Radical Treatment of Non-Small Cell Lung Cancer Patients with Synchronous Oligometastases: Long-Term Results of a Prospective Phase II Trial (NCT01282450)

ABSTRACT Background Stage IV non-small cell lung cancer (NSCLC) patients with oligometastases ( Methods Prospective single-arm phase II trial. Main inclusion criteria: pathological proven NSCLC stage IV with less than 5 metastases at primary diagnosis, amendable for radical local treatment (surgery or radiotherapy). The study is listed in clinicaltrials.gov number NCT01282450. Results 39 patients (18 males, 21 females) with a mean age of 62.1 ± 9.2 years, range 44-81) were analysed. 29 (74 %) had “local” stage III; 17 (44 %) brain, 7 (18 %) bone and 4 (10 %) adrenal gland metastases. 34 (87 %) had a single metastatic lesion. 37 (95 %) of patients received chemotherapy as part of their primary treatment. Median overall survival (OS) was 13.5 months (95 % CI 7.6-19.4); 1-, 2- and 3-year OS 56.4 %, 23.3 % and 17.5 %, respectively. Median progression-free survival (PFS) was 12.1 months (95 % CI 9.6-14.3); 1-year PFS was 51.3 %, both 2- and 3 year PFS 13.6 %. Only 2 patients (5 %) had a local recurrence. No patient or tumour parameter, including volume and FDG uptake was significantly correlated with OS or PFS. The treatment was well tolerated. Conclusion In this phase II study, long-term PFS was found in a subgroup of NSCLC patients with synchronous oligometastases when treated radically. Identification of this favourable subgroup before therapy is needed. Disclosure All authors have declared no conflicts of interest.