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【drug-news】FDA批准治疗后期头颈癌新疗法
FDA Approves New Treatment for Advanced Head and Neck Cancer
The Food and Drug Administration (FDA) today approved Taxotere (docetaxel) Injection Concentrate for use in combination with cisplatin and fluorouracil prior to radiotherapy for the treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and neck (SCCHN). This disease represents approximately 3 percent of all new cancer cases in the United States.
"Today's approval will provide prescribers with a new treatment option that has been shown to help slow the spread of the disease and prolong patients' survival," said Steven Galson, M.D., director of FDA's Center for Drug Evaluation and Research.
Taxotere was approved on the basis of the results of a multicenter, randomized trial of 358 patients with previously untreated, inoperable, locally advanced SCCHN. The patients were divided into two groups; one received Taxotere in combination with the chemotherapy drugs cisplatin and fluorouracil, and the other received only cisplatin and fluorouracil. Chemotherapy was administered prior to radiation therapy. Surgery was allowed after chemotherapy, either before or after radiation therapy. The patients in the Taxotere arm of the trial experienced a longer survival time (18.6 months versus 14.2 months) and a longer time to disease progression or death (11.4 months versus 8.3 months) than the group on cisplatin and fluorouracil alone.
The most frequent adverse events reported during the trial by the patients on Taxotere were decreases in white and red blood cells, loss of hair, inflammation of the mouth and esophagus, and nausea. Compared to patients in the control arm, patients on Taxotere had greater hair loss, decreases in white blood cells, fever or infection with low white blood cells, fluid retention, diarrhea and neurosensory abnormalities.
Taxotere is manufactured by Sanofi-Aventis, Paris, France. 认领了 http://www.fda.gov/bbs/topics/NEWS/2006/NEW01493.html
FDA Approves New Treatment for Advanced Head and Neck Cancer
The Food and Drug Administration (FDA) today approved Taxotere (docetaxel) Injection Concentrate for use in combination with cisplatin and fluorouracil prior to radiotherapy for the treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and neck (SCCHN). This disease represents approximately 3 percent of all new cancer cases in the United States.
FDA批准治疗晚期头颈部肿瘤的新方法
食品药品管理局（FDA）今日批准了泰素帝/多西他赛(Taxotere /docetaxel)注射剂与顺铂和氟脲嘧啶联合用于放射治疗之前，治疗那些已经失去手术机会的局限性晚期头颈部鳞状上皮癌（SCCHN）。这种疾病在美国新发生肿瘤患者中大约占到3%。
"Today's approval will provide prescribers with a new treatment option that has been shown to help slow the spread of the disease and prolong patients' survival," said Steven Galson, M.D., director of FDA's Center for Drug Evaluation and Research.
FDA药品评估与研究中心主任Steven Galson博士说“今日该药品的获准,使处方医师选择新的治疗方法成为可能.这一方法已经被证明可以延缓肿瘤转移并且能够延长患者生存时间。”
Taxotere was approved on the basis of the results of a multicenter, randomized trial of 358 patients with previously untreated, inoperable, locally advanced SCCHN. The patients were divided into two groups; one received Taxotere in combination with the chemotherapy drugs cisplatin and fluorouracil, and the other received only cisplatin and fluorouracil. Chemotherapy was administered prior to radiation therapy. Surgery was allowed after chemotherapy, either before or after radiation therapy. The patients in the Taxotere arm of the trial experienced a longer survival time (18.6 months versus 14.2 months) and a longer time to disease progression or death (11.4 months versus 8.3 months) than the group on cisplatin and fluorouracil alone.
Taxotere的获准是基于一项358例未经治疗及失去手术机会的晚期局限SCCHN进行的多中心随机实验结果。这些病例被分成两组；一组给予化疗药物顺铂及氟脲嘧啶,联合使用Taxotere;另一组仅给予顺铂及氟脲嘧啶治疗。化疗先于放疗进行，在化疗后允许采用手术治疗，手术可先于或在放疗后施行。实验结果显示Taxotere组较仅用顺铂和氟脲嘧啶组生存时间延长（18.6月对14.2月）,疾病进展或死亡时间滞后（11.4月较8.3月）。
The most frequent adverse events reported during the trial by the patients on Taxotere were decreases in white and red blood cells, loss of hair, inflammation of the mouth and esophagus, and nausea. Compared to patients in the control arm, patients on Taxotere had greater hair loss, decreases in white blood cells, fever or infection with low white blood cells, fluid retention, diarrhea and neurosensory abnormalities.
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作者:admin@医学,生命科学 2011-07-14 17:13
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