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Cited by 993

The DOI matches its Crossref record; 9 of the 9 references it cites were found in a registry or an index.

Pembrolizumab for patients with melanoma or non-small-cell lung cancer and untreated brain metastases: early analysis of a non-randomised, open-label, phase 2 trial

Open access
Goldberg, Sarah B, Gettinger, Scott N, Mahajan, Amit, Chiang, Anne C, Herbst, Roy S, Sznol, Mario, Tsiouris, Apostolos John, Cohen, Justine, Vortmeyer, Alexander, Jilaveanu, Lucia, Yu, James, Hegde, Upendra, Speaker, Stephanie, Madura, Matthew, Ralabate, Amanda, Rivera, Angel, Rowen, Elin, Gerrish, Heather, Yao, Xiaopan, Chiang, Veronica, Kluger, Harriet M·2016·The Lancet Oncology
DOI 10.1016/s1470-2045(16)30053-5
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Abstract

Background Immunotherapy targeting the PD-1 axis has activity in several tumor types. We aimed to determine the efficacy and safety of pembrolizumab in patients with untreated brain metastases. Here we present results from a Phase II trial of the PD-1 inhibitor pembrolizumab in patients with new or progressive brain metastases from melanoma or non-small cell lung cancer (NSCLC). Methods Thirty-six patients were enrolled, 18 with melanoma and 18 with NSCLC. Patients had at least one untreated or progressive brain metastasis between 5 and 20 mm in longest diameter without associated neurologic symptoms or the need for corticosteroids. NSCLC patients had tumor tissue demonstrating PD-L1 expression. Patients were treated with pembrolizumab 10 mg/kg every two weeks until progression, and brain metastasis response was assessed every eight weeks by modified RECIST. The primary endpoint was brain metastasis response rate and the analysis was performed on an intent-to-treat basis. The trial is ongoing and here we present an early analysis. The study is registered with clinicaltrials.gov, number NCT02085070. Findings Brain metastasis response rate was 22% and 33% among patients with melanoma and NSCLC, respectively. Responses were durable, with all but one patient who responded demonstrating an ongoing response at the time of data analysis. Treatment-related serious and grade 3–4 adverse events were rare and included transaminitis, colitis, pneumonitis, fatigue, endocrine abnormalities, and acute kidney injury (1 patient each). Serious neurological adverse events included cognitive dysfunction and seizures (1 and 3 patients, respectively), due to pembrolizumab, metastases or both. Interpretation Pembrolizumab demonstrates activity in brain metastases in patients with melanoma or NSCLC with an acceptable safety profile, indicating that there may be a role for systemic immunotherapy in patients with untreated or progressive brain metastases. Funding Merck and the Yale Cancer Center.

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Metadata

Authors
Goldberg, S. B., Gettinger, S. N., Mahajan, A., Chiang, A. C., Herbst, R. S., Sznol, M., Tsiouris, A. J., Cohen, J., Vortmeyer, A., Jilaveanu, L., Yu, J., Hegde, U., Speaker, S., Madura, M., Ralabate, A., Rivera, A., Rowen, E., Gerrish, H., Yao, X., Chiang, V., & Kluger, H. M.
Venue
The Lancet Oncology
Publisher
Elsevier BV
Published
2016-07
Volume
17
Issue
7
Pages
976-983
ISSN
1470-2045 (ISSN-L)
DOI
10.1016/s1470-2045(16)30053-5
OpenAlex
W2416791964
Cited by
993
References
9
FWCI
113.61
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Pembrolizumab for patients with melanoma or non-small-cell lung cancer and untreated brain metastases: early analysis of a non-randomised, open-label, phase 2 trial. https://app.cochat.ai/papers/10.1016/s1470-2045(16)30053-5
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Goldberg, S. B., Gettinger, S. N., Mahajan, A., Chiang, A. C., Herbst, R. S., Sznol, M., Tsiouris, A. J., Cohen, J., Vortmeyer, A., Jilaveanu, L., Yu, J., Hegde, U., Speaker, S., Madura, M., Ralabate, A., Rivera, A., Rowen, E., Gerrish, H., Yao, X., . . . Kluger, H. M. (2016). Pembrolizumab for patients with melanoma or non-small-cell lung cancer and untreated brain metastases: early analysis of a non-randomised, open-label, phase 2 trial. The Lancet Oncology. https://doi.org/10.1016/s1470-2045(16)30053-5

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.