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
Journal article

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

  • Bernhard, Jürg From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Dietrich, Daniel From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Scheithauer, Werner From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Gerber, Daniela From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Bodoky, György From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Ruhstaller, Thomas From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Glimelius, Bengt From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Bajetta, Emilio From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Schüller, Johannes From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Saletti, Piercarlo From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Bauer, Jean From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Figer, Arie From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Pestalozzi, Bernhard C. From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Köhne, Claus-Henning From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Mingrone, Walter From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Stemmer, Salomon M. From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Tàmas, Karin From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Kornek, Gabriela V. From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Koeberle, Dieter From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
  • Herrmann, Richard From the Swiss Group for Clinical Cancer Research Coordinating Center, Bern; Inselspital, Bern University Hospital, Bern; Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona; Centre Hospitalier Universitaire Vaudoise, Lausanne; Universitätsspital, Zurich; University Hospital, Basel; Kantonsspital, Aarau, Switzerland; Medical University of Vienna, Vienna; Krankenanstalt Rudolfstiftung, Wien, Austria; Szt László Hospital, Budapest, Hungary; University of Uppsala, Uppsala,...
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  • Journal of Clinical Oncology. - American Society of Clinical Oncology (ASCO). - 2008, vol. 26, no. 22, p. 3695-3701
English Purpose 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. Patients and Methods Patients were randomly assigned to receive GemCap (oral Cap 650 mg/m2 twice daily on days 1 through 14 plus Gem 1,000 mg/m2 in a 30-minute infusion on days 1 and 8 every 3 weeks) or Gem (1,000 mg/m2 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 ≥ 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). Conclusion 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.
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  • English
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