Indirect comparison of denosumab versus pamidronate in the treatment of bone metastases in breast cancer

• Autores: Patricia Monje Agudo, Emilio Jesús Alegre del Rey, Yolanda Borrego Izquierdo, Rocío Jiménez Galán, María Rosa Cantudo Cuenca
• Localización: European journal of clinical pharmacy: atención farmacéutica, ISSN 2385-409X, Vol. 16, Nº. 3, 2014, págs. 213-216
• Idioma: inglés
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• Resumen

  • Objetive: To perform an indirect comparison of denosumab vs. pamidronate in the treatment of bone metastases in breast cancer. Method: Two broad searches were conducted; «denosumab and zoledronic» and «zoledronic and pamidronate» (drug1 AND drug2 AND breast cancer (randomized controlled trial [PT] OR clinical trial [PT])) in the database «Pubmed» in May 2013. The selection of title or abstract was made based on PICO questions (P; patients included, I; intervention, C; comparator and O; outcome). Randomized clinical trials of breast cancer patients with at least one bone metastases were ineluded. Patients received subcutaneous denosumab or pamidronate intravenous infusion as intervention and zoledronic intravenous infusion as comparator. The proportion of patients who had on- study Skeletal Related Event (SRE); pathologic fracture, radiation therapy needed, spinal cord compression or surgery to bone was chosen as the principal outcome. An 8% non-inferiority limit was chosen. Statistical analysis was performed by Bucher's method. Results: Two clinical trials met the selection criteria for the adjusted indirect comparison. The Absolute Risk Reduction (ARR) for denosumab vs. pamidronate was 7.1% (CI 95% -0.2% to 14%), favourable to denosumab. Statistically significant differences between both treatments were not observed but the confidence interval exceeded the equivalence range. Conclusions: This case would be considered as dubious or inconclusive equivalence. According to the actual guidelines for the therapeutic positioning of potentially equivalent drugs, denosumab and pamidronate would not be considered as equivalent therapeutic alternatives