Skip to main content

Advertisement

SpringerLink
Log in

Safety and tolerability of regorafenib: a real-life experience

  • Original Research
  • Published:
Journal of Gastrointestinal Cancer Aims and scope Submit manuscript

Abstract

Background

Regorafenib has been approved among the treatment options for patients with advanced stage colorectal cancer (CRC), hepatocellular carcinoma (HCC), and gastrointestinal stromal tumors (GIST). In this study, we aim to report the real-life experience of the safety and tolerability regorafenib in our institution.

Methods

We conducted a retrospective chart review of 43 patients who received regorafenib in Kuwait Cancer Control Center (KCCC) from 2016 to the end of 2019. Data collected include diagnosis, patient demographics, performance status, number of previous lines of treatment, number of treatment cycles, side effects, best-tolerated dose, and treatment discontinuation due to intolerability. Univariate analysis with Pearson chi-square test were conducted to study co-relation between discontinuation rates and several factors.

Results

We had available data for 43 patients (23 males and 20 females). Of the patients, 83.7% had an ECOG performance status of 0 or 1. Seventy-three percent were diagnosed with metastatic CRC, 21% were diagnosed with HCC and 6% were diagnosed with GIST tumors. Half of the patients received 3 lines or more of treatment prior to regorafenib. The median number of cycles received was 3.7 with 11.6% of patients still on active treatment at the time of analysis. The most reported grade 3 and above side effects included rash (41.9%), fatigue (39.6 %), hypertension (25.6%), mucositis (21.9%), hand-foot syndrome (2.3%), and hyperbilirubinemia (4.6%). The best-tolerated dose was 80 mg and that was achieved in 44.2% of patients. The recommended dose of 160 mg could only be achieved in 20.9% of patients. The treatment was discontinued because of intolerability in 25.6% of patients. The discontinuation rates in those with ages 60 years and above versus below 60 years were 91% and 68%, respectively.

Conclusion

In our cohort, the best-tolerated dose of regorafenib was 80 mg. Toxicity and intolerability of regorafenib lead to treatment discontinuation in nearly a quarter of patients. Patient age may influence tolerance and adherence to regorafenib.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Wang DH, Park JY. Precision medicine in gastrointestinal pathology. Arch Pathol Lab Med. 2016;140(5):449–60.

    Article  Google Scholar 

  2. Wilhelm SM, Dumas J, Adnane L, Lynch M, Carter CA, Schütz G, 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;129:245–55.

  3. Van Cutsem E, Sobrero AF, Siena S, Falcone A, Ychou M, Humblet Y, Bouche O, Mineur L, Barone C, Adenis A, Tabernero J. Phase III CORRECT trial of regorafenib in metastatic colorectal cancer (mCRC).

  4. 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, randomized, placebo-controlled, phase 3 trial. Lancet (London, England). 2013;381:303–12.

    Article  CAS  Google Scholar 

  5. Li J, Qin S, Yau T, Ma B, Pan H, Xu J, et al. CONCUR: a randomized, double-blind, placebo-controlled phase 3 study of regorafenib monotherapy in Asian patients with previously treated metastatic colorectal cancer (mCRC). Ann Oncol. 2014;25:ii114.

  6. Chan SL, Ma BB. An update on the safety and efficacy of regorafenib in the treatment of solid cancers. Expert Opin Drug Metab Toxicol. 2014;10(11):1607–14.

    Article  CAS  Google Scholar 

  7. Ducreux M, Petersen LN, Öhler L, Bergamo F, Metges JP, de Groot JW, et al. Safety and effectiveness of regorafenib in patients with metastatic colorectal cancer in routine clinical practice in the prospective, observational CORRELATE study. Eur J Cancer. 2019;123:146–54.

  8. Demetri GD, Reichardt P, Kang YK, Blay JY, Joensuu H, Maki RG, Rutkowski P, Hohenberger P, Gelderblom H, Leahy MG, von Mehren M. Randomized phase III trial of regorafenib in patients (pts) with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) progressing despite prior treatment with at least imatinib (IM) and sunitinib (SU): GRID trial.

  9. Finn RS, Merle P, Granito A, Huang YH, Bodoky G, Pracht M, Yokosuka O, Rosmorduc O, Gerolami R, Caparello C, Cabrera R. Outcomes with sorafenib (SOR) followed by regorafenib (REG) or placebo (PBO) for hepatocellular carcinoma (HCC): results of the international, randomized phase 3 RESORCE trial.

  10. Bruix J, Merle P, Granito A, Huang YH, Bodoky G, Yokosuka O, Rosmorduc O, Breder VV, Gerolami R, Masi G, Ross PJ. Hand-foot skin reaction (HFSR) and overall survival (OS) in the phase 3 RESORCE trial of regorafenib for treatment of hepatocellular carcinoma (HCC) progressing on sorafenib.

  11. Rutkowski P, Stępniak J. The safety of regorafenib for the treatment of gastrointestinal stromal tumors. Expert Opin Drug Saf. 2016;15(1):105–16.

    Article  CAS  Google Scholar 

  12. Lam KO, Lee KC, Chiu J, Lee VH, Leung R, Choy TS, et al. The real-world use of regorafenib for metastatic colorectal cancer: a multicentre analysis of treatment pattern and outcomes in Hong Kong. Postgrad Med J. 2017;93(1101):395–400.

  13. Bekaii-Saab TS, Fang-Shu O, Anderson DM, Ahn DH, Boland PMK, Ciombor KK, et al. Regorafenib dose optimization study (ReDOS): randomized phase II trial to evaluate dosing strategies for regorafenib in refractory metastatic colorectal cancer (mCRC). J Clin Oncol. 2018;36(4_suppl):611–1.

  14. Gotfrit md J, Vickers md M, Sud md S, Asmis md T, Cripps md C, Goel md R, et al. md,D. Jonker md, and R. Goodwin. Real-life treatment of metastatic colorectal cancer with regorafenib: a single-center review. Curr Oncol. 2017;24(4):234–9.

  15. Calcagno F, Lenoble S, Lakkis Z, Nguyen T, Limat S, Borg C, 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.

  16. Del Prete S, Cennamo G, Leo L, Montella L, Vincenzi B, Biglietto M, et al. Adherence and safety of regorafenib for patients with metastatic colorectal cancer: observational real-life study. Future Oncol. 2017;13(5):415–4232.

Download references

Author information

Authors and Affiliations

  1. Medical Oncology Department, Kuwait Cancer Control Center, Kuwait, Kuwait

    Youssif Abo Elseud, Amrou Shaaban, Asit Mohanty & Jasem Albarrak

  2. Clinical Oncology Department, Faculty Of Medicine, Minia University, Minia, Egypt

    Amrou Shaaban

Authors
  1. Youssif Abo Elseud
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Amrou Shaaban
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Asit Mohanty
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Jasem Albarrak
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Amrou Shaaban.

Ethics declarations

Conflict of Interest

The authors declare that they have no conflict of interest.

Additional information

Legal entity responsible for the study: The authors.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Elseud, Y.A., Shaaban, A., Mohanty, A. et al. Safety and tolerability of regorafenib: a real-life experience. J Gastrointest Canc 53, 187–191 (2022). https://doi.org/10.1007/s12029-020-00570-1

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12029-020-00570-1

Keywords

Search

Navigation