Please use this identifier to cite or link to this item: https://hdl.handle.net/2440/127120
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Type: Journal article
Title: A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial
Author: Fuchs, C.
Azevedo, S.
Okusaka, T.
Van Laethem, J.
Lipton, L.
Riess, H.
Szczylik, C.
Moore, M.
Peeters, M.
Bodoky, G.
Ikeda, M.
Melichar, B.
Nemecek, R.
Ohkawa, S.
Swieboda-Sadlej, A.
Tjulandin, S.
Van Cutsem, E.
Loberg, R.
Haddad, V.
Gansert, J.
et al.
Citation: Annals of Oncology, 2015; 26(5):921-927
Publisher: Oxford University Press
Issue Date: 2015
ISSN: 0923-7534
1569-8041
Statement of
Responsibility: 
C.S.Fuchs, S.Azevedo, T.Okusaka, J.-L.Van Laethem, L.R.Lipton ... M.Peeters ... et al.
Abstract: This double-blind, phase 3 study assessed the efficacy and safety of ganitumab combined with gemcitabine as first-line treatment of metastatic pancreatic cancer.Patients with previously untreated metastatic pancreatic adenocarcinoma were randomly assigned 2 : 2 : 1 to receive intravenous gemcitabine 1000 mg/m(2) (days 1, 8, and 15 of each 28-day cycle) plus placebo, ganitumab 12 mg/kg, or ganitumab 20 mg/kg (days 1 and 15 of each cycle). The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), safety, and efficacy by levels of circulating biomarkers.Overall, 322 patients were randomly assigned to placebo, 318 to ganitumab 12 mg/kg, and 160 to ganitumab 20 mg/kg. The study was stopped based on results from a preplanned futility analysis; the final results are reported. Median OS was 7.2 months [95% confidence interval (CI), 6.3-8.2] in the placebo arm, 7.0 months (95% CI, 6.2-8.5) in the ganitumab 12-mg/kg arm [hazard ratio (HR), 1.00; 95% CI, 0.82-1.21; P = 0.494], and 7.1 months (95% CI, 6.4-8.5) in the ganitumab 20-mg/kg arm (HR, 0.97; 95% CI, 0.76-1.23; P = 0.397). Median PFS was 3.7, 3.6 (HR, 1.00; 95% CI, 0.84-1.20; P = 0.520), and 3.7 months (HR, 0.97; 95% CI, 0.77-1.22; P = 0.403), respectively. No unexpected toxicity was observed with ganitumab plus gemcitabine. The circulating biomarkers assessed [insulin-like growth factor-1 (IGF-1), IGF-binding protein-2, and -3] were not associated with a treatment effect on OS or PFS by ganitumab.Ganitumab combined with gemcitabine had manageable toxicity but did not improve OS, compared with gemcitabine alone in unselected patients with metastatic pancreatic cancer.ClinicalTrials.gov NCT01231347.
Keywords: Ganitumab; gemcitabine; pancreatic cancer; IGF-1 receptor; biomarker
Rights: © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology.All rights reserved.
DOI: 10.1093/annonc/mdv027
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