title: Stratified phase II trial to establish the usefulness of the collagen gel droplet embedded culture-drug sensitivity test (CD-DST) for advanced gastric cancer.
abstract: BACKGROUND
  We conducted a multicenter phase II trial to assess the suitability of three types of chemotherapy (docetaxel plus S-1, irinotecan plus S-1, or S-1 alone) for patients with advanced gastric cancer by means of the collagen gel droplet embedded culture-drug sensitivity test (CD-DST). To our knowledge, this is the first multicenter clinical trial that has employed CD-DST to choose anticancer agents for the treatment of advanced gastric cancer.
  
  
  METHODS
  Subjects (n = 64) were patients with advanced or recurrent gastric cancer. Patients were allocated to one of the treatment regimens on the basis of CD-DST results. Outcome of the patients was compared between the groups deemed chemosensitive or chemoresistant by the CD-DST.
  
  
  RESULTS
  Thirty-three patients showed high sensitivity (T/C ratio <60 %) to at least one type of anticancer agent (sensitive group), and 31 showed low sensitivity (T/C ratio ≥60 %) to all agents (resistant group). Specifically, the 1-year survival rate was significantly higher in the sensitive group (78.5 %; 95 % CI, 67.2-94.7 %) than in the resistant group (54.7 %; 95 % CI, 38.7-74.3 %; P = 0.019), whereas time to progression (TTP) was significantly longer in the sensitive group (59.8 %; 95 % CI, 48.2-81.7 %) than in the resistant group (30.0 %; 95 % CI 13.6-46.4 %; P = 0.023). Median survival time was also significantly longer in the sensitive group (15.5 months; 95 % CI, 12.8-18.2) than in the resistant group (12.5 months; 95 % CI, 10.2-14.9; P = 0.038).
  
  
  CONCLUSIONS
  CD-DST predicts the outcome of patients undergoing chemotherapy for advanced gastric cancer, presumably through evaluating chemosensitivity.
authors: Department of Surgery, Shiga University of Medical Science, Seta, Tsukiwa-cho, Otsu, Shiga, 520-2192, Japan, hnaito@hino-hp.jp.
authors: Hiroyuki
authors: H
authors: Naitoh
authors: Hiroshi
authors: H
authors: Yamamoto
authors: Satoshi
authors: S
authors: Murata
authors: Hisayuki
authors: H
authors: Kobayashi
authors: Katsunori
authors: K
authors: Inoue
authors: Tohru
authors: T
authors: Tani
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002945:Cisplatin / Q000008:administration & dosage; D003094:Collagen / Q000008:administration & dosage; D000077143:Docetaxel; D004338:Drug Combinations; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D010094:Oxonic Acid / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid; D000077146:Irinotecan; D003094:Collagen; D002945:Cisplatin; D002166:Camptothecin