Hematology 2, ASO S. Giovanni Battista, Turin, Italy.
Cancer. 2011 May 1;117(9):1884-90. doi: 10.1002/cncr.25743. Epub 2010 Nov 18.
Although treatment for multiple myeloma (MM) has considerably improved in the past decade, MM continues to be an incurable hematological malignancy that causes most patients to eventually relapse and die from their illness. Thus, the identification of effective salvage strategies remains a priority.
In this trial, the authors evaluated the safety and efficacy of bortezomib and dexamethasone [V: on days 1 and 15 (1.3 mg/mq); D: on days 1-2 and 15-16, every 28-day cycle until progression (20 mg/d)] as maintenance therapy (MT) in patients with advanced MM who responded to salvage therapy that used a bortezomib-containing regimen.
Forty-nine MM patients were enrolled in this study between October of 2004 and April of 2008. All patients who were included in this study were responsive to a prior salvage therapy with bortezomib and had a measurable disease. The bortezomib and dexamethasone MT improved the quality of responses to complete remission in 4 patients and very good partial response in 3 patients. In addition, 10 patients experienced at least a 50% improvement in their symptoms. The median time to progression (TTP) was 16 months with a progression-free survival of 61% after 1 year. The overall response after 1 year was 76%, and the cumulative incidence of death due to disease progression, which was adjusted for competitive risk events, was 14%. Non-dose-limiting toxicities included neuropathy (predominantly grade 1), herpes zoster reactivation, pneumonia, and gastrointestinal affections (constipation and diarrhea). Three patients developed grade 2 neuropathy, which required a bortezomib dose reduction to 1.0 mg/mq. No grade 3 or 4 toxicities were recorded.
The use of bortezomib and dexamethasone as MT in advanced MM was effective and well tolerated. The twice-monthly bortezomib infusion appeared to reduce the incidence of grade 3 and 4 neuropathies in comparison to similar experiences in other settings.
尽管多发性骨髓瘤（MM）的治疗在过去十年中得到了显著改善，但 MM 仍然是一种无法治愈的血液恶性肿瘤，导致大多数患者最终复发并死于该病。因此，确定有效的挽救策略仍然是当务之急。
在这项试验中，作者评估了硼替佐米和地塞米松[V：第 1 天和第 15 天（1.3mg/mq）；D：第 1-2 天和第 15-16 天，每个 28 天周期，直至进展（20mg/d）]作为维持治疗（MT）在接受含有硼替佐米方案的挽救治疗有反应的晚期 MM 患者中的安全性和疗效。
2004 年 10 月至 2008 年 4 月期间，共有 49 例 MM 患者入组本研究。所有纳入本研究的患者均对先前含有硼替佐米的挽救治疗有反应，且疾病可测量。硼替佐米和地塞米松 MT 使 4 例患者完全缓解，3 例患者非常好的部分缓解。此外，10 例患者的症状至少改善了 50%。中位无进展生存期（TTP）为 16 个月，1 年后无进展生存率为 61%。1 年后总缓解率为 76%，疾病进展导致的死亡累积发生率（经竞争风险事件调整）为 14%。非剂量限制性毒性包括周围神经病（主要为 1 级）、带状疱疹再激活、肺炎和胃肠道疾病（便秘和腹泻）。3 例患者出现 2 级周围神经病，需要将硼替佐米剂量减少至 1.0mg/mq。未记录到 3 级或 4 级毒性。
在晚期 MM 中，硼替佐米和地塞米松作为 MT 使用是有效且耐受良好的。与其他情况下的类似经验相比，每月两次的硼替佐米输注似乎降低了 3 级和 4 级神经病变的发生率。
