Betts Robert, Glasmacher Axel, Maertens Johan, Maschmeyer Georg, Vazquez Jose A, Teppler Hedy, Taylor Arlene, Lupinacci Robert, Sable Carole, Kartsonis Nicholas
Department of Infectious Diseases, University of Rochester, Rochester, New York, USA.
Cancer. 2006 Jan 15;106(2):466-73. doi: 10.1002/cncr.21615.
Neutropenia is an indicator of poor prognosis in patients with fungal infections. All available clinical trial experience from the caspofungin development program was reviewed to ascertain the efficacy of caspofungin in neutropenic patients with documented invasive aspergillosis (IA) or invasive candidiasis (IC).
The review was limited to neutropenic patients with proven IC or proven/probable IA at caspofungin onset. Data were available from four clinical trials. All patients had an absolute neutrophil count < 500/mm(3) at the initiation of caspofungin. In all cases caspofungin was administered as monotherapy at a dose of 50 mg/day, after a 70-mg loading dose. In all patients efficacy was assessed at the completion of caspofungin therapy. Success included complete and partial responses.
Sixty-eight neutropenic patients were identified with documented invasive infection, including 27 with IC and 41 with IA. Most patients had acute or chronic leukemia. A favorable response was noted in 63% (17 of 27 patients) of patients with IC, including a 58% (14 of 24 patients) response as first-line therapy and a 100% (3 of 3 patients) response as salvage therapy. Success in candidemia was 68% (17 of 25 patients). Outcomes across the different Candida species were similar. Favorable responses were noted in 39% (16 of 41 patients) of patients with IA, including a 42% (5 of 12 patients) response as first-line therapy and 38% (11 of 29 patients) response as salvage therapy. Success by site of IA was 40% for pulmonary (12 of 30 patients), 43% for sinus (3 of 7 patients), and 25% for skin/disseminated site (1 of 4 patients).
A review of the caspofungin database demonstrates that this echinocandin is effective in neutropenic patients with documented cases of IC or IA.
中性粒细胞减少是真菌感染患者预后不良的一个指标。对卡泊芬净研发项目中所有可得的临床试验经验进行了回顾,以确定卡泊芬净对有记录的侵袭性曲霉病(IA)或侵袭性念珠菌病(IC)的中性粒细胞减少患者的疗效。
该回顾仅限于卡泊芬净开始使用时确诊为IC或确诊/疑似IA的中性粒细胞减少患者。数据来自四项临床试验。所有患者在开始使用卡泊芬净时绝对中性粒细胞计数<500/mm³。在所有病例中,卡泊芬净在给予70mg负荷剂量后,以50mg/天的剂量作为单一疗法给药。在所有患者中,在卡泊芬净治疗结束时评估疗效。成功包括完全缓解和部分缓解。
确定了68例有记录的侵袭性感染的中性粒细胞减少患者,包括27例IC患者和41例IA患者。大多数患者患有急性或慢性白血病。IC患者中有63%(27例患者中的17例)出现了良好反应,包括一线治疗的58%(24例患者中的14例)反应和挽救治疗的100%(3例患者中的3例)反应。念珠菌血症的成功率为68%(25例患者中的17例)。不同念珠菌属的结果相似。IA患者中有39%(41例患者中的16例)出现了良好反应,包括一线治疗的42%(12例患者中的5例)反应和挽救治疗的38%(29例患者中的11例)反应。IA按部位的成功率为:肺部40%(30例患者中的12例),鼻窦43%(7例患者中的3例),皮肤/播散部位25%(4例患者中的1例)。
对卡泊芬净数据库的回顾表明,这种棘白菌素对有记录的IC或IA病例的中性粒细胞减少患者有效。