In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 4_suppl ( 2017-02-01), p. 721-721
Abstract:
721 Background: The oral multikinase inhibitor regorafenib (REG) was approved for unresectable mCRC in Japan in 2013 based on the results of the global CORRECT phase 3 trial, which included 100 Japanese patients (pts). A PMS (NCT01843400) was conducted to assess the safety and efficacy of REG for the treatment of Japanese mCRC in clinical practice. Methods: Pre-registration was applied in the PMS. Adverse events (AEs), laboratory tests, drug exposure and anti-tumor effects were prospectively monitored for 6 months after initiating REG. One-year survival data was also collected. Target enrollment was 1,250 pts. Results: 1,303 pts were enrolled from March 2013 to May 2015. At the interim analysis as of August 2015, 787 pts were evaluable for safety and efficacy: male 57%; age ≥ 65 yrs 52%; ECOG Performance Status (PS) 0/1/2 40%/51%/10%; KRAS status wild-type/mutant 50%/47%; treatment line of REG 3 rd /4 th / ≥ 5 th line 40%/36%/24%; starting dose of REG 160 mg/120mg 66%/22%. Drug related adverse events (AE) were reported in 702 pts (89%). Most common AEs were hand foot skin reaction [(HFSR) 56%], liver dysfunction (32%, including 17% hepatic laboratory abnormalities), hypertension (27%), platelet count decreased (17%) and fatigue (14%). Rates of any grade of the major AEs typically peaked the first 2 months after starting REG and were relatively stable afterwards. Median time to treatment failure (TTF) was 2.1 months [range 1.9– 2.2] ; median overall survival (OS) was 7.0 months [range 6.3– 7.8]. In exploratory analyses, rates of any grade and ≥ grade 3 HFSR and liver dysfunction were higher at the starting dose of 160mg (the dose of the first day of the first cycle) than in that of 120mg or less. Pts who had HFSR had a significantly longer OS than pts who did not (hazard ratio 0.573; 95% confidential interval0.470–0.698; p 〈 0.0001). TTF of pts with PS 0 tended to be longer than that of pts with PS ≥ 1. Conclusions: The safety and efficacy profiles of REG in Japanese pts in clinical practice are consistent with those of Japanese pts in the CORRECT trial. The results from 〉 1200 pts enrolled in the PMS will be presented at the meeting. Clinical trial information: NCT01843400.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2017.35.4_suppl.721
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2017
detail.hit.zdb_id:
2005181-5
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