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Clinical Trial
. 2023 Feb 9;388(6):489-498.
doi: 10.1056/NEJMoa2212083.

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

Nasser Altorki  1 , Xiaofei Wang  1 , David Kozono  1 , Colleen Watt  1 , Rodney Landrenau  1 , Dennis Wigle  1 , Jeffrey Port  1 , David R Jones  1 , Massimo Conti  1 , Ahmad S Ashrafi  1 , Moishe Liberman  1 , Kazuhiro Yasufuku  1 , Stephen Yang  1 , John D Mitchell  1 , Harvey Pass  1 , Robert Keenan  1 , Thomas Bauer  1 , Daniel Miller  1 , Leslie J Kohman  1 , Thomas E Stinchcombe  1 , Everett Vokes  1
Affiliations
Clinical Trial

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

Nasser Altorki et al. N Engl J Med. .

Abstract

Background: The increased detection of small-sized peripheral non-small-cell lung cancer (NSCLC) has renewed interest in sublobar resection in lieu of lobectomy.

Methods: We conducted a multicenter, noninferiority, phase 3 trial in which patients with NSCLC clinically staged as T1aN0 (tumor size, ≤2 cm) were randomly assigned to undergo sublobar resection or lobar resection after intraoperative confirmation of node-negative disease. The primary end point was disease-free survival, defined as the time between randomization and disease recurrence or death from any cause. Secondary end points were overall survival, locoregional and systemic recurrence, and pulmonary functions.

Results: From June 2007 through March 2017, a total of 697 patients were assigned to undergo sublobar resection (340 patients) or lobar resection (357 patients). After a median follow-up of 7 years, sublobar resection was noninferior to lobar resection for disease-free survival (hazard ratio for disease recurrence or death, 1.01; 90% confidence interval [CI], 0.83 to 1.24). In addition, overall survival after sublobar resection was similar to that after lobar resection (hazard ratio for death, 0.95; 95% CI, 0.72 to 1.26). The 5-year disease-free survival was 63.6% (95% CI, 57.9 to 68.8) after sublobar resection and 64.1% (95% CI, 58.5 to 69.0) after lobar resection. The 5-year overall survival was 80.3% (95% CI, 75.5 to 84.3) after sublobar resection and 78.9% (95% CI, 74.1 to 82.9) after lobar resection. No substantial difference was seen between the two groups in the incidence of locoregional or distant recurrence. At 6 months postoperatively, a between-group difference of 2 percentage points was measured in the median percentage of predicted forced expiratory volume in 1 second, favoring the sublobar-resection group.

Conclusions: In patients with peripheral NSCLC with a tumor size of 2 cm or less and pathologically confirmed node-negative disease in the hilar and mediastinal lymph nodes, sublobar resection was not inferior to lobectomy with respect to disease-free survival. Overall survival was similar with the two procedures. (Funded by the National Cancer Institute and others; CALGB 140503 ClinicalTrials.gov number, NCT00499330.).

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Figures

Figure 1.
Figure 1.. Disease-free and Overall Survival.
The shaded areas indicate 95% confidence intervals.
Figure 2.
Figure 2.. Exploratory Subgroup Analysis of Disease-free Survival.
Hazard ratios and 95% confidence intervals were estimated with the use of unstratified Cox proportional-hazards models. The size of the squares indicating the hazard ratios is proportional to the number of patients included in the analysis. Eastern Cooperative Oncology Group (ECOG) performance-status scores range from 0 to 5, with higher scores indicating greater disability.
Figure 3.
Figure 3.. Recurrence-free Survival and Cause of Death.
Panel A shows recurrence-free survival in the intention-to-treat population. Recurrence-free survival was defined as the time between randomization and the occurrence of locoregional or distant recurrence; all other events, including death from any cause, were censored at the occurrence of these events. The shaded areas indicate 95% confidence intervals. Panel B shows cumulative-incidence functions for death related to lung cancer as compared with death not related to lung cancer; four patients with an unknown cause of death (three in the lobar-resection group and one in the sublobar-resection group) were excluded from the analysis. In both panels, the widths of the confidence intervals have not been adjusted for multiplicity and may not be used in place of hypothesis testing.
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