Abstract
Amaç: Metastatik kolorektal kanserli hastalarda Regorafenib'in etkinliğini ve prognostik faktörlerini belirlemeyi amaçladık.
Gereç ve Yöntem: Bu çalışma tek merkezli ve retrospektif olarak tasarlandı. Çalışmaya Regorafenib ile tedavi edilen 72 metastatik kolorektal kanserli hasta dahil edildi. Sağkalımı etkileyen faktörlerin tek değişkenli ve çok değişkenli analizleri Cox Regresyon Modelleri ile oluşturuldu.
Bulgular: Hastaların yirmi üçü (%31,9) kadındı ve medyan yaş 65 idi. Hastalara ait medyan progresyonsuz sağkalım (PFS) ve toplam sağkalım (OS) sırasıyla 4,13 ay ve 8,7 aydı. Karsinoembriyonik antijen (CEA) seviyesi (p=0.001) ve Eastern Cooperative Oncology Group (ECOG) Skoru (p<0,001) PFS için çok değişkenli Cox-regresyon modelinde prognostik bulunmuştur. OS için yapılan çok değişkenli modelde ECOG (p<0,001), CEA (p<0,001), doz azaltımı (p=0,003), primer tümörün olduğu taraf (p=0,037) prognostik olarak bulundu.
Sonuç: Çalışmamız, ECOG skoru, tedavi sırasında doz azaltımı, ve daha düşük başlangıç CEA seviyelerinin OS için prognostik olduğunu ortaya koydu.
Ethical Statement
The present study was performed in line with the principles of the Declaration of Helsinki. The Tekirdag Namik Kemal University Ethics Committee granted formal approval to this study (approval no: 2023.72.08. 20 on April 25th, 2023).
Supporting Institution
No person/organization is supporting this study financially. The funding was supported by the authors themselves.
References
- Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023;73(1):17-48.
- Cronin KA, Scott S, Firth AU, et al. Annual report to the nation on the status of cancer, part 1: National cancer statistics. Cancer. 2022;128(24):4251-4284.
- Weir HK, Thun MJ, Hankey BF, et al. Annual report to the nation on the status of cancer, 1975-2000, featuring the uses of surveillance data for cancer prevention and control. J Natl Cancer Inst. 2003;95(17):1276-99.
- Li N, Lu B, Luo C, et al. Incidence, mortality, survival, risk factor and screening of colorectal cancer: A comparison among China, Europe, and northern America. Cancer Lett. 2021;522:255-268.
- Kies MS, Blumenschein GR, Christensen O, Lin T, Tolcher AW. Phase I study of regorafenib (BAY 73-4506), an inhibitor of oncogenic and angiogenic kinases, administered continuously in patients (pts) with advanced refractory non-small cell lung cancer (NSCLC). Journal of Clinical Oncology. 2010:7585-7585.
- Ettrich TJ, Seufferlein T. Regorafenib. Recent Results Cancer Res. 2014;201:185-196.
- Bayer AG. Regorafenib (Stivarga) Summary of product characteristics. European Medicines Agency.2018.
- Grothey A, Van Cutsem E, Sobrero A, et al; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomized, placebo-controlled, phase 3 trial. Lancet. 2013;26;381(9863):303-12.
- 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 randomized, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015;16(6):619-629.
- 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;25;16(1):518.
- 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. Journal of Clinical Oncology. 2018: 748-748.
- Del Prete M, Giampieri R, Loupakis F, et al. Prognostic clinical factors in pretreated colorectal cancer patients receiving regorafenib: implications for clinical management. Oncotarget. 2015;6(32):33982–92.
- Arai H, Miyakawa K, Denda T, et al. Early morphological change for predicting outcome in metastatic colorectal cancer after regorafenib. Oncotarget. 2017;8(66):110530–9.
- Duffaud F, Mir O, Boudou-Rouquette P, et al. Efficacy and safety of regorafenib in adult patients with metastatic osteosarcoma: a non-comparative, randomised, double-blind, placebo-controlled, phase 2 study. Lancet Oncol. 2019;20(1):120-133.
- McLellan B, Ciardiello F, Lacouture ME, Segaert S, Van Cutsem E. Regorafenib-associated hand-foot skin reaction: practical advice on diagnosis, prevention, and management. Ann Oncol. 2015;26(10):2017-2026.
- Calcagno F, Lenoble S, Lakkis Z, et al. Efficacy, Safety and Cost of Regorafenib in Patients with Metastatic Colorectal Cancer in French Clinical Practice. Clin Med Insights Oncol. 2016;10:59-66.
- Facciorusso A, Abd El Aziz MA, Sacco R. Efficacy of Regorafenib in Hepatocellular Carcinoma Patients: A Systematic Review and Meta-Analysis. Cancers (Basel). 2019;12(1):36.
- Wakatsuki T, Shinozaki E, Suenaga M, et al. Associations between regorafenib-induced adverse events (AEs) and efficacy in metastatic colorectal cancer (mCRC). J Clin Oncol. 2017;35, 556-556.
Abstract
Aim: We aimed to determine the efficacy and prognostic factors of Regorafenib in advanced colorectal cancer patients.
Materials and Methods: This study was designed as single-center and retrospective. The study included 72 patients with metastatic colorectal cancer treated with Regorafenib. Univariate and multivariate analyses of factors affecting survival were generated by Cox Regression Models.
Results: Twenty-three (31.9%) of the patients were female, the median age was 65 years. The median progression-free survival (PFS) and overall survival (OS) were 4.13 and 8.7 months, respectively. The carcinoembryonic antigen (CEA) level (p=0.001), and Eastern Cooperative Oncology Group (ECOG) score (p<0.001) were found to be prognostic in the multivariate model for PFS. ECOG (p<0.001), CEA level (p<0.001), dose reduction (p=0.003), and side of the primary tumor (p=0.037) were prognostic for OS.
Conclusion: Our study revealed that ECOG, requiring dose reduction during the treatment, and lower baseline CEA levels were found to be prognostic.
Ethical Statement
with the principles of the Declaration of Helsinki. The Tekirdag Namik Kemal University Ethics Committee granted formal approval to this study (approval no: 2023.72.08. 20 on April 25th, 2023).
Supporting Institution
No person/organization is supporting this study financially. The funding was supported by the authors themselves.
References
- Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023;73(1):17-48.
- Cronin KA, Scott S, Firth AU, et al. Annual report to the nation on the status of cancer, part 1: National cancer statistics. Cancer. 2022;128(24):4251-4284.
- Weir HK, Thun MJ, Hankey BF, et al. Annual report to the nation on the status of cancer, 1975-2000, featuring the uses of surveillance data for cancer prevention and control. J Natl Cancer Inst. 2003;95(17):1276-99.
- Li N, Lu B, Luo C, et al. Incidence, mortality, survival, risk factor and screening of colorectal cancer: A comparison among China, Europe, and northern America. Cancer Lett. 2021;522:255-268.
- Kies MS, Blumenschein GR, Christensen O, Lin T, Tolcher AW. Phase I study of regorafenib (BAY 73-4506), an inhibitor of oncogenic and angiogenic kinases, administered continuously in patients (pts) with advanced refractory non-small cell lung cancer (NSCLC). Journal of Clinical Oncology. 2010:7585-7585.
- Ettrich TJ, Seufferlein T. Regorafenib. Recent Results Cancer Res. 2014;201:185-196.
- Bayer AG. Regorafenib (Stivarga) Summary of product characteristics. European Medicines Agency.2018.
- Grothey A, Van Cutsem E, Sobrero A, et al; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomized, placebo-controlled, phase 3 trial. Lancet. 2013;26;381(9863):303-12.
- 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 randomized, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015;16(6):619-629.
- 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;25;16(1):518.
- 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. Journal of Clinical Oncology. 2018: 748-748.
- Del Prete M, Giampieri R, Loupakis F, et al. Prognostic clinical factors in pretreated colorectal cancer patients receiving regorafenib: implications for clinical management. Oncotarget. 2015;6(32):33982–92.
- Arai H, Miyakawa K, Denda T, et al. Early morphological change for predicting outcome in metastatic colorectal cancer after regorafenib. Oncotarget. 2017;8(66):110530–9.
- Duffaud F, Mir O, Boudou-Rouquette P, et al. Efficacy and safety of regorafenib in adult patients with metastatic osteosarcoma: a non-comparative, randomised, double-blind, placebo-controlled, phase 2 study. Lancet Oncol. 2019;20(1):120-133.
- McLellan B, Ciardiello F, Lacouture ME, Segaert S, Van Cutsem E. Regorafenib-associated hand-foot skin reaction: practical advice on diagnosis, prevention, and management. Ann Oncol. 2015;26(10):2017-2026.
- Calcagno F, Lenoble S, Lakkis Z, et al. Efficacy, Safety and Cost of Regorafenib in Patients with Metastatic Colorectal Cancer in French Clinical Practice. Clin Med Insights Oncol. 2016;10:59-66.
- Facciorusso A, Abd El Aziz MA, Sacco R. Efficacy of Regorafenib in Hepatocellular Carcinoma Patients: A Systematic Review and Meta-Analysis. Cancers (Basel). 2019;12(1):36.
- Wakatsuki T, Shinozaki E, Suenaga M, et al. Associations between regorafenib-induced adverse events (AEs) and efficacy in metastatic colorectal cancer (mCRC). J Clin Oncol. 2017;35, 556-556.
Details
| Primary Language | English |
|---|---|
| Subjects | Predictive and Prognostic Markers |
| Journal Section | Research Article |
| Authors | |
| Publication Date | December 31, 2023 |
| Submission Date | September 5, 2023 |
| Acceptance Date | October 13, 2023 |
| Published in Issue | Year 2023 Volume: 9 Issue: 3 |
