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• W3119679353 abstract "Nivolumab combined with Ipilimumab (Ipi/Nivo) has been shown to improve overall survival compared to chemotherapy in first-line treatment of stage IV non-small cell lung cancer (NSCLC). Brain metastasis patients have often been excluded from many clinical trials. We examined outcomes of brain metastasis patients included on a phase 1 trial of combined immune checkpoint blockade and multi-site stereotactic body radiation therapy (SBRT) in newly diagnosed stage IV NSCLC. All patients underwent brain MRI as part of trial screening. Treatment naïve patients with advanced NSCLC were eligible for enrollment. Patients received SBRT to 1 to 4 extracranial metastases and were randomized to receive 1st cycle of Ipi/Nivo either during or after multi-site SBRT. Ipi/Nivo continued until progression, development of toxicity, or up to two years. Brain metastases > 3 mm in size were treated with radiosurgery or WBRT prior to starting systemic therapy and multi-site SBRT. 35 patients were treated with multi-site SBRT and received at least one cycle of Ipi/Nivo. 9 patients had brain metastasis at diagnosis. 8 patients received SRS while one received WBRT. With a median follow-up time of 15 months for all patients, median OS for the brain metastasis cohort has not been reached. All 9 brain metastasis patients remain alive; 7 of these patients have remained alive for at least 15 months and continue on Ipi/Nivo. Two of 18 treated lesions (11%) developed radiation necrosis. Of 26 patients enrolled without brain metastases, 5 developed intracranial disease. Four of these 5 patients underwent salvage WBRT and remain alive, free of intracranial progression. The 1-year intracranial progression-free survival (PFS) was 81.7% and was 87.0% in those enrolled without brain metastasis. In the 9 patients with brain metastasis, only 3 went on to progress intracranially, notably within a short time frame (within 3 months). Median PFS did not differ between BM (13.1 months) and non-BM(5.86 months) cohorts (p=NS). Two patients in the brain metastasis cohort had lesions at diagnosis that were not treated with SRS which had complete response with immunotherapy alone. Ipi/nivo/SBRT is a successful treatment strategy in patients with NSCLC brain metastasis. Outcomes do not appear to be inferior for these patients compared to non-brain metastasis stage IV patients and they should be included in trials in the immunotherapy era. Intracranial control appears promising. Further intracranial efficacy of Ipi/Nivo and outcomes of brain metastasis patients will be explored in a phase II expansion." @default.
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• W3119679353 date "2021-01-01" @default.
• W3119679353 modified "2023-10-06" @default.
• W3119679353 title "RO01.01 Prospective Evaluation of Ipilimumab and Nivolumab in Patients with Non-Small Cell Lung Cancer Brain Metastasis" @default.
• W3119679353 doi "https://doi.org/10.1016/j.jtho.2020.10.089" @default.
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