7‐year follow‐up after stereotactic ablative radiotherapy for patients with stage I non–small cell lung cancer: Results of a phase 2 clinical trial

Abstract

Background We evaluated the efficacy, pattern of failure, and toxicity of stereotactic ablative radiotherapy (SABR) for medically inoperable clinical stage I non-small cell lung cancer (NSCLC) in a prospective clinical trial with 7 years follow-up. Methods Eligible patients with histologically confirmed NSCLC and PET clinically staged I disease were treated with SABR (50 Gy in 4 fractions). The primary endpoint was progression-free survival (PFS). Patients were followed with CT/PET-CT every 3 months for the first two years, then every 6 months for the next three years and then annually thereafter. Results Sixty-five patients were eligible for analysis. The median age was 71 years, and median follow-up was 7.2 years. A total of 18 (27.7%) patients had disease recurrence at a median of 14.5 months (range 4.3–71.5) after SABR. Estimated incidences of local, regional, and distant recurrence using competing risk analysis were 8.1%, 10.9%, and 11.0% at 5 years, respectively, and 8.1%, 13.6%, and 13.8% at 7 years. Second primary lung carcinoma (SPLC) developed in 12 (18.5%) patients at a median of 35 months (range 5–67) after SABR. Estimated 5- and 7-year PFS rates were 49.5% and 38.2%, respectively; corresponding overall survival rates were 55.7% and 47.5%. Three (4.6%) patients had grade 3 treatment-related adverse events. No patients had grade 4 or 5 events. Conclusion With long-term follow-up, our prospective study demonstrated outstanding local control and low toxicity after SABR in clinical stage I NSCLC. Regional recurrence and distant metastases were the dominant manifestations of failure. Surveillance for SPLC is recommended.

Radiotherapy improves the survival of patients with stage IV NSCLC: A propensity score matched analysis of the SEER database

“…It has been shown that using RT to control primary and metastatic tumors can reduce intra‐thoracic disease burden, bronchial/vascular compression, and pulmonary symptoms . In addition, local control of primary and metastatic tumors might result in better OS . Recently, a phase III randomized controlled trial (RCT) showed that thoracic radiotherapy (TRT) also improved OS of patients with extensive‐stage small cell lung cancer (SCLC) who responded to chemotherapy .…”

Stereotactic ablative radiotherapy of 60 Gy in eight fractions is safe for ultracentral non‐small cell lung cancer

“…RTOG 0236 suggested that peripheral stage I non‐small cell tumors treated with SABR could achieve acceptable local control (LC) and overall survival (OS) . A phase 3 randomized trial comparing SABR with surgery has suggested that SABR was better tolerated and might lead to better OS compared with surgery for operable clinical stage I NSCLC . In the past, we preferred to treat peripheral lung tumors with SABR, which has been proven safe and efficient.…”

Lobectomy versus stereotactic ablative radiotherapy for medically operable patients with stage IA non‐small cell lung cancer: A virtual randomized phase III trial stratified by age

“…Lobectomy is undoubtedly the standard of care for operable early‐stage NSCLC in the current situation where there are no randomized trials comparing SABR with lobectomy. However, most of the previously reported studies on lobectomy included young patients with an average age of 65 years, while those on SABR included older patients with an average age of 75 years . As a result, it is difficult to compare the overall survival between the two procedures directly using the existing research designs including patients of different age distributions.…”

“…Solitary distant metastasis or secondary primary lung cancer also could be re‐treated with SABR or surgery. However, our tumor board determined that the likelihood of either of these procedures affecting the outcome would be low because the probability of occurrence is unknown, could fall within a very wide range and be similar in both groups . As a result, all distant metastases were not considered as candidates for salvage treatment and secondary primary lung cancer was not reflected in this scenario to simplify the Markov model.…”

“…Lobectomy with sampling or dissection of mediastinal lymph nodes is the standard of care for early‐stage non‐small cell lung cancer (NSCLC). In the past decade, stereotactic ablative radiotherapy (SABR) has emerged as the preferred treatment for medically inoperable and operable early‐stage NSCLC . Compared with conventional radiation therapy, SABR delivers ablative doses of radiation (biologically effective dose [BED] >100 Gy), in fewer fractions as highly conformal beams with the goal of delivering radiation to the tumor while sparing nearby, crucial, normal structures from radiation‐induced damage.…”