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Bending the Curve Trial by Trial
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EXTREME

Platinum-based chemotherapy plus fluorouracil, with or without cetuximab, as first-line treatment of recurrent or metastatic squamous-cell carcinoma of the head and neck

Phase 3N = 442NCT00122460

Population
Untreated recurrent or metastatic squamous-cell carcinoma of the head and neck
Design
Randomised phase 3 trial (design labels beyond randomisation are not stated in the abstract). 442 eligible patients with untreated recurrent or metastatic SCCHN were randomly assigned to cisplatin (100 mg per square metre on day 1) or carboplatin (AUC 5) plus fluorouracil (1000 mg per square metre per day for 4 days) every 3 weeks for up to 6 cycles, or to the same chemotherapy plus weekly cetuximab; patients with stable disease on chemotherapy plus cetuximab continued cetuximab until progression or unacceptable toxic effects.
Arms
  • Cetuximab plus platinum-fluorouracil (experimental, n = 222): Cisplatin or carboplatin plus fluorouracil, plus weekly cetuximab (400 mg per square metre initially, then 250 mg per square metre)
  • Platinum-fluorouracil alone (control, n = 220): Cisplatin or carboplatin plus fluorouracil every 3 weeks for up to 6 cycles
People
Vermorken JB
OSHR 0.80 (95% CI 0.64–0.99)Δ median OS+2.7 monthsPFSHR 0.54Δ median PFS+2.3 monthsΔ ORR+16 points
Show the numbers
Results reported for EXTREME
EndpointAnalysisCetuximab plus platinum-fluorouracilPlatinum-fluorouracil aloneEffect
OSRandomised patients (N = 442)primaryVermorken 2008median 10.1 monthsmedian 7.4 monthsHR 0.80 (95% CI 0.64–0.99)P=0.04The abstract does not state which endpoint was primary.
PFSRandomised patients (N = 442)primaryVermorken 2008median 5.6 monthsmedian 3.3 monthsHR 0.54P<0.001No confidence interval for the progression-free survival hazard ratio appears in the abstract.
ORRRandomised patients (N = 442)primaryVermorken 200836%20%P<0.001
Results reported for EXTREME
EndpointAnalysisCetuximab plus platinum-fluorouracilPlatinum-fluorouracil aloneEffect
OSRandomised patients (N = 442)primaryVermorken 2008median 10.1 monthsmedian 7.4 monthsHR 0.80 (95% CI 0.64–0.99)P=0.04The abstract does not state which endpoint was primary.
PFSRandomised patients (N = 442)primaryVermorken 2008median 5.6 monthsmedian 3.3 monthsHR 0.54P<0.001No confidence interval for the progression-free survival hazard ratio appears in the abstract.
ORRRandomised patients (N = 442)primaryVermorken 200836%20%P<0.001
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.80.64–0.99
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Cetuximab plus platinum-fluorouracil (experimental)
  • Platinum-fluorouracil alone (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsCetuximab plus platinum-fluorouracilPlatinum-fluorouracil alone
0100.0%100.0%
666.2%57.0%
1341.0%29.6%
1927.1%16.9%
2518.0%9.6%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%02468101214Months (modelled)
  • Cetuximab plus platinum-fluorouracil (experimental)
  • Platinum-fluorouracil alone (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsCetuximab plus platinum-fluorouracilPlatinum-fluorouracil alone
0100.0%100.0%
461.0%43.2%
742.0%23.0%
1125.6%9.9%
1417.7%5.3%
Primary publication: Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008;359(11):1116-27. PubMedDOI

Appears in

Sources

  1. Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008;359(11):1116-27.

    PubMedDOI