title: Phase II study of docetaxel and S-1 (DS) as neoadjuvant chemotherapy for clinical stage III resectable gastric cancer.
abstract: BACKGROUND
  We conducted a phase II trial to evaluate the efficacy and safety of preoperative chemotherapy with docetaxel (DTX) plus S-1 for resectable advanced gastric cancer.
  
  
  METHODS
  A total of 47 patients from 14 centers were centrally registered. Patients received DTX (35 mg/m(2)) on days 1 and 15, and daily oral administration of S-1 (80 mg/m(2)/day) for days 1-14 every 4 weeks for two courses, followed by gastrectomy with D2 lymphadenectomy. The primary endpoint was pathological response rate (pRR). This study was registered in the UMIN clinical trial registry (UMIN000000875).
  
  
  RESULTS
  The primary endpoint pRR was 47 % (90 % confidence interval (CI), 34-60 %; p < 0.0001). The response rate to preoperative chemotherapy using Response Evaluation Criteria in Solid Tumors (RECIST) was 34 %. Forty-six patients (98 %) underwent surgery, and curative resection was performed in 44 patients. Thirty-seven patients completed the protocol treatment. The most common toxicities of neoadjuvant chemotherapy were grade 3/4 neutropenia (42 %), febrile neutropenia (4 %), grade 2 anorexia (21 %), and fatigue (15 %). Treatment-related death and operative mortality was not observed in this study.
  
  
  CONCLUSIONS
  The combination of docetaxel and S-1 was well tolerated. This is promising as a preoperative chemotherapy regimen for patients with potentially resectable advanced gastric cancer.
authors.affiliation: Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan, okieiji@surg2.med.kyushu-u.ac.jp.
authors.forename: Eiji
authors.initials: E
authors.lastname: Oki
authors.forename: Yasunori
authors.initials: Y
authors.lastname: Emi
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Kusumoto
authors.forename: Yoshihisa
authors.initials: Y
authors.lastname: Sakaguchi
authors.forename: Manabu
authors.initials: M
authors.lastname: Yamamoto
authors.forename: Noriaki
authors.initials: N
authors.lastname: Sadanaga
authors.forename: Mototsugu
authors.initials: M
authors.lastname: Shimokawa
authors.forename: Takeharu
authors.initials: T
authors.lastname: Yamanaka
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Saeki
authors.forename: Masaru
authors.initials: M
authors.lastname: Morita
authors.forename: Ikuo
authors.initials: I
authors.lastname: Takahashi
authors.forename: Naoki
authors.initials: N
authors.lastname: Hirabayashi
authors.forename: Kenji
authors.initials: K
authors.lastname: Sakai
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Orita
authors.forename: Shinichi
authors.initials: S
authors.lastname: Aishima
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Kakeji
authors.forename: Kazuya
authors.initials: K
authors.lastname: Yamaguchi
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yoshida
authors.forename: Hideo
authors.initials: H
authors.lastname: Baba
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Maehara
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D000077143:Docetaxel; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005743:Gastrectomy; D006801:Humans; D008197:Lymph Node Excision; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D011300:Preoperative Care; D011379:Prognosis; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage
chemical_list: D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid