|
Provenge是一个前列腺癌疫苗，其作用原理是通过激发晚期前列腺癌病人的免疫系统来延长生命
美批准治疗前列腺癌药物Provenge
美国中文网报道：美国食品医药局星期四批准第一种癌症免疫疗法，这种疗法使用所谓的癌症疫苗治疗癌症，疫苗可以培养人体自身免疫系统抵抗疾病。
那种名为 Provenge的药物是丹德里昂公司（Dendreon Corporation）开发的，已获准用于治疗前列腺癌。在临床试验中，这种药物可以延长病人生命4个月。
科学家已经为促使免疫系统攻击癌症努力了几十年，因为它比现在使用的化学疗法副作用小。但到目前为止，免疫疗法效果令人失望。
波士顿丹娜-法博癌症研究所（Dana-Farber Cancer Institute）坎托夫（Philip Kantoff）医生说，这里的大故事就是它首次证明免疫疗法治疗癌症可行，这很值得关注。他说，这是件大事，将带来人们对免疫疗法的新热情。
Provenge不是一种预防性疫苗，和防止感染病毒的麻疹、肝炎疫苗不同。它是一种所谓的治疗性疫苗，用于已经被诊断出来的前列腺癌。
食品医药局三年前拒绝批准这种药物，引起部分前列腺癌症患者的抗议。
在涉及512名男子的临床试验中，那些得到Provenge治疗的病人，平均存活时间为25.8个月，而那些对照组的病人平均存活时间为21.7个月。三年之后，得到Provenge治疗的病人中，32%仍然存活；而对照组只有23%存活。Provenge的主要副作用是发烧、发冷、疲劳和疼痛。
但这家公司明年生产的药物只能满足2000名病人的需要，部分病人可能失望。 Provenge将首先供应参加临床试验的50家中心。但随后产量将大幅提高。
Provenge治疗一个病人开支为9.3万美元，疗法为一个月内三次注射。
PROVENGE(sipuleucel T)说明书
Manufacturer:
Dendreon Corporation
Pharmacological Class:
Autologous cellular immunotherapy.
Active Ingredient(s):
Sipuleucel-T (autologous CD54+ cells activated with PAP-GM-CSF); minimum 50 million cells/dose; suspension for IV infusion.
Indication(s):
Asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
Pharmacology:
Sipuleucel-T is an autologous cellular immunotherapy designed to induce an immune response targeted against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers. During ex vivo culture with PAP-GM-CSF, antigen-presenting cells (APCs) take up and process the recombinant target antigen into small peptides that are then displayed on the APC surface. The product consists of autologous peripheral blood mononuclear cells, including APCs, that have been activated during a defined culture period with a recombinant antigen consisting of PAP linked to an immune cell activator, granulocyte-macrophage colony-stimulating factor (GM-CSF). The patient’s peripheral blood mononuclear cells are obtained by standard leukapheresis about 3 days before the infusion date. Both patient and physician must adhere to the personalized leukapheresis and infusion schedules.
In addition to the minimal 50 million autologous CD54+ activated cells, the product also contains T cells, B cells, natural killer cells, and others, and may contain residual amounts of intact PAP-GM-CSF.
Clinical Trials:
The effect of sipuleucel-T on patients with metastatic hormone refractory prostate cancer was studied in three similar placebo-controlled trials. After randomization, patients underwent a series of 3 leukapheresis procedures followed by an infusion of either sipuleucel-T or control (unactivated autologous peripheral mononuclear cells). After treatment, patients were followed and treated according to the discretion of their physicians.
In Study 1, 512 patients were randomized in a 2:1 ratio to receive sipuleucel-T or control. This study excluded patients with visceral metastases and moderate-to-severe cancer-related pain, and all patients had baseline testosterone levels <50ng/mL. In Study 2, a similar study in 127 patients with no cancer-related pain, the primary endpoint was time to disease progression. Analysis of the primary endpoint did not reach statistical significance. A third study was terminated before completion of planned accrual.
For Study 1, the overall median survival for patients treated with sipuleucel-T was 25.8 months, compared to 21.7 months for control. For Study 2, the overall survival results were 25.9 months for the sipuleucel-T group and 21.4 months for the control group.
Legal Classification:
Rx
Adults:
Autologous use only. Obtain product release from manufacturer, match patient identity on product and Cell Product Disposition form, check expiration date and time on product before infusing. Premedicate 30 minutes before infusion with acetaminophen and antihistamine. Give three doses at 2-week intervals. For each dose: give entire contents of bag by IV infusion over 60 minutes; do not use filter; do not use if clumps do not disperse with gentle mixing. Observe patient for at least 30 minutes after infusion. May interrupt or slow infusion if acute transfusion reaction occurs; do not restart if product at room temp for >3 hours.
Children:
Not applicable.
Warnings/Precautions:
Cardiac or pulmonary conditions. Each dose requires a standard leukapheresis procedure about 3 days before infusion. If scheduled infusion is missed, do an additional leukapheresis procedure if treatment course is to be continued. Risk of disease transmission. Pregnancy, lactation: not applicable.
Interaction(s):
May be antagonized by concomitant chemotherapy or immunosuppressive therapy.
Adverse Reaction(s):
Infusion reactions (eg, chills, fever, respiratory events, GI upset, hypertension, tachycardia), fatigue, back pain, joint ache, headache.
Notes:
If product sterility tests indicate microbial contamination, manufacturer will contact physician (tests are incomplete at time of infusion).
How Supplied:
Patient-specific bag (250mL)—1
Last Updated:
10/28/2010
| 
