Sekvenční terapie renálního karcinomu

Číslo: 2 / 2011 (Obsah)
Rubrika: Farmakoterapeutické postupy
Obor: Onkologie
Autoři: Doc. MUDr. Igor Puzanov, MSCI, FACP
Autoři - působiště: Vanderbilt Ingram Cancer Center, Associate Director of Phase I Drug Development, Renal and Melanoma Program, Nashville, Tennessee, USA
Klíčová slova: sekvenční léčba, kombinovaná léčba, sunitinib, sorafenib, bevacizumab/IFN-α, pazopanib, temsirolimus, everolimus
Citace: 1 Cowey C, Rathmell, WK. Using molecular biology to develop drugs for renal cell carcinoma. Exp Opin Drug Discovery 2008;3:311–27. 2 Rini BI. Vascular endothelial growth factor-targeted therapy in metastatic renal cell carcinoma. Cancer 2009;115:2306–12. 3 Flanigan RC, Salmon SE, Blumenstein BA, et al. Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer. N Engl J Med 2001;345:1655–9. 4 Mickisch GH, Garin A, van Poppel H, et al. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomized trial. Lancet 2001;358:966–70. 5 Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007;356:115–24. 6 Motzer RJ, Hutson TE, Tomczak P, et al. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol 2009;27:3584–90. 7 Sternberg CN, Davis ID, Mardiak J, et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol 2010;28(6):1061–8. 8 Escudier B, Eisen T, Stadler WM, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 2007;356:125–34. 9 Escudier B, 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 2009;27:3312–8. 10 Escudier B, Pluzanska A, Koralewski P, et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet 2007;370:2103–11. 11 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 2010;28:2144–50. 12 Rini BI, Halabi S, Rosenberg JE, et al. Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206. J Clin Oncol 2008;26:5422–8. 13 Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa or both for advanced renal-cell carcinoma. N Engl J Med 2007;356:2271–81. 14 Motzer RJ, Escudier B, Oudard S, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo controlled phase III trial. Lancet 2008;372:449–56. 15 Motzer RJ, Escudier B, Oudard S, et al. Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors. Cancer 2010;116:4256–65. 16 Jemal A, Siegel R, Xu J, et al. Cancer Statistics 2010. CA Cancer J Clin 2010;60:277–300. 17 Rini BI, Small EJ. Biology and clinical development of vascular endothelial growth factor-targeted therapy in renal cell carcinoma. J Clin Oncol 2005;23:1028–43. 18 Oudard S, Beuselinck B, Decoene J, et al. Sunitinib for the treatment of metastatic renal cell carcinoma. Cancer Treat Rev 2010. [Epub ahead of print] 19 Houk BE, Bello CL, Poland B, et al. Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/pharmacodynamic meta-analysis. Cancer Chemother Pharmacol 2010; 66:357–71 20 Amato, RJ, Harris, P, Dalton, M, et al. A phase II trial of intra-patient dose-escalated sorafenib in patients (pts) with metastatic renal cell cancer (MRCC) [abstract]. J Clin Oncol 2007;25:241s. 21 Tamaskar I, Shaheen P, Wood L. Antitumor effects of sorafenib and sunitinib in patients (pts) with metastatic renal cell carcinoma (mRCC) who had prior therapy with anti-angiogenic agents. J Clin Oncol 2006;24:4597. 22 Sablin M, Bouaita L, Balleyguier C et al. Sequential use of sorafenib and sunitinib in renal cancer: retrospective analysis in 90 patients. J Clin Oncol 2007;25(18S):Abstract 5038 23 Rini BI, Michaelson MD, Rosenberg JE, et al. Antitumor activity and biomarker analysis of sunitinib in patients with bevacizumab refractory metastatic renal cell carcinoma. J Clin Oncol 2008;26(22):3743–8. 24 Rini BI, Wilding G, Hudes G, et al. Phase II study of axitinib in sorafenib-refractory metastatic renal cell carcinoma. J Clin Oncol 2009;27:4462–68. 25 Cleary JM, Choueiri TK, Heng DYC, et al. Sunitinib rechallenge in metastatic renal cell carcinoma patients. Cancer 2010;116: 5400–6. 26 Motzer RJ, Escudier B, Oudard S, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet 2008;372:449–56. 27 Motzer RJ, Escudier B, Oudard S, et al. Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors. Cancer 2010;116:4256–65. 28 Casciano R, Malangone E, Sherman S, et al. An indirect comparison of everolimus and sorafenib therapy in sunitinib-refractory mRCC patients. J Clin Oncol 2010;28(15 suppl): Abstract 4611. 29 Gollob J, Rathmell, K, Richmond T, et al. Phase II trial of sorafenib plus interferon alfa-2b as first- or second-line therapy in patients with metastatic renal cell cancer. J Clin Oncol 2007;25;3288–95. 30 Thompson JA, Curti BD, Redman BG, et al. Phase I study of recombinant interleukin-21 in patients with metastatic melanoma and renal cell carcinoma. J Clin Oncol 2008;26: 2034–9. 31 Bhatia S, Heath E, Puzanov I, et al. Phase 2 study of recombinant IL-21 (rIL-21) plus sorafenib as second or third-line therapy for metastatic renal cell cancer (mRCC): Final results. J of Clin Oncol 2009;27(15 suppl):Abstract 3023. 32 Feldman DR, Baum MS, Ginsberg MS, et al. Phase I trial of bevacizumab plus escalated doses of sunitinib in patients with metastatic renal cell carcinoma. J Clin Oncol 2009;27:1432–9. 33 Sosman JA, Flaherty KT, Atkins MB, et al. Updated results of phase I trial of sorafenib and bevacizumab in patients with metastatic renal cell cancer [abstract]. J Clin Oncol 2008;26(Suppl):Abstract 5011. 34 Hainsworth JD, Spigel DR, Burris HA, 3rd, et al. Phase II trial of bevacizumab and everolimus in patients with advanced renal cell carcinoma. J Clin Oncol 2010;28:2131–6. 35 Escudier BJ, Negrier S, Gravis G, et al. Can the combination of temsirolimus and bevacizumab improve the treatment of metastatic renal cell carcinoma (mRCC)? Results of the randomized TORAVA phase II trial. J Clin Oncol 2010;28(15 suppl):Abstract 4516. 36 Hainsworth JD, Sosman JA, Spigel DR, et al. Treatment of metastatic renal cell carcinoma with a combination of bevacizumab and erlotinib. J Clin Oncol 2005;23:7889–96. 37 Hainsworth JD, Spigel DR, Sosman JA, et al. Treatment of advanced renal cell carcinoma with the combination bevacizumab/erlotinib/imatinib: a phase I/II trial. Clin Genitourin Cancer 2007;5:427–32. 38 Baselga J, De Jonge MJ, Rodon J, et al. A first-in-human phase I study of BKM120, an oral pan-class I PI3K inhibitor, in patients (pts) with advanced solid tumors. J Clin Oncol 2010;28(15 suppl):Abstract 3003. 39 Burris H, Rodon J, Sharma S, et al. First-in-human phase I study of the oral PI3K inhibitor BEZ235 in patients (pts) with advanced solid tumors. J Clin Oncol 2010;28(15 suppl): Abstract 3005. 40 Eisen T, Joensuu H, Nathan P, et al. Phase II trial of the oral multikinase inhibitor BAY 73-4506 as 1st-line therapy in patients with metastatic or unresectable renal cell carcinoma (RCC). Eur J Cancer Supplements 2009;7:Abstract 7.105. 41 Bhargava P, Esteves B, Nosov DA, et al. Updated activity and safety results of a phase II randomized discontinuation trial (RDT) of AV-951, a potent and selective VEGFR1, 2, and 3 kinase inhibitor, in patients with renal cell carcinoma (RCC). J Clin Oncol 2009;27:Abstract 5032. 42 Mulders P, Hawkins R, Nathan P, et al. Final results of a phase II randomised study of cediranib (RECENTIN™) in patients with advanced renal cell carcinoma (RCC). Eur J Cancer Supplements 2009;7:21. 43 Adjei AA, Sosman JA, Dy GK et al. A phase I dose-escalation trial evaluating ARQ 197 administered in combination with sorafenib in adult patients (pts) with advanced solid tumors. J  Clin Oncol 2010;28(15S):Abstract 3024.

Souhrn

Zvýšení účinnosti terapie metastatického karcinomu ledviny je možno dosáhnout pomocí sekvenční nebo kombinované terapie. Sekvenční terapie, cílená na rozdílné způsoby aktivace nádorových buněk, je jednou z možností, jak překonat rezistenci k jednotlivým lékům. Mezi přednosti sekvenční léčby patří možnost snadné optimalizace dávkování a kontroly toxicity. V konečném výsledku vede tato léčba k prodloužení přežití bez progrese onemocnění a velmi pravděpodobně též celkového prežití. Kombinovaná léčba vychází z předpokladu zlepšení objektivní odpovědi, přežití bez progrese a celkového přežití pomocí současného podávání dvou léčiv s komplementárními účinky. Tento způsob léčby závisí též na předpokladu přijatelné toxicity kombinací.

Literatura

1 Cowey C, Rathmell, WK. Using molecular biology to develop drugs for renal cell carcinoma. Exp Opin Drug Discovery 2008;3:311–27. 2 Rini BI. Vascular endothelial growth factor-targeted therapy in metastatic renal cell carcinoma. Cancer 2009;115:2306–12. 3 Flanigan RC, Salmon SE, Blumenstein BA, et al. Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer. N Engl J Med 2001;345:1655–9. 4 Mickisch GH, Garin A, van Poppel H, et al. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomized trial. Lancet 2001;358:966–70. 5 Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007;356:115–24. 6 Motzer RJ, Hutson TE, Tomczak P, et al. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol 2009;27:3584–90. 7 Sternberg CN, Davis ID, Mardiak J, et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol 2010;28(6):1061–8. 8 Escudier B, Eisen T, Stadler WM, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 2007;356:125–34. 9 Escudier B, 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 2009;27:3312–8.
10
Escudier B, Pluzanska A, Koralewski P, et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet 2007;370:2103–11.
11
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 2010;28:2144–50.
12
Rini BI, Halabi S, Rosenberg JE, et al. Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206. J Clin Oncol 2008;26:5422–8.
13
Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa or both for advanced renal-cell carcinoma. N Engl J Med 2007;356:2271–81.
14
Motzer RJ, Escudier B, Oudard S, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo controlled phase III trial. Lancet 2008;372:449–56.
15
Motzer RJ, Escudier B, Oudard S, et al. Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors. Cancer 2010;116:4256–65.
16
Jemal A, Siegel R, Xu J, et al. Cancer Statistics 2010. CA Cancer J Clin 2010;60:277–300.
17
Rini BI, Small EJ. Biology and clinical development of vascular endothelial growth factor-targeted therapy in renal cell carcinoma. J Clin Oncol 2005;23:1028–43.
18
Oudard S, Beuselinck B, Decoene J, et al. Sunitinib for the treatment of metastatic renal cell carcinoma. Cancer Treat Rev 2010. [Epub ahead of print]
19
Houk BE, Bello CL, Poland B, et al. Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/pharmacodynamic meta-analysis. Cancer Chemother Pharmacol 2010; 66:357–71
20
Amato, RJ, Harris, P, Dalton, M, et al. A phase II trial of intra-patient dose-escalated sorafenib in patients (pts) with metastatic renal cell cancer (MRCC) [abstract]. J Clin Oncol 2007;25:241s.
21
Tamaskar I, Shaheen P, Wood L. Antitumor effects of sorafenib and sunitinib in patients (pts) with metastatic renal cell carcinoma (mRCC) who had prior therapy with anti-angiogenic agents. J Clin Oncol 2006;24:4597.
22
Sablin M, Bouaita L, Balleyguier C et al. Sequential use of sorafenib and sunitinib in renal cancer: retrospective analysis in 90 patients. J Clin Oncol 2007;25(18S):Abstract 5038
23
Rini BI, Michaelson MD, Rosenberg JE, et al. Antitumor activity and biomarker analysis of sunitinib in patients with bevacizumab refractory metastatic renal cell carcinoma. J Clin Oncol 2008;26(22):3743–8.
24
Rini BI, Wilding G, Hudes G, et al. Phase II study of axitinib in sorafenib-refractory metastatic renal cell carcinoma. J Clin Oncol 2009;27:4462–68.
25
Cleary JM, Choueiri TK, Heng DYC, et al. Sunitinib rechallenge in metastatic renal cell carcinoma patients. Cancer 2010;116: 5400–6.
26
Motzer RJ, Escudier B, Oudard S, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet 2008;372:449–56.
27
Motzer RJ, Escudier B, Oudard S, et al. Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors. Cancer 2010;116:4256–65.
28
Casciano R, Malangone E, Sherman S, et al. An indirect comparison of everolimus and sorafenib therapy in sunitinib-refractory mRCC patients. J Clin Oncol 2010;28(15 suppl): Abstract 4611.
29
Gollob J, Rathmell, K, Richmond T, et al. Phase II trial of sorafenib plus interferon alfa-2b as first- or second-line therapy in patients with metastatic renal cell cancer. J Clin Oncol 2007;25;3288–95.
30
Thompson JA, Curti BD, Redman BG, et al. Phase I study of recombinant interleukin-21 in patients with metastatic melanoma and renal cell carcinoma. J Clin Oncol 2008;26: 2034–9.
31
Bhatia S, Heath E, Puzanov I, et al. Phase 2 study of recombinant IL-21 (rIL-21) plus sorafenib as second or third-line therapy for metastatic renal cell cancer (mRCC): Final results. J of Clin Oncol 2009;27(15 suppl):Abstract 3023.
32
Feldman DR, Baum MS, Ginsberg MS, et al. Phase I trial of bevacizumab plus escalated doses of sunitinib in patients with metastatic renal cell carcinoma. J Clin Oncol 2009;27:1432–9.
33
Sosman JA, Flaherty KT, Atkins MB, et al. Updated results of phase I trial of sorafenib and bevacizumab in patients with metastatic renal cell cancer [abstract]. J Clin Oncol 2008;26(Suppl):Abstract 5011.
34
Hainsworth JD, Spigel DR, Burris HA, 3rd, et al. Phase II trial of bevacizumab and everolimus in patients with advanced renal cell carcinoma. J Clin Oncol 2010;28:2131–6.
35
Escudier BJ, Negrier S, Gravis G, et al. Can the combination of temsirolimus and bevacizumab improve the treatment of metastatic renal cell carcinoma (mRCC)? Results of the randomized TORAVA phase II trial. J Clin Oncol 2010;28(15 suppl):Abstract 4516.
36
Hainsworth JD, Sosman JA, Spigel DR, et al. Treatment of metastatic renal cell carcinoma with a combination of bevacizumab and erlotinib. J Clin Oncol 2005;23:7889–96.
37
Hainsworth JD, Spigel DR, Sosman JA, et al. Treatment of advanced renal cell carcinoma with the combination bevacizumab/erlotinib/imatinib: a phase I/II trial. Clin Genitourin Cancer 2007;5:427–32.
38
Baselga J, De Jonge MJ, Rodon J, et al. A first-in-human phase I study of BKM120, an oral pan-class I PI3K inhibitor, in patients (pts) with advanced solid tumors. J Clin Oncol 2010;28(15 suppl):Abstract 3003.
39
Burris H, Rodon J, Sharma S, et al. First-in-human phase I study of the oral PI3K inhibitor BEZ235 in patients (pts) with advanced solid tumors. J Clin Oncol 2010;28(15 suppl): Abstract 3005.
40
Eisen T, Joensuu H, Nathan P, et al. Phase II trial of the oral multikinase inhibitor BAY 73-4506 as 1st-line therapy in patients with metastatic or unresectable renal cell carcinoma (RCC). Eur J Cancer Supplements 2009;7:Abstract 7.105.
41
Bhargava P, Esteves B, Nosov DA, et al. Updated activity and safety results of a phase II randomized discontinuation trial (RDT) of AV-951, a potent and selective VEGFR1, 2, and 3 kinase inhibitor, in patients with renal cell carcinoma (RCC). J Clin Oncol 2009;27:Abstract 5032.
42
Mulders P, Hawkins R, Nathan P, et al. Final results of a phase II randomised study of cediranib (RECENTIN™) in patients with advanced renal cell carcinoma (RCC). Eur J Cancer Supplements 2009;7:21.
43
Adjei AA, Sosman JA, Dy GK et al. A phase I dose-escalation trial evaluating ARQ 197 administered in combination with sorafenib in adult patients (pts) with advanced solid tumors. J  Clin Oncol 2010;28(15S):Abstract 3024.

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