Stereotactic radiosurgery combined with nivolumab or Ipilimumab for patients with melanoma brain metastases: evaluation of brain control and toxicity.

Stereotactic radiosurgery combined with nivolumab or Ipilimumab for patients with melanoma brain metastases: evaluation of brain control and toxicity.

Publication date: Apr 11, 2019

To investigate the efficacy and safety of concurrent stereotactic radiosurgery (SRS) and ipilimumab or nivolumab in patients with untreated melanoma brain metastases.

Eighty consecutive patients with 326 melanoma brain metastases receiving SRS in combination with ipilimumab or nivolumab were identified from an institutional database and retrospectively evaluated. Patients started systemic treatment with intravenous nivolumab or ipilimumab within one week of receiving SRS. Nivolumab was given at doses of 3 mg/kg every two weeks. Ipilimumab was administered up to four doses of 10 mg/kg, one every 3 weeks, then patients had a maintenance dose of 10 mg/kg every 12 weeks, until disease progression or inacceptable toxicity. Primary endpoint of the study was intracranial progression-free survival (PFS). Secondary endpoints were extracranial PFS, overall survival (OS), and neurological toxicity.

Eighty patients were analyzed. Forty-five patients received SRS and ipilimumab, and 35 patients received SRS and nivolumab. With a median follow-up of 15 months, the 6-month and 12-month intracranial PFS rates were 69% (95%CI,54-87%) and 42% (95%CI,24-65%) for patients receiving SRS and nivolumab and 48% (95%CI,34-64%) and 17% (95%CI,5-31%) for those treated with SRS and ipilimumab (p = 0.02), respectively. Extracranial PFS and OS were 37 and 78% in SRS and nivolumab group, respectively, and 17 and 68% in SRS and ipilimumab group, respectively, at 12 months. Sub-group analysis showed significantly better intracranial PFS for patients receiving multi-fraction SRS (3 cD7 9 Gy) compared to single-fraction SRS (70% versus 46% at 6 months, p = 0.01), especially in combination with nivolumab. Grade 3 treatment-related adverse events occurred in 11 (24%) patients treated with SRS and ipilimumab and 6 (17%) patients who received SRS and nivolumab. Radiation-induced brain necrosis (RN) occurred in 15% of patients.

Concurrent SRS and ipilimumab or nivolumab show meaningful intracranial activity in patients with either asymptomatic and symptomatic melanoma brain metastases, although a subset of patients may develop symptomatic RN. The combination of nivolumab with SRS is associated with better intracranial control.

Minniti, G., Anzellini, D., Reverberi, C., Cappellini, G.C.A., Marchetti, L., Bianciardi, F., Bozzao, A., Osti, M., Gentile, P.C., and , Esposito. Stereotactic radiosurgery combined with nivolumab or Ipilimumab for patients with melanoma brain metastases: evaluation of brain control and toxicity. 22294. 2019 J Immunother Cancer (7):1.

Concepts Keywords
Asymptomatic Radiation
Brain Radiosurgery
Concurrent Brain metastasis
Gy Nivolumab
Intravenous Monoclonal antibodies
Ipilimumab Ipilimumab
Melanoma Radiation therapy
Necrosis Neurosurgery
Neurological Radiobiology
Radiosurgery Bristol-Myers Squibb
Stereotactic Radiosurgery Medical specialties
Toxicity Clinical medicine
Medicine
Stereotactic radiosurgery
Immunotherapy
Radiation

Semantics

Type Source Name
disease MESH multi
drug DRUGBANK Tropicamide
disease MESH disease progression
gene UNIPROT SMS
disease DOID SRS
disease MESH metastases
pathway BSID Melanoma
disease DOID melanoma
disease MESH melanoma
drug DRUGBANK Ipilimumab
drug DRUGBANK Nivolumab

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