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Location: Marriott Marquis
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Main Session

SS 32 - Lung 4: Clinical Trials of SBRT and Hypofractionation for NSCLC

288 - A Phase I Study of Cyclical Hypofractionated Palliative Radiation (Quad Shot) for Lung Tumors in Patients with Stage IV Non-Small Cell Lung Cancer (NSCLC): Results from the PROMISE 006 Trial

Tuesday, October 1, 2024
1:35 PM – 1:45 PM ET
Location: Room 147
H. Y. Zhang1, A. Iqbal2, J. T. Yang1,3, E. F. Gillespie4, N. Toumbacaris5, Z. Zhang5, P. Brooks1, E. Khalyat1, N. Shaverdian1, D. Gelblum1, V. S. Brennan1, D. Guttman1, B. S. Imber1, P. Iyengar1, J. Y. Shin1, C. B. Simone II1,6, A. J. Wu1, A. Rimner7, D. R. Gomez1, and A. F. Shepherd1; 1Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, 2Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, 3New York University School of Medicine, New York, NY, 4Department of Radiation Oncology, University of Washington, Seattle, WA, 5Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, 6New York Proton Center, New York, NY, 7Department of Radiation Oncology, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, German Cancer Consortium (DKTK), partner site DKTK-Freiburg, Freiburg, Germany

Purpose/Objective(s): To assess the safety and feasibility of up to 3 cycles of Quad Shot (QS) for symptomatic or near-symptomatic centrally located lung tumors in patients with stage IV NSCLC undergoing concurrent systemic therapy (chemotherapy, immunotherapy or both). Secondary endpoints included local control, toxicity, and symptom relief. Materials/

Methods: This is a prospective, single-institution phase I trial that enrolled patients with stage IV NSCLC from 2020 to 2024. Each cycle of QS consisted of 14.8 Gy in 4 fractions, given twice a day for 2 consecutive days within 1 week of systemic therapy, followed by a 21–28 day break. The maximum tolerated dose (MTD) was established using a modified 3+3 design starting with 2 cycles of QS with 1 cycle increments between successive cohorts of patients. Dose-limiting toxicity (DLT) was defined as any radiation-related = grade 3 adverse event from start of RT to 3 months follow up. Local failure (LF), assessed by imaging, was defined as progression of disease within the RT fields. EORTC QLQ-LC13 and LQ-C30 were used to assess symptom relief. Percentages were calculated for feasibility, toxicity and symptom relief. Overall survival (OS) was estimated using the Kaplan-Meier method and LF was analyzed using the cumulative incidence (CI) function.
Results: A total of 27 patients were accrued to establish the MTD. In cohort 1 (2 cycles of QS), 81% of patients (13/16) completed both cycles of QS. 1 patient experienced a DLT (grade 3 esophagitis). In cohort 2 (3 cycles of QS), 91% of patients (10/11) completed all 3 cycles of QS and none experienced any DLT. Thus, 3 cycles of QS was established as the MTD. None of the patients from either cohort experienced a delay in systemic therapy due to radiation. The median follow-up for cohorts 1 and 2 were 4.5 and 6 months, respectively. Of the symptomatic patients, the majority experienced symptom improvement from shortness of breath (13/19; 68%), cough (14/20; 70%), and hemoptysis (5/5; 100%). For cohort 1, the cumulative incidence of LF was 6.3% (n=1) at 6 months and 14% at 12 months (n=2). There was no LF event in cohort 2. There were 4 patients with grade 2+ toxicity attributable to RT: 1 patient with grade 3 esophagitis after cycle 1. At 3 months, 1 patient experienced grade 2 fatigue and 2 patients experienced grade 2 radiation pneumonitis that improved with a course of steroids. OS at 6 months for cohorts 1 and 2 were 36% and 55%, respectively (p=0.5).
Conclusion: Our results show that QS can be safely and feasibly delivered up to 3 cycles with concurrent systemic therapy for NSCLC patients with centrally located lung tumors. This tailored regimen of RT has minimal toxicity and does not disrupt systemic therapy. There is a high rate of symptom relief as measured by patient-reported outcomes. These completed phase I results serve as the basis for a currently accruing expansion cohort to more robustly analyze secondary endpoints.