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首页> 外文期刊>Prescrire international >Temsirolimus and mantle cell lymphoma. Highly toxic, limited efficacy.
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Temsirolimus and mantle cell lymphoma. Highly toxic, limited efficacy.

机译：特罗罗莫司和套细胞淋巴瘤。剧毒，功效有限。

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Mantle cell lymphoma is a highly malignant non-Hodgkin's lymphoma. There is no consensus on chemotherapy regimens for patients who do not qualify for haematopoietic stem cell transplantation. Temsirolimus, a metabolic precursor of sirolimus, already marketed in the European Union for metastatic kidney cancer, recently received an extension of indications to include relapsed or refractory mantle cell lymphoma. In this setting, one trial involving 162 patients in whom 2 or 3 chemotherapy regimens had failed compared two doses of temsirolimus (175 mg per week for 3 weeks, followed by 75 mg or 25 mg per week) versus a control group receiving various other treatments. The median overall survival time was about 11 months, regardless of the treatment.The median survival time before radiological or clinical progression was slightly longer with the higher dose of temsirolimus than in the control group (4.8 versus 1.9 months). Both of the temsirolimus dose regimens were highly toxic: 5 deaths, haematological disorders in more than 90% of patients, and haemorrhage or severe thrombocytopenia in about 50% of cases. Reactions during the infusion, infections, mucositis, fatigue and diarrhoea were also frequent.The cytochrome P450 isoenzyme CYP 3A4 is involved in temsirolimus metabolism, hence a high risk of pharmacokinetic interactions. The packaging is inappropriate and represents a potential source of dosing errors. In practice, temsirolimus shows only limited efficacy but is highly toxic in patients with relapsed or refractory mantle cell lymphoma after several prior chemotherapy regimens. It is better to avoid using this drug.
机译：套细胞淋巴瘤是高度恶性的非霍奇金淋巴瘤。对于不符合造血干细胞移植资格的患者，对于化疗方案尚无共识。替莫罗莫司是西罗莫司的代谢前体，已经在欧盟销售用于转移性肾癌，最近接受了适应症的扩展，包括复发性或难治性套细胞淋巴瘤。在这种情况下，一项涉及162例患者的试验（其中2例或3例化疗方案均无效）比较了两剂替西罗莫司（每周175 mg，持续3周，然后每周75 mg或25 mg）与接受其他各种治疗的对照组的比较。无论采用何种治疗方法，中位总生存时间均约为11个月。替米罗莫司剂量更高时，放射学或临床进展前的中位生存时间略长于对照组（4.8与1.9个月）。两种西罗莫司剂量方案均具有剧毒：死亡5例，超过90％的患者出现血液系统疾病，大约50％的病例出现出血或严重血小板减少。输注，感染，粘膜炎，疲劳和腹泻时也经常发生反应。细胞色素P450同工酶CYP 3A4参与西罗莫司代谢，因此发生药代动力学相互作用的风险很高。包装不合适，并可能导致剂量错误。在实践中，替罗莫司仅显示出有限的疗效，但在经过几次先前的化疗方案后对复发或难治性套细胞淋巴瘤患者具有高毒性。最好避免使用这种药物。

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