title: A phase II prospective study of the trastuzumab combined with 5-weekly S-1 and CDDP therapy for HER2-positive advanced gastric cancer.
abstract: We evaluated the efficacy and safety of 5-weekly S-1 and cisplatin combined with trastuzumab, a monoclonal antibody against human epidermal growth factor receptor type 2 (HER2) for HER2-positive advanced gastric cancer (AGC).
  
  
  
  This phase II study treatment consisted of S-1 (80-120 mg per day) orally on day 1-21, cisplatin (60 mg/m(2)) intravenously on day 8, and trastuzumab (8 mg/kg on day 1 of the first cycle, followed by 6 mg/kg every 3 weeks) intravenously. The primary end point was 1-year survival rate. The secondary end points included overall survival, progression-free survival (PFS), response rate (RR), and safety.
  
  
  
  A total 22 patients from seven centers were enrolled. In the 20 patients evaluable for analysis, the 1-year survival rate was 70 % (95 % confidence interval (CI) 49.9-90.1 %), and median survival time, PFS, and RR were 15.3, 7.5 months and 41.2 %, respectively. Major grade 3/4 adverse events were neutropenia (30 %), anorexia (30 %), leukopenia (25 %), fatigue (20 %), and anemia (15 %).
  
  
  
  Five-weekly S-1 and cisplatin combined with trastuzumab showed effective with favorable safety profile in patients with HER2-positive AGC.
authors.affiliation: Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.
authors.forename: Hiromi
authors.initials: H
authors.lastname: Kataoka
authors.affiliation: Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan. ysmori@med.nagoya-cu.ac.jp.
authors.forename: Yoshinori
authors.identifier: 0000-0001-7199-4901
authors.initials: Y
authors.lastname: Mori
authors.affiliation: Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.
authors.forename: Takaya
authors.initials: T
authors.lastname: Shimura
authors.affiliation: Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.
authors.forename: Hirotada
authors.initials: H
authors.lastname: Nishie
authors.affiliation: Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Natsume
authors.affiliation: Department of Gastroenterology, Kasugai Municipal Hospital, 1-1-1 Takaki-cho, Kasugai, Aichi, 486-8510, Japan.
authors.forename: Hisato
authors.initials: H
authors.lastname: Mochizuki
authors.affiliation: Department of Gastroenterology, Kasugai Municipal Hospital, 1-1-1 Takaki-cho, Kasugai, Aichi, 486-8510, Japan.
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Hirata
authors.affiliation: Department of Gastroenterology, Kasugai Municipal Hospital, 1-1-1 Takaki-cho, Kasugai, Aichi, 486-8510, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Sobue
authors.affiliation: Gifu Prefectural Tajimi Hospital, 5-161, Maehata-cho, Tajimi, Gifu, 507-8522, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Mizushima
authors.affiliation: Gifu Prefectural Tajimi Hospital, 5-161, Maehata-cho, Tajimi, Gifu, 507-8522, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Sano
authors.affiliation: Toyokawa City Hospital, 23 Noji, Yahata-cho, Toyokawa, Aichi, 442-8561, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Mizuno
authors.affiliation: Toyokawa City Hospital, 23 Noji, Yahata-cho, Toyokawa, Aichi, 442-8561, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Nakamura
authors.affiliation: Nagoya City West Medical Center, 1-1-1 Hirate-cho, Kita-ku, Nagoya, Aichi, 462-8508, Japan.
authors.forename: Atsuyuki
authors.initials: A
authors.lastname: Hirano
authors.affiliation: Nagoya City West Medical Center, 1-1-1 Hirate-cho, Kita-ku, Nagoya, Aichi, 462-8508, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Tsuchida
authors.affiliation: Nagoya City West Medical Center, 1-1-1 Hirate-cho, Kita-ku, Nagoya, Aichi, 462-8508, Japan.
authors.forename: Kazunori
authors.initials: K
authors.lastname: Adachi
authors.affiliation: Nagoya City West Medical Center, 1-1-1 Hirate-cho, Kita-ku, Nagoya, Aichi, 462-8508, Japan.
authors.forename: Kyoji
authors.initials: K
authors.lastname: Seno
authors.affiliation: Nagoya City East Medical Center, 1-2-23 Wakamizu, Chikusa-ku, Nagoya, Aichi, 464-8547, Japan.
authors.forename: Mika
authors.initials: M
authors.lastname: Kitagawa
authors.affiliation: Nagoya City East Medical Center, 1-2-23 Wakamizu, Chikusa-ku, Nagoya, Aichi, 464-8547, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Kawai
authors.affiliation: Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Joh
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000037:antagonists & inhibitors* / Q000378:metabolism; D066066:Response Evaluation Criteria in Solid Tumors; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality / Q000473:pathology; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000068878:Trastuzumab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D002945:Cisplatin; D004338:Drug Combinations; D010094:Oxonic Acid; D018719:Erb-b2 Receptor Tyrosine Kinases; D005641:Tegafur; D000068878:Trastuzumab; C079198:S 1 (combination); C508053:ERBB2 protein, human
keywords: Advanced gastric cancer (AGC); Human epidermal growth factor receptor type 2 (HER2); Trastuzumab