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February 08, 2023
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Sublobar resection may become new standard for early-stage lung cancer

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Patients who received sublobar resection for early-stage non-small cell lung cancer had similar 5-year DFS rates compared with those who underwent lobectomy, according to results of a randomized phase 3 study.

The findings — published in The New England Journal of Medicine — also showed similar OS with either method, which suggests sublobar resection could supplant lobectomy as the new standard of care for patients with early-stage, node-negative NSCLC whose tumors are 2 cm or smaller, the investigators noted.

Quote from Nasser Altorki, MD

“This means we can preserve more tissue,” Nasser Altorki, MD, chief of the division of thoracic surgery at Weill Cornell Medicine and NewYork-Presbyterian Hospital, told Healio. “This is important because patients with lung cancer often develop subsequent tumors, and it leaves us with the option to more precisely remove additional tissue if needed in the future.”

Background

The basis for the current standard surgical approach for early-stage NSCLC is based on a small, decades-old, randomized trial showing favorable results for lobectomy, according to Altorki.

"We hypothesized that our increased capability to locate small tumors via more precise imaging and our ability to correctly stage tumors may make the results from this older trial irrelevant,” he said. "We feel that today we can more accurately select patients who would benefit from sublobar resection."

Methodology

CALGB 140503, a multicenter phase 3 noninferiority trial, compared outcomes of patients after sublobar resection or lobar resection of early-stage NSCLC.

The study included 697 patients (median age, 67.9 years; range, 37.8-89.7; 90% white; 57.4% women; 91% current or former smokers) with confirmed node-negative stage T1aN0 (tumor size 2 cm) NSCLC randomly assigned 1:1 to undergo either sublobar resection (n = 340) or lobar resection (n = 357).

DFS — defined as the time between randomization and disease recurrence or death due to any cause — served as the study’s primary endpoint. Secondary endpoints included OS, locoregional and systemic recurrence, and pulmonary function.

Median follow-up was 7 years.

Key findings

The investigators reported noninferior DFS between the treatment groups (HR = 1.01; 90% CI, 0.83-1.24), with 5-year DFS rates of 63.6% (95% CI, 57.9-68.8) for the sublobar resection group and 64.1% (95% CI, 58.5-69) for the lobar resection group.

The groups also had similar OS (HR = 0.95; 95% CI, 0.72-1.26), with 5-year OS rates of 80.3% (95% CI, 75.5-84.3) with sublobar resection and 78.9% (95% CI, 74.1-82.9) with lobar resection.

The investigators did not observe any substantial difference between treatment groups regarding the incidence of locoregional or distant disease recurrence.

A 6-month postoperative evaluation of pulmonary function showed a between-group difference of 2 percentage points in median percentage of predicted forced expiratory volume in 1 second in favor of the sublobar resection group.

Clinical implications

The results showed that removing less lung tissue is possible for patients with early-stage disease without affecting outcomes, but Altorki cautioned that lobectomy would still be the preferred approach unless patient tumors match the criteria of those treated in his group's trial.

“Removing less than an entire lobe is an acceptable treatment for patients who have small tumors and no lymph node involvement,” he said. "This new standard would apply to a highly selected group of patients."

Results of the study help confirm that “the era of precision surgery for NSCLC has arrived,” Valerie W. Rusch, MD, vice chair for clinical research in the department of surgery and Miner Family chair in intrathoracic cancers at Memorial Sloan Kettering Cancer Center, wrote in an accompanying editorial.

Rusch additionally highlighted results of a recent Japan-based randomized noninferiority trial (JCOG0802) that showed segmentectomy to be noninferior in terms of RFS and OS compared with lobectomy after more than 7 years of follow-up among patients with stage T1a-bN0 NSCLC.

“These two landmark trials are practice-changing because they establish sublobar resection as the standard of care for a select group of patients with NSCLC,” Rusch wrote. “As CT screening becomes more widespread, this patient population will increase in clinical practice. Although all these operations are now safe, sublobar resection is associated with an even lower risk than lobectomy.”

References:

For more information:

Nasser Altorki, MD, can be reached at Weill Cornell Medicine, New York–Presbyterian Hospital, 1300 York Ave., New York, NY 10065; email: nkaltork@med.cornell.edu.