Research Article
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Salvage Treatment Option for Metastatic Colorectal Cancer:Regorafenib

Year 2020, Volume: 27 Issue: 4, 471 - 476, 25.12.2020
https://doi.org/10.17343/sdutfd.581299

Abstract

Introduction: Colorectal
cancer (CRC)
is an important cause of
cancer-related deaths.
The aim of this study was to
evaluate the efficacy and toxicity profile of regorafenib treatment in metastatic
CRC patients.

Methods: This was a
retrospective study of 25 mCRC patients from a single center. All patients had
previously progressed fluorouracil, irinotecan, and oxaliplatin with or without
biologic agents such as epidermal growth factor receptör (anti-EGFR) or
vascular endothelial growth factor receptor (anti-VEGF).


Results: The median age
was 58 years
(range, 27 to 84 years), and there were 14 males and 11 females.
Patients had received a median of 3 lines of systemic
therapy before regorafenib initiation.
The most common grade 3 or 4
toxicities were fatigue 20%, daire 16% and mucositis 16%. Median PFS was 2.07
months (0.43-5.13) and median OS was 4.14 months (0.62-19.88). No factors were
significantly associated with PFS and OS 
in the univariate analysis.







                        Conclusion: Regorafenib shows a small but significant
survival benefit in patients with metastatic CRC who do not have any

                       further
treatment options after the failure over standard therapies. Its toxicity
profile along with the absence of predictive factors

                       suggest a careful
evaluation before its use in clinical practice

Supporting Institution

The author declared that this study received no financial support

References

  • Referans1.Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016.CA Cancer J Clin 2016;66(1):7-30
  • Referans2. Abrahao ABK, Ko YJ, Berry S, Chan KKW. A Comparison of regorafenib and TAS-102 for metastatic colorectal cancer: a systematic review and network meta-analysis. Clin Colorectal Cancer 2018; 17: 113-20
  • Referans3. Garcia-Alfonso P, Feliu J, Garcia-Carbonero R, Gravalos C, Guillen-Ponce C, Sastre J, et al. Is regorafenib providing clinically meaningful benefits to pretreated patients with metastatic colorectal cancer? Clin Transl Oncol 2016; 18: 1072-81
  • Referans4. Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, 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
  • Referans5. Kim ST, Kim TW, Kim KP, Kim TY, Han SW, Lee SH et al. Regorafenib as Salvage Treatment in Korean Patients with Refractory Metastatic Colorectal Cancer. Cancer Res Treat. 2015 Oct; 47(4): 790–795
  • Referans6. Li J, Qin S, Xu R, Yau TC, Ma B, Pan H, 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
  • Referans7. Sartore-Bianchi A, Zeppellini A, Amatu A, Ricotta R, Bencardino K, Siena S. Regorafenib in metastatic colorectal cancer. Expert Rev Anticancer Ther 2014;14:255–65
  • Referans8. Ganesan P, Sagar TG, Dubashi B, Rajendranath R, Kannan K, Cyriac S, et al. Nonadherence to imatinib adversely affects event free survival in chronic phase chronic myeloid leukemia. Am J Hematol 2011;86:471-4
  • Referans9. Hershman DL, Shao T, Kushi LH, Buono D, Tsai WY, Fehrenbacher L, et al. Early discontinuation and non-adherence to adjuvant hormonal therapy are associated with increased mortality in women with breast cancer. Breast Cancer Res Treat 2011;126:529-37
  • Referans10. Seal BS, Anderson S, Shermock KM. Factors associated with adherence rates for oral and intravenous anticancer therapy in commercially insured patients with metastatic colon cancer. J Manag Care Spec Pharm 2016;22:227-35
  • Referans11. Liu G, Franssen E, Fitch M, Warner E. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol 1997;15:110-5
  • Referans12. Shitara K, Yamanaka T, Denda T, Tsuji Y, Shinozaki K, Komatsu Y, et al. REVERCE: a randomized phase II study of regorafenib followed by cetuximab versus the reverse sequence for previously treated metastatic colorectal cancer patients. Ann Oncol 2019;30(2):259-265
  • Referans13. De Wit M, Boers-Doets CB, Saettini A, Vermeersch K, de Juan CR, Ouwerkerk J, et al. Prevention and management of adverse events related to regorafenib. Supportive Care Cancer 22(3), 837–846 (2014)
  • Referans14. Grothey A, George S, van Cutsem E, Blay JY, Sobrero A, Demetri GD. Optimizing treatment outcomes with regorafenib: personalized dosing and other strategies to support patient care. Oncologist 2014:19(6), 669–680
  • Referans15. Khan G, Moss RA, Braiteh F, Saltzman M. Proactive strategies for regorafenib in metastatic colorectal cancer: implications for optimal patient management. Cancer Manag Res 2014. 6, 93–103
  • Referans16. Adenis A, de la Fouchardiere C, Paule B, Burtin P, Tougeron D, Wallet J, 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

Metastatik Kolorektal Kanserde Kurtarma Tedavisi:Regorafenib

Year 2020, Volume: 27 Issue: 4, 471 - 476, 25.12.2020
https://doi.org/10.17343/sdutfd.581299

Abstract

Giriş: Kolorektal
kanser (KRK), kanser ilişkili ölümlerin önemli nedenlerinden biridir. Bu çalışmanın amacı, metastatik KRK hastalarında
regorafenib tedavisinin etkinlik ve toksisite profilini değerlendirmektir.



Method:
Bu
çalışmada tek merkezde takip edilen 25 mKRK hastasının retrospektif verileri
incelenmiştir. Tüm hastalarda biyolojik ajanlar olan anti-epidermal büyüme
faktörü reseptörü (anti-EGFR) ve anti-vasküler endotelyal büyüme faktörü
(anti-VEGF) ile kombine olarak veya olmaksızın 5-fluorourasil, irinotekan ve okzaliplatin
ile progresyon saptanmıştı.



Bulgular: Ortanca yaş 58
(dağılım 27-84) idi, ve 14 erkek ve 11 kadın vardı. Hastalar regorafenib
başlangıcından önce ortanca 3 sıra sistemik tedavi aldılar. En sık görülen
derece 3. veya 4. derece toksisiteler yorgunluk %20, daire %16 ve mukozit %16
idi. Ortanca PFS 2.07 ay (0.43-5.13) ve ortanca OS 4.14 ay (0.62-19.88) idi. Tek
değişkenli analizde hiçbir faktör PFS ve OS ile ilişkili bulunmadı.



Sonuç: Regorafenib,
standart tedavilerdeki başarısızlıktan sonra başka tedavi seçeneği bulunmayan metastatik
KRK hastalarında küçük fakat önemli bir sağkalım yararı göstermektedir.
Prediktif faktörlerin olmamasıyla birlikte toksisite profili klinik uygulamada
kullanılmadan önce dikkatli bir değerlendirme yapılmasını önerir.

References

  • Referans1.Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016.CA Cancer J Clin 2016;66(1):7-30
  • Referans2. Abrahao ABK, Ko YJ, Berry S, Chan KKW. A Comparison of regorafenib and TAS-102 for metastatic colorectal cancer: a systematic review and network meta-analysis. Clin Colorectal Cancer 2018; 17: 113-20
  • Referans3. Garcia-Alfonso P, Feliu J, Garcia-Carbonero R, Gravalos C, Guillen-Ponce C, Sastre J, et al. Is regorafenib providing clinically meaningful benefits to pretreated patients with metastatic colorectal cancer? Clin Transl Oncol 2016; 18: 1072-81
  • Referans4. Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, 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
  • Referans5. Kim ST, Kim TW, Kim KP, Kim TY, Han SW, Lee SH et al. Regorafenib as Salvage Treatment in Korean Patients with Refractory Metastatic Colorectal Cancer. Cancer Res Treat. 2015 Oct; 47(4): 790–795
  • Referans6. Li J, Qin S, Xu R, Yau TC, Ma B, Pan H, 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
  • Referans7. Sartore-Bianchi A, Zeppellini A, Amatu A, Ricotta R, Bencardino K, Siena S. Regorafenib in metastatic colorectal cancer. Expert Rev Anticancer Ther 2014;14:255–65
  • Referans8. Ganesan P, Sagar TG, Dubashi B, Rajendranath R, Kannan K, Cyriac S, et al. Nonadherence to imatinib adversely affects event free survival in chronic phase chronic myeloid leukemia. Am J Hematol 2011;86:471-4
  • Referans9. Hershman DL, Shao T, Kushi LH, Buono D, Tsai WY, Fehrenbacher L, et al. Early discontinuation and non-adherence to adjuvant hormonal therapy are associated with increased mortality in women with breast cancer. Breast Cancer Res Treat 2011;126:529-37
  • Referans10. Seal BS, Anderson S, Shermock KM. Factors associated with adherence rates for oral and intravenous anticancer therapy in commercially insured patients with metastatic colon cancer. J Manag Care Spec Pharm 2016;22:227-35
  • Referans11. Liu G, Franssen E, Fitch M, Warner E. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol 1997;15:110-5
  • Referans12. Shitara K, Yamanaka T, Denda T, Tsuji Y, Shinozaki K, Komatsu Y, et al. REVERCE: a randomized phase II study of regorafenib followed by cetuximab versus the reverse sequence for previously treated metastatic colorectal cancer patients. Ann Oncol 2019;30(2):259-265
  • Referans13. De Wit M, Boers-Doets CB, Saettini A, Vermeersch K, de Juan CR, Ouwerkerk J, et al. Prevention and management of adverse events related to regorafenib. Supportive Care Cancer 22(3), 837–846 (2014)
  • Referans14. Grothey A, George S, van Cutsem E, Blay JY, Sobrero A, Demetri GD. Optimizing treatment outcomes with regorafenib: personalized dosing and other strategies to support patient care. Oncologist 2014:19(6), 669–680
  • Referans15. Khan G, Moss RA, Braiteh F, Saltzman M. Proactive strategies for regorafenib in metastatic colorectal cancer: implications for optimal patient management. Cancer Manag Res 2014. 6, 93–103
  • Referans16. Adenis A, de la Fouchardiere C, Paule B, Burtin P, Tougeron D, Wallet J, 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
There are 16 citations in total.

Details

Primary Language English
Subjects Clinical Sciences
Journal Section Research Articles
Authors

Havva Yesil Cinkir 0000-0002-7870-8741

Publication Date December 25, 2020
Submission Date June 22, 2019
Acceptance Date October 2, 2019
Published in Issue Year 2020 Volume: 27 Issue: 4

Cite

Vancouver Yesil Cinkir H. Salvage Treatment Option for Metastatic Colorectal Cancer:Regorafenib. Med J SDU. 2020;27(4):471-6.

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