Regorafenib after failure of gemcitabine and platinum-based chemotherapy for locally advanced/metastatic biliary tumors: REACHIN, a randomized, double-blind, phase II trial
Anne DemolsIvan BorbathMarc Van den EyndeGhislain HoubiersMarc PeetersRaphaël MaréchalT. DelaunoitJ.-C. GoemineStéphanie LaurentStéphane HolbrechtsMarianne PaesmansJean‐Luc Van Laethem
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The oral multikinase inhibitor regorafenib targets multiple pathways involved in tumor development and progression. In the CORRECT study [Grothey A et al. Lancet. 2013], treatment with regorafenib improved overall survival (OS) in patients with metastatic colorectal cancer (mCRC) disease progression after standard therapies (HR, 0.77; 95% CI, 0.64 to 0.94; 1-sided p?=?.0052). This article presents the results from the Asian Subjects With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy study [CONCUR; NCT01584830], a trial examining the efficacy and safety of regorafenib in a larger group of Asian patients with mCRC.
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There is limited evidence-based guidance regarding treatment sequencing and outcomes following regorafenib in patients with refractory metastatic colorectal cancer (mCRC). A targeted literature review was conducted to identify studies with clinical outcomes associated with regorafenib therapy and subsequent treatment following regorafenib therapy. The median overall survival range of the nine studies with sequenced-based survival data was 2.1–19.3 months for regorafenib prior to subsequent therapy in refractory mCRC. Safety outcomes in patients treated with regorafenib prior to other therapies in mCRC were generally comparable to reported adverse events in clinical trials for subsequent agents. Data from this review demonstrate a potential correlation between survival and the use of regorafenib prior to subsequent chemotherapy or targeted therapy in patients with refractory mCRC.
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New agents with high anti-tumor effects have been developed since 1990. Monotherapy with one of these agents, gemcitabine, was confirmed to be as effective as the standard chemotherapy regimen against NSCLC, and to have a lower toxicity profile. In addition, the combination of gemcitabine plus cisplatin can be expected to show a survival advantage. The combination therapy consisting of these two new anti-cancer agents is expected to show effectiveness equal to that of platinum-based combination chemotherapy. Gemcitabine is well tolerated, so that it can be a useful treatment for maintaining QOL among the elderly or in poor performance status patients with NSCLC. Considering that this agent is also effective against pancreatic cancer, further investigation for efficacy against other cancers is warranted.
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Regorafenib, an oral multikinase inhibitor, was approved in September 2012 by the US Food and Drug Administration for the treatment of patients with metastatic colorectal cancer. Since this time, however, few case reports outlining real-world usage have been published in the literature. Here, we detail the clinical history of an elderly woman with KRAS wild-type colon cancer who received regorafenib after prior treatment with other agents. We show that by employing dose modification strategies to address adverse events, this patient was able to remain on therapy for 11 months and achieve stable disease.
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