ABSTRACT

Electrochemical Therapy (ECT) was applied to one hundred five (105) cases of middle and late stage breast cancer from 1987 to 1990. Among them, 74 cases were primary breast cancer and 31 cases were recurrent cancers after surgical resection. There were 102 female patients and 3 male patients ranging in age from 38 to 91 years; the average age was 52.5 years.

According to the standard 0fTNM staging of breast cancers adopted by the UTCC in 1988, 110 cases were of stage one. Of the 74 primary cases, 16 cases were stage 11; 51 cases were stage III; and 7 cases were stage IV. Thirty one (31) cases of recurrent breast cancer were all stage IV. Pathological examination revealed that of the 74 primary cases, 55 cases were glandular adenocarcinoma, 19 cases were tubular- adenocarcinoma. The 3 1 cases of recurrent cancer were all adenocarcinoma.

According to the UICC standard of 4 grade evaluation of effectiveness, (CR, PR, NC, PD), the short term effective rates of the 105 cases was: CR 35.2%; PR 43.8%; NC 13.4 %; PD 7.6%. The total effective rate was 79.0 % excepting the 11 cases which died in the first year, the five year survival rate of the 94 remaining cases was:

One year survival rate=89.5% (94/105)
Two year survival rate=82.9% (87/105)
Three year survival rate=69.5% (73/105)
Four year survival rate=58.1% (6 1/105)
Five year survival rate=50.5% (53/105)

Therapeutic Method

Using B-type ultrasonography, platinum electrodes were accurately inserted into the cancer and placed all through the tumor mass. Anodes (+ charge) were usually in the center and cathodes (- charge) were at the periphery. The distance between two electrodes was about 2.5 cm. Hence the number of electrodes needed were calculated upon the size of the tumor. The manipulation of the electrodes is simple, easy to handle, safe, and effective. Moreover, recovery time is very rapid. ECT is applicable to various kinds of cancers or tumors. lt may be used safely and effectively with old, weak patients as well as other patients who have no remaining means of treatment. This method is especially suitable for recurrent cancers, and can heal large areas of ulceration. Key words electrochemical! Therapy (ECT), middle and late stage cancer, therapeutic effectiveness.

Electrochemical therapy (ECT) was first used in the treatment of malignant tumors in the early seventies. In 1983, publications of B. Nordenström (1-4) introduced systematically experimental and clinical results of ECT. In 1988, Pekar (5) reported his clinical results in using ECT to treat superficial tumors. In Japan (6), there have been experimental and clinical applications of ECT. Recognising its‘ efficacy as a cancer treatment, it is surprising that ECT has been all but ignored in many parts of the scientific world.

In China, ECT has been studied experimentally and used clinically since 1987. In 1993 a summary of therapeutic results of 2516 cases with ~ kinds of malignant tumors was published (7). The total effective rate ranged between 70 and 80 percent. The results of ECT in treating 105 cases of breast cancer is reported hereof.

1. Clinical Data:
Diagnosis of this group of patients was made by X-ray film, B-type ultrasonography and pathological examination. One hundred and two (102) cases were female and three (3) male. Age ranged from 38 to 91 years; with the average age of 52.2. Among them, 74 cases were primary cancer and 31 cases were e recurrent cancer following surgical resection. Compared with primary cancer, recurrent cancer was difficult to treat and bad an unfavourable prognosis.

Table 1. Age of 105 cases with breast cancer

There were 63 cases with right breast cancer and 42 cases with left. The diameters ofprimary cancer mass and ulceration of recurrent cancer are shown in Table 2.

Table 2. Diameters (cm) of breast cancers

The staging of cancer according to the standards issued by UICC in 1988 is shown in Table 3. No cases fell into stage 1.

Table 3. TNM Staging of Cancers

Table 3 indicates that 84.8% (89/105) cases were at stage III stage IV.

Pathological examination revealed that all recurrent cancers were adenocarcinoma. Of the 74primary cancers, 55 were glandular type and 19 were tubular type. (See Table 4.)

Table 4. Histological type of breast cancers
 

Table 4. Histological type of breast cancers

Twenty six (26) cases of this group were found to have remote metastasis. Eighteen (18) cases of them were in the group of thirty one (31) recurrent cancer. Among the 18 cases, 6 cases were with lung and pleural cavity metastasis, 7 with mediastinum and cervical lymph node metastasis, and 5 with thoracic vertebrae and rib metastasis. In the group of primary cancers, there were 8 cases with cervical lymph node metastasis.

2.      Method of Treatment.

2.1   Instrument and electrodes: BK 92 type instrument, capable of regulating voltage, current, electric quantity, and time was used. The above Parameters could be preset. Alarm System is built in. Electrodes are made of platinum, with a diameter of 0.65 mm and length of 15 cm.

22.     Patients and their families were informed about the features and perceptions of doing ECT before receiving treatment.

2.3     ECT was carried out under lidocaine local anaesthesia. Dolantin (50-100 mg) or morphine (5-10 mg) may be used to ensure the least painful sensation to the patient.

2.4     Patient was told to lie comfortably on the bed. The size and diameter of the cancer was measured by 8-type ultrasonograph, and was marked an the surface of the skin. The number of electrodes and insertion points were then determined based upon the cancer cell killing area around each electrode. The radius of the killing area is about 1.3 cm. The distance between electrodes, hence, should not exceed 2.5 cm.

The procedure was done under aseptic conditions. A cannula (small flexible plastic tubing) encasing a trocar (a stiff, pointed rod) was inserted into the cancer mass; with the tip of the cannula reaching the far side of the mass. Then the trocar was withdrawn and an electrode was inserted into the full length of the tubing. The tubing was then withdrawn through the cancer mass to the point where it reached normal tissue. Thus, the electrode was exposed only within the cancer mass while normal tissue was insulated from the electrode by means of the plastic cannula.

The electrodes were then connected by wire to the power source. The voltage ranged from 6-8 Volts, the current ranged from 60-80 mA. The diameter of the cancer mass was used to determine the quantity of electricity to be absorbed. For each centimetre of diameter from 80 to 100 coulombs (a measure of electrical charge) were applied.

For recurrent cancer, a series of treatments should be to the patient. The size of the ulceration should be used to indicate the number of treatments. For patients with stage IV cancer and metastasis, ECT treatment should be combined with radio~ or chemotherapy in order prolong the patient‘s life.

3. Therapeutic Results.

The effectiveness was graded according to the standard put forth by UICC (CR, PR, NC, and PD). The "effective rate" is determined by adding CR (Complete Remission) to PR (Partial Remission).

3.1 Short-term effectiveness: See Table 5.

Table 5 indicates that the effective rate of treating primary cancer (87.8%; 65/74) is significantly higher (P<0.05) than that of treating recurrent cancer (58.1%; 18/31). Effectiveness of treatment was inversely proportional to the staging.

Table 5. Short-term Effectiveness of 105 Cases

The effective rate was 100% for stage II patients, 90% for stage III patients, and 42.8% for stage IV patients. The differences between stages II, III, and IV is significant (p<0.01). See Table 6.

Table 6. Effectiveness of Primary Cancer Patients with different stages

The effective rate was inversely proportional to the size of the cancer. When the diameter of the cancer was from 3 to 5 cm, the CR+PR of the group of primary cancer was 93.8% (I5/16), and that of the recurrent cancer group was 100% (22). For cancers 5.1 to 7.0 cm in diameter, the effective rate for primary cancer was 94.I% (48/51), and that of the recurrent group 77.8% (7/9). For patients having cancer larger than 7.I cm, the CR+PR of the primary cancer group declined to 28.6% (2/7), and the recurrent cancer group declined to 45.0% (9/20). See Table 7.

Table 7. Effective rate and size of cancer of 105 cases.
 

Figures on table 7 indicate that seventy eight (78) patients had cancers of no more than seven centimetres in diameter (16+51+2 +9 78). Of this group, seventy two (72) patients were categorised as either CR or PR; (11+18+4+30+2+3+4 = 72). This group had combined CR+PR rate of92.3%; (72/78). The number of cases with cancers larger than 7.0 cm was 27 (7+13+7=27). In this group, the combined CR+PR rate was 40.7% (2+1+7+1= 11; 11/27).

3.2  Long Term Effectiveness.

Among the 105 cases, 11 cases were dead within one year. The remaining 94 cases were followed for 5 years. See Table 8.

Table 8. Five Year Survival Rates of 105 Cases

From table 8, the one, three, and five year survival rates of the primary cancer group were 94.6%, 82.4%, and 66.2% respectively, while those of the recurrent group were 77.4%, 3 8.7%, and 12.9% respectively. There were significant differences between survival rates of these two groups.

Of 31 cases of the recurrent group, 18 cases were with general metastasis, and dead in one or two years after treatment. Of the thirteen cases having no metastasis, ten of these cases lived for 3 years, and three for 5 years.

The five year survival rates of different stages differed. Of the 74 cases of primary cancers, the five year survival rates of stage II, III and IV were 81.3%, 75.0%, and 0% respectively. There were significant differences between the survival rates of the different stages. See tables 9 and 10.

Table 9. Five year survival rates of different stages of 74 cases with primary cancer.

Table 10 Five year survival rates of 31 cases with recurrent cancer

Table 10 indicates that none of recurrent cases with general metastasis Iived longer than 3 years, and their survival rates of one to three years were lower than those of the recurrent cases with 110 metastasis.

4.     Discussion.

4.1   Indications. Cases of stages II or III breast cancer which had not undergone prior surgical procedures, and for which other conventional treatments had proven ineffective, responded very well when treated with ECT. In this group of 105 cases, 67 cases were at stages II and III. Among them, 62 cases were of grade CR and PR. that is, were of total effective rate of 92.5%.The five year survival rates of cases at stages II and III were 81.3% and 70.6%, respectively. Hence, ECT is the indicated treatment for stage II and III breast cancers.

In stage IV breast cancers, remote metastasis is found. Following ECT, patients usually died of pre-existing general metastasis even though the lesion(s) treated with ECT usually respond well. Even though there were large areas of ulceration, recurrent breast cases could be treated effectively with ECT. Wounds healed and the short term effect was satisfactory. Yet, most of the 18 cases of recurrent cancer with general metastasis die Within two years.

4.2   Therapeutic Methods. The application of ECT is simple, easy to handle and safe. Because trauma induced by ECT is minimal, recovery is rapid. Healthy tissue and skin should be protected from damage. Electrodes should be inserted passing all the way through the cancer proper. The number of electrodes used should be determined according to the size of the cancer mass. Experimental and clinical experience indicates that the radius of the cancer cell-killing area around each electrode is approximately 1.3 cm. Therefore, the distance between two electrodes should be approximately 2.5 cm. for cases with recurrent cancers and ulceration, the insertion of electrodes would differ according to the differing shapes of the wound. For large cancerous masses, ECT may be applied several tomes. When granulomatous tissue is formed on the wound, skin grafts may become necessary to complete the treatment.

4.3   Electric Quantity Needed. Experimental and clinical results showed that 80 to 100 coulombs are needed per 1 cm of diameter of cancerous tissue. When the application of ECT was in the experimental stage, three cases of breast cancer received only 30 to 50 coulombs per 1 cm diameter of cancer tissue. Three to five months after treatment the cancer mass had been reduced very little. One patients received a surgical operation. The cancer mass resected was examined pathologically. The exam indicated that there were cancer cells at the periphery of the cancer mass. The other two patients received ECT once more and were cured.

4.4   Complications and Recurrence Rate. No serious complications have occurred. Occasionally there have been burns to healthy tissue, but the burns healed without any treatment. For primary cancers treated with ECT, the recurrence rate was 9.5% (7/74). For recurrent cancers treated with ECT, the re­recurrent rate was 19.4% (6/31). All of these recurrences could be treated by ECT again.

Fifty three of the 105 cases lived longer that five years. The other 52 cases died within 5 years. Thirty nine cases were dead of remote metastasis (lung 9, neck and mediastinum 6, pleural cavity~ 7, liver 5, bone 9 and brain 3). Eight of the 52 cases were dead of cardiac and cerebral vascular diseases, and five cases over 80 years of age were dead of pneumonia

4.5    Combined Treatment. Chemotherapy in small doses may be combined with ECT to eliminate residual cancer cells and to reduce the recurrence rate. For those cases already having metastasised, chemotherapy or Chinese herbal drugs combined with western medicines should be given to control the disease. Supportive treatment should be given to patients ~manifesting weakness or low immunity. Chinese herbs and immune ~stimulating agents can increase the patients body strength and enhance the effect of ECT.

Typical Cases

The following cases were following for five years after their treatment.

Case one. You XX, female, 51 years old. A tumour mass was discovered in the right breast in February)‘ 1990. X-ray film revealed a tumour mass of 3.8 x 4.1 cm. a biopsy indicated it as adenocarcinoma. lt did not respond to tamoxifen. In May, ECT was applied. Six electrodes were inserted& two anodes in the center and 4 cathodes at the periphery~ of the cancer. The voltage was 7.5 V, the current was 65 mA~ and the total electric quantity was 450 coulombs. Two months after treatment, the tumour had shrunk by two thirds. One year later an X-ray exam indicated that the tumour had disappeared. Only a small fibrous focus remained, and no tumour ceils were found by biopsy.

Case Two. Wang XX, female, age 55. A mass was found in her left breast in April 1989. The size of the tumour was 3.5 x 4.0 cm as shown by X-ray. Adenocarcinoma ceils were found by biopsy. Chemotherapy was given for ~o months without any response. ECT was given in June. Similarly to the case above, six electrodes were inserted into the tumour. The voltage was 8 V, current 75 mV, and total electric quantity was 400 coulombs. Three months later the tumour disappeared. No tumour cell was found by biopsy in the residual fibrous node. The patient lived well over five years.

Case Three. Liu XX, female, age 56. After finding breast cancer in the right breast, a mastectomy was performed an the right side in October, 1988. Cancer recurred in July, 1989 on the wound surface. Chemotherapy was administered for three months with no response. the ulceration extended to about 8.5 9.0    cm accompanied by pain and oozing blood. No general metastasis was found during clinical x

examination In October 1989, ECT was administered on four occasions. Electrodes were inserted on the wound surface. Three anodes and six cathodes were used and 500 to 600 coulombs were administered each time. The total electric quantity~ given was 2100 coulombs. Two months later the ~un0ur had disappeared and the wound healed quite well. The patient was well after five years.

Case Four. Cai XX, female, age 45. Left mastectomy was done in August, 1987, and cancer recurred on the wound in May, 1989. The tumor appeared as a cauliflower, bulging up to a size of 4.5 x 5.0 cm. After failing to respond to chemotherapy, radiotherapy was applied causing a large area of ischemic necrosis forming and ulceration of 15.0 x 20.0 cm in size. No general metastasis was found. ECT was given six times. Four anodes and 8 cathodes were just put an the wound. 400 to 500 coulombs were given each time for a cumulative total of 2700 coulombs received. Three months later the tumour cells had disappeared and a new ~anuiomat0US area had ~own up. A spot skin ~aft was done and the wound healed well. The patient lived well when followed up for five years. 

REFERENCES:

1.   Nordenström BEW. Biologically closed electric circuits (BCEC); clinical, experimental and theoretical evidence for an additional circulatory system. Stockholm, Nordic Medical Publications, 1983

2.   Nordenström BEW. Clinical trials of electrophoretic ionisation in the treatment of malignant tumours. IRCS Med Sci 1987; 6: 537

3.    Nordenström BEW. Electrochemical treatment of cancer. 1. Variable response to anodic and cathodic fields. Am J Clin Oncol (CCT) 1989; 12: 530:53 6

4.    Nordenström BEW. An electrophysiologic view of acupuncture: roe of capacitative and closed circuits currents and their clinical affects in the treatment of cancer and chronic pain. Am J Acupuncture 1989; 17: 105-117

5.  Pekar R. PercutaneouS gaivanotherapy oftumours. Verlag W. Maudrich; Vienna-Munch-Bern. 1988

6. Matsushima Y. et al. Clinical and experimental studies of anti-tumour effects of electrochemical therapy (ECT) alone or in combination with chemotherapy. Eur J Surg 1994; Suppl 574: 5967

7.    Xin YL. Advances in the treatment of malignant tumours by ECT. Ibid. 1994; Suppl 574: 3

lt is shown from the table 2 that 62.5% (44.4% + 18.1 %) of malignant tumours are at stage III and Iv.

The size of tumours were shown in Tables 3 and 4.