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Место регорафениба в лечении метастатического колоректального рака
Трякин А.А. Место регорафениба в лечении метастатического колоректального рака. Современная Онкология. 2016; 18 (2): 52–56.
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Tryakin A.A. The role of regorafenib in the treatment of metastatic colorectal cancer. Journal of Modern Oncology. 2016; 18 (2): 52–56.
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Аннотация
Регорафениб – ингибитор множества тирозинкиназ, показавший свою активность при метастатическом колоректальном раке (мКРР) и гастроинтестинальных стромальных опухолях. Применение его у пациентов с мКРР с исчерпанными возможностями лекарственной терапии привело к достоверному увеличению продолжительности жизни по сравнению с лучшей поддерживающей терапией. В данной статье обсуждаются вопросы, касающиеся эффективности, переносимости и места препарата в лечении рефрактерного мКРР.
Ключевые слова: регорафениб, антиангиогенная терапия, метастатический колоректальный рак.
Ключевые слова: регорафениб, антиангиогенная терапия, метастатический колоректальный рак.
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Regorafenib is a multi-tyrosine kinase inhibitor, associated with the activity in metastatic colorectal cancer (mCRC) and gastrointestinal stromal tumors. Regorafenib application in patients with mCRC after exhausting all available drug therapies have resulted in statistically significant increase in life expectancy in comparison with best supportive therapy. This article discusses the issues concerning the efficacy, tolerability and the role of the drug in the treatment of refractory mCRC.
Key words: regorafenib, antiangiogenic therapy, metastatic colorectal cancer.
Полный текст
Список литературы
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2. Cremolini C, Loupakis F, Antoniotti C et al. FOLFOXIRI plus bevacizumab versus FOLFIRI plus bevacizumab as first-line treatment of patients with metastatic colorectal cancer: updated overall survival and molecular subgroup analyses of the open-label, phase 3 TRIBE study. Lancet Oncol 2015; 16 (13): 1306–15.
3. Stintzing S, Jung A, Rossius L et al. Mutations within the EGFR signaling pathway: Influence on efficacy in FIRE-3 – A randomized phase III study of FOLFIRI plus cetuximab or bevacizumab as first-line treatment for wild-type (WT) KRAS (exon 2) metastatic colorectal cancer (mCRC) patients. J Clin Oncol 2014; 32 (Suppl. 3; abstr. 445).
4. Price TJ, Peeters M, Kim TW et al. Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): a randomised, multicentre, open-label, non-inferiority phase 3 study. Lancet Oncol 2014; 15 (6): 569–79.
5. Amado RG, Wolf M, Peeters M et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol 2008; 26 (10): 1626–34.
6. Wilhelm SM, Dumas J, Adnane L et al. Regorafenib (BAY 73-4506): a new oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases with potent preclinical antitumor activity. Int J Cancer 2011; 129 (1): 245–55.
7. Cyran CC, Kazmierczak PM, Hirner H et al. Regorafenib effects on human colon carcinoma xenografts monitored by dynamic contrast-enhanced computed tomography with immunohistochemical validation. PLoS One 2013; 8 (9): e76009.
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9. Grothey A, Van Cutsem E, Sobrero A et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 2013; 381 (9863): 303–12.
10. Li J, Qin S, Xu R et al. Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol 2015; 16: 619–29.
11. Tougeron D, Desseigne F, Etienne PL et al. REBECCA: a large cohort study of regorafenib (REG) in the real-life setting in patients (pts) previously treated for metastatic colorectal cancer (mCRC). Ann Oncol 2014; 25 (4): iv167–209.
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13. Tabernero J, Lenz HJ, Siena S et al. Analysis of circulating DNA and protein biomarkers to predict the clinical activity of regorafenib and assess prognosis in patients with metastatic colorectal cancer: a retrospective, exploratory analysis of the CORRECT trial. Lancet Oncol 2015; 16 (8): 937–48.
14. Rechsteiner M, Wild P, Kiessling MK et al. A novel germline mutation of PDGFR-beta might be associated with clinical response of colorectal cancer to regorafenib. Ann Oncol 2015; 26 (1): 246–8.
15. Федянин М.Ю., Трякин А.А., Тюляндин С.А. Химиотерапия больных метастатическим раком толстой кишки. Онкологическая колопроктология. 2012; 2: 26–35. / Fedianin M.Iu., Triakin A.A., Tiuliandin S.A. Khimioterapiia bol'nykh metastaticheskim rakom tolstoi kishki. Onkologicheskaia koloproktologiia. 2012; 2: 26–35. [in Russian]
16. Karapetis CS, Khambata-Ford S, Jonker DJ et al. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 2008; 359 (17): 1757–65.
17. Amado RG, Wolf M, Peeters M et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol 2008; 26 (10): 1626–34.
18. Shitara K, Yamazaki K, Uetake H et al. Randomized phase II study of regorafenib followed by cetuximab versus reverse sequence for wild-type KRAS metastatic colorectal cancer previously treated with fluoropyrimidine, oxaliplatin, and irinotecan (REVERCE). J Clin Oncol 2014; 32 (Suppl.; abstr. TPS3662): 5s.
19. Kidd MT, Wilcox RE, Rogers J et al. Efficacy of chemotherapy after treatment with regorafenib in metastatic colorectal cancer (mCRC). J Clin Oncol 2015; 33 (Suppl. 3; abstr. 678).
20. Clinical Practice Guidelines in Oncology (NCCN Guidelines). Colon Cancer. Version 2.2016. http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf.
21. Van Cutsem E, Cervantes A, Nordlinger B, Arnold D. Metastatic colorectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. An Oncol 2014; 25 (Suppl. 3): iii1–ii9.
22. Трякин А.А., Артамонова Е.В., Бесова Н.С. и др. Практические рекомендации по лекарственному лечению рака ободочной кишки. Злокачественные опухоли. 2015; 4 (Спецвып.): 214–29. / Triakin A.A., Artamonova E.V., Besova N.S. i dr. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu raka obodochnoi kishki. Zlokachestvennye opukholi. 2015; 4 (Spetsvyp.): 214–29. [in Russian]
2. Cremolini C, Loupakis F, Antoniotti C et al. FOLFOXIRI plus bevacizumab versus FOLFIRI plus bevacizumab as first-line treatment of patients with metastatic colorectal cancer: updated overall survival and molecular subgroup analyses of the open-label, phase 3 TRIBE study. Lancet Oncol 2015; 16 (13): 1306–15.
3. Stintzing S, Jung A, Rossius L et al. Mutations within the EGFR signaling pathway: Influence on efficacy in FIRE-3 – A randomized phase III study of FOLFIRI plus cetuximab or bevacizumab as first-line treatment for wild-type (WT) KRAS (exon 2) metastatic colorectal cancer (mCRC) patients. J Clin Oncol 2014; 32 (Suppl. 3; abstr. 445).
4. Price TJ, Peeters M, Kim TW et al. Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): a randomised, multicentre, open-label, non-inferiority phase 3 study. Lancet Oncol 2014; 15 (6): 569–79.
5. Amado RG, Wolf M, Peeters M et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol 2008; 26 (10): 1626–34.
6. Wilhelm SM, Dumas J, Adnane L et al. Regorafenib (BAY 73-4506): a new oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases with potent preclinical antitumor activity. Int J Cancer 2011; 129 (1): 245–55.
7. Cyran CC, Kazmierczak PM, Hirner H et al. Regorafenib effects on human colon carcinoma xenografts monitored by dynamic contrast-enhanced computed tomography with immunohistochemical validation. PLoS One 2013; 8 (9): e76009.
8. Abou-Elkacem L, Arns S, Brix G et al. Regorafenib inhibits growth, angiogenesis, and metastasis in a highly aggressive, orthotopic colon cancer model. Mol Cancer Ther 2013; 12 (7): 1322–31.
9. Grothey A, Van Cutsem E, Sobrero A et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 2013; 381 (9863): 303–12.
10. Li J, Qin S, Xu R et al. Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol 2015; 16: 619–29.
11. Tougeron D, Desseigne F, Etienne PL et al. REBECCA: a large cohort study of regorafenib (REG) in the real-life setting in patients (pts) previously treated for metastatic colorectal cancer (mCRC). Ann Oncol 2014; 25 (4): iv167–209.
12. Van Cutsem E, Ciardiello F, Seitz J-F et al. Results from the large, open-label phase 3b CONSIGN study of regorafenib in patients with previously treated metastatic colorectal cancer. Ann Oncol 2015; 26 (Suppl. 4): iv118.
13. Tabernero J, Lenz HJ, Siena S et al. Analysis of circulating DNA and protein biomarkers to predict the clinical activity of regorafenib and assess prognosis in patients with metastatic colorectal cancer: a retrospective, exploratory analysis of the CORRECT trial. Lancet Oncol 2015; 16 (8): 937–48.
14. Rechsteiner M, Wild P, Kiessling MK et al. A novel germline mutation of PDGFR-beta might be associated with clinical response of colorectal cancer to regorafenib. Ann Oncol 2015; 26 (1): 246–8.
15. Федянин М.Ю., Трякин А.А., Тюляндин С.А. Химиотерапия больных метастатическим раком толстой кишки. Онкологическая колопроктология. 2012; 2: 26–35. / Fedianin M.Iu., Triakin A.A., Tiuliandin S.A. Khimioterapiia bol'nykh metastaticheskim rakom tolstoi kishki. Onkologicheskaia koloproktologiia. 2012; 2: 26–35. [in Russian]
16. Karapetis CS, Khambata-Ford S, Jonker DJ et al. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 2008; 359 (17): 1757–65.
17. Amado RG, Wolf M, Peeters M et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol 2008; 26 (10): 1626–34.
18. Shitara K, Yamazaki K, Uetake H et al. Randomized phase II study of regorafenib followed by cetuximab versus reverse sequence for wild-type KRAS metastatic colorectal cancer previously treated with fluoropyrimidine, oxaliplatin, and irinotecan (REVERCE). J Clin Oncol 2014; 32 (Suppl.; abstr. TPS3662): 5s.
19. Kidd MT, Wilcox RE, Rogers J et al. Efficacy of chemotherapy after treatment with regorafenib in metastatic colorectal cancer (mCRC). J Clin Oncol 2015; 33 (Suppl. 3; abstr. 678).
20. Clinical Practice Guidelines in Oncology (NCCN Guidelines). Colon Cancer. Version 2.2016. http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf.
21. Van Cutsem E, Cervantes A, Nordlinger B, Arnold D. Metastatic colorectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. An Oncol 2014; 25 (Suppl. 3): iii1–ii9.
22. Трякин А.А., Артамонова Е.В., Бесова Н.С. и др. Практические рекомендации по лекарственному лечению рака ободочной кишки. Злокачественные опухоли. 2015; 4 (Спецвып.): 214–29. / Triakin A.A., Artamonova E.V., Besova N.S. i dr. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu raka obodochnoi kishki. Zlokachestvennye opukholi. 2015; 4 (Spetsvyp.): 214–29. [in Russian]
________________________________________________
1. Tournigand C, André T, Achille E et al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: A randomized GERCOR study. J Clin Oncol 2004; 22: 229–37.
2. Cremolini C, Loupakis F, Antoniotti C et al. FOLFOXIRI plus bevacizumab versus FOLFIRI plus bevacizumab as first-line treatment of patients with metastatic colorectal cancer: updated overall survival and molecular subgroup analyses of the open-label, phase 3 TRIBE study. Lancet Oncol 2015; 16 (13): 1306–15.
3. Stintzing S, Jung A, Rossius L et al. Mutations within the EGFR signaling pathway: Influence on efficacy in FIRE-3 – A randomized phase III study of FOLFIRI plus cetuximab or bevacizumab as first-line treatment for wild-type (WT) KRAS (exon 2) metastatic colorectal cancer (mCRC) patients. J Clin Oncol 2014; 32 (Suppl. 3; abstr. 445).
4. Price TJ, Peeters M, Kim TW et al. Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): a randomised, multicentre, open-label, non-inferiority phase 3 study. Lancet Oncol 2014; 15 (6): 569–79.
5. Amado RG, Wolf M, Peeters M et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol 2008; 26 (10): 1626–34.
6. Wilhelm SM, Dumas J, Adnane L et al. Regorafenib (BAY 73-4506): a new oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases with potent preclinical antitumor activity. Int J Cancer 2011; 129 (1): 245–55.
7. Cyran CC, Kazmierczak PM, Hirner H et al. Regorafenib effects on human colon carcinoma xenografts monitored by dynamic contrast-enhanced computed tomography with immunohistochemical validation. PLoS One 2013; 8 (9): e76009.
8. Abou-Elkacem L, Arns S, Brix G et al. Regorafenib inhibits growth, angiogenesis, and metastasis in a highly aggressive, orthotopic colon cancer model. Mol Cancer Ther 2013; 12 (7): 1322–31.
9. Grothey A, Van Cutsem E, Sobrero A et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 2013; 381 (9863): 303–12.
10. Li J, Qin S, Xu R et al. Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol 2015; 16: 619–29.
11. Tougeron D, Desseigne F, Etienne PL et al. REBECCA: a large cohort study of regorafenib (REG) in the real-life setting in patients (pts) previously treated for metastatic colorectal cancer (mCRC). Ann Oncol 2014; 25 (4): iv167–209.
12. Van Cutsem E, Ciardiello F, Seitz J-F et al. Results from the large, open-label phase 3b CONSIGN study of regorafenib in patients with previously treated metastatic colorectal cancer. Ann Oncol 2015; 26 (Suppl. 4): iv118.
13. Tabernero J, Lenz HJ, Siena S et al. Analysis of circulating DNA and protein biomarkers to predict the clinical activity of regorafenib and assess prognosis in patients with metastatic colorectal cancer: a retrospective, exploratory analysis of the CORRECT trial. Lancet Oncol 2015; 16 (8): 937–48.
14. Rechsteiner M, Wild P, Kiessling MK et al. A novel germline mutation of PDGFR-beta might be associated with clinical response of colorectal cancer to regorafenib. Ann Oncol 2015; 26 (1): 246–8.
15. Fedianin M.Iu., Triakin A.A., Tiuliandin S.A. Khimioterapiia bol'nykh metastaticheskim rakom tolstoi kishki. Onkologicheskaia koloproktologiia. 2012; 2: 26–35. [in Russian]
16. Karapetis CS, Khambata-Ford S, Jonker DJ et al. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 2008; 359 (17): 1757–65.
17. Amado RG, Wolf M, Peeters M et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol 2008; 26 (10): 1626–34.
18. Shitara K, Yamazaki K, Uetake H et al. Randomized phase II study of regorafenib followed by cetuximab versus reverse sequence for wild-type KRAS metastatic colorectal cancer previously treated with fluoropyrimidine, oxaliplatin, and irinotecan (REVERCE). J Clin Oncol 2014; 32 (Suppl.; abstr. TPS3662): 5s.
19. Kidd MT, Wilcox RE, Rogers J et al. Efficacy of chemotherapy after treatment with regorafenib in metastatic colorectal cancer (mCRC). J Clin Oncol 2015; 33 (Suppl. 3; abstr. 678).
20. Clinical Practice Guidelines in Oncology (NCCN Guidelines). Colon Cancer. Version 2.2016. http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf.
21. Van Cutsem E, Cervantes A, Nordlinger B, Arnold D. Metastatic colorectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. An Oncol 2014; 25 (Suppl. 3): iii1–ii9.
22. Triakin A.A., Artamonova E.V., Besova N.S. i dr. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu raka obodochnoi kishki. Zlokachestvennye opukholi. 2015; 4 (Spetsvyp.): 214–29. [in Russian]
Авторы
А.А.Трякин*
ФГБУ Российский онкологический научный центр им. Н.Н.Блохина Минздрава России. 115478, Россия, Москва, Каширское ш., д. 23
*atryakin@mail.ru
ФГБУ Российский онкологический научный центр им. Н.Н.Блохина Минздрава России. 115478, Россия, Москва, Каширское ш., д. 23
*atryakin@mail.ru
________________________________________________
A.A.Tryakin*
N.N.Blokhin Russian Cancer Research Center of the Ministry of Health of the Russian Federation. 115478, Russian Federation, Moscow, Kashirskoe sh., d. 23
*atryakin@mail.ru
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