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Title: | Re-induction using whole cell melanoma vaccine genetically modified to melanoma stem cells-like beyond recurrence extends long term survival of high risk resected patients - updated results | Authors: | Mackiewicz, Jacek BURZYKOWSKI, Tomasz Izycki, Dariusz Mackiewicz, Andrzej |
Issue Date: | 2018 | Publisher: | BMC | Source: | JOURNAL FOR IMMUNOTHERAPY OF CANCER, 6 (Art N° 134) | Abstract: | BackgroundAGI-101H is an allogeneic gene modified whole cell therapeutic melanoma vaccine, evaluated in over 400 melanoma patients in the adjuvant and therapeutic settings. We present updated long-term survival results from two single-arm, phase II adjuvant trials (Trial 3 and Trial 5) with the focus on treatment beyond recurrence of the disease.MethodsPatients with resected high-risk melanoma (stage IIIB-IV) were enrolled to Trial 3 (n=99) and Trial 5 (n=97). The primary endpoint was disease-free survival (DFS), and the secondary was overall survival (OS). In the induction phase, the vaccine was administered every 2weeks (eight times), followed by the maintenance phase every month until progression. At progression, maintenance was continued or re-induction was applied with or without surgery.ResultsIn Trial 3, the 10-year DFS was equal to 33.0% overall and to 52.4, 25.0, and 8.7% for stage IIIB, IIIC, and stage IV patients, respectively. In Trial 5, the overall 10-year DFS was equal to 24.2%, and to 37.5, 18.0, and 17.6% for stage IIIB, IIIC, and stage IV patients, respectively. In Trial 3, the 10-year OS was equal to 42.3% overall, and to 59.5, 37.5, and 17.4% for stage IIIB, IIIC, and stage IV patients, respectively. In Trial 5, the 10-year OS was equal to 34.3% overall and to 46.9, 28.0, and 29.4% for stage IIIB, IIIC, and stage IV patients, respectively. Among the 65 patients of Trial 3 who developed progression, 43 received re-induction with (n=22) or without (n=21) surgery. Two patients received surgery without re-induction. All the 22 progressing patients, who did not receive re-induction, died. Among the 75 patients of Trial 5 who experienced progression, 39 received re-induction with (n=21) or without (n=18) surgery. Among the 36 progressing patients who did not receive the re-induction, 35 died. Surgery and re-induction reduced (independently) the increase of mortality after progression in both trials, with the effect of re-induction reaching statistical significance in Trial 5.ConclusionsVaccination beyond recurrence of the disease with additional re-induction combined with surgery or alone increased long term survival of melanoma patients. However, further studies on larger patient cohorts are required.Trial registrationCentral Evidence of Clinical Trials (EudraCT Number 2008-003373-40) | Notes: | [Mackiewicz, Jacek; Izycki, Dariusz; Mackiewicz, Andrzej] Univ Med Sci, Chair Med Biotechnol, 15 Garbary St, PL-61866 Poznan, Poland. [Mackiewicz, Jacek; Mackiewicz, Andrzej] Greater Poland Canc Ctr, Dept Diagnost & Canc Immunol, 15 Garbary St, PL-61866 Poznan, Poland. [Mackiewicz, Jacek; Mackiewicz, Andrzej] Poznan Univ Med Sci, Heliodor Swiecicki Univ Hosp, Dept Med & Expt Oncol, Poland 15,16-18 Grunwaldzka St, PL-60780 Poznan, Poland. [Mackiewicz, Jacek] Univ Med Sci, Dept Biol & Environm Studies, 8 Rokietnicka St, PL-60806 Poznan, Poland. [Burzykowski, Tomasz] Hasselt Univ, Interuniv Inst Biostat & Stat Bioinformat, 42 Martelarenlaan St, B-3500 Diepenbeek, Belgium. [Mackiewicz, Andrzej] BioContract Sp Zoo, 36 Zambrowska St, PL-61051 Poznan, Poland. | Keywords: | Melanoma; Immunotherapy; Genetic melanoma vaccine; Long-term survivals; Phase II clinical trials; Re-induction;Melanoma; Immunotherapy; Genetic melanoma vaccine; Long-term survivals; Phase II clinical trials; Re-induction | Document URI: | http://hdl.handle.net/1942/28837 | e-ISSN: | 2051-1426 | DOI: | 10.1186/s40425-018-0456-1 | ISI #: | 000451620400001 | Rights: | The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2019 |
Appears in Collections: | Research publications |
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