An Exploratory Analysis on the Effectiveness of Four Strong Opioids in Patients with Cancer Pain

Authors

  • Oscar Corli MD,

    Corresponding author
    1. Center for the Evaluation and Research on Pain, “Mario Negri” Institute of Pharmacological Research, Milan
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  • Mauro Montanari BSc,

    1. Center for the Evaluation and Research on Pain, “Mario Negri” Institute of Pharmacological Research, Milan
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  • Silvia Deandrea MD,

    1. Center for the Evaluation and Research on Pain, “Mario Negri” Institute of Pharmacological Research, Milan
    2. Dipartimento di Medicina del Lavoro “Clinica del Lavoro Luigi Devoto,” Sezione di Statistica Medica e Biometria “GA Maccacaro,” Milan, Italy
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  • Maria Teresa Greco MD,

    1. Center for the Evaluation and Research on Pain, “Mario Negri” Institute of Pharmacological Research, Milan
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  • Walter Villani BSc,

    1. Center for the Evaluation and Research on Pain, “Mario Negri” Institute of Pharmacological Research, Milan
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  • Giovanni Apolone MD

    1. Center for the Evaluation and Research on Pain, “Mario Negri” Institute of Pharmacological Research, Milan
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  • Conflict of interests/disclosure: Dr. Apolone and Dr. Corli received consulting and lecture fees from Grunenthal, Italy.

Oscar Corli, MD, Center for the Evaluation and Research of Pain, Istituto di Ricerche Farmacologiche “Mario Negri,” Via Giuseppe La Masa 19, 20156 Milan, Italy. Tel: +39-02-39014654; Fax: +39-02-33200231; E-mail: oscar.corli@marionegri.it.

Abstract

Objective.  This analysis, carried out in the context of a wider observational prospective study, tried to explore whether four World Health Organization/step-III opioids (morphine, oxycodone, fentanyl, and buprenorphine) had different effectiveness when using several different outcomes and endpoints.

Design.  Cross-sectional and longitudinal design.

Setting.  Oncologic, palliative, and pain centers in Italy.

Patients.  Two hundred fifty-eight cancer patients monitored over a 3-week follow-up program.

Intervention.  Not applicable.

Outcome Measures.  The analgesic efficacy was assessed using effectiveness endpoints, such as pain intensity, pain intensity difference (PID), proportion of nonresponders (NR) and full-responders (FR) subjects, percentage of switches and dose escalation.

Results.  Mean values of PID led to differences among opioids ranging from 10% to 30%. FR (PID ≥ 30%) were more frequent in buprenorphine-fentanyl-oxycodone groups than in morphine; NR (PID ≤ 0%) were variable. The percentage of switches resulted three times more frequent when using morphine than buprenorphine (24.4% vs 8.6%). An increase of dose ≥5% a day was observed in 33.3% of fentanyl patients vs 15% of buprenorphine. As a whole, opioids show some different behaviors on the basis of the considered endpoints.

Conclusions.  The observed results, even if the small sample size and the nature itself of the study do not allow a definitive evaluation of the effectiveness of the drugs, underline a degree of variability among opioids and address toward a correct planning of a comparative randomized clinical trial that is now underway in Italy. For this reason, a confirmative effectiveness randomized controlled trial is required.

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