Brian A Costello1, Nrupen A Bhavsar2, Yousef Zakharia3, Sumanta K Pal4, Ulka Vaishampayan5, Heather Jim6, Mayer N Fishman6, Ana M Molina7, Christos E Kyriakopoulos8, Che-Kai Tsao9, Leonard J Appleman10, Benjamin A Gartrell11, Arif Hussain12, Walter M Stadler13, Neeraj Agarwal14, Russell K Pachynski15, Thomas E Hutson16, Hans J Hammers17, Christopher W Ryan18, Jack Mardekian19, Azah Borham19, Daniel J George2, Michael R Harrison2. 1. Mayo Clinic, Division of Medical Oncology, Rochester, MN. Electronic address: costello.brian@mayo.edu. 2. Duke University Medical Center, Durham, NC. 3. University of Iowa Hospitals and Clinics, Iowa City, IA. 4. City of Hope, Duarte, CA. 5. University of Michigan, Ann Arbor, MI. 6. Moffitt Cancer Center, Tampa, FL. 7. Department of Medicine, Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York, NY. 8. University of Wisconsin Carbone Cancer Center, Madison, WI. 9. Tisch Cancer Institute, Mount Sinai Medical Center, New York, NY. 10. UPMC Cancer Pavilion, Pittsburgh, PA. 11. Departments of Medical Oncology and Urology, Montefiore Medical Center, Bronx, NY. 12. University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, MD. 13. University of Chicago, Department of Medicine, Section of Hematology/Oncology, Comprehensive Cancer Center, Chicago, IL. 14. Huntsman Cancer Institute, University of Utah, Salt Lake City, UT. 15. Siteman Cancer Center, Department of Medicine, Washington University School of Medicine, St. Louis, MO. 16. Baylor Sammons Cancer Center-Texas Oncology, Dallas, TX. 17. University of Texas Southwestern, Dallas, TX. 18. Oregon Health and Science University, Portland, OR. 19. Pfizer Inc, New York, NY.
Abstract
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.
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.
Authors: Daniel J George; David R Spigel; Lucio N Gordan; Samith T Kochuparambil; Ana M Molina; Jeff Yorio; Arash Rezazadeh Kalebasty; Heidi McKean; Nishan Tchekmedyian; Scott S Tykodi; Joshua Zhang; Margarita Askelson; Jennifer L Johansen; Thomas E Hutson Journal: BMJ Open Date: 2022-09-14 Impact factor: 3.006