title: Phase II Study of S-1 Monotherapy as a First-line, Combination Therapy of S-1 plus Cisplatin as a Second-line, and Weekly Paclitaxel Monotherapy as a Third-line Therapy in Patients with Advanced Gastric Carcinoma: Phase II Study of S-1, S-1 plus Cisplatin, and Weekly Paclitaxel in Patients with Advanced Gastric Carcinoma.
abstract: BACKGROUND
  We conducted a pilot phase II study to evaluate the efficacy and safety of S-1 as a first-line, S-1 plus cisplatin as a second-line, and weekly paclitaxel as a third-line therapy for advanced gastric cancer.
  
  
  METHODS
  Between 2002 and 2005, 19 patients were enrolled in this study. Chemotherapy consisted of either 60 mg/m(2) of S-1 for 4 weeks at 6 weeks interval, a combination of 60 mg/m(2) S-1 for 3 weeks and 60 mg/m(2) cisplatin on day 8 at 5 weeks interval, or 60 mg/m(2) paclitaxel at day 1, 8, 15, at 4 weeks interval. The regimen was repeated until the occurrence of unacceptable toxicities, disease progression, or patient refusal. The primary end point was the overall survival.
  
  
  RESULTS
  The response rates were 33.3%, 12.5%, and 0% after the first, second, and third line chemotherapy, respectively. The mean overall survival time was 994 days. The median survival time could not be calculated because 12 out of 19 patients were still alive when the study was concluded. Regarding hematological toxicity, the major adverse effect was leukopenia, which reached grades 3-4 in all lines of chemotherapy investigated. In addition, regarding non-hematological toxicities, the major adverse effect was anorexia, which reached grade 3-4 in the second line chemotherapy, and no deaths were attributable to the adverse effects of the drugs.
  
  
  CONCLUSIONS
  This sequential therapy was an effective treatment for advanced gastric cancer with acceptable toxic side-effects. We considered this sequential therapy to be effective because of the smooth switch to the next regimen.
authors: Department of Surgery, School of Medicine, Yokohama City University.
authors: Yasushi
authors: Y
authors: Rino
authors: Norio
authors: N
authors: Yukawa
authors: Nobuyuki
authors: N
authors: Wada
authors: Makoto
authors: M
authors: Suzuki
authors: Hitoshi
authors: H
authors: Murakami
authors: Takanobu
authors: T
authors: Yamada
authors: Hirotaka
authors: H
authors: Nakayama
authors: Naoto
authors: N
authors: Yamamoto
authors: Tsutomu
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authors: Sato
authors: Roppei
authors: R
authors: Yamada
authors: Takashi
authors: T
authors: Ohshima
authors: Munetaka
authors: M
authors: Masuda
authors: Toshio
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authors: Imada