Are strong opioids equally effective and safe in the treatment of chronic cancer pain? A multicenter randomized phase IV ‘real life’ trial on the variability of response to opioids

Guidelines tend to consider morphine and morphine-like opioids comparable and interchangeable in the treatment of chronic cancer pain, but individual responses can vary. This study compared the analgesic efficacy, changes of therapy and safety profile over time of four strong opioids given for cance...

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Published in:	Annals of oncology Vol. 27; no. 6; pp. 1107 - 1115
Main Authors:	Corli, O., Floriani, I., Roberto, A., Montanari, M., Galli, F., Greco, M.T., Caraceni, A., Kaasa, S., Dragani, T.A., Azzarello, G., Luzzani, M., Cavanna, L., Bandieri, E., Gamucci, T., Lipari, G., Di Gregorio, R., Valenti, D., Reale, C., Pavesi, L., Iorno, V., Crispino, C., Pacchioni, M., Apolone, G., Monfredo, M., Mistretta, R., di Salemi, P.O., Zecca, E., Cartoni, C., Brunetti, G.A., Tassinari, D., Drudi, F., Rizzi, F., Pizzuto, M., Formaglio, F., Luzi, M., Narducci, F., Boscolo, G., Mangiapia, M., Artioli, F., Lazzari, M., Dauri, M., Diodati, M., Cupaiolo, A., Mameli, S., Preti, P., Ferrari, P., Vasini, G., Roy, M.T., Piva, L., Nardi, L.F., Montanari, L., Reina, V., Fusco, F., Orsi, L., Molinari, E.
Format:	Journal Article
Language:	English
Published:	England Elsevier Ltd 01-06-2016
Subjects:	Adult Aged Analgesics, Opioid - administration & dosage Analgesics, Opioid - adverse effects Cancer Pain - complications Cancer Pain - drug therapy Cancer Pain - pathology changes of therapy Drug-Related Side Effects and Adverse Reactions - classification Drug-Related Side Effects and Adverse Reactions - pathology Female Fentanyl - administration & dosage Fentanyl - adverse effects Humans Male Middle Aged Morphine - administration & dosage Morphine - adverse effects Neoplasms - complications Neoplasms - drug therapy Neoplasms - pathology neurotoxic effects opioids in cancer pain Oxycodone - administration & dosage Oxycodone - adverse effects variability of response variability of response neurotoxic effects opioids in cancer pain changes of therapy
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Summary:	Guidelines tend to consider morphine and morphine-like opioids comparable and interchangeable in the treatment of chronic cancer pain, but individual responses can vary. This study compared the analgesic efficacy, changes of therapy and safety profile over time of four strong opioids given for cancer pain. In this four-arm multicenter, randomized, comparative, of superiority, phase IV trial, oncological patients with moderate to severe pain requiring WHO step III opioids were randomly assigned to receive oral morphine or oxycodone or transdermal fentanyl or buprenorphine for 28 days. At each visit, pain intensity, modifications of therapy and adverse drug reactions (ADRs) were recorded. The primary efficacy end point was the proportion of nonresponders, meaning patients with worse or unchanged average pain intensity (API) between the first and last visit, measured on a 0–10 numerical rating scale. (NCT01809106). Forty-four centers participated in the trial and recruited 520 patients. Worst pain intensity and API decreased over 4 weeks with no significant differences between drugs. Nonresponders ranged from 11.5% (morphine) to 14.4% (buprenorphine). Appreciable changes were made in the treatment schedules over time. Each group required increases in the daily dose, from 32.7% (morphine) to 121.2% (transdermal fentanyl). Patients requiring adjuvant analgesics ranged from 68.9% (morphine) to 81.6% (oxycodone), switches varied from 22.1% (morphine) to 12% (oxycodone), discontinuation of treatment from 27% ( morphine) to 14.5% (fentanyl). ADRs were similar except for effects on the nervous system, which significantly prevailed with morphine. The main findings were the similarity in pain control, response rates and main adverse reactions among opioids. Changes in therapy schedules were notable over time. A considerable proportion of patients were nonresponders or poor responders. NCT01809106 (https://clinicaltrials.gov/ct2/show/NCT01809106?term=cerp&rank=2).
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0923-7534 1569-8041
DOI:	10.1093/annonc/mdw097