Study protocol of HGCSG1404 SNOW study: a phase I/II trial of combined chemotherapy of S-1, nab-paclitaxel and oxaliplatin administered biweekly to patients with advanced gastric cancer

被引：4

作者：

Kawamoto, Yasuyuki ^{[1
,2
]}

Komatsu, Yoshito ^{[1
]}

Yuki, Satoshi ^{[2
]}

Sawada, Kentaro ^{[2
]}

Muranaka, Tetsuhito ^{[1
,2
]}

Harada, Kazuaki ^{[1
,2
]}

Nakatsumi, Hiroshi ^{[1
,2
]}

Fukushima, Hiraku ^{[3
]}

Ishiguro, Atsushi ^{[4
]}

Dazai, Masayoshi ^{[5
]}

Hatanaka, Kazuteru ^{[6
]}

Nakamura, Michio ^{[7
]}

Iwanaga, Ichiro ^{[8
]}

Uebayashi, Minoru ^{[8
]}

Sogabe, Susumu ^{[9
]}

Kobayashi, Yoshimitsu ^{[9
]}

Miyagishima, Takuto ^{[9
]}

Ono, Kota ^{[10
]}

Sakamoto, Naoya ^{[2
]}

Sakata, Yuh ^{[11
]}

机构：

[1] Hokkaido Univ Hosp, Dept Canc Ctr, Sapporo, Hokkaido, Japan

[2] Hokkaido Univ, Grad Sch Med, Dept Gastroenterol & Hepatol, Sapporo, Hokkaido, Japan

[3] Sapporo Hokushin Hosp, JCHO, Dept Gastroenterol, Sapporo, Hokkaido, Japan

[4] Teine Keijinkai Hosp, Dept Med Oncol, Sapporo, Hokkaido, Japan

[5] Sapporo Med Ctr NTT EC, Dept Gastroenterol, Sapporo, Hokkaido, Japan

[6] Hakodate Municipal Hosp, Dept Gastroenterol, Hakodate, Hokkaido, Japan

[7] Sapporo City Gen Hosp, Dept Gastroenterol, Sapporo, Hokkaido, Japan

[8] Japanese Red Cross Kitami Hosp, Dept Gastroenterol, Kitami, Hokkaido, Japan

[9] Kushiro Rosai Hosp, Dept Internal Med, Kushiro, Japan

[10] Hokkaido Univ Hosp, Clin Res & Med Innovat Ctr, Sapporo, Hokkaido, Japan

[11] Misawa City Hosp, CEO, Misawa, Japan

来源：

BMC CANCER | 2017年 / 17卷

关键词：

Gastric cancer; Chemotherapy; S-1; Nab-paclitaxel; Oxaliplatin; CISPLATIN; FLUOROURACIL; DOCETAXEL; ADENOCARCINOMA; CAPECITABINE;

D O I：

10.1186/s12885-017-3850-z

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: In Japan, S-1 plus cisplatin (SP) regimen has become a standard therapy for patients with advanced gastric cancer. Moreover, the S-1 plus oxaliplatin regimen is now a standard treatment. Nab-paclitaxel was developed for chemotherapy of gastric cancer in Japanese clinical practice. Nab-paclitaxel, created with albumin-bound paclitaxel particles, has high transferability to tumour tissues and does not cause hypersensitivity reactions because of a different chemical composition compared with docetaxel and paclitaxel. A combination of S-1, nab-paclitaxel and oxaliplatin (which we named ` SNOW regimen') can be a promising triplet therapy for advanced gastric cancer. Although we have to pay attention to chemotherapy-induced neuropathy, we aim to investigate the recommended dose of this regimen in a phase I study. Furthermore, we will investigate its efficacy and toxicity in a phase II study. Methods: The phase I study is a dose-escalation study using a standard 3 plus 3 design, followed by expansion cohorts. The SNOW regimen involves 28-day cycles with escalated doses of nab-paclitaxel (100-175 mg/m2 on days 1 and 15) and fixed doses of oxaliplatin (65 mg/m(2) on days 1 and 15) and S-1 (80 mg/m(2)/day on day 1 to 14). The primary endpoints are assessment of dose limiting toxicities and determination of maximum tolerated dose to investigate the recommended dose in the subsequent phase II study. In the phase II study, the primary endpoint is objective response rate. Secondary endpoints are assessment of safety, progression-free survival, disease control rate, overall survival and time to treatment failure. Adverse events were monitored and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Discussion: Triplet therapies for advanced gastric cancer patients have been evaluated in clinical trials. The SNOW regimen can be a promising new triplet therapy.

引用

页数：6

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