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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorGeynisman, Daniel M.
dc.contributor.authorBurotto, Mauricio
dc.contributor.authorPorta, Camillo
dc.contributor.authorSuárez Rodríguez, Cristina
dc.contributor.authorBourlon, Maria T.
dc.contributor.authorHuo, Stephen
dc.date.accessioned2022-09-09T13:40:26Z
dc.date.available2022-09-09T13:40:26Z
dc.date.issued2022-07
dc.identifier.citationGeynisman DM, Burotto M, Porta C, Suarez C, Bourlon MT, Huo S, et al. Temporal Trends in Grade 3/4 Adverse Events and Associated Costs of Nivolumab Plus Cabozantinib Versus Sunitinib for Previously Untreated Advanced Renal Cell Carcinoma. Clin Drug Investig. 2022 Jul;42:611–622.
dc.identifier.issn1179-1918
dc.identifier.urihttp://hdl.handle.net/11351/8126
dc.descriptionAdvanced Renal Cell Carcinoma; Adverse Events; Nivolumab
dc.description.abstractBackground and Objectives Novel immunotherapy-based combination treatments have drastically improved clinical outcomes for previously untreated patients with advanced/metastatic renal cell carcinoma (aRCC). This study aimed to assess the temporal trends in grade 3/4 adverse event (AE) rates and associated costs of nivolumab plus cabozantinib combination therapy versus sunitinib monotherapy in previously untreated patients with aRCC. Methods Individual patient data from the CheckMate 9ER trial (nivolumab plus cabozantinib: N = 320; sunitinib: N = 320) were used to calculate the proportion of patients experiencing grade 3/4 AEs. AE unit costs were obtained from the United States (US) 2017 Healthcare Cost and Utilization Project (HCUP) and inflated to 2020 US dollars. Per-patient-per-month (PPPM) all-cause and treatment-related grade 3/4 AE costs over 18-months, temporal trends, and top drivers of AE costs were evaluated in both treatment arms. Results Overall, the proportion of patients experiencing grade 3/4 AEs decreased over time, with the highest rates observed in the first 3 months for the nivolumab plus cabozantinib and sunitinib arms. Compared with sunitinib, nivolumab plus cabozantinib was associated with consistently lower average all-cause AE costs PPPM [month 3: $2021 vs. $3097 (p < 0.05); month 6: $1653 vs. $2418 (p < 0.05); month 12: $1450 vs. $1935 (p > 0.05); month 18: $1337 vs. $1755 (p > 0.05)]. Over 18 months, metabolism and nutrition disorders ($244), laboratory abnormalities ($182), and general disorders and administration site conditions ($122) were the costliest all-cause PPPM AE categories in the nivolumab plus cabozantinib arm, and laboratory abnormalities ($443), blood and lymphatic system disorders ($254), and metabolism and nutrition disorders ($177) were the costliest in the sunitinib arm. Trends of treatment-related AE costs were consistent with all-cause AE costs. Conclusions Nivolumab plus cabozantinib was associated with lower costs of grade 3/4 AE management PPPM than sunitinib, which accumulated over the 18-month study period.
dc.language.isoeng
dc.publisherSpringer
dc.relation.ispartofseriesClinical Drug Investigation;42
dc.rightsAttribution-NonCommercial 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/
dc.sourceScientia
dc.subjectFetge - Càncer - Tractament
dc.subjectQuimioteràpia combinada
dc.subjectMedicaments antineoplàstics - Efectes secundaris
dc.subject.meshCarcinoma, Renal Cell
dc.subject.mesh/drug therapy
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.titleTemporal Trends in Grade 3/4 Adverse Events and Associated Costs of Nivolumab Plus Cabozantinib Versus Sunitinib for Previously Untreated Advanced Renal Cell Carcinoma
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1007/s40261-022-01170-6
dc.subject.decscarcinoma de células renales
dc.subject.decs/farmacoterapia
dc.subject.decsprotocolos de quimioterapia antineoplásica combinada
dc.relation.publishversionhttps://doi.org/10.1007/s40261-022-01170-6
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Geynisman DM] Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA. [Burotto M] Oncology Department, Bradford Hill Clinical Research Center, Santiago, Chile. [Porta C] Interdisciplinary Department of Medicine, University of Bari ‘A.Moro’ and Division of Oncology, A.O.U. Consorziale Policlinico di Bari, Bari, Italy. [Suarez C] Servei d’Oncologia Mèdica, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Bourlon MT] Department of Hemato-Oncology, Urologic Oncology Clinic, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. [Huo S] Worldwide Health Economics and Outcomes Research-US Market, Bristol Myers Squibb, Princeton, NJ, USA
dc.identifier.pmid35696045
dc.identifier.wos000810311300001
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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