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Gemcitabine Plus Capecitabine Compared With Gemcitabine Alone in Advanced Pancreatic Cancer: A Randomized, Multicenter, PowerPoint Presentation
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Gemcitabine Plus Capecitabine Compared With Gemcitabine Alone in Advanced Pancreatic Cancer: A Randomized, Multicenter, - PowerPoint PPT Presentation


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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, 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

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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

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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)

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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

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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