Breakthrough Pain Management with Sublingual Fentanyl Tablets in Patients with Cancer: Age Subgroup Analysis of a Multicenter Prospective Study

Abstract

IntroductionBreakthrough pain (BTP) management in patients with cancer is challenging, especially in the elderly. However, no studies examining the influence of age on BTP medication have been conducted. The aim of this work was to investigate the effect of sublingual fentanyl tablets (SFTs) in terms of efficacy, safety, and quality of life in two age categories.MethodsWe performed age subgroup analyses (<65 and ≥65 years) from a recently completed study conducted in Spain. Pain intensity (PI), onset of pain relief, frequency and duration of BTP episodes, and adverse events (AEs) were assessed at 3, 7, 15, and 30 days. Health-status instruments used were the Short Form 12, version 2 (SF-12v2) questionnaire, and the Hospital Anxiety and Depression Scale (HADS-A and HADS-D).ResultsTwenty-six patients were aged <65 years and 54 were aged ≥65 years. SF-12v2 scores did not enhance significantly from baseline. HADS scores and PI decreased significantly at the end of the study, particularly in younger patients (HADS-A: 19.05 vs. 14.41%; HADS-D: 21.35 vs. 18.57%; PI: 67.23 vs. 56.30%). Onset of analgesia began in 2–5 min in 63.3% of subjects aged <65 years and in 36.4% of subjects aged >65 years. Most patients experienced one to five daily episodes after 30 days, and <5% needed a treatment change. AEs were less frequently reported in older individuals (20.5 vs. 36.4%).ConclusionAge subgroup analyses suggest that SFTs are an effective and safe treatment for the management of BTP in cancer patients of all ages. SFTs may offer a well-tolerated and efficient option to control cancer BTP in the elderly.

Efficacy and Safety of Fentanyl Compared With Morphine among Adult Patients with Cancer: A Meta-Analysis

“… 30 In cluding the spray sublingual form, fentanyl is generally well tolerated and is recommended for use for the management of breakthrough pain in opioid-tolerant adult patients with cancer. 28 , 31 , 32 …”

“…30 Including the spray sublingual form, fentanyl is generally well tolerated and is recommended for use for the management of breakthrough pain in opioid-tolerant adult patients with cancer. 28,31,32 A transdermal fentanyl formulation has been in clinical use since the 1990s. 33 It is used in palliative care and cancer pain.…”

Impact of individualized management of breakthrough cancer pain on quality of life in advanced cancer patients: CAVIDIOPAL study

“…Regarding analgesic efficacy and tolerability of transmucosal fentanyl in patients with BTcP, previous studies did not find any differences by age groups except a slower onset of analgesia in patients ≥ 65 years old [33,34]. However, in spite of the analgesic effect of fentanyl, no conclusive change in QoL of patients ≥ 65 years was shown [34].…”

Fentanyl in cancer pain management: avoiding hasty judgments and discerning its potential benefits

“…Additionally, HADS scores decreased, particularly in younger patients. 169 An updated study was published by Guitart 155 in 2018 showing that sublingual fentanyl tablets have good efficacy and safety regardless of the cancer stage and opioid regimen for background pain. Significant improvements in HADS scores were observed in this subgroup analyses of patients with locally advanced cancer or metastatic cancer treated with transdermal fentanyl for background pain whilst, in the same subgroups defined by cancer stage, no significant improvements in SF-12v2 scores were observed.…”