Topical MAL-PDT for cervical intraepithelial neoplasia treatment: a non-surgical option to prevent a cervical cancer Natalia Mayumi Inada (1), Welington Lombardi (2), Natalia Cossetin (2), Fernanda Carbinatto (1), Jose Roberto Trujillo (3), Cristina Kurachi (1), Vanderlei Salvador Bagnato (1) (1) São Carlos Institute of Physics, University of Sao Paulo, Brazil/ (2) Woman Health Ambulatory, UNIARA, Brazil (3) Trubios, Johns Hopkins University, Rockville, MD, United States of America *
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Abstract 35 words: This work presents a device under approval and successful of topical MAL-PDT of over than 60 patients with CIN 1. Based on these results, a multicenter study is ongoing for CIN 2 treatment.
Abstract 200 words: Cervical cancer is the third most commonly diagnosed cancer and the fourth leading cause of 1 cancer death in women worldwide . The highest incidence rates are in Africa, as well as South1 Central Asia and South America . According to the National Institute of Cancer (INCA) at the 2 last year, it was estimated 15,590 new cases of cervical cancer in Brazil . About 90% of cervical cancers originate in the evolution of cervical intraepithelial neoplasia (CIN) which is classified on 3 the basis of cyto-histological characteristics (low and high grade lesions) . The equipment (CerCa 150 System, MMOptics Ltda., Trubios LLC, Brazil-USA) and the medication (20% 4 MAL cream, PDTPharma, Brazil) are produced in Brazil with relative low cost . The Photodynamic Therapy is a promising procedure and it is even known as safe to normal 5,6,7 tissue . The device includes two components specifically adapted to detect and treat abnormal cervical tissue, enabling proper lighting of the cervix. It is portable and does not require special infrastructure or installation. More than 60 patients between the ages of 14-57 years and with CIN 1 were treated and presented 100% of cure. Based on these results a larger randomized study with patients with CIN 2, placebo and follow-up only is ongoing.
References (complete): 1- Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global Cancer Statistics. CA Cancer J. Clin 2011; 61(2):69–90. doi: 10.3322/caac.20107. 2- Estimativa 2014: Incidência de Câncer no Brasil. In: Instituto Nacional de Câncer José Alencar Gomes da Silva, Coordenação de Prevenção e Vigilância. Rio de Janeiro: INCA, 2014. 124p. 3- Bosch FX, Lorincz A, Muñoz N, Meijer CJ, Shah KV. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol. 2002 Apr;55(4):244-65. 4- Inada NM, Lombardi W, Leite MFM, Trujillo JR, Kurachi C, Bagnato VS. Photodynamic therapy of cervical intraepithelial neoplasia. Proc. SPIE 8931, Optical Methods for Tumor Treatment and Detection: Mechanisms and Techniques in Photodynamic Therapy XXIII, 89310X (March 14, 2014); doi:10.1117/12.2040004.
5- Soergel P, Loehr-Schulz R, Hillemanns M, Landwehr S, Makowski L, Hillemanns P. Effects of photodynamic therapy using topical applied hexylaminolevulinate and methylaminolevulinate upon the integrity of cervical epithelium. Lasers Surg Med. 2010 Nov;42(9):624-30. doi: 10.1002/lsm.20979.
6- Hillemanns P, Petry KU, Soergel P, Collinet P, Ardaens K, Gallwas J, Luyten A, Dannecker C. Efficacy and safety of hexaminolevulinate photodynamic therapy in patients with low-grade cervical intraepithelial neoplasia. Lasers Surg Med. 2014 Aug;46(6):456-61. doi: 10.1002/lsm.22255. 7- Hillemanns P, Einstein MH, Iversen OE. Topical hexaminolevulinate photodynamic therapy for the treatment of persistent human papilloma virus infections and cervical intraepithelial neoplasia. Expert Opin Investig Drugs. 2015 Feb;24(2):273-81. doi: 10.1517/13543784.2015.990150. References (reduced): [1] Jemal A, et al. Global Cancer Statistics. CA Cancer J. Clin 2011; 61(2):69–90. doi: 10.3322/caac.20107. [2] Estimativa 2014: Incidência de Câncer no Brasil. In: Instituto Nacional de Câncer José Alencar Gomes da Silva, Coordenação de Prevenção e Vigilância. Rio de Janeiro: INCA, 2014. 124p. [3] Bosch FX, et al. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol. 2002 Apr;55(4):244-65. [4] Inada NM, et al. Proc. SPIE 8931, March 14, 2014; doi:10.1117/12.2040004. [5] Soergel P, et al. Effects of photodynamic therapy using topical applied hexylaminolevulinate and methylaminolevulinate upon the integrity of cervical epithelium. Lasers Surg Med. 2010 Nov;42(9):624-30. doi: 10.1002/lsm.20979.
[6] Hillemanns P, et al. Efficacy and safety of hexaminolevulinate photodynamic therapy in patients with low-grade cervical intraepithelial neoplasia. Lasers Surg Med. 2014 Aug;46(6):456-61. doi: 10.1002/lsm.22255. [7] Hillemanns P, et al. Topical hexaminolevulinate photodynamic therapy for the treatment of persistent human papilloma virus infections and cervical intraepithelial neoplasia. Expert Opin Investig Drugs. 2015 Feb;24(2):273-81. doi: 10.1517/13543784.2015.990150.
