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Long-term Duration of First-Line Axitinib Treatment in Advanced Renal Cell Carcinoma

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Abstract

Objective

We conducted a retrospective analysis of two clinical trials in treatment-naïve patients (n = 402) with advanced renal cell carcinoma (RCC) treated with axitinib. Our objective was to compare duration of treatment (DT) and clinical outcome in patients who achieved DT >18 months (longer DT) versus ≤18 months (shorter DT).

Patients and Methods

DT, objective response rate (ORR), tumor shrinkage, and overall survival (OS) were summarized for patients with longer and shorter DT.

Results

Overall, 152 patients (37.8%) had longer DT and 250 (62.2%) had shorter DT (median, 34.7 vs. 6.5 months, respectively). ORR in all 402 patients with advanced RCC was 43.5%. ORR was 75% for longer DT versus 24.4% for shorter DT (p < 0.0001). More patients with longer DT versus shorter DT had ≥10% tumor shrinkage at first scan (74.8% vs. 55.3%; p = 0.0001) and maximum on-study tumor shrinkage was greater in longer-DT versus shorter-DT group (−51.8% vs. –22.1%; p < 0.0001). Median OS was 32.6 months in the overall population while in the patients with longer DT the median was not reached. Treatment-related adverse events (AEs) grade ≥3 were more frequent in longer-DT versus shorter-DT and included hypertension (25.7% vs. 18.8%), diarrhea (15.1% vs. 4.4%), and weight decrease (11.2% vs. 3.2%); however, these AEs decreased over time in both groups. Eastern Cooperative Oncology Group performance status 0, favorable hematology values, no bone or liver metastases, and baseline tumor burden below the overall median were associated with longer DT.

Conclusions

Longer duration (>18 months) of axitinib treatment was associated with increased frequency of early tumor shrinkage, greater magnitude of tumor shrinkage, and a favorable OS.

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Acknowledgements

The study was funded by Pfizer Inc. Medical writing support was provided by Vardit Dror, PhD, of Engage Scientific Solutions and was funded by Pfizer Inc.

Author information

Authors and Affiliations

  1. Department of Hematology and Oncology, Cleveland Clinic Taussig Cancer Institute, 9500 Euclid Ave., Desk R35, Cleveland, OH, 44195, USA

    Brian I. Rini

  2. Hannover Medical School, Hannover, Germany

    Victor Gruenwald

  3. Department of Genitourinary Oncology, Division of Cancer Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, TX, USA

    Eric Jonasch

  4. H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA

    Mayer N. Fishman

  5. Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan

    Yoshihiko Tomita

  6. Massachusetts General Hospital Cancer Center, Boston, MA, USA

    M. Dror Michaelson

  7. Pfizer Oncology, La Jolla, CA, USA

    Jamal Tarazi, Angel H. Bair & Brad Rosbrook

  8. Pfizer Oncology, Pfizer Inc, New York, NY, USA

    Laura Cisar & Subramanian Hariharan

  9. Baylor-Sammons Cancer Center, Genitourinary Oncology Program, Dallas, TX, USA

    Thomas E. Hutson

Authors
  1. Brian I. Rini
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  2. Victor Gruenwald
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  4. Mayer N. Fishman
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  7. Jamal Tarazi
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  8. Laura Cisar
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  9. Subramanian Hariharan
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  10. Angel H. Bair
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  11. Brad Rosbrook
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  12. Thomas E. Hutson
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Corresponding author

Correspondence to Brian I. Rini.

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Funding

This study was funded by Pfizer Inc.

Conflicts of Interest

JC Tarazi, B Rosbrook, AH Bair, S Hariharan and L Cisar are full-time employees of and declare stocks from Pfizer Inc.

BI Rini received research funding and consulting fees from Pfizer.

V Gruenwald received consulting fees and honoraria from Pfizer Oncology, Roche Pharma, GSK and Novartis Oncology, research funding from Wyeth Oncology, and a lecture honorarium from Bayer.

E Jonasch received research funding and consulting fees from Pfizer.

MN Fishman received research funding and honoraria from Aveo, Altor Biosciences, Bayer, Genentech, GSK, and Pfizer; research funding from BMS, Eisai and Exelixis; honoraria from Alkermes, and Prometheus; and has served on speakers bureaus for Bayer, Exelixis, GSK, Novartis, Pfizer, and Prometheus.

Y Tomita received honoraria and research funding from Pfizer and Novartis.

MD Michaelson received research funding and consulting fees from Pfizer, Novartis, and Exelixis.

TE Hutson received consulting fees and research funding from Pfizer, Exelexis, Eisai, Novartis, and BMS.

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Rini, B.I., Gruenwald, V., Jonasch, E. et al. Long-term Duration of First-Line Axitinib Treatment in Advanced Renal Cell Carcinoma. Targ Oncol 12, 333–340 (2017). https://doi.org/10.1007/s11523-017-0487-4

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  • DOI: https://doi.org/10.1007/s11523-017-0487-4

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