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Increasing the likelihood of survival
Focusing on colorectal carcinoma itself.
The crude incidence of colorectal cancer (CRC) in the European Union is 53 cases/100,000 per year, with a mortality rate of 30/100,000 per year. In 2001, 2594 Hungarian men and 2258 women died from CRC, twice as many as 25 years earlier. The figures are also double that of current EU mortality rates. CRC accounts for approximately 12-13 % of all cancers and around 50 % of newly diagnosed CRC patients will eventually progress due to micro-metastases (and possibly macro-metastases) and die of their disease. As a result, effective systemic treatment is an important and integral part of the management strategy for CRC. Curative surgery means, in addition to that of the localized primary tumour, the removal of solitary or localized multifocal metastases in the liver and lung, if possible. Removal of regional lymph nodes (a minimum of 12 nodes is required for pathological staging) is an integral part of radical surgery. Preoperative radiotherapy may effectively decrease the local recurrence rate.
Postoperative radiotherapy and chemotherapy. Radiotherapy (for the most part in doses of 50 Gy) and/or 5 FU-based chemotherapy is the backbone of postoperative therapy recommended for patients with pT3 and pT4 (Dukes' B2 and B3) tumours and for patients with nodal involvement (N1-2, i.e., Dukes' C1-3) when there has been no preoperative radiotherapy. Frequently used schedules include 5 FU 425mg/m2 + Leucovorin 20 mg/m2 five days a week for four weeks. Combination with irinotecan or oxaliplatin may enhance the efficacy of 5 FU-based therapy.
As the limitations of the efficacy of systemic therapy for this condition are well known, every opportunity needs to be taken to improve it. Experimental data, the product's known selective anti-tumour activity and multiple effect mechanisms, and preliminary clinical results all support the expectation that Avemar, used as a supportive agent in CRC treatment, has beneficial effects.
A prospective cohort study was conducted on 170 UICC-TNM stage I-IV patients who had undergone radical surgery. 66 were given Avemar as a complementary therapy alongside standard treatment, while the remaining 104 patients received only standard therapy and served as a control group. The proportion of progression-related events within the groups was as follows: Avemar vs. control: local recurrence: 3% vs.17.3%; new metastases: 7.6% vs. 23.1%; death: 12.1% vs. 31.7% (p<0.01). The cumulative number of patients with progression was 16.7% vs. 42.3% (p<0.001). The overall and progression-free survival time (p=0.0278 and p=0.0184 respectively) was longer in the Avemar group.
Conclusions: supportive treatment resulted in an unquestionable increase in anti-cancer efficacy. The results of supportive Avemar therapy, as well as knowledge of the many facets of its effect mechanism, makes the clinical study of colorectal cancer particularly important. The significance of these results is increased when one takes into consideration the fact that the prognosis for the Avemar group was worse than that for the control group. Supportive treatment with Avemar has the potential to contribute to the improvement of global prognosis in a disease with high incidence and whose current systemic therapy has limited efficacy.
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