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槲寄生作为含卡铂联合方案治疗晚期非小细胞肺癌患者的补充治疗:一项随机 II 期研究。

Mistletoe as complementary treatment in patients with advanced non-small-cell lung cancer treated with carboplatin-based combinations: a randomised phase II study.

机构信息

Division of Oncology, Rambam Health Care Campus, and Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.

出版信息

Eur J Cancer. 2013 Mar;49(5):1058-64. doi: 10.1016/j.ejca.2012.11.007. Epub 2012 Dec 5.

DOI:10.1016/j.ejca.2012.11.007
PMID:23218588
Abstract

INTRODUCTION

Mistletoe preparations, such as iscador, are common complementary medications. This randomised phase II study of iscador combined with carboplatin-containing regimens was conducted in chemotherapy-naïve advanced non-small-cell lung cancer (NSCLC) patients to assess its influence on chemotherapy-related side-effects and QoL.

METHODS

Patients with advanced NSCLC were randomised to receive chemotherapy alone or chemotherapy plus iscador thrice weekly until tumour progression. Chemotherapy consisted of 21-day cycles of carboplatin combined with gemcitabine or pemetrexed.

RESULTS

Seventy-two patients (control: 39; iscador: 33) were enrolled in the study. Most (65%) were in stage IV, and 62% had squamous histology. Median overall survival in both groups was 11 months. Median TTP was 4.8 months for the controls and 6 months in the iscador arm (p=NS). Differences in grade 3-4 haematological toxicity were not significant but more control patients had chemotherapy dose reductions (44% versus 13%, p=0.005), grade 3-4 non-haematological toxicities (41% versus 16%, p=0.043) and hospitalisations (54% versus 24%, p=0.016).

CONCLUSION

No effect of iscador could be found on quality of life or total adverse events. Nevertheless, chemotherapy dose reductions, severe non-haematological side-effects and hospitalisations were less frequent in patients treated with iscador, warranting further investigation of iscador as a modifier of chemotherapy-related toxicity.

摘要

简介

槲寄生制剂,如伊斯科达,是常见的补充药物。这项关于伊斯科达联合含卡铂方案治疗化疗初治晚期非小细胞肺癌(NSCLC)的随机 II 期研究,旨在评估其对化疗相关副作用和生活质量的影响。

方法

晚期 NSCLC 患者被随机分为单纯化疗组或化疗加伊斯科达组,伊斯科达每周三次,直至肿瘤进展。化疗方案为卡铂联合吉西他滨或培美曲塞,每 21 天为一个周期。

结果

72 例患者(对照组 39 例,伊斯科达组 33 例)入组本研究。大多数患者(65%)处于 IV 期,62%为鳞状组织学类型。两组的中位总生存期均为 11 个月。对照组中位无进展生存期为 4.8 个月,伊斯科达组为 6 个月(p=NS)。3-4 级血液学毒性差异无统计学意义,但对照组更多患者需要减少化疗剂量(44%比 13%,p=0.005)、出现 3-4 级非血液学毒性(41%比 16%,p=0.043)和住院治疗(54%比 24%,p=0.016)。

结论

伊斯科达对生活质量或总不良事件没有影响。然而,伊斯科达治疗组的化疗剂量减少、严重的非血液学副作用和住院治疗的频率较低,这表明伊斯科达可能是一种化疗相关毒性的调节剂,值得进一步研究。

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