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Title: Tecemotide in unresectable stage III non-small-cell lung cancer in the phase III START study: updated overall survival and biomarker analyses.
Austin Authors: Mitchell, Paul L R ;Thatcher, N;Socinski, M A;Wasilewska-Tesluk, E;Horwood, K;Szczesna, A;Martín, C;Ragulin, Y;Zukin, M;Helwig, C;Falk, M;Butts, C;Shepherd, F A
Affiliation: Olivia Newton-John Cancer Wellness and Research Centre, Austin Health, Heidelberg, Victoria, Australia
Christie Hospital NHS Trust, Manchester, UK
UPMC Cancer Pavilion, Pittsburgh, USA
University of Warmia and Mazury, Olsztyn, Poland
Princess Alexandra Hospital, Woolloongabba, Australia
Mazowieckie Centrum Leczenia Chorób Pluc i Gruzlicy, Otwock, Poland
Division of Clinical Oncology, Instituto Especializado Alexander Fleming, Buenos Aires, Argentina
Medical Radiological Research Center, Obninsk, Russia
Clinical Oncology, Instituto Nacional do Câncer-INCA, Rio de Janeiro, Brazil
Merck KGaA, Darmstadt, Germany
Cancer Care, Cross Cancer Institute, Edmonton
University Health Network, Princess Margaret Cancer Centre, Toronto, Canada
Issue Date: Jun-2015
Date: 2015-02-26
Publication information: Annals of oncology : official journal of the European Society for Medical Oncology 2015; 26(6): 1134-1142
Abstract: Tecemotide is a MUC1-antigen-specific cancer immunotherapy. The phase III START study did not meet its primary end point but reported notable survival benefit with tecemotide versus placebo in an exploratory analysis of the predefined patient subgroup treated with concurrent chemoradiotherapy. Here, we attempted to gain further insight into the effects of tecemotide in START. START recruited patients who did not progress following frontline chemoradiotherapy for unresectable stage III non-small-cell lung cancer. We present updated overall survival (OS) data and exploratory analyses of OS for baseline biomarkers: soluble MUC1 (sMUC1), antinuclear antibodies (ANA), neutrophil/lymphocyte ratio (NLR), lymphocyte count, and HLA type. Updated OS data are consistent with the primary analysis: median 25.8 months (tecemotide) versus 22.4 months (placebo) (HR 0.89, 95% CI 0.77-1.03, P = 0.111), with ∼20 months additional median follow-up time compared with the primary analysis. Exploratory analysis of the predefined subgroup treated with concurrent chemoradiotherapy revealed clinically relevant prolonged OS with tecemotide versus placebo (29.4 versus 20.8 months; HR 0.81, 95% CI 0.68-0.98, P = 0.026). No improvement was seen with sequential chemoradiotherapy. High sMUC1 and ANA correlated with a possible survival benefit with tecemotide (interaction P = 0.0085 and 0.0022) and might have future value as biomarkers. Interactions between lymphocyte count, NLR, or prespecified HLA alleles and treatment effect were not observed. Updated OS data support potential treatment benefit with tecemotide in patients treated with concurrent chemoradiotherapy. Exploratory biomarker analyses suggest that elevated sMUC1 or ANA levels correlate with tecemotide benefit. NCT00409188.
DOI: 10.1093/annonc/mdv104
Journal: Annals of oncology : official journal of the European Society for Medical Oncology
PubMed URL: 25722382
Type: Journal Article
Subjects: ANA
soluble MUC1
Appears in Collections:Journal articles

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