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Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial

Phase 3N = 322NCT00241670

Population
Patients aged 23 to 73 years with suspected malignant glioma amenable to complete resection of contrast-enhancing tumour; interim full-analysis population 270 (139 and 131) after central review excluded ineligible histology and imaging
Design
Randomised, controlled, multicentre phase 3 trial; 5-aminolevulinic acid 20 mg/kg for fluorescence-guided resection versus conventional microsurgery with white light; primary endpoints were absence of contrast-enhancing tumour on early postoperative MRI (within 72 h) and 6-month progression-free survival by MRI; interim analysis in 270 patients (full-analysis population) terminated the study as defined by the protocol
Primary endpoint
PFS, Complete resection of contrast-enhancing tumour
Arms
  • 5-ALA fluorescence-guided resection (experimental, n = 161): 5-aminolevulinic acid 20 mg/kg body weight with fluorescence-guided resection
  • White-light microsurgery (control, n = 161): Conventional microsurgery with white light
People
Stummer W, senior author Reulen HJ, ALA-Glioma Study Group
Δ Complete resection of contrast-enhancing tumour+29 pointsΔ 6-month PFS+19.9 points
Show the numbers
Results reported for Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial
EndpointAnalysis5-ALA fluorescence-guided resectionWhite-light microsurgeryEffect
Complete resection of contrast-enhancing tumourInterim full-analysis population (n=270: 139 5-ALA, 131 white light)Absence of contrast-enhancing tumour on MRI within 72 hours after surgeryinterimmedian follow-up 35.4 monthsStummer 200665%36%P<0.0001Complete resection was in 90 of 139 patients assigned 5-ALA and 47 of 131 assigned white light; difference between groups 29% (95% CI 17 to 40).
PFSInterim full-analysis population (n=270: 139 5-ALA, 131 white light)Progression-free survival at 6 months, assessed by MRIinterimmedian follow-up 35.4 monthsStummer 200641% at 6 mo (32.8–49.2%)21.1% at 6 mo (14.0–28.2%)P=0.0003Six-month progression-free survival as assessed by MRI; difference between groups 19.9% (95% CI 9.1 to 30.7). Median follow-up 35.4 months (95% CI 1.0 to 56.7).
Results reported for Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial
EndpointAnalysis5-ALA fluorescence-guided resectionWhite-light microsurgeryEffect
Complete resection of contrast-enhancing tumourInterim full-analysis population (n=270: 139 5-ALA, 131 white light)Absence of contrast-enhancing tumour on MRI within 72 hours after surgeryinterimmedian follow-up 35.4 monthsStummer 200665%36%P<0.0001Complete resection was in 90 of 139 patients assigned 5-ALA and 47 of 131 assigned white light; difference between groups 29% (95% CI 17 to 40).
PFSInterim full-analysis population (n=270: 139 5-ALA, 131 white light)Progression-free survival at 6 months, assessed by MRIinterimmedian follow-up 35.4 monthsStummer 200641% at 6 mo (32.8–49.2%)21.1% at 6 mo (14.0–28.2%)P=0.0003Six-month progression-free survival as assessed by MRI; difference between groups 19.9% (95% CI 9.1 to 30.7). Median follow-up 35.4 months (95% CI 1.0 to 56.7).
Primary publication: Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006;7(5):392-401. PubMedDOI

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Sources

  1. Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006;7(5):392-401.

    PubMedDOI