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.

一项随机的 II 期试验 ， 包括有或没有热疗和维生素 C 的最佳支持治疗 ，先进,难治性非小细胞肺癌。

• 影响指数: 12.822
• 发表时间: Jul 2020
• 来源期刊: J Adv Res
• DOI: 10.1016/j.jare.2020.03.004
• PMID: 32368355
• 文章类型: Journal Article
• 作者列表: Ou J,Zhu X,Chen P,Du Y,Lu Y,Peng X,Bao S,Wang J,Zhang X,Zhang T,Pang CLK

关键词: AUC, area under the curve; BSC, best supportive care; CA15-3, carbohydrate antigen 15-3; CEA, carcinoembryonic antigen; CI, confidence interval; CR, complete response; CRP, C-reactive protein; CT, computed tomography; CYFRA21-1, cytokeratin-19 fragments; DCR, disease control rate; ECOG, Eastern Cooperative Oncology Group; EGFR, epidermal growth factor receptor; G6PD, glucose 6-phosphate dehydrogenase; HT, hyperthermia; IL-6, interleukin- 6; IVC, intravenous vitamin C; Modulated electrohyperthermia; NSCLC, non-small-cell lung cancer; Non-small-cell lung cancer; OS, overall survival; Overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; QLQ-C30, Quality of Life Questionnaire; QoL, quality of life; Quality of life; RECIST, Response Evaluation Criteria in Solid Tumors; Remission rate; SCC, squamous cell carcinoma antigen; SD, stable disease; TKIs, tyrosine kinase inhibitors; TNF-α, Tumor Necrosis Factor-α; Vitamin C; mEHT, modulated electrohyperthermia

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

我们先前的研究表明，静脉内维生素C（IVC）治疗与调制热疗（mEHT）同时使用是安全的，并改善了非小细胞肺癌（NSCLC）患者的生活质量（QoL）。该试验的目的是进一步验证上述联合疗法在先前治疗的难治性晚期（IIIb或IV期）NSCLC患者中的疗效。共有97例患者随机接受IVC和mEHT加最佳支持治疗（BSC）（n=49，在活动臂中，同时接受1g/kg*dIVC和mEHT，每周三次，共25次治疗）或单独使用BSC（对照组中n=48）。经过24个月的中位随访，与单独使用BSC相比，联合治疗的无进展生存期（PFS）和总生存期（OS）显着延长（PFS：3个月vs1.85个月，P<0.05；OS：9.4个月vs5.6个月，P<0.05)。尽管疾病处于晚期，但活动臂的QoL显着增加。治疗后3个月疾病控制率主动臂为42.9%,对照臂为16.7%(P<0.05)。总的来说,IVC和mEHT可能具有改善晚期NSCLC患者预后的能力。