Systemic enzyme therapy in the complex treatment of breast cancer

Tarutinov V.I., Nosa P.P., Ros N.V., Galakhin K.A., Shpilevaja S.I.

Ukrainian Research Institute of Oncology and Radiobiology

6th International Congress on Hormones and Cancer, September 5-9, 1999, Jerusalem, Israel


Russian version available here


Breast cancer occupies a first place among oncopathology in Ukrainian women. In many cases (up to 60%), cancer is diagnosed in the late stages, requiring chemo- and radiotherapy in the neoadjuvant regime. Unfortunately, tumor is often not sensitive enough to the radio- and chemotherapy. More than 50% of viable tumor tissue still outlasts. Combination of radiotherapy and polychemotherapy reduces viable tumor tissue to 40%. However, the efficacy of radiotherapy followed by polychemotherapy decreases because of postirradiation reactions - fibrous changes, edema, development of "protective" lymphocytary fornix surrounding the tumor. Therefore, systemic enzyme therapy is necessary to facilitate a contact between the tumor and chemo-preparation. Over the recent years, systemic enzyme therapy has become an essential part of treatment of both breast cancer and dyshormonal hyperplasias. Very important is the capacity of enzymes to act as "carrier" helping to transport chemo-preparations to the target place. Furthermore, enzymes are able to reduce number and severity of toxic complications developing during chemo- and radiotherapy. A "fornix" surrounding the tumor prevents from the effect of chemo-preparations. Additionally, macromolecules and fat-soluble compounds penetrate more easily to the tumor tissue in comparison to the normal one. Therefore, enzymes can facilitate the effect on the tumor. Additionally, macromolecules and fat-soluble compounds penetrate more easily to the tumor tissue in comparison to the normal one. Therefore, enzymes can facilitate the effect on the tumor. Enzymes destroy the net which connects tumor cells with each other and with endothelium, realize a proteolysis of tumor cell membranes. Consequently, tumor size is reduced, tumor necrosis occurs, and tumor is more easily attainable for chemo- and hormone-preparations. Results of experimental and clinical studies (Zeneca and Pur, 1964) have shown that proteinases increase tissue permeability. Moreover, enzymes slow down formation of immune complexes and show an indirect immunoregulatory effect (Kunze, 1993, 1995). Currently, attention has been focused on dynamics of TGF-? alterations under the effect of enzymes. Overproduction of TGF-? leads to the undesirable postirradiation changes and enhances development of fibrous tissue. Administration of proteinases (Phlogenzym) decreases TGF-? level and reduces fibrous changes (Heidland, 1997). Thus, systemic enzyme therapy appears to be suitable for the treatment of fibrous forms of hyperplasias.
We observed 55 patients with breast cancer, II-IV clinical stage (T 2-4 N 1-3 M 0), aged 35-64 years. All patients were subject to the complex treatment, including enzyme preparations Wobe-Mugos and Wobenzym (Mucos Pharma, Germany). Patients received in the preoperative period neoadjuvant course of polychemotherapy with respect to the tumor sensitivity towards chemo-preparations (method according to Kulik). In most of the cases, the treatment schemes were CMF (cyclophosphamide, methotrexate, 5-fluorouracil) or CAF (cyclophosphamide, Adriablastin-doxorubicin, 5-fluorouracil). At the same time patients received Wobe-Mugos, 3-5 tablets 3 times a day, 1 hour before meals. After neoadjuvant polychemotherapy (1-3 days), a radical surgery was performed (depending on the volume from quandrantectomy to mastectomy, according to Halstedt). The effect of neoadjuvant polychemotherapy was evaluated by morphometry: comparison was done with tumors of analogous patients which received neoadjuvant polychemotherapy without systemic enzyme therapy and which also received radiotherapy. Volume of viable tumor tissue remained in the control group 50%, in the group with neoadjuvant polychemotherapy without enzymes 40%, and in the group with enzyme therapy up to 34%. In the postoperative period, development of postirradiation dermatitis, lymphostasis and lymphorhea, as well as healing of surgical wounds, volume of viable tumor tissue were observed and evaluated in comparison to the control. It was found that complex treatment of breast cancer, including neoadjuvant chemo- and hormone-therapy and systemic enzyme therapy showed less complications and also smaller volume of viable tumor tissue (by 15-16%), as compared to the control group. This corresponds to the decrease of TGF-? during administration of enzyme therapy.
Therefore, preparations of systemic enzyme therapy were successfully used as "supportive" ones during chemotherapy. The main chemotherapy side-effects are: immunodepressive effect, impaired function of liver, kidneys, neurological damage, hemopoiesis suppression, dyspeptic complaints. The effects of enzymes include:

  1. Immunomodulatory effect;
  2. Decrease of hepatotoxicity and pneumotoxicity;
  3. Improvement of rheological properties of blood and microcirculation;
  4. Normalization of cytokine concentration which enables an increased efficacy of chemotherapy.

Our results showed a decrease of postirradiation reactions in 20 out of 31 patients.
Lymphedema is caused by the lymph stagnation which is developed as a result of obliteration of deep lymphatic vessels and local compensatory mechanism disorders. Plasma, rich on proteins, penetrates to the surrounding tissues, causing a development of fibrous and sclerotic changes. Wobenzym positively influences this complication thanks to the following mechanisms:

  1. Antiinflammatory and antiedematous effect of proteinases
  2. Degradation of inflammatory products
  3. Normalization of equilibrium between fibrin formation and cleavage on the vessel walls.
  4. Hydrolases, causing breakdown of proteins and detritus, decrease the exsudate viscosity and, therefore, improve its liquid properties.
  5. Rutin shows antihemorrhagic effect, decreases capillary permeability, and by strengthening of vessel walls prevents development of edemas, rich on proteins.
  6. Lysis of complex macromolecules reduces oncotic pressure, small residues are removed through lymphatic system.

Wobenzym causes edema reduction and its resorption. Thus, pain syndrome caused by a tension also decreases. Recommended dosage (lymphedema prophylaxis): preoperatively Wobe-Mugos, 3 tablets 3 times a day for 2 weeks, postoperatively Wobenzym 5 dragees 3 times a day.