Yonsei Cancer Center, Severance Hospital, Seoul, South Korea.
Ann Hematol. 2010 Sep;89(9):905-12. doi: 10.1007/s00277-010-0943-z. Epub 2010 Mar 27.
We conducted a phase 2 study with bortezomib, doxorubicin, and dexamethasone (PAD) followed by thalidomide and dexamethasone (TD) in patients with relapsed multiple myeloma (MM). Forty patients were enrolled between November 2005 and October 2007, with follow-up continuing until January 2009. Efficacy could be assessed in 37 patients. The overall response rate to PAD followed by TD was 83.6%: complete response 51.4%, near-complete response 13.4%, very good partial remission 5.4%, and partial response 13.4%. The median follow-up was 27 months (range 13-39). The median progression-free survival (PFS) from the start of treatment was 18 months (95% CI, 9.7-26.2 months), with a 1-year PFS rate of 56.9% and 3-year PFS rate of 25.7%. Median overall survival was 35.1 months (95% CI, 18.5-51.7), with a 1-year survival rate of 75% and 3-year survival rate of 27.3%. One hundred seventy-eight PAD cycles (median 6, range 1-6) in 38 patients were assessable for safety. The most common hematologic toxicity was thrombocytopenia, with grade 3-4 in 35.8%. Sensory neuropathy occurred at grade 2 in 26.3% and grade 3 in 10.3%. Two hundred TD treatment cycles (median 4, range 0-12 cycles) were administered. Most adverse events were of mild degree and manageable. PAD followed by TD in patients with relapsed MM is very effective and tolerable.
我们进行了一项硼替佐米、多柔比星和地塞米松（PAD）联合沙利度胺和地塞米松（TD）治疗复发性多发性骨髓瘤（MM）患者的 2 期研究。40 例患者于 2005 年 11 月至 2007 年 10 月入组，随访持续至 2009 年 1 月。可评估 37 例患者的疗效。PAD 序贯 TD 的总缓解率为 83.6%：完全缓解 51.4%，接近完全缓解 13.4%，非常好的部分缓解 5.4%，部分缓解 13.4%。中位随访时间为 27 个月（范围 13-39）。从治疗开始的中位无进展生存期（PFS）为 18 个月（95%CI，9.7-26.2 个月），1 年 PFS 率为 56.9%，3 年 PFS 率为 25.7%。中位总生存期为 35.1 个月（95%CI，18.5-51.7），1 年生存率为 75%，3 年生存率为 27.3%。38 例患者中可评估 178 个 PAD 周期（中位数 6 个，范围 1-6 个）的安全性。最常见的血液学毒性是血小板减少症，3-4 级占 35.8%。感觉神经病变发生率为 26.3%的 2 级和 10.3%的 3 级。共给予 20 个 TD 治疗周期（中位数 4 个，范围 0-12 个周期）。大多数不良事件为轻度且可管理。复发性 MM 患者中 PAD 序贯 TD 非常有效且耐受良好。
