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Gemcitabine Plus Capecitabine Compared With Gemcitabine Alone in Advanced Pancreatic Cancer: A Randomized, Multicenter,

Gemcitabine Plus Capecitabine Compared With Gemcitabine Alone in Advanced Pancreatic Cancer: A Randomized, Multicenter, Phase III Trial. Authors: Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group Reviewer: Dr. Chris Booth Date posted: December 12 2007.

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Gemcitabine Plus Capecitabine Compared With Gemcitabine Alone in Advanced Pancreatic Cancer: A Randomized, Multicenter,

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  1. Gemcitabine Plus Capecitabine Compared With Gemcitabine Alone in Advanced Pancreatic Cancer: A Randomized, Multicenter, Phase III Trial Authors: Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology GroupReviewer: Dr. Chris Booth Date posted: December 12 2007

  2. Treatment A: • 21 day cycles • Gem 1000mg/m2 D1 and 8 • Cape 650 mg/m2 for 14 days R • Treatment B: • Burris regimen • 1000 mg/m2 7/8 weeks, then ¾ weeks Locally advanced/ Metastatic Pancreas cancer Primary endpoint: overall survival Secondary endpoints: PFS, ORR, safety, QOL

  3. RESULTS

  4. STUDY COMMENTARY •  Single agent Gem is current standard for advanced/locally advanced PC •  Clinical benefit and small OS benefit over 5-FU •  Multiple trials have added “something” to Gem with no (or little) success - For a comprehensive review please see Van Cutsem et al. JCO 2007. (reference) - NCIC CTG PA.3 trial was the first study to show a survival benefit (albeit a modest one) with the addition of erlotinib to gemcitabine (reference)

  5. STUDY COMMENTARY CONTINUED ESMO 2005 - Interim data presented for RCT in UK of Gem-Cap vs Gem - Median survival 7.4 vs 6 months (p=0.014) - ORR 14 vs 7% (p=0.0001) - OS at 1 year 26 vs 19% - This has led to some change in practice in Canada and US despite the fact that 2 years later ths data have not yet been published in full The current well designed study failed to detect any improvement in outcome with the addition of Capecitabine to Gemcitabine - Post-hoc sub-group analysis suggests benefit to Cape-Gem among patients with good performance status (OS 10.1 vs 7.4 mos, p=0.014)  No QOL data presented in the current article

  6. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • This study does not support the use of Gem-Cape over Gem along in patients with advanced pancreas cancer • Results are discordant with the UK study presented at ESMO 2005 • - Doses of Gem and Cape were higher in the UK study • Until the UK study is published in full, the standard of care for advanced pancreas cancer remains single agent Gemcitabine

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