Tyrosine kinase inhibitors still play a very important role in the treatment of metastatic renal cell carcinoma despite a continuously changing scenario, in which immunotherapy and several combination-based approaches are also available. In this light, patient-reported outcomes and health-related quality of life are important factors in the selection of the best first-line treatment. This Review focuses on the existing evidence on patient-reported outcomes and health-related quality of life with several tyrosine kinase inhibitors (pazopanib, sunitinib, cabozantinib and tivozanib) used as first-line treatment for metastatic renal cell carcinoma.

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References

1. Di Maio M, Basch E, Bryce J, Perrone F. Patient-reported outcomes in the evaluation of toxicity of anticancer treatments. Nat. Rev. Clin. Oncol. 13(5), 319–325 (2016).
MedlineGoogle Scholar
2. US FDA. Food and Drug Administration’s overall risk management activities. (2009). www.fda.gov/Safety/SafetyofSpecificProducts/ucm180589.htm
Google Scholar
3. European Medicines Agency. Reflection paper on benefit-risk assessment methods in the context of the evaluation of marketing authorisation application of medicinal products for human use. www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/01/WC500069634.pdf
Google Scholar
4. European Medicines Agency. Guideline on the evaluation of anticancer products in man. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/01/WC500137128.pdf
Google Scholar
5. Basch E. The missing voice of patients in drug-safety reporting. N. Engl. J. Med. 362, 865–869 (2010).
Medline CASGoogle Scholar
6. Trotti A, Colevas AD, Setser A, Basch E. Patient-reported outcomes and the evolution of adverse event reporting in oncology. J. Clin. Oncol. 25, 5121–5127 (2007).
MedlineGoogle Scholar
7. Reeve BB, Mitchell SA, Dueck AC et al. Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. J. Natl Cancer Inst. 106(7), pii:dju129 (2014).
Google Scholar
8. Dos Santos M, Brachet PE, Chevreau C, Joly F. Impact of targeted therapies in metastatic renal cell carcinoma on patient-reported outcomes: methodology of clinical trials and clinical benefit. Cancer Treat. Rev. 53, 53–60 (2017).
MedlineGoogle Scholar
9. Cella D. Beyond traditional outcomes: improving quality of life in patients with renal cell carcinoma. Oncologist 16(Suppl. 2), 23–31 (2011).
MedlineGoogle Scholar
10. Gill DM, Hahn AW, Hale P, Maughan BL. Overview of current and future first-line systemic therapy for metastatic clear cell renal cell carcinoma. Curr. Treat. Options Oncol. 19(1), 6 (2018).
MedlineGoogle Scholar
11. Jain R, George S. First-line vascular endothelial growth factor inhibitors for advanced renal cell carcinoma and the impact of new agents entering the treatment paradigm. BJU Int. 120(6), 749–751 (2017).
MedlineGoogle Scholar
12. Takyar S, Diaz J, Sehgal M, Sapunar F, Pandha H. First-line therapy for treatment-naive patients with advanced/metastatic renal cell carcinoma: a systematic review of published randomized controlled trials. Anticancer Drugs 27(5), 383–397 (2016).
Medline CASGoogle Scholar
13. Castellano D, del Muro XG, Pérez-Gracia JL et al. Patient-reported outcomes in a Phase III, randomized study of sunitinib versus interferon-{α} as first-line systemic therapy for patients with metastatic renal cell carcinoma in a European population. Ann. Oncol. 20(11), 1803–1812 (2009).
Medline CASGoogle Scholar
14. Cella D, Michaelson MD, Bushmakin AG et al. Health-related quality of life in patients with metastatic renal cell carcinoma treated with sunitinib vs interferon-α in a Phase III trial: final results and geographical analysis. Br. J. Cancer 102(4), 658–664 (2010).
Medline CASGoogle Scholar
15. Cella D, Bushmakin AG, Cappelleri JC, Charbonneau C, Michaelson MD, Motzer RJ. Baseline quality of life as a prognostic survival tool in patients receiving sunitinib for metastatic renal cell carcinoma. Br. J. Cancer 106(4), 646–650 (2012).
Medline CASGoogle Scholar
16. Cella D, Davis MP, Négrier S et al. Characterizing fatigue associated with sunitinib and its impact on health-related quality of life in patients with metastatic renal cell carcinoma. Cancer 120(12), 1871–1880 (2014).
Medline CASGoogle Scholar
17. Miyake H, Miyazaki A, Harada K, Fujisawa M. Assessment of efficacy, safety and quality of life of 110 patients treated with sunitinib as first-line therapy for metastatic renal cell carcinoma: experience in real-world clinical practice in Japan. Med. Oncol. 31(6), 978 (2014).
MedlineGoogle Scholar
18. Miyake H, Harada K, Kusuda Y, Fujisawa M. Health-related quality of life in Japanese patients with metastatic renal cell carcinoma treated with sunitinib. Int. J. Clin. Oncol. 18(2), 220–225 (2013).
Medline CASGoogle Scholar
19. Miyake H, Harada K, Miyazaki A, Fujisawa M. Improved health-related quality of life of patients with metastatic renal cell carcinoma treated with a 2 weeks on and 1 week off schedule of sunitinib. Med. Oncol. 32(3), 78 (2015).
MedlineGoogle Scholar
20. Pan X, Huang H, Huang Y et al. Sunitinib dosing schedule 2/1 improves tolerability, efficacy, and health-related quality of life in Chinese patients with metastatic renal cell carcinoma. Urol. Oncol. 33(6), 268.e9-15 (2015).
Google Scholar
21. Cai W, Kong W, Dong B et al. Comparison of efficacy, safety, and quality of life between sorafenib and sunitinib as first-line therapy for Chinese patients with metastatic renal cell carcinoma. Chin. J. Cancer 36(1), 64 (2017).
MedlineGoogle Scholar
22. Bracarda S, Iacovelli R, Boni L et al. Sunitinib administered on 2/1 schedule in patients with metastatic renal cell carcinoma: the RAINBOW analysis. Ann. Oncol. 26(10), 2107–2113 (2015).
Medline CASGoogle Scholar
23. Calvo-Aller E, Maroto P, Kreif N et al. Cost–effectiveness evaluation of sunitinib as first-line targeted therapy for metastatic renal cell carcinoma in Spain. Clin. Transl. Oncol. 13(12), 869–877 (2011).
Medline CASGoogle Scholar
24. De Groot S, Blommestein HM, Redekop WK et al. Potential health gains for patients with metastatic renal cell carcinoma in daily clinical practice: a real-world cost–effectiveness analysis of sequential first- and second-line treatments. PLoS ONE 12(5), e0177364 (2017).
MedlineGoogle Scholar
25. Escudier B, Porta C, Bono P et al. Randomized, controlled, double-blind, cross-over trial assessing treatment preference for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma: PISCES study. J. Clin. Oncol. 32(14), 1412–1418 (2014).
Medline CASGoogle Scholar
26. Beaumont JL, Salsman JM, Diaz J et al. Quality-adjusted time without symptoms or toxicity analysis of pazopanib versus sunitinib in patients with renal cell carcinoma. Cancer 122(7), 1108–1115 (2016).
Medline CASGoogle Scholar
27. Capri S, Porta C, Delea TE. Cost–effectiveness of pazopanib versus sunitinib as first-line treatment for locally advanced or metastatic renal cell carcinoma from an Italian National Health Service perspective. Clin. Ther. 39(3), 567–580.e2 (2017).
Medline CASGoogle Scholar
28. Amdahl J, Diaz J, Sharma A, Park J, Chandiwana D, Delea TE. Cost–effectiveness of pazopanib versus sunitinib for metastatic renal cell carcinoma in the United Kingdom. PLoS ONE 12(6), e0175920 (2017).
MedlineGoogle Scholar
29. Cella D, Ivanescu C, Skaltsa K et al. Treatment benefit of tivozanib hydrochloride versus sorafenib on health-related quality of life (HRQoL) among patients (pts) with advanced/metastatic renal cell carcinoma (mRCC): Tivo-1 study results. J. Clin. Oncol. 31(Suppl. 6), Abstract 355 (2013).
Google Scholar
30. Cirkel GA, Hamberg P, Sleijfer S et al. Dutch WIN-O Consortium. Alternating treatment with pazopanib and everolimus vs continuous pazopanib to delay disease progression in patients with metastatic clear cell renal cell cancer: the ROPETAR randomized clinical trial. JAMA Oncol. 3(4), 501–508 (2017).
MedlineGoogle Scholar
31. Chen RC, Feuilly M, Meng J et al. Quality-adjusted time without symptoms or toxicity (Q-TWiST): analysis of cabozantinib (Cabo) vs sunitinib (Sun) in patients with advanced renal cell carcinoma (aRCC) of intermediate or poor risk (Alliance A031203). Presented at: 2018 ASCO Annual Meeting. Chicago, IL, USA, 2 June 2018.
Google Scholar
32. Cella D, Grünwald V, Escudier B et al. Quality of life in patients with advanced renal cell carcinoma in the randomized, open-label CheckMate 214 trial. Presented at: 2018 ASCO Annual Meeting. Chicago, IL, USA, 4 June 2018.
Google Scholar
33. Escudier B, Motzer RJ, Rini BI et al. Patient-reported outcomes (PROs) in IMmotion151: atezolizumab (atezo) + bevacizumab (bev) vs sunitinib (sun) in treatment (tx) naive metastatic renal cell carcinoma (mRCC). Presented at: 2018 ASCO Annual Meeting. Chicago, IL, USA, 3 June 2018.
Google Scholar

Vol. 15, No. 22

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Received 13 November 2018

Accepted 19 June 2019

Published online 24 July 2019

Published in print August 2019

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Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Medical writing was performed by L Giacomelli, A Corti and A Shah (Polistudium srl, Milan, Italy) on behalf of Content Ed Net; this assistance was supported by Novartis Farma, Origgio, Italy.

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