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

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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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RESULTS
Treatment A Treatment B p-value
Response Rate () 10.0 7.8 NS
PFS (median, mos) 4.3 mos 3.9 mos NS
OS (median, mos) 8.4 mos 7.2 mos NS
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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 (p0.014)
• - ORR 14 vs 7 (p0.0001)
• - 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, p0.014)
• ? 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