Improved Outcome Reported With Local Consolidative Therapy in Oligometastatic NSCLC Without Progression After First-Line Systemic Therapy
In a phase II trial reported in The Lancet Oncology, Gomez et al found that local consolidative therapy (with or without maintenance therapy) improved progression-free survival in patients with stage IV non–small cell lung cancer (NSCLC) who had up to three metastatic disease lesions and no progression after first-line systemic therapy.
In the trial, 74 patients were enrolled from 2 U.S. sites and 1 Canadian site between November 2012 and January 2016 during or at completion of first-line systemic therapy. First-line therapy was 4 or more cycles of platinum doublet therapy or 3 or more months of epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) inhibitors for patients with EGFR mutations or ALK rearrangements.
Patients were randomized to receive either local consolidative therapy, consisting of (chemo)radiotherapy or resection of all lesions with or without subsequent maintenance treatment, or maintenance treatment alone. Maintenance treatment was selected by treating physicians from among a predefined set of standard-of-care options and could consist of observation only. The primary endpoint was progression-free survival.
Improved Progression-Free Survival
The study was terminated early after randomization of 49 patients, including 25 to the local consolidative group and 24 to the maintenance group, as part of annual analyses performed by the data safety monitoring committee for all randomized trials at The University of Texas MD Anderson Cancer Center; the study had not reached the planned interim analysis scheduled to occur at 44 events.
At a median follow-up of 12.39 months among the 49 randomized patients, median progression-free survival was 11.9 months (90% confidence interval [CI] = 5.7–20.9 months) in the local consolidative therapy group vs 3.9 months (90% CI = 2.3–6.6 months) in the maintenance group (hazard ratio = 0.35, P = .0054).
Adverse Events
Adverse events were similar in the two groups. Grade 3 adverse events consisted of esophagitis (n = 2), anemia (n = 1), pneumothorax (n = 1), and abdominal pain (n = 1) in the local consolidative group and fatigue (n = 1) and anemia (n = 1) in the maintenance therapy group. No grade 4 adverse events or deaths due to treatment were observed.
The investigators concluded: “Local consolidative therapy with or without maintenance therapy for patients with three or fewer metastases from NSCLC that did not progress after initial systemic therapy improved progression-free survival compared with maintenance therapy alone. These findings suggest that aggressive local therapy should be further explored in phase 3 trials as a standard treatment option in this clinical scenario.”
The study was funded by MD Anderson Lung Cancer Priority Fund, MD Anderson Cancer Center Moon Shot Initiative, and the National Cancer Institute.
Daniel R. Gomez, MD, of the Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, is the corresponding author of The Lancet Oncology article.
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