In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. e19031-e19031
Abstract:
e19031 Background: The monoclonal antibody ipilimumab (ipi) showed a survival benefit in patients (pts) with unrespectable metastatic melanoma leading to its approval in 2011. Methods: Ipi was available in Germany before its approval in a Named-Patient Program for pts with unrespectable stage IV/IIIC melanoma. Pts were eligible if they failed at least one prior systemic treatment or were intolerant and did not suffer from auto-immune diseases. Ipi was administered at a dosage of 3mg/kg iv (4 cycles, q21). A re-induction was possible in case of progressive disease after initial clinical benefit. Results: Data from 185 pts (114 male; 71 female, median age: 60 [18-88Y]) of 12 German centers was evaluable. 175 pts actually received ipilimumab (100 pts received all 4 cycles). Reasons for early termination were: Reduced general condition (44%), tumor progression (28%), toxicity or wish of pts (11% each), and incompliance (6%). Response was evaluable in 161 pts. Objective response was observed in 17 pts (1 CR+16 PR), SD in 19 pts (disease control rate 22%). PD was diagnosed in 125 pts. Responding pts were characterized by less organs involved (p=0.028). Median survival for all pts was 8.1 months, 1-year overall survival was 36.4%. Median survival is not yet reached for pts with disease control (94% alive at last observation), whereas it was 5.5 for pts with PD (40% alive at last observation). Treatment was generally well tolerated. Severe (Grade 3+4) auto-immune related toxicities were diarrhea (15 pts), skin rash (1 pt) and hepatitis (1 pt). Aseptic meningitis was observed in 1 pt; and hypophysitis (Grade 2) likewise in 1 pt. Conclusions: Data coming from these 161 patients appear to be consistent with safety and efficacy profiles determined in large clinical trials. Tumor responses were induced in a subset of pts and associated with prolonged survival.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2012.30.15_suppl.e19031
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2012
detail.hit.zdb_id:
2005181-5
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