Abstract
Photodynamic Therapy (PDT) is a therapeutic treatment for certain kinds of tumors, approved by the FDA in 1998. Recent research data shows that a related procedure, Sonodynamic Therapy (SDT), is another new promising complementary method for cancer treatment. Here we report clinical results in an advanced pancreas cancer patient who was treated using a combination of Sonodynamic and Photodynamic Therapy (SPDT), along with conventional therapies. The patient was pathologically diagnosed with metastatic pancreas carcinoma (non-respectable advanced pancreas cancer) by the patient’s local oncology team. The advanced pancreas carcinoma had responded unsatisfactorily to conventional therapies. SPDT treatment involved using a new sensitizing agent Sonoflora a TM (SFa), which was administered sublingually; 12-hour latter, the patient was treated with a combination of light and ultrasound devices, and a low dosage of chemotherapy simultaneously as a whole body treatment (SPDT follows the chemotherapy cycle periodically). Patient had good partial responses. The results indicate that SPDT could be a promising new complementary therapeutic combination for the treatment of pancreas cancer.
Keywords: Sonodynimic therapy; Photodynamic therapy; Pancreas cancer; Chemotherapy; HIFU sensitizer; Sonosensitizer
Introduction
Photodynamic Therapy (PDT) was first approved as established therapeutic method by the FDA for certain kinds of cancer in 1998. However, In view of the limitation of the penetration of light energy into tumor tissues [1,2], the successful application from LED or coherent laser emission source of PDT has been mostly limited to superficial pathology or through invasive method which could approach to the pathology with unwanted side- effects. Ultrasound is a mechanical wave which could penetrate tissue excellently and safely without major attenuation of its energy [3,4]. Therefore, the potential medical application of ultrasound has been evaluated extensively and has led to the routine use of ultrasound for diagnostic imaging. Sonodynamic Therapy (SDT) has been widely researched to develop as a complementary or alternative therapy to PDT [5-10]. In SDT treatment, patients first ingest a sonosensitizer, an agent that can be activated by ultrasound. This agent is tailored to be activated through the use of low-intensity ultrasound energy producing a cascade of endogenous cytotoxic radicals. The therapy is thus similar to PDT, which is an attractive modality for cancer treatment with potential to focus the energy on tumor sites buried deep in tissues and to locally activate a preloaded sonosensitizer. The body transmits ultrasound energy much more efficiently than light energy, and this is a critical advantage when treating inside tumors and with minimal damage to peripheral healthy tissue. So far, many compounds were found to have sonodynamic activity [5- 13]. In recent years, a novel sonosensitizer was developed by the late Donald Burke, MD, of Advanced Technologies, Boston, USA. He named this Sonoflora 1™ (SF1). This agent is a chlorophyll derivative with very high sonodynamic as well as photodynamic activity. Embryonic zebra fish assay had showed SF1 has no evidence of toxicity [3]. Our animal studies demonstrate that SDT with SF1 inhibits the growth of mouse S-180 sarcoma, even when the tumor is covered by a bone [4]. We had successfully used Sonodynamic and Photodynamic Therapy (SPDT) with SF1 and a portable ultrasound device in terminally ill breast cancer patients [14].
Here, we report initial clinical data using two new chlorophyllderived sono-photo-sensitizing agents (SFa and UF) along with a new equipment, supplied by EEC Biotech (Guangzhou) Co. for systemic SDT. The sensitizers SFa and UF were given to patients through lingual absorption on day one and day three. On Day two today four ozone treatment was given twice a day. The tumor area and the whole body were irradiated by ultrasound on day two and day four twice a day for 40mins each time, then by red LED light at 45mV/cm2 and 554 nm of wavelength for 30 minutes once a day. We used multiple ultrasound transducers within systemic SDT device, the tumor area and whole body was irradiated for 40 minutes at 75% pulse, 1 MHz and 2.0 W/cm2. The second week the same treatment was repeated. One cycle of SPDT included two round treatments and a week free.
Case Presentation
The patient is female, at the age of 61. She went to the local hospital for medical examination for abdominal pain with jaundice for a month in November 2017. Examination indicated space occupying lesion in pancreatic head. CA19-9 was high. Local Doctor diagnosed pancreatic cancer. A stand was implanted in patient’s bile duct. Patient underwent chemotherapy of Gemcitabine for three months after her jaundice was gone. Patient then had severe digestive tract symptoms, bone marrow suppression grade IV, Rechecked CA199 dropped significantly. However, no tumor shrinkage was seen in original lesion in CT images. Patient had been on Abraxane+Gemcitabine for three months Since February 2018, during which she was showed digestive tract symptoms and had bone marrow suppression as well. Rechecked CT scan showed progression and patient started to build up a large amount of ascites.
Surgery and radiation were not suitable for the patients as metastasis and location of the tumor in pancreatic head. Two types of chemo failed after three months treatment and no conventional therapy was available for option.
July 2018 after all the necessary tests, the patient came to our hospital for treatment, she started the first cycle of SPDT on July 25, 2018, cooperating chemotherapy with targeted medicine Erlotinib 150mg Po Qd +Xeloda 1.5g Po Bid D1-14+Oxaliplatin 80mg D3, 50mg D10, assisting with 5 days of HIFU treatments. During the course, patient had Grade II of digestive symptoms, nausea and vomiting, which were attenuated after symptomatic treatment. Ascites reduced obviously after the first cycle treatment. Tumor marker dropped from 4289U/ml to 3038U/ml.
Second cycle of SPDT cooperating chemotherapy (same regimen as the first one). During this course, patient had mild nausea, no myelosuppression. Tumor marker CA199 after second cycle of SPDT dropped to 1873/ml and ascites reduced rapidly. Doctor’s assessment indicated “stable”.
Third and fourth cycles of SPDT started on September 05, 2018, continuing chemotherapy with Erlotinib 150mg Po Qd +Xeloda 1.0g in the morning and 1.5g in the afternoon D1-14+Oxaliplatin 80mg D3. Reduced the dosage of chemo’s for her Grade III nausea, with Grade I myelosuppression.
A review of PET/CT (Oct 15, 2018) compared with July 23, 2018 before treatment.
A. Metabolism in the head of pancreas slightly rises, size of focal obviously narrows and the metabolism obviously reduced. Considered suppressed in most tumor activity after treatment (Figure 1).
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