3420 - Phase II Trial of Biology Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) in Oligoprogressive Non-Small Cell Lung Cancer: Interim Report
Presenter(s)
A. Amini1, Y. Liu1, J. Li2, N. Correnti1, T. Abuali1, W. T. Watkins1, C. Han3, Q. Feng3, Z. Huang1, N. Lin1, A. Rodriguez1, A. Rock1, R. Muddasani1, M. Lee1, R. Salgia1, L. Antrim1, C. Lovly1, S. Szeja4, S. Sampath3, P. Lee5, T. M. Williams1, and Y. R. Li1; 1City of Hope, Duarte, CA, 2Division of Biostatistics, City of Hope National Medical Center, Duarte, CA, 3Department of Radiation Oncology, City of Hope National Medical Center, Duarte, CA, 4City of Hope, Upland, CA, 5City of Hope, Irvine, CA
Purpose/Objective(s):
The role of local ablative therapy (LAT) in the setting of limited progression in non-small cell lung cancer is an active area of research. A major goal of LAT in the setting of oligoprogressive disease is to target areas of resistance allowing patients to continue on their current line of therapy, which could potentially translate to improved oncologic outcomes. Here we report early data on a phase II trial using stereotactic body radiation therapy (SBRT) and biology guided radiotherapy (BgRT) with real time positron emission tomography (PET) imaging to target oligoprogressive disease.Materials/Methods:
This is a single arm, phase II study (NCT06014827) enrolling patients with oligoprogressive NSCLC defined as 1-5 sites of measurable disease by PERCIST v1.0 or RECIST v1.1. Patients may be on any line of systemic therapy with or without an actionable driver mutation. Eligible patients received BgRT to at least one oligoprogressive site. The primary endpoint of this study is time to next line of therapy. Secondary endpoints include progression-free survival, toxicity, and quality of life. Circulating tumor DNA (ctDNA) are collected at baseline, completion of treatment and every 3 months thereafter until progression. Study accrual goal is 32 patients. Interim outcomes are reported here for the first 10 patients enrolled.Results:
A total of 10 patients were treated with BgRT/SBRT. Median follow up was 4.2 months (range, 1-15 months). BgRT treated sites included bone (n=5) and lung (n=5); SBRT treated lesions included lung (n=5), bone (n=5), lymph nodes (n=2), and breast (n=1). Dose included 27-50 Gy in 3-5 fractions. Median total number of treated sites was 2 (range, 1-5). The majority of patients (n=8) had EGFR mutant NSCLC and were treated with osimertinib. Currently, 6 out of 10 patients remain on their current line of therapy. For those who progressed, median time to next line therapy was 2.9 months. Three patients received an additional course of radiation for an oligoprogressive lung (n=1), bone (n=1), and brain metastasis (n=1). No in-field recurrences were noted. At this interim analysis, median progression-free and overall survival were 4.2 and 7.1 months respectively. There was one grade 3+ adverse events including G3 pneumonitis. G3 pneumonitis occurred in a reirradiation case with SBRT to a lung nodule in the setting of prior definition radiation to the lung and lymph nodes, progressing on osimertinib.Conclusion:
Utilization of SBRT/BgRT in oligoprogressive NSCLC appears to provide some delay to next line systemic therapy. Continued accrual, data maturation, and toxicity monitoring, in addition to quality of life and biomarker correlatives including ctDNA, which are currently being collected, will provide further insight to the potential benefit of LAT for this patient population.