霍奇金淋巴瘤一线治疗方案
权威癌症研究机构美国国家癌症研究所 (NCI)对霍奇金淋巴瘤(复发性成人经典霍奇金淋巴瘤(HL))一线治疗方案:维布妥昔单抗。
维布妥昔单抗治疗霍奇金淋巴瘤(复发性成人经典霍奇金淋巴瘤(HL))医学证据
一、在针对复发患者的多项试验中,包括在异基因 SCT 后进行的一项试验,观察到以下结果:
1.对于复发患者,反应率约为 75%,完全缓解率约为 50%,中位无进展生存期 (PFS) 为 4 至 8 个月。[1-2] [证据级别:3iiiDiv ]
二、27 名 60 岁以上未经治疗的患者接受了brentuximab(维布妥昔单抗)。 [3]
1.据报道,总体缓解率为 92%,完全缓解率为 73%。[3][证据级别:3iiiDiv ]
三、据报道,复发患者使用brentuximab(维布妥昔单抗)成功再治疗,缓解率为 60%。[4][证据级别:3iiiDiv ]
四、对于 329 名 SCT 后残留 HL 高风险的患者,双盲AETHERA试验 [NCT01100502][7]评估了brentuximab vedotin 与安慰剂。 [5,6]
1.中位随访 5.0 年,brentuximab(维布妥昔单抗)的5年PFS率为 59%(95% 置信区间 [CI],51%–66%)与 41%(95% CI,33%–49%)对于安慰剂(风险比 [HR],0.521;95% CI,0.379–0.717)。[5,6] [证据级别:1iDiii ]
2.大多数患者未能达到移植后 16 个月的治疗持续时间,因为他们发展为进行性周围神经病变,在停用 brentuximab 后部分可逆。
五、在两项 I/II 期研究中,120 名复发或难治性 HL 患者接受了 brentuximab vedotin 和苯达莫司汀(BVB 方案)。 [8]
1.两个周期后,客观缓解率分别为93%和78%,完全缓解率分别为74%和32%。[8、9] [证据等级:3iiiDiv ]
参考资料:
[1]Gopal AK, Ramchandren R, O'Connor OA, et al.: Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood 120 (3): 560-8, 2012.
[2]Bazarbachi A, Boumendil A, Finel H, et al.: Brentuximab vedotin for recurrent Hodgkin lymphoma after allogeneic hematopoietic stem cell transplantation: A report from the EBMT Lymphoma Working Party. Cancer 125 (1): 90-98, 2019.
[3]Forero-Torres A, Holkova B, Goldschmidt J, et al.: Phase 2 study of frontline brentuximab vedotin monotherapy in Hodgkin lymphoma patients aged 60 years and older. Blood 126 (26): 2798-804, 2015.
[4]Bartlett NL, Chen R, Fanale MA, et al.: Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies. J Hematol Oncol 7: 24, 2014.
[5]Moskowitz CH, Nademanee A, Masszi T, et al.: Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 385 (9980): 1853-62, 2015.
[6]Moskowitz CH, Walewski J, Nademanee A, et al.: Five-year PFS from the AETHERA trial of brentuximab vedotin for Hodgkin lymphoma at high risk of progression or relapse. Blood 132 (25): 2639-2642, 2018.
[7]A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)[NCT01100502].
[8]LaCasce AS, Bociek RG, Sawas A, et al.: Brentuximab vedotin plus bendamustine: a highly active first salvage regimen for relapsed or refractory Hodgkin lymphoma. Blood 132 (1): 40-48, 2018.
[9]O'Connor OA, Lue JK, Sawas A, et al.: Brentuximab vedotin plus bendamustine in relapsed or refractory Hodgkin's lymphoma: an international, multicentre, single-arm, phase 1-2 trial. Lancet Oncol 19 (2): 257-266, 2018.