Hospital Universitário Clementino Fraga Filho, Rio de Janeiro, Brazil.
Clin Infect Dis. 2010 Dec 1;51(11):1273-80. doi: 10.1086/657065. Epub 2010 Oct 29.
The European Organization for Research and Treatment of Cancer (EORTC) and the Mycosis Study Group (MSG) definition of invasive aspergillosis used in clinical trials lacks sensitivity. We hypothesize that giving lower weight to the prespecified radiologic findings in patients with a positive serum galactomannan index test result will improve the definition's diagnostic sensitivity.
The medical records of 121 patients with 125 cases of invasive aspergillosis treated at a referral cancer institute from January 2003 through December 2009 were reviewed. Aspergillosis was diagnosed as EORTC-MSG proven or probable (controls, 83) or probable invasive aspergillosis without prespecified radiologic criteria (cases, 42). The latter differed from the former by the inclusion of patients whose pulmonary infiltrates, although well described in invasive aspergillosis, do not fulfill EORTC-MSG invasive aspergillosis requirements. The host, clinical, and mycologic characteristics and survival of cases and controls served as end points.
A total of 114 (91%) of 125 patients had multiple myeloma. Patients had a median age was 65 years (range, 26-81 years), and 74 were male. All had received antineoplastic therapy, including stem cell transplantation (58 [46%]). Aspergillosis involved lungs (88 patients), sinuses (9 patients), or both (28 patients). Except for higher median baseline platelet count and shorter duration of neutropenia among cases, there were no statistically significant differences between groups on all predefined end points, including 4-, 6-, and 12-week survival. Eleven of 26 cases were reclassified as controls on the basis of subsequent imaging.
Except for less well-circumscribed consolidations, the host, clinical, radiologic, and mycologic characteristics and outcome of patients with probable invasive aspergillosis but without prespecified radiologic criteria are similar to those with EORTC-MSG invasive aspergillosis. Enrolling such patients in clinical trials of novel therapies will increase the pool of eligible study participants and improve trial speed and efficiency.
欧洲癌症研究与治疗组织（EORTC）和霉菌病研究组（MSG）在临床试验中用于侵袭性曲霉菌病的定义缺乏敏感性。我们假设，在血清半乳甘露聚糖指数检测结果阳性的患者中，降低预先指定的影像学发现的权重，将提高该定义的诊断敏感性。
回顾了 2003 年 1 月至 2009 年 12 月在一家转诊癌症研究所治疗的 121 例侵袭性曲霉菌病患者的 125 例病例。曲霉菌病的诊断为 EORTC-MSG 确诊或可能（对照组，83 例）或无预先指定影像学标准的可能侵袭性曲霉菌病（病例组，42 例）。后者与前者的区别在于，纳入了肺部浸润虽符合侵袭性曲霉菌病的描述，但不符合 EORTC-MSG 侵袭性曲霉菌病要求的患者。病例组和对照组的宿主、临床和真菌学特征以及生存率是研究终点。
125 例患者中共有 114 例（91%）患有多发性骨髓瘤。患者的中位年龄为 65 岁（范围，26-81 岁），74 例为男性。所有患者均接受了抗肿瘤治疗，包括干细胞移植（58 例[46%]）。曲霉菌病累及肺部（88 例）、鼻窦（9 例）或两者均累及（28 例）。除病例组的中位基线血小板计数较高和中性粒细胞减少持续时间较短外，两组在所有预先定义的终点上，包括 4、6 和 12 周生存率，均无统计学差异。根据随后的影像学检查，26 例中的 11 例被重新分类为对照组。
除了边界不太清晰的实变外，无预先指定影像学标准的可能侵袭性曲霉菌病患者的宿主、临床、影像学和真菌学特征及结局与 EORTC-MSG 侵袭性曲霉菌病患者相似。将此类患者纳入新型疗法的临床试验将增加合格研究参与者的数量，并提高试验速度和效率。
