PMID- 27742577
OWN - NLM
STAT- MEDLINE
DCOM- 20171220
LR  - 20180322
IS  - 1873-6513 (Electronic)
IS  - 0885-3924 (Linking)
VI  - 52
IP  - 6
DP  - 2016 Dec
TI  - Comparison of the Tolerability Profile of Controlled-Release Oral Morphine and 
      Oxycodone for Cancer Pain Treatment. An Open-Label Randomized Controlled Trial.
PG  - 783-794.e6
LID - S0885-3924(16)30321-9 [pii]
LID - 10.1016/j.jpainsymman.2016.05.030 [doi]
AB  - CONTEXT: Oxycodone and morphine are recommended as first-choice opioids for 
      moderate/severe cancer pain, but evidence about their relative tolerability has 
      significant methodological limitations. OBJECTIVES: This study was mainly aimed 
      at comparing the risk of developing adverse events (AEs) with controlled-release 
      oral morphine vs. oxycodone; secondary aims were comparing their analgesic 
      efficacy and testing heterogeneity in tolerability across different age and renal 
      function subgroups. METHODS: An open-label multicenter RCT (EudraCT number: 
      2006-003151-21) was carried out in patients with moderate/severe cancer pain. At 
      baseline, 7 and 14 days, patients scored on 0-10 rating scales (0-10 numerical 
      rating scale) the intensity of pain and of a list of common opioid side effects. 
      The primary end point was the percentage of patients reporting an AE (a worsening 
      >/= 2 points on any of the listed side effects); tolerability by subgroups and 
      average follow-up pain intensity were compared through regression models. 
      RESULTS: One hundred eighty-seven patients were enrolled (47% of originally 
      planned). Intention to treat (ITT) analysis (N = 185, morphine 94, oxycodone 91) 
      did not show any difference in the risk of developing AEs (risk difference -0.6%, 
      95% CI -11.0% to 9.9%) nor in analgesia (0-10 numerical rating scale pain 
      intensity difference -0.28, 95% CI -0.83 to 0.27). No evidence of heterogeneity 
      of tolerability across age and renal function patient subgroups emerged. 
      CONCLUSION: This trial failed to show any difference in tolerability and 
      analgesic efficacy of morphine and oxycodone as first-line treatment for 
      moderate/severe cancer pain but results interpretation is difficult due to lack 
      of power, potential bias from open-label design, and concerns about assay 
      sensitivity. These data, however, can significantly contribute to future 
      meta-analyses comparing WHO Step-III opioids and are relevant in designing future 
      randomized studies.
CI  - Copyright (c) 2016 American Academy of Hospice and Palliative Medicine. Published 
      by Elsevier Inc. All rights reserved.
FAU - Zecca, Ernesto
AU  - Zecca E
AD  - Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto 
      Nazionale dei Tumori, Milano, Italy.
FAU - Brunelli, Cinzia
AU  - Brunelli C
AD  - Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto 
      Nazionale dei Tumori, Milano, Italy; European Palliative Care Research Centre 
      (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, 
      Norwegian University of Science and Technology (NTNU), Trondheim, Norway. 
      Electronic address: cinzia.brunelli@istitutotumori.mi.it.
FAU - Bracchi, Paola
AU  - Bracchi P
AD  - Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto 
      Nazionale dei Tumori, Milano, Italy.
FAU - Biancofiore, Giuseppe
AU  - Biancofiore G
AD  - Emergency Medicine Unit, Istituto Clinico Humanitas Rozzano, Milano, Italy.
FAU - De Sangro, Carlo
AU  - De Sangro C
AD  - Oncology Unit Ospedale San Gennaro, Napoli, Italy.
FAU - Bortolussi, Roberto
AU  - Bortolussi R
AD  - Palliative Care and Pain Therapy Unit, CRO Aviano National Cancer Institute, 
      Aviano, Pordenone, Italy.
FAU - Montanari, Luigi
AU  - Montanari L
AD  - Palliative Care Unit, AUSL Della Romagna, Ravenna, Italy.
FAU - Maltoni, Marco
AU  - Maltoni M
AD  - Palliative Care Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei 
      Tumori (IRST) IRCCS, Meldola, Forli-Cesena, Italy.
FAU - Moro, Cecilia
AU  - Moro C
AD  - Medical Oncology Unit, Ospedale Papa Giovanni XXIII, Bergamo, Italy.
FAU - Colonna, Ugo
AU  - Colonna U
AD  - Pain and Palliative Medicine Unit, AAS 2 Bassa Friulana-Isontina, Latisana, 
      Udine, Italy.
FAU - Finco, Gabriele
AU  - Finco G
AD  - Department of Medical sciences "M. Aresu", University of Cagliari, Cagliari, 
      Italy.
FAU - Roy, Maria Teresa
AU  - Roy MT
AD  - Hospice e Cure Palliative, IRCCS Azienda Ospedaliera Universitaria San Martino, 
      IST Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.
FAU - Ferrari, Vittorio
AU  - Ferrari V
AD  - Medical Oncology Unit, A.O. Spedali Civili di Brescia, Brescia, Italy.
FAU - Alabiso, Oscar
AU  - Alabiso O
AD  - Oncology Unit, Ospedale di Novara, Novara, Italy.
FAU - Rosti, Giovanni
AU  - Rosti G
AD  - Medical Oncology, Ospedale Regionale Treviso, Treviso, Italy.
FAU - Kaasa, Stein
AU  - Kaasa S
AD  - European Palliative Care Research Centre (PRC), Department of Cancer Research and 
      Molecular Medicine, Faculty of Medicine, Norwegian University of Science and 
      Technology (NTNU), Trondheim, Norway; Department of Oncology, Oslo University 
      Hospital and University of Oslo, Oslo, Norway.
FAU - Caraceni, Augusto
AU  - Caraceni A
AD  - Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto 
      Nazionale dei Tumori, Milano, Italy; European Palliative Care Research Centre 
      (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, 
      Norwegian University of Science and Technology (NTNU), Trondheim, Norway.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20161011
PL  - United States
TA  - J Pain Symptom Manage
JT  - Journal of pain and symptom management
JID - 8605836
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Delayed-Action Preparations)
RN  - 76I7G6D29C (Morphine)
RN  - CD35PMG570 (Oxycodone)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Analgesics, Opioid/*administration & dosage/adverse effects
MH  - Cancer Pain/*drug therapy
MH  - Delayed-Action Preparations
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Morphine/*administration & dosage/adverse effects
MH  - Oxycodone/*administration & dosage/adverse effects
MH  - Pain Measurement
MH  - Palliative Care
MH  - Risk
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Morphine
OT  - adverse drug reactions
OT  - cancer
OT  - oxycodone
OT  - pain
OT  - palliative care
EDAT- 2016/10/16 06:00
MHDA- 2017/12/21 06:00
CRDT- 2016/10/16 06:00
PHST- 2016/02/29 00:00 [received]
PHST- 2016/05/24 00:00 [revised]
PHST- 2016/05/25 00:00 [accepted]
PHST- 2016/10/16 06:00 [pubmed]
PHST- 2017/12/21 06:00 [medline]
PHST- 2016/10/16 06:00 [entrez]
AID - S0885-3924(16)30321-9 [pii]
AID - 10.1016/j.jpainsymman.2016.05.030 [doi]
PST - ppublish
SO  - J Pain Symptom Manage. 2016 Dec;52(6):783-794.e6. doi: 
      10.1016/j.jpainsymman.2016.05.030. Epub 2016 Oct 11.