Doctor's Guide May 25, 2000 LONDON, UK -- May 25, 2000 -- The results of Scotia's pivotal clinical trial on FoscanŽ mediated photodynamic therapy were presented by Dr Barry Wenig, principal investigator in the US centres, at the 36th Annual Meeting of ASCO (The American Society for Clinical Oncologists) in New Orleans. The study, which looked at the palliative benefits of FoscanŽ-PDT in patients with advanced, inoperable head and neck cancer who were considered incurable, revealed impressive results. The researchers found that not only is Foscan-PDT (temoporfin, mTHPC) an effective palliation tool, but that a significant number of patients achieved complete or partial elimination of their tumours following the treatment. Photodynamic therapy is a technique that uses non-thermal lasers to activate light-sensitive drugs (photosensitisers), to treat cancer and other diseases in a non-surgical, minimally invasive way. Foscan (temoporfin, mTHPC, developed by Scotia Pharmaceuticals) is a new, photosensitising agent with many advantages over earlier photosensitisers. The aim of the study (known as the 08b study) was to determine the palliative clinical benefit of Foscan-PDT in patients with recurrent, refractory or second primary squamous cell carcinoma of the head and neck cancer. These patients were classed as incurable as all other standard forms of treatment (surgery, radiotherapy and chemotherapy) had been exhausted. The only options left would be to refer these patients to hospices or palliative care settings. The study also set out to measure patient survival time and the tolerability and safety of Foscan-PDT. Sixty-four patients between them underwent 82 Foscan-PDT treatments. Each patient received Foscan (0.15 mg/kg IV), followed 4 days later by a single non-thermal illumination of the tumour (light dose 20 J/cm2, irradiance 100 mW/cm2, l=652 nm). An independent expert panel made up of palliative medicine specialists, oncologists, surgeons, PDT experts and radiotherapists assessed the palliative benefit. The results revealed that 58 percent of patients achieved meaningful palliative benefit. However, the investigators also found that 25 percent of patients achieved a complete or partial reduction of their tumour. Sixteen per cent of this group achieved total tumour elimination. The median survival time was 226 days (95 percent CI 173?279 days) and follow-up is ongoing. Dr Wenig explained, "These results are very significant and exciting. We had not set out specifically to achieve tumour response, which appears to be very impressive. It is important to remember that we were dealing with patients who were considered incurable. In light of this, the results are remarkable." Foscan-PDT has significant clinical benefits in that the treatment is not associated with a deterioration in quality of life, nor with impaired function. The cosmetic results following the treatment are excellent and it is free of major toxicity and can be repeated. The most common adverse event was pain at the treatment site and following the treatment. The pain is due to necrosis of the tumour following treatment and can be managed with standard analgesics. Mild photosensitivity reactions occurred in 10 percent of patients. These reactions are managed by counselling patients and giving them a simple lighting guide. The lighting guide allows the patient to gradually increase their light exposure during the period of photosensitivity, which is around two-three weeks. Dr Wenig and his colleagues concluded that not only does Foscan-PDT provide objective palliative benefit in the majority of patients with advanced cancer of the head and neck but a significant number of patients achieve complete or partial elimination of their tumours Dr Robert Dow, CEO of Scotia Pharmaceuticals commented, "The presentation of this study is a very important step for Foscan-PDT as the data for this potential indication will now be peer-reviewed for the first time by the oncology community. The ASCO congress attracts thousands of abstracts and the selection of the 08b study reflects a growing interest in PDT amongst this group of clinicians." Ann's NOTE: Next step should be using PDT alone or as first-line therapy Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.