Oncology Gold StandardTM practical consensus recommendations 2016 for treatment of advanced clear cell renal cell carcinoma

U Batra; PM Parikh; K Prabhash; HB Tongaonkar; P Chibber; D Dabkara; C Deshmukh; N Ghadyalpatil; S Hingmire; A Joshi; SK Raghunath; S Rajappa; R Rajendranath; SK Rawal; Manisha Singh; R Singh; SP Somashekhar; R Sood

doi:10.4103/2278-330X.189933

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RCC Practical Consensus Recommendations

05 (

); 167-175

doi:

10.4103/2278-330X.189933

Oncology Gold Standard^TM practical consensus recommendations 2016 for treatment of advanced clear cell renal cell carcinoma

U Batra¹, PM Parikh^1,, K Prabhash¹, HB Tongaonkar¹, P Chibber¹, D Dabkara¹, C Deshmukh¹, N Ghadyalpatil¹, S Hingmire¹, A Joshi¹, SK Raghunath¹, S Rajappa¹, R Rajendranath¹, SK Rawal¹, Manisha Singh¹, R Singh¹, SP Somashekhar¹, R Sood¹

1 Department of Precision Oncology, Asian Cancer Institute, Somaiya Hospital, Sion East, Mumbai.

*Corresponding author: Dr Purvish M. Parikh. purvish1@gmail.com

Published: 2020-12-28

MedIntel Services Pvt Ltd. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/.)

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Abstract

The Oncology Gold Standard (OGS) Expert Group on renal cell carcinoma (RCC) developed the consensus statement to provide community oncologists practical guidelines on the management of advanced clear cell (cc) RCC using published evidence, practical experience of experts in real life management, and results of a nationwide survey involving 144 health-care professionals. Six broad question categories containing 33 unique questions cover major situations in the routine management of RCC. This document serves as a ready guide for the standard of care to optimize outcome. The table of "Take Home Messages" at the end is a convenient tool for busy practitioners.

Keywords

References

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ); 2016. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. [Last accessed on 2016 Aug 12].
Singapore Cancer Network (SCAN); 2015. Available from: http://www.cancernetwork.sg/professional/renal-cell-carcinoma. [Last accessed on 2016 Aug 12].
European Association of Urology Guidelines (EAU) 2015 Edition. Available from: http://www.uroweb.org/wp-content/uploads/EAU-Extended-Guidelines-2015-Edn.pdf. [Last accessed on 2016 Aug 12].
Escudier B, Porta C, Schmidinger M, Algaba F, Patard JJ, et al. European Society For Medical Oncology (ESMO) Guidelines 2014. Ann Oncol 2014;25 Suppl 3:iii49-56. Available from: http://www.esmo.org/Guidelines/Genitourinary-Cancers/Renal-Cell-Carcinoma. [Last accessed on 2016 Aug 12].
Kumar L. Manual of Urologic Malignancies. p. 3-9.
Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C. Cancer incidence and mortality worldwide: Sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer 2015;136:E359-86.
Three Year Report of Population Based Cancer Registries 2006-2008, NCRP, ICMR, November, 2010.
Katoch VM, Nandkumar A. Time trends in cancer incidence rates 1982-2010, ICMR Publication, July 2013. Available from: http://www.ncrpindia.org. [Last accessed on 2016 Aug 12].
Cancer by 2020 and Indian Cancer Society. Available from: http://www.indiancancersociety.org/. [Last accessed on 2016 Aug 12].
American Cancer Society Report. Available from: http://www.healthline.com/health/rcc/stage-4-renal-cell-carcinoma. [Last accessed on 2016 Aug 12].
Bharthuar A. Metastatic renal cell carcinoma: Current scenario and future trends. South Asian J Cancer 2012;1:30-5.
Capitanio U, Leibovich BC. The rationale and the role of lymph node dissection in renal cell carcinoma. World J Urol 2016. [Epub ahead of print].
Moschini M, Dell′Oglio P, Larcher A, Capitanio U. Lymph node dissection for renal cell carcinoma: What are we missing? Curr Opin Urol 2016;26:424-31.
Capitanio U, Becker F, Blute ML, Mulders P, Patard JJ, Russo P, et al. Lymph node dissection in renal cell carcinoma. Eur Urol 2011;60:1212-20.
Mutlu H, Gündüz S, Büyükçelik A, Yildiz O, Uysal M, Tural D, et al. The necessity of cytoreductive nephrectomy in patients with metastatic renal cell carcinoma using antiangiogenic targeted therapy after interferon alfa-2b. Clin Genitourin Cancer 2014;12:447-50.
Petrelli F, Coinu A, Vavassori I, Cabiddu M, Borgonovo K, Ghilardi M, et al. Cytoreductive nephrectomy in metastatic renal cell carcinoma treated with targeted therapies: A systematic review with a meta-analysis. Clin Genitourin Cancer 2016. pii: S1558-767330077-5.
Motzer RJ, Bukowski RM. Targeted therapy for metastatic renal cell carcinoma. J Clin Oncol 2006;24:5601-8.
Duensing S, Hohenfellner M. Adjuvant therapy for renal-cell carcinoma: Settled for now. Lancet 2016;387:1973-4.
Haas NB, Manola J, Uzzo RG, Flaherty KT, Wood CG, Kane C, et al. Adjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): A double-blind, placebo-controlled, randomised, phase 3 trial. Lancet 2016;387:2008-16.
(ECOG-ACRIN E2805): Neoadjuvant systemic therapy is not standard of care: A double-blind, placebo-controlled, randomised, phase 3 trial. Lancet 2016;387:2008-16.
Borregales LD, Adibi M, Thomas AZ, Wood CG, Karam JA. The role of neoadjuvant therapy in the management of locally advanced renal cell carcinoma. Ther Adv Urol 2016;8:130-41.
Ko JJ, Xie W, Kroeger N, Lee JL, Rini BI, Knox JJ, et al. The international metastatic renal cell carcinoma database consortium model as a prognostic tool in patients with metastatic renal cell carcinoma previously treated with first-line targeted therapy: A population-based study. Lancet Oncol 2015;16:293-300.
Santini D, Santoni M, De Giorgi U, Iacobelli S, Procopio G. A proposed new model for prognostic stratification of poor-risk patients with metastatic renal cell carcinoma (mRCC) in the era of targeted therapy. J Clin Oncol 2014;32. [Suppl; abstr e15588].
Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: Results of a randomized phase III trial. J Clin Oncol 2010;28:1061-8.
Motzer RJ, Hutson TE, Cella D, Reeves J, Hawkins R, Guo J, et al. Pazopanib versus sunitinib in metastatic renal-cell carcinoma. N Engl J Med 2013;369:722-31.
Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007;356:115-24.
Hutson TE, Lesovoy V, Al-Shukri S, Stus VP, Lipatov ON, Bair AH, et al. Axitinib versus sorafenib as first-line therapy in patients with metastatic renal-cell carcinoma: A randomised open-label phase 3 trial. Lancet Oncol 2013;14:1287-94.
Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Staehler M, 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 2009;27:3312-8.
Escudier B, Porta C, Bono P, Powles T, Eisen T, Sternberg CN, 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 2014;32:1412-8.
Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007;356:2271-81.
Escudier B, Porta C, Schmidinger M, Algaba F, Patard JJ, Khoo V, et al. Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2014;25 Suppl 3:iii49-56.
Motzer RJ, Hutson TE, Olsen MR, Hudes GR, Burke JM, Edenfield WJ, et al. Randomized phase II trial of sunitinib on an intermittent versus continuous dosing schedule as first-line therapy for advanced renal cell carcinoma. J Clin Oncol 2012;30:1371-7.
Singapore Cancer Network (SCAN) Genitourinary Cancer Workgroup. Singapore Cancer Network (SCAN) Guidelines for Systemic Therapy of Metastatic Renal Cell Carcinoma (mRCC). Ann Acad Med Singapore 2015;44:406-14.
Steger GG, Hubalek M, Pfeiler G, Greil R, Öhler L, Helfgott R, et al. STEPAUT: Efficacy and Safety of Everolimus Plus Exemestane in Patients with HR+, HER2- Advanced Breast Cancer Progressing on/After Prior Endocrine Therapy, in Routine Clinical Practice Poster Presented at EBCC-10, Amsterdam, The Netherlands; 9-11 March, 2016.
Parikh P, Prabhash K, Naik R, Vaid AK, Goswami C, Rajappa S, et al. Practical recommendation for rash and diarrhea management in Indian patients treated with tyrosine kinase inhibitors for the treatment of non-small cell lung cancer. Indian J Cancer 2016;53:87-91.
Lacouture ME, Wu S, Robert C, Atkins MB, Kong HH, Guitart J, et al. Evolving strategies for the management of hand-foot skin reaction associated with the multitargeted kinase inhibitors sorafenib and sunitinib. Oncologist 2008;13:1001-11.
Rugo HS, Seneviratne L, Beck JT, Glaspy JA, Peguero JA, et al. Prevention of Everolimus/Exemestane Stomatitis in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer Using a Dexamethasone-Based Mouthwash: Results of the SWISH Trial. Poster Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, Ilinois; 3-7 June, 2016.
Available from: http://www.ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_40. [Last accessed 2016 Mar 11].
Motzer RJ, Alyasova A, Ye D, Karpenko A, Li H, Alekseev B, et al. Phase II trial of second-line everolimus in patients with metastatic renal cell carcinoma (RECORD-4). Ann Oncol 2016;27:441-8.
Calvo E, Grünwald V, Bellmunt J. Controversies in renal cell carcinoma: Treatment choice after progression on vascular endothelial growth factor-targeted therapy. Eur J Cancer 2014;50:1321-9.
Beaumont JL, Salsman JM, Diaz J, Deen KC, McCann L, Powles T, et al. Quality-adjusted time without symptoms or toxicity analysis of pazopanib versus sunitinib in patients with renal cell carcinoma. Cancer 2016;122:1108-15.
Granovetter M. Benefits of pazopanib over sunitinib for renal cell carcinoma. Lancet Oncol 2016;17:e93.

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[1] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ); 2016. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. [Last accessed on 2016 Aug 12].

[2] Singapore Cancer Network (SCAN); 2015. Available from: http://www.cancernetwork.sg/professional/renal-cell-carcinoma. [Last accessed on 2016 Aug 12].

[3] European Association of Urology Guidelines (EAU) 2015 Edition. Available from: http://www.uroweb.org/wp-content/uploads/EAU-Extended-Guidelines-2015-Edn.pdf. [Last accessed on 2016 Aug 12].

[4] Escudier B, Porta C, Schmidinger M, Algaba F, Patard JJ, et al. European Society For Medical Oncology (ESMO) Guidelines 2014. Ann Oncol 2014;25 Suppl 3:iii49-56. Available from: http://www.esmo.org/Guidelines/Genitourinary-Cancers/Renal-Cell-Carcinoma. [Last accessed on 2016 Aug 12].

[5] Kumar L. Manual of Urologic Malignancies. p. 3-9.

[6] Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C. Cancer incidence and mortality worldwide: Sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer 2015;136:E359-86.

[7] Three Year Report of Population Based Cancer Registries 2006-2008, NCRP, ICMR, November, 2010.

[8] Katoch VM, Nandkumar A. Time trends in cancer incidence rates 1982-2010, ICMR Publication, July 2013. Available from: http://www.ncrpindia.org. [Last accessed on 2016 Aug 12].

[9] Cancer by 2020 and Indian Cancer Society. Available from: http://www.indiancancersociety.org/. [Last accessed on 2016 Aug 12].

[10] American Cancer Society Report. Available from: http://www.healthline.com/health/rcc/stage-4-renal-cell-carcinoma. [Last accessed on 2016 Aug 12].

[11] Bharthuar A. Metastatic renal cell carcinoma: Current scenario and future trends. South Asian J Cancer 2012;1:30-5.

[12] Capitanio U, Leibovich BC. The rationale and the role of lymph node dissection in renal cell carcinoma. World J Urol 2016. [Epub ahead of print].

[13] Moschini M, Dell′Oglio P, Larcher A, Capitanio U. Lymph node dissection for renal cell carcinoma: What are we missing? Curr Opin Urol 2016;26:424-31.

[14] Capitanio U, Becker F, Blute ML, Mulders P, Patard JJ, Russo P, et al. Lymph node dissection in renal cell carcinoma. Eur Urol 2011;60:1212-20.

[15] Mutlu H, Gündüz S, Büyükçelik A, Yildiz O, Uysal M, Tural D, et al. The necessity of cytoreductive nephrectomy in patients with metastatic renal cell carcinoma using antiangiogenic targeted therapy after interferon alfa-2b. Clin Genitourin Cancer 2014;12:447-50.

[16] Petrelli F, Coinu A, Vavassori I, Cabiddu M, Borgonovo K, Ghilardi M, et al. Cytoreductive nephrectomy in metastatic renal cell carcinoma treated with targeted therapies: A systematic review with a meta-analysis. Clin Genitourin Cancer 2016. pii: S1558-767330077-5.

[17] Motzer RJ, Bukowski RM. Targeted therapy for metastatic renal cell carcinoma. J Clin Oncol 2006;24:5601-8.

[18] Duensing S, Hohenfellner M. Adjuvant therapy for renal-cell carcinoma: Settled for now. Lancet 2016;387:1973-4.

[19] Haas NB, Manola J, Uzzo RG, Flaherty KT, Wood CG, Kane C, et al. Adjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): A double-blind, placebo-controlled, randomised, phase 3 trial. Lancet 2016;387:2008-16.

[20] (ECOG-ACRIN E2805): Neoadjuvant systemic therapy is not standard of care: A double-blind, placebo-controlled, randomised, phase 3 trial. Lancet 2016;387:2008-16.

[21] Borregales LD, Adibi M, Thomas AZ, Wood CG, Karam JA. The role of neoadjuvant therapy in the management of locally advanced renal cell carcinoma. Ther Adv Urol 2016;8:130-41.

[22] Ko JJ, Xie W, Kroeger N, Lee JL, Rini BI, Knox JJ, et al. The international metastatic renal cell carcinoma database consortium model as a prognostic tool in patients with metastatic renal cell carcinoma previously treated with first-line targeted therapy: A population-based study. Lancet Oncol 2015;16:293-300.

[23] Santini D, Santoni M, De Giorgi U, Iacobelli S, Procopio G. A proposed new model for prognostic stratification of poor-risk patients with metastatic renal cell carcinoma (mRCC) in the era of targeted therapy. J Clin Oncol 2014;32. [Suppl; abstr e15588].

[24] Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: Results of a randomized phase III trial. J Clin Oncol 2010;28:1061-8.

[25] Motzer RJ, Hutson TE, Cella D, Reeves J, Hawkins R, Guo J, et al. Pazopanib versus sunitinib in metastatic renal-cell carcinoma. N Engl J Med 2013;369:722-31.

[26] Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007;356:115-24.

[27] Hutson TE, Lesovoy V, Al-Shukri S, Stus VP, Lipatov ON, Bair AH, et al. Axitinib versus sorafenib as first-line therapy in patients with metastatic renal-cell carcinoma: A randomised open-label phase 3 trial. Lancet Oncol 2013;14:1287-94.

[28] Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Staehler M, 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 2009;27:3312-8.

[29] Escudier B, Porta C, Bono P, Powles T, Eisen T, Sternberg CN, 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 2014;32:1412-8.

[30] Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007;356:2271-81.

[31] Escudier B, Porta C, Schmidinger M, Algaba F, Patard JJ, Khoo V, et al. Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2014;25 Suppl 3:iii49-56.

[32] Motzer RJ, Hutson TE, Olsen MR, Hudes GR, Burke JM, Edenfield WJ, et al. Randomized phase II trial of sunitinib on an intermittent versus continuous dosing schedule as first-line therapy for advanced renal cell carcinoma. J Clin Oncol 2012;30:1371-7.

[33] Singapore Cancer Network (SCAN) Genitourinary Cancer Workgroup. Singapore Cancer Network (SCAN) Guidelines for Systemic Therapy of Metastatic Renal Cell Carcinoma (mRCC). Ann Acad Med Singapore 2015;44:406-14.

[34] Steger GG, Hubalek M, Pfeiler G, Greil R, Öhler L, Helfgott R, et al. STEPAUT: Efficacy and Safety of Everolimus Plus Exemestane in Patients with HR+, HER2- Advanced Breast Cancer Progressing on/After Prior Endocrine Therapy, in Routine Clinical Practice Poster Presented at EBCC-10, Amsterdam, The Netherlands; 9-11 March, 2016.

[35] Parikh P, Prabhash K, Naik R, Vaid AK, Goswami C, Rajappa S, et al. Practical recommendation for rash and diarrhea management in Indian patients treated with tyrosine kinase inhibitors for the treatment of non-small cell lung cancer. Indian J Cancer 2016;53:87-91.

[36] Lacouture ME, Wu S, Robert C, Atkins MB, Kong HH, Guitart J, et al. Evolving strategies for the management of hand-foot skin reaction associated with the multitargeted kinase inhibitors sorafenib and sunitinib. Oncologist 2008;13:1001-11.

[37] Rugo HS, Seneviratne L, Beck JT, Glaspy JA, Peguero JA, et al. Prevention of Everolimus/Exemestane Stomatitis in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer Using a Dexamethasone-Based Mouthwash: Results of the SWISH Trial. Poster Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, Ilinois; 3-7 June, 2016.

[38] Available from: http://www.ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_40. [Last accessed 2016 Mar 11].

[39] Motzer RJ, Alyasova A, Ye D, Karpenko A, Li H, Alekseev B, et al. Phase II trial of second-line everolimus in patients with metastatic renal cell carcinoma (RECORD-4). Ann Oncol 2016;27:441-8.

[40] Calvo E, Grünwald V, Bellmunt J. Controversies in renal cell carcinoma: Treatment choice after progression on vascular endothelial growth factor-targeted therapy. Eur J Cancer 2014;50:1321-9.

[41] Beaumont JL, Salsman JM, Diaz J, Deen KC, McCann L, Powles T, et al. Quality-adjusted time without symptoms or toxicity analysis of pazopanib versus sunitinib in patients with renal cell carcinoma. Cancer 2016;122:1108-15.

[42] Granovetter M. Benefits of pazopanib over sunitinib for renal cell carcinoma. Lancet Oncol 2016;17:e93.

Oncology Gold Standard^TM practical consensus recommendations 2016 for treatment of advanced clear cell renal cell carcinoma

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