STereotactic Ablative RadioTherapy in NEWly diagnosed and recurrent locally advanced non-small cell lung cancer patients unfit for concurrEnt RAdio-chemotherapy: early analysis of the START-NEW-ERA non-randomised phase II trial
Mené entre 2015 et 2020 sur 50 patients atteints d'un cancer du poumon non à petites cellules de stade localement avancé et n'étant pas éligible à une chimioradiothérapie concomitante (durée médiane de suivi : 38 mois), cet essai de phase II évalue l'efficacité, du point de vue du contrôle local, et la sécurité d'une radiochirurgie
Purpose: This is a single arm phase 2 trial (Clinical trials.gov NCT05291780) to assess local control (LC) and safety of stereotactic ablative radiotherapy (SAbR) in unresectable locally advanced non-small cell lung cancer (LA-NSCLC) patients unfit for concurrent chemo-radiotherapy (ChT-RT). Methods and Materials: Neoadjuvant ChT was prescribed in fit patients. The tumor volume included primary tumor (T) and any regionally positive node/s (N). The co-primary study endpoints were LC and safety. Results: Between December 31, 2015 and December 31, 2020 50 LA-NSCLC patients were enrolled. Histology was squamous cell carcinoma (SCC) and adenocarcinoma (ADC) in 52% and 48%, respectively. 40 (80%) patients had ultra-central tumor. Twenty-seven (54%) received neoadjuvant ChT and 7 (14%) adjuvant Durvalumab. Median prescribed dose was 45 Gy (range, 35-55) and 40 Gy (35-45) in 5 daily fractions to T and N, respectively. After a median follow-up of 38 months (range, 12-80), 19 (38%) patients had experienced local recurrence (LR) at a median time of 13 months (range, 7-34). The median LR-free survival (FS) was not reached (95% CI, 28 to not reached). The 1-, 2- and 3- year LR-FS rates were 86±5%, 66±7% and 56±8%, respectively. At last follow-up, 33 (66%) patients were alive. Median overall survival (OS) was 55 months (95% CI, 43-55 months). The 1, 2, and 3-year OS rates were 94±3%, 79±6% and 72±7%, respectively. No patients developed ≥ grade (G) 3 toxicity. ADC (HR, 3.61;95% CI, 1.15-11.35) resulted significant predictor of better LC, while OS was significantly conditioned by smaller PTVs (HR, 1.004;95% CI, 1.001-1.010) and TNM stage (HR, 4.8;95% CI, 1.34-17). Conclusions: LA-NSCLC patients treated with SAbR had optimal LC and promising OS in absence of ≥G3 toxicity. Our early outcomes would suggest the feasibility of using this approach in LA-NSCLC patients unfit for concurrent ChT-RT.
International Journal of Radiation Oncology, Biology, Physics 2022