Mian Hira, Mian Owais S, Rochwerg Bram, Foley Ronan, Wildes Tanya M
Juravinski Cancer Center, Department of Oncology, McMaster University, Hamilton, Canada.
Faculty of Medicine, University of Ottawa, Ottawa, Canada.
J Geriatr Oncol. 2020 Jan;11(1):93-99. doi: 10.1016/j.jgo.2019.05.014. Epub 2019 May 30.
While autologous stem cell transplant (ASCT) is a standard of care for newly-diagnosed younger patients with multiple myeloma, its role in older patients remains controversial. We conducted a systematic review and meta-analysis of observational studies and randomized controlled trials (RCTs) assessing the efficacy and toxicity of ASCT in older patients (age ≥ 65 years) with newly-diagnosed myeloma.
We searched Medline, Embase, and the Cochrane database through February 2, 2018. The primary outcome was overall survival; secondary outcomes included progression-free survival, response rates and toxicity. The Grading of Recommendations Assessment, Development and Evaluation criteria (GRADE) method was used to assess certainty in evidence.
Of 8614 abstracts screened, six observational studies and two RCTs were included in the systematic review. For overall survival, pooled observational data favored ASCT (Hazard Ratio [HR] 0.44, 95% Confidence Interval [CI] 0.34-0.58, p < .0001), while the impact of the RCT data was uncertain (HR 0.94, 95% CI 0.25-3.54, p = .93). Observational data showed higher complete response rates with ASCT (odds ratio 5.06, 95% CI 2.60-9.88, p < .0001). Progression free survival benefit from the RCTs was uncertain (HR 1.05, 95% CI 0.36-3.12, p = .93). Data were insufficient to pool for toxicity.
For older patients with newly diagnosed multiple myeloma, ASCT may improve the overall survival and complete response rates based upon observational data although the quality of this evidence is very low. The role of ASCT in improving overall survival based upon RCT data remains uncertain with low quality of evidence. Our study highlights the urgent need for well-conducted studies to understand the role of ASCT in older patients.
自体干细胞移植（ASCT）是新诊断的年轻多发性骨髓瘤患者的标准治疗方法，但其在老年患者中的作用仍存在争议。我们对评估ASCT在新诊断的骨髓瘤老年患者（年龄≥65岁）中的疗效和毒性的观察性研究和随机对照试验（RCT）进行了系统评价和荟萃分析。
我们检索了截至2018年2月2日的Medline、Embase和Cochrane数据库。主要结局是总生存期；次要结局包括无进展生存期、缓解率和毒性。采用推荐分级评估、制定和评价标准（GRADE）方法评估证据的确定性。
在筛选的8614篇摘要中，6项观察性研究和2项RCT被纳入系统评价。对于总生存期，汇总的观察性数据支持ASCT（风险比[HR]0.44，95%置信区间[CI]0.34 - 0.58，p <.0001），而RCT数据的影响不确定（HR 0.94，95%CI 0.25 - 3.54，p =.93）。观察性数据显示ASCT的完全缓解率更高（优势比5.06，95%CI 2.60 - 9.88，p <.0001）。RCT中无进展生存期的获益不确定（HR 1.05，95%CI 0.36 - 3.12，p =.93）。数据不足以汇总毒性情况。
对于新诊断的多发性骨髓瘤老年患者，基于观察性数据，ASCT可能改善总生存期和完全缓解率，尽管该证据质量很低。基于RCT数据，ASCT在改善总生存期方面的作用仍不确定，证据质量较低。我们的研究突出了开展高质量研究以了解ASCT在老年患者中作用的迫切需求。
