Abstract
Background: Trastuzumab when combined with fluoropyrimidine and cisplatin was proven to improve survival in patients with human epidermal growth factor receptor 2 (HER2)-positive gastric cancer (GC) in the ToGA study. The safety and efficacy of trastuzumab in combination with docetaxel and S-1 have not yet been evaluated. Methods: This study was a multicenter, phase II study. Patients with chemotherapy-naïve HER2-positive advanced or metastatic GC were eligible. Trastuzumab was administered intravenously on day 1 of the first cycle at 8 and 6 mg/kg in subsequent cycles. Docetaxel was administered intravenously at 40 mg/m2 on day 1 of each cycle. S-1 was administered at a dosage based on body surface area for 14 days in a 3-weekly cycle. The primary endpoint was progression-free survival (PFS). Results: A total of 23 patients were enrolled. Median PFS was 6.7 months (95% CI 4.1–10.1). The response rate (RR) was 39.1%. Median overall survival (OS) and time to treatment failure (TTF) were 17.5 and 4.4 months, respectively. Major grade 3–4 adverse events were neutropenia (39.1%), leukopenia (30.4%), and febrile neutropenia (8.7%). Conclusion: Trastuzumab in combination with docetaxel and S-1 showed effective antitumor activity and manageable toxicities as first-line treatment for patients with HER2-positive GC.
| Original language | English |
|---|---|
| Pages (from-to) | 1-6 |
| Number of pages | 6 |
| Journal | Cancer Chemotherapy and Pharmacology |
| DOIs | |
| Publication status | Accepted/In press - Dec 30 2017 |
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Keywords
- Chemotherapy
- Docetaxel
- Gastric cancer
- HER2-positive
- S-1
- Trastuzumab
ASJC Scopus subject areas
- Oncology
- Toxicology
- Pharmacology
- Cancer Research
- Pharmacology (medical)
Cite this
A multi-institution phase II study of docetaxel and S-1 in combination with trastuzumab for HER2-positive advanced gastric cancer (DASH study). / Kagawa, Shunsuke; Muraoka, Atsushi; Kambara, Takeshi; Nakayama, Hiroshi; Hamano, Ryosuke; Tanaka, Norimitsu; Noma, Kazuhiro; Tanakaya, Kohji; Kishimoto, Hiroyuki; Shigeyasu, Kunitoshi; Kuroda, Shinji; Kikuchi, Satoru; Kuwada, Kazuya; Nishizaki, Masahiko; Shirakawa, Yasuhiro; Fujiwara, Toshiyoshi.
In: Cancer Chemotherapy and Pharmacology, 30.12.2017, p. 1-6.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A multi-institution phase II study of docetaxel and S-1 in combination with trastuzumab for HER2-positive advanced gastric cancer (DASH study)
AU - Kagawa, Shunsuke
AU - Muraoka, Atsushi
AU - Kambara, Takeshi
AU - Nakayama, Hiroshi
AU - Hamano, Ryosuke
AU - Tanaka, Norimitsu
AU - Noma, Kazuhiro
AU - Tanakaya, Kohji
AU - Kishimoto, Hiroyuki
AU - Shigeyasu, Kunitoshi
AU - Kuroda, Shinji
AU - Kikuchi, Satoru
AU - Kuwada, Kazuya
AU - Nishizaki, Masahiko
AU - Shirakawa, Yasuhiro
AU - Fujiwara, Toshiyoshi
PY - 2017/12/30
Y1 - 2017/12/30
N2 - Background: Trastuzumab when combined with fluoropyrimidine and cisplatin was proven to improve survival in patients with human epidermal growth factor receptor 2 (HER2)-positive gastric cancer (GC) in the ToGA study. The safety and efficacy of trastuzumab in combination with docetaxel and S-1 have not yet been evaluated. Methods: This study was a multicenter, phase II study. Patients with chemotherapy-naïve HER2-positive advanced or metastatic GC were eligible. Trastuzumab was administered intravenously on day 1 of the first cycle at 8 and 6 mg/kg in subsequent cycles. Docetaxel was administered intravenously at 40 mg/m2 on day 1 of each cycle. S-1 was administered at a dosage based on body surface area for 14 days in a 3-weekly cycle. The primary endpoint was progression-free survival (PFS). Results: A total of 23 patients were enrolled. Median PFS was 6.7 months (95% CI 4.1–10.1). The response rate (RR) was 39.1%. Median overall survival (OS) and time to treatment failure (TTF) were 17.5 and 4.4 months, respectively. Major grade 3–4 adverse events were neutropenia (39.1%), leukopenia (30.4%), and febrile neutropenia (8.7%). Conclusion: Trastuzumab in combination with docetaxel and S-1 showed effective antitumor activity and manageable toxicities as first-line treatment for patients with HER2-positive GC.
AB - Background: Trastuzumab when combined with fluoropyrimidine and cisplatin was proven to improve survival in patients with human epidermal growth factor receptor 2 (HER2)-positive gastric cancer (GC) in the ToGA study. The safety and efficacy of trastuzumab in combination with docetaxel and S-1 have not yet been evaluated. Methods: This study was a multicenter, phase II study. Patients with chemotherapy-naïve HER2-positive advanced or metastatic GC were eligible. Trastuzumab was administered intravenously on day 1 of the first cycle at 8 and 6 mg/kg in subsequent cycles. Docetaxel was administered intravenously at 40 mg/m2 on day 1 of each cycle. S-1 was administered at a dosage based on body surface area for 14 days in a 3-weekly cycle. The primary endpoint was progression-free survival (PFS). Results: A total of 23 patients were enrolled. Median PFS was 6.7 months (95% CI 4.1–10.1). The response rate (RR) was 39.1%. Median overall survival (OS) and time to treatment failure (TTF) were 17.5 and 4.4 months, respectively. Major grade 3–4 adverse events were neutropenia (39.1%), leukopenia (30.4%), and febrile neutropenia (8.7%). Conclusion: Trastuzumab in combination with docetaxel and S-1 showed effective antitumor activity and manageable toxicities as first-line treatment for patients with HER2-positive GC.
KW - Chemotherapy
KW - Docetaxel
KW - Gastric cancer
KW - HER2-positive
KW - S-1
KW - Trastuzumab
UR - http://www.scopus.com/inward/record.url?scp=85039723810&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85039723810&partnerID=8YFLogxK
U2 - 10.1007/s00280-017-3505-4
DO - 10.1007/s00280-017-3505-4
M3 - Article
C2 - 29290024
AN - SCOPUS:85039723810
SP - 1
EP - 6
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
SN - 0344-5704
ER -