演題抄録

International Session

開催概要
開催回
第55回・2017年・横浜
 

切除不能大腸癌に対するFOLFOXIRI+bevacizumab療法の第II相試験(QUATTRO study)

演題番号 : IS7-1

[筆頭演者]
山﨑 健太郎:1 
[共同演者]
吉野 孝之:2、室 圭:3、加藤 健志:4、沖 英次:5、辻 晃仁:6、江見 泰徳:7、向坂 英樹:8、坂東 英明:2、谷口 浩也:3、賀川 義規:9、山中 竹春:10、金澤 旭宣:11

1:静岡県立静岡がんセンター・消化器内科、2:国立研究開発法人国立がん研究センター東病院・消化管内科、3:愛知県がんセンター中央病院・薬物療法部、4:独立行政法人国立病院機構大阪医療センター・外科、5:九州大学・病院・消化器・総合外科、6:香川大学・医学部・臨床腫瘍学、7:社会福祉法人恩賜財団済生会支部福岡県済生会福岡総合病院・外科、8:市立川西病院・外科、9:独立行政法人労働者健康安全機構関西労災病院・下部消化器外科、10:横浜市立大学・大学院医学研究科・臨床統計学、11:島根県立中央病院・外科

 

【Background】The TRIBE study showed that FOLFOXIRI plus bevacizumab (Bmab) significantly improved efficacy outcomes as first-line treatment in patients (pts) with metastatic colorectal cancer. This phase II study was conducted to evaluate the efficacy and safety of FOLFOXIRI + Bmab in Japanese pts.
【Methods】The main eligibility criteria were age 20-75 years, PS 0-1, and wild-type or single heterozygous UGT1A1 genotype. Pts were treated with 12 cycles of FOLFOXIRI plus Bmab (oxaliplatin, 85 mg/m2; irinotecan, 165 mg/m2; 5-FU, 3,200 mg/m2; and Bmab, 5 mg/kg) as induction therapy followed by maintenance therapy with 5-FU plus Bmab until disease progression or unacceptable toxicities. The primary endpoint was progression-free survival (PFS) rate at 10 months with the planned sample size of 65 patients (threshold 50%, expected value 70%).
【Results】Totally, 69 pts were enrolled. The median age was 60 (range, 28-74) years, 63 pts were PS 0, and 39 pts with the UGT1A1 single heterozygous genotype. At a median follow-up time of 19.6 months, the PFS rate at 10 months and the median PFS were 75.2% (95% CI, 63.8-86.6; P<0.0001) and 13.3 months, respectively. The response and disease control rates by central review were 73.9% and 95.7%, respectively. The resulting in R0 resection rate was 24.6%. The major grade ≥3 adverse events were neutropenia (73.9%), hypertension (34.8%), febrile neutropenia (FN; 21.7%), diarrhea (10.1%), anorexia (10.1%). The incidence of grade 4 neutropenia (46.2%, 13.3%, respectively) and grade ≥3 FN (25.6% 10.0%) during the first 2 cycles was higher in UGT1A1 single heterozygous pts than wild-type pts.
【Conclusions】The efficacy of FOLFOXIRI plus Bmab in Japanese were consistent with the previous reports, with manageable but different incidence of neutropenia and FN between UGT1A1 genotypes. Prophylactic use of G-CSF in UGT1A1 single heterozygous pts were suggested considering the high incidence of grade 4 neutropenia and FN.

キーワード

臓器別:大腸・小腸

手法別:化学療法

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