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Место регорафениба в лечении метастатического колоректального рака
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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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.
Key words: regorafenib, antiangiogenic therapy, metastatic colorectal cancer.
Ключевые слова: регорафениб, антиангиогенная терапия, метастатический колоректальный рак.
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Key words: regorafenib, antiangiogenic therapy, metastatic colorectal cancer.
Полный текст
Список литературы
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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]
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]
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]
________________________________________________
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
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
ФГБУ Российский онкологический научный центр им. Н.Н.Блохина Минздрава России. 115478, Россия, Москва, Каширское ш., д. 23
*atryakin@mail.ru
________________________________________________
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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