Measuring the Integration of Stereotactic Ablative Radiotherapy Plus Surgery for Early-Stage Non–Small Cell Lung Cancer

Abstract

IMPORTANCE Stereotactic ablative radiotherapy (SABR) is a standard treatment option in patients with medically inoperable early-stage non-small cell lung cancer (NSCLC), yet the pathologic complete response (pCR) rate after SABR is unknown. Neoadjuvant SABR in patients with cancer who are fit for resection has been hypothesized to improve local control and induce antitumor immune activity, potentially leading to better outcomes.OBJECTIVES To determine the pCR rate after SABR and to assess oncologic and toxicity outcomes after a combined approach of neoadjuvant SABR followed by surgery. DESIGN, SETTING, AND PARTICIPANTSA phase 2, single-arm trial, with patient accrual from September 30, 2014, to August 15, 2017 (median follow-up, 19 months), was performed at a tertiary academic cancer center. Patients 18 years or older with T1T2N0M0 NSCLC and good performance status, with adequate pulmonary reserve to undergo surgical resection, were studied.INTERVENTIONS Patients underwent neoadjuvant SABR using a risk-adapted fractionation scheme followed by surgery 10 weeks later. MAIN OUTCOMES AND MEASURESThe pCR rate as determined by hematoxylin-eosin staining.RESULTS Forty patients (mean [SD] age, 68 [8] years; 23 [58%] female) were enrolled. Thirty-five patients underwent surgery and were evaluable for the primary end point. The pCR rate was 60% (95% CI, 44%-76%). The 30-and 90-day postoperative mortality rates were both 0%. Grade 3 or 4 toxic effects occurred in 7 patients (18%). In patients receiving surgery, 2-year overall survival was 77% (95% CI, 48%-91%), local control was 100% (95% CI, not defined), regional control was 53% (95% CI, 22%-76%), and distant control was 76% (95% CI, 45%-91%). Quality of life did not decline after treatment, with no significant changes in mean Functional Assessment of Cancer Therapy for Lung-Trial Outcome Index score during the first year of follow-up. CONCLUSIONS AND RELEVANCEThe pCR rate after SABR for early-stage NSCLC was 60%, lower than hypothesized. The combined approach had toxic effects comparable to series of surgery alone, and there was no perioperative mortality. Further studies are needed to evaluate this combined approach compared with surgical resection alone.

Microwave Ablation in Primary Lung Malignancies

“…15 Recent evidence shows a higher pathological complete response rate reported for lung ablation (reported at 90.9%) 16,17 compared with SBRT (which was reported at 60%). 18 Taken together, the clinical significance of reported higher local recurrence rate in ablation remains unclear. Therefore, patients with high surgical risk but who are still operable (defined as patients who can tolerate sublobar resection, but not lobectomy) may undergo sublobar resection, SBRT, or ablation (recommendation category 2A).…”

SABR-BRIDGE: Stereotactic ABlative Radiotherapy Before Resection to AvoId Delay for Early-Stage LunG Cancer or OligomEts During the COVID-19 Pandemic

“…Patients were treated with SABR followed by surgical resection 10 weeks later (33). The primary endpoint was the pathologic complete response (pCR) rate, with secondary endpoints including toxicity and efficacy (33). The trial demonstrated reasonable toxicity outcomes, similar to studies reporting on surgery alone, no 30-or 90-day mortality, and a pathologic complete response rate of 60% (33).…”

“…The use of SABR as neoadjuvant therapy prior to surgery was evaluated in the MISSILE phase II trial (33). In this trial, 40 operable patients with T1-2N0 NSCLC were enrolled (33). Patients were treated with SABR followed by surgical resection 10 weeks later (33).…”

“…In this trial, 40 operable patients with T1-2N0 NSCLC were enrolled (33). Patients were treated with SABR followed by surgical resection 10 weeks later (33). The primary endpoint was the pathologic complete response (pCR) rate, with secondary endpoints including toxicity and efficacy (33).…”

Predicting Pathological Complete Response (Pcr) After Stereotactic Ablative Radiation Therapy (Sabr) of Lung Cancer Using Quantitative Dynamic [18f]fdg Pet and Ct Perfusion: A Prospective Exploratory Clinical Study

“…Respiratory gating was considered in cases where motion was > 7 mm in any direction. The detail protocol of SABR and surgery have been described in the original publication [7].…”