Method for treating patients for vulva cancer

FIELD: medicine.

SUBSTANCE: method involves excising basic tumor as one-stage operation by means of high-energy СО2 laser or cytoreduction operation is carried out (basic tumor component removal) using laser output power of 20-40 W at the first stage. Remote photodynamic therapy is applied by irradiating the whole vulva surface with radiation dose of 100-150 J/cm2, power density of 50-70 mW/cm2 and irradiating tumor localization zone with radiation dose of 200-300 J/cm, power density of 150-200 mW/cm at the second stage. Additional interstitial laser irradiation with radiation dose of 200-300 J is optionally carried out at radiation power of 200-300 mW in tumor invasion zone.

EFFECT: enhanced effectiveness of organ-retaining and sparing treatment; accelerated treatment course; reduced risk of postoperative complications.

2 cl

 

The present invention relates to medicine, namely to Oncology, and can be used as a method of treatment of patients with vulvar cancer, including photodynamic therapy (PDT).

Vulvar cancer is 4th on morbidity and mortality of malignant tumor of the female genital organs. The standard is a combined treatment comprising: a 1-stage surgical intervention - vulvectomy and in the stage 2 radiation therapy. Independently radiotherapy or surgical method is used only in the initial stages of the disease when the 1-St stage of the process. (Vishnevskaya E.E. Guide to gynecology. Minsk. 1980, p.49-56; Oncogynecology. Edited galazutdinov SS and others, Moscow. 2002, str-198; Operative gynecology. Under the editorship of RAMS Academician V.I. Kulakov, C. 1998, str-447). Difficulties in the treatment of cancer of the vulva is related to the fact that this tumor has a multicenter option growth, i.e. in addition to the visible identified hearth has the beginnings of a tumor, not determined visually. Surgical treatment of patients with this pathology requires a broad knife excision of the vulva. (Bohman AV and other vulvar Cancer. Tashkent. 1996, p.93-120; Operative gynecology. Under the editorship of RAMS Academician V.I. Kulakov, C. 1998, str-447). Vulvectomy involves the removal of the body and leads to an immediate disability women, and is followed by radiology the treatment significantly complicates the process of rehabilitation. Radiation damage to healthy tissue in the radiation zone in the form of fibrosis, radiation epithelitis, stenosis of the vagina, radiation ulcers, etc. are observed in 75-80% of cases. Time rehabilitation of these patients can be from 1 year to 6-7 years. Five-year survival in the combined treatment of patients with cancer of the vulva does not exceed 57%. (Vishnevskaya E.E. Guide to gynecology. Minsk. 1980, p.49-56).

Surgical intervention in the form of CO2laser excision of a tumor of the vulva within healthy tissue is used in the case of precancerous pathology. In the case of vulvar cancer CO2laser destruction is not a radical intervention and requires additional treatment given multicenter tumor growth (Operative gynecology. Under the editorship of RAMS Academician V.I. Kulakov, C. 1998, str-145; Clinical Oncology. Volume 2. Edited Bay, Beiderman, Moscow: Medicine, 1979, str-611).

PDT is a fundamentally new method in the treatment of patients with malignant tumors. During PDT, the patient is usually systemically injected photosensitizer (PS), selectively accumulate in malignant tumors. After the introduction of the Federal Assembly of the tumor is exposed to laser light of a specific wavelength in accordance with the peak excitation FS. In the exposure occurs photochemical reaction, where FS is essentially plays the role of catalyst, the formation of active forms of oxygen (the main of which is singlet oxygen) and various radicals that are cytotoxic agents and cause the destruction of tumor cells. The second mechanism of PDT - destruction of the endothelium of blood vessels in the area of laser irradiation, which takes place thrombosis and malnutrition in the tumor. The third mechanism of PDT - stimulation of local and General antitumor immunity. As a result of PDT selectively affects tumor cells with preservation of surrounding healthy tissue, which is conserving therapy for patients with malignant tumors. PDT can be used alone and in combination with traditional methods of treatment. (Chissov V.I., Sokolov V.V., Filonenko E.V. Photodynamic therapy of malignant tumors. A brief outline of the development of and clinical experience in Russia. Russian chemical journal, 1998, No. 5, p.5-9; R. Jakubowski, Kazatchkine NI, Karmakova T., Shitova L., E. Pechersky, G. Fomina, Nemtsov ER Derkacheva VM, Chissov V.I. Screening and medical-biological study of the domestic photosensitizers. Russian chemical journal, No. 5, 1998, volume XLII, p.17).

When exposed to laser light in biological tissue according to optical laws observed atragene the light, penetration into the tissue and the propagation of light in tissue. The laser radiation of the visible spectrum is weakened when removing depth from the surface of the tissue due to absorption and scattering. The efficiency of the photodynamic effect decreases with increasing distance from the surface of the tumor into the fabric. When conducting remote PDT with laser light with a wavelength of 670 nm, the effective impact possible on the depth of not more than 4-6 mm (Kiselev G.L., Loshchenov V.B. have been the Distribution of laser radiation in biological tissue during photodynamic therapy and diagnosis. Russian chemical journal, No. 5, 1998, p.53). Remote PDT patients with cancer of the vulva is possible in the case of a flat surface bounded tumors in the early stages of the disease. In the case of solid (having a certain amount), exophytic malignant tumors or tumors with invasion into underlying tissues PDT efficacy is reduced taking into account the propagation of light in biological tissues. For a complete regression of the tumor in this situation requires a single exposure to high doses of light energy or making a multisession PDT with layer-by-layer removal of necrotic tissue that required invasive interstitial irradiation.

As the prototype is accepted publication for the treatment of patients with cancer of the vulva methodology the PDT using the remote and interstitial laser irradiation (Balandin A.G. Photodynamic therapy in the treatment of the background of precancerous processes and cancer of the female external genital organs. Abstract, Moscow, 2005, p.15-23). A remote laser light irradiation dose of 600 j/cm2zone location of the tumor and remote irradiating the entire surface of body light dose of 100-150 j/cm2. In the case of invasion of the tumor into underlying tissues it is proposed to conduct exposure through diffusers installed in fabric peritumoral, 24 hours after remote PDT. The radiated power of 200 mW, course length dose of 600 to 1200 joules.

Photodynamic therapy in these modes leads to severe necrotic changes both in the tumor and the surrounding healthy tissues. In the next place long-term rehabilitation, long-term healing of wounds 7-10 weeks. The consequence of deep necrotic changes, as a rule, is a gross scar tissue.

Thus, the main disadvantages of the proposed method are: pronounced destructive tissue changes in the area of PDT in the case of the use of large doses of light emission and, consequently, prolonged wound healing, rough, scarring, prolonged rehabilitation of patients.

The invention is a method of treating patients with cancer of the vulva is aimed at achieving the following objectives: to improve the giving of the effectiveness of PDT patients with cancer of the vulva 1-2A-3A stage as in the case of superficial tumors, so in the case of solid and exophytic tumors, organ-sparing treatment, reduction of terms of treatment of patients with this pathology, reduce recovery time, minimize complications due to the treatment.

The tasks are solved in the following way: in the first stage of treatment by high-energy CO2laser simultaneously excised primary tumor within healthy tissue or produce the maximum possible cytoreductive surgery (removal of the main component of the tumor) when the output power of the laser 20-40 watts, in the second stage - 2-3 weeks - hold of PDT with remote laser irradiation of the entire surface of the vulva light dose of 100-150 j/cm2when the power density of 50-70 mW/cm2and remote laser irradiation area of the location of the tumor light dose of 200-300 j/cm2when the power density of 150-200 mW/cm2in the area of invasion of the tumor may also additional interstitial laser irradiation light dose of 200-300 j, when the power light radiation 200-300 mW.

Surgical stage simultaneously performed under General anesthesia. The operation is carried out using high-energy CO2laser domestic production "Scalpel-1" (Ulyanovsk laser technology. Russia). The power of the laser radiation when excision of tumors and 20-40 watts, the operation time is from 3 to 7 minutes. The advantage of laser destruction of malignant tumors of the vulva is a short-term intervention, minimality caused injury to the patient, maintaining the external genital organs, the absence of spontaneous metastasis in connection with the coagulation of the blood vessels, the absence of active bleeding, and rapid rehabilitation in the postoperative period and the creation of opportunities for the 2nd stage of PDT treatment.

PDT is performed 2-3 weeks after the first stage of treatment in the form of laser irradiation under General anesthesia.

the combination of PDT is based on the system application of the photosensitizer "photosense", which is introduced in a dose of 0.5 mg/kg 24 hours prior to laser irradiation. Radiation is laser light of a wavelength of 670 nm all over the surface of the vulva: the total dose of light energy treatment 100-150 j/cm2the power density of 50-70 mW/cm2. At the same time separate fields irradiated area of localization of the detected tumors: the total dose of light energy of 200-300 j/cm2the power density of 150-200 mW/cm2. In areas of invasion of the tumor (based on preliminary histological study) may optionally be conducted interstitial laser irradiation: the total dose of light energy is 200-300 j depending on the size and volume of irradiated tissue. The power of the laser irradiation is 200-300 mW.

Indications for combined treatment with PDT: vulvar cancer 1-2A-3 stage.

The proposed method is illustrated by the following examples.

Example 1.

Patient Century 60 years (13335/01). The diagnosis of vulvar cancer stage 2A (prior to treatment exophytic tumor 3×2×2 cm). CO2laser excision of the tumor 03.03.02. Power on the laser output of 40 watts. Histological study of squamous cell carcinoma (No. 6506-07 from 09.03.02). PDT was performed 2 weeks after laser destruction. The drug "photosense" administered intravenously at a dose of 0.5 mg/kg 24 hours prior to laser irradiation. Laser irradiation with light of a wavelength of 670 nm. The total light dose of remote laser irradiation on the area of the vulva 100 j/cm2the irradiation capacity of 50 mW/cm2the total light dose of remote laser irradiation on the area of location of the tumor 300 j/cm2the irradiation capacity of 200 mW/cm2. The total light dose interstitial laser irradiation in the area of location of the tumor 200 j, the irradiation capacity of 200 mW. Complete wound healing within 3 weeks. Result: achieved complete regression of the tumor. During 3 years of follow-up of tumor recurrence was not detected. There are no complications.

Example 2.

Patient F. 72 years (7204/02). The diagnosis of vulvar cancer stage 2A (prior to treatment e is sofina tumor 4× 1,5×1 cm). CO2laser excision of the tumor 09.06.02. The output power of the laser 30 watts. Histological study of squamous cell carcinoma (No. 17274-75 from 15.06.02). PDT 2 weeks after laser destruction. The drug "photosense" administered intravenously at a dose of 0.5 mg/kg 24 hours prior to laser irradiation. Laser irradiation with light of a wavelength of 670 nm. The total light dose of remote laser irradiation on the area of the vulva 150 j/cm2the irradiation capacity of 70 mW/cm2the total light dose to the tumor's location 300 j/cm2the irradiation capacity of 150 mW/cm2. The total light dose interstitial laser irradiation in the area of location of the tumor 200 j, the irradiation capacity of 300 mW. Complete wound healing within 4 weeks. Result: achieved complete regression of the tumor. During 3 years of follow-up of tumor recurrence was not detected. There are no complications.

Example 3.

Patient M 44 years (9069/02). Diagnosis: cancer of the vulva stage 1 (before treatment flat tumor 2×2 cm). CO2laser excision of the tumor 7.06.02. The output power of the laser 30 watts. Histological examination - glandular cancer (No. 4539-41/02 from 13.06.02). PDT 2 weeks after laser destruction. The drug "photosense" administered intravenously at a dose of 0.5 mg/kg 24 hours prior to laser irradiation. Laser irradiation with light of a wavelength of 670 nm. Total length to the and remote laser irradiation on the area of the vulva 100 j/cm 2the power density of 50 mW/cm2the total light dose to the tumor's location 300 j/cm2the irradiation capacity of 200 mW/cm2. Complete wound healing within 3 weeks. The result achieved complete regression of the tumor. During 3 years of follow-up of tumor recurrence was not detected. There are no complications.

Example 4.

Patient W. 73 years (15124/02). The diagnosis of vulvar cancer stage 3A (prior to treatment exophytic tumor 4×2×1 cm with the transition on the eve of the vagina). Partial CO2laser excision of the tumor (cytoreductive surgery) 04.11.02. Power on the laser output of 40 watts. Histology squamous orogovevshi cancer invasion (No. 33212-16/02 from 10.11.02). PDT 2 weeks after laser destruction. The drug "photosense" administered intravenously at a dose of 0.5 mg/kg 24 hours prior to laser irradiation. Laser irradiation with light of a wavelength of 670 nm. The total light dose of remote laser irradiation on the area of the vulva 100 j/cm2the power density of 50 mW/cm2the total light dose to the tumor's location 300 j/cm2the irradiation capacity of 200 mW/cm2. The total light dose interstitial laser irradiation in the area of location of the tumor 300 j, irradiation capacity of 200 mW. Complete wound healing after 6 weeks. Result: achieved complete regression of the tumor. the 3 years of observation of tumor recurrence was not detected. There are no complications.

For the period since 2000 in Cancer clinical hospital №1 of the health Department of the city of Moscow were treated using this method, 57 patients with cancer of the vulva 1-2A-3A stage.

The objective effect was present in all patients. In 96% of cases received a complete regression of the tumors (morphologically confirmed)4% partial (the tumor is not less than 50%). Complications associated with CO2laser excision of tumors and subsequent PDT, was not.

Thus, the proposed method of treatment of patients with vulvar cancer can improve the effectiveness of the treatment in the case of all these stages of the disease, to save the body, to reduce the treatment time, reduce recovery time, minimize complications after treatment.

1. A method of treating patients with cancer of the vulva, including photodynamic therapy using Photosens, characterized in that the first stage of treatment by high-energy CO2laser simultaneously excised primary tumor within healthy tissue or produce the maximum possible cytoreductive surgery (removal of the main component of the tumor) when the output power of the laser 20-40 watts, in the second stage, after 2-3 weeks spend PDT with remote laser irradiation of the entire surface is ti vulva light dose of 100-150 j/cm 2when the power density of 50-70 mW/cm2and remote laser irradiation area of the location of the tumor light dose of 200-300 j/cm2when the power density of 150-200 mW/cm2.

2. The method according to claim 1, characterized in that in the zone of invasion of the tumor spend additional interstitial laser irradiation light dose of 200-300 j when the power light radiation 200-300 mW.



 

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