MO57-1 A phase II study of chemotherapy plus local therapy for non-small cell lung cancer with oligometastases: TORG1529

Stage IV non-small cell lung cancer (NSCLC) with oligometastases (oligo-meta) is potentially curable by radical treatment. The aim of the present study is to evaluate the efficacy and safety of chemoradiotherapy (CRT) for thoracic disease, including the primary lesion and lymph node metastases, combined with local consolidative therapy, such as resection and radiotherapy, for distant oligo-meta. This was a multicenter prospective single-arm phase II trial for patients with stage IV NSCLC having oligo-meta for whom CRT for thoracic disease was possible. Patients with common EGFR mutation and ALK fusion gene were excluded. The treatment procedures were CRT containing platinum-doublet for thoracic disease, and local therapy for distant disease within 8 weeks of starting or finishing CRT. The primary endpoint was the 2-year survival rate (threshold: 30% and expected: 50%). Between June 2016 and May 2020, 19 pts were enrolled, but this trial was terminated before completing full enrollment (n=20), because of slow accrual. Median age was 68 (range, 51-74). Twelve (63%) adenocarcinoma and 6 (32%) squamous cell carcinoma were included. Metastases sites were 9 brain, 7 bone, 2 adrenal grand, 1 cervical node and lung. All patients finished CRT during concurrent phase and local treatment for all oligo-meta. Eleven PR were confirmed, resulting in response rate of 58% (95% confidence interval [CI]: 33.5-79.7%) and disease control rate of 100%. Median progression-free survival and overall survival were 8.5 (95%CI: 7.0-10.1) and 42.0 (80%CI: 24.5-48.2) months, respectively. The 2-year survival rate was 68.4 (80% CI: 52.6-79.9) %. Fourteen patients (74%) progressed by emerging new lesions. There was no sever adverse event, and toxicities were similar to CRT for stage III NSCLC. Chemotherapy in combination with aggressive local consolidative therapy might be obtain long survival and local control.