演題抄録

一般口演

開催概要
開催回
第56回・2018年・横浜
 

HER2陽性進行・再発胃癌に対するHER-SOX130療法の第II相試験: KSCC1501B最新予後解析

演題番号 : O28-6

[筆頭演者]
演者)楠本 哲也:1 
[共同演者]
柏田 知美:2、篠崎 勝則:3、結城 敏志:4、岩槻 政晃:5、佐竹 悠良:6、徳永 章二:7、江見 泰徳:8、牧山 明資:9、佐伯 浩司:10、沖 英次:10、馬場 秀夫:5、前原 喜彦:10

1:九州医療センター・消化管外科、2:佐賀大学・血液・呼吸器・腫瘍内科、3:県立広島病院・臨床腫瘍科、4:北海道大学・消化器内科、5:熊本大学・消化器外科、6:神戸市立医療センター中央市民病院・腫瘍内科、7:九州大学病院・メディカルインフォメーションセンター、8:福岡総合病院・外科、9:九州病院・血液・腫瘍内科、10:九州大学・消化器・総合外科

 

Background: Trastuzumab (T-mab) combination therapies with cisplatin and fluoropyrimidines is the standard therapy for the patients with HER2-positive advanced gastric cancer (AGC). We conducted first phase II trial to assess the efficacy and safety of T-mab in combination with S-1 and oxaliplatin (HER-SOX130) for HER2-positive AGC or recurrent gastric cancer.
Methods: Patients with IHC 3+ or IHC 2+/FISH positive received 80 mg/m2 (80-120 mg/body) S-1 per day orally on days 1-14, 130 mg/m2 oxaliplatin intravenously on day 1, and T-mab (8-mg/kg loading dose and 6 mg/kg thereafter) intravenously on day 1 of a 21-day cycle until one of the criteria for withdrawal of the study treatment occurred. The primary end-point was the response rate (RR). Adverse events were recorded based on the NCI-CTCAE Vers.4.0.
Results: 42 patients were enrolled from June 2015 to May 2016. Efficacy and safety analyses were conducted in the full analysis set of 39 patients. The data cut off specific to the survival status was February 19, 2018. The proportion of patients with IHC 3+ was 87%. The confirmed RR assessed by the independent review committee was 82.1(32/39) % (95% CI: 67.3-91.0), and the disease control rate was 87.2 (34/39) % (95% CI: 73.3-94.4). 10 cases were converted to surgery. Median progression-free survival and overall survival was 7.0 and 27.7 months respectively. The most frequent incidence rates of grade 3 or 4 adverse events were thrombocytopenia (17.9%) and anorexia (17.9%).
Conclusions: S-1/oxaliplatin plus trastuzumab demonstrates promising response and survival with favorable safety profile. The therapy should be considered for the patients with HER2-positive AGC.

キーワード

臓器別:胃・十二指腸

手法別:Clinical Trial (臨床試験)

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