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Bending the Curve Trial by Trial
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A randomized comparison of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma: a cooperative group study

N = 269

Population
Advanced urothelial carcinoma; 269 entered, 246 fully assessable
Design
International intergroup randomised trial, October 1984 to May 1989: intravenous cisplatin 70 mg/m2 alone, or with methotrexate 30 mg/m2 (days 1, 15, 22), vinblastine 3 mg/m2 (days 2, 15, 22) and doxorubicin 30 mg/m2 (day 2); cycles every 28 days until progression or a maximum of six cycles.
Arms
  • Cisplatin alone (control, n = 126): Cisplatin 70 mg/m2 every 28 days, maximum six cycles
  • M-VAC (experimental, n = 120): Methotrexate, vinblastine, doxorubicin and cisplatin every 28 days, maximum six cycles
People
Loehrer PJ Sr
Δ median OS+4.3 monthsΔ median PFS+5.7 monthsΔ ORR+27 points
Show the numbers
Results reported for A randomized comparison of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma: a cooperative group study
EndpointAnalysisM-VACCisplatin aloneEffect
OS246 fully assessable patientsprimaryLoehrer 1992median 12.5 monthsmedian 8.2 monthsAbstract calls the difference significant; it gives no hazard ratio, confidence interval or P value for survival. Arm sizes are the numbers randomised among assessable patients.
PFS246 fully assessable patientsprimaryLoehrer 1992median 10 monthsmedian 4.3 months—
ORR246 fully assessable patientsprimaryLoehrer 199239%12%P<0.0001
Results reported for A randomized comparison of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma: a cooperative group study
EndpointAnalysisM-VACCisplatin aloneEffect
OS246 fully assessable patientsprimaryLoehrer 1992median 12.5 monthsmedian 8.2 monthsAbstract calls the difference significant; it gives no hazard ratio, confidence interval or P value for survival. Arm sizes are the numbers randomised among assessable patients.
PFS246 fully assessable patientsprimaryLoehrer 1992median 10 monthsmedian 4.3 months—
ORR246 fully assessable patientsprimaryLoehrer 199239%12%P<0.0001
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%051015202530Months (modelled)
  • M-VAC (experimental)
  • Cisplatin alone (control)

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

Data table (modelled values)
MonthsM-VACCisplatin alone
0100.0%100.0%
864.2%50.9%
1641.2%25.9%
2327.9%14.3%
3117.9%7.3%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • M-VAC (experimental)
  • Cisplatin alone (control)

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

Data table (modelled values)
MonthsM-VACCisplatin alone
0100.0%100.0%
666.0%38.0%
1340.6%12.3%
1926.8%4.7%
2517.7%1.8%
Primary publication: Loehrer PJ Sr, Einhorn LH, Elson PJ, Crawford ED, Kuebler P, Tannock I, et al. A randomized comparison of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma: a cooperative group study. J Clin Oncol. 1992;10(7):1066-73. PubMedDOI

Appears in

Sources

  1. Loehrer PJ Sr, Einhorn LH, Elson PJ, Crawford ED, Kuebler P, Tannock I, et al. A randomized comparison of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma: a cooperative group study. J Clin Oncol. 1992;10(7):1066-73.

    PubMedDOI