Phase II trial of intralesional therapy with interleukin-2 in soft-tissue melanoma metastases
Phase II trial of intralesional therapy with interleukin-2 in soft-tissue melanoma metastases
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DOI：
10.1038/sj.bjc.6601320
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发表时间：
2003-11-03
影响因子：
8.8
通讯作者：
Garbe, C
中科院分区：
文献类型：
--
作者：
Radny, P;Caroli, UM;Garbe, C
本研究的目的是验证皮肤和软组织黑色素瘤转移患者病灶内注射白细胞介素-2（IL-2）的使用。共纳入24例AJCC III期或IV期黑色素瘤和单个或多个皮肤和软组织转移的患者。在1-57周内，将白细胞介素-2注射剂病灶内施用到皮肤和软组织转移瘤的总数中，每周2-3次。单次剂量范围为0.6至6x 10（6）IU，取决于病变大小。通过超声检查监测临床反应，并通过组织病理学证实;反应评价仅限于病灶内治疗的肿瘤。15例患者（62.5%）的治疗转移瘤达到完全缓解（CR），迄今为止最长缓解持续38个月。在5例患者中，实现了部分缓解（PR）（21%），在另外3例患者中，观察到疾病进展（1例患者无法评估）。共有245个转移灶接受了治疗，其中209个（85%）为CR，21个（6%）为PR。该治疗通常耐受良好;观察到的不良事件主要为1-2级严重程度。免疫组化研究表明，肿瘤细胞发生凋亡，并揭示了混合字符的炎性浸润。转移性黑色素瘤的不寻常的高CR率为62.5%和有限的毒性表明，皮肤和软组织黑色素瘤转移病灶内注射IL-2治疗可能是一个安全和有效的替代传统疗法。这种治疗的最佳剂量和持续时间仍有待于在更大的前瞻性多中心试验中确定。
The objective of the present study was to validate the use of intralesional injection of interleukin-2 (IL-2) in patients with skin and soft-tissue melanoma metastases. A total of 24 patients with AJCC stage III or IV melanoma and single or multiple skin and soft-tissue metastases were included. Interleukin-2 injections were administered intralesionally into the total number of cutaneous and soft-tissue metastases accessible from the skin, 2-3 times weekly, over 1-57 weeks. Single doses varied from 0.6 to 6x10(6) IU, depending on lesion size. The clinical response was monitored by sonography and confirmed by histopathology; response evaluation was confined to the intralesionally treated tumours. Complete response (CR) of the treated metastases was achieved in 15 patients (62.5%), the longest remission lasting 38 months to date. In five patients, partial response (PR) was achieved (21%) and in another three patients, progressive disease was observed (one patient not assessable). A total of 245 metastases were treated with CR in 209 (85%), and PR in 21 (6%). The therapy was generally well tolerated; the observed adverse events were mainly of grade 1-2 severity. Immunohistochemical studies showed the tumour cells undergoing apoptosis and revealed a mixed character of the inflammatory infiltrate. The unusual high CR rate in metastatic melanoma of 62.5% and the limited toxicity suggest that treatment of skin and soft-tissue melanoma metastases with intralesional injection of IL-2 may be a safe and effective alternative to conventional therapies. The optimal dosage and duration of this therapy still remain to be defined in larger prospective multicentre trials.