Cisplacel

(Cisplatin)

Antitumor drug

Prescription:

Cisplacel (cisplatin)

Cisplacel is used for local chemotherapy after complete or partial removal malignant tumor by implantation in place of removed tumor.

Description:

Swabs of 1,5 x 1,5 cm or swabs 3,0 x 5,0 cm are obtained from oxidated cellulose. Active substange cisplatin of 1 mg is contained at 1cm² of the swab.

Release form:

10 or 20 swabs 1,5 x 1,5 cm in package №10 or №20 respectively or
5 swabs of 3,0 x 5,0 cm in package №5.

Pharmacological action

of the drug is provided by cytostatic effect of cisplatin, which is immobilized on oxidated cellulose (pharmacological group: alkylating agents). Cisplatin bifunctionally alkylates DNA, inhibits the biosynthesis of nucleic acids and causes cell death.

Indications for use:

Cisplacel

Drug Cisplacel is used for local chemotherapy after total or partial removal of supratentorial neuropithelial brain tumor regardless the the tumor grade. It’s also used after head and neck tumor removal (maxilectomy, arcula tumor, cervical lymphadenectomy, soft tissues tumor removal etc.)

Clinical experience of application:

The studies were perfomed ib “National Research and Development Institute of neurology and neurosurgery” (State Institution of MoH of Republic of surgical Belarus) on patients with low-differentiated cerebral glioma (grade III-IV). After surgical removal of tumor “Cisplacel” was implanted into the wall of post-surgical wound within the range of invariable brain tissues. Next, all the patient underwent radiotherapy. When using “Cisplacel” as antitumor agent for post-surgical local chemopherapy of supratentional brain tumor in combination ith radio-therapy, the following results were obtaned.
1) Reliabe increase of ane-year survival from 67,6 + 10,1% to 90,9 + 6,1%, three-year survival from 12,1 + 7,9% to 25,3 + 10,9%, five-year survival from 12,1 + 7,9% до 16,8 + 10,9% (p=0,048).

Application of “Cisplacel” after surgical removal of localy advanced head and neck tumors, and including tumors advanced the base of the skull increases one year recurrence free survial to rate of 12% and 15% respectively.

Advantages of «Cisplacel» compared with conventional treatment:

- Targeted transport, of cytostatic agent into the area of affected organ;
- Prolongation of therapeutic effect;
- Potentiation of radiotherapy effect complete bioresorption after implantation;
- Reduction of total dose of cytostatyc agent and toxic damage on the organism.

 

Posology and method of administration

For patients with brain tumor:

For brain surgery, after partial or total removal of supratentorial neuropithelial tumor, its bed is imbricated with 20 Cisplacel swabs in a way that all wound walls are covered uniformly with the medicinal product. The swabs are soaked with sanioserous emission from brain wound wall and adhere to it, primarily supporting final homeostasis. Optimum effective dose is 45 mg (20 swabs of 1,5(±0,1)x1,5(±0,1) cm, package №20). Dose lowering is permitted in case of small area of brain wound. If the mentioned swabs area is insufficient for wound coverage, the medicinal product is placed in the areas of the most probable homolization of residual tumor (on the vessels, in the area of pedunculated tumor etc). The wound is taken in tightly.

For patients with brain tumor:

When using Cisplacel, there is no need to take into considera-tion special indications for surgical intervention with this product. In case of impossibility of tumor eradication associated with its intergrowth into adjacent tissues, cleavage with great vessels etc. into the area of the highest potential of tumor recurrence 1-2 layers of Cisplacel swabs are placed. Recom-mended total dose is 80-100 mg. In the wound, the swabs adhere to the tissues, quickly soak the liquid, swell and stay in the areaa where they were applied. Tube drainage is inserted and the wound is taken in tightly.

 

Results of Cisplacel clinical studies in patients with
brain tumor

Results of Cisplacel clinical studies The studies were performed in the State Institution “National Research and Development Institute of neuro-logy and neurosurgery”, Ministry of Health of the Republic of Belarus, in 95 patients with low-grade cerebral glioma (grade III-IV). After surgical removal of tumor, the Cisplacel was implanted into the wall of post-surgical wound within the extent of unaltered-brain tissues. Next, the patients under-went radiotherapy. When using Cispla-cel as antitumor agent for post-surgical local chemotherapy of supratentorial brain tumor in combination with radio-therapy, the following results were obtained:
1) Proved increase of recurrence-free period duration from 31,9±2,8 weeks (control group B) to 50,8±3,2 week
(study group A) (p<0,05);
2) Proved increase of patient’s average life duration from 211±21,4 to 427,5±28,4 days.

 

Potential complications of Cisplacel use in patients with brain, 

head and neck malignant neoplasm

Local chemotherapy in combination with Cisplacel swabs is harmless and painless. It was well tolerated by patients, didn’t cause general loss of condition. General (nausea, vomiting), and local toxic responses (enathesis and mucous rash) were not detected. There were no changesin blood and urine analyses. The medicinal product didn’t provoke any irritation, alopecia, oto- and nephrotoxic effects or necrosis of various tissues in the area of implantation (nerve trunks, arcula tissues, brain linings etc.). Cisplacel implantation didn’t change the patients’ wound healing period and duration of their stay in hospital.