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Bending the Curve Trial by Trial
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Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer

Needs review

N = 317

Population
Patients with muscle-invasive bladder cancer (stage T2 to T4a) to be treated with radical cystectomy
Design
Randomised trial in muscle-invasive bladder cancer (stage T2 to T4a) to be treated with radical cystectomy: cystectomy alone, or three cycles of methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) followed by cystectomy. Stratified by age (under 65 vs 65 or older) and stage (superficial muscle invasion vs more extensive disease). 317 patients enrolled over 11 years, 10 of whom were found ineligible, leaving 154 and 153 in the two arms. The abstract does not name the primary endpoint or the phase.
Arms
  • Cystectomy alone (control, n = 154): Radical cystectomy alone
  • MVAC then cystectomy (experimental, n = 153): Three cycles of methotrexate, vinblastine, doxorubicin and cisplatin (MVAC), then radical cystectomy
People
Grossman HB, senior author Crawford ED
Δ median OS+31 monthsΔ No residual disease at cystectomy+23 points
Show the numbers
Results reported for Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer
EndpointAnalysisMVAC then cystectomyCystectomy aloneEffect
OSprimaryGrossman 2003median 77 monthsmedian 46 monthsP=0.06 (two-sided stratified log-rank test)The abstract states that the median survival comparison is an intention-to-treat analysis and gives no hazard ratio or confidence intervals. Median follow-up is not given in the abstract.
No residual disease at cystectomyRandomised patients (denominator not stated in the abstract)primaryGrossman 200338%15%P<0.001
Results reported for Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer
EndpointAnalysisMVAC then cystectomyCystectomy aloneEffect
OSprimaryGrossman 2003median 77 monthsmedian 46 monthsP=0.06 (two-sided stratified log-rank test)The abstract states that the median survival comparison is an intention-to-treat analysis and gives no hazard ratio or confidence intervals. Median follow-up is not given in the abstract.
No residual disease at cystectomyRandomised patients (denominator not stated in the abstract)primaryGrossman 200338%15%P<0.001
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%050100150Months (modelled)
  • Cystectomy alone (control)
  • MVAC then cystectomy (experimental)

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

Data table (modelled values)
MonthsCystectomy aloneMVAC then cystectomy
0100.0%100.0%
4848.5%64.9%
9623.5%42.1%
14411.4%27.4%
1935.5%17.6%
Primary publication: Grossman HB, Natale RB, Tangen CM, Speights VO, Vogelzang NJ, Trump DL, et al. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. N Engl J Med. 2003;349(9):859-66. PubMedDOI

Appears in

Sources

  1. Grossman HB, Natale RB, Tangen CM, Speights VO, Vogelzang NJ, Trump DL, et al. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. N Engl J Med. 2003;349(9):859-66.

    PubMedDOI