Show simple item record

dc.contributor.authorKirkwood, John M
dc.contributor.authorLorigan, Paul C
dc.contributor.authorHersey, Peter
dc.contributor.authorHauschild, Axel
dc.contributor.authorRobert, Caroline
dc.contributor.authorMcDermott, David F
dc.contributor.authorMarshall, Margaret A
dc.contributor.authorGomez-Navarro, Jesus
dc.contributor.authorLiang, Jane Q
dc.contributor.authorBulanhagui, Cecile A
dc.date.accessioned2010-09-15T09:31:14Z
dc.date.available2010-09-15T09:31:14Z
dc.date.issued2010-02-01
dc.identifier.citationPhase II trial of tremelimumab (CP-675,206) in patients with advanced refractory or relapsed melanoma. 2010, 16 (3):1042-8 Clin Cancer Resen
dc.identifier.issn1078-0432
dc.identifier.pmid20086001
dc.identifier.doi10.1158/1078-0432.CCR-09-2033
dc.identifier.urihttp://hdl.handle.net/10541/111193
dc.description.abstractPURPOSE: This phase II study assessed the antitumor activity of tremelimumab, a fully human, anti-CTL-associated antigen 4 monoclonal antibody, in patients with melanoma. EXPERIMENTAL DESIGN: Patients with refractory/relapsed melanoma received 15 mg/kg tremelimumab every 90 days. After 4 doses, patients with tumor response or stable disease were eligible to receive < or =4 additional doses. Primary endpoint was best overall tumor response assessed by an independent endpoint review committee, and secondary endpoints included duration of response, overall survival, progression-free survival, and safety. RESULTS: Of 251 patients enrolled, 246 (241 response-evaluable) received tremelimumab. Objective response rate was 6.6% (16 partial responses); duration of response was 8.9 to 29.8 months. Eight (50%) objective responses occurred in patients with stage IV M(1c) disease, and 11 (69%) were ongoing at last tumor assessment. Eight (3.3%) patients achieved responses in target lesions (Response Evaluation Criteria in Solid Tumors) despite progressive disease within the first cycle. All 8 survived for >20 months; 5 (63%) remained alive. Clinical benefit rate (overall response + stable disease) was 21% (16 partial responses and 35 stable disease), and median overall survival was 10.0 months. Progression-free survival at 6 months was 15%, and survival was 40.3% at 12 months and 22% at 24 months. Common treatment-related adverse events were generally mild to moderate, and grade 3/4 adverse events included diarrhea (n = 28, 11%), fatigue (n = 6, 2%), and colitis (n = 9, 4%). There were 2 (0.8%) treatment-related deaths. CONCLUSIONS: Tremelimumab showed an objective response rate of 6.6%, with all responses being durable > or =170 days since enrollment, suggesting a potential role for tremelimumab in melanoma.
dc.language.isoenen
dc.subjectSkin Canceren
dc.subjectCancer Drug Resistance
dc.subject.meshAdolescent
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAged, 80 and over
dc.subject.meshAntibodies, Monoclonal
dc.subject.meshDrug Administration Schedule
dc.subject.meshDrug Resistance, Neoplasm
dc.subject.meshFemale
dc.subject.meshHumans
dc.subject.meshMale
dc.subject.meshMelanoma
dc.subject.meshMiddle Aged
dc.subject.meshRecurrence
dc.subject.meshSkin Neoplasms
dc.titlePhase II trial of tremelimumab (CP-675,206) in patients with advanced refractory or relapsed melanoma.en
dc.typeArticleen
dc.contributor.departmentUniversity of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA. kirkwoodjm@upmc.eduen
dc.identifier.journalClinical Cancer Researchen
html.description.abstractPURPOSE: This phase II study assessed the antitumor activity of tremelimumab, a fully human, anti-CTL-associated antigen 4 monoclonal antibody, in patients with melanoma. EXPERIMENTAL DESIGN: Patients with refractory/relapsed melanoma received 15 mg/kg tremelimumab every 90 days. After 4 doses, patients with tumor response or stable disease were eligible to receive < or =4 additional doses. Primary endpoint was best overall tumor response assessed by an independent endpoint review committee, and secondary endpoints included duration of response, overall survival, progression-free survival, and safety. RESULTS: Of 251 patients enrolled, 246 (241 response-evaluable) received tremelimumab. Objective response rate was 6.6% (16 partial responses); duration of response was 8.9 to 29.8 months. Eight (50%) objective responses occurred in patients with stage IV M(1c) disease, and 11 (69%) were ongoing at last tumor assessment. Eight (3.3%) patients achieved responses in target lesions (Response Evaluation Criteria in Solid Tumors) despite progressive disease within the first cycle. All 8 survived for >20 months; 5 (63%) remained alive. Clinical benefit rate (overall response + stable disease) was 21% (16 partial responses and 35 stable disease), and median overall survival was 10.0 months. Progression-free survival at 6 months was 15%, and survival was 40.3% at 12 months and 22% at 24 months. Common treatment-related adverse events were generally mild to moderate, and grade 3/4 adverse events included diarrhea (n = 28, 11%), fatigue (n = 6, 2%), and colitis (n = 9, 4%). There were 2 (0.8%) treatment-related deaths. CONCLUSIONS: Tremelimumab showed an objective response rate of 6.6%, with all responses being durable > or =170 days since enrollment, suggesting a potential role for tremelimumab in melanoma.


This item appears in the following Collection(s)

Show simple item record