title: Induction of a pathological complete response by four courses of neoadjuvant chemotherapy for gastric cancer: early results of the randomized phase II COMPASS trial.
abstract: BACKGROUND
  The prognosis for stage 3 gastric cancer is not satisfactory, even with S-1 adjuvant chemotherapy. A randomized phase II trial was conducted to compare two and four courses of neoadjuvant S-1/cisplatin (SC) and paclitaxel/cisplatin (PC) using a two-by-two factorial design for locally advanced gastric cancer. The primary endpoint was overall survival. We clarified the impact of these regimens on the secondary endpoints, including the clinical and pathological responses, chemotherapy-related toxicities, and surgical results.
  
  
  METHODS
  Patients received S-1 (80 mg/m(2) for 21 days with 1 week's rest)/cisplatin (60 mg/m(2) at day 8) or paclitaxel/cisplatin (80 and 25 mg/m(2), respectively, on days 1, 8, and 15 with 1 week's rest) as neoadjuvant chemotherapy.
  
  
  RESULTS
  Eighty-three patients were assigned to arm A (two courses of SC, n = 21), arm B (four courses of SC, n = 20), arm C (two courses of PC, n = 21), and arm D (four courses of PC, n = 21). Pathological response rate was 43 % in arm A, 40 % in arm B, 29 % in arm C, and 38 % in arm D. Pathological complete response was only observed in arms B (10 %) and D (10 %). Most bone marrow toxicities, nausea, vomiting, alopecia, and fatigue were slightly higher but acceptable in arms B and D. Grade 3/4 surgical morbidities were not commonly observed in all four arms.
  
  
  CONCLUSIONS
  Pathological complete response could be induced by four courses of neoadjuvant chemotherapy without a marked increase of toxicities, regardless of a SC or PC regimen.
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan, yoshikawat@kcch.jp.
authors.forename: Takaki
authors.initials: T
authors.lastname: Yoshikawa
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Tanabe
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Nishikawa
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Ito
authors.forename: Takanori
authors.initials: T
authors.lastname: Matsui
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Kimura
authors.forename: Naoki
authors.initials: N
authors.lastname: Hirabayashi
authors.forename: Shoki
authors.initials: S
authors.lastname: Mikata
authors.forename: Makoto
authors.initials: M
authors.lastname: Iwahashi
authors.forename: Ryoji
authors.initials: R
authors.lastname: Fukushima
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Takiguchi
authors.forename: Isao
authors.initials: I
authors.lastname: Miyashiro
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Yumi
authors.initials: Y
authors.lastname: Miyashita
authors.forename: Aakira
authors.initials: A
authors.lastname: Tsuburaya
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D017239:Paclitaxel; D002945:Cisplatin