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Inhibiting progression
Focusing on the melanoma of the skin itself.
Focusing on squamous cell cancer of the oral cavity itself.
Focusing on the melanoma of the skin itself.
Locoregional metastases (stage III) are considered a crucial stage in treatment of the disease, and this provided the subject of a clinical study conducted with Avemar. A complete resection of positive lymph nodes should be performed, though the isolated perfusion of in-transit metastases and/or inoperable primary tumours of the extremities through the use of melphalan or tumour necrosis factor (TNF?) represents another therapeutic approach. However, as the facilities needed for such treatment are available in very few centres, most patients choose radiotherapy treatment. Systemic adjuvant chemotherapy is recommended after a complete resection, but there is as yet no standard accepted form of such therapy. Nevertheless, the basic component of all chemotherapy is Dacarbazine, and no combination of cytostatic drugs has proven more effective than Dacarbazin monotherapy.
Considering the poor efficacy of standard therapy, it is particularly noteworthy that the application of Avemar as a supportive therapy enhanced the effect of Dacarbazine therapy in stage III melanoblastoma. Demidov and his colleagues, after an average observation period of 12 months for a group of 46 stage III melanoma patients (24 standard, 22 standard + Avemar), reported a significant decrease in progression-related events (recurrence of the primary tumour, recurrence of lymph node metastases, new lymph node metastases, development of distant (visceral) metastases) in the Avemar group. The average progression-free interval was 306 days for the Avemar group versus 213 for the control group. The average length of time without distant metastases was 340 days for the Avemar group versus 255 for the control group. The number of progression-related events was 10 for the Avemar group versus 38 for the control group. No new distant metastases developed in the Avemar group, as compared with 5 in the control patients. There was one recurrent lymph node metastasis in the Avemar group compared with 9 in the control group.
Conclusions: the use of Avemar as a supportive therapy reduced the overall risk of progression-related events by 52.2%. As a result, the application of Avemar as a complementary treatment in stage III melanoma is strongly recommended.
Focusing on squamous cell cancer of the oral cavity itself
Regional lymph node metastases occur relatively more frequently in oral cavity squamous cell carcinomas than in other types of head and neck cancer. Their presence indicates an aggressive and therapy-resistant form of the disease. Responsiveness to chemotherapy is poor. Current therapeutic strategies include radical surgery, postoperative radiation (percutaneous teletherapy and/or afterloading brachytherapy), or adjuvant (or neoadjuvant) chemotherapy, depending on the localisation, stage, and histopathological grading of the tumour. The poor quality of life associated with the illness and its treatment justify the application of an effective supportive therapy in order to maintain and improve the relief of symptoms and the results obtained by standard therapy. Local recurrences and distant metastases are particularly frequent with this form of cancer.
An open label clinical study was performed at the Semmelweis University's Clinic of Oral and Maxillofacial Surgery in Budapest in which 43 patients with locally advanced oral cavity squamous cell carcinoma (UICC stages II-III, and locally advanced- stage IV, i.e.T4N0M0) aged between 18 and 80 with a definitive diagnosis of less than 3 months took part. 21 of these patients received the standard anti-cancer therapy (SAT - consisting of radical surgery and postoperative radiation or adjuvant chemotherapy), while the remaining 22 patients received SAT and a one-year complementary treatment with Avemar. The incidence of local recurrences and disease progression differed significantly between the two groups: 4.5% and 9.09 % in the SAT+A group against 57.1% and 61.9 % in the control group (p<0.001). A non-comparative quality of life (QOL) study involving 50 patients with head and neck cancer was also performed in the Oto-rhino-laryngology Clinic at Semmelweis University, in which 22 experienced substantial improvement in cachectic symptoms and a long-term delay of progression was observed in five out of six salivary gland tumour patients. The above results suggest that the supportive use of Avemar in this localisation may improve QOL and enhance the anti-tumour effectiveness of standard oncotherapy.
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