TY - JOUR
T1 - A Prospective Multicenter Evaluation of Initial Treatment Choice in Metastatic Renal Cell Carcinoma Prior to the Immunotherapy Era
T2 - The MaRCC Registry Experience
AU - Costello, Brian A.
AU - Bhavsar, Nrupen A.
AU - Zakharia, Yousef
AU - Pal, Sumanta K.
AU - Vaishampayan, Ulka
AU - Jim, Heather
AU - Fishman, Mayer N.
AU - Molina, Ana M.
AU - Kyriakopoulos, Christos E.
AU - Tsao, Che Kai
AU - Appleman, Leonard J.
AU - Gartrell, Benjamin A.
AU - Hussain, Arif
AU - Stadler, Walter M.
AU - Agarwal, Neeraj
AU - Pachynski, Russell K.
AU - Hutson, Thomas E.
AU - Hammers, Hans J.
AU - Ryan, Christopher W.
AU - Mardekian, Jack
AU - Borham, Azah
AU - George, Daniel J.
AU - Harrison, Michael R.
N1 - Funding Information:
Brian A Costello: Research funding (to institution) from Pfizer and Novartis. Nrupen A Bhavsar: Research funding (to institution) from Pfizer. Yousef Zakharia: Advisory boards for Janssen, Amgen, Roche Diagnostics, Novartis, Eisai, Exelixis, Castle Bioscience, Array, Bayer, Clovis, EMD Serono, and Pfizer; research funding (to institution) from NewLink Genetics, Pfizer, Exelixis, and Eisai; data safety and monitoring committee for Janssen Research and Development; consulting honorarium from Pfizer and Novartis. Sumanta K Pal: Consulting fees from Genentech, Aveo, Eisai, Roche, Pfizer, Novartis, Exelixis, Ipsen, BMS, and Astellas. Ulka Vaishampayan: Research support, consulting, and honoraria from Alkermes, Bristol-Myers Squibb Inc, Eisai, Astellas Inc, Merck, and Exelixis Inc; consulting and honoraria from Bayer and Pfizer. Heather Jim: Consulting for RedHill Biopharma, Janssen Scientific Affairs, and Merck; research funding (to institution) from Kite. Mayer N Fishman: Study sponsorships from Acceleron, Alkermes, AstraZeneca, Bristol-Myers Squibb, Merck, Nektar, Pfizer, and Prometheus; advisory boards for Eisai, Alkermes, Astellas, and Seattle Genetics; speakers’ bureau for Bristol-Myers Squibb, EMD Serono, Exelixis, and Pfizer. Ana M Molina: Advisory boards for Novartis and Exelixis. Christos E Kyriakopoulos: Consulting or advisory role for Exelixis; travel, accommodations, and expenses from Exelixis; research funding and support from Sanofi, Genzyme, Pfizer, Incyte, and Merck. Che-Kai Tsao: Consulting fees from Pfizer, Eisai, and Boehringer Ingelheim. Leonard J Appleman: Research funding from Pfizer. Benjamin A Gartrell: Advisory boards for Exelixis and Pfizer. Arif Hussain: Consulting and honoraria from Novartis, Bayer, Bristol-Myers Squibb, AstraZeneca, and Pfizer. Walter M Stadler: Consulting fees from AstraZeneca, Bayer, Bristol-Myers Squibb, Caremark-CVS, Eisai, Genentech, Pfizer; grants from Pfizer, AstraZeneca, Bayer, Bristol-Myers Squibb, Calithera, Eisai, Exelixis, Genentech, Merck, Novartis, and X4 Pharmaceuticals. Neeraj Agarwal: Consultancy fees from Pfizer, Novartis, Merck, Genentech, Eisai, Exelixis, Clovis, EMD Serono, Bristol-Myers Squibb, AstraZeneca, Astellas, Ely Lilly, Bayer, Pharmacyclics, Active Biotech, Bavarian Nordic, Calithera, Celldex, GlaxoSmithKline, Immunomedics, Janssen, Medivation, New link Genetics, Prometheus, Rexahn, Sanofi, Takeda, and TRACON. Russell K Pachynski: Consulting and honoraria from Argos, AstraZeneca, Bristol-Myers Squibb, Dendreon, EMD Serono, Exelixis, Jounce, Sanofi-Genzyme; speakers’ bureau and honoraria from AstraZeneca, Dendreon, Genentech/Roche, Genomic Health, Merck, Sanofi-Genzyme; research funding (to institution) from Ferring and Janssen. Thomas E Hutson: Honoraria, consulting, and research grant support from Exelixis, Pfizer, Bristol-Myers Squibb, Novartis, Aveo, Astellas, Genentech/Roche, and Merck. Hans J Hammers: Fees from Bristol-Myers Squibb, Merck, SFJ Pharmaceuticals, Novartis, Armo Biosciences, and Pfizer. Christopher W Ryan: Consulting and honoraria from Eisai, Exelixis, Genentech/Roche, Novartis, and Pfizer; research funding (to institution) from Argos Therapeutics, Bristol-Myers Squibb, CytRx Corporation, Daiichi-Sankyo, Eisai, Exelixis, Genentech, GlaxoSmithKline/Novartis, Janssen, Karyopharm Therapeutics, MabVax Therapeutics, Merck, Morphotek, Threshold Pharmaceuticals, and TRACON Pharma. Jack Mardekian: Was an employee of Pfizer when the study was carried out. Azah Borham: Is an employee of, and has stock or stock options, in Pfizer. Daniel J George: Honoraria and consulting from Sanofi, Exelixis, and Bayer; consulting fees from Merck and Sanofi; grants from Genentech/Roche, Novartis, Astellas, Celldex, and Acerta; grants and consulting fees from Exelixis, Janssen, Pfizer, Innocrin Pharma, and Bristol-Myers Squibb. Michael R Harrison: Consulting and honoraria from Argos, AstraZeneca, Bayer, Exelixis, Genentech and Pfizer; speakers’ bureau and honoraria from Exelixis and Genentech; research funding (to institution) from Acerta, Argos, Bristol-Myers Squibb, Exelixis, Genentech, Merck, and Pfizer.
Funding Information:
Medical writing support was provided by David Cope, PhD, of Engage Scientific Solutions and funder by Pfizer . This study was sponsored by Pfizer. Some of the authors are employees of Pfizer and medical writing support was funded by Pfizer. Therefore, the funding source had a role in study design; the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.
Publisher Copyright:
© 2021 The Authors
PY - 2022/2
Y1 - 2022/2
N2 - Introduction: The Metastatic Renal Cell Carcinoma (MaRCC) Registry provides prospective data on real-world treatment patterns and outcomes in patients with metastatic renal cell carcinoma (mRCC). Methods and Materials: Patients with mRCC and no prior systemic therapy were enrolled at academic and community sites. End of study data collection was in March 2019. Outcomes included overall survival (OS). A survey of treating physicians assessed reasons for treatment initiations and discontinuations. Results: Overall, 376 patients with mRCC initiated first-line therapy; 171 (45.5%) received pazopanib, 75 (19.9%) sunitinib, and 74 (19.7%) participated in a clinical trial. Median (95% confidence interval) OS was longest in the clinical trial group (50.3 [35.8-not reached] months) versus pazopanib (39.0 [29.7-50.9] months) and sunitinib 26.2 [19.9-61.5] months). Non-clear cell RCC (21.5% of patients) was associated with worse median OS than clear cell RCC (18.0 vs. 47.3 months). Differences in baseline characteristics, treatment starting dose, and relative dose exposure among treatment groups suggest selection bias. Survey results revealed a de-emphasis on quality of life, toxicity, and patient preference compared with efficacy in treatment selection. Conclusion: The MaRCC Registry gives insights into real-world first-line treatment selection, outcomes, and physician rationale regarding initial treatment selection prior to the immunotherapy era. Differences in outcomes between clinical trial and off-study patients reflect the difficulty in translating trial results to real-world patients, and emphasize the need to broaden clinical trial eligibility. Physician emphasis on efficacy over quality of life and toxicity suggests more data and education are needed regarding these endpoints.
AB - Introduction: The Metastatic Renal Cell Carcinoma (MaRCC) Registry provides prospective data on real-world treatment patterns and outcomes in patients with metastatic renal cell carcinoma (mRCC). Methods and Materials: Patients with mRCC and no prior systemic therapy were enrolled at academic and community sites. End of study data collection was in March 2019. Outcomes included overall survival (OS). A survey of treating physicians assessed reasons for treatment initiations and discontinuations. Results: Overall, 376 patients with mRCC initiated first-line therapy; 171 (45.5%) received pazopanib, 75 (19.9%) sunitinib, and 74 (19.7%) participated in a clinical trial. Median (95% confidence interval) OS was longest in the clinical trial group (50.3 [35.8-not reached] months) versus pazopanib (39.0 [29.7-50.9] months) and sunitinib 26.2 [19.9-61.5] months). Non-clear cell RCC (21.5% of patients) was associated with worse median OS than clear cell RCC (18.0 vs. 47.3 months). Differences in baseline characteristics, treatment starting dose, and relative dose exposure among treatment groups suggest selection bias. Survey results revealed a de-emphasis on quality of life, toxicity, and patient preference compared with efficacy in treatment selection. Conclusion: The MaRCC Registry gives insights into real-world first-line treatment selection, outcomes, and physician rationale regarding initial treatment selection prior to the immunotherapy era. Differences in outcomes between clinical trial and off-study patients reflect the difficulty in translating trial results to real-world patients, and emphasize the need to broaden clinical trial eligibility. Physician emphasis on efficacy over quality of life and toxicity suggests more data and education are needed regarding these endpoints.
KW - First-line cancer treatment
KW - Kidney cancer
KW - Real-world practice patterns
KW - Renal cell carcinoma
KW - Tyrosine kinase inhibitors
UR - http://www.scopus.com/inward/record.url?scp=85112003295&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85112003295&partnerID=8YFLogxK
U2 - 10.1016/j.clgc.2021.07.002
DO - 10.1016/j.clgc.2021.07.002
M3 - Article
C2 - 34364796
AN - SCOPUS:85112003295
VL - 20
SP - 1
EP - 10
JO - Clinical Genitourinary Cancer
JF - Clinical Genitourinary Cancer
SN - 1558-7673
IS - 1
ER -