Department of Preventive Medicine and Myeloma Institute forResearch and Therapy, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Clin Infect Dis. 2011 Oct;53(7):671-6. doi: 10.1093/cid/cir441. Epub 2011 Aug 16.
Current criteria for assessing treatment response of invasive aspergillosis (IA) rely on nonspecific subjective parameters. We hypothesized that an Aspergillus-specific response definition based on the kinetics of serum Aspergillus galactomannan index (GMI) would provide earlier and more objective response assessment.
We compared the 6-week European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) response criteria with GMI-based response among 115 cancer patients with IA. Success according to GMI required survival with repeatedly negative GMI for ≥2 weeks. Time to response and agreement between the 2 definitions were the study endpoints.
Success according to EORTC/MSG and GMI criteria was observed in 73 patients (63%) and 83 patients (72%), respectively. The GMI-based response was determined at a median of 21 days after treatment initiation (range, 15-41 days), 3 weeks before the EORTC/MSG time point, in 72 (87%) of 83 responders. Agreement between definitions was shown in all 32 nonresponders and in 73 of the 83 responders (91% overall), with an excellent κ correlation coefficient of 0.819. Among 10 patients with discordant response (EORTC/MSG failure, GMI success), 1 is alive without IA 3 years after diagnosis; for the other, aspergillosis could not be detected at autopsy. The presence of other life-threatening complications in the remaining 8 patients indicates that IA had resolved.
The Aspergillus-specific GMI-based criteria compare favorably to current response definitions for IA and significantly shorten time to response assessment. These criteria rely on a simple, reproducible, objective, and Aspergillus-specific test and should serve as the primary endpoint in trials of IA.
目前评估侵袭性曲霉病（IA）治疗反应的标准依赖于非特异性的主观参数。我们假设基于血清曲霉半乳甘露聚糖指数（GMI）动力学的曲霉特异性反应定义将提供更早和更客观的反应评估。
我们比较了 115 例 IA 癌症患者的 6 周欧洲癌症研究与治疗组织/霉菌病研究组（EORTC/MSG）反应标准与基于 GMI 的反应。根据 GMI 的成功需要生存并重复检测到 GMI 连续阴性 ≥2 周。反应时间和两种定义之间的一致性是本研究的终点。
根据 EORTC/MSG 和 GMI 标准，73 例（63%）和 83 例（72%）患者成功。基于 GMI 的反应在治疗开始后中位数 21 天（范围，15-41 天）确定，早于 EORTC/MSG 时间点 3 周，在 83 例反应者中的 72 例（87%）中确定。在所有 32 例非反应者和 83 例反应者中的 73 例（总体 91%）中显示了定义之间的一致性，κ 相关系数为 0.819。在 10 例反应不一致的患者中（EORTC/MSG 失败，GMI 成功），1 例在诊断后 3 年无 IA 存活；对另一个患者，尸检未检测到曲霉病。其余 8 例患者存在其他危及生命的并发症，表明 IA 已得到解决。
基于曲霉特异性 GMI 的标准与当前的 IA 反应标准相比具有优势，并显著缩短了反应评估的时间。这些标准依赖于简单、可重复、客观和曲霉特异性的测试，应作为 IA 试验的主要终点。
