TY - JOUR
T1 - Randomized trial of low-dose morphine versus weak opioids in moderate cancer pain
AU - Bandieri, Elena
AU - Romero, Marilena
AU - Ripamonti, Carla Ida
AU - Artioli, Fabrizio
AU - Sichetti, Daniela
AU - Fanizza, Caterina
AU - Santini, Daniele
AU - Cavanna, Luigi
AU - Melotti, Barbara
AU - Conte, Pier Franco
AU - Roila, Fausto
AU - Cascinu, Stefano
AU - Bruera, Eduardo
AU - Tognoni, Gianni
AU - Luppi, Mario
N1 - Publisher Copyright:
© 2016 by American Society of Clinical Oncology. All rights reserved.
PY - 2016/2/10
Y1 - 2016/2/10
N2 - Purpose: The WHO guidelines on cancer pain management recommend a sequential three-step analgesic ladder. However, conclusive data are lacking as to whether moderate pain should be treated with either step II weak opioids or low-dose step III strong opioids. Patients and Methods: In a multicenter, 28-day, open-label randomized controlled study, adults with moderate cancer pain were assigned to receive either a weak opioid or low-dose morphine. The primary outcome was the number of responder patients, defined as patientswith a 20% reduction in pain intensity on the numerical rating scale. Results: A total of 240 patients with cancer (118 in the low-dose morphine and 122 in the weak-opioid group) were included in the study. The primary outcome occurred in 88.2% of the low-dose morphine and in 57.7% of the weak-opioid group (odds risk, 6.18; 95% CI, 3.12 to 12.24; P<001). The percentage of responder patients was higher in the low-dose morphine group, as early as at 1 week. Clinically meaningful (> 30%) and highly meaningful (> 50%) pain reduction from baseline was significantly higher in the low-dose morphine group (P <.001). A change in the assigned treatment occurred more frequently in the weak-opioid group, because of inadequate analgesia. The general condition of patients, which was based on the Edmonton Symptom Assessment System overall symptom score, was better in the morphine group. Adverse effects were similar in both groups. Conclusion: In patients with cancer and moderate pain, low-dose morphine reduced pain intensity significantly compared with weak opioids, with a similarly good tolerability and an earlier effect.
AB - Purpose: The WHO guidelines on cancer pain management recommend a sequential three-step analgesic ladder. However, conclusive data are lacking as to whether moderate pain should be treated with either step II weak opioids or low-dose step III strong opioids. Patients and Methods: In a multicenter, 28-day, open-label randomized controlled study, adults with moderate cancer pain were assigned to receive either a weak opioid or low-dose morphine. The primary outcome was the number of responder patients, defined as patientswith a 20% reduction in pain intensity on the numerical rating scale. Results: A total of 240 patients with cancer (118 in the low-dose morphine and 122 in the weak-opioid group) were included in the study. The primary outcome occurred in 88.2% of the low-dose morphine and in 57.7% of the weak-opioid group (odds risk, 6.18; 95% CI, 3.12 to 12.24; P<001). The percentage of responder patients was higher in the low-dose morphine group, as early as at 1 week. Clinically meaningful (> 30%) and highly meaningful (> 50%) pain reduction from baseline was significantly higher in the low-dose morphine group (P <.001). A change in the assigned treatment occurred more frequently in the weak-opioid group, because of inadequate analgesia. The general condition of patients, which was based on the Edmonton Symptom Assessment System overall symptom score, was better in the morphine group. Adverse effects were similar in both groups. Conclusion: In patients with cancer and moderate pain, low-dose morphine reduced pain intensity significantly compared with weak opioids, with a similarly good tolerability and an earlier effect.
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U2 - 10.1200/JCO.2015.61.0733
DO - 10.1200/JCO.2015.61.0733
M3 - Article
C2 - 26644526
AN - SCOPUS:84958817595
SN - 0732-183X
VL - 34
SP - 436
EP - 442
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 5
ER -