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
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
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DOI：
10.1016/j.jare.2020.03.004
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发表时间：
2020-07-01
影响因子：
10.7
通讯作者：
Pang, Clifford L. K.
中科院分区：
文献类型：
--
作者：
Ou, Junwen;Zhu, Xinyu;Pang, Clifford L. K.
我们之前的研究表明，静脉注射维生素 C (IVC) 联合调节电热疗 (mEHT) 治疗是安全的，并且可以改善非小细胞肺癌 (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既往治疗的难治性晚期（IIIb或IV期）NSCLC患者的疗效。共有 97 名患者被随机分配接受 IVC 和 mEHT 加最佳支持治疗 (BSC)（主动组 n = 49，同时接受 1 g/kg * d IVC 和 mEHT，每周 3 次，总共 25 次治疗）或单独 BSC（对照组 n = 48）。中位随访 24 个月后，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 vs 1.85 个月，P < 0.05；OS：9.4 个月 vs 5.6 个月，P < 0.05）。尽管已处于疾病晚期，但活动组的生活质量仍显着提高。治疗后3个月疾病控制率，治疗组为42.9%，对照组为16.7%（P < 0.05）。总体而言，IVC 和 mEHT 可能有能力改善晚期 NSCLC 患者的预后。 (C) 2020 作者。由 Elsevier B.V. 代表开罗大学出版。这是一篇遵循 CC BY-NC-ND 许可证 (http://creativecommons.org/licenses/by-nc-nd/4.0/) 的开放获取文章。
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. (C) 2020 The Authors. Published by Elsevier B.V. on behalf of Cairo University. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).