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一项针对经过大量预处理的晚期难治性非小细胞肺癌患者,对比最佳支持治疗联合或不联合热疗及维生素C的随机II期试验。

A randomized phase II trial of best supportive care with or without hyperthermia and vitamin C for heavily pretreated, advanced, refractory non-small-cell lung cancer.

作者信息

Ou Junwen, Zhu Xinyu, Chen Pengfei, Du Yanping, Lu Yimin, Peng Xiufan, Bao Shuang, Wang Junhua, Zhang Xinting, Zhang Tao, Pang Clifford L K

机构信息

Cancer Center, Clifford Hospital, Jinan University, Guangzhou, PR China.

Hyperthermia Center, Clifford Hospital, Jinan University, PR China.

出版信息

J Adv Res. 2020 Mar 17;24:175-182. doi: 10.1016/j.jare.2020.03.004. eCollection 2020 Jul.

DOI:10.1016/j.jare.2020.03.004
PMID:32368355
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7190757/
Abstract

Our previous study indicated that intravenous vitamin C (IVC) treatment concurrent with modulated electrohyperthermia (mEHT) was safe and improved the quality of life (QoL) of non-small-cell lung cancer (NSCLC) patients. The aim of this trial was to further verify the efficacy of the above combination therapy in previously treated patients with refractory advanced (stage IIIb or IV) NSCLC. A total of 97 patients were randomized to receive IVC and mEHT plus best supportive care (BSC) (n = 49 in the active arm, receiving 1 g/kg * d IVC concurrently with mEHT, three times a week for 25 treatments in total) or BSC alone (n = 48 in the control arm). After a median follow-up of 24 months, progression-free survival (PFS) and overall survival (OS) were significantly prolonged by combination therapy compared to BSC alone (PFS: 3 months vs 1.85 months, P < 0.05; OS: 9.4 months vs 5.6 months, P < 0.05). QoL was significantly increased in the active arm despite the advanced stage of disease. The 3-month disease control rate after treatment was 42.9% in the active arm and 16.7% in the control arm (P < 0.05). Overall, IVC and mEHT may have the ability to improve the prognosis of patients with advanced NSCLC.

摘要

我们之前的研究表明,静脉注射维生素C(IVC)联合调制式电高热疗法(mEHT)进行治疗是安全的,并且改善了非小细胞肺癌(NSCLC)患者的生活质量(QoL)。本试验的目的是进一步验证上述联合疗法对先前接受过治疗的难治性晚期(IIIb期或IV期)NSCLC患者的疗效。总共97例患者被随机分组,分别接受IVC和mEHT加最佳支持治疗(BSC)(治疗组n = 49,接受1 g/kg·d的IVC并同时进行mEHT,每周3次,共进行25次治疗)或仅接受BSC(对照组n = 48)。中位随访24个月后,与单独使用BSC相比,联合疗法显著延长了无进展生存期(PFS)和总生存期(OS)(PFS:3个月对1.85个月,P < 0.05;OS:9.4个月对5.6个月,P < 0.05)。尽管疾病处于晚期,但治疗组的生活质量仍显著提高。治疗后3个月时,治疗组的疾病控制率为42.9%,对照组为16.7%(P < 0.05)。总体而言,IVC和mEHT可能具有改善晚期NSCLC患者预后的能力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/639b/7190757/cf7f276c8574/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/639b/7190757/79de5b4f6d04/ga1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/639b/7190757/53d8240edbef/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/639b/7190757/cf7f276c8574/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/639b/7190757/79de5b4f6d04/ga1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/639b/7190757/53d8240edbef/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/639b/7190757/cf7f276c8574/gr2.jpg

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