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

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Title: Stereotactic radiosurgery combined with nivolumab or Ipilimumab for patients with melanoma brain metastases: evaluation of brain control and toxicity
Authors: Giuseppe Minniti, Dimitri Anzellini, Chiara Reverberi, Gian Carlo Antonini Cappellini, Luca Marchetti, Federico Bianciardi, Alessandro Bozzao, Mattia Osti, Pier Carlo Gentile, Vincenzo Esposito
Source: Journal for ImmunoTherapy of Cancer, Vol 7, Iss 1, Pp 1-11 (2019)
Publisher Information: BMJ Publishing Group, 2019.
Publication Year: 2019
Collection: LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Subject Terms: stereotactic radiosurgery, melanoma brain metastases, fractionated stereotactic radiosurgery, checkpoint inhibitors, immunotherapy, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
More Details: Abstract Purpose To investigate the efficacy and safety of concurrent stereotactic radiosurgery (SRS) and ipilimumab or nivolumab in patients with untreated melanoma brain metastases. Patients and Methods 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. Results 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 × 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. Conclusions 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.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 2051-1426
Relation: http://link.springer.com/article/10.1186/s40425-019-0588-y; https://doaj.org/toc/2051-1426
DOI: 10.1186/s40425-019-0588-y
Access URL: https://doaj.org/article/71ed64b533a64663b16c816ac3911543
Accession Number: edsdoj.71ed64b533a64663b16c816ac3911543
Database: Directory of Open Access Journals
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  Data: <searchLink fieldCode="AR" term="%22Giuseppe+Minniti%22">Giuseppe Minniti</searchLink><br /><searchLink fieldCode="AR" term="%22Dimitri+Anzellini%22">Dimitri Anzellini</searchLink><br /><searchLink fieldCode="AR" term="%22Chiara+Reverberi%22">Chiara Reverberi</searchLink><br /><searchLink fieldCode="AR" term="%22Gian+Carlo+Antonini+Cappellini%22">Gian Carlo Antonini Cappellini</searchLink><br /><searchLink fieldCode="AR" term="%22Luca+Marchetti%22">Luca Marchetti</searchLink><br /><searchLink fieldCode="AR" term="%22Federico+Bianciardi%22">Federico Bianciardi</searchLink><br /><searchLink fieldCode="AR" term="%22Alessandro+Bozzao%22">Alessandro Bozzao</searchLink><br /><searchLink fieldCode="AR" term="%22Mattia+Osti%22">Mattia Osti</searchLink><br /><searchLink fieldCode="AR" term="%22Pier+Carlo+Gentile%22">Pier Carlo Gentile</searchLink><br /><searchLink fieldCode="AR" term="%22Vincenzo+Esposito%22">Vincenzo Esposito</searchLink>
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  Data: Journal for ImmunoTherapy of Cancer, Vol 7, Iss 1, Pp 1-11 (2019)
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  Data: Abstract Purpose To investigate the efficacy and safety of concurrent stereotactic radiosurgery (SRS) and ipilimumab or nivolumab in patients with untreated melanoma brain metastases. Patients and Methods 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. Results 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 × 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. Conclusions 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.
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        Value: 10.1186/s40425-019-0588-y
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      – SubjectFull: stereotactic radiosurgery
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