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. 2017 Aug 22;8(8):CD003870.
doi: 10.1002/14651858.CD003870.pub6.

Oxycodone for cancer-related pain

Mia Schmidt-Hansen  1 , Michael I Bennett, Stephanie Arnold, Nathan Bromham, Jennifer S Hilgart
Affiliations

Oxycodone for cancer-related pain

Mia Schmidt-Hansen et al. Cochrane Database Syst Rev. .

Update in

  • Oxycodone for cancer-related pain.
    Schmidt-Hansen M, Bennett MI, Arnold S, Bromham N, Hilgart JS, Page AJ, Chi Y. Schmidt-Hansen M, et al. Cochrane Database Syst Rev. 2022 Jun 9;6(6):CD003870. doi: 10.1002/14651858.CD003870.pub7. Cochrane Database Syst Rev. 2022. PMID: 35679121 Free PMC article.

Abstract

Background: Many people with cancer experience moderate to severe pain that requires treatment with strong opioids, such as oxycodone and morphine. Strong opioids are, however, not effective for pain in all people, neither are they well-tolerated by all people. The aim of this review was to assess whether oxycodone is associated with better pain relief and tolerability than other analgesic options for adults with cancer pain. This is an updated version of the original Cochrane review published in 2015, Issue 2 on oxycodone for cancer-related pain.

Objectives: To assess the effectiveness and tolerability of oxycodone by any route of administration for pain in adults with cancer.

Search methods: For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE and MEDLINE In-Process (Ovid), Embase (Ovid), Science Citation Index, Conference Proceedings Citation Index - Science (ISI Web of Science), BIOSIS (ISI), and PsycINFO (Ovid) to November 2016. We also searched four trial registries, checked the bibliographic references of relevant studies, and contacted the authors of the included studies. We applied no language, date, or publication status restrictions.

Selection criteria: We included randomised controlled trials (parallel group or cross-over) comparing oxycodone (any formulation or route of administration) with placebo or an active drug (including oxycodone) for cancer background pain in adults by examining pain intensity/relief, adverse events, quality of life, and participant preference.

Data collection and analysis: Two review authors independently extracted data and assessed the included studies using standard Cochrane methodology. We meta-analysed pain intensity data using the generic inverse variance method, and adverse events using the Mantel-Haenszel method, or summarised these data narratively along with the quality of life and participant preference data. We assessed the overall quality of the evidence using GRADE.

Main results: For this update, we identified six new studies (1258 participants) for inclusion. In total, we included 23 studies which enrolled/randomised 2648 participants, with 2144 of these analysed for efficacy and 2363 for safety. The studies examined a number of different drug comparisons.Pooled analysis of three of the four studies comparing controlled-release (CR) oxycodone to immediate-release (IR) oxycodone showed that the ability of CR and IR oxycodone to provide pain relief were similar (standardised mean difference (SMD) 0.1, 95% confidence interval (CI) -0.06 to 0.26; low quality evidence). Pooled analyses of adverse events showed no significant differences between CR and IR oxycodone for asthenia (risk ratio (RR) 0.58, 95% CI 0.2 to 1.68), confusion (RR 0.78, 95% CI 0.2 to 3.02), constipation (RR 0.71, 95% CI 0.45 to 1.13), dizziness/lightheadedness (RR 0.74, 95% CI 0.4 to 1.37), drowsiness/somnolence (RR 1.03, 95% CI 0.69 to 1.54), dry mouth (RR 1.14, 95% CI 0.48 to 2.75), insomnia (RR 1.04, 95% CI 0.31 to 3.53), nausea (RR 0.85, 95% CI 0.56 to 1.28), nervousness (RR 0.57, 95% CI 0.2 to 1.64), pruritus (RR 1.46, 95% CI 0.65 to 3.25), vomiting (RR 0.66, 95% CI 0.38 to 1.15), and discontinuation due to adverse events (RR 0.6, 95% CI 0.29 to 1.22). The quality of the evidence was very low for all these adverse events. Three of the four studies found similar results for treatment acceptability.Pooled analysis of seven of the nine studies comparing CR oxycodone to CR morphine indicated that pain relief was significantly better after treatment with CR morphine than CR oxycodone (SMD 0.14, 95% CI 0.01 to 0.27; low quality evidence). However, sensitivity analysis did not corroborate this result (SMD 0.12, 95% CI -0.02 to 0.26).Pooled analyses of adverse events showed no significant differences between CR oxycodone and CR morphine for confusion (RR 1.01 95% CI 0.78 to 1.31), constipation (RR 0.98, 95% CI 0.82 to 1.16), dizziness/lightheadedness (RR 0.76, 95% CI 0.33 to 1.76), drowsiness/somnolence (RR 0.9, 95% CI 0.75 to 1.08), dry mouth (RR 1.01, 95% CI 0.8 to 1.26), dysuria (RR 0.71, 95% CI 0.4 to 1.26), nausea (RR 1.02, 95% CI 0.82 to 1.26), pruritus (RR 0.81, 95% CI 0.51 to 1.29), vomiting (RR 0.94, 95% CI 0.68 to 1.29), and discontinuation due to adverse events (RR 1.06, 95% CI 0.43 to 2.6). However, the RR for hallucinations was significantly lower after treatment with CR oxycodone compared to CR morphine (RR 0.52, 95% CI 0.28 to 0.97). The quality of the evidence was very low for all these adverse events. There were no marked differences in treatment acceptability or quality of life ratings.The remaining studies either compared oxycodone in various formulations or compared oxycodone to different alternative opioids. None found any clear superiority or inferiority of oxycodone for cancer pain, neither as an analgesic agent nor in terms of adverse event rates and treatment acceptability.The quality of this evidence base was limited by the high or unclear risk of bias of the studies and by imprecision due to low or very low event rates or participant numbers for many outcomes.

Authors' conclusions: The conclusions have not changed since the previous version of this review. The data suggest that oxycodone offers similar levels of pain relief and overall adverse events to other strong opioids including morphine. Although we identified a clinically insignificant benefit on pain relief in favour of CR morphine over CR oxycodone, this did not persist following sensitivity analysis and so we do not consider this important. However, in this updated analysis, we found that hallucinations occurred less often with CR oxycodone than with CR morphine, but the quality of this evidence was very low so this finding should be treated with utmost caution. Our conclusions are consistent with other reviews and suggest that while the reliability of the evidence base is low, given the absence of important differences within this analysis it seems unlikely that larger head to head studies of oxycodone versus morphine are justified, although well-designed trials comparing oxycodone to other strong analgesics may well be useful. For clinical purposes, oxycodone or morphine can be used as first-line oral opioids for relief of cancer pain in adults.

PubMed Disclaimer

Conflict of interest statement

MSH: none known.

MIB is a specialist palliative medicine physician and manages people with cancer pain. MIB received lecture fees from Pfizer in 2016.

SA: none known.

NB: none known.

JSH: none known.

Figures

1
1
Study flow diagram. PICO: P = patient, problem, or population; I = intervention; C = comparison, control, or comparator; O = outcome.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
4
4
Forest plot of comparison: 1 Pain, outcome: 1.1 Pain intensity and pain relief.
See this image and copyright information in PMC

Update of

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Stambaugh 1991 {published data only}
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Taeron 2002 {published data only}
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Wallace 2013 {published data only}
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Wu 2009 {published data only}
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Wu 2015 {published data only}
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Xu 2008 {published data only}
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References to studies awaiting assessment

Aurilio 2009 {published data only}
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Song 2009 {published data only}
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References to ongoing studies

2008‐002273‐12 {unpublished data only}
    1. Long term opioid administration in oncologic chronic pain: open label, prospective study on efficacy, safety and pharmacogenetic factors. Ongoing study Not reported.
2009‐013118‐28 {unpublished data only}
    1. Bukkaalinen fentanyyli syöpäpotilaiden toimenpidekivun hoidossa ("The buccal fentanyl in cancer pain management measure"). Ongoing study Not reported.
Elsayem 2010 {unpublished data only}
    1. Elsayem AF, Bain KT, Palmer JL, Bearden J, Fisch M. A randomized comparison of oral methadone as a "first‐switch" opioid versus opioid switching between sustained‐release morphine and oxycodone for oncology outpatients with pain management problems. Journal of Clinical Oncology 2010;28(15 Suppl 1):TPS324.
JapicCTI‐132338 {unpublished data only}
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NCT00916890 {unpublished data only}
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NCT01165281 {unpublished data only}
    1. A Randomized, Double‐Blind, Active Controlled, Optimal Dose Titration, Multicenter Study to Evaluate the Safety and Efficacy of Oral JNS024 Extended Release (ER) in Japanese and Korean Subjects With Moderate to Severe Chronic Malignant Tumor Related Cancer Pain. Ongoing study August 2012.
NCT01675622 {unpublished data only}
    1. A Comparative Study of Immediate‐Release Oxycodone Capsules Versus Immediate‐Release Morphine Tablets for the Treatment of Chinese Patients With Cancer Pain.. Ongoing study December 2010.
NCT02084355 {unpublished data only}
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UMIN000011756 {unpublished data only}
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References to other published versions of this review

Reid 2010
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