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CALGB 140503

Lobar or Sublobar Resection for Peripheral Stage IA Non-Small-Cell Lung Cancer

Phase 3N = 697NCT00499330

Population
Patients with peripheral non-small cell lung cancer clinically staged T1aN0 (tumour size 2 cm or less) and pathologically confirmed node-negative disease in the hilar and mediastinal lymph nodes.
Design
Multicentre, noninferiority, phase 3 trial; randomised from June 2007 through March 2017, after intraoperative confirmation of node-negative disease, to sublobar resection or lobar resection. Primary end point disease-free survival (randomization to recurrence or death from any cause); secondary end points overall survival, locoregional and systemic recurrence, and pulmonary function. Type of sublobar resection (wedge resection or segmentectomy) at the surgeon's discretion (full text).
Primary endpoint
DFS
Arms
  • Lobar resection (control, n = 357): Lobar resection
  • Sublobar resection (experimental, n = 340): Sublobar resection
People
Altorki N, CALGB (now part of the Alliance for Clinical Trials in Oncology)
DFSHR 1.01Δ 60-month DFS−0.5 pointsOSHR 0.95 (95% CI 0.72–1.26)Δ 60-month OS+1.4 points
Show the numbers
Results reported for CALGB 140503
EndpointAnalysisSublobar resectionLobar resectionEffect
DFSITT population (697 randomised)primarymedian follow-up 7 yearsAltorki 202363.6% at 5 y (57.9–68.8%)64.1% at 5 y (58.5–69.0%)HR 1.01Hazard ratio for disease recurrence or death was 1.01 with a 90% confidence interval of 0.83 to 1.24 (not a 95% CI, so not entered in the CI field). Sublobar resection was noninferior for disease-free survival.
OSITT population (697 randomised)primarymedian follow-up 7 yearsAltorki 202380.3% at 5 y (75.5–84.3%)78.9% at 5 y (74.1–82.9%)HR 0.95 (95% CI 0.72–1.26)Overall survival is a secondary end point; the abstract describes it as similar with the two procedures.
Results reported for CALGB 140503
EndpointAnalysisSublobar resectionLobar resectionEffect
DFSITT population (697 randomised)primarymedian follow-up 7 yearsAltorki 202363.6% at 5 y (57.9–68.8%)64.1% at 5 y (58.5–69.0%)HR 1.01Hazard ratio for disease recurrence or death was 1.01 with a 90% confidence interval of 0.83 to 1.24 (not a 95% CI, so not entered in the CI field). Sublobar resection was noninferior for disease-free survival.
OSITT population (697 randomised)primarymedian follow-up 7 yearsAltorki 202380.3% at 5 y (75.5–84.3%)78.9% at 5 y (74.1–82.9%)HR 0.95 (95% CI 0.72–1.26)Overall survival is a secondary end point; the abstract describes it as similar with the two procedures.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.950.72–1.26
Primary publication: Altorki N, Wang X, Kozono D, Watt C, Landrenau R, Wigle D, et al. Lobar or Sublobar Resection for Peripheral Stage IA Non-Small-Cell Lung Cancer. N Engl J Med. 2023;388(6):489-498. PubMedDOI

Appears in

Sources

  1. Altorki N, Wang X, Kozono D, Watt C, Landrenau R, Wigle D, et al. Lobar or Sublobar Resection for Peripheral Stage IA Non-Small-Cell Lung Cancer. N Engl J Med. 2023;388(6):489-498.

    PubMedDOI