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Bending the Curve Trial by Trial
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SCORPION

Randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer (SCORPION-NCT01461850)

Phase 3N = 171NCT01461850

Population
Stage IIIC to IV epithelial ovarian, fallopian tube or primary peritoneal cancer with high tumour load assessed by a laparoscopic predictive index
Design
Patients with stage IIIC to IV epithelial ovarian, fallopian tube or primary peritoneal cancer underwent laparoscopy; those with high tumour load by a standardised laparoscopic predictive index were randomly assigned 1:1 to primary debulking surgery then adjuvant chemotherapy, or neoadjuvant chemotherapy then interval debulking surgery and adjuvant chemotherapy. Co-primary outcomes were progression-free survival and postoperative complications. The phase is taken from the ClinicalTrials.gov record (not stated in the abstract).
Primary endpoint
PFS, Postoperative complications
Arms
  • Primary debulking surgery (control, n = 84): Primary debulking surgery followed by adjuvant chemotherapy
  • Neoadjuvant chemotherapy (experimental, n = 87): Neoadjuvant chemotherapy followed by interval debulking surgery and adjuvant chemotherapy
People
Fagotti A
PFSHR 1.05 (95% CI 0.77–1.44)Δ median PFS−1 monthsOSHR 1.12 (95% CI 0.76–1.65)Δ median OS+2 monthsΔ Complete resection rate+29.4 pointsΔ Postoperative complications−18.3 points
Show the numbers
Results reported for SCORPION
EndpointAnalysisNeoadjuvant chemotherapyPrimary debulking surgeryEffect
PFSIntention-to-treat population (171 patients)primarymedian follow-up 59 monthsFagotti 2020median 14 monthsmedian 15 monthsHR 1.05 (95% CI 0.77–1.44)P=0.73The abstract does not state which arm is the reference for the hazard ratio. Overall median follow-up 59 months (95% CI 53 to 64); 142 progressions or recurrences.
OSIntention-to-treat population (171 patients)primarymedian follow-up 59 monthsFagotti 2020median 43 monthsmedian 41 monthsHR 1.12 (95% CI 0.76–1.65)P=0.56Secondary outcome in this report. The abstract does not state which arm is the reference for the hazard ratio. 103 deaths overall.
Complete resection rateIntention-to-treat population (171 patients)Complete resection (R0) at primary debulking surgery or at interval debulking surgery.primaryFagotti 202077%47.6%P=0.001
Postoperative complicationsIntention-to-treat population (171 patients)Major postoperative complications (53 registered), more frequent after primary debulking surgery.primaryFagotti 20207.6%25.9%P=0.0001
Results reported for SCORPION
EndpointAnalysisNeoadjuvant chemotherapyPrimary debulking surgeryEffect
PFSIntention-to-treat population (171 patients)primarymedian follow-up 59 monthsFagotti 2020median 14 monthsmedian 15 monthsHR 1.05 (95% CI 0.77–1.44)P=0.73The abstract does not state which arm is the reference for the hazard ratio. Overall median follow-up 59 months (95% CI 53 to 64); 142 progressions or recurrences.
OSIntention-to-treat population (171 patients)primarymedian follow-up 59 monthsFagotti 2020median 43 monthsmedian 41 monthsHR 1.12 (95% CI 0.76–1.65)P=0.56Secondary outcome in this report. The abstract does not state which arm is the reference for the hazard ratio. 103 deaths overall.
Complete resection rateIntention-to-treat population (171 patients)Complete resection (R0) at primary debulking surgery or at interval debulking surgery.primaryFagotti 202077%47.6%P=0.001
Postoperative complicationsIntention-to-treat population (171 patients)Major postoperative complications (53 registered), more frequent after primary debulking surgery.primaryFagotti 20207.6%25.9%P=0.0001
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS1.050.77–1.44
OS1.120.76–1.65
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0102030Months (modelled)
  • Primary debulking surgery (control)
  • Neoadjuvant chemotherapy (experimental)

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

Data table (modelled values)
MonthsPrimary debulking surgeryNeoadjuvant chemotherapy
0100.0%100.0%
966.0%64.0%
1941.6%39.0%
2827.4%25.0%
3817.3%15.2%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%020406080100Months (modelled)
  • Primary debulking surgery (control)
  • Neoadjuvant chemotherapy (experimental)

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

Data table (modelled values)
MonthsPrimary debulking surgeryNeoadjuvant chemotherapy
0100.0%100.0%
2763.4%64.7%
5440.1%41.9%
8125.4%27.1%
10816.1%17.5%
Primary publication: Fagotti A, Ferrandina MG, Vizzielli G, Pasciuto T, Fanfani F, Gallotta V, et al. Randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer (SCORPION-NCT01461850). Int J Gynecol Cancer. 2020;30(11):1657-1664. PubMedDOI

Appears in

Sources

  1. Fagotti A, Ferrandina MG, Vizzielli G, Pasciuto T, Fanfani F, Gallotta V, et al. Randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer (SCORPION-NCT01461850). Int J Gynecol Cancer. 2020;30(11):1657-1664.

    PubMedDOI