Continuous or Fixed-Duration Maintenance Therapy in Multiple Myeloma.

The appropriate duration of maintenance therapy with lenalidomide has been unclear.

雷那度胺维持治疗的适当持续时间尚不明确。

Methods

In this phase 3 trial, we enrolled patients with standard-risk newly diagnosed multiple myeloma who were not undergoing up-front autologous stem-cell transplantation.

在这项III期试验中，我们招募了接受诱导治疗的初诊标准风险多发性骨髓瘤患者，这些患者未进行自体干细胞移植。

After induction treatment with a proteasome inhibitor-lenalidomide combination, patients were randomly assigned to receive indefinite-duration (continuous) lenalidomide or fixed-duration lenalidomide (for 2 years).

在使用蛋白酶体抑制剂-雷那度胺联合治疗后，患者被随机分配接受无限期（连续）雷那度胺治疗或固定期限雷那度胺治疗（为期2年）。

The primary end point was overall survival; the trial had 80% power to detect a 50% increase in median survival (from 5 years to 7.5 years), with a two-sided alpha level of 5%, 395 patients undergoing randomization, and 204 deaths occurring during 9 years of follow-up.

主要终点是总生存期；该试验有80%的把握度检测到中位生存期增加50%（从5年增加到7.5年），双侧α水平为5%，395名患者进行了随机分组，随访9年期间发生了204例死亡。

Results

At the end of induction, 516 patients were randomly assigned to the indefinite-duration group (260 patients) or the fixed-duration group (256 patients).

诱导治疗结束时，516名患者被随机分配到无限期组（260名患者）或固定期组（256名患者）。

At a median follow-up of 86 months, overall survivaldid not differ significantly between the groups.

在中位随访86个月时，各组之间的总生存率没有显著差异。

With 80 deaths in each group, overall survivalat 7 years was 68.6% in the indefinite-duration group and 69.0% in the fixed-duration group (difference, -0.4 percentage points; 95 confidence interval[CI], -9.0 to 8.3; P = 0.93).

在每个组有80例死亡的情况下，7年总生存率在无限期组为68.6%，在固定期组为69.0%（差异，-0.4个百分点；95%置信区间[CI]，-9.0至8.3；P = 0.93）。

Progression-free survivalat 7 years was 36.1% in the indefinite-duration group and 29.7% in the fixed-duration group (difference, 6.4 percentage points; 95% CI, -2.6 to 15.4).

在无限期治疗组中，7年无进展生存率为36.1%，而在固定期治疗组中为29.7%（差异为6.4个百分点；95%置信区间，-2.6至15.4）。

The 5-year cumulative incidenceof second primary cancers, excluding nonmelanoma skin cancer, was 11.2% with indefinite-duration lenalidomide and 8.3% with fixed-duration lenalidomide.

在无限期使用来那度胺的患者中，5年内第二原发癌症（不包括非黑色素瘤皮肤癌）的累积发生率为11.2%，而在固定期使用来那度胺的患者中为8.3%。

More adverse events occurred with indefinite-duration lenalidomide; the incidenceof nonhematologic events of grade 3 or higher was 48.2% with indefinite-duration therapy and 31.5% with fixed-duration therapy.

在使用无固定期限的雷利度胺治疗中，不良事件的发生率更高；3级或更高级别的非血液学事件发生率为无固定期限治疗的48.2%，固定期限治疗的31.5%。

Conclusions

In this phase 3 trial involving patients with standard-risk newly diagnosed multiple myeloma who were not undergoing up-front autologous stem-cell transplantation, indefinite-duration maintenance therapy after induction therapy did not result in significantly longer overall survivalthan fixed-duration maintenance therapy.

在这项涉及标准风险新诊断的多发性骨髓瘤患者（未进行首次自体干细胞移植）的III期试验中，诱导治疗后的无固定期限维持治疗并未显著延长总生存期，与固定期限维持治疗相比。

(Funded by the National Cancer Institute of the National Institutes of Health and Amgen; ENDURANCE ClinicalTrials.gov number, NCT01863550.).

(该研究由美国国立卫生研究院国家癌症研究所和安进公司资助; ENDURANCE 临床试验注册号为 NCT01863550.)