Breast Cancer

SS 21 - Breast 2 - Biology and SBRT

136 - Phase I Trial of Stereotactic Body Radiation Therapy(SBRT) to Multiple Metastatic Sites: A NRG Oncology Study

Tuesday, October 23
8:25 AM - 8:35 AM
Location: Room 214 A/B

Phase I Trial of Stereotactic Body Radiation Therapy(SBRT) to Multiple Metastatic Sites: A NRG Oncology Study
S. J. Chmura1, K. Winter2, J. K. Salama3, C. G. Robinson4, T. M. Pisansky5, V. Borges6, H. A. Al-Hallaq1, M. M. Matuszak7, S. S. Park5, V. J. Gonzalez8, Y. Hasan1, J. G. Bazan9, P. Wong10, H. A. Yoon11, J. K. Horton3, G. N. Gan12, M. T. Milano13, E. R. Sigurdson14, J. Moughan15, and J. R. White9; 1University of Chicago, Chicago, IL, 2NRG Oncology Statistics and Data Management Center-ACR, Philadelphia, PA, 3Duke University Medical Center, Durham, NC, 4Washington University School of Medicine, Department of Radiation Oncology, St. Louis, MO, 5Department of Radiation Oncology, Mayo Clinic, Rochester, MN, 6University of Colorado - Anschutz Medical Center, Denver, CO, 7Department of Radiation Oncology, University of Michigan, Ann Arbor, MI, 8University of Arizona, Tucson, AZ, 9The Ohio State University Wexner Medical Center, Department of Radiation Oncology, Columbus, OH, 10Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada, 11Cancer Care Specialists of Central Illinois, Decatur, IL, 12Department of Internal Medicine, Section of Radiation Oncology, University of New Mexico School of Medicine, Albuquerque, NM, 13University of Rochester Medical Center, Rochester, NY, 14Fox Chase Cancer Center, Philadelphia, PA, 15NRG, Philadelphia, PA

Purpose/Objective(s): SBRT to all metastases (mets) is hypothesized to improve survival for oligometastatic breast and other cancers. However, there is scant prospective evidence supporting SBRT safety when multiple mets are targeted. In NRG-BR001 we sought to establish the safety of SBRT dose schedules commonly used to treat a single met, in patients (pts) with 2-4 mets.

Materials/Methods: Eligibility included pts with 3-4 mets or 2 mets within 5 cm amenable to SBRT from breast, lung, or prostate cancer with ECOG performance 0-2. Mets were categorized into 7 anatomic locations: (bone/osseous (BO), spinal/paraspinal (SP), peripheral lung (PL), central lung (CL), abdominal/pelvic (AP), mediastinal/cervical (MC), and liver (L)). The starting dose was 50Gy in 5 fractions (CL, MC), 45Gy in 3 (PL, AP, L), and 30Gy in 3 (BO, SP). The primary endpoint was dose-limiting toxicity (DLT) defined as grade 3-5 CTCAEv4 adverse events (AEs) probably or definitely related to SBRT within 6 months. Six pts were required to evaluate DLTs for each location and a single pt could contribute to multiple mets locations. A dose level was considered safe if DLTs were observed in ≤ 1 of 6 within the location otherwise that anatomic location would undergo dose de-escalation.

Results: From Aug 2014-Dec 2017, 42 pts were accrued. Three pts did not receive protocol therapy, 2 died prior to completion of the DLT period, and one was lost to follow-up, leaving 36 evaluable pts. Twelve, 11, and 13 pts had breast, NSCLC, and prostate cancer, respectively. The median number of mets per pt was 3. There were zero pre-specified DLTs reported for BO, SP, PL, CL, and/or AP locations. At the time of data lock for this analysis, the DLT follow-up periods for MC and L were ongoing.

Conclusion: NRG-BR001 demonstrated that SBRT for patients with 3-4 mets or 2 mets in close proximity in the peripheral lung, central lung, abdomen/pelvic, bone/osseous, and spinal/paraspinal locations is safe. Treatment of pts with multiple mets in these locations has been expanded into ongoing randomized trials NRG-BR002 and LU002.

Author Disclosure: S.J. Chmura: Employee; Astellas. K. Winter: None. J.K. Salama: Employee; Duke University School of Medicine. Research Grant; BMS, Celldex, Immunocore, Merck, Reata, Dynavax, Genentech. PI of Alliance Foundation Study Partnered with AbbVie; AbbVie. Speaker's Bureau; BMS. Advisory Board; BMS, Merck. C.G. Robinson: Research Grant; Varian Medical Systems, Elekta. Speaker's Bureau; Varian Medical Systems, DFINE. Advisory Board; Radialogica. Stock Options; Radialogica. T.M. Pisansky: None. H.A. Al-Hallaq: Research Grant; Varian Medical Systems. Honoraria; Reflexion Medical Systems. Royalty; The University of Chicago. Associate Editor; Red Journal. Board member; Society of Directors of Academic Medical Physics. M.M. Matuszak: Employee; William Beaumont Hospital. V.J. Gonzalez: Consultant; iCad inc. Travel Expenses; iCad inc. Y. Hasan: None. J.G. Bazan: None. P. Wong: None. J.K. Horton: Research Grant; Gateway for Cancer Research. Stipend - Senior Editor; Int J of Radiation Oncology, Biology, Physics. Loan repayment; NIH Loan Repayment Program. Honoraria; The Oakstone Institute, Varian Medical Systems. Board Member; New Life After Cancer. M.T. Milano: Honoraria; UpToDate. E.R. Sigurdson: None. J.R. White: Co-chair, Breast Cancer Committee; NRG. Member; NCI Breast Cancer Steering Group.

Steven Chmura, MD, PhD

Disclosure:
Employment
Astellas: Medical DIrector: Employee; Reflexion Medical: Consultant: Independent Contractor; University of Chicago: Associate Professor: Employee

Biography:
Dr. Steven J. Chmura is an Associate Professor in the Department of Radiation and Cellular Oncology and Director of Clinical and Translational Research at The University of Chicago.


Steven J. Chmura MD, PhD is the director of Clinical and Translational Research for Radiation Oncology at the University of Chicago for over a decade. He has been actively involved in both the clinical implementation of stereotactic radiosurgery (SRS) and stereotactic body radiotherapy (SBRT) and related translational and clinical research, as well as the integration of SRS and SBRT into other systemic therapies. His clinical interests include breast cancer, limited metastatic disease, immunotherapy, and technologic improvements in the delivery of radiotherapy. Dr. Chmura is a leader in the NCI cooperative groups. His work has led to the first international oligmetastatic trials through NRG Oncology examining the safety of treating lung and breast cancer patients as a Phase II/III trial examining potential improvements to progression-free survival and overall survival. Dr. Chmura's work in radio-immunology has also translated into multiple investigator-sponsored trials along with the now accruing NCI-sponsored (A091605) trial randomizing the role of SBRT combined with pembrolizumab in advanced Merkel cell carcinoma; such integration of ablative radiotherapy and immunotherapy along with advancing the search for biomarkers is currently Dr. Chmura's focus.

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