title: Combination phase II study of weekly paclitaxel and 5'-DFUR for unresectable or recurrent gastric cancer.
abstract: BACKGROUND
  Paclitaxel and 5'-deoxy-5-fluorouridine (5'-DFUR) have single-agent activity in gastric cancer and have distinct mechanisms of action and no overlap of key toxicities. To evaluate the efficacy and safety of their combination, we conducted a combination phase II study of paclitaxel and 5'-DFUR in patients with unresectable or recurrent gastric cancer who had received up to one prior chemotherapy.
  
  
  METHODS
  Treatment included paclitaxel at 70 mg/m(2) i.v. on days 1, 8 and 15 every four weeks, and 5'-DFUR at 600 mg p.o. every day. The primary end-point was the response rate (RR) and secondary end-points were overall survival (OS), progression-free survival (PFS), time-to-treatment failure (TTF) and rate of adverse events.
  
  
  RESULTS
  In 42 eligible patients, the RR was 40.5%. OS, PFS and TTF were 371 days, 170 days, and 147 days, respectively. Adverse events were relatively mild. Commonly observed grade 3/4 adverse events were neutropenia (26.2%), anorexia (4.8%), neuropathy (4.8%) and fatigue (4.8%).
  
  
  CONCLUSIONS
  The combination of weekly paclitaxel and 5'-DFUR chemotherapy is active and well-tolerated.
authors.affiliation: Department of Digestive Surgery and Surgical Oncology, Graduate School of Medicine, Yamaguchi University, Ube, Japan. sigefumi@yamaguchi-u.ac.jp
authors.forename: Shigefumi
authors.initials: S
authors.lastname: Yoshino
authors.forename: Takumi
authors.initials: T
authors.lastname: Furuya
authors.forename: Ryoichi
authors.initials: R
authors.lastname: Shimizu
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Ozasa
authors.forename: Taku
authors.initials: T
authors.lastname: Nishimura
authors.forename: Shintaro
authors.initials: S
authors.lastname: Fukuda
authors.forename: Toru
authors.initials: T
authors.lastname: Kawaoka
authors.forename: Shoichi
authors.initials: S
authors.lastname: Hazama
authors.forename: Masaaki
authors.initials: M
authors.lastname: Oka
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005467:Floxuridine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D013274:Stomach Neoplasms / Q000188:drug therapy*; D015996:Survival Rate
chemical_list: D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D005467:Floxuridine; D017239:Paclitaxel; C025034:doxifluridine
keywords: 5’-DFUR; Paclitaxel; gastric cancer; phase II study