Risk of hand-foot skin reaction with the novel multikinase inhibitor regorafenib: A meta-analysis

Investigational New Drugs

Volumn 31, Issue 4, 2013, Pages 1078-1086

  Belum, Viswanath Reddy ^a   Wu, Shenhong ^b   Lacouture, Mario E ^a  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b STONY BROOK UNIVERSITY   (United States)

Author keywords

BAY 73 4506; Hand foot skin reaction; Hand foot syndrome; HFS; HFSR; Palmar plantar erythrodysesthesia; PPE; Regorafenib; Stivarga; TIE 2

Indexed keywords

AXITINIB; PAZOPANIB; PLACEBO; PROTEIN TYROSINE KINASE INHIBITOR; REGORAFENIB; SORAFENIB; SUNITINIB;

ARTICLE; ERYTHEMA; FOOT EDEMA; GASTROINTESTINAL STROMAL TUMOR; HAND FOOT SYNDROME; HIGH RISK PATIENT; HUMAN; HYPERKERATOSIS; INCIDENCE; KIDNEY CARCINOMA; LIVER CELL CARCINOMA; MAJOR CLINICAL STUDY; META ANALYSIS; METASTATIC COLORECTAL CANCER; MULTICENTER STUDY (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK ASSESSMENT; RISK FACTOR; SYSTEMATIC REVIEW;

CLINICAL TRIALS AS TOPIC; HAND-FOOT SYNDROME; HUMANS; INCIDENCE; NEOPLASMS; PHENYLUREA COMPOUNDS; PROTEIN KINASE INHIBITORS; PYRIDINES; RISK FACTORS; SKIN;

EID: 84880916933     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-013-9977-0     Document Type: Article

References (31)

1. Regorafenib [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc.; 2013 (accessed from: http://labeling.bayerhealthcare.com/html/products/ pi/Stivarga-PI.pdf, on March 17, 2013)
2. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). Regorafenib. Available from http://www.clinicaltrials.gov/ct2/ results?term=regorafenib&Search=Search [accessed on Mar 20, 2013]
3. Frost A, Buechert M, Unger C et al (2008) Phase I study of BAY 73-4506, an inhibitor of oncogenic and angiogenic kinases, in patients with advanced solid tumors: final results of a dose-escalation study. J Clin Oncol 26:126 (suppl; abstr 2558)
4. Kies MS, Blumenschein GRJ, Christensen O, Lin T, Tolcher AW (2010) 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). J Clin Oncol 28:15 (suppl; abstr 7585)
5. Bolondi L, Tak WY, Gasbarrini A, Santoro A (2011) Phase II safety study of the oral multikinase inhibitor regorafenib (BAY 73-4506) as second-line therapy in patients with hepatocellular carcinoma. Eur J Cancer 47(Supplement 1):S464
6. Mross K, Frost A, Steinbild S et al (2012) 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 18(9):2658-2667
7. Strumberg D, Schultheis B (Jun 2012) Regorafenib for cancer. Expert Opin Investig Drugs 21(6):879-889
8. George S, Wang Q, Heinrich MC et al (2012) Efficacy and safety of regorafenib in patients with metastatic and/or unresectable GI stromal tumor after failure of imatinib and sunitinib: a multicenter phase II trial. J Clin Oncol 30(19):2401-2407
9. Eisen T, Joensuu H, Nathan PD et al (Oct 2012) Regorafenib for patients with previously untreated metastatic or unresectable renal-cell carcinoma: a single-group phase 2 trial. Lancet Oncol 13(10):1055-1062
10. Demetri GD, Reichardt P, Kang YK et al (2013) Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 381(9863):295-302
11. Grothey A, Van Cutsem E, Sobrero A et al (2013) Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 381(9863):303-312
12. Lacouture ME, Reilly LM, Gerami P, Guitart J (Nov 2008) Hand foot skin reaction in cancer patients treated with the multikinase inhibitors sorafenib and sunitinib. Ann Oncol 19(11):1955-1961
13. Nardone B, Hensley JR, Kulik L et al (Nov 2012) The effect of hand-foot skin reaction associated with the multikinase inhibitors sorafenib and sunitinib on health-related quality of life. J Drugs Dermatol 11(11):e61-65
14. Borenstein M, Hedges L, Higgins J, Rothstein H (2005) Comprehensive meta-analysis version 2. Biostat, Englewood NJ
15. Chu D, Lacouture ME, Fillos T, Wu S (2008) Risk of hand-foot skin reaction with sorafenib: a systematic review and meta-analysis. Acta Oncol 47(2):176-186
16. Chu D, Lacouture ME, Weiner E, Wu S (Jan 2009) Risk of hand-foot skin reaction with the multitargeted kinase inhibitor sunitinib in patients with renal cell and non-renal cell carcinoma: a meta-analysis. Clin Genitourin Cancer 7(1):11-19
17. Balagula Y, Wu S, Su X, Feldman DR, Lacouture ME (Aug 2012) The risk of hand foot skin reaction to pazopanib, a novel multikinase inhibitor: a systematic review of literature and meta-analysis. Invest New Drugs 30(4):1773-1781
18. Fischer A, Wu S, Ho AL, Lacouture ME (2013) The risk of hand-foot skin reaction to axitinib, a novel VEGF inhibitor: a systematic review of literature and meta-analysis. Invest New Drugs. Jan 24 2013
19. Grothey A, Cutsem EV, Sobrero AF et al (2012) Time course of regorafenib-associated adverse events in the phase III CORRECT study. J Clin Oncol 30(suppl 34; abstr 467)
20. Strumberg D, Awada A, Hirte H et al (2006) Pooled safety analysis of BAY 43-9006 (sorafenib) monotherapy in patients with advanced solid tumours: Is rash associated with treatment outcome? Eur J Cancer 42(4):548-556
21. Jain L, Gardner ER, Figg WD, Chernick MS, Kong HH (Jan 2010) Lack of association between excretion of sorafenib in sweat and hand-foot skin reaction. Pharmacotherapy 30(1):52-56
22. Ponten F, Ren Z, Nister M, Westermark B, Ponten J (1994) Epithelial-stromal interactions in basal cell cancer: the PDGF system. J Invest Dermatol 102(3):304-309
23. Lammie A, Drobnjak M, Gerald W, Saad A, Cote R, Cordon-Cardo C (1994) Expression of c-kit and kit ligand proteins in normal human tissues. J Histochem Cytochem 42(11):1417-1425
24. Erber R, Thurnher A, Katsen AD et al (Feb 2004) Combined inhibition of VEGF and PDGF signaling enforces tumor vessel regression by interfering with pericyte-mediated endothelial cell survival mechanisms. FASEB J 18(2):338-340
25. Cascone T, Heymach JV (2012) Targeting the angiopoietin/Tie2 pathway: cutting tumor vessels with a double-edged sword? J Clin Oncol 30(4):441-444
26. Yang CH, Chuang CK, Hsieh JJ, Chang JW (2010) Targeted therapy and hand-foot skin reaction in advanced renal cell carcinoma. Expert Opin Drug Saf 9(3):459-470
27. Yoo C, Kim JE, Lee JL et al (2010) The efficacy and safety of sunitinib in korean patients with advanced renal cell carcinoma: high incidence of toxicity leads to frequent dose reduction. Jpn J Clin Oncol 40(10):980-985
28. Lim WT, Ng QS, Ivy P et al (2011) A Phase II study of pazopanib in Asian patients with recurrent/metastatic nasopharyngeal carcinoma. Clin Cancer Res 17(16):5481-5489
29. Tomita Y, Uemura H, Fujimoto H et al (2011) Key predictive factors of axitinib (AG-013736)-induced proteinuria and efficacy: a phase II study in Japanese patients with cytokine-refractory metastatic renal cell Carcinoma. Eur J Cancer 47(17):2592-2602
30. Ren Z, Zhu K, Kang H et al (2012) A randomized controlled phase II study of the prophylactic effect of urea-based cream on the hand-foot skin reaction associated with sorafenib in advanced hepatocellular carcinoma. J Clin Oncol 30(suppl; abstr 4008)
31. Sibaud V, Dalenc F, Chevreau C et al (2011) HFS-14, a specific quality of life scale developed for patients suffering from hand-foot syndrome. Oncologist 16(10):1469-1478