Hospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Instituto de Biología Molecular y Celular del Cáncer (Universidad de Salamanca-Consejo Superior de Investigaciones Científicas), CIBERONC, Salamanca, Spain.
Hospital Universitario de Canarias, Tenerife, Spain.
Eur J Cancer. 2022 Oct;174:243-250. doi: 10.1016/j.ejca.2022.07.030. Epub 2022 Sep 5.
Smoldering multiple myeloma (SMM) is a heterogeneous disease in terms of progression to myeloma (MM), but its standard of care continues to be observation.
The QuiRedex phase 3 trial initiated in 2007 included 119 high-risk patients with SMM randomized to treatment or observation. Treatment consisted of nine 4-week induction cycles (lenalidomide [Rd], 25 mg on days 1-21 plus dexamethasone, 20 mg on days 1-4 and 12-15), followed by maintenance (R, 10 mg on days 1-21) for up to 2 years. The primary end-point was time to progression (TTP) to myeloma based on per protocol population. Secondary end-points were overall survival (OS), response rate, and safety. An update of the trial after a long-term follow-up is presented here. This trial was registered with ClinicalTrials.gov (NCT00480363).
After a median follow-up time of 12.5 years (range: 10.4-13.6), the median TTP to MM was 2.1 years in the observation arm and 9.5 years in the Rd arm (HR: 0.28, 95% CI: 0.18-0.44, p < 0.0001). The median OS was 8.5 years in the abstention arm and not reached in the Rd group (HR: 0.57, 95% CI: 0.34-0.95, p = 0.032). Patients who progressed received optimized treatments according to the standards of care, and the OS from progression was comparable in both arms (p = 0.96).
This analysis confirms that early treatment with Rd for high-risk SMM translates into a sustained benefit in both TTP and OS.
Pethema (Spanish Program for the Treatment of Hematologic Diseases), Spain.
冒烟型多发性骨髓瘤（SMM）在向多发性骨髓瘤（MM）进展方面是一种具有异质性的疾病，但它的治疗标准仍然是观察。
QuiRedex 三期临床试验于 2007 年启动，纳入了 119 例高危 SMM 患者，随机分为治疗组或观察组。治疗包括 9 个 4 周诱导周期（来那度胺[Rd]，第 1-21 天 25mg，第 1-4 天和第 12-15 天 20mg，加上地塞米松），随后进行维持治疗（R，第 1-21 天 10mg），最多 2 年。主要终点是根据方案人群的骨髓瘤进展时间（TTP）。次要终点是总生存期（OS）、缓解率和安全性。现将试验的长期随访结果更新如下。该试验在 ClinicalTrials.gov 注册（NCT00480363）。
中位随访时间为 12.5 年（范围：10.4-13.6）后，观察组 MM 的中位 TTP 为 2.1 年，Rd 组为 9.5 年（HR：0.28，95%CI：0.18-0.44，p<0.0001）。观察组的中位 OS 为 8.5 年，Rd 组未达到（HR：0.57，95%CI：0.34-0.95，p=0.032）。进展的患者根据标准治疗接受了优化治疗，并且两组的 OS 从进展开始时相当（p=0.96）。
这项分析证实，早期使用 Rd 治疗高危 SMM 可在 TTP 和 OS 方面均获得持续获益。
西班牙血液疾病治疗计划（Pethema）。
