ESTRO 2023

Session Item

Monday

May 15

10:30 - 11:30

Plenary Hall

Late-breaking Papers

Chair: , The Netherlands;

Chair: Pierre Blanchard, France

Session Code: 3190

Session Type: Proffered Papers

Track: Clinical

11:20 - 11:30

SAbR in LA-NSCLC patients unfit for concurrent ChT-RT: START-NEW-ERA non-randomised phase II trial

Fabio Arcidiacono , Italy

Presentation Number: OC-0763

Abstract

Abstract Title:

SAbR in LA-NSCLC patients unfit for concurrent ChT-RT: START-NEW-ERA non-randomised phase II trial

Authors:

Fabio Arcidiacono¹, Paola Anselmo¹, Michelina Casale¹, Cristina Zannori², Fabio Loreti³, Mark Ragusa⁴, Benedetta Enrico⁵, Francesco Mancioli⁵, Giovanni Marchetti⁶, Marco Italiani¹, Stefania Fabiani¹, Annalisa Guida⁷, Valentina Tassi⁴, Cecilia Caprera⁸, Matteo Corsi⁸, Sergio Bracarda⁹, Ernesto Maranzano¹⁰, Fabio Trippa¹⁰

¹Radiotherapy Oncology Centre "S.Maria" Hospital, Oncology, Terni, Italy; ²Medical Oncolgy "S.Maria" Hospital, Oncology, Terni, Italy; ³Nuclear Medicine Service "S.Maria" Hospital, Oncology, Terni, Italy; ⁴Thoracic Surgery Division "S.Maria" Hospital, Oncology, Terni, Italy; ⁵Radiology Service "S.Maria" Hospital, Oncology, Terni, Italy; ⁶Pathology Unit "S.Maria" Hospital, Oncology, Terni, Italy; ⁷Medical Oncology "S.Maria" Hospital, Oncology, Terni, Italy; ⁸Pathology Unit “S. Maria” Hospital, Oncology, Terni, Italy; ⁹Medical Oncology “S. Maria” Hospital, Oncology, Terni, Italy; ¹⁰Radiotherapy Oncology Centre “S. Maria” Hospital, Oncology, Terni, Italy

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Purpose or Objective

This is an update of a single arm phase 2 trial (Clinical trials.gov NCT05291780) to assess local control (LC) and safety of stereotactic ablative radiotherapy (SAbR) in newly diagnosed and recurrent unresectable locally advanced non-small cell lung cancer (LA-NSCLC) patients unfit for concurrent chemo-radiotherapy (ChT-RT). Early results on first 50 enrolled patients were recently published (1).

Material and Methods

Patients were staged with PET-CT and brain MRI. 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 June 30, 2022 71 LA-NSCLC patients were enrolled. All analyses, including the primary end-points of LC and safety, included patients with at least 6 months of follow-up after treatment with clinical and imaging tumor response evaluation. Histology was squamous cell carcinoma (SCC) and adenocarcinoma (ADC) in 41% and 59%, respectively. 61 (86%) patients had ultra-central tumor. Forty (56%) received neoadjuvant ChT and 15 (21%) 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 26 months (range, 6-92), 23 (32%) patients had experienced local recurrence (LR). The median LR-free survival (FS) was not reached (95% CI, 28 to not reached). The 1-, 2- and 4- year LR-FS rates were 84±5%, 67±6% and 58±7%, respectively. At last follow-up, 46 (65%) patients were alive. Median overall survival (OS) was 55 months (95% CI, 43-55 months). The 1, 2, and 4-year OS rates were 92±3%, 72±6% and 58±7%, respectively. Twenty-two (31%) patients developed distant progression (dP). The median dP-FS was not reached (95% CI, 24 to not reached). The 1, 2, and 4-year dP-FS rates were 85±4%, 64±6% and 60±7%, respectively. Two patients developed grade (G) 3 esophageal and lung toxicity

Conclusion

LA-NSCLC patients treated with SAbR had optimal LC and promising OS with low rate of G3 toxicity. Our updated clinical outcomes confirm the feasibility of using this approach in LA-NSCLC patients unfit for concurrent ChT-RT.

1. Int J Radiat Oncol Biol Phys 2022;S0360-3016(22)03459-9. doi: 10.1016/j.ijrobp.2022.10.025