Randomized phase II/III trial of neoadjuvant chemotherapy with gemcitabine and S-1 versus upfront surgery for resectable pancreatic cancer (Prep-02/JS']JSAP05)

被引：343

作者：

Motoi, Fuyuhiko ^{[1
]}

Kosuge, Tomoo ^{[2
]}

Ueno, Hideki ^{[3
]}

Yamaue, Hiroki ^{[4
]}

Satoi, Sohei ^{[5
]}

Sho, Masayuki ^{[6
]}

Honda, Goro ^{[7
]}

Matsumoto, Ippei ^{[8
]}

Wada, Keita ^{[9
]}

Furuse, Junji ^{[10
]}

Matsuyama, Yutaka ^{[11
]}

Unno, Michiaki ^{[1
]}

机构：

[1] Tohoku Univ, Sch Med, Dept Surg, Sendai, Miyagi 9808574, Japan

[2] Natl Canc Ctr, Hepatobiliary & Pancreat Surg Div, Tokyo, Japan

[3] Natl Canc Ctr, Hepatobiliary & Pancreat Oncol Div, Tokyo, Japan

[4] Wakayama Med Univ, Dept Surg 2, Wakayama, Japan

[5] Kansai Med Univ, Dept Surg, Osaka, Japan

[6] Nara Med Univ, Dept Surg, Nara, Japan

[7] Tokyo Metropolitan Canc & Infect Dis Ctr, Komagome Hosp, Dept Surg, Tokyo, Japan

[8] Kindai Univ, Dept Surg, Fac Med, Osaka, Japan

[9] Teikyo Univ, Sch Med, Dept Surg, Tokyo, Japan

[10] Kyorin Univ, Fac Med, Dept Med Oncol, Tokyo, Japan

[11] Univ Tokyo, Sch Publ Hlth, Dept Biostat, Tokyo, Japan

来源：

JAPANESE JOURNAL OF CLINICAL ONCOLOGY | 2019年 / 49卷 / 02期

关键词：

pancreatic cancer; neoadjuvant chemotherapy; gemcitabine; S-1; phase III; ADJUVANT CHEMOTHERAPY; III TRIAL; OUTCOMES; THERAPY;

D O I：

10.1093/jjco/hyy190

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

A randomized, controlled trial has begun to compare neoadjuvant chemotherapy using gemcitabine and S-1 with upfront surgery for patients planned resection of pancreatic cancer. Patients were enrolled after the diagnosis of resectable or borderline resectable by portal vein involvement pancreatic cancer with histological confirmation. They were randomly assigned to either neoadjuvant chemotherapy or upfront surgery. Adjuvant chemotherapy using S-1 was administered for 6 months to patients with curative resection who fully recovered within 10 weeks after surgery in both arms. The primary endpoint is overall survival; secondary endpoints include adverse events, resection rate, recurrence-free survival, residual tumor status, nodal metastases and tumor marker kinetics. The target sample size was required to be at least 163 (alpha-error 0.05; power 0.8) in both arms. A total of 360 patients were required after considering ineligible cases. This trial began in January 2013 and was registered with the UMIN Clinical Trials Registry (UMIN000009634).

引用

页码：190 / 194

页数：5

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