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JCOG0802/WJOG4607L

Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial

Phase 3N = 1,106

Population
Patients with clinical stage IA non-small cell lung cancer, tumour diameter 2 cm or less and consolidation-to-tumour ratio above 0.5 (small-sized peripheral tumours).
Design
Multicentre, open-label, phase 3, randomised (1:1, minimisation), non-inferiority trial at 70 institutions in Japan, enrolled 10 August 2009 to 21 October 2014. Overall survival in all randomly assigned patients, analysed by intention to treat with a stratified Cox model and a non-inferiority margin of 1.54 for the upper limit of the 95% CI of the hazard ratio. In the segmentectomy group 22 patients were switched to lobectomy and one received wide wedge resection. Registered with UMIN (UMIN000002317).
Primary endpoint
OS
Arms
  • Lobectomy (control, n = 554): Lobectomy
  • Segmentectomy (experimental, n = 552): Segmentectomy
People
Saji H, West Japan Oncology Group and Japan Clinical Oncology Group
OSHR 0.663 (95% CI 0.474–0.927)Δ 60-month OS+3.2 pointsRFSHR 0.998 (95% CI 0.753–1.323)Δ 60-month RFS+0.1 pointsΔ Proportion with local relapse+5.1 points
Show the numbers
Results reported for JCOG0802/WJOG4607L
EndpointAnalysisSegmentectomyLobectomyEffect
OSprimarymedian follow-up 7.3 yearsSaji 202294.3% at 5 y (92.1–96.0%)91.1% at 5 y (88.4–93.2%)HR 0.663 (95% CI 0.474–0.927)P=one-sided p<0.0001 for non-inferiority; p=0.0082 for superiorityHazard ratio is segmentectomy versus lobectomy from a stratified Cox model; non-inferiority margin 1.54 for the upper limit of the 95% CI. Follow-up range 0.0 to 10.9 years.
RFSprimarymedian follow-up 7.3 yearsSaji 202288% at 5 y (85.0–90.4%)87.9% at 5 y (84.8–90.3%)HR 0.998 (95% CI 0.753–1.323)P=0.9889Relapse-free survival is a secondary endpoint of the trial.
Proportion with local relapseprimarySaji 202210.5%5.4%P=0.0018Crude proportions of patients with local relapse, a secondary endpoint; no time point or confidence interval is given in the abstract.
Results reported for JCOG0802/WJOG4607L
EndpointAnalysisSegmentectomyLobectomyEffect
OSprimarymedian follow-up 7.3 yearsSaji 202294.3% at 5 y (92.1–96.0%)91.1% at 5 y (88.4–93.2%)HR 0.663 (95% CI 0.474–0.927)P=one-sided p<0.0001 for non-inferiority; p=0.0082 for superiorityHazard ratio is segmentectomy versus lobectomy from a stratified Cox model; non-inferiority margin 1.54 for the upper limit of the 95% CI. Follow-up range 0.0 to 10.9 years.
RFSprimarymedian follow-up 7.3 yearsSaji 202288% at 5 y (85.0–90.4%)87.9% at 5 y (84.8–90.3%)HR 0.998 (95% CI 0.753–1.323)P=0.9889Relapse-free survival is a secondary endpoint of the trial.
Proportion with local relapseprimarySaji 202210.5%5.4%P=0.0018Crude proportions of patients with local relapse, a secondary endpoint; no time point or confidence interval is given in the abstract.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSRFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.6630.474–0.927
RFS0.9980.753–1.323
Primary publication: Saji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, et al. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial. Lancet. 2022;399(10335):1607-1617. PubMedDOI

Appears in

Sources

  1. Saji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, et al. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial. Lancet. 2022;399(10335):1607-1617.

    PubMedDOI