A phase III study of anti-B4-blocked ricin as adjuvant therapy post-autologous bone marrow transplant: CALGB 9254.
A phase III study of anti-B4-blocked ricin as adjuvant therapy post-autologous bone marrow transplant: CALGB 9254.
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DOI：
10.3109/10428194.2010.543714
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发表时间：
2011-04
影响因子：
2.6
通讯作者：
Eastern Cooperative Oncology Group
中科院分区：
文献类型：
--
作者：
Furman RR;Grossbard ML;Johnson JL;Pecora AL;Cassileth PA;Jung SH;Peterson BA;Nadler LM;Freedman A;Bayer RL;Bartlett NL;Hurd DD;Cheson BD;Cancer Leukemia Group B;Eastern Cooperative Oncology Group
抗B4阻断蓖麻毒素（抗B4-bR）是一种针对CD 19抗原的强效免疫毒素。先前的I期和II期研究表明，抗B4-bR可能在高剂量化疗和自体干细胞移植后巩固治疗中发挥作用。癌症和白血病组B（CALGB）9254是一项III期研究，将157例自体移植后完全缓解的B细胞淋巴瘤患者随机分为抗B4-bR治疗组或观察组。患者的中位随访时间为5.8年，方案治疗和观察的中位无事件生存期分别为2.1年和2.9年（p = 0.275）。治疗和观察的中位总生存期分别为6.1年和未达到（p = 0.063）。因此，方案治疗和观察组之间的无事件生存期和总生存期无差异，尽管观察组的生存期有改善的趋势。这些数据不支持抗B4-bR作为B细胞淋巴瘤患者骨髓移植后巩固治疗的作用。
Anti-B4-blocked ricin (anti-B4-bR) is a potent immunotoxin directed against the CD 19 antigen. Previous phase I and II studies suggested a possible role for anti-B4-bR as consolidation after high-dose chemotherapy and autologous stem cell transplant. Cancer and Leukemia Group B (CALGB) 9254 is a phase III study which randomized 157 patients with B-cell lymphoma in complete remission following autologous transplant to treatment with anti-B4-bR or observation. With a median follow-up time for patients of 5.8 years, the median event-free survival for protocol treatment and observation are 2.1 and 2.9 years, respectively (p = 0.275). The median overall survival for treatment and observation are 6.1 years and not reached, respectively (p = 0.063). Therefore, no differences were found in event-free survival and overall survival between protocol treatment and observation, although there was a trend toward improved survival with observation. These data fail to support a role for anti-B4-bR as consolidative therapy after bone marrow transplant in patients with B-cell lymphoma.
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