title: Randomized phase II trial of S-1 plus irinotecan versus S-1 plus paclitaxel as first-line treatment for advanced gastric cancer (OGSG0402).
abstract: BACKGROUND
  S-1-based regimens are commonly used for advanced gastric cancer (AGC) in Japan. We performed this trial to evaluate the efficacy and safety of S-1 plus irinotecan (SIri) and S-1 plus paclitaxel (SPac) as first-line treatments for AGC in order to select the optimal regimen for a subsequent phase III trial.
  
  
  METHODS
  Patients with previously untreated, locally advanced or metastatic measurable gastric adenocarcinoma were randomly assigned to receive SIri (irinotecan 80 mg/m(2) was administered intravenously (i.v.) on day 1 and 15, while 40 mg/m(2) S-1 was orally administered twice daily for three weeks from days 1-21 followed by a two-week pause) or SPac (paclitaxel 50 mg/m(2) was administered i.v. on day 1 and 8, while 40 mg/m(2) S-1 was orally administered twice daily for two weeks from day 1-14 followed by a one-week pause) regimen. The primary end-point was the overall response rate (ORR), and the secondary end-points were progression-free survival (PFS), overall survival (OS), and toxicity.
  
  
  RESULTS
  A total of 102 patients were enrolled. The ORR was 33.3% for SIri and 31.4% for SPac, which did not achieved the predicted ORR in either group. PFS and OS were 5.7 and 12.4 months for SIri, 4.6 and 11.9 months for SPac respectively. No treatment-related deaths occurred during the study. Although grade 3/4 neutropenia and anemia were more frequent in the Siri group, both regimens were well-tolerated.
  
  
  CONCLUSIONS
  Both regimens were well-tolerated in patients with AGC, but we conclude that neither regimen was optimal for a phase III trial.
authors: Department of Cancer Chemotherapy Center, Osaka Medical College, 2-7 Daigaku Cho, Takatsuki, Osaka, 569-0801, Japan. in2030@poh.osaka-med.ac.jp.
authors: Naotoshi
authors: N
authors: Sugimoto
authors: Kazumasa
authors: K
authors: Fujitani
authors: Hiroshi
authors: H
authors: Imamura
authors: Noriya
authors: N
authors: Uedo
authors: Shohei
authors: S
authors: Iijima
authors: Motohiro
authors: M
authors: Imano
authors: Toshio
authors: T
authors: Shimokawa
authors: Yukinori
authors: Y
authors: Kurokawa
authors: Hiroshi
authors: H
authors: Furukawa
authors: Masahiro
authors: M
authors: Goto
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy*; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000077146:Irinotecan; D017239:Paclitaxel; D002166:Camptothecin
keywords: Irinotecan; S-1; gastric cancer; paclitaxel; phase II study