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2010年2月18日，基因泰克公司宣布，美国食品药品管理局(FDA)批准Rituxan(利妥昔单抗)与氟达拉滨和环磷酰胺(FC)联用，治疗CD20阳性的慢性淋巴细胞白血病(CLL)患者，既往未接受过治疗的患者及既往接受过治疗的患者均适用。Rituxan是一种与CD20抗原结合的治疗性抗体，此抗原存在于恶性和非恶性B细胞表面。该药先前曾获准用于治疗非霍奇金淋巴瘤和类风湿关节炎患者。 据基因泰克公司称，CLL一直被认为是最常见的一类成人白血病。由于该病被视为不可治愈性疾病，故其主要治疗目标是延长无进展生存期(PFS)。 FDA批准Rituxan用于治疗CLL的依据是两项分别名为CLL8和REACH的III期临床研究的结果。CLL8研究由罗氏资助，是一项全球性、多中心、随机、开标签研究，受试者为817例既往未接受治疗、CD20阳性的患者。REACH研究由基因泰克、Biogen Idec及罗氏资助，也是一项全球性、多中心、随机、开标签研究，受试者为552例既往经过治疗、CD20阳性、无Rituxan治疗史的患者。两项研究均评价了Rituxan+ FC的疗效，并将其与FC单药治疗进行比较，主要研究终点均为PFS，次要研究终点包括总体生存率、无事件生存率、有效时程、有效率、完全有效以及毒性。 在CLL8研究中，接受Rituxan+ FC治疗者的PFS较接受FC单药治疗者延长79%(基于风险减少44%，风险比[HR]，0.56；P < 0.01；95% 可信区间[CI]，0.43-0.71)。接受Rituxan+ FC治疗者在病情未恶化情况下的中位生存期为39.8个月，而接受FC单药治疗者为31.5个月。总体有效率和完全有效率的结果均与PFS结果一致。 在REACH研究中，既往接受过治疗(无Rituxan治疗史)的患者中，接受Rituxan+ FC治疗者的PFS较接受FC单药治疗者延长32%(基于风险减少24%，HR，0.76；P =0.02； 95% CI，0.60~0.96)。既往接受过治疗、研究中接受Rituxan+ FC治疗者的中位PFS为26.7个月，而接受FC单药治疗者为21.7个月。对年龄在70岁或70岁以上的老年人进行的探索性分析表明，在FC治疗的基础上添加Rituxan并未获得收益。与年轻的患者相比，无论是否添加Rituxan，70岁或70岁以上的患者接受的FC的剂量强度均较低。 在CLL8或REACH研究中均未观察到新的安全性信号，总体来说，Rituxan的安全性与其先前的应用经验一致。与接受FC单药治疗的患者相比，接受Rituxan+ FC治疗者中较常见的严重不良事件包括血细胞减少(中性粒细胞减少、白细胞减少、发热性中性粒细胞减少、血小板减少、全血细胞减少)和输血反应，在既往未接受治疗的患者中低血压和乙型肝炎较常见。两个研究亚组(整个研究群体)之间在3级或4级感染的发生率上相近，与CLL患者既往是否接受过治疗无关。在接受Rituxan+ FC治疗的患者中，年龄>70岁的患者3级和4级不良事件的发生率高于年轻患者。
RituxanGeneric name: Rituximab What is Rituxan?Return to top Rituxan is used to treat mild-to-moderate rheumatoid arthritis (RA) that has not responded to other therapy. It is also used in combination with chemotherapy to treat non-Hodgkin's Lymphoma (NHL). What is the most important information I should know about Rituxan?Return to top Rituxan may cause hives, swelling, dizziness, blurred vision, drowsiness, headache, cough, wheezing, or have trouble breathing while receiving or after receiving it. Also, this drug may cause severe skin reactions, such as painful sores, ulcers, blisters, or peeling of the skin. Rituxan may cause Tumor Lysis syndrome (TLS); this is the quick breakdown of blood cancer, which may lead to kidney problems. People with non-Hodgkin's Lymphoma are more likely to develop TLS. Who should not take Rituxan?Return to top Do not take Rituxan if you are allergic to any of it ingredients. What should I tell my doctor before I take the first dose of Rituxan?Return to top Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Rituxan. Also, talk to your doctor about your complete medical history, including previous therapies used, especially if you have stomach/bowel problems, heart problems, kidney problems, or if you have/had hepatitis B. What is the usual dosage?Return to top The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval. Non-Hodgkin's Lymphoma The recommended dose of Rituxan is 375 milligrams (mg)/m2 IV infusion once weekly for 4 or 8 doses. Rheumatoid Arthritis The recommended dose Rituxan is two-1000 mg IV infusions separated by 2 weeks. How should I take Rituxan?Return to top This drug will be administered to you by your doctor. The Rituxan solution for IV infusion should be given at an initial rate of 50 mg/hr. Rituxan should not be mixed or diluted with any other drugs. What are the possible side effects of Rituxan?Return to top Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug. Side effects for RA patients may include: Aching joints, chills, cough, fever, headache, hives, itching, nausea, shakes, sneezing, swelling, throat irritation or tightness, upper respiratory tract infection Side effects for NHL patients may include: Fever, headache, nausea, shaking chills, tiredness Can I receive Rituxan if I am pregnant or breastfeeding?Return to top The effects of Rituxan during pregnancy and breastfeeding are unknown. Talk with your doctor before taking this drug if you are pregnant, plan to become pregnant, or are breastfeeding. How should I store Rituxan?Return to top Store in a refrigerator. Do not freeze or shake the vials. |
