chemotherapy regimens based on Taxotere, reduces the risk of death by 23%.
Paris, France - May 15, 2005.- The final results of the largest international studies have shown that chemotherapy Taxotere (docetaxel) in combination with cisplatin and 5-fluorouracil significantly increases the overall survival of patients with advanced
"The findings suggest that the addition of Taxotere to standard scheme allows you to extend the life of patients with advanced cancer of the stomach," - said Jaffer A. Ajani, MD, Professor of Anderson Cancer Center at the University of Texas, who was the principal investigator."The two-year survival of these patients has reached 18% for the first time in a randomized trial."
In addition, researchers in the treatment Taxotere showed a significant increase in time to tumor progression (5.6 versus 3.7 months in the control group, p = 0.0004) and a significant increaseobjective response rate (37 and 26%, p = 0.01).
"The findings are the best results in the treatment of advanced gastric cancer in recent years," - said Professor V.Moiseenko of the Research Institute of Oncology (St. Petersburg)."The use of Taxotere in combination with a standard scheme would lead to significant advances in the treatment of this cancer."
locally advanced or metastatic gastric cancer with a poor prognosis: 2-year survival rate is only 11.5%. The objective ofstudy was investigate the efficacy of Taxotere in combination with standard chemotherapy regimen.The primary endpoint was time to tumor progression.In addition, the study possessed statistical power, sufficient to identify the improvement in overall survival.
The study included patients with locally spread or metastatic adenocarcinoma of the stomach, which had not previously received chemotherapy.In 22% of patients with carcinomas localized in the area of junction of the esophagus and stomach.Patients received six cycles of TCF (Taxotere, cisplatin and 5-FU) or 4 cycles CF (cisplatin and 5-fluorouracil).Response to treatment was assessed every 8 weeks by independent experts.
Combination therapy with Taxotere (docetaxel) has led to increased incidence of leukopenia (82.3 and 56.8%), diarrhea (20.4% and 8), and infections (16.3 and 10.3%).To combat these undesirable effects can be used symptomatic agents.At least one side effect of grade 3/4 recorded in 81.4% of patients the main group and 75.4% of patients in the control group.
"Patients with this form of cancer can not tolerate cytotoxic therapy.However, the use of Taxotere in combination with cisplatin and 5FU (TCF) in conjunction with the correction of risk factors seems to be promising for the treatment of advanced cancer of the stomach, "- said Professor Eric Van Cutsem from the University Hospital Gastuisberga (Belgium), who was the principal investigator in the TAX325.
results of an interim analysis of this study were previously presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in 2003.
About stomach cancer
Stomach cancer is most common in fourth place among malignant tumors.Annually in the world diagnosed approximately 870,000 new cases of gastric cancer, and 650,000 patients die from this form of cancer.It is expected that in 2005 will be diagnosed with stomach cancer at 21,860 Americans (13,510 men and 8,350 women), and 11,550 patients will die from it.
docetaxel (Taxotere) refers to Taxoids - a chemotherapeutic agent that inhibits cancer cell division by "freezing" internal "skeleton" of the cell, composed of microtubules.During cell cycle progression occur assembly and disassembly of microtubules.Taxotere enhances their assembly and disassembly blocked.In this way it inhibits the division of many tumor cells and cause their death.
Taxotere is used to treat early and metastatic breast cancer, non-small cell lung cancer, and androgen-independent (hormone-refractory) metastatic prostate cancer.
efficacy and safety of Taxotere actively studied in clinical trials in patients with head and neck cancer, gastric cancer.
Important Safety Information
WARNING: Taxotere can cause serious and potentially life-threatening side effects, such as infection, decreased blood cell counts, allergic reactions and fluid retention (edema).
Taxotere should not be administered to patients with a low number of white blood cells in the blood, impaired liver function, allergic reactions to Taxotere® or inactive components of the drug in history.
Before the appointment of Taxotere, all patients should receive dexamethasone, which reduces the risk of fluid retention (edema) and allergic reactions.
Taxotere should be used only under the supervision of a qualified physician experienced in cancer chemotherapy.Appropriate management of complications is possible only with adequate diagnostic and treatment facilities.
patients treated with anthracyclines and / or tsiklofosfosfamid, including Taxotere for the adjuvant treatment of breast cancer, described cases of acute myeloid leukemia.
The most common severe side effects are a decrease in the number of leukocytes in the blood, anemia, fatigue, diarrhea, and irritation of the mucous membranes of the mouth and throat.Reduced number of leukocytes in the blood can lead to life-threatening infections.The earliest sign of infection is fever, so the increase in body temperature immediately consult a doctor.
Other common side effects of Taxotere include nausea, vomiting, hair loss, rash, reactions at the infusion site, paresthesia (numbness, tingling, or burning) or weakness in the hands and feet, nail changes, muscle and / or bone and tearing.
in patients aged 65 years and older, some side effects are more likely than younger people.
Taxotere has a damaging effect on the fetus, so it should not be used during pregnancy.Women of childbearing age receiving Taxotere, to avoid pregnancy.
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