Elena Bandieri1, Marilena Romero1, Carla Ida Ripamonti1, Fabrizio Artioli1, Daniela Sichetti1, Caterina Fanizza1, Daniele Santini1, Luigi Cavanna1, Barbara Melotti1, Pier Franco Conte1, Fausto Roila1, Stefano Cascinu1, Eduardo Bruera1, Gianni Tognoni1, Mario Luppi2. 1. Elena Bandieri and Fabrizio Artioli, Unità Sanitaria Locale, Modena; Marilena Romero, Daniela Sichetti, Caterina Fanizza, and Gianni Tognoni, Fondazione Mario Negri Sud, Santa Maria Imbaro, Chieti; Carla Ida Ripamonti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Istituto Nazionale Tumori, Milan; Daniele Santini, Unità di Oncologia Medica, Università Campus Bio-Medico, Rome; Luigi Cavanna, Ospedale di Piacenza, Piacenza; Barbara Melotti, Unità di Oncologia Medica, Ospedale Sant'Orsola-Malpighi, Bologna; Pier Franco Conte, Istituto Oncologico Veneto, IRCCS, Università di Padova, Padova; Fausto Roila, Ospedale "S.Maria", Terni; Stefano Cascinu, Azienda Ospedaliero Universitaria Ospedali Riuniti, Università Politecnica delle Marche, Ancona; Mario Luppi, Università degli Studi di Modena e Reggio Emilia, Azienda Ospedaliero Universitaria Policlinico, Modena, Italy; and Eduardo Bruera, MD Anderson Cancer Center, Houston, TX. 2. Elena Bandieri and Fabrizio Artioli, Unità Sanitaria Locale, Modena; Marilena Romero, Daniela Sichetti, Caterina Fanizza, and Gianni Tognoni, Fondazione Mario Negri Sud, Santa Maria Imbaro, Chieti; Carla Ida Ripamonti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Istituto Nazionale Tumori, Milan; Daniele Santini, Unità di Oncologia Medica, Università Campus Bio-Medico, Rome; Luigi Cavanna, Ospedale di Piacenza, Piacenza; Barbara Melotti, Unità di Oncologia Medica, Ospedale Sant'Orsola-Malpighi, Bologna; Pier Franco Conte, Istituto Oncologico Veneto, IRCCS, Università di Padova, Padova; Fausto Roila, Ospedale "S.Maria", Terni; Stefano Cascinu, Azienda Ospedaliero Universitaria Ospedali Riuniti, Università Politecnica delle Marche, Ancona; Mario Luppi, Università degli Studi di Modena e Reggio Emilia, Azienda Ospedaliero Universitaria Policlinico, Modena, Italy; and Eduardo Bruera, MD Anderson Cancer Center, Houston, TX. mario.luppi@unimore.it.
Abstract
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 patients with 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.
RCT Entities:
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 patients with 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.
Authors: Ali Haider; Donna S Zhukovsky; Yee Choon Meng; Joseph Baidoo; Kimberson C Tanco; Holly A Stewart; Tonya Edwards; Manju P Joy; Leela Kuriakose; Zhanni Lu; Janet L Williams; Diane D Liu; Eduardo Bruera Journal: J Oncol Pract Date: 2017-10-13 Impact factor: 3.840