title: A 4-week versus a 3-week schedule of gemcitabine monotherapy for advanced pancreatic cancer: a randomized phase II study to evaluate toxicity and dose intensity.
abstract: BACKGROUND
  This randomized phase II study compared the efficacy and toxicity between 4-week and 3-week schedules of gemcitabine monotherapy in advanced pancreatic cancer.
  
  
  METHODS
  Patients with advanced pancreatic cancer were randomly assigned to either a 4-week schedule (gemcitabine at 1000 mg/m² as a 30-min infusion weekly for 3 consecutive weeks every 4 weeks) or a 3-week schedule (gemcitabine at 1000 mg/m² as a 30-min infusion weekly for 2 consecutive weeks every 3 weeks). The primary endpoint was the compliance rate during the first 8 weeks between the two groups.
  
  
  RESULTS
  A total of 90 patients were enrolled. The compliance rate during the first 8 weeks was the same (53.3%). For the 4- and 3-week schedules, the tumor response rates were 14.2 and 17.1% (p = 0.92), median progression free survival was 112 and 114 days (p = 0.82), and median overall survival was 206 and 250 days (p = 0.84), respectively. Grade 3-4 neutropenia was the major adverse event in both schedules: 37.7 and 35.5% (p = 0.82). In contrast, thrombocytopenia (platelet count <70000/mm³) was significantly higher for the 4-week schedule: 26.6 and 4.4% (p = 0.008). The mean received dose intensity was equal: 588 and 550 mg/m²/week (p = 0.14).
  
  
  CONCLUSIONS
  The 3-week schedule of gemcitabine did not improve the compliance rate during 8 weeks compared with the 4-week schedule, but it attained a comparable efficacy with lower toxicity. Further investigation will be needed to introduce it into daily practice.
  
  
  BACKGROUND
  UMIN ID 974.
authors.affiliation: Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Okayama 700-8558, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Hirao
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Kawamoto
authors.forename: Ichiro
authors.initials: I
authors.lastname: Sakakihara
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Noma
authors.forename: Naoki
authors.initials: N
authors.lastname: Yamamoto
authors.forename: Ryo
authors.initials: R
authors.lastname: Harada
authors.forename: Koichiro
authors.initials: K
authors.lastname: Tsutsumi
authors.forename: Masakuni
authors.initials: M
authors.lastname: Fujii
authors.forename: Hironari
authors.initials: H
authors.lastname: Kato
authors.forename: Naoko
authors.initials: N
authors.lastname: Kurihara
authors.forename: Osamu
authors.initials: O
authors.lastname: Mizuno
authors.forename: Tsuneyoshi
authors.initials: T
authors.lastname: Ogawa
authors.forename: Etsuji
authors.initials: E
authors.lastname: Ishida
authors.forename: Kazuhide
authors.initials: K
authors.lastname: Yamamoto
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018450:Disease Progression; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine