Regorafenib plus modified FOLFOX6 as first-line treatment of metastatic colorectal cancer: A phase II trial

Argilés, Guillem; Saunders, Mark; Rivera, Fernando; Sobrero, Alberto; Benson, Al B.; Ponce, Carmen Guillén; Cascinu, Stefano; Cutsem, Éric Van; Macpherson, Iain; Strumberg, Dirk; Köhne, Claus‐Henning; Zalcberg, John; Wagner, Andrea; Garosi, Vittorio Luigi; Grunert, Julia; Tabernero, Josep; Ciardiello, Fortunato

doi:10.1016/j.ejca.2015.02.013

Cited by 47 publications

(31 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…[81] The study did not meet its primary end point of an increased response rate (43.9%) compared to historical data from patients treated with FOLFOX alone (35-55%). The secondary end point, PFS (8.5 months), was comparable to results from other studies using FOLFOX and FOLFIRI alone (8.0 and 8.5 months, respectively).…”

Section: Regorafenib Combination Treatmentmentioning

confidence: 91%

Oral drugs in the treatment of metastatic colorectal cancer

Kwakman

Punt

2016

Expert Opinion on Pharmacotherapy

View full text Add to dashboard Cite

Introduction: Intravenous administration of fluoropyrimidine-based chemotherapy has been the cornerstone of treatment in metastatic colorectal cancer (mCRC) for decades. The availability of oral capecitabine has improved the tolerability in monotherapy schedules, and has simplified combination schedules. Since then, other oral drugs have proven efficacy in this setting. Areas covered: We review the available evidence and most recent data concerning oral drugs with proven efficacy in mCRC, including capecitabine, S-1, trifluridine-tipiracil (TAS-102) and regorafenib. Expert opinion: The use of capecitabine is widely implemented in the care of mCRC. However, with recent data supporting its prolonged use, the relatively high incidence of hand-foot syndrome (HFS) may impair quality of life. In Asian populations, S-1 is associated with equivalent efficacy but lower incidence of HFS compared to capecitabine. Further studies evaluating the effects of S-1 in Western populations are needed. Both regorafenib and TAS-102 improve the overall survival of patients in whom all other treatment options have failed. Since only a subset of patients appears to benefit, future studies to identify predictive biomarkers are needed. ARTICLE HISTORY

show abstract

Section: Regorafenib Combination Treatmentmentioning

confidence: 91%

Oral drugs in the treatment of metastatic colorectal cancer

Kwakman

Punt

2016

Expert Opinion on Pharmacotherapy

View full text Add to dashboard Cite

show abstract

“…Phase 2 clinical trials in mCRC investigating regorafenib combined with chemotherapy have produced mixed results. In the second-line setting, the addition of regorafenib to folinic acid-fluorouracil-irinotecan (FOLFIRI) resulted in a modest PFS improvement versus FOLFIRI alone, while regorafenib in combination with folinic acid-fluorouracil-oxaliplatin (mFOLFOX6) in first line did not improve objective response rate over historical controls, although some patients remained on treatment for an extended period of time (> 1 year) [33,34].…”

Section: Mcrcmentioning

confidence: 99%

Evolving role of regorafenib for the treatment of advanced cancers

Grothey

Blay

Pavlakis

et al. 2020

Cancer Treatment Reviews

View full text Add to dashboard Cite

Regorafenib is an oral tyrosine kinase inhibitor (TKI) approved for the treatment of refractory metastatic colorectal cancer (mCRC), advanced gastrointestinal stromal tumors (GIST) previously treated with imatinib and sunitinib, and unresectable hepatocellular carcinoma (HCC) following progression on sorafenib. Regorafenib was initially approved for mCRC based on improved overall survival (OS) in the randomized, placebo-controlled, phase 3 CORRECT trial, which was confirmed in an expanded population of Asian patients in the randomized, placebo-controlled phase 3 CONCUR trial. Approvals in GIST, and more recently in HCC, were based on the results from the randomized, placebocontrolled, phase 3 GRID and RESORCE trials, respectively. In this review, we provide a comprehensive summary of the clinical evidence for approval of regorafenib in mCRC, GIST, and HCC, present emerging evidence of regorafenib activity in other tumor types (namely, gastroesophageal cancer, sarcomas, biliary tract cancer, and glioblastoma), and discuss trials in progress within the context of regorafenib's mechanism of action. We describe recent advances and key lessons learned with regorafenib, including the importance of managing common drug-related toxicities using doseoptimization strategies, the search for biomarkers to predict response to treatment, and highlight some of the unaddressed questions and future directions for regorafenib across tumors.

show abstract

“…Combination therapy with regorafenib and FOLFIRI produced highly promising results, with overall disease control rate (DCR), median PFS, and median OS equal to 58.5%, 6.0 and 12.0 months, respectively [8]. An objective response rate to regorafenib combined with modified FOLFOX (mFOLFOX6) as the first-line treatment was no better than that observed in historical controls, with 85.4% DCR and median PFS of 8.5 months [18]. Negative results, specifically the lack of either OS or PFS benefit, were obtained in a study investigating the efficacy and toxicity of regorafenib plus ruxolitinib, a Janus kinase/signal transducer and activator of transcription (JAK-STAT) signaling pathway [19].…”

Section: Regorafenib Combined With Other Anticancer Agentsmentioning

confidence: 99%

Further Therapeutic Options in Heavily Pretreated Colorectal Cancer Patients

Zygulska¹

2019

Multidisciplinary Approach for Colorectal Cancer

View full text Add to dashboard Cite

In this paper, currently available systemic treatment options (regorafenib, trifluridine/tipiracil, re-challenge chemotherapy, mitomycin C plus capecitabine) for pretreated patients with metastatic colorectal cancer are discussed and compared in terms of their efficacy and safety profiles. Treatment of these patients has remained a challenge for oncologists. The evidence from clinical trials is encouraging. Knowledge of response biomarkers and/or prognostic factors may be helpful in the identification of patients who could benefit most from the treatment. Adequate medication compliance can be achieved due to awareness of toxicity risk among both physicians and cancer patients and appropriate prevention and management of adverse events.

show abstract

Regorafenib plus modified FOLFOX6 as first-line treatment of metastatic colorectal cancer: A phase II trial

Abstract: Regorafenib+mFOLFOX6 as first-line treatment in patients with metastatic CRC did not improve ORR over historical controls. Regorafenib plus mFOLFOX6 did not appear to be associated with a markedly worse tolerability profile versus mFOLFOX6 alone.

Cited by 47 publications

References 17 publications

Oral drugs in the treatment of metastatic colorectal cancer

Oral drugs in the treatment of metastatic colorectal cancer

Evolving role of regorafenib for the treatment of advanced cancers

Further Therapeutic Options in Heavily Pretreated Colorectal Cancer Patients

Contact Info

Product

Resources

About