Angiogenesis inhibitor therapies for advanced renal cell carcinoma: Toxicity and treatment patterns in clinical practice from a global medical chart review

Oh,William  K.; McDermott,David; Porta,Camillo; Levy,Antonin; Elaidi,Reza; Scotte,Florian; Hawkins,Robert; Castellano,Daniel; Bellmunt,Joaquim; Rha,Sun  Young; Sun,Jong-Mu; Nathan,Paul; Feinberg,Bruce  A.; Scott,Jeffrey; McDermott,Ray; Ahn,Jin-Hee; Wagstaff,John; Chang,Yen-Hwa; Ou,Yen-Chuan; Donnellan,Paul; Huang,Chao-Yuan; McCaffrey,John; Chiang,Po-Hui; Chuang,Cheng-Keng; Korves,Caroline; Neary,Maureen  P.; Diaz,Jose  R.; Mehmud,Faisal; Duh,Mei  Sheng

doi:10.3892/ijo.2013.2181

2014-January Volume 44 Issue 1

Full Size Image

Cover Legend PDF

Journals

International Journal of Molecular Medicine

International Journal of Molecular Medicine is an international journal devoted to molecular mechanisms of human disease.

International Journal of Oncology

International Journal of Oncology is an international journal devoted to oncology research and cancer treatment.

Molecular Medicine Reports

Covers molecular medicine topics such as pharmacology, pathology, genetics, neuroscience, infectious diseases, molecular cardiology, and molecular surgery.

Oncology Reports

Oncology Reports is an international journal devoted to fundamental and applied research in Oncology.

Experimental and Therapeutic Medicine

Experimental and Therapeutic Medicine is an international journal devoted to laboratory and clinical medicine.

Oncology Letters

Oncology Letters is an international journal devoted to Experimental and Clinical Oncology.

Biomedical Reports

Explores a wide range of biological and medical fields, including pharmacology, genetics, microbiology, neuroscience, and molecular cardiology.

Molecular and Clinical Oncology

International journal addressing all aspects of oncology research, from tumorigenesis and oncogenes to chemotherapy and metastasis.

World Academy of Sciences Journal

Multidisciplinary open-access journal spanning biochemistry, genetics, neuroscience, environmental health, and synthetic biology.

International Journal of Functional Nutrition

Open-access journal combining biochemistry, pharmacology, immunology, and genetics to advance health through functional nutrition.

International Journal of Epigenetics

Publishes open-access research on using epigenetics to advance understanding and treatment of human disease.

Medicine International

An International Open Access Journal Devoted to General Medicine.

2014-January Volume 44 Issue 1

Full Size Image

Cover Legend PDF

Article Open Access

Angiogenesis inhibitor therapies for advanced renal cell carcinoma: Toxicity and treatment patterns in clinical practice from a global medical chart review

Authors:
- William K. Oh
- David McDermott
- Camillo Porta
- Antonin Levy
- Reza Elaidi
- Florian Scotte
- Robert Hawkins
- Daniel Castellano
- Joaquim Bellmunt
- Sun Young Rha
- Jong-Mu Sun
- Paul Nathan
- Bruce A. Feinberg
- Jeffrey Scott
- Ray McDermott
- Jin-Hee Ahn
- John Wagstaff
- Yen-Hwa Chang
- Yen-Chuan Ou
- Paul Donnellan
- Chao-Yuan Huang
- John McCaffrey
- Po-Hui Chiang
- Cheng-Keng Chuang
- Caroline Korves
- Maureen P. Neary
- Jose R. Diaz
- Faisal Mehmud
- Mei Sheng Duh
View Affiliations / Copyright

Affiliations: Dana-Farber Cancer Institute, Boston, MA, USA, Beth Israel Deaconess Medical Center, Boston, MA, USA, IRCCS San Matteo University Hospital Foundation, Pavia, Italy, Institut Gustave Roussy, Paris, France, Hôpital Européen Georges Pompidou, Paris, France, The Christie and University of Manchester, Manchester, UK, Unit of Uro-Oncology, Department of Medical Oncology, 12 de Octubre University Hospital, I+12 Research Institute, Madrid, Spain, Hospital del Mar - IMIM, Barcelona, Spain, Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea, Samsung Medical Center, Seoul, Republic of Korea, Mount Vernon Cancer Centre, Northwood, Middlesex, UK, P4 Healthcare, Ellicott City, MD, USA, Adelaide and Meath Hospital, Tallaght, Republic of Ireland, Asan Medical Center, Seoul, Republic of Korea, South West Wales Cancer Institute, Singleton Hospital, Swansea, UK, Taipei Veterans General Hospital, Taipei, Taiwan, R.O.C., Taichung Veterans General Hospital, Taichung, Taiwan, R.O.C., University College Hospital Galway, Galway, Republic of Ireland, National Taiwan University Hospital, Taipei, Taiwan, R.O.C., Mater Misericordiae Hospital, Dublin, Republic of Ireland, Chang Gung Memorial Hospital, Kaohsiung, Taiwan, R.O.C., Chang Gung Memorial Hospital, Linkuo, Taiwan, R.O.C., Analysis Group Inc., Boston, MA, USA, GlaxoSmithKline, Collegeville, PA, USA

Copyright: © Oh et al. This is an open access article distributed under the terms of Creative Commons Attribution License [CC BY_NC 3.0].
Pages: 5-16
|
Published online on: November 15, 2013

https://doi.org/10.3892/ijo.2013.2181
Expand metrics +

Abstract

The aim of this study was to assess the treatment patterns and safety of sunitinib, sorafenib and bevacizumab in real-world clinical settings in US, Europe and Asia. Medical records were abstracted at 18 community oncology clinics in the US and at 21 tertiary oncology centers in US, Europe and Asia for 883 patients ≥18 years who had histologically/cytologically confirmed diagnosis of advanced RCC and received sunitinib (n=631), sorafenib (n=207) or bevacizumab (n=45) as first‑line treatment. No prior treatment was permitted. Data were collected on all adverse events (AEs) and treatment modifications, including discontinuation, interruption and dose reduction. Treatment duration was estimated using Kaplan-Meier analysis. Demographics were similar across treatment groups and regions. Median treatment duration ranged from 6.1 to 10.7 months, 5.1 to 8.5 months and 7.5 to 9.8 months for sunitinib, sorafenib and bevacizumab patients, respectively. Grade 3/4 AEs were experienced by 26.0, 28.0 and 15.6% of sunitinib, sorafenib and bevacizumab patients, respectively. Treatment discontinuations occurred in 62.4 (Asia) to 63.1% (US) sunitinib, 68.8 (Asia) to 90.0% (Europe) sorafenib, and 66.7 (Asia) to 81.8% (US) bevacizumab patients. Globally, treatment modifications due to AEs occurred in 55.1, 54.2 and 50.0% sunitinib, sorafenib and bevacizumab patients, respectively. This study in a large, global cohort of advanced RCC patients found that angiogenesis inhibitors are associated with high rates of AEs and treatment modifications. Findings suggest an unmet need for more tolerable agents for RCC treatment.

View Figures

View References

1.	Cohen HT and McGovern FJ: Renal-cell carcinoma. N Engl J Med. 353:2477–2490. 2005. View Article : Google Scholar : PubMed/NCBI
2.	Gitlitz BJ and Figlin RA: Cytokine-based therapy for meta-static renal cell cancer. Urol Clin North Am. 30:589–600. 2003. View Article : Google Scholar : PubMed/NCBI
3.	Motzer RJ, Mazumdar M, Bacik J, Berg W, Amsterdam A and Ferrara J: Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 17:2530–2540. 1999.PubMed/NCBI
4.	Motzer RJ, Hutson TE, Tomczak P, et al: Overall survival and updated results for sunitinib compared with interferon alpha in patients with metastatic renal cell carcinoma. J Clin Oncol. 27:3584–3590. 2009. View Article : Google Scholar : PubMed/NCBI
5.	Escudier BE, Eisen T, Stadler WM, et al: Sorafenib for treatment of renal cell carcinoma: final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol. 27:3312–3318. 2009. View Article : Google Scholar : PubMed/NCBI
6.	Escudier BE, Pluzanska A, Koralewski P, et al: Bevacizumab plus interferon alpha-2a for treatment of metastatic renal cell carcinoma: a randomized, double-blind phase III trial. Lancet. 370:2103–2111. 2007. View Article : Google Scholar : PubMed/NCBI
7.	Gore ME, Szczylik C, Porta C, et al: Safety and efficacy of sunitinib for metastatic renal-cell carcinoma: an expanded-access trial. Lancet Oncol. 10:757–763. 2009. View Article : Google Scholar : PubMed/NCBI
8.	Stadler WM, Figlin RA, McDermott DF, et al: Safety and efficacy results of the advanced renal cell carcinoma sorafenib expanded access program in North America. Cancer. 116:1272–1280. 2010. View Article : Google Scholar : PubMed/NCBI
9.	Food and Drug Administration: Available at http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021923ltr.pdf. Accessed December 19, 2011.
10.	Bayer and Onyx press release: ‘Nexavar approved by European Commission for Treatment of Advanced Kidney Cancer’. July 24, 2006.
11.	Zhang H, Dong B, Lu JJ, et al: Efficacy of sorafenib on meta-static renal cell carcinoma in Asian patients: results from a multicenter study. BMC Cancer. 9:2492009. View Article : Google Scholar : PubMed/NCBI
12.	National Cancer Institute: Available at: http://www.cancer.gov/cancertopics/druginfo/fda-sunitinib-malate. Accessed December 19, 2011.
13.	Pfizer press release: ‘Pfizer's Sutent^® is Granted Full Marketing Authorization for First-Line Use in Advanced Kidney Cancer in European Union’. January 18, 2007.
14.	Hong MH, Kim HS, Kim C, et al: Treatment outcomes of sunitinib treatment in advanced renal cell carcinoma patients: a single cancer center experience in Korea. Cancer Res Treat. 41:67–72. 2009. View Article : Google Scholar : PubMed/NCBI
15.	Hwang E, Lee HJ, Sul CK and Lim JS: Efficacy and safety of sunitinib on metastatic renal cell carcinoma: a single institution experience. Korean J Urol. 51:450–455. 2010. View Article : Google Scholar : PubMed/NCBI
16.	Ansari J, Fatima A, Fernando K, Collins S, James ND and Porfiri E: Sunitinib in patients with metastatic renal cell carcinoma: Birmigham experience. Oncol Rep. 24:507–510. 2010. View Article : Google Scholar : PubMed/NCBI
17.	Yoo C, Kim JE, Lee JE, Ahn JH, Lee DH, Lee JS, et al: The efficacy and safety of sunitinib in Korean patients with advanced renal cell carcinoma: high incidence of toxicity leads to frequent dose reduction. Jpn J Clin Oncol. 40:980–985. 2010. View Article : Google Scholar : PubMed/NCBI
18.	Ueda T, Imamura Y, Komaru A, et al: Treatment outcomes of sorafenib for first line or cytokinerefractory advanced renal cell carcinoma in Japanese patients. Int J Urol. 17:811–816. 2010. View Article : Google Scholar : PubMed/NCBI
19.	Porta C, Paglino C, Imarisio I, et al: Safety and treatment patterns of multikinase inhibitors in patients with metastatic renal cell carcinoma at a tertiary oncology center in Italy. BMC Cancer. 11:1052011. View Article : Google Scholar : PubMed/NCBI
20.	Feinberg BA, Jolly P, Wang S, et al: Safety and treatment patterns of angiogenesis inhibitors in patients with metastatic renal cell carcinoma: evidence from US community oncology clinics. Med Oncol. 29:786–794. 2012. View Article : Google Scholar : PubMed/NCBI
21.	Choueiri TK, Duh MS, Clement J, et al: Angiogenesis inhibitor therapies for metastatic renal cell carcinoma: effectiveness, safety and treatment patterns in clinical practice based on medical chart review. BJU Int. 105:1247–1254. 2010. View Article : Google Scholar
22.	Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Available: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf. Accessed: November, 2011.
23.	Houk BE, Bello CL, Kang D, et al: A population pharmaco-kinetic meta-analysis of sunitinib malate (SU11248) and its primary metabolite (SU12662) in healthy volunteers and oncology patients. Clin Cancer Res. 15:2497–2506. 2009. View Article : Google Scholar : PubMed/NCBI
24.	Escudier B, Bellmunt J, Negrier S, et al: Phase III trial of bevacizumab plus interferon alfa-2a in patients with metastatic renal cell carcinoma (AVOREN): final analysis of overall survival. J Clin Oncol. 28:2144–2150. 2010. View Article : Google Scholar : PubMed/NCBI
25.	Rini BI, Halabi S, Rosenberg JE, et al: Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206. Clin Oncol. 28:2137–2143. 2010. View Article : Google Scholar : PubMed/NCBI

Journals

International Journal of Molecular Medicine

International Journal of Oncology

Molecular Medicine Reports

Oncology Reports

Experimental and Therapeutic Medicine

Oncology Letters

Biomedical Reports

Molecular and Clinical Oncology

World Academy of Sciences Journal

International Journal of Functional Nutrition

International Journal of Epigenetics

Medicine International

Angiogenesis inhibitor therapies for advanced renal cell carcinoma: Toxicity and treatment patterns in clinical practice from a global medical chart review

This article is mentioned in:

Abstract

Related Articles