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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

Jürg Bernhard, Daniel Dietrich, Werner Scheithauer, Daniela Gerber, György Bodoky, Thomas Ruhstaller, Bengt Glimelius, Emilio Bajetta, Johannes Schüller, Piercarlo Saletti, Jean Bauer, Arie Figer, Bernhard C. Pestalozzi, Claus-Henning Köhne, Walter Mingrone, Salomon M. Stemmer, Karin Tàmas, Gabriela V. Kornek, Dieter Koeberle, Richard Herrmann

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, Sweden; Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan, Italy; Sourasky Medical Center, Tel Aviv; Rabin Medical Center, Petach Tikva, Israel; and Universitätsklinikum, Dresden, Germany

Corresponding author: Jürg Bernhard, PhD, International Breast Cancer Study Group Coordinating Center, Effingerstr 40, 3008 Bern, Switzerland; e-mail: juerg.bernhard{at}ibcsg.org

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.

Supported by Roche Pharma Switzerland, Eli Lilly Switzerland, and the Swiss Federal Government.

Presented at the 9th World Conference of Psycho-Oncology, September 16-20, 2007, London, United Kingdom.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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