CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：Outcomes in newly diagnosed young or high-risk myeloma patients receiving tandem autologous/allogeneic transplant followed by bortezomib maintenance: a phase II study.
Outcomes in newly diagnosed young or high-risk myeloma patients receiving tandem autologous/allogeneic transplant followed by bortezomib maintenance: a phase II study.
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尽管有新药和自体 HCT，MM 仍不可治愈，生物学特征差的患者生存期短。Allo HCT 可能对部分患者有治愈作用，但受到高毒性和复发率的限制。
我们假设硼替佐米（BTZ）凭借其抗骨髓瘤和免疫学特性，可以改善新诊断 MM 患者接受 allo HCT 后的 PFS 和 cGVHD。在这项前瞻性 II 期研究中，我们纳入了 39 名年轻（≤50 岁）高危患者，他们接受了串联 auto-allo HCT 后给予 BTZ。患者在 allo HCT 前、BTZ 前以及此后每 3 个月进行前瞻性微小残留病（MRD）评估，使用 Next-Generation Flow 流式细胞术，持续 2 年。中位随访 48 个月，我们报告 5 年 PFS 和 OS 分别为 41% 和 80%，非复发死亡率为 12%。12 个月时 II-IV 级 aGVHD 和 2 年时中度/重度 cGVHD 的发生率分别为 26% 和 57%。在包含细胞遗传学、ISS 和 MRD 状态的多变量分析模型中，allo HCT 前 MRD 阳性（HR 3.75，p = 0.037）、BTZ 前（HR 11.3，p = 0.018）和 BTZ 开始后 3 个月（HR 9.7，p = 0.001）高度预测疾病进展。因此，围移植期 MRD 评估强烈预测疾病进展。
Despite novel drugs and autologous HCT, MM remains incurable, with short survival in patients with poor biological characteristics. Allo HCT may be curative in some patients but is hampered by high rates of toxicity and relapse.
We hypothesized that bortezomib (BTZ), with its anti-myeloma and immunologic properties, could improve PFS and cGVHD after allo HCT in newly diagnosed MM patients. In this prospective phase II study, we included 39 young (≤50 years) and high-risk patients who received a tandem auto-allo HCT followed by BTZ. Patients had prospective minimal residual disease (MRD) evaluations using Next-Generation Flow cytometry prior to allo HCT, prior BTZ and every 3 months for 2 years.
With a median follow-up of 48 months, we report PFS and OS at 5 years of 41% and 80%, with a non-relapse mortality of 12%. Incidences of grade II-IV aGVHD at 12 months and moderate/severe cGVHD at 2 years were 26% and 57%. In a multivariate analysis model including cytogenetics, ISS and MRD status, MRD positivity prior to allo HCT (HR 3. 75, p = 0. 037), prior BTZ (HR 11. 3, p = 0. 018) and 3 months post-BTZ initiation (HR 9. 7, p = 0. 001) was highly predictive of progression. Peritransplant MRD assessment thus strongly predicts disease progression.
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