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Observational Study
. 2021 Jul 1;127(13):2204-2212.
doi: 10.1002/cncr.33494. Epub 2021 Mar 25.

Active surveillance of metastatic renal cell carcinoma: Results from a prospective observational study (MaRCC)

Michael R Harrison  1 , Brian A Costello  2 , Nrupen A Bhavsar  1 , Ulka Vaishampayan  3 , Sumanta K Pal  4 , Yousef Zakharia  5 , Heather S L Jim  6 , Mayer N Fishman  6 , Ana M Molina  7 , Christos E Kyriakopoulos  8 , Che-Kai Tsao  9 , Leonard J Appleman  10 , Benjamin A Gartrell  11   12 , Arif Hussain  13 , Walter M Stadler  14 , Neeraj Agarwal  15 , Russell K Pachynski  16 , Thomas E Hutson  17 , Hans J Hammers  18 , Christopher W Ryan  19 , Brant A Inman  1 , Jack Mardekian  20 , Azah Borham  20 , Daniel J George  1
Affiliations
Observational Study

Active surveillance of metastatic renal cell carcinoma: Results from a prospective observational study (MaRCC)

Michael R Harrison et al. Cancer. .

Abstract

Background: Systemic therapy (ST) can be deferred in patients who have metastatic renal cell carcinoma (mRCC) and slow-growing metastases. Currently, this subset of patients managed with active surveillance (AS) is not well described in the literature.

Methods: This was a prospective observational study of patients with mRCC across 46 US community and academic centers. The objective was to describe baseline characteristics and demographics of patients with mRCC initially managed by AS, reasons for AS, and patient outcomes. Descriptive statistics were used to characterize demographics, baseline characteristics, and patient-related outcomes. Wilcoxon 2-sample rank-sum tests and χ2 tests were used to assess differences between ST and AS cohorts in continuous and categorical variables, respectively. Kaplan-Meier survival curves were used to assess survival.

Results: Of 504 patients, mRCC was initially managed by AS (n = 143) or ST (n = 305); 56 patients were excluded from the analysis. Disease was present in 69% of patients who received AS, whereas the remaining 31% had no evidence of disease. At data cutoff, 72 of 143 patients (50%) in the AS cohort had not received ST. The median overall survival was not reached (95% CI, 122 months to not estimable) in patients who received AS versus 30 months (95% CI, 25-44 months) in those who received ST. Quality of life at baseline was significantly better in patients who were managed with AS versus ST.

Conclusions: AS occurs frequently (32%) in real-world clinical practice and appears to be a safe and appropriate alternative to immediate ST in selected patients.

Keywords: active surveillance; metastatic; observational study; renal cell carcinoma.

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Conflict of interest statement

Michael R. Harrison reports personal fees and honoraria from Argos, AstraZeneca, Bayer, Exelixis Inc, Genentech, and Pfizer; and institutional research funding from Acerta, Argos, Bristol‐Myers Squibb, Exelixis Inc, Genentech, Merck, and Pfizer, outside the submitted work. Nrupen A. Bhavsar reports institutional research funding from Pfizer, outside the submitted work. Ulka Vaishampayan reports grants and personal fees from Astellas Inc, Bristol‐Myers Squibb, and Exelixis Inc, and personal fees from Bayer, Pfizer, and Genentech, outside the submitted work. Sumanta K. Pal reports personal fees from Astellas, Aveo, Bristol‐Myers Squibb, Eisai, Exelixis Inc, Genentech, Ipsen, Novartis, Pfizer, and Roche, outside the submitted work. Yousef Zakharia reports personal fees from Amgen, Castle Bioscience, Eisai, Exelixis Inc, Novartis, Pfizer, and Roche Diagnostics; and personal fees and other support from Janssen, outside the submitted work. Heather S. L. Jim reports institutional research funding from Kite and personal fees from Redhill BioPharma, Janssen Scientific Affairs, and Merck, outside the submitted work. Mayer N. Fishman reports grants from Acceleron, Alkermes, AstraZeneca, Nektar, and Prometheus; personal fees from EMD Serrono and Ipsen; and grants and personal fees from Bristol‐Myers Squibb, Eisai, Exelixis Inc, Merck, and Pfizer, outside the submitted work. Ana M. Molina reports personal fees from Novartis and Exelixis Inc, outside the submitted work. Christos E. Kyriakopoulos reports grants from Sanofi Genzyme, Pfizer, Incyte, and Merck; and personal fees and other support from Exelixis Inc, outside the submitted work. Che‐Kai Tsao reports personal fees from Pfizer, Eisai, and Boehringer Ingelheim, outside the submitted work. Leonard J. Appleman reports grants from Pfizer, outside the submitted work. Benjamin A. Gartrell reports personal fees from Exelixis Inc, Pfizer, Janssen, Genomic Health, and EMD Serono, outside the submitted work. Arif Hussain reports personal fees from Novartis, Bayer, Bristol‐Myers Squibb, AstraZeneca, and Pfizer, outside the submitted work. Walter M. Stadler reports grants from Calithera, Exelixis Inc, Merck, Novartis, and X4 Pharmaceuticals; grants and personal fees from AstraZeneca, Bayer, Bristol‐Myers Squibb, Eisai, Genentech, and Pfizer; and personal fees from Caremark‐CVS, outside the submitted work. Neeraj Agarwal reports personal fees from Astellas, AstraZeneca, Bayer, Bristol‐Myers Squibb, Clovis, Eisai, Eli Lilly, EMD Serono, Exelixis Inc, Foundation Medicine, Genentech, Janssen, Merck, Nektar, Novartis, Pfizer, Pharmacyclics, and Seattle Genetics, outside the submitted work. Russell K. Pachynski reports institutional research funding from Ferring; institutional research funding and personal fees from Janssen; and personal fees from Argos, AstraZeneca, Bristol‐Myers Squibb, Dendreon, EMD Serrono, Exelixis Inc, Jounce, Sanofi‐Genzyme, Genentech/Roche, Genomic Health, and Merck, outside the submitted work. Thomas E. Hutson reports grants and personal fees from Bristol‐Myers Squibb, Exelixis Inc, Pfizer, Novartis, Aveo, Astellas, Genentech/Roche, and Merck, outside the submitted work. Hans Joerg Hammers reports personal fees from Bristol‐Myers Squibb, Merck, SFJ Pharmaceuticals, Novartis, Armo Biosciences, and Pfizer, outside the submitted work. Christopher W. Ryan reports institutional research funding from Argos Therapeutics, Bristol‐Myers Squibb, CytRx Corporation, Daiichi‐Sankyo, Genentech, GlaxoSmithKline/Novartis, Janssen, Karyopharm Therapeutics, MabVax Therapeutics, Merck, Morphotek, Threshold Pharmaceuticals, and TRACON Pharma; institutional research funding and personal fees from Eisai, and Exelixis Inc; and personal fees from Genentech/Roche, Novartis, and Pfizer, outside the submitted work. Brant A. Inman reports grants from Dendreon, FKD Therapies, QED Therapeutics, Abbott Laboratories, and Anchiano Therapeutics; grants and personal fees from Genentech/Roche, Combat Medical, Nucleix, and Taris Biomedical; and personal fees from Fergene, outside the submitted work. Jack Mardekian was an employee of Pfizer during the conduct of the study. Azah Borham is an employee of Pfizer and holds shares in the company. Daniel J. George reports grants from Genentech/Roche, Novartis, Astellas, Celldex, and Acerta; grants and personal fees from Exelixis Inc, Janssen, Pfizer, Innocrin Pharma, and Bristol‐Myers Squibb; and personal fees from Sanofi, Bayer, and Merck, outside the submitted work. Brian A. Costello made no disclosures.

Figures

Figure 1
Figure 1
This chart describes the active surveillance (AS) cohort. MaRCC Registry indicates the Metastatic Renal Cell Carcinoma Registry; PTSAS, Physician Treatment Selection Assessment Survey; ST, systemic therapy.
Figure 2
Figure 2
This Kaplan‐Meier curve illustrates systemic therapy (ST)–free survival in the active surveillance cohort. Dx indicates diagnosis; met, metastatic.
Figure 3
Figure 3
Kaplan‐Meier curves illustrate overall survival in (A) the active surveillance (AS) versus systemic therapy (ST) cohorts, (B) the AS cohort according to the time from initial diagnosis to metastatic diagnosis <1 year versus ≥1 year, (C) the ST cohort according to the time from initial diagnosis to metastatic diagnosis <1 year versus ≥1 year, (D) the AS cohort comparing those with International Metastatic Renal Cell Database Consortium (IMDC) favorable‐risk versus intermediate‐risk versus poor‐risk scores, and (E) the ST cohort comparing those with IMDC favorable‐risk versus intermediate‐risk versus poor‐risk scores.
See this image and copyright information in PMC

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