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Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma

Phase 3N = 305

Population
Advanced metastatic melanoma (305 patients)
Design
Randomised phase 3 trial of oral temozolomide versus intravenous dacarbazine in advanced metastatic melanoma, comparing overall survival, progression-free survival, response, safety, health-related quality of life and pharmacokinetics.
Arms
  • Temozolomide (experimental): Oral temozolomide starting at 200 mg per square metre per day for 5 days every 28 days
  • Dacarbazine (control): Intravenous dacarbazine starting at 250 mg per square metre per day for 5 days every 21 days
People
Middleton MR, senior author Thatcher N
Δ median OS+1.3 monthsΔ median PFS+0.4 months
Show the numbers
Results reported for Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma
EndpointAnalysisTemozolomideDacarbazineEffect
OSprimaryMiddleton 2000median 7.7 monthsmedian 6.4 monthsThe abstract reports a hazards ratio of 1.18 (95% CI 0.92 to 1.52) for survival without stating which group is the reference, and concludes that temozolomide has efficacy equal to dacarbazine.
PFSprimaryMiddleton 2000median 1.9 monthsmedian 1.5 monthsP=0.012The abstract reports a hazards ratio of 1.37 (95% CI 1.07 to 1.75) without stating which group is the reference.
Results reported for Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma
EndpointAnalysisTemozolomideDacarbazineEffect
OSprimaryMiddleton 2000median 7.7 monthsmedian 6.4 monthsThe abstract reports a hazards ratio of 1.18 (95% CI 0.92 to 1.52) for survival without stating which group is the reference, and concludes that temozolomide has efficacy equal to dacarbazine.
PFSprimaryMiddleton 2000median 1.9 monthsmedian 1.5 monthsP=0.012The abstract reports a hazards ratio of 1.37 (95% CI 1.07 to 1.75) without stating which group is the reference.
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%051015Months (modelled)
  • Temozolomide (experimental)
  • Dacarbazine (control)

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

Data table (modelled values)
MonthsTemozolomideDacarbazine
0100.0%100.0%
563.8%58.2%
1040.6%33.9%
1428.4%22.0%
1918.1%12.8%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%01234Months (modelled)
  • Temozolomide (experimental)
  • Dacarbazine (control)

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

Data table (modelled values)
MonthsTemozolomideDacarbazine
0100.0%100.0%
169.4%63.0%
248.2%39.7%
423.2%15.7%
516.1%9.9%
Primary publication: Middleton MR, Grob JJ, Aaronson N, Fierlbeck G, Tilgen W, Seiter S, et al. Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol. 2000;18(1):158-66. PubMedDOI

Appears in

Sources

  1. Middleton MR, Grob JJ, Aaronson N, Fierlbeck G, Tilgen W, Seiter S, et al. Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol. 2000;18(1):158-66.

    PubMedDOI