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• W2897860933 abstract "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. 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. 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. 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." @default.
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• W2897860933 date "2018-11-01" @default.
• W2897860933 modified "2023-10-16" @default.
• W2897860933 title "Phase I Trial of Stereotactic Body Radiation Therapy (SBRT) to Multiple Metastatic Sites: A NRG Oncology Study" @default.
• W2897860933 doi "https://doi.org/10.1016/j.ijrobp.2018.06.187" @default.
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