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Title: Safety and Immunogenicity of MAGE-A3 Cancer Immunotherapeutic with or without Adjuvant Chemotherapy in Patients with Resected Stage IB to III MAGE-A3-Positive Non-Small-Cell Lung Cancer
Authors: Pujol, Jean-Louis
Vansteenkiste, Johan F.
De Pas, Tommaso Martino
Atanackovic, Djordje
Reck, Martin
Thomeer, Michiel
Douillard, Jean-Yves
Fasola, Gianpiero
Potter, Vanessa
Taylor, Paul
Bosquee, Lionel
Scheubel, Robert
Jarnjak, Silvija
Debois, Muriel
Alves, Pedro de Sousa
Louahed, Jamila
Brichard, Vincent G.
Lehmann, Frederic F.
Issue Date: 2015
Citation: JOURNAL OF THORACIC ONCOLOGY, 10 (10), p. 1458-1467
Abstract: Introduction: To assess the safety and immunogenicity of MAGE-A3 immunotherapeutic in patients with stage IB-III MAGE-A3-positive non-small-cell lung cancer (NSCLC) who were or were not undergoing standard cisplatin/vinorelbine chemotherapy. Methods: This open, prospective, multicenter, parallel-group phase I study (NCT00455572) enrolled patients with resected (cohorts 1-3) or unresectable (cohort 4) MAGE-A3-positive NSCLC. MAGE-A3 immunotherapeutic (300 g recombinant MAGE-A3 formulated with AS15) was administered (eight doses, 3 weeks apart) concurrent with (cohort 1), after (cohort 2), or without (cohort 3) standard-adjuvant chemotherapy, or after standard radiotherapy and/or chemotherapy (cohort 4). Results: Sixty-seven patients received greater than or equal to 1 dose of MAGE-A3 immunotherapeutic. Grade 3/4 adverse events (AEs) were reported for 16 out of 19 (84%), 2 out of 18 (11%), 5 out of 18 (28%), and 1 out of 12 (8%) patients in cohorts 1, 2, 3, and 4, respectively. Many grade 3/4 AEs in cohort 1 (e.g., neutropenia) were typical of chemotherapy. Six patients, including three in cohort 1, reported study treatment-related grade 3/4 AEs (injection-site reactions or musculoskeletal/back pain, which resolved within 5 days). One patient (in cohort 4) died, but this and the other serious adverse events were not study treatment related. MAGE-A3-specific antibody responses to immunotherapy were induced in all patients evaluated in all cohorts. MAGE-A3-specific CD4(+) T-cell responses to immunotherapy were detected in 4 out of 11 (36%), 4 out of 15 (27%), 2 out of 8 (25%), and 5 out of 6 (83%) evaluated patients in cohorts 1, 2, 3, and 4, respectively; and CD8(+) T-cell responses were only detected in four patients. Conclusion: In resected and unresectable NSCLC patients and irrespective of whether standard chemotherapy was concurrent or not, MAGE-A3 immunotherapeutic is well tolerated and induces MAGE-A3-specific immune responses.
Notes: [Pujol, Jean-Louis] CHRU Montpellier, Thorac Oncol Unit, Arnaud de Villeneuve Hosp, F-34295 Montpellier, France. [Vansteenkiste, Johan F.] Katholieke Univ Leuven, Univ Hosp, Dept Pneumol, Leuven, Belgium. [De Pas, Tommaso Martino] European Inst Oncol, Med Oncol, Milan, Italy. [Atanackovic, Djordje] Univ Utah, Huntsman Canc Inst, Div Hematol & Hematol Malignancies, Salt Lake City, UT USA. [Reck, Martin] Hosp Grosshansdorf, Dept Thorac Oncol, Grosshansdorf, Germany. [Thomeer, Michiel] Ziekenhuis Oost Limburg, Dept Resp Med, Genk, Belgium. [Thomeer, Michiel] Univ Hasselt, LCRP Oncol Cluster, Hasselt, Belgium. [Douillard, Jean-Yves] ICO R Gauducheau, Dept Med Oncol, St Herblain, France. [Fasola, Gianpiero] Univ Hosp S Maria della Misericordia, Dept Oncol, Udine, Italy. [Potter, Vanessa] Nottingham Univ Hosp NHS Trust, Nottingham, England. [Taylor, Paul] Univ S Manchester Hosp, Northwest Lung Ctr, Manchester M20 8LR, Lancs, England. [Bosquee, Lionel] Andre Renard Clin, Thorac Oncol Pneumol Serv, Herstal, Belgium. [Scheubel, Robert] Waldburg Zeil Clin, Clin Thorac Surg, Wangen Im Allgau, Germany. [Jarnjak, Silvija; Debois, Muriel; Alves, Pedro de Sousa; Louahed, Jamila; Brichard, Vincent G.; Lehmann, Frederic F.] GSK Vaccines, Rixensart, Belgium.
URI: http://hdl.handle.net/1942/19855
DOI: 10.1097/JTO.0000000000000653
ISI #: 000361719200010
ISSN: 1556-0864
Category: A1
Type: Journal Contribution
Validation: ecoom, 2016
Appears in Collections: Research publications

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