Are strong opioids equally effective and safe in the treatment of chronic cancer pain?

O. Corli, I Floriani, A Roberto, M Montanari, F. Galli, M T Greco, A Caraceni, S. Kaasa, T A Dragani, G. Azzarello, Massimo Luzzani, L. Cavanna, Elena Bandieri, T. Gamucci, G. Lipari, R. Gregorio, D. Valenti, C. A. Reale, L Pavesi, V IornoCarlo Crispino, M. Pacchioni, G Apolone, CERP STUDY OF PAIN GROUP (List of collaborators)

Research output: Contribution to journalArticle

Abstract

BACKGROUND: 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.PATIENT AND METHODS: 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).RESULTS: 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.CONCLUSION: 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.CLINICAL TRIAL REGISTRATION: NCT01809106 (https://clinicaltrials.gov/ct2/show/NCT01809106?term=cerp&rank=2).
Original languageEnglish
Pages (from-to)1107-1115
Number of pages9
JournalAnnals of Oncology
Volume27
Issue number6
DOIs
Publication statusPublished - Jun 2016

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Chronic Pain
Morphine
Opioid Analgesics
Oxycodone
Pain
Fentanyl
Buprenorphine
Therapeutics
Drug-Related Side Effects and Adverse Reactions
Analgesics
Appointments and Schedules
Cancer Pain
Nervous System
Clinical Trials
Guidelines
Safety
Pharmaceutical Preparations

Keywords

  • Journal Article

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Corli, O., Floriani, I., Roberto, A., Montanari, M., Galli, F., Greco, M. T., ... collaborators), CERP. STUDY. OF. PAIN. GROUP. L. O. (2016). Are strong opioids equally effective and safe in the treatment of chronic cancer pain? Annals of Oncology, 27(6), 1107-1115. https://doi.org/10.1093/annonc/mdw097

Are strong opioids equally effective and safe in the treatment of chronic cancer pain? / Corli, O.; Floriani, I; Roberto, A; Montanari, M; Galli, F.; Greco, M T; Caraceni, A; Kaasa, S.; Dragani, T A; Azzarello, G.; Luzzani, Massimo; Cavanna, L.; Bandieri, Elena; Gamucci, T.; Lipari, G.; Gregorio, R.; Valenti, D.; Reale, C. A.; Pavesi, L; Iorno, V; Crispino, Carlo; Pacchioni, M.; Apolone, G; collaborators), CERP STUDY OF PAIN GROUP (List of.

In: Annals of Oncology, Vol. 27, No. 6, 06.2016, p. 1107-1115.

Research output: Contribution to journalArticle

Corli, O, Floriani, I, Roberto, A, Montanari, M, Galli, F, Greco, MT, Caraceni, A, Kaasa, S, Dragani, TA, Azzarello, G, Luzzani, M, Cavanna, L, Bandieri, E, Gamucci, T, Lipari, G, Gregorio, R, Valenti, D, Reale, CA, Pavesi, L, Iorno, V, Crispino, C, Pacchioni, M, Apolone, G & collaborators), CERPSTUDYOFPAINGROUPLO 2016, 'Are strong opioids equally effective and safe in the treatment of chronic cancer pain?', Annals of Oncology, vol. 27, no. 6, pp. 1107-1115. https://doi.org/10.1093/annonc/mdw097
Corli, O. ; Floriani, I ; Roberto, A ; Montanari, M ; Galli, F. ; Greco, M T ; Caraceni, A ; Kaasa, S. ; Dragani, T A ; Azzarello, G. ; Luzzani, Massimo ; Cavanna, L. ; Bandieri, Elena ; Gamucci, T. ; Lipari, G. ; Gregorio, R. ; Valenti, D. ; Reale, C. A. ; Pavesi, L ; Iorno, V ; Crispino, Carlo ; Pacchioni, M. ; Apolone, G ; collaborators), CERP STUDY OF PAIN GROUP (List of. / Are strong opioids equally effective and safe in the treatment of chronic cancer pain?. In: Annals of Oncology. 2016 ; Vol. 27, No. 6. pp. 1107-1115.
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T1 - Are strong opioids equally effective and safe in the treatment of chronic cancer pain?

AU - Corli, O.

AU - Floriani, I

AU - Roberto, A

AU - Montanari, M

AU - Galli, F.

AU - Greco, M T

AU - Caraceni, A

AU - Kaasa, S.

AU - Dragani, T A

AU - Azzarello, G.

AU - Luzzani, Massimo

AU - Cavanna, L.

AU - Bandieri, Elena

AU - Gamucci, T.

AU - Lipari, G.

AU - Gregorio, R.

AU - Valenti, D.

AU - Reale, C. A.

AU - Pavesi, L

AU - Iorno, V

AU - Crispino, Carlo

AU - Pacchioni, M.

AU - Apolone, G

AU - collaborators), CERP STUDY OF PAIN GROUP (List of

N1 - © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

PY - 2016/6

Y1 - 2016/6

N2 - BACKGROUND: 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.PATIENT AND METHODS: 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).RESULTS: 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.CONCLUSION: 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.CLINICAL TRIAL REGISTRATION: NCT01809106 (https://clinicaltrials.gov/ct2/show/NCT01809106?term=cerp&rank=2).

AB - BACKGROUND: 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.PATIENT AND METHODS: 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).RESULTS: 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.CONCLUSION: 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.CLINICAL TRIAL REGISTRATION: NCT01809106 (https://clinicaltrials.gov/ct2/show/NCT01809106?term=cerp&rank=2).

KW - Journal Article

U2 - 10.1093/annonc/mdw097

DO - 10.1093/annonc/mdw097

M3 - Article

VL - 27

SP - 1107

EP - 1115

JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

IS - 6

ER -