Results from phase III clinical trials with radachlorine for photodynamic therapy of pre-cancer and early cancer of cervix
https://doi.org/10.24931/2413-9432-2015-4-3-36-42
Abstract
The results of clinical study for efficacy of photodynamic therapy (PDT) with radachlorine in patients with pre-cancer and cancer of cervix are represented. The study enrolled 30 patients including 4 patients with cervical erosion, 5 patients with cervical intraepithelial neoplasia II, 13 patients with cervical intraepithelial neoplasia III, 4 patients with carcinoma in situ and 4 patients with cervical cancer stage Ia. Radachlorine was administrated as single 30 minute intravenous injection at dose of 1,0 mg/kg of body weight 3 h before irradiation (wavelength of 662 nm, light dose of 300–350 J/cm2). The results of treatment in 26 (86,7%) patients was assessed as complete tumor regression and in 4 (13,3%) patients — as partial regression. In cervical erosion, intraepithelial neoplasia II and carcinoma in situ groups total regression was in all cases. In the cervical intraepithelial neoplasia III group total regression after first course of PDT was achieved in 77% of patients, in cervical cancer stage Ia group – in 75% of patients. From 3 to 6 months after first course of treatment all patients with partial tumor regression underwent the second course of PDT with complete regression. There were no side-effects due to radachorine or PDT in the course of treatment and during follow-up. Thus, PDT with Russian photosensitizer radachlorine showed high efficiency for treatment of pre-cancer and cancer of cervix.
About the Authors
E. V. Filonenko
P.A. Herzen MCRI (branch of FSBI «NMRRC» of the Ministry of Health of the Russian Federation), Moscow, Russia
Russian Federation
Russian Federation
L. G. Serova
P.A. Herzen MCRI (branch of FSBI «NMRRC» of the Ministry of Health of the Russian Federation), Moscow, Russia
Russian Federation
Russian Federation
V. I. Ivanova-Radkevich
FSAEI of HPE «PFUR», Moscow, Russia
Russian Federation
Russian Federation
References
1. Ashrafyan L.A. Sovremennye predstavleniya o kantserogeneze raka sheiki matki (Contemporary conceptions of cancerogenesis of cervical cancer), Prakticheskaya onkologiya, 2002, T. 3, No. 3, pp. 146–155.
2. Trushina O.I., Novikova E.G. Vozmozhnosti FDT dlya vtorichnoi profilaktiki virus-assotsiirovannogo predraka sheiki matki (Capabilities of PDT for secondary prevention of virus-associated pre-cancer of the cervix), Sibirskii onkologicheskii zhurnal, 2011. – №3. – S. 45.
3. Bosch F.X., Lorincz A., Munoz N. et al. The causal relation between human papillomavirus and cervical cancer, J. Clin. Pathol., 2002, Vol. 55, pp. 244–265.
4. Kiselev V.I., Ashrafyan L.A., Budarshina S.O. Etiologicheskaya rol' virusa papillomy cheloveka v razvitii raka sheiki matki: geneticheskie i patogeneticheskie mekhanizmy, vozmozhnosti terapii i profilaktiki (An etiologic role for human papillomavirus in a subset of cervical cancer: genetic and pathological mechanisms, possibilities for therapy and prevention), Ginekologiya, 2004, T. 6, No. 4, pp. 174–180.
5. Mikhailov I.G., Maksimov S.Ya., Novik V.I. i dr. Sravnitel'naya otsenka nekotorykh sposobov lecheniya genital'noi VPCh-infektsii u zhenshchin s razlichnymi genotipami virusa (Comparative analysis of certain methods of treating of genital HPV-infection in women with different virus genotypes), Vopr. Onkolog., 2000, T. 46 (3), pp. 340–343.
6. Kulakov V.I., Prilepskaya V.I., Paavonen I. Profilaktika raka sheiki matki. Rukovodstvo dlya vrachei (Prevention of cervical cancer: guidelines for physicians), M.: MEDpress-inform, 2008, pp. 1–56.
7. Dougherty T.J. Photodynamic therapy, Photohem Photobiol, 1993, Vol. 58, pp. 895–900.
8. Sibata C. H. et al. Photodynamic therapy in oncology, J. Expert. Opin. Pharmacother., 2001, Vol. 2, No. 6, pp. 917–927.
9. Monk A., Brewer C., Van Nostrand K., Bems M. Photodynamic therapy using topically applied dihematoporphyrin ether in the treatment of cervical intraepithelial neoplasia, Gynecol Oncol., 1997, Vol. 64 (1), pp. 70–75.
10. Löning M., Diddens H, Friedrich M. et al. Fluorescence diagnosis and photodynamic therapy with 5-aminolevulinic acid induced protoporphyrin IX in gynecology: an overview, Zentralbl. Gynakol., 2006, Vol. 12 (6), pp. 311–317.
11. Pahernik S.A., Botzlar A., Hillemanns P. et al. Pharmacokinetics and selectivity of aminolevulinic acid-induced porphyrin synthesis in patients with cervical intra-epithelial neoplasia, Int. J. Cancer, 1998, Vol. 78(3), pp. 310–314.
12. Hillemanns P., Wang X., Hertel H. et al. Pharmacokinetics and selectivity of porphyrin synthesis after topical application of hexaminolevulinate in patients with cervical intraepithelial neoplasia, Am. J. Obstet. Gynecol., 1999, Vol. 198(3), pp. 301–317.
13. Andikyan V., Kronschnabl M., Hillemanns M. et al. Fluorescence diagnosis with 5-ALA thermogel of cervical intraepithelial neoplasia, Gynakol. Geburtshilfliche. Rundsch., 2004, Vol. 44 (1), pp. 31–37.
Review
For citations:
Filonenko E.V., Serova L.G., Ivanova-Radkevich V.I. Results from phase III clinical trials with radachlorine for photodynamic therapy of pre-cancer and early cancer of cervix. Biomedical Photonics. 2015;4(3):36-42. (In Russ.) https://doi.org/10.24931/2413-9432-2015-4-3-36-42
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