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INTERLACE

Induction chemotherapy followed by standard chemoradiotherapy versus standard chemoradiotherapy alone in patients with locally advanced cervical cancer (GCIG INTERLACE)

Phase 3N = 500NCT01566240

Population
Adults with locally advanced cervical cancer: FIGO 2008 stage IB1 with nodal involvement, or stage IB2, IIA, IIB, IIIB or IVA; 70% had stage IIB and 43% positive pelvic lymph nodes
Design
Multicentre, randomised (1:1) phase 3 trial at 32 medical centres in Brazil, India, Italy, Mexico and the UK. Control: cisplatin 40 mg/m2 weekly for 5 weeks with 45.0-50.4 Gy external-beam radiotherapy plus brachytherapy (minimum total 78-86 Gy equivalent dose in 2 Gy fractions). Experimental: six weekly doses of carboplatin (AUC 2) and paclitaxel 80 mg/m2, then the same chemoradiotherapy.
Primary endpoint
PFS, OS
Arms
  • Standard chemoradiotherapy alone (control, n = 250): Weekly cisplatin 40 mg/m2 for 5 weeks with external-beam radiotherapy and brachytherapy
  • Induction chemotherapy then chemoradiotherapy (experimental, n = 250): Weekly carboplatin (AUC 2) and paclitaxel 80 mg/m2 for 6 weeks, then standard cisplatin chemoradiotherapy
People
McCormack M, Gynecologic Cancer InterGroup
PFSHR 0.65 (95% CI 0.46–0.91)Δ 60-month PFS+8 pointsOSHR 0.60 (95% CI 0.40–0.91)Δ 60-month OS+8 points
Show the numbers
Results reported for INTERLACE
EndpointAnalysisInduction chemotherapy then chemoradiotherapyStandard chemoradiotherapy aloneEffect
PFSprimarymedian follow-up 67 monthsMcCormack 202472% at 5 y64% at 5 yHR 0.65 (95% CI 0.46–0.91)P=0.013Grade 3 or greater adverse events: 147 of 250 (59%) in the induction group versus 120 of 250 (48%) with chemoradiotherapy alone.
OSprimarymedian follow-up 67 monthsMcCormack 202480% at 5 y72% at 5 yHR 0.60 (95% CI 0.40–0.91)P=0.015
Results reported for INTERLACE
EndpointAnalysisInduction chemotherapy then chemoradiotherapyStandard chemoradiotherapy aloneEffect
PFSprimarymedian follow-up 67 monthsMcCormack 202472% at 5 y64% at 5 yHR 0.65 (95% CI 0.46–0.91)P=0.013Grade 3 or greater adverse events: 147 of 250 (59%) in the induction group versus 120 of 250 (48%) with chemoradiotherapy alone.
OSprimarymedian follow-up 67 monthsMcCormack 202480% at 5 y72% at 5 yHR 0.60 (95% CI 0.40–0.91)P=0.015
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.650.46–0.91
OS0.60.4–0.91
Primary publication: McCormack M, Eminowicz G, Gallardo D, Diez P, Farrelly L, Kent C, et al. Induction chemotherapy followed by standard chemoradiotherapy versus standard chemoradiotherapy alone in patients with locally advanced cervical cancer (GCIG INTERLACE): an international, multicentre, randomised phase 3 trial. Lancet. 2024;404(10462):1525-1535. PubMedDOI

Appears in

Sources

  1. McCormack M, Eminowicz G, Gallardo D, Diez P, Farrelly L, Kent C, et al. Induction chemotherapy followed by standard chemoradiotherapy versus standard chemoradiotherapy alone in patients with locally advanced cervical cancer (GCIG INTERLACE): an international, multicentre, randomised phase 3 trial. Lancet. 2024;404(10462):1525-1535.

    PubMedDOI