演題抄録

International Session

開催概要
開催回
第55回・2017年・横浜
 

RAS変異大腸癌に対するmodified-FOLFOXIRI+bevacizumab療法の第II相試験:JACCRO CC-11

演題番号 : IS7-2

[筆頭演者]
宮本 裕士:1 
[共同演者]
砂川 優:2、関川 高志:3、佐竹 悠良:4、中村 将人:5、片岡 政人:6、塩澤 学:7、牧山 明資:8、小林 和真:9、久保田 祐太郎:10、森 美鈴:11、小髙 雅人:12、竹内 正弘:13、藤井 雅志:14、市川 度:15

1:熊本大学・大学院・消化器外科学、2:聖マリアンナ医科大学・臨床腫瘍学、3:昭和大学・藤が丘病院・腫瘍内科・緩和医療科、4:神戸市立医療センター中央市民病院・腫瘍内科、5:社会医療法人財団慈泉会相澤病院がん集学治療センター・化学療法科、6:名古屋医療センター・外科、7:神奈川県立がんセンター・消化器外科、8:JCHO九州病院・血液・腫瘍内科、9:長崎大学病院・移植・消化器外科、10:昭和大学・病院・腫瘍内科、11:自治医科大学・臨床腫瘍科、12:佐野病院・消化器がんセンター、13:北里大学・薬学部・臨床医学(臨床統計学)、14:日本大学・医学部・消化器外科、15:昭和大学・藤が丘病院・腫瘍内科・緩和医療科

 

Background: FOLFOXIRI plus bevacizumab (bev) is considered to be a standard initial therapy for metastatic colorectal cancer (mCRC); it should be one of preferred regimens in RAS mutant (mt) tumors. However, frequent severe adverse events (AEs) were reported in Japanese patients (pts). JACCRO performed a multicenter phase II trial to evaluate modified (m)-FOLFOXIRI plus bev in RAS mt mCRC pts.
Methods: Pts with PS 0/1, 20-75y and unresectable/measurable tumors harboring RAS mt, were given the combination of bev (5 mg/kg on day 1) and m-FOLFOXIRI (irinotecan 150 mg/m², oxaliplatin 85 mg/m², and levofolinate [LV] 200 mg/m² on day 1, and fluorouracil 2400 mg/m² for 46-h continuous infusion starting on day 1 and repeated every 2 weeks) as 1st-line treatment. After induction therapy of a maximum of 12 cycles, maintenance therapy with fluorouracil/LV plus bev was administered. The primary endpoint was objective response rate (ORR). Progression-free survival (PFS), overall survival, early tumor shrinkage (ETS), depth of response (DpR), and safety were secondary endpoints.
Results: Among 64 pts who were enrolled between 2014 and 2016, 62 pts were evaluable for efficacy based on the RECIST criteria: median 62.5-y old, 55% male, 92% PS0, 27% right-sided tumor pts, and 12 median cycles for m-FOLFOXIRI. Sixteen pts still continued the protocol treatment at cut-off date of July 2017. AEs of Gr 3/4 were neutropenia (52%), leukopenia (29%), anorexia (9.5%), diarrhea (13%), hypertension (27%), and febrile neutropenia (4.8%). No treatment-related deaths occurred. ORR and disease control rate were 75.8% and 96.8%, respectively. ETS was 73.8%, and median DpR was 48.7%. Median PFS was not reached.
Conclusions: This study shows m-FOLFOXIRI plus bev might potentially become an alternative regimen of triplet chemotherapy for mCRC in Japan. The safety analysis demonstrates that the m-regimen is more tolerable than regimen with standard dosage for Japanese mCRC pts (UMIN000015152).

キーワード

臓器別:大腸・小腸

手法別:化学療法

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