Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome
Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome
复制标题
DOI：
10.1182/blood-2002-09-2802
复制
发表时间：
2003-06-01
期刊：
影响因子：
20.3
通讯作者：
Österborg, A
中科院分区：
文献类型：
--
作者：
Lundin, J;Hagberg, H;Österborg, A
这项II期研究评价了Alemtuzumab在22例晚期蕈样肉芽肿/Sezary综合征（MF/SS）患者中的安全性和疗效。大多数患者患有III期或IV期疾病，体能状态下降，严重瘙痒。总有效率（OR）为55%，其中32%的患者完全缓解（CR），M部分缓解（PR）。7例患者中有6例（86%）从血液中清除了Sezary细胞，11例患者中有6例（55%）观察到淋巴结CR。对红皮病的疗效（OR，69%）优于斑块或皮肤肿瘤（OR，40%），在接受过1 - 2种既往治疗方案的患者中（OR，80%），在接受过3种或3种以上既往治疗方案的患者中（OR，33%）。瘙痒，自我评估0至10视觉模拟量表，从治疗前的中位数8减少到结束时的2。心理治疗至治疗失败的中位时间为12个月（范围：5-32+个月）。4例（18%）患者发生巨细胞病毒（CMV）再激活（引起发热，无肺炎，对更昔洛韦有反应）。另外6名患者有疑似或明显感染（不明原因发热，3例;全身性单纯疱疹，1例;致死性曲霉菌病，1例）。1例患者在10+个月时发生致死性分枝杆菌肺炎。所有严重感染性不良事件（CMV除外）均发生在接受过3种或以上既往治疗方案的患者中。在1例患者中观察到鳞状细胞皮肤癌进展。Alemtuzumab在晚期MF/SS患者中显示出有前景的临床活性和可接受的安全性特征，特别是在红皮病和重度瘙痒患者以及未经大量预治疗的患者中。(C)2003年，美国血液学会。
This phase 2 study evaluated the safety and efficacy of alemtuzumab in 22 patients with advanced mycosis fungoides/Sezary syndrome (MF/SS). Most patients had stage III or IV disease, reduced performance status, and severe itching. The overall response (OR) rate was 55%, with 32% of patients in complete remission (CR) and M in, partial remission (PR). Sezary cells were cleared from the blood in 6 of 7 (86%) patients, and CR in lymph nodes was observed in 6 of 11 (55%) patients. The effect was better on erythro-derma (OR, 69%) than on plaque or skin tumors (OR, 40%) and in patients who had received 1 to 2 previous regimens (OR, 80%) thin in those who had received 3 or more prior regimens (OR, 33%). Itching, self-assessed on a 0 to 10 visual analog scale, was reduced from a median of 8 before treatment to 2 at end. of therapy. Median time to treatment failure was 12 months (range, 5-32+ months). Cytomegalovirus (CMV), reactivation (causing fever without pneumonitis and responding to ganciclovir) occurred in 4 (18%) patients. Six additional patients had suspect or manifest infection (fever of unknown origin, 3; generalized herpes simplex, 1; fatal aspergillosis, 1). One patient had fatal Mycobacterium pneumonia at 10+ months. All serious infectious adverse events (except CMV) occurred in patients who had received 3 or more prior regimens. Progression of squamous cell skin carcinoma was noted in 1 patient. Alemtuzumab shows promising clinical activity and an acceptable safety profile in patients with advanced MF/SS, particularly in patients with erythroderma and severe itching and those who were not heavily pretreated. (C) 2003 by The American Society of Hematology.