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Báo cáo hóa học: " The application of adjuvant autologous antravesical macrophage cell therapy vs. BCG in non-muscle invasive bladder cancer: a multicenter, randomized trial"

Tuyển tập báo cáo các nghiên cứu khoa học quốc tế ngành hóa học dành cho các bạn yêu hóa học tham khảo đề tài: The application of adjuvant autologous antravesical macrophage cell therapy vs. BCG in non-muscle invasive bladder cancer: a multicenter, randomized trial | Burger et al. Journal of Translational Medicine 2010 8 54 http www.translational-medicine.eom content 8 1 54 RESEARCH JOURNAL OF TRANSLATIONAL MEDICINE Open Access The application of adjuvant autologous antravesical macrophage cell therapy vs. BCG in non-muscle invasive bladder cancer a multicenter randomized trial Maximilian Burger 1 Nicolas Thiounn2 Stefan Denzinger1 Jozsef Kondas3 Gerard Benoit4 Manuel S Chapado5 Fernando J Jimenz-Cruz6 Laszlo Kisbenedek7 Zoltán Szabo8 Domján Zsolt8 Marc O Grimm9 Imre Romics10 Joachim WThuroff11 Tamas Kiss12 Bertrand Tombal13 Manfred Wirth9 Marc Munsell14 Bonnie Mills15 Tung Koh15 and Jeff Sherman16 Abstract Introduction While adjuvant immunotherapy with Bacille Calmette Guérin BCG is effective in non-muscle-invasive bladder cancer BC adverse events AEs are considerable. Monocyte-derived activated killer cells MAK are discussed as essential in antitumoural immunoresponse but their application may imply risks. The present trial compared autologous intravesical macrophage cell therapy BEXIDEM to BCG in patients after transurethral resection TURB of BC. Materials and methods This open-label trial included 137 eligible patients with TaG1-3 T1G1-2 plurifocal or unifocal tumours and 2 occurrences within 24 months and was conducted from June 2004 to March 2007. Median follow-up for patients without recurrence was 12 months. Patients were randomized to BCG or mononuclear cells collected by apheresis after ex vivo cell processing and activation BEXIDEM . Either arm treatment consisted of 6 weekly instillations and 2 cycles of 3 weekly instillations at months 3 and 6. Toxicity profile primary endpoint and prophylactic effects secondary endpoint were assessed. Results Patient characteristics were evenly distributed. Of 73 treated with BCG and 64 with BEXIDEM 85 vs. 45 experienced AEs and 26 vs. 14 serious AEs SAE respectively p 0.001 . Recurrence occurred significantly less frequent with BCG than with BEXIDEM 12 vs. 38 p 0.001 . Discussion