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Chemotherapy has helped prolong survival in patients with malignant lymphoma, enhancing their quality of life (QOL). Despite the eventual decline in the QOL of patients, the impact of initial chemotherapy remains poorly understood. A prospective patient-reported QOL survey among patients with malignant lymphoma receiving initial chemotherapy was conducted, targeting those treated at Gifu Municipal Hospital (Gifu, Japan) between January 2021 and December 2022. Surveys were conducted pre- and post-chemotherapy based on the EuroQol 5 dimensions. Drug costs were calculated using official prices and analyzed from the cost payer's perspective via cost-utility analysis. Among the 60 patients included in the present study, 28 had diffuse large B-cell lymphoma. Cyclophosphamide, doxorubicin, vincristine, prednisolone ± rituximab therapy was the most common treatment (38 patients) and demonstrated superior cost-effectiveness due to its lowest cost and change in utility value. Initial chemotherapy for patients with malignant lymphoma generally improved the QOL. Clinical trial registration: UMIN000042868 (registered on December 28, 2020).
RESUMEN
INTRODUCTION: Anaplastic lymphoma kinase (ALK) has been to be involved in the uptake and regulation of dopamine 2 receptor (D2R), a G protein-coupled receptor expressed in various brain regions. Therefore, it is crucial to understand the relationship between ALK inhibitors and seizures is an important issue. This study investigated the relationship between ALK inhibitors and seizures. METHODS: This study investigated the relationship between ALK inhibitors and seizures through a disproportionality analysis using the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). The target drugs were the ALK inhibitors crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib. The seizures covered were defined high-level group term (HLGT): "Seizures (incl. subtype)" including high-level term (HLT): "seizures and seizure disorders NEC." This study used the information component (IC), a signal score, as a Bayesian statistical method for disproportionality analysis. The signal detection criteria used in this study were the same as those reported previously: a lower limit of 95% credible interval (CrI) for IC >0. RESULTS: The signal scores of '"seizures and seizure disorders not elsewhere classified (NEC)" "for each ALK inhibitor were crizotinib (IC: -0.00052, 95% CrI: -0.38-0.27), ceritinib (IC: 1.18, 95% CrI: 0.68-1.54), alectinib (IC: 0.68, 95% CrI: 0.19-1.02), brigatinib (IC: 1.04, 95% CrI: 0.32-1.54), and lorlatinib (IC: 0.82, 95% CrI: 0.11-1.32). On the other hand, "generalized tonic-clonic seizures," "partial simple seizures NEC," "absence seizures," and "partial complex seizures" had no or few reported cases, and no signal was detected. CONCLUSION: To our knowledge, this is the first report to evaluate the relationship between ALK inhibitors and seizures using post-marketing surveillance data. These results suggest that ceritinib, alectinib, brigatinib, and lorlatinib, which are highly brain-migrating drugs, are associated with seizures.