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10.1200/JCO.2014.56.2736

http://scihub22266oqcxt.onion/10.1200/JCO.2014.56.2736
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C5089162!5089162 !25667295
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suck abstract from ncbi


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pmid25667295
      J+Clin+Oncol 2015 ; 33 (17 ): 1889-94
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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]
  • |Clinical Trials, Phase II as Topic [MESH]
  • |Clinical Trials, Phase III as Topic [MESH]
  • |Drug Administration Schedule [MESH]
  • |Follow-Up Studies [MESH]
  • |Humans [MESH]
  • |Ipilimumab [MESH]
  • |Kaplan-Meier Estimate [MESH]
  • |Melanoma/*drug therapy/secondary [MESH]
  • |Prospective Studies [MESH]
  • |Retrospective Studies [MESH]
  • |Skin Neoplasms/drug therapy/*pathology [MESH]


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