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  • Showing results for Pembrolizumab[Title] AND advanced[Title] AND melanoma[Title] AND experience[Title] AND Expanded[Title] AND Access[Title] AND Program[Title]. Your search for Pembrolizumab for advanced melanoma: experience from the Spanisch Expanded Access Program retrieved no results.
Clin Transl Oncol. 2017 Jun;19(6):761-768. doi: 10.1007/s12094-016-1602-1. Epub 2017 Jan 4.

Pembrolizumab for advanced melanoma: experience from the Spanish Expanded Access Program.

Author information

1
Translational Cancer Research Unit, Dr. Rosell Oncology Institute, Quiron Dexeus University Hospital, 08028, Barcelona, Spain. mgonzalezcao@oncorosell.com.
2
Hospital Clinic I Provincial, Barcelona, Spain.
3
Catalan Institute of Oncology, Barcelona, Spain.
4
Gregorio Marañón Institute of Health Research, Madrid, Spain.
5
Germans Trias I Pujol University Hospital, Barcelona, Spain.
6
General University Hospital, Valencia, Spain.
7
Burgos University Hospital, Burgos, Spain.
8
Insular University Hospital of Gran Canaria, Canary Islands, Spain.
9
Costa del Sol Hospital, Marbella, Malaga, Spain.
10
Regional University Hospital of Malaga, Malaga, Spain.
11
Ramony Cajal Hospital, Madrid, Spain.
12
Marqués de Valdecilla University Hospital, Santander, Spain.
13
La Paz University Hospital, Madrid, Spain.
14
Del Mar University Hospital, Barcelona, Spain.
15
Virgen de la Victoria Hospital, Malaga, Spain.
16
Miguel Servet University Hospital, Zaragoza, Spain.
17
San Carlos Hospital, Madrid, Spain.
18
Dr. Peset Hospital, Valencia, Spain.
19
Consorci Sanitari de Terrassa, Barcelona, Spain.
20
Clara Campal Hospital, Madrid, Spain.
21
Valld'Hebron University Hospital, Barcelona, Spain.
22
Son Llatzer University Hospital, Mallorca, Spain.
23
National Cancer Institute, Mexico City, Mexico.
24
Navarra University Clinic, Pamplona, Spain.

Abstract

BACKGROUND:

The programmed death (PD-1) inhibitor pembrolizumab has been recently approved for the treatment of advanced melanoma. We evaluated the clinical activity of pembrolizumab in melanoma patients treated under the Spanish Expanded Access Program.

METHODS:

Advanced melanoma patients who failed to previous treatment lines were treated with pembrolizumab 2 mg/kg every three weeks. Patients with brain metastases were not excluded if they were asymptomatic. Data were retrospectively collected from 21 centers in the Spanish Melanoma Group.

RESULTS:

Sixty-seven advanced melanoma patients were analyzed. Most patients were stage M1c (73.1%), had high LDH levels (55.2%) and had ECOG PS 1 or higher (59.7%). For cutaneous melanoma patients, median overall survival was 14.0 months; the 18-month overall survival rate was 47.1%. Overall response rate was 27%, including three patients with complete responses (6.5%). Median response duration was not reached, with 83.3% of responses ongoing (3.5 m+ to 20.4 m+). From ten patients included with brain metastases, four (40%) had an objective response, two (20%) of them achieved a complete response. Significant prognostic factors for overall survival were LDH level, ECOG PS and objective response. There were no serious adverse events.

CONCLUSION:

Although this was a heavily pretreated cohort, pembrolizumab activity at the approved dose and schedule was confirmed in the clinical setting with long-term responders, also including patients with brain metastases.

KEYWORDS:

CNS metastases; Expanded access program; Melanoma; Pembrolizumab; Survival

PMID:
28054320
DOI:
10.1007/s12094-016-1602-1
[Indexed for MEDLINE]

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