Improving patient outcomes with regorafenib for metastatic colorectal cancer-patient selection, dosing, patient education, prophylaxis, and management of adverse events

Oncology Research and Treatment

Volumn 38, Issue 6, 2015, Pages 300-308

  Hofheinz, Ralf Dieter ^a   Arnold, Dirk ^b   Kubicka, Stefan ^c   Prasnikar, Nicole ^d   Vogel, Arndt ^e  

^a UNIVERSITY OF HEIDELBERG   (Germany)

^b Department of Medical Oncology ^*  (Germany)

^c KLINIKUM LUDWIGSBURG   (Germany)

^d Cancer Center Reutlingen   (Germany)

^e HANNOVER MEDICAL SCHOOL   (Germany)

Author keywords

Adverse event management; Adverse event prophylaxis; Metastatic colorectal cancer; Patient selection; Regorafenib

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ANALGESIC AGENT; ANTIHYPERTENSIVE AGENT; ANTIINFECTIVE AGENT; ANTIPRURITIC AGENT; ASPARTATE AMINOTRANSFERASE; BETAMETHASONE; BICARBONATE; BILIRUBIN; CHLORIDE; CORTICOSTEROID; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; FLUOROPYRIMIDINE; HEXETIDINE; IRINOTECAN; LIDOCAINE; LOPERAMIDE; MEPIVACAINE; MOUTHWASH; NYSTATIN; OCTREOTIDE; OXALIPLATIN; REGORAFENIB; SALICYLIC ACID; ANTINEOPLASTIC AGENT; CARBANILAMIDE DERIVATIVE; PYRIDINE DERIVATIVE;

ANALGESIA; ANTIHYPERTENSIVE THERAPY; CANCER CHEMOTHERAPY; COLORECTAL LIVER METASTASIS; DIARRHEA; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG WITHDRAWAL; FATIGUE; GRAPEFRUIT JUICE; HAND FOOT SYNDROME; HUMAN; HYPERBILIRUBINEMIA; HYPERTENSION; HYPERTENSIVE CRISIS; HYPERTRANSAMINASEMIA; LIVER DYSFUNCTION; METASTATIC COLORECTAL CANCER; ORAL MUCOSITIS; ORANGE JUICE; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PATIENT EDUCATION; PATIENT SELECTION; PHASE 3 CLINICAL TRIAL (TOPIC); PROGRESSION FREE SURVIVAL; PROPHYLAXIS; RASH; REVIEW; SKIN EXFOLIATION; STOMATITIS; COLORECTAL NEOPLASMS; PATHOLOGY; PROCEDURES; TREATMENT OUTCOME;

ANTINEOPLASTIC AGENTS; COLORECTAL NEOPLASMS; HUMANS; PATIENT EDUCATION AS TOPIC; PATIENT SELECTION; PHENYLUREA COMPOUNDS; PYRIDINES; TREATMENT OUTCOME;

EID: 84930588021     PISSN: 22965270     EISSN: 22965262     Source Type: Journal    
DOI: 10.1159/000382067     Document Type: Review

References (30)

1. Kirstein MM, Lange A, Prenzler A, Manns MP, Kubicka S, Vogel A: Targeted therapies in metastatic colorectal cancer: a systematic review and assessment of currently available data. Oncologist 2014; 19: 1156-1168.
2. Arnold D, Stein A: New developments in the secondline treatment of metastatic colorectal cancer: potential place in therapy. Drugs 2013; 73: 883-891.
3. Ibrahim EM, Abouelkhair KM: Clinical outcome of panitumumab for metastatic colorectal cancer with wild-type KRAS status: a meta-analysis of randomized clinical trials. Med Oncol 2011; 28(suppl 1):S310-S317.
4. www.fda.gov/Drugs/InformationOnDrugs/Approved-Drugs/ucm321378.htm
5. www.ema.europa.eu/docs/en-GB/document-library/Summary-of-opinion-Initial-authorisation/human/002573/WC500144844.pdf
6. Wilhelm S, Adnane J, Lynch M, Hornberg J, Schutz G, Thierauch K-H, Zopf D: Regorafenib: a new oral multikinase inhibitor of angiogenic, stromal and oncogenic (receptor tyrosine) kinases with potent preclinical antitumor activity. Mol Cancer Ther 2009; 8(12 suppl):B4.
7. Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, Humblet Y, Bouche O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz HJ, Goldberg RM, Sargent DJ, Cihon F, Cupit L, Wagner A, Laurent D: Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicenter, randomized, placebo-controlled, phase 3 trial. Lancet 2013; 381: 303-312.
8. Grothey A, Falcone A, Humblet Y, Bouche O, Mineur L, Adenis A, Tabernero J, Yoshino T, Lenz H-J, Goldberg RM, Xu L, Wagner A, Van Cutsem E: Subgroup analysis of patients with metastatic colorectal cancer (mCRC) treated with regorafenib (REG) in the CORRECT trial who had progression-free survival (PFS) longer than 4 months. J Clin Oncol 2015;suppl 3:abstr 710. Presented at the 2015 Gastrointestinal Cancers Symposium, San Francisco, CA, 15-17 January 2015.
9. Pan H, Xu J, Bai Y, Chi Y, Wang L, Bi F, Le AT, Liu T, Ma D, Kappeler C, Kalmus J, Kim TW: CONCUR: a randomized, double-blind, placebo-controlled phase 3 study of regorafenib monotherapy in Asian patients with previously treatment metastatic colorectal cancer (mCRC). Ann Oncol 2014; 25(suppl 2):ii105-ii117.
10. Grothey A, George S, van Cutsem E, Blay J-Y, Sobrero A, Demetri GD: Optimizing treatment outcomes with regorafenib: personalized dosing and other strategies to support patient care. Oncologist 2014; 19: 669-680.
11. Grothey A, Van Cutsem E, Sobrero AF, Siena S, Falcone A, Ychou M, Humblet Y, Bouche O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz H-J, Goldberg RM, Sargent DJ, Cihon F, Wagner A, Laurent D, Cupit L: Time course of regorafenib-associated adverse events in the phase III CORRECT study. J Clin Oncol 2013;suppl 4:abstr 467.
12. Tougeron D, C de la Fouchardiere, Etienne PL, Dourthe LM, Mineur L, Paule B, Hollebecque A, Tresch E, Spaeth D, Michel P, Dauba J, Laplaige P, Borg C, Bechade D, Clisant S, JM Phelip, Desseigne F, Andre T, Adenis A: 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
13. Bayer Pharma AG: Stivarga 40 mg film-coated tablets. Summary of Product Characteristics, 2013.
14. Van Cutsem E, Cervantes A, Nordlinger B, Arnold D: Metastatic colorectal cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2014; 25(suppl 3):ii1-ii9.
15. ctep.cancer.gov/protocolDevelopment/electronic-applications/docs/ctcaev3.pdf
16. De Wit M, Boers-Doets CB, Saettini A, Vermeersch K, Roncero de Juan C, Ouwerkerk J, Raynard S-S, Bazin A, Cremolini C: Prevention and management of adverse events related to regorafenib. Support Cancer Care 2014; 22: 837-846.
17. Curt GA, Breitbart W, Cella D, Groopman JE, Horning SJ, Itri LM, Johnson DH, Miaskowski C, Scherr SL, Portenoy RK, Vogelzang NJ: Impact of cancer-related fatigue on the lives of patients: new findings from the Fatigue Coalition. Oncologist 2000; 5: 353-360.
18. Demetri GD, Reichardt P, Kang Y-K, Blay J-Y, Rutkowski P, Gelderblom H, Hohenberger P, Leahy M, von Mehren M, Joensuu H, Badalamenti G, Blackstein M, Le Cesne A, Schoffski P, Maki RG, Bauer S, Nguyen BB, Xu J, Nishida T, Chung J, Kappeler C, Kuss I, Laurent D, Casali PG: Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicenter, randomised, placebo-controlled, phase 3 trial. Lancet 2013; 381: 295-302.
19. Radbruch L, Sabatowski R, Elsner F, Everts J, Mendoza T, Cleeland C: Validation of the German Version of the Brief Fatigue Inventory. J Pain Symptom Manage 2003; 25: 449-458.
20. DeSimone PA: Nightly dosing of regorafenib. J Clin Oncol 2015;suppl 3:abstr 549. Presented at the 2015 Gastrointestinal Cancers Symposium, San Francisco, CA, 15-17 January 2015.
21. Yennurajalingam S, Frisbee-Hume S, Palmer JL, Delgado-Guay MO, Bull J, Phan AT, Tannir NM, Litton JK, Reddy A, Hui D, Dalal S, Massie L, Reddy SK, Bruera E: Reduction of cancer-related fatigue with dexamethasone: a double-blind, randomized placebo-controlled trial in patients with advanced cancer. J Clin Oncol 2013; 31: 1-11.
22. Fukuoka S, Shitara K, Noguchi M, Kawazoe A, Kuboki Y, Bando H, Okamoto W, Kojima T, Doi T, Ohtsu A, Yoshino T: Prophylactic use of oral dexamethasone (DEX) to alleviate fatigue during regorafenib (REG) treatment for patients with advanced colorectal cancer (sCRC). J Clin Oncol 2015; 33(suppl 3):abstr 774. Presented at the 2015 Gastrointestinal Cancers Symposium. San Francisco, CA, 15-17 January 2015.
23. Lacouture ME, Wu S, Robert C, Atkins MB, Kong HH, Guitart J, Garbe C, Hauschild A, Puzanov I, Alexandrescu DT, Anderson RT, Wood L, Dutcher JP: Evolving strategies for the management of hand-foot skin reaction associated with the multitargeted kinase inhibitors sorafenib and sunitinib. Oncologist 2008; 13: 100-111.
24. Urban C, Anadkat MJ: A review of cutaneous toxicities from targeted therapies in the treatment of colorectal cancers. J Gastrointest Oncol 2013; 4: 319-327.
25. Doets-Boers CB, Epstein JB, Raber-Durlacher JE, Oewerkerk J, Logan RM, Brakenhoff JA, Lacouture ME, Gelderblom H: Oral adverse events associated with tyrosine kinase and mammalian target of rapamycin inhibitors in renal cell carcinoma: a structured literature review. Oncologist 2012; 17: 135-144.
26. Peterson DE, Bensadoun R-J, Roila F: Management of oral and gastrointestinal mucositis: ESMO Clinical Practice Guidelines. Ann Oncol 2011; 22:vi78-vi84.
27. Bowen JM: mechanisms of TKI-induced diarrhea in cancer patients. Curr Opin Support Palliat Care 2013; 7: 162-167.
28. Benson III AB, Ajani JA, Catalano RB, Engelking C, Kornblau SM, Martenson Jr JA, McCallum R, Mitchell EP, O'Dorisio TM, Vokes EE, Wadler S: Recommended guidelines for the treatment of cancer treatment-induced diarrhea. J Clin Oncol 2004; 22: 2918-2926.
29. Lenihan DJ, Kowey PR: Overview and management of cardiac adverse events associated with tyrosine kinase inhibitors. Oncologist 2013; 18: 900-908.
30. Casali P, Kang Y-K, Blay J-Y, Rutkowski P, Gelderblom H, Hohenberger P, Leahy M, von Mehren M, Joensuu H, Maki R, Xu J, Nishida T, Kappeler C, Kuss I, Laurent D, Demetri G: Updated results from the GRID trial-an international phase 3, randomized, double-blind, placebo-controlled 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). Presented at Connective Tissue Oncology Society (CTOS 2012). Prague, Czech Republic, 14-17 November 2012.