Topical 5-aminolevulinic acid-mediated photodynamic therapy is an established approach for the treatment of basal cell carcinoma. The study with 5- aminolevulinic acid drug Levulon was conducted in patients with superficial skin basal cell carcinoma. The study included 82 patients with overall number of tumor foci of 119. Tumor sites were as follows: head and neck, trunk, extremities. A photodynamic therapy session was performed using a laser with a wavelength of 630 nm, an energy density of 350 J/cm2. A complete response was recorded in 77 patients (114 foci) with an excellent cosmetic result. According to the analysis of survival in the group of patients with a complete response, the overall RFS was as follows: 1-year rate – 92.1%, 3-year – 88.3%. Photodynamic therapy with topical Levulon in patients with superficial BCC of the skin was effective and safe.
Superficial transitional cell carcinoma represents 50 to 80% of newly diagnosed bladder cancer in various countries. Transurethral resection of the urinary bladder is the standard procedure for biopsy and treatment superficial bladder cancer. However recurrence tumors after transurethral resection alone is high enough (50-90%). Intravesical chemotherapy for prophylaxis after complete transurethral resection is reducing recurrence rate about 1 5%. Adjuvant intravesical Bacillus of Calmette and Guerin (BCG) is reducing recurrence rate about 30%, but frequency side effects of this therapy is very high. Purpose of this study is appreciate efficacy adjuvant PDT with photosensitizer Photogeme (Russia) of superficial bladder cancer for prophylaxis after complete transurethral resection. The follow up was from 3 to 63 months (27 months, on average). Sixty-five patients (75.6%) showed no recurrence. For the follow up period, the recurrence was revealed in 21 (24.4%) patient, in two of them it was progressing (one case of invasive growth and one case of remote metastases). Four cases of recurrence were revealed 4 months after the surgery. In other cases, the recurrence was diagnosed from 9 to 18 months.
We have analyzed the results of photodynamic therapy using light-sensitizing agent "Photoheme" in 56 patients - 44 women with pre-cancerous lesions of cervix (group 1) and 12 women with early cervical cancer (group 2). The results were as follows: group 1 - c omplete regression - 3 7 (84%), partial regression - 4 (9,%), stabilization - 2 (4,6%), progression -1 (2,3%); group 2 - complete regression - 8 (66,7%), partial regression - 1 (8,3%), stabilization - 3 (25%). Anti-viral effect was registered in 38 (90,4%) cases after first procedure, in 4 cases - after second procedure.
The paper presents the latest potentialities of the endoscopic fluorescent diagnostics as well as endoscopic electric-, laser surgery and photodynamic therapy (PDT) of the early cancer in the respiratory and digestive tracts. We present in detail indication and factors determining the application of the endoscopic resection of the tumor. The advantages of the combination application of PDT, electro-, Nd:YAG laser surgery and brachitherapy are stressed. The near and remote results of endoscopic treatment of the early cancer in larynx (37), lung (109), esophagus (39) and stomach (58) are shown.
The first clinical trials of photodynamic therapy (PDT) of cancer with two photosensitizers, PHOTOHEME and PHOTOSENS, were started in P.A. Hertzen Research Oncological Institute (Moscow, Russia) in 1992 and 1994. Up to now, 208 patients with primary, recurrent and metastatic malignant tumors (469) of skin (34 patients/185 tumors), breast cancer (24/101), head and neck (30/31), trachea and bronchus (31/42), esophagus (35/35), stomach (31/32), rectum (4/4), vagina and uterine cervix (7/8) and bladder (12/31) have been treated by PDT. One-hundred-thirty patients were injected with PHOTOHEME, 64 patients were injected with PHOTOSENS, 14 patients were injected with PHOTOHEME and PHOTOSENS. Totally, 302 courses of treatment were performed: 155 patients had one course and 53 patients were subjected to two to nine PDT sources with intervals from 1 to 18 months. A therapeutic effect of a one-course and multi- course PDT of malignant tumors (respiratory, digestive and urogenital systems) was evaluated clinically, histologically, roentgenologically, sonographically and endoscopically. The biochemical, hematological and immunological investigations were performed for all the patients in dynamics. Results of our study showed that a multi-course PDT method seems to be perspective in treatment of malignant tumors of basic localizations.
Victor Sokolov, Valery Chissov, Raisa Yakubovskaya, E. Aristarkhova, E. Filonenko, T. Belous, Georgy Vorozhtsov, Natalia Zharkova, V. Smirnov, Margarita Zhitkova
Photosensitizer Photosens is a mixture of sulphonated Al-phthalocyanines with a different number of substituents per phthalocyanine molecule. In the beginning of 1994, this photosensitizer was approved for clinical trials. Since that time till May 1995, 45 patients with 120 tumors were treated by PDT-Photosens. The main tumor localizations were lung (5/6), head and neck (4/4), esophagus (8/8), stomach (2/2), vulva (2/2), bladder (1/1), breast cancer (3/3), skin (basalioma, melanoma, sarcoma Kaposi, mts breast cancer) (20 patients/94 tumors). The lesions were photoirradiated 48-72 h after intravenous injection of Photosens in doses from 0.5 to 2.0 mg/kg b.w. (1.0 mg/kg b.w., on average). PDT was performed by laser power density from 20 to 1400 mW/sq cm (300 mW/sq.cm, on average), energy density varying from 15 to 200 J/sq cm (100 J/sq.cm, on average). The therapeutical effect of PDT was evaluated histologically, endoscopically, roentgenologically and sonographically 3 - 4 weeks after the treatment. Complete regression of tumors was reached in 56%, significant remission was reached in 34%, and partial remission was observed in 10% of cases. The follow-up of patients with complete tumor regression was to 15 months.
Valery Chissov, Victor Sokolov, A. Trakhtenberg, A. Mamontov, L. Vaschakmadze, George Frank, E. Filonenko, L. Telegina, T. Belous, V. Gladunov, E. Aristarkhova, Natalia Zharkova, V. Menenkov
The paper presents the results of photodynamic therapy (PDT) of early-stage cancer of lung (17 patients), esophagus (8 patients) and stomach (10 patients). Fifteen patients had second primary tumors. New drugs photoheme and photosens were used as photosensitizers. Complete remission was obtained in 87%. The patients are followed up without relapses to 2.5 years.
Victor Sokolov, Valery Chissov, A. Trakhtenberg, A. Mamontov, George Frank, E. Filonenko, L. Telegina, V. Gladunov, T. Belous, E. Aristarkhova, Natalia Zharkova, V. Smirnov, Dmitrij Kozlov
In this paper the results of fluorescence diagnostics and photodynamic therapy of early stage malignancies of lung (17 patients) and esophagus (8 patients) are presented. 13 patients had multiple primary tumors. As photosensitizers the new drugs Photoheme and Photosense were used. Complete remission was obtained in 92%. The patients are followed up without relapses to 2,5 years.
The results are described of the first clinical fluorescence diagnostic observations of tumors, carried out in P. A. Hertzen Moscow Research Oncology Institute in the course of clinical trials of a new HpD-type photosensitizer Photogem, developed for cancer treatment by photodynamic therapy. The method of tumor diagnostics using fluorescence spectra of photogem has been developed and a designed spectrometric system has been tested.
Victor Sokolov, Valery Chissov, E. Filonenko, Raisa Yakubovskaya, Garry Sukhin, Maria Galpern, Georgy Vorozhtsov, Alexander Gulin, Margarita Zhitkova, Natalia Zharkova, Dmitrij Kozlov, V. Smirnov
After experimental investigation clinical trials of photodynamic therapy (PDT) with the new photosensitizer Photosens -- (AL-sulphonated phthalocyanine) -- have been started. Four patients (with basal cell carcinoma, sarcoma Kaposi and early stage lung cancer) were treated by PDT. After an intravenous injection of drug in dose 2.0 mg/kg b.w. tumors were exposed to frequency-doubled radiation of Nd:yttrium aluminate laser (670 nm) with power densities from 80 to 200 mW/sq cm and total energies up to 2144 J. Immunological and clinical observations of patients are performed. First results indicate the high efficacy of the new drug as a tumor photosensitizer.
In the course of clinical trials of Photosens (Al-sulphonated phthalocyanine) as a new drug for PDT of cancer fluorescence observations of patients with injected photosensitizer are performed. The aim of current investigations is to develop the clinical method of cancer diagnostics with Photosens, to study the pharmaco-kinetics of the drug in the human body and its retention in tumors.
The first clinical trials of photodynamic therapy (PDT) in Russia were started in P. A. Hertzen Moscow Research Oncology Institute in October of 1992. Up to now, 61 patients with primary or recurrent malignant tumors of the larynx (3), trachea (1), bronchus (11), nose (1), mouth (3), esophagus (12), vagina and uterine cervix (3), bladder (2), skin (6), and cutaneous and subcutaneous metastases of breast cancer and melanomas (6) have been treated by PDT with the photosensitizer Photogem. At least partial tumor response was observed in all of the cases, but complete remission indicating no evident tumors has been reached in 51% of the cases. Among 29 patients with early and first stage cancer 14 patients had multifocal tumors. Complete remission of tumors in this group reached 86%.
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