Patients with T1aN0 NSCLC have typically been treated with lobectomy versus sublobar resection, according to Nasser Altorki, MD, based on previous research that revealed worse outcomes with sublobar resection, such as an increase in local recurrence and cancer-related mortality. Dr. Nasser and colleagues sought to evaluate sublobar resection versus lobectomy for the treatment of patients with peripheral NSCLC with a tumor size of 2 cm or less and node-negative disease in the mediastinal and hilar lymph nodes. The findings were published in The New England Journal of Medicine.
Disease-Free Survival Was Primary Endpoint
“Advances in imaging and staging methods since those initial studies, as well as new research showing the noninferiority of sublobar resection, have now reopened the debate,” the study authors wrote. They conducted a multicenter, noninferiority, phase 3 trial that included patients with NSCLC clinically staged as T1aN0. Patients were randomly assigned to undergo sublobar resection or lobar resection after intraoperative confirmation of nodenegative disease. The primary endpoint, according to Dr. Nasser, was disease-free survival (DFS), which was defined as the time between randomization and disease recurrence or death from any cause. Secondary endpoints were pulmonary function, locoregional and systemic recurrence, and overall survival (OS).
The study team found similar 5-year OS, DFS, and recurrence rates in both groups; 63.6% in the sublobar resection group versus 64.1% in the lobar resection group with HR 1.01 for DFS, 80.3% versus 78.9% HR 0.95 for OS, and 70.2% versus 71.2% and an HR 1.05 for recurrence rate.
At 6 months postoperatively, mean expiratory flow rates were tested. Compared with the sublobar resection group (−4.0 and −3.0, respectively), researchers observed that both FEV1 and FVC had a greater reduction in the lobar resection group (−6.0 and −5.0 respectively). “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,” Dr. Nasser wrote. “Overall survival was similar with the two procedures,” Dr. Nasser and colleagues wrote.
Total Deaths From Lung Cancer & Other Causes Similar in Both Groups
In the sublobar resection group, the 5-year recurrence-free survival was 70.2% (95% CI, 64.6-75.1) versus 71.2% (95% CI, 65.8-75.9) in the lobar resection group (HR, 1.05; 95% CI, 0.80-1.39).
Across both groups, total deaths from lung cancer and other causes of death were similar. Expiratory flow rates were tested at 6 months postoperatively, and FEV1 was found to have a greater reduction in the lobar resection group (−6.0; 95% CI, −8.0 to −5.0) compared with the sublobar resection group (−4.0; 95% CI, −5.0 to −2.0).
Similarly, FVC was found to have a greater reduction in the lobar resection group (−5.0; 95% CI, −7.0 to −3.0) compared with the sublobar resection group (−3.0; 95% CI, −4.0 to −1.0). Overall, this study found that sublobar resection is non-inferior to lobar resection for patients with T1aN0 disease.
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