Morphine Versus Oxycodone for Cancer Pain Using a Catechol-O-methyltransferase Genotype Biomarker: A Multicenter, Randomized, Open-Label, Phase III Clinical Trial (RELIEF Study)

Oncologist. 2023 Mar 17;28(3):278-e166. doi: 10.1093/oncolo/oyac233.

Abstract

Background: We hypothesized that the high-dose opioid requirement in patients carrying the rs4680-GG variant in the COMT gene encoding catechol-O-methyltransferase would be greater for patients taking morphine than for those taking oxycodone, thus providing a much-needed biomarker to inform opioid selection for cancer pain.

Methods: A randomized, multicenter, open-label trial was conducted at a Japanese hospital's palliative care service. Patients with cancer pain treated with regular doses of nonsteroidal anti-inflammatory drugs or acetaminophen were enrolled and randomized (1:1) into morphine (group M) and oxycodone (group O) groups. The minimum standard dose of immediate-release (IR) oral opioids was repeatedly administered by palliative care physicians to achieve pain-reduction goals (Pain reduction ≥ 33% from baseline and up to ≤ 3 on a numerical rating scale). The primary endpoint was the proportion of subjects requiring high-dose opioids on day 0 with the GG genotype.

Results: Of 140 participants who developed cancer-related pain among 378 subjects registered and pre-screened for the genotype, 139 were evaluated in the current study. Among patients carrying a COMT rs4680-GG genotype, 48.3% required high-dose opioids in group M, compared with the 20.0% in group O (95% CI, 3.7%-50.8%; P = .029). Of those with the non-GG genotype, 41.5% treated with morphine and 23.1% with oxycodone required high-dose opioids (95% CI, 3.3%-38.3%; P = 0.098).

Conclusion: Using the COMT rs4680 genotype alone is not recommended for selecting between morphine and oxycodone for pain relief.

Keywords: biomarker; cancer pain; genotype; humans; morphine; opioid analgesics.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Clinical Trial, Phase III
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Analgesics, Opioid / adverse effects
  • Analgesics, Opioid / therapeutic use
  • Biomarkers
  • Cancer Pain* / drug therapy
  • Cancer Pain* / genetics
  • Catechol O-Methyltransferase / genetics
  • Catechol O-Methyltransferase / therapeutic use
  • Genotype
  • Humans
  • Morphine / therapeutic use
  • Neoplasms* / complications
  • Neoplasms* / drug therapy
  • Neoplasms* / genetics
  • Oxycodone / adverse effects
  • Oxycodone / therapeutic use
  • Pain / etiology
  • Pain / genetics

Substances

  • Morphine
  • Oxycodone
  • Analgesics, Opioid
  • Catechol O-Methyltransferase
  • Biomarkers

Associated data

  • UMIN-CTR/UMIN000015579