| Added by | mollevi |
|---|---|
| Last modified by | amaraver |
| Group name | EquipeAM |
| Item Type | Journal Article |
| 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 |
| Creator | Pujol et al. |
| Author | J. L. Pujol |
| Author | J. F. Vansteenkiste |
| Author | T. M. De Pas |
| Author | D. Atanackovic |
| Author | M. Reck |
| Author | M. Thomeer |
| Author | J. Y. Douillard |
| Author | G. Fasola |
| Author | V. Potter |
| Author | P. Taylor |
| Author | L. Bosquee |
| Author | R. Scheubel |
| Author | S. Jarnjak |
| Author | M. Debois |
| Author | P. de Sousa Alves |
| Author | J. Louahed |
| Author | V. G. Brichard |
| Author | F. F. Lehmann |
| 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 mug 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. |
| Publication | J Thorac Oncol |
| Volume | 10 |
| Pages | 1458-67 |
| Date | Oct 2015 |
| Journal Abbr | Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer |
| DOI | 10.1097/JTO.0000000000000653 |
| ISSN | 1556-1380 (Electronic) 1556-0864 (Linking) |
| Tags | clinic |
| Date Added | 2018/11/14 - 12:43:03 |
| Date Modified | 2019/05/16 - 11:04:44 |
| Notes and Attachments | (Note) (Note) 26309191 (Attachment) |
Institut de Recherche en Cancérologie de
