TY - JOUR
T1 - Long-term efficacy and tolerability of intranasal fentanyl in the treatment of breakthrough cancer pain
AU - Mercadante, Sebastiano
AU - Vellucci, Renato
AU - Cuomo, Arturo
AU - Adile, Claudio
AU - Cortegiani, Andrea
AU - Valle, Alessandro
AU - Villari, Patrizia
AU - Casuccio, Alessandra
PY - 2015/5/1
Y1 - 2015/5/1
N2 - Purpose: The aim of the present study was to assess the long-term tolerability and efficacy of intranasal fentanyl (INFS) in opioid-tolerant patients with breakthrough cancer pain (BTP). Patients and methods: A 6 months, observational, prospective, cohort study design was employed to follow advanced cancer patients with BTP receiving INFS under routine clinical practice. Eligible adult cancer patients suffering from BTP had been prescribed INFS at effective doses. Data were collected at T0 and at month intervals for six months. The principal outcomes were the evaluation of possible serious adverse effects with prolonged use of INFS, the efficacy of BTP treatment with INFS, the quality of sleep, the rate of INFS discontinuation, and reasons for that. Results: Seventy-five patients were surveyed. Thirty-four patients (45.3 %) had a follow-up at 3 months, and twelve patients (16 %) were followed up at 6 months. The mean opioid doses, expressed as oral morphine equivalents, ranged 111–180 mg/day, while the mean INFS doses were 87–119 μg. Adverse effects were reported in a minority of patients and were considered to be associated with opioid therapy used for background pain. The quality of sleep significantly improved during the first 3–4 months. Finally, efficacy based on a general impression regarding the efficacy of INFS was good-excellent in most patients and statistically improved in time up to the third month. Conclusion: The long-term use of INFS in advanced cancer patients is effective and safe. No serious adverse effects were found up to six months of assessment. The level of quality of sleep and patients’ satisfaction was relatively good, considering the advanced stage of disease.
AB - Purpose: The aim of the present study was to assess the long-term tolerability and efficacy of intranasal fentanyl (INFS) in opioid-tolerant patients with breakthrough cancer pain (BTP). Patients and methods: A 6 months, observational, prospective, cohort study design was employed to follow advanced cancer patients with BTP receiving INFS under routine clinical practice. Eligible adult cancer patients suffering from BTP had been prescribed INFS at effective doses. Data were collected at T0 and at month intervals for six months. The principal outcomes were the evaluation of possible serious adverse effects with prolonged use of INFS, the efficacy of BTP treatment with INFS, the quality of sleep, the rate of INFS discontinuation, and reasons for that. Results: Seventy-five patients were surveyed. Thirty-four patients (45.3 %) had a follow-up at 3 months, and twelve patients (16 %) were followed up at 6 months. The mean opioid doses, expressed as oral morphine equivalents, ranged 111–180 mg/day, while the mean INFS doses were 87–119 μg. Adverse effects were reported in a minority of patients and were considered to be associated with opioid therapy used for background pain. The quality of sleep significantly improved during the first 3–4 months. Finally, efficacy based on a general impression regarding the efficacy of INFS was good-excellent in most patients and statistically improved in time up to the third month. Conclusion: The long-term use of INFS in advanced cancer patients is effective and safe. No serious adverse effects were found up to six months of assessment. The level of quality of sleep and patients’ satisfaction was relatively good, considering the advanced stage of disease.
KW - Breakthrough pain
KW - Cancer pain
KW - Intranasal fentanyl
KW - Tolerability
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U2 - 10.1007/s00520-014-2491-x
DO - 10.1007/s00520-014-2491-x
M3 - Article
C2 - 25351457
AN - SCOPUS:84931055697
VL - 23
SP - 1349
EP - 1354
JO - Supportive Care in Cancer
JF - Supportive Care in Cancer
SN - 0941-4355
IS - 5
ER -