苯达莫司汀/利妥昔单抗联合治疗可取代应用利妥昔单抗的标准化疗方案,用于晚期淋巴瘤的一线治疗。 一项纳入513例患晚期滤泡性、套细胞、边缘区、Waldenströms和小淋巴细胞性淋巴瘤的患者的III期试验显示,苯达莫司汀/利妥昔单抗联合治疗在无进展生存率方面的疗效优于利妥昔单抗/CHOP联合化疗,并且其毒性小于后者。 Indication(s):Chronic lymphocytic leukemia (CLL). Pharmacology:Bendamustine is a bi-functional mechlorethamine derivative.Mechlorethamine and its derivatives dissociate into electrophilic alkyl groups.These groups form covalent bonds with electron-rich nucleophilic moieties.The bifunctional covalent linkage can lead to cell death via several pathways.The exact mechanism of action of bendamustine remains unknown.Bendamustine is active against both quiescent and dividing cells. Clinical Trials:The safety and efficacy of bendamustine were evaluated in an open-label, randomized, controlled multicenter trial comparing bendamustine to chlorambucil. The trial was conducted in 301 previously-untreated patients with Binet Stage B or C (Rai Stages I-IV) CLL requiring treatment. Patients were randomized to receive either bendamustine 100mg/m2 IV on Days 1 and 2 or chlorambucil 0.8mg/kg orally on Days 1 and 15 of each 28-day cycle. Efficacy endpoints of objective response rate and progression-free survival were calculated using a pre-specified algorithm based on NCI working group criteria for CLL. The results of this study demonstrated a significantly higher rate of overall response (59% vs. 26%) and a significantly longer progression-free survival (18 months vs 6 months) for bendamustine compared to chlorambucil. Legal Classification:Rx Adults:Give by IV infusion over 30 minutes.100mg/m2 on Days 1 and 2 of a 28-day cycle, up to 6 cycles.May give allopurinol prophylactically for those at high risk of tumor lysis syndrome.Delay treatment for Grade 4 hematologic toxicity or clinically significant ≥Grade 2 non-hematologic toxicity.Hematologic toxicity (≥Grade 3): reduce dose to 50mg/m2 on Days 1 and 2 of each cycle; if toxicity recurs, reduce dose to 25mg/m2 on Days 1 and 2.Non-hematologic toxicity (clinically significant ≥Grade 3): reduce dose to 50mg/m2 on Days 1 and 2 of each cycle. Subsequent cycles: may consider dose re-escalation.Severe renal impairment (CrCl <40mL/min) or moderate to severe hepatic impairment: not recommended. Children:Not recommended. Warnings/Precautions:Myelosuppression; monitor leukocytes, platelets, hemoglobin, neutrophils closely; restart treatment based on ANC and platelet count recovery. Renal or hepatic impairment. Monitor for infection, infusion reactions, tumor lysis syndrome. Pregnancy (Cat.D); avoid use.Nursing mothers: not recommended. Interaction(s):May be potentiated or antagonized by CYP1A2 inhibitors, inducers. Adverse Reaction(s):Neutropenia, pyrexia, thrombocytopenia, nausea, anemia, leukopenia, vomiting, asthenia, fatigue, malaise, dry mouth, somnolence, cough, constipation, headache, mucosal inflammation, stomatitis, increased bilirubin, increased AST or ALT; infection, infusion reactions (discontinue if severe), tumor lysis syndrome, skin reactions (if severe or progressive, withhold dose or discontinue). How Supplied:Single-use vial—1 Manufacturer:Cephalon, Inc. Pharmacological Class:Alkylating agent Active Ingredient(s):Bendamustine HCl 100mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains mannitol; preservative-free. |
苯达莫司汀治疗惰性淋巴瘤的疗效优于CHOP简介:
苯达莫司汀/利妥昔单抗联合治疗可取代应用利妥昔单抗的标准化疗方案,用于晚期淋巴瘤的一线治疗。
一项纳入513例患晚期滤泡性、套细胞、边缘区、Waldenströms和小淋巴细胞性淋巴瘤的患者的III期 ... 责任编辑:admin
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