Including Benefits, Limitations and
When does XPDT fail?

Case Histories

We first present below case histories for two patients with breast cancer. We chose to report these because we can most easily prove the benefits of our Cancer treatment with Breast and Skin Cancer. Additionally we can easily monitor our treatment progress using Photodynamic Diagnostic (PDD) and sonography. Note the tremendous benefits of using PDD are further explained under the Diagnostic section of this website.

Patient A. Female, aged 62y, infiltrating intraductal breast carcinoma, grade III.

February 2005. Tumor detected by mammography and diagnosed by needle biopsy. This showed a 15 mm lump in the right breast under the nipple. Liver ultrasound was clear, but a CT scan of the abdomen showed possible liver lesions. Two liver enzyme tests were abnormal. Recommended treatment was surgical removal of the lump and of the axillary lymph gland into which it drained. This would be followed by hormone and radiation therapy and possibly chemotherapy.

February 2005. The patient chose to do a round of XyChloro Photodynamic Therapy (XPDT) therapy, followed by Photodynamic Diagnostic (PDD). PDD showed:

• A tumor in the right breast under the nipple where it had been detected by mammography.
• Two small luminescent spots in the right axillary node, where cancer had not been detected, but where it typically metastasis.
• Much diffuse luminescence in the left breast, believed to be cancer. This had not been found using other diagnostic techniques.
• A small luminescent "spot" over the liver, also believed to be cancer. (This did not show up on ultrasound and CT scans, but it was suspected from the abnormal liver enzyme values).

March, 2005. Surgical removal of the breast lump and the corresponding axillary lymph node. Pathological examination of the breast tissue confirmed cancer in the breast lump, but no cancer was detected in the lymph tissue.

March 2005. Round 2 XPDT/ PDD. This showed:

• No luminescence in the right breast, showing that surgery (helped by XPDT) had removed the cancer.
• No luminescence in the axilla. The two previously detected spots had disappeared. XyChloro Photodynamic Therapy (XPDT) had been effective in killing these tumors before surgery; otherwise they would have been detected by pathology.
• The spot over the liver had gone. XyChloro Photodynamic Therapy (XPDT) had successfully killed this tumor, as the liver received no other treatment.
• About 80% of the luminescence from the left breast had disappeared. Once again, XyChloro Photodynamic Therapy (XPDT) was effective in this area because the left breast had received no other treatment.

April 2005. Round 3. XPDT/ PDD. The remaining left breast luminescence had completely disappeared, and there were no signs of cancer at all.

The patient also reported about a 30 % improvement in general health during this period, though she had also made some lifestyle improvements.

Conclusion
This is an exceptional outcome compared to those achieved when XyChloro Photodynamic Therapy (XPDT) is not used. Surgery alone may have removed the primary tumor and possibly also the lymph gland metastases. However, it would not have removed cancer from sites where it had not been detected, such as the liver.
Radiation therapy would have been ineffective for the same reason. Chemotherapy and/or hormone therapy may have slowed down the growth of the remaining cancer. All may have resulted in unacceptable side effects. XyChloro Photodynamic Therapy (XPDT) had no negative side effects.

The patient will continue to do tests for any recurrence, and she has changed her lifestyle for the better. She is extremely happy with this outcome.

Patient B. Female, aged 54y, grade III ductal carcinoma in situ.

March 2003. Diagnosed with stage 2, grade 3 oestrogen-negative breast cancer, followed by a lumpectomy.

April 2003. Her doctor decided that she had ductal carcinoma in situ and suggested a mastectomy. This left a large scar, created congestion; the wound became infected, and she required 12 days hospital treatment with IV antibiotics.

May 2003. She was told that the surgery had a 35 % probability of 'curing' her, chemotherapy would add 3 % to possibly up to 10 % and radiation another 5 % to this probability.
She turned down chemotherapy and radiation therapy for quality of life reasons.

June 2003 - October 2004. She took various alternative treatments including Ukrain, vitamin C and dendritic cell vaccine.

November 2004. She arrived at our treatment center in good general health but with a large secondary tumor in the axilla about the size of half a hand. She refused surgery to remove the tumor.

November 2004 - April 2005. The patient had multiple rounds of XyChloro Photodynamic Therapy (XPDT). The tumor progressively shrunk and softened until it was the size of a large coin. She felt very well during this time and vacationed between treatment rounds.

April 2005. The tumor had shrunk sufficiently so that it could be removed surgically with a local anesthetic (the patient did not want a general anesthetic).

May 2005. A further round of XyChloro Photodynamic Therapy (XPDT) followed by Photodynamic Diagnostic (PDD) showed no signs of cancer.

Outcome
This illustrates the performance of XyChloro Photodynamic Therapy (XPDT) with large tumors. It shrank the tumor over a period of several months, i.e. progress was slow. It would have been better to surgically remove the tumor and then carry out XyChloro Photodynamic Therapy (XPDT). This would have saved time and money.

XyChloro Photodynamic Therapy (XPDT)
Outcomes for patients with grade III and grade IV cancers, 2005

This is a summary of outcomes achieved during the first 8 months of 2005. Almost all patients were grade IV. Many had been "given up on" by their treating doctors.

Note that we changed to a much more aggressive XyChloro photodynamic therapy protocol in January 2005, and this significantly improved performance compared with earlier years. In June 2005, we introduced a new therapy protocol, and this resulted in another big increase in performance.

Types of cancer treated and patient information

We mainly treated prostate and breast cancers, but also melanoma, ovarian, squamous cell, mesothelioma, adrenal, colon, endometrial and unknown (primary not found). We have excluded patients who are too early in the treatment program to expect detectable improvement, and we have excluded results for patients with grades I and II cancers. All early stage patients were treated with apparent success, but there was often no evidence to prove this. We of course were able to prove success with breast and skin cancer along with a selection of other cancers using Photodynamic Diagnostic (PDD)

Definitions

1. No evidence of cancer: complete absence of all previously occurring symptoms. The available tests for cancer all negative.
2. Symptoms all gone. The patient had significant symptoms pre-treatment, which have now ceased. One or more clinical tests for cancer not yet normal.
3. Much improved: symptoms and general health much improved, but evidence of remaining cancer.
4. Failed but did not get receive the new therapy protocol (not available at the time)

Results

No evidence of cancer 38 %
Symptoms all gone 23
Much improved 31
Failed 8

Conclusion
These results are significantly better than results that can be obtained with other therapies. Another significant aspect of XyChloro Photodynamic Therapy (XPDT) is that these results were achieved using our therapies which cause patients negligible side effects during treatment and which have no evidence of any longer term side effects

XyChloro Photodynamic Therapy (XPDT)
Prostate Cancer

Results Summary

Listed below are results for six randomly selected patients with prostate cancer treated with XyChloro Photodynamic Therapy (XPDT) / XyChloro®

1. All patients, except one, benefited from the therapy.
2. No patient has experienced any side effects from the therapy. This contrasts sharply with conventional therapies, which have major risks, particularly impotence.
3. No patient experienced any significant problems with the treatment.
4. The earlier stage patients showed no evidence of cancer after XPDT.
5. The one failure was patient #3 whose disease had progressed too far prior to XPDT. He experienced a major reduction in PSA level, but this was overwhelmed by other problems.
6. Patient #5 would normally have surgery, but he refused.

Results

* "clear" means no evidence of cancer

Brief summary of reported incidence of impotence and incontinence with other therapies

Conclusion

These results support our view that we can make major improvements in the health of substantially all prostate cancer patients who are in reasonably good general health. For many of them, we will remove all evidence of cancer. This is a significant statement since this year alone 232,090 men will be diagnosed with prostate cancer, and it will kill 30,350.

How Good is XPDT?

Let us start by looking at results with local PDT and earlier photosensitizers. Hopper has reviewed the field and reports that trials with many cancers have shown that PDT can achieve control rates similar to those achieved with the standard techniques of surgery and radiotherapy6. The advantages of PDT are: fewer side-effects; improved functional and cosmetic outcomes and simplicity. He reports many complete responses with various skin cancers and oral cancers. There were impressive results for early stage lung cancer (85 % complete response), early bronchial and esophageal cancers (83 % showed no recurrence after an average follow up time of 15.3 months) and early gastric cancer (complete response in 80 % of patients with intestinal cancer). As expected, best results are obtained with early stage cancers, but unlike radiation therapy and surgery, PDT can be repeated many times.

Okunaka and Kato reported on the PDT treatment of 145 patients with a total of 191 early lung cancer lesions12. Complete remission was obtained with 86.4 % of the total number of lesions.

Kato et al reported a complete response with 83 % of patients treated with PDT for early squamous cell carcinoma of the lung8.

Sheleg et al used PDT to treat 14 patients with skin metastases from melanoma13. All skin melanoma metastases showed complete regression with no recurrence during the study period.

These results are so good that cancer specialists should be reporting them to patients as part of a full disclosure of treatment options.

PDT Plus Surgery

Hopper makes the point that in a large number of solid tumors, surgery leaves behind residual microscopic disease that may lead to local recurrence or metastatic disease6. PDT is an ideal adjuvant therapy especially when the risk of local failure is high, as in gastrointestinal and prostate surgery. A review of the treatment of more than 310 brain cancer patients concluded that there is a clear trend towards improved survival when PDT is used along with surgery.

XPDT for Early-Stage Breast Cancer

XyChloro Photodynamic Therapy (XPDT), usually in conjunction with a lumpectomy or a mastectomy is expected to be very effective with early-stage breast cancer. Why? Because the cancer is near the surface where the advanced light delivery system can easily reach it and where Photodynamic Diagnostic (PDD) plus sonography can be used to map the cancer spread and clearly see the result of the XYTOS Cancer Treatment. In early stage disease, fortunately there will not be much cancer to kill.

Although we have not found reports in the medical literature regarding the use of PDT for early-stage breast cancer, there are studies reporting good results with later-stage breast cancer. Wyss et al treated chest wall recurrences in patients treated by mastectomy for breast cancer16. They treated 7 patients with a total of 89 metastatic skin nodes. They achieved a complete response in all cases.

Allison et al carried out a similar study of 9 patients at a total of 102 chest wall sites, with lesions up to 9 cm1. Despite the fact that all patients had failed surgery, full dose radiation and multi-agent chemo-hormonal therapy, chest wall lesions healed with no scarring after PDT was used.

Clearly, if doctors can get such good results with metastatic breast cancer, it is reasonable to expect even better results earlier in the disease process.

See more information on Breast Cancer under our section on (Cancer Diagnostics / Earliest Detection)

The Earlier the Better

To maximize the probability of success, it is best to do XyChloro Photodynamic Therapy (XPDT), shortly after diagnosis and (usually) surgery, no matter whether the surgery was "successful" or not. XYTOS can often prove the presence of cancer, but we cannot prove its absence. The only down side with doing XyChloro Photodynamic Therapy (XPDT), early in the disease process is that the surgery may well have solved the problem and the XYTOS treatment may not be necessary.
The down sides with deferring treatment until recurrence is certain are that
a. The therapy will be more expensive and take longer.
b. The outcome is less certain.
c. The cancer may have had time to do significant and permanent damage.
d. The patient may then fall into the Exclusion Criteria Area (see exclusion criteria under typical treatment)

Benefits

Our current XyChloro Photodynamic Therapy (XPDT) protocol has only been in use since January, 2005. Based on this limited number of patients, we can report as follows:

• No patient has experienced significant side effects from the therapy. Some have reported tiredness requiring extra bed rest and only a select few have reported very slight nausea.
• For several patients with grade IV cancers, XyChloro Photodynamic Therapy (XPDT), has resulted in the removal of all evidence of cancer.
• All patients except one with detectable cancer have shown significant improvements in symptoms and/or cancer test results. The one "failure" was a patient with grade IV breast cancer with liver metastases who began with XPDT but did not receive our latest protocol. We believe this failure is due to the XPDT failing to destroy the (deep) liver metastases. Our new protocol would have addressed this deep tumor metastases
• As expected, patients with no detectable cancer showed no detectable changes.

Limitations

The known limitations associated with this therapy are:

• Limitations applicable to all cancer treatments: patient in too poor health to recover, patient has no wish to survive, patient prematurely discontinues treatment, etc.
• Tumors are too large. The therapy is basically a metastases killer, and is very slow to reduce large tumors (possibly because of the limited blood supply within these large tumors). It may require many rounds of therapy to remove a large tumor, or it may never succeed. Such tumors should be removed surgically, and then our XyChloro Photodynamic Therapy (XPDT) treatment should be applied. (Refer to "Patient B" case history above)
• It is slow in killing very difficult cancers such as mesothelioma and may never succeed in completely removing detectable cancer.
• If patients have cancer widely distributed throughout the body, XyChloro Photodynamic Therapy (XPDT) is likely to kill some or even most of the cancer and improve patient condition. In these cases of wide spread cancer it is unlikely that XyChloro Photodynamic Therapy (XPDT) will kill all cancer.

Possible Limitations Are:

• It may fail with tumor types, which we have not yet treated.
• We have succeeded in removing all evidence of cancer in some of our patients, but we do not know long-term outcomes. Cancer may still be present but not be detectable. Life style changes should be adapted.
• Further, we do not know the long-term outcomes for patients where we have removed some but not all cancer. For patients with slow growing cancers, this may be enough. For others, it may not. Long-term studies will be necessary to make these determinations.

When Does XPDT Fail?

There are some obvious failure modes. When the patient:

• doesn't believe that any treatment other than conventional therapies are worth considering.
• is in such poor health that nothing can be done even if all cancer magically disappeared.
• has no great interest in surviving the disease.
• abandons the therapy before completion.
• Waits too long before getting the therapy, or too long in resuming the therapy after previous therapy had helped, but not solved the problem.
• has medical problems which preclude the use of the therapy. For example, cancer in a large blood vessel. (see Exclusion Criteria under Typical Procedure)

Apart from these, we have experienced little failure since we improved the XPDT treatment protocol in early 2005.

Note that "failure" is defined as not providing clearly observable benefits to patients. Using the same definition, most of our patients have failed with other therapies.