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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 J+Clin+Oncol
2015 ; 33
(17
): 1889-94
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gab.com Text
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Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of
Ipilimumab in Unresectable or Metastatic Melanoma
#MMPMID25667295
Schadendorf D
; Hodi FS
; Robert C
; Weber JS
; Margolin K
; Hamid O
; Patt D
; Chen TT
; Berman DM
; Wolchok JD
J Clin Oncol
2015[Jun]; 33
(17
): 1889-94
PMID25667295
show ga
PURPOSE: To provide a more precise estimate of long-term survival observed for
ipilimumab-treated patients with advanced melanoma, we performed a pooled
analysis of overall survival (OS) data from multiple studies. METHODS: The
primary analysis pooled OS data for 1,861 patients from 10 prospective and two
retrospective studies of ipilimumab, including two phase III trials. Patients
were previously treated (n = 1,257) or treatment naive (n = 604), and the
majority of patients received ipilimumab 3 mg/kg (n = 965) or 10 mg/kg (n = 706).
We also conducted a secondary analysis of OS data (n = 4,846) with an additional
2,985 patients from an expanded access program. OS rates were estimated using the
Kaplan-Meier method. RESULTS: Among 1,861 patients, median OS was 11.4 months
(95% CI, 10.7 to 12.1 months), which included 254 patients with at least 3 years
of survival follow-up. The survival curve began to plateau around year 3, with
follow-up of up to 10 years. Three-year survival rates were 22%, 26%, and 20% for
all patients, treatment-naive patients, and previously treated patients,
respectively. Including data from the expanded access program, median OS was 9.5
months (95% CI, 9.0 to 10.0 months), with a plateau at 21% in the survival curve
beginning around year 3. CONCLUSION: To our knowledge, this is the largest
analysis of OS to date for ipilimumab-treated patients with advanced melanoma. We
observed a plateau in the survival curve, beginning at approximately 3 years,
which was independent of prior therapy or ipilimumab dose. These data add to the
evidence supporting the durability of long-term survival in ipilimumab-treated
patients with advanced melanoma.
|Antibodies, Monoclonal/administration & dosage/adverse effects/*therapeutic use
[MESH]
|Antineoplastic Agents/administration & dosage/adverse effects/*therapeutic use
[MESH]