Salles Gilles, Barrett Martin, Foà Robin, Maurer Joerg, O'Brien Susan, Valente Nancy, Wenger Michael, Maloney David G
Hématologie, Hospices Civils de Lyon and Université de Lyon, Pierre-Bénite, Lyon, France.
Roche Products Ltd., Welwyn Garden City, UK.
Adv Ther. 2017 Oct;34(10):2232-2273. doi: 10.1007/s12325-017-0612-x. Epub 2017 Oct 5.
Rituximab is a human/murine, chimeric anti-CD20 monoclonal antibody with established efficacy, and a favorable and well-defined safety profile in patients with various CD20-expressing lymphoid malignancies, including indolent and aggressive forms of B-cell non-Hodgkin lymphoma. Since its first approval 20 years ago, intravenously administered rituximab has revolutionized the treatment of B-cell malignancies and has become a standard component of care for follicular lymphoma, diffuse large B-cell lymphoma, chronic lymphocytic leukemia, and mantle cell lymphoma. For all of these diseases, clinical trials have demonstrated that rituximab not only prolongs the time to disease progression but also extends overall survival. Efficacy benefits have also been shown in patients with marginal zone lymphoma and in more aggressive diseases such as Burkitt lymphoma. Although the proven clinical efficacy and success of rituximab has led to the development of other anti-CD20 monoclonal antibodies in recent years (e.g., obinutuzumab, ofatumumab, veltuzumab, and ocrelizumab), rituximab is likely to maintain a position within the therapeutic armamentarium because it is well established with a long history of successful clinical use. Furthermore, a subcutaneous formulation of the drug has been approved both in the EU and in the USA for the treatment of B-cell malignancies. Using the wealth of data published on rituximab during the last two decades, we review the preclinical development of rituximab and the clinical experience gained in the treatment of hematologic B-cell malignancies, with a focus on the well-established intravenous route of administration. This article is a companion paper to A. Davies, et al., which is also published in this issue.
F. Hoffmann-La Roche Ltd., Basel, Switzerland.
利妥昔单抗是一种人/鼠嵌合抗CD20单克隆抗体,已证实具有疗效,在患有各种表达CD20的淋巴系统恶性肿瘤(包括惰性和侵袭性B细胞非霍奇金淋巴瘤)的患者中具有良好且明确的安全性。自20年前首次获批以来,静脉注射用利妥昔单抗彻底改变了B细胞恶性肿瘤的治疗方式,并已成为滤泡性淋巴瘤、弥漫性大B细胞淋巴瘤、慢性淋巴细胞白血病和套细胞淋巴瘤治疗的标准组成部分。对于所有这些疾病,临床试验表明利妥昔单抗不仅延长了疾病进展时间,还延长了总生存期。在边缘区淋巴瘤患者以及更具侵袭性的疾病(如伯基特淋巴瘤)中也显示出疗效益处。尽管近年来利妥昔单抗已证实的临床疗效促使其他抗CD20单克隆抗体(如奥滨尤妥珠单抗、奥法木单抗、维妥珠单抗和奥瑞珠单抗)得以开发,但利妥昔单抗可能会在治疗药物库中保持一席之地,因为它已确立了成功的临床应用悠久历史。此外,该药物的皮下制剂已在欧盟和美国获批用于治疗B细胞恶性肿瘤。利用过去二十年中发表的关于利妥昔单抗的大量数据,我们回顾了利妥昔单抗的临床前开发以及在血液学B细胞恶性肿瘤治疗中获得的临床经验,重点关注已确立的静脉给药途径。本文是A. Davies等人文章的配套论文,该文章也发表在本期杂志上。
瑞士巴塞尔的F. Hoffmann-La Roche Ltd.公司。