Randomised phase II trial of pegylated liposomal doxorubicin (DOXIL®/CAELYX®) versus doxorubicin in the treatment of advanced or metastatic soft tissue sarcoma:: a study by the EORTC Soft Tissue and Bone Sarcoma Group
Randomised phase II trial of pegylated liposomal doxorubicin (DOXIL®/CAELYX®) versus doxorubicin in the treatment of advanced or metastatic soft tissue sarcoma:: a study by the EORTC Soft Tissue and Bone Sarcoma Group
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DOI：
10.1016/s0959-8049(01)00050-8
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发表时间：
2001-05-01
影响因子：
8.4
通讯作者：
Nielsen, S
中科院分区：
文献类型：
--
作者：
Judson, I;Radford, JA;Nielsen, S
楷莱（CAELYX®）/多柔比星脂质体（DOXIL®），即聚乙二醇化脂质体多柔比星，在其他肿瘤类型中与标准多柔比星相比已显示出抗肿瘤活性且毒性降低。在这项前瞻性随机试验中，对94例符合条件的晚期软组织肉瘤（STS）患者进行了治疗，50例使用楷莱（50mg/m²，每4周静脉输注1小时），44例使用多柔比星（75mg/m²，每3周静脉推注）。组织学亚型匹配良好，33%为平滑肌肉瘤（楷莱组：16例；多柔比星组：13例）。原发疾病部位匹配良好。楷莱的骨髓抑制作用明显更轻，只有3例（6%）患者出现3级和4级中性粒细胞减少，而多柔比星组有33例（77%）；多柔比星组有7例（16%）患者出现发热性中性粒细胞减少，而楷莱组只有1例（2%）。多柔比星组有37例（86%）患者出现2 - 3级脱发，而楷莱组只有3例（6%），楷莱的主要毒性作用于皮肤。楷莱引起的手足红斑感觉迟钝为1级：4例（8%）患者，2级：11例（22%）患者，3级：9例（18%）患者，4级：1例（2%）患者。其他3级和4级非血液学毒性罕见。两种药物均观察到确诊的疗效反应：楷莱：完全缓解（CR）1例（子宫），部分缓解（PR）4例（缓解率（RR）10%）；多柔比星：CR 1例，PR 3例（RR为9%）；病情稳定（NC）分别为16例和18例患者，为最佳反应。缓解率低的原因不明，但可能部分由于胃肠道间质瘤比例较高。总之，楷莱在软组织肉瘤中的活性与多柔比星相当，但毒性特征有所改善，应考虑与其他药物（如异环磷酰胺）联合进一步研究。（C）2001爱思唯尔科学有限公司。保留所有权利。
CAELYX (R) /DOXIL (R), pegylated liposomal doxorubicin, has shown antitumour activity and reduced toxicity compared with standard doxorubicin in other tumour types, in this prospective randomised trial, 94 eligible patients with advanced soft-tissue sarcoma (STS) were treated, 50 with CAELYX (R) (50 mg/m(2) by a 1 h intravenous (i.v.) infusion every 4 weeks) and 44 with doxorubicin (75 mg/m(2) by an i.v. bolus every 3 weeks). Histological subtypes were evenly matched, 33% were leiomyosarcoma (CAELYX (R): is. doxorubicin: 13). Primary disease sites were well matched. CAELYX (R) was significantly less myelosuppressive, only 3 (6%) patients had grade 3 and 4 neutropenia, versus 33 (77%) on doxorubicin; febrile neutropenia occurred in 7 (16%) patients given doxorubicin, but only 1 (2%) given CAELYX (R). 37 (86%) patients on doxorubicin had grade 2-3 alopecia, but only. 3 (6%) on CAELYX (R), and the major toxicity with CAELYX (R) was to the skin. Palmar-plantar erythrodysesthesia with CAELYX (R) was grade I. 4 (8%) patients, grade 2: 11 (22%) patients, grade 3: 9 (18%) patients and grade 4: 1 (2%) patient. Other non-haematological grade 3 and 4 toxicities were rare. Confirmed responses were observed with both agents: CAELYX (R): complete response (CR) 1 (uterine), partial response (PR) 4 (response rate (RR) 10%): and doxorubicin: CR 1, PR 3 (RR of 9%): with the best response being stable disease (NC) in 16 and 18 patients, respectively. The reason for the low response rate is unknown. but it may be due partly to a high proportion of gastrointestinal stromal rumours. In conclusion. CAELYX (R) has equivalent activity to doxorubicin in STS with an improved toxicity profile and should be considered for further investigation in combination with other agents such as ifosfamide. (C) 2001 Elsevier Science Ltd. All rights reserved.