Docetaxel plus S-1 versus cisplatin plus S-1 in unresectable gastric cancer without measurable lesions: a randomized phase II trial (HERBIS-3)

被引：5

作者：

Kurokawa, Yukinori ^{[1
]}

Matsuyama, Jin ^{[2
]}

Nishikawa, Kazuhiro ^{[3
]}

Takeno, Atsushi ^{[4
]}

Kimura, Yutaka ^{[5
]}

Fujitani, Kazumasa ^{[6
]}

Kawabata, Ryohei ^{[7
]}

Makari, Yoichi ^{[8
]}

Terazawa, Tetsuji ^{[9
]}

Kawakami, Hisato ^{[10
]}

Sakai, Daisuke ^{[11
]}

Shimokawa, Toshio ^{[12
]}

Satoh, Taroh ^{[11
]}

机构：

[1] Osaka Univ, Dept Gastroenterol Surg, Grad Sch Med, 2-2-E2 Yamadaoka, Suita, Osaka 5650871, Japan

[2] Yao Municipal Hosp, Dept Surg, Osaka, Japan

[3] Natl Hosp Org Osaka Natl Hosp, Dept Surg, Osaka, Japan

[4] Kansai Rosai Hosp, Dept Surg, Amagasaki, Hyogo, Japan

[5] Sakai City Med Ctr, Dept Surg, Osaka, Japan

[6] Osaka Gen Med Ctr, Dept Surg, Osaka, Japan

[7] Osaka Rosai Hosp, Dept Surg, Osaka, Japan

[8] Minoh City Hosp, Dept Surg, Osaka, Japan

[9] Osaka Med Coll, Canc Chemotherapy Ctr, Osaka, Japan

[10] Kindai Univ, Fac Med, Dept Med Oncol, Osaka, Japan

[11] Osaka Univ, Dept Frontier Sci Canc & Chemotherapy, Grad Sch Med, Osaka, Japan

[12] Wakayama Med Univ, Clin Study Support Ctr, Wakayama, Japan

来源：

GASTRIC CANCER | 2021年 / 24卷 / 02期

关键词：

S-1; Cisplatin; Docetaxel; R1; gastrectomy; HERBIS-3; TRASTUZUMAB;

D O I：

10.1007/s10120-020-01112-1

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background Cisplatin plus S-1 (CS) is the standard first-line chemotherapy for advanced gastric cancer (AGC) in Japan. A previous phase III trial showed that docetaxel plus S-1 (DS) was effective for AGC without measurable lesions, but no studies have compared these two regimens. Methods Eligible patients had unresectable or recurrent HER2-negative AGC without measurable lesions. Patients were randomized to DS (docetaxel 40 mg/m(2)on day 1, S-1 80-120 mg on days 1-14, every 3 weeks) or CS (cisplatin 60 mg/m(2)on day 8, S-1 80-120 mg on days 1-21, every 5 weeks). The primary endpoint was overall survival (OS). Results All patients had unresectable primary disease. Sixty-one patients were randomly assigned to DS (n = 30) or CS (n = 31). One CS patient was ineligible due to HER2 positivity. The median number of cycles was 9.5 (range 2-49) with DS and 5.5 (range 1-10) with CS. There were no treatment-related deaths. The most common grade 3-4 non-hematological toxicity was fatigue (7% with DS, 13% with CS), followed by anorexia (3% with DS, 10% with CS) and diarrhea (3% with DS, 10% with CS). The 2-year OS rates were 43.3% with DS and 30.0% with CS (log-rankP = 0.113), with a hazard ratio of 0.617 (95% confidence interval 0.337-1.128), indicating non-inferiority of DS to CS with respect to OS (P < 0.001). Conclusions DS showed slightly but nonsignificantly less toxicity and higher efficacy than CS for AGC without measurable lesions. DS should be further investigated in phase III trials.

引用

页码：428 / 434

页数：7