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每周长春新碱治疗复发性或难治性小儿低级别胶质瘤的 II 期研究。

Phase II study of weekly vinblastine in recurrent or refractory pediatric low-grade glioma.

机构信息

Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.

出版信息

J Clin Oncol. 2012 Apr 20;30(12):1358-63. doi: 10.1200/JCO.2011.34.5843. Epub 2012 Mar 5.

DOI:10.1200/JCO.2011.34.5843
PMID:22393086
Abstract

PURPOSE

To evaluate the efficacy of single-agent vinblastine in pediatric patients with recurrent or refractory low-grade glioma.

PATIENTS AND METHODS

Patients were eligible if they had experienced previous treatment failure (chemotherapy and/or radiation) for incompletely resected or unresectable low-grade glioma (LGG). Vinblastine (6 mg/m(2)) was administered weekly for 1 year unless unacceptable toxicity or progression (confirmed on two consecutive imaging studies) occurred.

RESULTS

Fifty-one patients (age range, 1.4 to 18.2 years; median age, 7.2 years) were prospectively enrolled onto this phase II study. Fifty patients had previously received at least one prior regimen of chemotherapy, and 10 patients had previously received radiation treatment. Fifty patients were evaluable for response; 18 patients (36%) had a complete, partial, or minor response, and 31 patients completed 1 year of treatment. At a median follow-up of 67 months, 23 patients had not experienced progression; three patients have died. Five-year overall survival was 93.2% ± 3.8%, and 5-year progression-free survival was 42.3% ± 7.2%. Toxicity was manageable and mostly hematologic, although a few patients needed transfusions.

CONCLUSION

Weekly vinblastine seems to be a reasonable alternative to radiation for pediatric patients with LGG who have experienced treatment failure with first-line chemotherapy. The 5-year progression-free survival observed in this phase II trial is comparable to results observed with first-line chemotherapy in chemotherapy-naive patients. The role of single-agent vinblastine and other vinca alkaloid in the management of pediatric LGGs deserves further investigation.

摘要

目的

评估单药长春碱治疗复发性或难治性低级别胶质瘤患儿的疗效。

方法

患者为不完全切除或无法切除的低级别胶质瘤(LGG),经先前治疗(化疗和/或放疗)失败后有资格入组。长春碱(6mg/m²)每周给药 1 年,除非出现不可耐受的毒性或进展(连续两次影像学研究证实)。

结果

51 例患者(年龄 1.4-18.2 岁,中位年龄 7.2 岁)前瞻性入组该 II 期研究。50 例患者此前至少接受过 1 种化疗方案,10 例患者此前接受过放疗。50 例患者可评估疗效;18 例(36%)患者完全缓解、部分缓解或轻微缓解,31 例患者完成 1 年治疗。中位随访 67 个月时,23 例患者未发生进展,3 例患者死亡。5 年总生存率为 93.2%±3.8%,5 年无进展生存率为 42.3%±7.2%。毒性可耐受,主要为血液学毒性,少数患者需要输血。

结论

对于接受一线化疗治疗失败的 LGG 患儿,每周长春碱似乎是放疗的合理替代方案。本 II 期试验中观察到的 5 年无进展生存率与化疗初治患者接受一线化疗的结果相当。单药长春碱和其他长春花生物碱在儿科 LGG 治疗中的作用值得进一步研究。

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