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Cited by 163

The DOI matches its Crossref record; 6 of the 6 references it cites were found in a registry or an index.

Clinical experience with ipilimumab 3 mg/kg: real-world efficacy and safety data from an expanded access programme cohort

Open access
Ascierto, Paolo A, Simeone, Ester, Sileni, Vanna, Pigozzo, Jacopo, Maio, Michele, Altomonte, Maresa, Del Vecchio, Michele, Di Guardo, Lorenza, Marchetti, Paolo, Ridolfi, Ruggero, Cognetti, Francesco, Testori, Alessandro, Bernengo, Maria, Guida, Michele, Marconcini, Riccardo, Mandalà, Mario, Cimminiello, Carolina, Rinaldi, Gaetana, Aglietta, Massimo, Queirolo, Paola·2014·Journal of Translational Medicine
DOI 10.1186/1479-5876-12-116
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Abstract

BACKGROUND: Ipilimumab improves survival in patients with advanced melanoma. The activity and safety of ipilimumab outside of a clinical trial was assessed in an expanded access programme (EAP). METHODS: Ipilimumab was available upon physician request for patients aged 16 or over with pretreated stage III (unresectable)/IV melanoma, for whom no other therapeutic option was available. Patients received ipilimumab 3 mg/kg every 3 weeks for four doses. Patients with stable disease or an objective response to ipilimumab were eligible for retreatment upon disease progression. Tumour assessments were conducted at baseline and week 12. Patients were monitored for adverse events (AEs) within 3 to 4 days of each scheduled visit. RESULTS: Of 855 patients participating in the EAP in Italy, 833 were evaluable for response. Of these, 13% had an objective immune response, and the immune-related disease control rate was 34%. Median progression-free survival and overall survival were 3.7 and 7.2 months, respectively. Efficacy was independent of BRAF and NRAS mutational status. Overall, 33% of patients reported an immune-related AE (irAE). The frequency of irAEs was not associated with response to ipilimumab. CONCLUSIONS: Outside of a clinical trial setting, ipilimumab is a feasible treatment option in patients with pretreated metastatic melanoma, regardless of BRAF and NRAS mutational status. Data from this large cohort of patients support clinical trial evidence that ipilimumab can induce durable disease control and long-term survival in patients who have failed to respond to prior treatment.

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Metadata

Authors
Ascierto, P. A., Simeone, E., Sileni, V., Pigozzo, J., Maio, M., Altomonte, M., Del Vecchio, M., Di Guardo, L., Marchetti, P., Ridolfi, R., Cognetti, F., Testori, A., Bernengo, M., Guida, M., Marconcini, R., Mandalà, M., Cimminiello, C., Rinaldi, G., Aglietta, M., & Queirolo, P.
Venue
Journal of Translational Medicine
Publisher
Springer Science and Business Media LLC
Published
2014
Volume
12
Issue
1
Pages
116
ISSN
1479-5876 (ISSN-L)
DOI
10.1186/1479-5876-12-116
OpenAlex
W2166667372
Cited by
163
References
6
FWCI
11.78
Type
journal article
Language
en
Open access
gold

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CoChat. (2026). Citation check: Clinical experience with ipilimumab 3 mg/kg: real-world efficacy and safety data from an expanded access programme cohort. https://app.cochat.ai/papers/10.1186/1479-5876-12-116
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Ascierto, P. A., Simeone, E., Sileni, V., Pigozzo, J., Maio, M., Altomonte, M., Del Vecchio, M., Di Guardo, L., Marchetti, P., Ridolfi, R., Cognetti, F., Testori, A., Bernengo, M., Guida, M., Marconcini, R., Mandalà, M., Cimminiello, C., Rinaldi, G., Aglietta, M., & Queirolo, P. (2014). Clinical experience with ipilimumab 3 mg/kg: real-world efficacy and safety data from an expanded access programme cohort. Journal of Translational Medicine. https://doi.org/10.1186/1479-5876-12-116

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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.