Dataciencia

Colección SciELO Chile

Temporal Trends in Grade 3/4 Adverse Events and Associated Costs of Nivolumab Plus Cabozantinib Versus Sunitinib for Previously Untreated Advanced Renal Cell Carcinoma

Indexado

WoS	WOS:000810311300001
Scopus	SCOPUS_ID:85131901316

DOI

10.1007/S40261-022-01170-6

Año

2022

Tipo

artículo de investigación

Citas Totales

Autores Afiliación Chile

Instituciones Chile

% Participación
Internacional

Autores
Afiliación Extranjera

Instituciones
Extranjeras

Abstract

Background 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.

Revista

Revista	ISSN
Clinical Drug Investigation	1173-2563

Métricas Externas

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Disciplinas de Investigación

WOS
Pharmacology & Pharmacy

Scopus
Pharmacology (Medical)

SciELO
Sin Disciplinas

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Publicaciones WoS (Ediciones: ISSHP, ISTP, AHCI, SSCI, SCI), Scopus, SciELO Chile.

Colaboración Institucional

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Autores - Afiliación

Ord.	Autor	Género	Institución - País
1	Geynisman, Daniel M.	Hombre	Fox Chase Cancer Center - Estados Unidos Fox Chase Canc Ctr - Estados Unidos
2	BUROTTO-PICHUN, MAURICIO	Hombre	Bradford Hill Clinical Research Center - Chile Bradford Hill Clin Res Ctr - Chile
3	Porta, Camillo	Hombre	Università degli studi di Bari Aldo Moro - Italia AOU Consorziale Policlin Bari - Italia Univ Bari A Moro - Italia
4	Suarez, C.	Mujer	Vall d‘Hebron Institut de Oncologia - España Hosp Univ Vall dHebron - España
5	Bourlon, Maria T.	Mujer	Instituto Nacional de la Nutrición Salvador Zubiran - México Inst Nacl Ciencias Med & Nutr Salvador Zubiran - México
6	Huo, Stephen	Hombre	Bristol-Myers Squibb - Estados Unidos Bristol Myers Squibb - Estados Unidos
7	Del Tejo, Viviana	Mujer	Bristol-Myers Squibb - Estados Unidos Bristol Myers Squibb - Estados Unidos
8	Du, Ella X.	Mujer	Analysis Group, Inc. - Estados Unidos Anal Grp Inc - Estados Unidos
9	Yang, Xiaoran	-	Analysis Group, Inc. - Estados Unidos Anal Grp Inc - Estados Unidos
10	Betts, Keith A.	Hombre	Analysis Group, Inc. - Estados Unidos Anal Grp Inc - Estados Unidos
11	Choueiri, Toni K.	Hombre	Dana-Farber Cancer Institute - Estados Unidos Dana Farber Canc Inst - Estados Unidos
12	McGregor, Bradley	Hombre	Dana-Farber Cancer Institute - Estados Unidos Dana Farber Canc Inst - Estados Unidos

Muestra la afiliación y género (detectado) para los co-autores de la publicación.

Financiamiento

Fuente
Novartis
GlaxoSmithKline
Bristol-Myers Squibb
Pfizer
AstraZeneca
Meso Scale Diagnostics
Merck
Genentech
Calithera Biosciences
F. Hoffmann-La Roche
Clovis Oncology
EUSA Pharma
Exelixis
AB Science
Bristol Myers Squibb
Astellas Pharma US
Ipsen Biopharmaceuticals
Bayer Fund
Blueprint Medicines
Aragon Pharmaceuticals
Loraine Georgy
Boehringer Ingelheim España

Muestra la fuente de financiamiento declarada en la publicación.

Agradecimientos

Agradecimiento
Stephen Huo and Viviana Del Tejo are employees of Bristol Myers Squibb, which funded the development and conduct of this study and manuscript. Ella X. Du, Xiaoran Yang, and Keith A. Betts are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Bristol Myers Squibb. Daniel M. Geynisman received consulting fees from Pfizer, Exelixis, AstraZeneca, Seattle Genetics/Astellas, Eisai, Merck, Myovant Sciences, and 2nd.MD, as well as research funding from Genentech, Merck, Calithera Biosciences, Astellas Pharma, and Harpoon therapeutics. Mauricio Burotto received consulting fees from Roche/Genentech, Bristol Myers Squibb, MSD Oncology, Novartis, and AstraZeneca, as well as honoraria from Roche/Genentech, MSD Oncology, Bristol Myers Squibb, and AstraZeneca. Camillo Porta received consulting fees from Angelini Pharma, AstraZeneca, Bristol Myers Squibb, Eisai, EUSA Pharma, Ipsen, Merck Serono, and MSD, as well as honoraria from Bristol Myers Squibb, EUSA Pharma, General Electric, Ipsen, and MSD, payment for expert testimony from EUSA Pharma and Pfizer, and fees for attending meetings/travel from Roche. Cristina Suarez received research funding from AB Science, Aragon Pharmaceuticals, Astellas Pharma, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim España, Bristol Myers Squibb, Clovis Oncology, Exelixis, Genentech, GlaxoSmithKline, Hoffmann-La Roche, Novartis, Pfizer, and Sanofi-Aventis, as well as honoraria from Astellas Pharma, Bristol Myers Squibb, Hoffmann-La Roche, Ipsen, and Pfizer, and scientific advisory fees from Astellas Pharma, Bayer, Bristol Myers Squibb, EUSA Pharma, Hoffmann-La Roche, Ipsen, MSD, Novartis, Pfizer, and Sanofi-Aventis. Maria T. Bourlon received consulting fees from Bristol Myers Squibb, Asofarma, Eisai, MSD Oncology, Janssen Oncology, Novartis, Bayer, Ferring, as well as honoraria from Asofarma, MSD Oncology, Bristol Myers Squibb, Bayer, Eisai, Janssen Oncology, Ipsen, Pfizer, Merck, Ferring, Tecnofarma, Medicamenta, AstraZeneca, and Astellas Pharma, payment for expert testimony from Asofarma, support for attending meetings/travel from Asofarma, Janssen-Cilag, MSD Oncology, Bristol Myers Squibb Mexico, Pfizer, Ipsen, and Sanofi, and steering committee honoraria from Bristol Myers Squibb. Toni K. Choueiri participated in Data Safety Monitoring/Advisory Boards and received grants/contracts and consulting fees from AstraZeneca, Aravive, Aveo, Bayer, Bristol Myers Squibb, Calithera, Circle Pharma, Eisai, EMD Serono, Exelixis, GlaxoSmithKline, IQVIA, Infinity, Ipsen, Janssen, Kanaph, Lilly, Merck, Nikang, Nuscan, Novartis, Pfizer, Roche, Sanofi/Aventis, Surface Oncology, Takeda, Tempest, and UpToDate, and declares a leadership or fiduciary role in NCCN, GU Steering Committee, and ASCO/ESMO, owning stock or stock options in Pionyr, Tempest, Osel, and NuscanDx, institutional patents filed on molecular mutations and immunotherapy response, and ctDNA, medical writing and editorial assistance support which may have been funded in part by Communications companies, mentoring several non-US citizens on research projects with potential funding (in part) from non-US sources/Foreign Components, and receiving independent funding of drug companies or/and royalties potentially involved in research around the subject matter. Bradley McGregor received consulting fees from Exelixis, Bristol Myers Squibb, Pfizer, Seattle Genetics, Calithera, EMD Serono, Eisai, Asetellas, Dendreon, Nektar, and Bayer, as well as research funding from Exelixis, Bristol Myers Squibb, Pfizer, Seattle Genetics, and Calithera.
Stephen Huo and Viviana Del Tejo are employees of Bristol Myers Squibb, which funded the development and conduct of this study and manuscript. Ella X. Du, Xiaoran Yang, and Keith A. Betts are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Bristol Myers Squibb. Daniel M. Geynisman received consulting fees from Pfizer, Exelixis, AstraZeneca, Seattle Genetics/Astellas, Eisai, Merck, Myovant Sciences, and 2nd.MD, as well as research funding from Genentech, Merck, Calithera Biosciences, Astellas Pharma, and Harpoon therapeutics. Mauricio Burotto received consulting fees from Roche/Genentech, Bristol Myers Squibb, MSD Oncology, Novartis, and AstraZeneca, as well as honoraria from Roche/Genentech, MSD Oncology, Bristol Myers Squibb, and AstraZeneca. Camillo Porta received consulting fees from Angelini Pharma, AstraZeneca, Bristol Myers Squibb, Eisai, EUSA Pharma, Ipsen, Merck Serono, and MSD, as well as honoraria from Bristol Myers Squibb, EUSA Pharma, General Electric, Ipsen, and MSD, payment for expert testimony from EUSA Pharma and Pfizer, and fees for attending meetings/travel from Roche. Cristina Suarez received research funding from AB Science, Aragon Pharmaceuticals, Astellas Pharma, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim España, Bristol Myers Squibb, Clovis Oncology, Exelixis, Genentech, GlaxoSmithKline, Hoffmann-La Roche, Novartis, Pfizer, and Sanofi-Aventis, as well as honoraria from Astellas Pharma, Bristol Myers Squibb, Hoffmann-La Roche, Ipsen, and Pfizer, and scientific advisory fees from Astellas Pharma, Bayer, Bristol Myers Squibb, EUSA Pharma, Hoffmann-La Roche, Ipsen, MSD, Novartis, Pfizer, and Sanofi-Aventis. Maria T. Bourlon received consulting fees from Bristol Myers Squibb, Asofarma, Eisai, MSD Oncology, Janssen Oncology, Novartis, Bayer, Ferring, as well as honoraria from Asofarma, MSD Oncology, Bristol Myers Squibb, Bayer, Eisai, Janssen Oncology, Ipsen, Pfizer, Merck, Ferring, Tecnofarma, Medicamenta, AstraZeneca, and Astellas Pharma, payment for expert testimony from Asofarma, support for attending meetings/travel from Asofarma, Janssen-Cilag, MSD Oncology, Bristol Myers Squibb Mexico, Pfizer, Ipsen, and Sanofi, and steering committee honoraria from Bristol Myers Squibb. Toni K. Choueiri participated in Data Safety Monitoring/Advisory Boards and received grants/contracts and consulting fees from AstraZeneca, Aravive, Aveo, Bayer, Bristol Myers Squibb, Calithera, Circle Pharma, Eisai, EMD Serono, Exelixis, GlaxoSmithKline, IQVIA, Infinity, Ipsen, Janssen, Kanaph, Lilly, Merck, Nikang, Nuscan, Novartis, Pfizer, Roche, Sanofi/Aventis, Surface Oncology, Takeda, Tempest, and UpToDate, and declares a leadership or fiduciary role in NCCN, GU Steering Committee, and ASCO/ESMO, owning stock or stock options in Pionyr, Tempest, Osel, and NuscanDx, institutional patents filed on molecular mutations and immunotherapy response, and ctDNA, medical writing and editorial assistance support which may have been funded in part by Communications companies, mentoring several non-US citizens on research projects with potential funding (in part) from non-US sources/Foreign Components, and receiving independent funding of drug companies or/and royalties potentially involved in research around the subject matter. Bradley McGregor received consulting fees from Exelixis, Bristol Myers Squibb, Pfizer, Seattle Genetics, Calithera, EMD Serono, Eisai, Asetellas, Dendreon, Nektar, and Bayer, as well as research funding from Exelixis, Bristol Myers Squibb, Pfizer, Seattle Genetics, and Calithera.
Financial support for this research was provided by Bristol Myers Squibb. The study sponsor was involved in several aspects of the research, including the study design, the interpretation of data, the writing of the manuscript, and the decision to submit the manuscript for publication.