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.
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.
Bernhard
Jürg
J
Swiss Group for Clinical Cancer Research Coordinating Center, Bern, Switzerland. juerg.bernhard@ibcsg.org
Dietrich
Daniel
D
Scheithauer
Werner
W
Gerber
Daniela
D
Bodoky
György
G
Ruhstaller
Thomas
T
Glimelius
Bengt
B
Bajetta
Emilio
E
Schüller
Johannes
J
Saletti
Piercarlo
P
Bauer
Jean
J
Figer
Arie
A
Pestalozzi
Bernhard C
BC
Köhne
Claus-Henning
CH
Mingrone
Walter
W
Stemmer
Salomon M
SM
Tàmas
Karin
K
Kornek
Gabriela V
GV
Koeberle
Dieter
D
Herrmann
Richard
R
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
D000700:Analgesics; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine