authors presented by alberts and goldberg analysis by scott berry date posted june 21 2010
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Phase III Clinical Trial of FOLFOX with or without Cetuximab in Resected Stage 3 Colon Cancer: Cooperative Group Trial N0147 (NCCTG*, CALGB, ECOG, NCIC, NSABP, SWOG). Authors: Presented by Alberts and Goldberg Analysis By Scott Berry Date posted: June 21 2010.

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authors presented by alberts and goldberg analysis by scott berry date posted june 21 2010

Phase III Clinical Trial of FOLFOX with or without Cetuximab in Resected Stage 3 Colon Cancer:Cooperative Group Trial N0147(NCCTG*, CALGB, ECOG, NCIC, NSABP, SWOG)

Authors: Presented by Alberts and Goldberg

Analysis By Scott Berry

Date posted: June 21 2010

slide2

Thank you for downloading this update. Please feel free to use it for educational purposes.

Please acknowledge OncologyEducation.ca and Dr. Berry when using these slides.

slide3

Initial Study Design

N=2300

Primary Outcome: DFS

Treatment A:

mFOLFOX6 (12 cycles)

R

Treatment B:

mFOLFOX6 + Cetux (12 cycles)

slide4

Revised Study Design

KRAS WT ONLY

N=3768

Primary Outcome: DFS

Treatment A:

mFOLFOX6 (12 cycles)

R

Treatment B:

mFOLFOX6 + Cetux (12 cycles)

trial closed early
Trial Closed Early
  • 1864 randomized to A (FOLFOX) or D (FOLFOX + cetuximab)
    • Trial halted on findings of planned interim analysis
    • 90% of planned accrual
  • Median follow-up 23 months
conclusions
Conclusions
  • No benefit to adding cetuximab in patients with resected stage 3 K-ras WT expressing colon cancer
  • ? Explanation
    • Decreased tolerance with cetuximab
    • Differences in dose intensity
    • Interaction with age:
      • Worse outcomes in older patients receiving cetuximab
      • Lessened ability to complete therapy
was adverse impact of cetuximab due to dosing issues
Was adverse impact of Cetuximab due to dosing issues?

In post-hoc analysis, attempted to identify ‘ideal’ patients

First 6 cycles with > 80% dose intensity for all drugs

Consider only patients aged < 70

If no benefit in these pts (young, > 80% dose rec’d), then adverse impact not likely due to reduced dosing

was adverse impact of cetuximab due to dosing issues1
Was adverse impact of Cetuximab due to dosing issues?

Comparison based on dosing not protected by randomization, thus possibly confounded with other reasons for stopping treatment

Alternative

Use Time to Recurrence endpoint

Most sensitive

Least confounded

slide13

“Idealized” Patient Comparison: Time to Recurrence – K-Ras WT

All Patients

“Ideal” Patients

was adverse impact of cetuximab due to dosing issues2
Was adverse impact of Cetuximab due to dosing issues?

GOLDBERG:

While they had lower drug exposure, we don’t believe that is the key reason based on the idealized patient analysis

We believe that the explanation is related to tumor biology

slide15

STUDY COMMENTARY

  • Adding Cetuximab to adjuvant FOLFOX for resected Stage III colon cancer patients does not improve outcome
  • Results do not appear to be explained by attendant increased toxicity / decreased dose intensity with combination
  • ? Tumour Biology
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