title: Biweekly S-1 plus paclitaxel (SPA) as second-line chemotherapy after failure from fluoropyrimidine and platinum in advanced gastric cancer: a phase II study.
abstract: OBJECTIVE
  Second-line chemotherapy is now considered a standard therapy option in patients with advanced gastric cancer (AGC) who failed from first-line chemotherapy. Single agents, such as irinotecan, docetaxel or paclitaxel, provided an overall response rate of about 10 %. However, the efficacy was not satisfactory. The authors conducted a phase II study to investigate biweekly regimen of S-1 plus paclitaxel in Chinese AGC in second-line setting, with response rate as the primary end point.
  
  
  METHODS
  Patients with AGC failed from first-line chemotherapy with fluoropyrimidine/platinum who had measurable lesions were enrolled. Paclitaxel was administered intravenously on day 1 at a dose of 120 mg/m(2), and oral S-1 was administered twice a day from days 1 to 7, followed by a 7-day drug-free interval.
  
  
  RESULTS
  A total of 30 patients with pretreated AGC were accrued. No complete responses were observed. Partial responses were documented in 10 (33.3 %) patients. Ten (33.3 %) patients had stable disease. The median progression-free survival was 3.6 months and the overall survival was 7.2 months. The main toxicity was bone marrow suppression. The most frequent grade 3/4 hematological toxicities were neutropenia and anemia, which were observed in 8 (26.7 %) and 6 (20 %) patients, respectively. The most common grade 3/4 non-hematological toxicity was neuropathy, which was reported in 4 (13.3 %) patients.
  
  
  CONCLUSIONS
  Biweekly S-1 plus paclitaxel showed promising activity with acceptable toxicities as second-line chemotherapy in pretreated patients with AGC. This regimen deserves further investigation in a phase III trial.
authors.affiliation: Department of Medical Oncology, The First Affiliated Hospital of Zhejiang University, 79 Qingchun Road, Hangzhou, 310003, Zhejiang, China.
authors.forename: Yulong
authors.initials: Y
authors.lastname: Zheng
authors.forename: Weijia
authors.initials: W
authors.lastname: Fang
authors.forename: Chenyu
authors.initials: C
authors.lastname: Mao
authors.forename: Joing
authors.initials: J
authors.lastname: Qian
authors.forename: Peng
authors.initials: P
authors.lastname: Zhao
authors.forename: Xiaochen
authors.initials: X
authors.lastname: Zhang
authors.forename: Haiping
authors.initials: H
authors.lastname: Jiang
authors.forename: Yi
authors.initials: Y
authors.lastname: Zheng
authors.forename: Nong
authors.initials: N
authors.lastname: Xu
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D010094:Oxonic Acid / Q000008:administration & dosage; D017239:Paclitaxel / Q000008:administration & dosage; D010984:Platinum / Q000627:therapeutic use; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010984:Platinum; D010094:Oxonic Acid; D017239:Paclitaxel; D005472:Fluorouracil