Department of Palliative Care, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK.
Department of Clinical Oncology, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK.
Lung Cancer. 2017 Feb;104:75-78. doi: 10.1016/j.lungcan.2016.12.010. Epub 2016 Dec 21.
Clarithromycin may improve cachexia and survival in non-small cell lung cancer (NSCLC), but adequately controlled data are lacking. This study was undertaken primarily to inform the feasibility and scale of a phase III trial. Eligible consenting patients with stage IV NSCLC and cachexia were to be randomized to receive either clarithromycin 250mg twice daily or placebo for eight weeks. Aspects of trial feasibility recorded included numbers eligible, approached and recruited, together with adherence and completion of treatment and assessments. Over 6 months, none of 125 patients identified fulfilled the entry criteria. The commonest reasons for ineligibility were the use of an excluded concurrent drug (45, 36%), brain metastases (22, 18%), poor performance status (21, 17%) and current chemotherapy (15, 12%). A phase III trial of clarithromycin using these entry criteria is not feasible in this setting. Other macrolides that have a lower risk of a drug-drug interaction may be more practical to pursue.
克拉霉素可能改善非小细胞肺癌（NSCLC）恶病质和生存，但缺乏充分对照的数据。本研究主要是为了阐明 III 期临床试验的可行性和规模。符合条件的 IV 期 NSCLC 合并恶病质患者将被随机分为克拉霉素 250mg 每日 2 次或安慰剂组，治疗 8 周。记录的试验可行性方面包括符合条件、入组和招募的人数，以及治疗和评估的依从性和完成情况。6 个月内，125 名确定的患者中没有一人符合入选标准。最常见的排除标准是使用了排除的合并药物（45 例，36%）、脑转移（22 例，18%）、较差的功能状态（21 例，17%）和当前化疗（15 例，12%）。在这种情况下，使用这些纳入标准进行克拉霉素的 III 期试验是不可行的。其他具有较低药物相互作用风险的大环内酯类药物可能更适合研究。
