TY - JOUR T1 - Reduced Dose of Salvage-line Regorafenib Monotherapy for Metastatic Colorectal Cancer in Japan JF - Anticancer Research JO - Anticancer Res SP - 371 LP - 377 VL - 35 IS - 1 AU - GEN HIRANO AU - AKITAKA MAKIYAMA AU - CHINATSU MAKIYAMA AU - TAITO ESAKI AU - HISANOBU ODA AU - KEITA UCHINO AU - MASATO KOMODA AU - RISA TANAKA AU - YUZO MATSUSHITA AU - KENJI MITSUGI AU - YOSHIHIRO SHIBATA AU - HOZUMI KUMAGAI AU - SHUJI ARITA AU - HIROSHI ARIYAMA AU - HITOSHI KUSABA AU - KOICHI AKASHI AU - EISHI BABA Y1 - 2015/01/01 UR - http://ar.iiarjournals.org/content/35/1/371.abstract N2 - Background: Salvage-line regorafenib monotherapy exhibited a marked survival benefit for metastatic colorectal cancer (mCRC). However, the toxicity of this regimen has resulted in the clinical use of a reduced dose of regorafenib. Patients and Methods: Thirty-two Japanese mCRC patients (median age=61 years) who had been treated with regorafenib were retrospectively examined. Results: Best objective response rate was 0% and stable disease (SD) was 31%. Median progression-free survival was 81 days and median overall survival was 233 days. Adverse events of any grade were observed in all patients: 17 (53%) patients suffered grade 3 or 4 adverse events including fatigue (13%), anorexia (13%), hand-foot skin reaction (22%) and elevations of alanine aminotransferase/aspartate aminotransferase (19%/16%). One patient with grade 5 liver dysfunction was identified (3%). Twenty-nine (91%) patients required treatment dose reduction or a delay in treatment. The relative dose intensity was 59%. Regorafenib treatments were terminated because of disease progression (59%) or adverse events (34%). Conclusion: Despite a decrease in the intensity of regorafenib treatment, because of severe adverse events, a fairly favorable efficacy was achieved in Japanese patients. ER -