title: Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone: a randomized multicenter phase III clinical trial--SAKK 44/00-CECOG/PAN.1.3.001.
abstract: OBJECTIVE
  To compare clinical benefit response (CBR) and quality of life (QOL) in patients receiving gemcitabine (Gem) plus capecitabine (Cap) versus single-agent Gem for advanced/metastatic pancreatic cancer.
  
  
  METHODS
  Patients were randomly assigned to receive GemCap (oral Cap 650 mg/m(2) twice daily on days 1 through 14 plus Gem 1,000 mg/m(2) in a 30-minute infusion on days 1 and 8 every 3 weeks) or Gem (1,000 mg/m(2) in a 30-minute infusion weekly for 7 weeks, followed by a 1-week break, and then weekly for 3 weeks every 4 weeks) for 24 weeks or until progression. CBR criteria and QOL indicators were assessed over this period. CBR was defined as improvement from baseline for >or= 4 consecutive weeks in pain (pain intensity or analgesic consumption) and Karnofsky performance status, stability in one but improvement in the other, or stability in pain and performance status but improvement in weight.
  
  
  RESULTS
  Of 319 patients, 19% treated with GemCap and 20% treated with Gem experienced a CBR, with a median duration of 9.5 and 6.5 weeks, respectively (P < .02); 54% of patients treated with GemCap and 60% treated with Gem had no CBR (remaining patients were not assessable). There was no treatment difference in QOL (n = 311). QOL indicators were improving under chemotherapy (P < .05). These changes differed by the time to failure, with a worsening 1 to 2 months before treatment failure (all P < .05).
  
  
  CONCLUSIONS
  There is no indication of a difference in CBR or QOL between GemCap and Gem. Regardless of their initial condition, some patients experience an improvement in QOL on chemotherapy, followed by a worsening before treatment failure.
authors.affiliation: Swiss Group for Clinical Cancer Research Coordinating Center, Bern, Switzerland. juerg.bernhard@ibcsg.org
authors.forename: Jürg
authors.initials: J
authors.lastname: Bernhard
authors.forename: Daniel
authors.initials: D
authors.lastname: Dietrich
authors.forename: Werner
authors.initials: W
authors.lastname: Scheithauer
authors.forename: Daniela
authors.initials: D
authors.lastname: Gerber
authors.forename: György
authors.initials: G
authors.lastname: Bodoky
authors.forename: Thomas
authors.initials: T
authors.lastname: Ruhstaller
authors.forename: Bengt
authors.initials: B
authors.lastname: Glimelius
authors.forename: Emilio
authors.initials: E
authors.lastname: Bajetta
authors.forename: Johannes
authors.initials: J
authors.lastname: Schüller
authors.forename: Piercarlo
authors.initials: P
authors.lastname: Saletti
authors.forename: Jean
authors.initials: J
authors.lastname: Bauer
authors.forename: Arie
authors.initials: A
authors.lastname: Figer
authors.forename: Bernhard C
authors.initials: BC
authors.lastname: Pestalozzi
authors.forename: Claus-Henning
authors.initials: CH
authors.lastname: Köhne
authors.forename: Walter
authors.initials: W
authors.lastname: Mingrone
authors.forename: Salomon M
authors.initials: SM
authors.lastname: Stemmer
authors.forename: Karin
authors.initials: K
authors.lastname: Tàmas
authors.forename: Gabriela V
authors.initials: GV
authors.lastname: Kornek
authors.forename: Dieter
authors.initials: D
authors.lastname: Koeberle
authors.forename: Richard
authors.initials: R
authors.lastname: Herrmann
mesh_terms: D000230:Adenocarcinoma / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001835:Body Weight / Q000187:drug effects; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005060:Europe; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D007263:Infusions, Parenteral; D017567:Karnofsky Performance Status; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D010147:Pain Measurement; D010190:Pancreatic Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D011788:Quality of Life; D013997:Time Factors; D017211:Treatment Failure; D000093542:Gemcitabine
chemical_list: D000700:Analgesics; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine