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低剂量甲氨蝶呤治疗晚期骨肉瘤的II期研究及疾病进展后的剂量递增:欧洲癌症研究与治疗组织软组织和骨肉瘤小组的一项研究

Phase II study of low-dose methotrexate in advanced osteosarcoma followed by escalation after disease progression: a study of the Soft Tissue and Bone Sarcoma Group of the European Organization for Research on Treatment of Cancer.

作者信息

Wagener D J, van Oosterom A T, Mulder J H, Somers R, Mouridsen H T, Cortes Funes H, Thomas D, Sylvester R

出版信息

Cancer Treat Rep. 1986 May;70(5):615-8.

PMID:3458532
Abstract

Twenty-seven patients with osteosarcoma and measurable metastases were treated with low-dose methotrexate (LDMTX) (80 mg/m2), followed by high-dose methotrexate (HDMTX) (7.5 g/m2) after disease progression in 14 patients. LDMTX was administered on Days 1, 8, and 15; if response or stable disease occurred, it was repeated on Days 29 and 43. If response occurred by Day 57, LDMTX was continued every 2 weeks until disease progression. If stable disease occurred by Day 57, the patient crossed over (optional) to HDMTX. HDMTX was given weekly during the first 3 weeks and continued once every 14 days until disease progression. Twenty-five of the patients were evaluable for response. Three patients (12%) achieved complete remission, with durations of 5, 14, and 34 weeks, respectively. The time to disease progression from the start of treatment was 19, 28, and 42 weeks. Twelve patients (48%) had stable disease, with a median duration of 7.5 weeks (range, 6-20). Ten patients (40%) had disease progression. In general, toxicity with LDMTX was mild. The most frequent toxic effect was stomatitis. Twelve of 14 patients who crossed over to HDMTX were evaluated for response. Six patients had stable disease and six had disease progression. We conclude that the results achieved with LDMTX seem inferior to the results achieved with HDMTX described in the literature.

摘要

27例患有骨肉瘤且有可测量转移灶的患者接受了低剂量甲氨蝶呤(LDMTX)(80mg/m²)治疗,14例患者疾病进展后接受了高剂量甲氨蝶呤(HDMTX)(7.5g/m²)治疗。LDMTX于第1、8和15天给药;如果出现缓解或疾病稳定,则在第29和43天重复给药。如果在第57天出现缓解,则每2周继续给予LDMTX直至疾病进展。如果在第57天出现疾病稳定,患者可选择交叉接受HDMTX治疗。HDMTX在前3周每周给药一次,并每14天继续给药一次直至疾病进展。25例患者可评估疗效。3例患者(12%)实现完全缓解,缓解持续时间分别为5周、14周和34周。从治疗开始到疾病进展的时间分别为19周、28周和42周。12例患者(48%)疾病稳定,中位持续时间为7.5周(范围6 - 20周)。10例患者(40%)疾病进展。总体而言,LDMTX的毒性较轻。最常见的毒性反应是口腔炎。14例交叉接受HDMTX治疗的患者中有12例接受了疗效评估。6例患者疾病稳定,6例患者疾病进展。我们得出结论,LDMTX所取得的结果似乎不如文献中描述的HDMTX所取得的结果。

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