Phase II Study of Weekly Vinblastine in Recurrent or Refractory Pediatric Low-Grade Glioma
Phase II Study of Weekly Vinblastine in Recurrent or Refractory Pediatric Low-Grade Glioma
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DOI：
10.1200/jco.2011.34.5843
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发表时间：
2012-04-20
影响因子：
45.3
通讯作者：
Baruchel, Sylvain
中科院分区：
文献类型：
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作者：
Bouffet, Eric;Jakacki, Regina;Baruchel, Sylvain
目的评价长春碱单药治疗小儿复发性或难治性低级别胶质瘤的疗效。患者和方法如果患者之前经历过未完全切除或不可切除的低级别胶质瘤（LGG）的治疗失败（化疗和/或放疗），则符合条件。长春碱（6mg /m(2)）每周给药1年，除非出现不可接受的毒性或进展（连续两次影像学检查证实）。51例患者（年龄范围1.4 - 18.2岁，中位年龄7.2岁）被前瞻性纳入这项II期研究。50名患者之前至少接受过一次化疗方案，10名患者之前接受过放射治疗。50例患者可评估反应；18名患者（36%）有完全、部分或轻微缓解，31名患者完成了1年的治疗。在中位67个月的随访中，23名患者没有出现进展；已有3名患者死亡。5年总生存率为93.2% +/- 3.8%，5年无进展生存率为42.3% +/- 7.2%。毒性是可控的，主要是血液学上的，尽管少数患者需要输血。结论对于一线化疗失败的LGG患儿，每周长春花碱治疗可能是替代放疗的合理选择。在这项II期试验中观察到的5年无进展生存期与首次化疗患者的一线化疗观察到的结果相当。长春花碱和其他长春花生物碱单药在小儿lgg治疗中的作用值得进一步研究。
PurposeTo evaluate the efficacy of single-agent vinblastine in pediatric patients with recurrent or refractory low-grade glioma.Patients and MethodsPatients 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.ResultsFifty-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.ConclusionWeekly 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.