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TG4010 疫苗对晚期非小细胞肺癌患者健康相关生活质量的影响:一项 IIB 期临床试验结果。

Impact of TG4010 Vaccine on Health-Related Quality of Life in Advanced Non-Small-Cell Lung Cancer: Results of a Phase IIB Clinical Trial.

机构信息

National Quality of Life in Oncology Platform, Nancy, France; INSERM, CIC-EC CIE6, Nancy, France; CHU Nancy, Clinical Epidemiology and Evaluation Department, Nancy, France.

National Quality of Life in Oncology Platform, Nancy, France; Université de Franche-Comté, EA 3181, Besançon, France; CHU Besançon, Methodological and quality of life unit in oncology, Besançon, France.

出版信息

PLoS One. 2015 Jul 24;10(7):e0132568. doi: 10.1371/journal.pone.0132568. eCollection 2015.

Abstract

BACKGROUND

This study describes the effect of TG4010 vaccine on Health related Quality of Life (HRQOL) in patients with stage IIIb and IV non-small-cell lung cancer (NSCLC).

METHODS

148 patients with advanced NSCLC expressing MUC1 were randomly assigned to receive TG4010 plus chemotherapy or chemotherapy alone. HRQOL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) at baseline and every 6 weeks until disease progression. Time until definitive deterioration (TUDD) of the four well-being dimensions of the FACT-L physical (PWB), functional (FWB), emotional (EWB) and social well-being (SWB) and the Lung Cancer Subscale (LCS) domains were analyzed for a 5-point minimal clinically important difference.

RESULTS

No difference of TUDD of HRQOL has been found between treatment arms. No prognostic factors have been found to have a significant impact on the TUDD of PWB, SWB and LCS domains. The gender, the performance status and the smoking habits seemed to be associated with a shorter TUDD of EWB domain. The smokers and the former smokers seemed to present a shorter TUDD of FWB domain.

CONCLUSION

This study suggests that adding therapeutic vaccination with TG4010 to standard chemotherapy in patients with advanced NSCLC is associated with a similar evolution in HRQOL compared to chemotherapy alone.

摘要

背景

本研究描述了 TG4010 疫苗对 IIIb 期和 IV 期非小细胞肺癌(NSCLC)患者健康相关生活质量(HRQOL)的影响。

方法

148 例表达 MUC1 的晚期 NSCLC 患者被随机分配接受 TG4010 联合化疗或单纯化疗。在基线和疾病进展前每 6 周使用癌症治疗功能评估-肺(FACT-L)评估 HRQOL。分析 FACT-L 身体(PWB)、功能(FWB)、情感(EWB)和社会福祉(SWB)以及肺癌子量表(LCS)四个维度的 FACT-L 总体健康状况的明确恶化(TUDD)的时间,以确定 5 分最小临床重要差异。

结果

治疗组之间 HRQOL 的 TUDD 无差异。未发现预后因素对 PWB、SWB 和 LCS 领域的 TUDD 有显著影响。性别、表现状态和吸烟习惯似乎与 EWB 领域的 TUDD 较短有关。吸烟者和曾经吸烟者的 FWB 领域的 TUDD 似乎较短。

结论

本研究表明,与单纯化疗相比,在晚期 NSCLC 患者中加入 TG4010 治疗性疫苗与 HRQOL 的相似演变相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bc53/4514809/ec412efd44d2/pone.0132568.g001.jpg

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