Department of Hematology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
Cancer Med. 2021 Mar;10(5):1656-1667. doi: 10.1002/cam4.3762. Epub 2021 Feb 2.
In the new therapeutic era, comparisons between regimens containing lenalidomide and bortezomib are needed.
In this single-center, prospective study, patients received four to six cycles of lenalidomide+liposomal doxorubicin+dexamethasone (RAD) or bortezomib+liposomal doxorubicin+dexamethasone (PAD) every 4 weeks, with subsequent autologous stem cell transplantation (ASCT) and maintenance therapy. We compared the efficacy, safety, patients' quality of life, and doctors' occupational stress between RAD and PAD induction in newly diagnosed MM patients.
The complete response (CR) rate was comparable between the RAD and PAD groups after induction (30.8% vs. 32.0%, p = 0.92). Common adverse events, including infections, peripheral neuropathy, and gastrointestinal disturbances, were more frequent in the PAD group, while leukopenia and rashes were more common in the RAD group. Compared with PAD, RAD improved patients' quality of life more quickly and caused less occupational stress for doctors. However, only 31.6% of patients collected adequate CD34+ cells (≥2 × 10 /kg) in the RAD group, which was significantly lower than that in the PAD group (95.5%, p < 0.001). The number of CD34+ cells collected was significantly higher in patients within three courses of RAD than in patients with four or five to six courses (14.18 ± 13.57 vs. 2.07 ± 2.42 vs. 1.51 ± 1.81 × 10 /kg, p = 0.028). The median progression-free survival and overall survival of the two groups were not reached by the end of follow-up.
Compared to PAD, RAD induction had comparable efficacy and a significantly better safety profile, improved quality of life for patients, and reduced occupational stress for doctors. However, RAD induction may need to be limited to four cycles to avoid irreversible damage to hematopoietic stem cells.
This study was registered at www.chictr.org.cn (ChiCTR1900021558).
在新的治疗时代，需要对含来那度胺和硼替佐米的方案进行比较。
在这项单中心、前瞻性研究中，患者每 4 周接受 4 至 6 个周期的来那度胺+脂质体多柔比星+地塞米松（RAD）或硼替佐米+脂质体多柔比星+地塞米松（PAD）治疗，随后进行自体干细胞移植（ASCT）和维持治疗。我们比较了 RAD 和 PAD 诱导在新诊断的 MM 患者中的疗效、安全性、患者生活质量和医生职业压力。
诱导后 RAD 和 PAD 组的完全缓解（CR）率相当（30.8% vs. 32.0%，p=0.92）。常见的不良反应，包括感染、周围神经病变和胃肠道紊乱，在 PAD 组更为常见，而白细胞减少和皮疹在 RAD 组更为常见。与 PAD 相比，RAD 能更快地改善患者的生活质量，且对医生的职业压力较小。然而，RAD 组仅有 31.6%的患者采集到足够的 CD34+细胞（≥2×10 /kg），显著低于 PAD 组（95.5%，p<0.001）。RAD 组三个疗程内采集的 CD34+细胞数量明显高于四个或五个至六个疗程的患者（14.18±13.57 与 2.07±2.42 与 1.51±1.81×10 /kg，p=0.028）。两组的中位无进展生存期和总生存期均未达到随访结束。
与 PAD 相比，RAD 诱导具有相当的疗效，且安全性显著更好，可改善患者的生活质量，降低医生的职业压力。然而，RAD 诱导可能需要限制在四个疗程以内，以避免对造血干细胞造成不可逆转的损害。
本研究在中国临床试验注册中心（ChiCTR1900021558）注册。
