Literature DB >> 24821824

Optimizing treatment outcomes with regorafenib: personalized dosing and other strategies to support patient care.

Axel Grothey1, Suzanne George1, Eric van Cutsem2, Jean-Yves Blay2, Alberto Sobrero2, George D Demetri2.   

Abstract

Regorafenib is an oral multikinase inhibitor that inhibits several kinases relevant to tumor biology in several cancers, including colorectal carcinoma (CRC) and gastrointestinal stromal tumor (GIST). In phase III trials, regorafenib significantly improved overall survival versus placebo in patients with metastatic CRC progressing after all available standard therapies, and significantly prolonged progression-free survival in patients with advanced GIST in whom at least imatinib and sunitinib had failed. Thus, this agent holds promise as a new standard of care for CRC and GIST patients after disease progression following all other approved therapies. The clinical trials reported to date show that this new treatment has a consistent adverse event profile that is quite different from that of traditional cytotoxic chemotherapies. The most common adverse events of regorafenib include dermatologic and mucosal toxicities (especially hand-foot skin reaction, rash, and oral mucositis), constitutional symptoms (e.g., fatigue, nausea, and weight loss), vascular effects (especially hypertension), and gastrointestinal symptoms (e.g., diarrhea). To help health care professionals anticipate and manage the adverse events associated with regorafenib, we describe our experiences in clinical trials and show that such toxicities can be effectively managed with close observation of patients from initiation of dosing, along with prompt appropriate interventions, including dose modifications, if necessary. ©AlphaMed Press.

Entities:  

Keywords:  Adverse events; Dose optimization; Hand-foot skin reaction; Multikinase inhibitor; Regorafenib; Supportive management

Mesh:

Substances:

Year:  2014        PMID: 24821824      PMCID: PMC4041675          DOI: 10.1634/theoncologist.2013-0059

Source DB:  PubMed          Journal:  Oncologist        ISSN: 1083-7159


  27 in total

1.  Skin toxicity and efficacy of sunitinib and sorafenib in metastatic renal cell carcinoma: a national registry-based study.

Authors:  A Poprach; T Pavlik; B Melichar; I Puzanov; L Dusek; Z Bortlicek; R Vyzula; J Abrahamova; T Buchler
Journal:  Ann Oncol       Date:  2012-06-13       Impact factor: 32.976

2.  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.

Authors:  Suzanne George; Qian Wang; Michael C Heinrich; Christopher L Corless; Meijun Zhu; James E Butrynski; Jeffrey A Morgan; Andrew J Wagner; Edwin Choy; William D Tap; Jeffrey T Yap; Annick D Van den Abbeele; Judith B Manola; Sarah M Solomon; Jonathan A Fletcher; Margaret von Mehren; George D Demetri
Journal:  J Clin Oncol       Date:  2012-05-21       Impact factor: 44.544

3.  Hypothyroidism after sunitinib treatment for patients with gastrointestinal stromal tumors.

Authors:  Jayesh Desai; Leila Yassa; Ellen Marqusee; Suzanne George; Mary C Frates; Ming Hui Chen; Jeffrey A Morgan; Samuel S Dychter; P Reed Larsen; George D Demetri; Erik K Alexander
Journal:  Ann Intern Med       Date:  2006-11-07       Impact factor: 25.391

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

Authors:  Viswanath Reddy Belum; Shenhong Wu; Mario E Lacouture
Journal:  Invest New Drugs       Date:  2013-05-23       Impact factor: 3.850

5.  Intermittent target inhibition with dasatinib 100 mg once daily preserves efficacy and improves tolerability in imatinib-resistant and -intolerant chronic-phase chronic myeloid leukemia.

Authors:  Neil P Shah; Hagop M Kantarjian; Dong-Wook Kim; Delphine Réa; Pedro E Dorlhiac-Llacer; Jorge H Milone; Jorge Vela-Ojeda; Richard T Silver; H Jean Khoury; Aude Charbonnier; Nina Khoroshko; Ronald L Paquette; Michael Deininger; Robert H Collins; Irma Otero; Timothy Hughes; Eric Bleickardt; Lewis Strauss; Stephen Francis; Andreas Hochhaus
Journal:  J Clin Oncol       Date:  2008-06-09       Impact factor: 44.544

Review 6.  Evolving strategies for the management of hand-foot skin reaction associated with the multitargeted kinase inhibitors sorafenib and sunitinib.

Authors:  Mario E Lacouture; Shenhong Wu; Caroline Robert; Michael B Atkins; Heidi H Kong; Joan Guitart; Claus Garbe; Axel Hauschild; Igor Puzanov; Doru T Alexandrescu; Roger T Anderson; Laura Wood; Janice P Dutcher
Journal:  Oncologist       Date:  2008-09-08

7.  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.

Authors:  George D Demetri; Peter Reichardt; Yoon-Koo Kang; Jean-Yves Blay; Piotr Rutkowski; Hans Gelderblom; Peter Hohenberger; Michael Leahy; Margaret von Mehren; Heikki Joensuu; Giuseppe Badalamenti; Martin Blackstein; Axel Le Cesne; Patrick Schöffski; Robert G Maki; Sebastian Bauer; Binh Bui Nguyen; Jianming Xu; Toshirou Nishida; John Chung; Christian Kappeler; Iris Kuss; Dirk Laurent; Paolo G Casali
Journal:  Lancet       Date:  2012-11-22       Impact factor: 79.321

8.  Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial.

Authors:  Axel Grothey; Eric Van Cutsem; Alberto Sobrero; Salvatore Siena; Alfredo Falcone; Marc Ychou; Yves Humblet; Olivier Bouché; Laurent Mineur; Carlo Barone; Antoine Adenis; Josep Tabernero; Takayuki Yoshino; Heinz-Josef Lenz; Richard M Goldberg; Daniel J Sargent; Frank Cihon; Lisa Cupit; Andrea Wagner; Dirk Laurent
Journal:  Lancet       Date:  2012-11-22       Impact factor: 79.321

9.  Regorafenib for patients with previously untreated metastatic or unresectable renal-cell carcinoma: a single-group phase 2 trial.

Authors:  Tim Eisen; Heikki Joensuu; Paul D Nathan; Peter G Harper; Marek Z Wojtukiewicz; Steve Nicholson; Amit Bahl; Piotr Tomczak; Seppo Pyrhonen; Kate Fife; Petri Bono; Jane Boxall; Andrea Wagner; Michael Jeffers; Tiffany Lin; David I Quinn
Journal:  Lancet Oncol       Date:  2012-09-06       Impact factor: 41.316

10.  The effect of hand-foot skin reaction associated with the multikinase inhibitors sorafenib and sunitinib on health-related quality of life.

Authors:  Beatrice Nardone; Jennifer R Hensley; Laura Kulik; Dennis P West; Mary Mulcahy; Alfred Rademaker; Mario E Lacouture
Journal:  J Drugs Dermatol       Date:  2012-11       Impact factor: 2.114

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  23 in total

1.  Comment on: "Regorafenib: Start Low and Go Slow".

Authors:  Christelle de la Fouchardière
Journal:  Target Oncol       Date:  2016-02       Impact factor: 4.493

2.  Regorafenib: start low and go slow.

Authors:  S Tabchi; M Ghosn
Journal:  Target Oncol       Date:  2014-12-30       Impact factor: 4.493

3.  Optimizing Regorafenib Dosing and Patient Management in Colorectal Cancer in Latin America: Perspectives from Argentina.

Authors:  Mariano Dioca; Juan Manuel O'Connor
Journal:  Oncologist       Date:  2021-03-06

4.  Regorafenib: lights and shadows of antiangiogenic therapies in gastric cancer.

Authors:  Caterina Vivaldi; Alfredo Falcone; Lorenzo Fornaro
Journal:  Transl Gastroenterol Hepatol       Date:  2017-02-23

Review 5.  Regorafenib: A Review of Its Use in Patients with Advanced Gastrointestinal Stromal Tumours.

Authors:  Matt Shirley; Gillian M Keating
Journal:  Drugs       Date:  2015-06       Impact factor: 9.546

Review 6.  Regorafenib in gastrointestinal stromal tumors: clinical evidence and place in therapy.

Authors:  Danielle Ferraro; John Zalcberg
Journal:  Ther Adv Med Oncol       Date:  2014-09       Impact factor: 8.168

Review 7.  Management of regorafenib-related toxicities: a review.

Authors:  Saravanan K Krishnamoorthy; Valerie Relias; Sunit Sebastian; Vijay Jayaraman; Muhammad Wasif Saif
Journal:  Therap Adv Gastroenterol       Date:  2015-09       Impact factor: 4.409

8.  Cost-Effectiveness Analysis of Regorafenib for Metastatic Colorectal Cancer.

Authors:  Daniel A Goldstein; Bilal B Ahmad; Qiushi Chen; Turgay Ayer; David H Howard; Joseph Lipscomb; Bassel F El-Rayes; Christopher R Flowers
Journal:  J Clin Oncol       Date:  2015-08-24       Impact factor: 44.544

9.  Regorafenib dose-optimisation in patients with refractory metastatic colorectal cancer (ReDOS): a randomised, multicentre, open-label, phase 2 study.

Authors:  Tanios S Bekaii-Saab; Fang-Shu Ou; Daniel H Ahn; Patrick M Boland; Kristen K Ciombor; Erica N Heying; Travis J Dockter; Nisha L Jacobs; Boris C Pasche; James M Cleary; Jeffrey P Meyers; Rodwige J Desnoyers; Jeannine S McCune; Katrina Pedersen; Afsaneh Barzi; E Gabriela Chiorean; Jeffrey Sloan; Mario E Lacouture; Heinz-Josef Lenz; Axel Grothey
Journal:  Lancet Oncol       Date:  2019-06-28       Impact factor: 54.433

Review 10.  An updated review of the treatment landscape for advanced gastrointestinal stromal tumors.

Authors:  Shreyaskumar R Patel; Peter Reichardt
Journal:  Cancer       Date:  2021-05-11       Impact factor: 6.860

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