Pain is a major complication in patients suffering from advanced cancer. Cancer diseases are frequently associated with physical complaints that severely affect the quality of life of the patients concerned. The prevalence of pain in the case of solid tumors is reported to be between 15% and more than 75% [
11,
21]. Pain might be disease related or caused by antineoplastic treatment [
2]. However, a high percentage of patients remain insufficiently treated [
7,
19]. As distinct from background cancer pain in the form of consistent pain, breakthrough cancer pain (BTcP) is classified as an acute painful episode that occurs in patients already receiving baseline opioids who describe a baseline pain of mild to moderate intensity [
5]. Cancer patients experience BTcP of varying severity and intensity [
28]. BTcP has a rapid onset and brief duration, with 64% of patients reporting the end of a BTcP episode after 30 min [
10,
18]. It negatively affects the quality of life and impairs activities of daily living and mood [
22]. According to the high prevalence of pain in oncology and palliative care, individualized pain assessments to differentiate background pain, neuropathic pain, visceral pain, and BTcP should be a standard of care in mitigating suffering and burden of disease. Treatment options consist of opioid-based pharmacotherapy according to the World Health Organization (WHO) analgesic ladder and interventional, radiotherapeutic, and rehabilitative, surgical, or psychological interventions [
13]. Since the development of the WHO analgesic ladder, the use of opioids has led to much better pain control, making it possible for many patients to maintain their quality of life [
25,
30]. In the case of BTcP, the analgesic onset of extended-release opioids starts after 30 min, and patients may experience insufficient pain relief after their administration. Therefore, BTcP may be more effectively managed by rapid-onset opioids. In clinical practice, rapid-onset opioids still remain unused, and the treatment of BTcP can be described as far from encouraging [
29]. Transmucosal fentanyl formulations have been developed to provide analgesia with a rapid onset between 10 and 15 min [
8,
14,
23,
24,
27]. Fentanyl buccal tablets (FBTs) have been developed to improve cancer pain treatment and have shown to be well tolerated in clinical trials [
9]. Patients responding to extended-release opioids, with well-controlled background pain, and having rapid pain onset and frequent cancer BTcP episodes per day, may benefit from rapid acting opioids or rapid-onset opioids such as FBTs. Treatment with rapid-onset opioids starts with the lowest dose and is titrated until an effective analgesic effect is reached [
6]. The FBT drug Effentora® received marketing approval in April 2008. It is indicated for the treatment of BTcP in adult cancer patients who are already receiving baseline opioid therapy. The active substance fentanyl citrate is rapidly absorbed through the oral mucosa (buccal) or by a sublingual route directly into the blood and thus shows a rapid onset. The aim of this prospective, non-interventional study (NIS) named “ErkentNIS” was to document the tolerability, patient satisfaction, manageability, and safety of the use of FBT in patients suffering from BTcP in a large patient cohort in real-world clinical practice.
ErkentNIS stands for
Effentor
Ra® im
Klinisch
EN All
Tag — eine
Nicht-
Interventionelle
Studie which is German and signifies “Effentora in clinical routine—a non-interventional study.”