KEY TAKEAWAYS
- The START-NEW-ERA phase II trial evaluated the effectiveness of combining ChT with SAbR for LA-NSCLC pts.
- The study’s co-primary endpoints were LC and safety.
- The study reported a low rate of severe (G3) toxicity, specifically esophageal and lung toxicity, in pts who received ChT and SAbR.
The phase II trial’s initial analysis evaluated the local control (LC) and safety of Stereotactic Ablative Radiotherapy (SAbR) for patients (pts) with unresectable locally advanced non-small cell lung cancer (LA-NSCLC) who were not suitable candidates for simultaneous chemotherapy and radiotherapy (ChT-RT). This study shared the results for LA-NSCLC pts who underwent both chemotherapy (ChT) and SAbR.
Between December 31, 2015, and June 30, 2022, 71 LA-NSCLC pts were enrolled. Among them, 40 (56%) received neoadjuvant ChT followed by SAbR, while 31 (44%) received SAbR alone. Among the ChT recipients, 15 (37%) also received Durvalumab immunotherapy. The treatment target encompassed both the primary tumor (T) and any regionally positive lymph nodes (N). The co-primary study objectives were to assess LC and safety.
The median age of the pts was 71 years (ranging from 52 to 85). Most pts, 36 (90%), had a performance status (PS) of 0–1, while 4 (10%) had a PS of 2. Histologically, 52% had squamous cell carcinoma (SCC), and 48% had adenocarcinoma (ADC). Staging showed that 4 (10%) patients were at stage IIB, 13 (33%) at stage IIIA, 17 (42%) at stage IIIB, and 6 (15%) at stage IIIC. The prescribed radiation doses were a median of 45 Gy (ranging from 35 to 55) for the primary tumor (T) and 40 Gy (ranging from 35 to 45) for lymph nodes (N), administered in 5 daily fractions. With a median follow-up period of 26 months (ranging from 6 to 66), 14 (35%) pts experienced local recurrence (LR).
The median LR-free survival (FS) has not been reached (95% CI, 28 to not reached), and the 1-, 2-, and 4-year LR-FS rates were 86 ± 6%, 67 ± 8%, and 50 ± 10%, respectively. At the latest follow-up, 23 (58%) pts were alive, having a median overall survival (OS) of 50 months (95% CI, 31–55). The 1-, 2-, and 4-year OS rates were 92 ± 5%, 70 ± 8%, and 51 ± 9%, respectively. Distant progression (dP) occurred in 14 (35%) pts, with a median dP-free survival (FS) that has not been reached (95% CI, 16 to not reached). The 1-, 2-, and 4-year dP-FS rates were 86 ± 6%, 56 ± 9%, and 56 ± 9%, respectively. Two (5%) pts experienced grade (G) ≥3 esophageal and lung toxicity.
The study suggested that LA-NSCLC pts treated with both ChT and SAbR achieved optimal LC and promising OS with a low incidence of severe (G3) toxicity. These early findings indicate the potential viability of this treatment approach for LA-NSCLC pts who cannot undergo concurrent ChT-RT.
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT05291780
Arcidiacono, F., Anselmo, P., Casale, M., Zannori, C., Loreti, F., Italiani, M., Enrico, B., Fabiani, S., Marchetti, G., Tassi, V., Mancioli, F.A., Muti, M., Guida, A., Bracarda, S., Ragusa, M., Maranzano, E., Trippa, F. 126P – Chemotherapy and stereotactic ablative radiotherapy in newly diagnosed and recurrent locally advanced non-small cell lung cancer patients unfit for concurrent radio-chemotherapy: Sub-analysis and update of START-NEW-ERA non-randomised phase II trial. Journal of Thoracic Oncology (2023) 18 (4S): S106-S115.
