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未接受过治疗的犬原发性组织细胞肉瘤中单药洛莫司汀的 II 期、开放标签试验。

Phase II, open-label trial of single-agent CCNU in dogs with previously untreated histiocytic sarcoma.

机构信息

Department of Clinical Sciences, College of Veterinary Medicine, Cornell University, Ithaca, NY 14853, USA.

出版信息

J Vet Intern Med. 2010 Nov-Dec;24(6):1528-31. doi: 10.1111/j.1939-1676.2010.0588.x.

DOI:10.1111/j.1939-1676.2010.0588.x
PMID:21155191
Abstract

BACKGROUND

Histiocytic sarcoma (HS) is an aggressive neoplasm in dogs, and in most instances, the disease is localized, but not amenable to surgical removal, or is disseminated. Affected patients usually die within 6 months. There have been no prospective studies to determine efficacy of single-agent chemotherapy in dogs with HS.

HYPOTHESIS

Single-agent CCNU [1-(2-chloroethyl)3-cyclohexyl-1-nitrosourea; lomustine] has antitumor activity against HS in dogs.

ANIMALS

Twenty-one dogs with histologically confirmed, nonresectable localized or disseminated HS.

METHODS

Prospective, open-label phase II clinical trial in which dogs with previously untreated HS were uniformly treated with CCNU as a single oral dosage of 90 mg/m2 every 4 weeks. The primary outcome measure was reduction in tumor size.

RESULTS

Fourteen dogs with disseminated HS and 7 with localized HS were enrolled between 1999 and 2008. Overall response rate was 29% (95% confidence interval [CI], 14–50%) for a median of 96 days (95% CI, 55–137 days). Three dogs (1 disseminated, 2 localized) had complete responses lasting for 54–269 days and 3 dogs (2 disseminated, 1 localized) had partial responses lasting for 78–112 days.

CONCLUSIONS AND CLINICAL IMPORTANCE

CCNU, when used as a single agent, has activity against HS in dogs. Evaluation of CCNU postoperatively for dogs with resectable localized HS and as part of combination therapy for tumors that are nonresectable or disseminated should be considered.

摘要

背景

组织细胞肉瘤(HS)是一种侵袭性犬肿瘤,大多数情况下,该疾病局限但无法通过手术切除,或已发生扩散。受影响的犬通常在 6 个月内死亡。目前还没有前瞻性研究来确定单药化疗对 HS 犬的疗效。

假设

单药洛莫司汀(CCNU)[1-(2-氯乙基)-3-环己基-1-亚硝脲]对犬 HS 具有抗肿瘤活性。

动物

21 只经组织学证实的、无法手术切除的局限性或播散性 HS 犬。

方法

对未经治疗的 HS 犬进行前瞻性、开放标签的 II 期临床试验,犬接受洛莫司汀单药治疗,口服剂量为 90mg/m2,每 4 周 1 次。主要疗效评估指标为肿瘤大小的缩小。

结果

1999 年至 2008 年期间共纳入 14 只播散性 HS 犬和 7 只局限性 HS 犬。总体缓解率为 29%(95%置信区间 [CI]:14%50%),中位缓解持续时间为 96 天(95%CI:55137 天)。3 只犬(1 只播散性、2 只局限性)完全缓解,持续时间为 54269 天,3 只犬(2 只播散性、1 只局限性)部分缓解,持续时间为 78112 天。

结论和临床意义

洛莫司汀单药治疗犬 HS 有效。对于可切除的局限性 HS 犬,应考虑在手术后使用洛莫司汀,对于不可切除或播散性肿瘤,也应考虑将其作为联合治疗的一部分。

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