breathlessness, although patients receiving disease-oriented therapy were less likely to have episodic breathlessness. Conclusion This study showed that episodic breathlessness frequently occurs in patients with breathlessness in the advanced stage of disease, has a severe intensity, and is characterized by rapid onset and short duration, which require rapid measures. © 2016 American Academy of Hospice and Palliative Medicine.


Mercadante S.,Pain Relief and Supportive Care Unit | Aielli F.,University of LAquila | Aielli F.,LAquila per la Vita Home Care Unit | Adile C.,Pain Relief and Supportive Care Unit | And 10 more authors.
Supportive Care in Cancer | Year: 2015

Background: Oral symptoms can be a sign of an underlying systemic condition and have a significant impact on quality of life, nutrition, and cost of care, while these lesions are often studied in the context of cancer treatment. However, information regarding oral symptoms in advanced cancer patients is poor. The aim of this multicenter study was to determine the prevalence and the characteristics of oral symptoms in a large population of advanced cancer patients. Methods: A consecutive sample of patients with advanced cancer for a period of 6 months was prospectively assessed for an observational study. At time of admission, the epidemiological characteristics, surgery-radiotherapy of head and neck, and oncologic treatments in the last month were recorded. The presence of mucositis, dry mouth, and dysphagia was assessed by clinical examination and patients’ report and their intensity recorded. Patients were also asked whether they had limitation on nutrition of hydration due to the local condition. Results: Six hundred sixty-nine patients were surveyed in the period taken into consideration. The mean age was 72.1 years (SD 12.3), and 342 patients were males. The primary tumors are listed in Table 1. The prevalence of mucositis was 22.3 %. The symptom relevantly reduced the ingestion of food or fluids and was statistically associated with the Karnofsky level and head and neck cancer. The prevalence of dry mouth was 40.4 %, with a mean intensity of 5.4 (SD 2.1). Several drugs were concomitantly given, particularly opioids (78 %), corticosteroids (75.3 %), and diuretics (70.2 %). Various and nonhomogeneous treatments were given for dry mouth, that was statistically associated with current or recent chemotherapy, and hematological tumors. The prevalence of dysphagia was 15.4 % with a mean intensity of 5.34 (SD 3). Dysphagia for liquids was observed in 52.4 % of cases. A high level of limitation for oral nutrition due to dysphagia was found, and in 53.4 % of patients, alternative routes to the oral one were used. Dysphagia was statistically associated with the Karnofsky level and head and neck cancer. A strong relationship between the three oral symptoms was found. Conclusion: In advanced cancer patients, a range of oral problems significantly may impact on the physical, social, and psychological well-being of advanced cancer patients to varying degrees. These symptoms should be carefully assessed early but become imperative in the palliative care setting when they produce relevant consequences that may be life-threatening other than limiting the daily activities, particularly eating and drinking. © 2015, Springer-Verlag Berlin Heidelberg.

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