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Влияние стартовой дозы регорафениба на общую выживаемость пациентов с метастатическим раком толстой кишки: систематический обзор и метаанализ
Влияние стартовой дозы регорафениба на общую выживаемость пациентов с метастатическим раком толстой кишки: систематический обзор и метаанализ
Федянин М.Ю., Полянская Е.М., Трякин А.А. и др. Влияние стартовой дозы регорафениба на общую выживаемость пациентов с метастатическим раком толстой кишки: систематический обзор и метаанализ. Современная Онкология. 2019; 21 (3): 10–15. DOI: 10.26442/18151434.2019.3.190651
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Аннотация
Цель. Провести систематический обзор литературы и метаанализ исследований по влиянию стартовой дозы регорафениба на общую выживаемость (ОВ) пациентов с химиорефрактерным метастатическим раком толстой кишки.
Материалы и методы. Проведен поиск результатов исследований в системе PubMed. В анализ включали все работы по 20.08.2019, в которых проводилось сравнение показателей ОВ в зависимости от стартовой дозы регорафениба (160 мг или менее) на 1-м курсе терапии. Метаанализ проводился в программе Review Manager Ver. 5.3.
Результаты. В двух работах отмечено ухудшение ОВ при стартовой дозе менее 160 мг (A. Adenis и соавт., 2016: отношение рисков – ОР 1,26, 95% доверительный интервал – ДИ 1,01–1,56; A. Aljubran и соавт., 2019: ОР 2,25, 95% ДИ 0,93–5,43). В двух работах отмечено улучшение ОВ при применении стартовой дозы 1-го курса менее 160 мг (T. Bekaii-Saab и соавт., 2018: ОР 0,72, 95% ДИ 0,47–1,11; J. Gotfrit и соавт., 2017: ОР 0,46, 95% ДИ 0,17–1,22). Еще в двух работах стартовая доза регорафениба не влияла на показатели ОВ (K. Yamaguchi и соавт., 2019: ОР 0,95, 95% ДИ 0,82–1,1; G. Argiles и соавт., 2019: ОР 0,86, 95% ДИ 0,65–1,13). Проведенный метаанализ не выявил влияния на ОВ стартовой дозы препарата: ОР 0,97, 95% ДИ 0,78–1,21; p=0,79; I2=64.
Выводы. Снижение стартовой дозы регорафениба на 1-м курсе не ухудшает показатели ОВ и может быть рекомендовано к рутинной клинической практике.
Ключевые слова: рак толстой кишки, регорафениб, метаанализ.
Materials and methods. We searched for research data in the PubMed. The analysis included all publications till 08.20.2019 which compared OS depending on the starting dose of regorafenib (160 mg or less) in the 1st course of therapy. Meta-analysis was conducted using Review Manager Ver. 5.3.
Results. Two studies demonstrated decreased OS at starting dose of less than 160 mg (A. Adenis et al., 2016: risk ratio – RR 1.26, 95% confidence interval – CI 1.01–1.56; A. Aljubran et al., 2019: RR 2.25, 95% CI 0.93–5.43). Two studies showed an improvement in OS with a starting dose of less than 160 mg in the 1st course (T. Bekaii-Saab et al., 2018: RR 0.72, 95% CI 0.47–1,11; J. Gotfrit et al., 2017: RR 0.46, 95% CI 0.17–1.22). In two other studies, there was no effect of a starting dose of regorafenib on OS (K. Yamaguchi et al., 2019: RR 0.95, 95% CI 0.82–1.1; G. Argiles et al., 2019: RR 0,86, 95% CI 0.65–1.13). The meta-analysis did not reveal the effect of starting dose of the drug on OS: RR 0.97, 95% CI 0.78–1.21; p=0.79; I2=64.
Conclusions. Reducing the starting dose of regorafenib in the 1st course does not decrease OS and can be recommended for routine clinical practice.
Key words: colorectal cancer, regorafenib, meta-analysis.
Материалы и методы. Проведен поиск результатов исследований в системе PubMed. В анализ включали все работы по 20.08.2019, в которых проводилось сравнение показателей ОВ в зависимости от стартовой дозы регорафениба (160 мг или менее) на 1-м курсе терапии. Метаанализ проводился в программе Review Manager Ver. 5.3.
Результаты. В двух работах отмечено ухудшение ОВ при стартовой дозе менее 160 мг (A. Adenis и соавт., 2016: отношение рисков – ОР 1,26, 95% доверительный интервал – ДИ 1,01–1,56; A. Aljubran и соавт., 2019: ОР 2,25, 95% ДИ 0,93–5,43). В двух работах отмечено улучшение ОВ при применении стартовой дозы 1-го курса менее 160 мг (T. Bekaii-Saab и соавт., 2018: ОР 0,72, 95% ДИ 0,47–1,11; J. Gotfrit и соавт., 2017: ОР 0,46, 95% ДИ 0,17–1,22). Еще в двух работах стартовая доза регорафениба не влияла на показатели ОВ (K. Yamaguchi и соавт., 2019: ОР 0,95, 95% ДИ 0,82–1,1; G. Argiles и соавт., 2019: ОР 0,86, 95% ДИ 0,65–1,13). Проведенный метаанализ не выявил влияния на ОВ стартовой дозы препарата: ОР 0,97, 95% ДИ 0,78–1,21; p=0,79; I2=64.
Выводы. Снижение стартовой дозы регорафениба на 1-м курсе не ухудшает показатели ОВ и может быть рекомендовано к рутинной клинической практике.
Ключевые слова: рак толстой кишки, регорафениб, метаанализ.
________________________________________________
Materials and methods. We searched for research data in the PubMed. The analysis included all publications till 08.20.2019 which compared OS depending on the starting dose of regorafenib (160 mg or less) in the 1st course of therapy. Meta-analysis was conducted using Review Manager Ver. 5.3.
Results. Two studies demonstrated decreased OS at starting dose of less than 160 mg (A. Adenis et al., 2016: risk ratio – RR 1.26, 95% confidence interval – CI 1.01–1.56; A. Aljubran et al., 2019: RR 2.25, 95% CI 0.93–5.43). Two studies showed an improvement in OS with a starting dose of less than 160 mg in the 1st course (T. Bekaii-Saab et al., 2018: RR 0.72, 95% CI 0.47–1,11; J. Gotfrit et al., 2017: RR 0.46, 95% CI 0.17–1.22). In two other studies, there was no effect of a starting dose of regorafenib on OS (K. Yamaguchi et al., 2019: RR 0.95, 95% CI 0.82–1.1; G. Argiles et al., 2019: RR 0,86, 95% CI 0.65–1.13). The meta-analysis did not reveal the effect of starting dose of the drug on OS: RR 0.97, 95% CI 0.78–1.21; p=0.79; I2=64.
Conclusions. Reducing the starting dose of regorafenib in the 1st course does not decrease OS and can be recommended for routine clinical practice.
Key words: colorectal cancer, regorafenib, meta-analysis.
Полный текст
Список литературы
1. 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 (6): 619–29.
2. Grothey A, Van Cutsem E, Sobrero Arto et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 2013; 381: 303–12.
3. Van Cutsem E, Martinelli E, Cascinu S et al. Regorafenib for Patients with Metastatic Colorectal Cancer Who Progressed After Standard Therapy: Results of the Large, Single-Arm, Open-Label Phase IIIb CONSIGN Study. Oncologist 2019; 24 (2): 185–92.
4. Schulz H, Janssen J, Strauss UP et al. Clinical efficacy and safety of regorafenib (REG) in the treatment of metastatic colorectal cancer (mCRC) in daily practice in Germany: Final results of the prospective multicentre non-interventional RECORA study. J Clin Oncol 2018; 36 (Suppl. 4): 748.
5. Kopeckova K, Chloupkova R, Melichar B et al. Regorafenib for metastatic colorectal carcinoma: a registry-based analysis. ESMO 2018. Abstract 468P.
6. Del Prete S, Cennamo G, Leo L et al. Adherence and safety of regorafenib for patients with metastatic colorectal cancer: observational real-life study. Future Oncol 2017; 13 (5): 415–23.
7. Aljubran A, Elshenawy MA, Kandil M et al. Efficacy of Regorafenib in Metastatic Colorectal Cancer: A Multi-institutional Retrospective Study. Clinical Medicine Insights: Oncology 2019; 13: 1–6.
8. Yamaguchi K, Komatsu Y, Satoh T et al. Large-Scale, prospective observational study of regorafenib in Japanese patients with metastatic colorectal cancer in a real-world clinical setting. Oncologist 2019. pii: theoncologist.2018-0377. DOI: 10.1634/theoncologist.2018-0377.
9. Tougeron D, de la Fouchardière C, 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 (Suppl. 4): iv167-iv209.
10. Wilhelm SM, Carter C, Tang L et al. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res 2004; 64: 7099–109.
11. Escudier B, Szczylik C, Hutson TE et al. Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma. J Clin Oncol 2009; 27: 1280–9.
12. Mross K, Frost A, Steinbild S et al. A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res 2012; 18 (9): 2658–67.
13. Gotfrit J, Vickers M, Sud S et al. Real-life treatment of metastatic colorectal cancer with regorafenib: a single-centre review. Curr Oncol 2017; 24 (4): 234–9.
14. Adenis A, de la Fouchardiere C, Paule B et al. Survival, safety, and prognostic factors for outcome with Regorafenib in patients with metastatic colorectal cancer refractory to standard therapies: results from a multicenter study (REBECCA) nested within a compassionate use program. BMC Cancer 2016; 16: 412.
15. Bekaii-Saab TS, Ou FS, Ahn DH et al. Regorafenib dose-optimisation in patients with refractory metastatic colorectal cancer (ReDOS): a randomised, multicentre, open-label, phase 2 study. Lancet Oncol 2019
16. Argiles G, Mulet Margalef N, Valladares-Ayerbes M et al. Results of REARRANGE trial: A randomized phase 2 study comparing different dosing approaches for regorafenib (REG) during the first cycle of treatment in patients (pts) with metastatic colorectal cancer (mCRC). Ann Oncol 2019; 30 (Issue Suppl. 4): mdz154.025
17. Angeles A, Hung W, Cheung WY. Eligibility of real-world patients with chemo-refractory, K-RAS wild-type, metastatic colorectal cancer for palliative intent regorafenib monotherapy. Med Oncol 2018; 35: 114.
18. Kies M, Blumenschein G, Christensen O et al. Phase I study of regorafenib (BAY 73-4506), an inhibitor of oncogenic and angiogenic kinases, administered continuously in patients with advanced refractory non-small cell lung cancer. J Clin Oncol 2010; 28: abstr. #7585.
19. Finn RS, Blumenschein G, Tolcher A et al. Continuous-dose regorafenib (REG) in hepatocellular carcinoma (HCC): phase I safety and pharmacokinetic (PK) study. J Clin Oncol 2013; 31 (Suppl. 4):abstract 300.
20. Kudo T, Kato Ti, Kagawa Y et al. Phase II dose titration study of regorafenib for patients with unresectable metastatic colorectal cancer that progressed after standard chemotherapy. J Clin Oncol 2018; 36 (Suppl. 4S); abstr 821.
21. Petrioli R, Chirra M, Messuti L et al. Efficacy and safety of regorafenib with 2/1 schedule for patients ≥75 years with metastatic colorectal cancer (mCRC) after failure of 2 lines of chemotherapy. Clin Colorect Cancer 2018; 17: 307–12.
22. Mayer RJ, Van Cutsem E, Falcone A et al. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med 2015; 372 (20): 1909–19.
23. Taieb J, Falcone A, Lonardi S et al. Safety and Efficacy of Trifluridine/Tipiracil(FTD/TPI) in Metastatic Colorectal Cancer (mCRC) Patients According to Previous Treatment With Regorafenib in the International Phase 3b PRECONNECT Study. Ann Oncol 2018; 29 (Suppl. 8): viii150-viii204.
2. Grothey A, Van Cutsem E, Sobrero Arto et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 2013; 381: 303–12.
3. Van Cutsem E, Martinelli E, Cascinu S et al. Regorafenib for Patients with Metastatic Colorectal Cancer Who Progressed After Standard Therapy: Results of the Large, Single-Arm, Open-Label Phase IIIb CONSIGN Study. Oncologist 2019; 24 (2): 185–92.
4. Schulz H, Janssen J, Strauss UP et al. Clinical efficacy and safety of regorafenib (REG) in the treatment of metastatic colorectal cancer (mCRC) in daily practice in Germany: Final results of the prospective multicentre non-interventional RECORA study. J Clin Oncol 2018; 36 (Suppl. 4): 748.
5. Kopeckova K, Chloupkova R, Melichar B et al. Regorafenib for metastatic colorectal carcinoma: a registry-based analysis. ESMO 2018. Abstract 468P.
6. Del Prete S, Cennamo G, Leo L et al. Adherence and safety of regorafenib for patients with metastatic colorectal cancer: observational real-life study. Future Oncol 2017; 13 (5): 415–23.
7. Aljubran A, Elshenawy MA, Kandil M et al. Efficacy of Regorafenib in Metastatic Colorectal Cancer: A Multi-institutional Retrospective Study. Clinical Medicine Insights: Oncology 2019; 13: 1–6.
8. Yamaguchi K, Komatsu Y, Satoh T et al. Large-Scale, prospective observational study of regorafenib in Japanese patients with metastatic colorectal cancer in a real-world clinical setting. Oncologist 2019. pii: theoncologist.2018-0377. DOI: 10.1634/theoncologist.2018-0377.
9. Tougeron D, de la Fouchardière C, 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 (Suppl. 4): iv167-iv209.
10. Wilhelm SM, Carter C, Tang L et al. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res 2004; 64: 7099–109.
11. Escudier B, Szczylik C, Hutson TE et al. Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma. J Clin Oncol 2009; 27: 1280–9.
12. Mross K, Frost A, Steinbild S et al. A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res 2012; 18 (9): 2658–67.
13. Gotfrit J, Vickers M, Sud S et al. Real-life treatment of metastatic colorectal cancer with regorafenib: a single-centre review. Curr Oncol 2017; 24 (4): 234–9.
14. Adenis A, de la Fouchardiere C, Paule B et al. Survival, safety, and prognostic factors for outcome with Regorafenib in patients with metastatic colorectal cancer refractory to standard therapies: results from a multicenter study (REBECCA) nested within a compassionate use program. BMC Cancer 2016; 16: 412.
15. Bekaii-Saab TS, Ou FS, Ahn DH et al. Regorafenib dose-optimisation in patients with refractory metastatic colorectal cancer (ReDOS): a randomised, multicentre, open-label, phase 2 study. Lancet Oncol 2019
16. Argiles G, Mulet Margalef N, Valladares-Ayerbes M et al. Results of REARRANGE trial: A randomized phase 2 study comparing different dosing approaches for regorafenib (REG) during the first cycle of treatment in patients (pts) with metastatic colorectal cancer (mCRC). Ann Oncol 2019; 30 (Issue Suppl. 4): mdz154.025
17. Angeles A, Hung W, Cheung WY. Eligibility of real-world patients with chemo-refractory, K-RAS wild-type, metastatic colorectal cancer for palliative intent regorafenib monotherapy. Med Oncol 2018; 35: 114.
18. Kies M, Blumenschein G, Christensen O et al. Phase I study of regorafenib (BAY 73-4506), an inhibitor of oncogenic and angiogenic kinases, administered continuously in patients with advanced refractory non-small cell lung cancer. J Clin Oncol 2010; 28: abstr. #7585.
19. Finn RS, Blumenschein G, Tolcher A et al. Continuous-dose regorafenib (REG) in hepatocellular carcinoma (HCC): phase I safety and pharmacokinetic (PK) study. J Clin Oncol 2013; 31 (Suppl. 4):abstract 300.
20. Kudo T, Kato Ti, Kagawa Y et al. Phase II dose titration study of regorafenib for patients with unresectable metastatic colorectal cancer that progressed after standard chemotherapy. J Clin Oncol 2018; 36 (Suppl. 4S); abstr 821.
21. Petrioli R, Chirra M, Messuti L et al. Efficacy and safety of regorafenib with 2/1 schedule for patients ≥75 years with metastatic colorectal cancer (mCRC) after failure of 2 lines of chemotherapy. Clin Colorect Cancer 2018; 17: 307–12.
22. Mayer RJ, Van Cutsem E, Falcone A et al. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med 2015; 372 (20): 1909–19.
23. Taieb J, Falcone A, Lonardi S et al. Safety and Efficacy of Trifluridine/Tipiracil(FTD/TPI) in Metastatic Colorectal Cancer (mCRC) Patients According to Previous Treatment With Regorafenib in the International Phase 3b PRECONNECT Study. Ann Oncol 2018; 29 (Suppl. 8): viii150-viii204.
2. Grothey A, Van Cutsem E, Sobrero Arto et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 2013; 381: 303–12.
3. Van Cutsem E, Martinelli E, Cascinu S et al. Regorafenib for Patients with Metastatic Colorectal Cancer Who Progressed After Standard Therapy: Results of the Large, Single-Arm, Open-Label Phase IIIb CONSIGN Study. Oncologist 2019; 24 (2): 185–92.
4. Schulz H, Janssen J, Strauss UP et al. Clinical efficacy and safety of regorafenib (REG) in the treatment of metastatic colorectal cancer (mCRC) in daily practice in Germany: Final results of the prospective multicentre non-interventional RECORA study. J Clin Oncol 2018; 36 (Suppl. 4): 748.
5. Kopeckova K, Chloupkova R, Melichar B et al. Regorafenib for metastatic colorectal carcinoma: a registry-based analysis. ESMO 2018. Abstract 468P.
6. Del Prete S, Cennamo G, Leo L et al. Adherence and safety of regorafenib for patients with metastatic colorectal cancer: observational real-life study. Future Oncol 2017; 13 (5): 415–23.
7. Aljubran A, Elshenawy MA, Kandil M et al. Efficacy of Regorafenib in Metastatic Colorectal Cancer: A Multi-institutional Retrospective Study. Clinical Medicine Insights: Oncology 2019; 13: 1–6.
8. Yamaguchi K, Komatsu Y, Satoh T et al. Large-Scale, prospective observational study of regorafenib in Japanese patients with metastatic colorectal cancer in a real-world clinical setting. Oncologist 2019. pii: theoncologist.2018-0377. DOI: 10.1634/theoncologist.2018-0377.
9. Tougeron D, de la Fouchardière C, 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 (Suppl. 4): iv167-iv209.
10. Wilhelm SM, Carter C, Tang L et al. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res 2004; 64: 7099–109.
11. Escudier B, Szczylik C, Hutson TE et al. Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma. J Clin Oncol 2009; 27: 1280–9.
12. Mross K, Frost A, Steinbild S et al. A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res 2012; 18 (9): 2658–67.
13. Gotfrit J, Vickers M, Sud S et al. Real-life treatment of metastatic colorectal cancer with regorafenib: a single-centre review. Curr Oncol 2017; 24 (4): 234–9.
14. Adenis A, de la Fouchardiere C, Paule B et al. Survival, safety, and prognostic factors for outcome with Regorafenib in patients with metastatic colorectal cancer refractory to standard therapies: results from a multicenter study (REBECCA) nested within a compassionate use program. BMC Cancer 2016; 16: 412.
15. Bekaii-Saab TS, Ou FS, Ahn DH et al. Regorafenib dose-optimisation in patients with refractory metastatic colorectal cancer (ReDOS): a randomised, multicentre, open-label, phase 2 study. Lancet Oncol 2019
16. Argiles G, Mulet Margalef N, Valladares-Ayerbes M et al. Results of REARRANGE trial: A randomized phase 2 study comparing different dosing approaches for regorafenib (REG) during the first cycle of treatment in patients (pts) with metastatic colorectal cancer (mCRC). Ann Oncol 2019; 30 (Issue Suppl. 4): mdz154.025
17. Angeles A, Hung W, Cheung WY. Eligibility of real-world patients with chemo-refractory, K-RAS wild-type, metastatic colorectal cancer for palliative intent regorafenib monotherapy. Med Oncol 2018; 35: 114.
18. Kies M, Blumenschein G, Christensen O et al. Phase I study of regorafenib (BAY 73-4506), an inhibitor of oncogenic and angiogenic kinases, administered continuously in patients with advanced refractory non-small cell lung cancer. J Clin Oncol 2010; 28: abstr. #7585.
19. Finn RS, Blumenschein G, Tolcher A et al. Continuous-dose regorafenib (REG) in hepatocellular carcinoma (HCC): phase I safety and pharmacokinetic (PK) study. J Clin Oncol 2013; 31 (Suppl. 4):abstract 300.
20. Kudo T, Kato Ti, Kagawa Y et al. Phase II dose titration study of regorafenib for patients with unresectable metastatic colorectal cancer that progressed after standard chemotherapy. J Clin Oncol 2018; 36 (Suppl. 4S); abstr 821.
21. Petrioli R, Chirra M, Messuti L et al. Efficacy and safety of regorafenib with 2/1 schedule for patients ≥75 years with metastatic colorectal cancer (mCRC) after failure of 2 lines of chemotherapy. Clin Colorect Cancer 2018; 17: 307–12.
22. Mayer RJ, Van Cutsem E, Falcone A et al. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med 2015; 372 (20): 1909–19.
23. Taieb J, Falcone A, Lonardi S et al. Safety and Efficacy of Trifluridine/Tipiracil(FTD/TPI) in Metastatic Colorectal Cancer (mCRC) Patients According to Previous Treatment With Regorafenib in the International Phase 3b PRECONNECT Study. Ann Oncol 2018; 29 (Suppl. 8): viii150-viii204.
________________________________________________
2. Grothey A, Van Cutsem E, Sobrero Arto et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 2013; 381: 303–12.
3. Van Cutsem E, Martinelli E, Cascinu S et al. Regorafenib for Patients with Metastatic Colorectal Cancer Who Progressed After Standard Therapy: Results of the Large, Single-Arm, Open-Label Phase IIIb CONSIGN Study. Oncologist 2019; 24 (2): 185–92.
4. Schulz H, Janssen J, Strauss UP et al. Clinical efficacy and safety of regorafenib (REG) in the treatment of metastatic colorectal cancer (mCRC) in daily practice in Germany: Final results of the prospective multicentre non-interventional RECORA study. J Clin Oncol 2018; 36 (Suppl. 4): 748.
5. Kopeckova K, Chloupkova R, Melichar B et al. Regorafenib for metastatic colorectal carcinoma: a registry-based analysis. ESMO 2018. Abstract 468P.
6. Del Prete S, Cennamo G, Leo L et al. Adherence and safety of regorafenib for patients with metastatic colorectal cancer: observational real-life study. Future Oncol 2017; 13 (5): 415–23.
7. Aljubran A, Elshenawy MA, Kandil M et al. Efficacy of Regorafenib in Metastatic Colorectal Cancer: A Multi-institutional Retrospective Study. Clinical Medicine Insights: Oncology 2019; 13: 1–6.
8. Yamaguchi K, Komatsu Y, Satoh T et al. Large-Scale, prospective observational study of regorafenib in Japanese patients with metastatic colorectal cancer in a real-world clinical setting. Oncologist 2019. pii: theoncologist.2018-0377. DOI: 10.1634/theoncologist.2018-0377.
9. Tougeron D, de la Fouchardière C, 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 (Suppl. 4): iv167-iv209.
10. Wilhelm SM, Carter C, Tang L et al. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res 2004; 64: 7099–109.
11. Escudier B, Szczylik C, Hutson TE et al. Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma. J Clin Oncol 2009; 27: 1280–9.
12. Mross K, Frost A, Steinbild S et al. A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res 2012; 18 (9): 2658–67.
13. Gotfrit J, Vickers M, Sud S et al. Real-life treatment of metastatic colorectal cancer with regorafenib: a single-centre review. Curr Oncol 2017; 24 (4): 234–9.
14. Adenis A, de la Fouchardiere C, Paule B et al. Survival, safety, and prognostic factors for outcome with Regorafenib in patients with metastatic colorectal cancer refractory to standard therapies: results from a multicenter study (REBECCA) nested within a compassionate use program. BMC Cancer 2016; 16: 412.
15. Bekaii-Saab TS, Ou FS, Ahn DH et al. Regorafenib dose-optimisation in patients with refractory metastatic colorectal cancer (ReDOS): a randomised, multicentre, open-label, phase 2 study. Lancet Oncol 2019
16. Argiles G, Mulet Margalef N, Valladares-Ayerbes M et al. Results of REARRANGE trial: A randomized phase 2 study comparing different dosing approaches for regorafenib (REG) during the first cycle of treatment in patients (pts) with metastatic colorectal cancer (mCRC). Ann Oncol 2019; 30 (Issue Suppl. 4): mdz154.025
17. Angeles A, Hung W, Cheung WY. Eligibility of real-world patients with chemo-refractory, K-RAS wild-type, metastatic colorectal cancer for palliative intent regorafenib monotherapy. Med Oncol 2018; 35: 114.
18. Kies M, Blumenschein G, Christensen O et al. Phase I study of regorafenib (BAY 73-4506), an inhibitor of oncogenic and angiogenic kinases, administered continuously in patients with advanced refractory non-small cell lung cancer. J Clin Oncol 2010; 28: abstr. #7585.
19. Finn RS, Blumenschein G, Tolcher A et al. Continuous-dose regorafenib (REG) in hepatocellular carcinoma (HCC): phase I safety and pharmacokinetic (PK) study. J Clin Oncol 2013; 31 (Suppl. 4):abstract 300.
20. Kudo T, Kato Ti, Kagawa Y et al. Phase II dose titration study of regorafenib for patients with unresectable metastatic colorectal cancer that progressed after standard chemotherapy. J Clin Oncol 2018; 36 (Suppl. 4S); abstr 821.
21. Petrioli R, Chirra M, Messuti L et al. Efficacy and safety of regorafenib with 2/1 schedule for patients ≥75 years with metastatic colorectal cancer (mCRC) after failure of 2 lines of chemotherapy. Clin Colorect Cancer 2018; 17: 307–12.
22. Mayer RJ, Van Cutsem E, Falcone A et al. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med 2015; 372 (20): 1909–19.
23. Taieb J, Falcone A, Lonardi S et al. Safety and Efficacy of Trifluridine/Tipiracil(FTD/TPI) in Metastatic Colorectal Cancer (mCRC) Patients According to Previous Treatment With Regorafenib in the International Phase 3b PRECONNECT Study. Ann Oncol 2018; 29 (Suppl. 8): viii150-viii204.
Авторы
М.Ю. Федянин*, Е.М. Полянская, А.А. Трякин, И.А. Покатаев, С.А. Тюляндин
ФГБУ «Национальный медицинский исследовательский центр онкологии им. Н.Н. Блохина» Минздрава России, Москва, Россия
*fedianinmu@mail.ru
Blokhin National Medical Research Center of Oncology, Moscow, Russia
*fedianinmu@mail.ru
ФГБУ «Национальный медицинский исследовательский центр онкологии им. Н.Н. Блохина» Минздрава России, Москва, Россия
*fedianinmu@mail.ru
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Blokhin National Medical Research Center of Oncology, Moscow, Russia
*fedianinmu@mail.ru
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