Divison of Hematology, Mayo Clinic, Rochester, MN 55905, USA.
Leukemia. 2012 Jan;26(1):149-57. doi: 10.1038/leu.2011.196. Epub 2011 Jul 29.
Promising new drugs are being evaluated for treatment of multiple myeloma (MM), but their impact should be measured against the expected outcome in patients failing current therapies. However, the natural history of relapsed disease in the current era remains unclear. We studied 286 patients with relapsed MM, who were refractory to bortezomib and were relapsed following, refractory to or ineligible to receive, an IMiD (immunomodulatory drug), had measurable disease, and ECOG PS of 0, 1 or 2. The date patients satisfied the entry criteria was defined as time zero (T(0)). The median age at diagnosis was 58 years, and time from diagnosis to T(0) was 3.3 years. Following T(0), 213 (74%) patients had a treatment recorded with one or more regimens (median=1; range 0-8). The first regimen contained bortezomib in 55 (26%) patients and an IMiD in 70 (33%). A minor response or better was seen to at least one therapy after T(0) in 94 patients (44%) including ≥ partial response in 69 (32%). The median overall survival and event-free survival from T(0) were 9 and 5 months, respectively. This study confirms the poor outcome, once patients become refractory to current treatments. The results provide context for interpreting ongoing trials of new drugs.
有许多有前景的新药正在评估用于多发性骨髓瘤（MM）的治疗，但应该根据这些药物在现有疗法失败的患者中的预期结果来衡量它们的影响。然而，目前对于复发疾病的自然史仍不清楚。我们研究了 286 例复发的 MM 患者，这些患者对硼替佐米耐药，并且在接受 IMiD（免疫调节药物）后复发、耐药或无资格接受，有可测量的疾病，ECOG PS 为 0、1 或 2。患者满足入组标准的日期定义为时间零（T(0)）。诊断时的中位年龄为 58 岁，从诊断到 T(0)的时间为 3.3 年。在 T(0)之后，213 例（74%）患者有记录的治疗方案，其中一个或多个方案（中位数=1；范围 0-8）。第一个方案中 55 例（26%）患者包含硼替佐米，70 例（33%）患者包含 IMiD。在 T(0)后，94 例（44%）患者至少对一种治疗有轻微反应或更好的反应，其中 69 例（32%）患者有≥部分缓解。从 T(0)开始的中位总生存期和无事件生存期分别为 9 个月和 5 个月。这项研究证实了一旦患者对现有治疗产生耐药性，其预后较差。研究结果为解释正在进行的新药试验提供了背景。
