Justification for the benefit of IMMUCOTHEL® the
superficial bladder carcinoma.
For submission to health insurance
IMMUCOTHEL® as an effective ingredient Immunocyanin, a stable form of the blood pigment keyhole limpet hemocyanin (KLH) of sea snail Megatura crenulata.
IMMUCOTHEL® resulted in animal studies and preclinical studies by instillation into the bladder to an activation of macrophages and T lymphocytes and humoral immune response. In the top layer of Bladder-epitels there is a significant increase of T-helper cells, an increase in the CD4 / CD (quotient, an increased release of interferon-α and other cytokines The cytokines interleukin-1α and β increased by IMMUCOTHEL® instillation excreted in the urine, indicating a strong macrophage activation. (Dome 1984 Munder 1986 Recker et al.1989, Linn et al. 1997 Jurinčić et al 1989. Jurinčić-Winkler et al. 1995). The glycoprotein KLH contains Gal (β1 -3) -. Gal NAC-containing oligosaccharides This structure corresponds to the Thomsen-Friedenreich antigen, increasingly expressed freely on bladder carcinoma cells but not on normal Blasenepitel (Wirguin et al 1995) The result is the immunization of T… lymphocytes with a KLH-specific immune response against bladder cancer cells.
Superficial bladder tumors (PTA, pT1, G1-G2) have transuretraler after resection (TUR) is a high recurrence rate of up to over 70%. To reduce the rate of recurrence instillations of adriamycin or mitomycin C, thiotepa or BCG over a period of one year are performed postoperatively.
Intravesical chemotherapy was studied in a total of 17 studies of 2,331 patients. In this case, an advantage for Adriamycin (30-61% relapse in 17-29 months) Mytomycin C gave (16-83% relapse in 12-65 months) Ethoglucid (7-81% recurrence in 6-60 months) and thiotepa (24 -65% recurrence in 24-60 months).
Any adjuvant therapies were but better than TUR alone (Lamb et al., 1992, Rübben et al. 1997 Rübben et al., 1990, Otero-Mauricio et al. 1992).
Side effects of chemotherapy are intravesical heavy Chemozystitis in 20-38% of patients (Rübben et al., 1990, Otero-Mauricio, et al. 1992).
An improvement in the prevention of relapse is the opposite, the instillation of BCG. There was a reduction of recurrence by 20-30% compared with TUR and to 19-41% compared with chemotherapy after TUR. After BCG the recurrence rate is 11-75% at 6-67 months of observation (Rübben et al. 1997). Side effects of this therapy are available in up to 91% cystitis, often severe, in 40% fever, 3% BCG sepsis with a total so far 8 deaths after BCG instillation (Orihuela et al.1987, IZES et al. 1993 Lammetal. 1992).
Instillation with IMMUCOTHEL®:
As early as 1974 (Olsson et al. 1974) was described in bladder tumors efficacy of subcutaneously administered KLH.
The previously conducted prospective randomized studies with IMMUCOTHEL® show a statistically significant superiority compared to mitomycin C (Jurinčić et al. 1988), an equally good effect as Ethoglucid (flame et al., 1990, Flash et al., 1991, Flash et al. 1994) , The effect of IMMUCOTHEL® is comparable to that of BCG (Kälble et al. 1991).
The side effects of IMMUCOTHEL® to 572 documented patients grade I fever in 3%, 6% and cystitis in sporadically (<1%) feeling of pressure, pain, urinary urgency and increased -γGT and GPT.
The instillation prophylaxis of superficial bladder-carzinoms is today a recognized adjuvant method with the aim of preventing recurrence after TUR. Given the approximately same effect, the rate of side effects for the rash should be for the use of IMMUCOTHEL®.Especially the chemotherapy and BCG regularly occurring, severe cystitis is stressful for patients in the highest degree, especially as the total treatment lasts one year. You should also keep in mind that cytostatics, which are instilled into the bladder, be issued without metabolized in the environment.
After all, are mutagenic and carcinogenic substances so that cytostatic agents. BCG is a live vaccine, which is potentially infectious.IMMUCOTHEL® does not have these undesirable characteristics and therefore should have priority over other materials. In Holland IMMUCOTHEL® approved since 1998 for the indication of superficial bladder carcinoma, in Austria since of 2002.
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Prof. Dr. med. K. Schumacher
chief physician retired
specialist in internal medicine,
hematology and internal oncology