Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, 322 Seoyangro, Hwasun, Jeollanamdo, 519-763, Republic of Korea.
Ann Hematol. 2014 Sep;93(9):1571-7. doi: 10.1007/s00277-014-2067-3. Epub 2014 Apr 12.
This phase II study prospectively evaluated the efficacy and tolerability of an early change in induction therapy before autologous stem cell transplantation (ASCT) in multiple myeloma (MM) patients who failed to achieve more than a partial response (PR) after two cycles of a cyclophosphamide, thalidomide, and dexamethasone (CTD) regimen. Patients aged 18-65 years received two cycles of CTD therapy, and then the patients who achieved more than a PR received two additional cycles of CTD therapy, while those who failed to achieve more than a PR were given intensified therapy with four cycles of a Vel-CD regimen (bortezomib, cyclophosphamide, and dexamethasone). After completing primary chemotherapy, the patients underwent ASCT. This study initially enrolled 64 patients, although four were excluded. Of the patients, 60 were treated with CTD regimen and 8 patients also had the intensified Vel-CD regimen, of whom five showing improved responses. The overall response rate before ASCT in 59 patients was 94.9 %, including 27.1 % with a stringent complete response/complete response, 23.7 % with a very good partial response (VGPR), and 44.1 % with a PR. The median time to progression (TTP) was 33.2 months (95 % CI, 26.6-34.8). Patients who attained a VGPR or better after ASCT tended to have a longer TTP than the patients who did not (not reached vs. 24.2 months, P = 0.04). In conclusion, early response-adapted intensification with a Vel-CD regimen was a well-tolerated, effective strategy for improving the response before ASCT in patients with newly diagnosed MM.
这项 II 期前瞻性研究评估了在接受环磷酰胺、沙利度胺和地塞米松（CTD）方案两个周期治疗后未能达到部分缓解（PR）以上的多发性骨髓瘤（MM）患者中，在自体干细胞移植（ASCT）前早期改变诱导治疗的疗效和耐受性。年龄在 18-65 岁之间的患者接受了两个周期的 CTD 治疗，然后对达到 PR 以上的患者给予两个周期的 CTD 治疗，而对未达到 PR 的患者给予四个周期的 Vel-CD 方案（硼替佐米、环磷酰胺和地塞米松）强化治疗。完成初级化疗后，患者接受 ASCT。该研究最初纳入了 64 例患者，但有 4 例被排除。其中 60 例患者接受 CTD 方案治疗，8 例患者还接受了强化 Vel-CD 方案治疗，其中 5 例患者的缓解情况有所改善。59 例患者在 ASCT 前的总体缓解率为 94.9%，包括 27.1%的严格完全缓解/完全缓解、23.7%的非常好的部分缓解（VGPR）和 44.1%的 PR。无进展生存期（TTP）的中位数为 33.2 个月（95%CI，26.6-34.8）。ASCT 后达到 VGPR 或更好缓解的患者 TTP 倾向于长于未达到 VGPR 或更好缓解的患者（未达到 vs. 24.2 个月，P=0.04）。总之，用 Vel-CD 方案进行早期反应适应性强化是一种耐受良好、有效的策略，可以提高新诊断 MM 患者 ASCT 前的反应。
