Use of strong opioids in advanced cancer pain: a randomized trial

Abstract

The World Health Organization (WHO) guidelines for the treatment of cancer pain recommend nonopioid analgesics as first-line therapy, so-called "weak" analgesics combined with nonopioid analgesics as second-line therapy, and so-called "strong" opioids (with nonopioid analgesics) only as third-line therapy. However, these guidelines can be questioned with regard to the extent of efficacy as well as the rationale for not using strong opioids as first-line treatment, especially in terminal cancer patients. The purpose of this randomized study was to prospectively compare the efficacy and tolerability of strong opioids as first-line agents with the recommendations of the WHO in terminal cancer patients. One hundred patients with mild-moderate pain were randomized to treatment according to WHO guidelines or to treatment with strong opioids. Evaluated outcomes included pain intensity, need for change in therapy, quality of life, Karnofsky Performance Status, general condition of the patient, and adverse events. No between-treatment differences were observed for changes in quality of life or performance status, but patients started on strong opioids had significantly better pain relief than patients treated according to WHO guidelines (P=0.041). Additionally, patients started on strong opioids required significantly fewer changes in therapy, had greater reduction in pain when a change was initiated, and reported greater satisfaction with treatment than the comparator group (P=0.041). Strong opioids were safe and well-tolerated, with no development of tolerance or serious adverse events. These data suggest the utility of strong opioids for first-line treatment of pain in patients with terminal cancer.

Cancer Pain Prevalence and its Management

“…Therefore, a RCT is required to be conducted for the role of 2 nd step (Marinangeli et al, 2004;Maltoni et al, 2005;.…”

Clinical Guideline for Pharmacological Management of Cancer Pain: The Japanese Society of Palliative Medicine Recommendations

“…On the other hand, two randomized controlled trials demonstrated that using a Step 3 opioid first (two-step strategy) is significantly more effective than using the three-step strategy, in improving cancer pain (36,37). However, some adverse events such as nausea or constipation tended to be more frequent in the two-step strategy group in these studies.…”

Latin-American Guidelines for Cancer Pain Management

“…Given the wide interindividual variability in the response to a specific opioid, it is important to know the pharmacological differences between them. There is no proven evidence that one opioid agonist is better than another as first-line therapy [12,37].…”

“…Tramadol is well tolerated and has low addictive potential [38]. For several years now, it has been suggested in clinical trials that strong opioids can prove useful as first-line treatment, especially of terminal cancer pain [37]. Some organizations, such as the National Comprehensive Cancer Network (NCCN) currently recommend considering the option of low doses of strong opioids for this group of patients (Table 2) [36,39,40].…”