Safety profile of therapeutic radiopharmaceuticals for bone metastases pain palliation: evidence from a systematic literature review.

Radiopharmaceutical therapy is one of the treatment modalities used for the palliative management of pain associated with bone metastases. Given that radiopharmaceuticals may cause adverse reactions, this study aims to systematize the findings of published research on the use of strontium-89, samarium-153, rhenium-186, rhenium-188, and lutetium-177 in this clinical context. Adverse reactions were analyzed through a two-part approach. The first section presents a systematic literature review conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement, using the MEDLINE and EBSCO databases, from which 29 articles were selected. Findings indicate that the four radiopharmaceuticals yielded broadly comparable results across pain relief, reduction in analgesic consumption, acute administration-related adverse reactions, hematological toxicity, and disease progression. The second section critically appraises the methodological quality of the included publications, using a structured assessment tool. Results indicate that, although therapeutic radiopharmaceuticals generally demonstrate a favorable safety profile, hematological toxicity, particularly leukopenia and thrombocytopenia, is the most frequently reported adverse reaction. The spontaneous reporting system continues to face significant challenges, including data limitations in vulnerable populations, conflicting causality assessments, and underreporting. In conclusion, the use of radiopharmaceuticals for pain palliation appears to be safe and represents a viable alternative to existing treatments. This work underscores the importance of integrating pharmacovigilance practices specific to radiopharmaceuticals, promoting structured adverse reactions reporting, and enhancing clinical awareness to safeguard patient safety.