Fulranumab as Adjunctive Therapy for Cancer-Related Pain: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study
| Autor: | John Louie, Naim Zaki, Kathleen Kelly, Neal E Slatkin, Steven Wang, Panna Sanga, John Thipphawong |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Injections Subcutaneous Phases of clinical research Antibodies Monoclonal Humanized Placebo 03 medical and health sciences Subcutaneous injection 0302 clinical medicine Double-Blind Method Fulranumab 030202 anesthesiology Internal medicine Outcome Assessment Health Care Clinical endpoint Humans Immunologic Factors Pain Management Medicine Treatment Failure Adverse effect Aged Pain Measurement Aged 80 and over business.industry Cancer Cancer Pain Middle Aged Cancer-Related Pain medicine.disease Analgesics Opioid Anesthesiology and Pain Medicine Neurology Drug Therapy Combination Female Neurology (clinical) business 030217 neurology & neurosurgery Follow-Up Studies |
| Zdroj: | The Journal of Pain. 20:440-452 |
| ISSN: | 1526-5900 |
| DOI: | 10.1016/j.jpain.2018.09.014 |
| Popis: | This randomized, double-blind (DB), placebo-controlled, phase 2 study assessed the efficacy and safety of fulranumab as a pain therapy adjunctive to opioids in terminally ill cancer patients. Ninety-eight patients were randomized (2:1) to receive one subcutaneous injection of fulranumab (9 mg) or placebo in the 4-week DB phase. Seventy-one (72%) patients entered the 48-week open-label extension phase and were administered 9 mg of fulranumab every 4 weeks. The study failed to demonstrated efficacy at the end of the DB phase (primary endpoint, mean [SD] change in average cancer-related pain intensity was −.8 (1.26) for fulranumab and −.7 (1.56) for placebo; P = .592). However, potential benefit is suggested based on secondary endpoints (30% responder rate [P = .020], Brief Pain Inventory-Short Form [BPI-SF] pain intensity subscale [P = .003], and pain interference subscale [P = .006]). The most commonly reported treatment-emergent adverse events were (fulranumab vs placebo): asthenia (16% vs 10%), decreased appetite (12% vs 6%), fatigue (10% vs 0%), and malignant neoplasm progression (10% vs 0%). Although no differences were seen between fulranumab and placebo groups on the primary endpoint, improvements in BPI-SF pain subscale scores and responder rates support further research of anti-nerve growth factor therapy in cancer-related pain. Perspective Efficacy and safety of fulranumab as adjunctive pain therapy in terminally ill cancer patients were assessed. Results suggest that anti-NGF agents may prove to be novel additions in helping to optimize pain relief in cancer patients who fail to respond adequately to opioids and other common co-analgesics. |
| Databáze: | OpenAIRE |
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