10-year clinical trial report finds radiation comparable to surgery for early-stage non-small cell lung cancer

A new clinical trial report finds that stereotactic radiation therapy offers long-term survival outcomes comparable to surgery for patients with small, early-stage non-small cell lung cancer (NSCLC). Patients in the study who received radiation also reported fewer side effects after treatment.

The STARS trial (NCT02357992) is the first to report 10-year clinical outcomes from a prospective comparison of stereotactic radiation and surgical resection for operable NSCLC. Findings were presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting.

“Our study confirms, based on a decade of data, that stereotactic radiotherapy is a strong alternative to surgery for most patients with operable stage I NSCLC,” said Joe Y. Chang, MD, Ph.D., FASTRO, senior author of the study and professor of thoracic radiation oncology and director of stereotactic ablative radiotherapy at the University of Texas MD Anderson Cancer Center.

“This highly targeted, noninvasive treatment achieved the same long-term overall survival as lobectomy, while offering many patients an easier recovery and potentially better quality of life.”

Lung cancer is the leading cause of cancer death in the U.S. and worldwide, though survival rates have improved in recent years due to treatment advances and earlier detection through screening programs. NSCLC accounts for more than 85% of all lung cancers, including among the estimated 226,650 U.S. adults expected to be newly diagnosed with the disease in 2025.

Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT), involves delivering high doses of radiation with pinpoint accuracy over typically five or fewer treatment sessions. It is the standard of care for patients with early-stage NSCLC who cannot undergo surgery, and growing evidence suggests it may offer survival benefits comparable to surgery even for patients who are eligible for surgery.

“Surgery historically was the only standard option for early-stage NSCLC, but upwards of 50% of patients experience moderate or severe side effects afterward. And as patients age, many cannot tolerate surgery, so there’s a growing demand for noninvasive options that provide durable local control,” said Dr. Chang.

“This study offers the clearest picture yet that radiation can also be an appealing option for suitable surgical candidates. It included a larger patient population than previously published randomized studies, and we’ve followed these patients for much longer.”

In the phase II trial, researchers enrolled 80 patients with tumors smaller than 3 centimeters, no lymph node involvement and no distant metastases to receive SABR, given in three or four sessions. The SABR group was matched with a surgical cohort of 80 patients who received video-assisted thoracoscopic (VATS) lobectomy with mediastinal lymph node removal.

Surgical patients were selected from an institutional dataset of patients prospectively registered during the same time window, matched to the SABR cohort for age, gender, tumor size and health status.

All patients in the trial were healthy enough to undergo either surgery or radiation and were treated at MD Anderson between 2015 and 2017. Researchers followed both groups for up to 10 years to track survival, recurrence, side effects, quality of life and financial impact.

After a median follow-up of 8.3 years, overall survival was virtually identical between groups: 69% of patients treated with SABR and 66% treated with surgery were alive 10 years after treatment. The rates of lung-cancer specific survival (92% vs. 89%, respectively) and recurrence-free survival (57% vs. 65%) were also similar for both patient cohorts.

Dr. Chang and his colleagues previously reported three- and five-year overall survival rates of 91% and 87% following SABR.

They also reported minimal side effects following radiotherapy, with no treatment-related hospitalizations or deaths and only three isolated cases of grade 2–3 side effects. Most patients who reported long-term outcomes in the trial maintained good quality of life after treatment, he said.

Some patients with larger or more complex tumors remain better candidates for surgery, explained Dr. Chang. He also stressed the importance of multidisciplinary collaboration between thoracic surgeons and radiation oncologists in caring for these patients and the need to carefully monitor patients who receive SABR over time for possible recurrences.

The researchers are now exploring strategies to further reduce recurrence rates, including pairing local therapies with immunotherapy and using artificial intelligence tools to predict hidden lymph node involvement before it appears on PET/CT scans, said Dr. Chang.

“While SABR has delivered excellent long-term results, up to a third of patients treated with local therapies still developed locoregional or distant recurrences from this aggressive cancer. Our goal is to find new ways to push survival even higher.”