Fuchida Shin-Ichi, Sunami Kazutaka, Matsumoto Morio, Okumura Hirokazu, Murayama Tohru, Miyamoto Toshihiro, Otsuka Eichi, Fujishima Naohito, Izumi Tohru, Tamaki Shigehisa, Hiramatsu Yasushi, Kuroda Yoshiaki, Shimazaki Chihiro, Akashi Koichi, Harada Mine
Department of Hematology, Japan Community Health care Organization Kyoto Kuramaguchi Medical Center, 27 Shimofusa-cho, Kita-ku, Kyoto, Kyoto, 603-8151, Japan.
National Hospital Organization Okayama Medical Center, Okayama, Japan.
Int J Hematol. 2019 Jan;109(1):107-114. doi: 10.1007/s12185-018-2543-y. Epub 2018 Oct 4.
The efficacy and safety of lenalidomide (LEN) consolidation therapy and subsequent LEN maintenance therapy after high-dose therapy with autologous peripheral blood stem cell transplantation (auto-PBSCT) were evaluated in patients with newly diagnosed symptomatic multiple myeloma (MM). Forty-one patients were enrolled and received high-dose dexamethasone (DEX) therapy as an initial induction. The patients who did not respond to the DEX therapy were further treated with four cycles of bortezomib plus DEX (BD) induction therapy. For patients who responded to BD, PBSC harvesting was scheduled following high-dose cyclophosphamide and filgrastim administration. After PBSC harvesting, high-dose chemotherapy of melphalan with auto-PBSCT was performed. One hundred days after auto-PBSCT, patients received consolidation therapy consisting two cycles of LEN plus low-dose DEX (Ld) and LEN maintenance therapy. Only one death occurred during mobilization therapy, but the protocol developed in this study was considered generally safe to provide. Overall response rates after consolidation and maintenance therapies were 73.7% and 81.6%, respectively. Two-year progression-free survival and overall survival were 76.3% and 92.1%, respectively. These observations suggest that LEN consolidation and maintenance therapy are effective and safe, and provide favorable response rates in patients with MM.
在新诊断的有症状多发性骨髓瘤（MM）患者中，评估了来那度胺（LEN）巩固治疗以及自体外周血干细胞移植（auto-PBSCT）大剂量治疗后随后的LEN维持治疗的疗效和安全性。41例患者入组并接受大剂量地塞米松（DEX）治疗作为初始诱导治疗。对DEX治疗无反应的患者进一步接受4个周期的硼替佐米联合DEX（BD）诱导治疗。对BD有反应的患者，在给予大剂量环磷酰胺和非格司亭后安排采集外周血干细胞（PBSC）。采集PBSC后，进行美法仑大剂量化疗及auto-PBSCT。auto-PBSCT后100天，患者接受由两个周期的LEN加小剂量DEX（Ld）组成的巩固治疗以及LEN维持治疗。在动员治疗期间仅发生1例死亡，但本研究制定的方案被认为总体提供是安全的。巩固治疗和维持治疗后的总缓解率分别为73.7%和81.6%。两年无进展生存率和总生存率分别为76.3%和92.1%。这些观察结果表明，LEN巩固和维持治疗有效且安全，并且在MM患者中提供了良好的缓解率。
