External beam irradiation and the combination of cisplatin and carmustine followed by carmustine alone for the treatment of high-grade glioma - A phase 2 Southwest Oncology Group trial
External beam irradiation and the combination of cisplatin and carmustine followed by carmustine alone for the treatment of high-grade glioma - A phase 2 Southwest Oncology Group trial
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DOI：
10.1002/cncr.23585
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发表时间：
2008-08-01
期刊：
影响因子：
6.2
通讯作者：
Petersdorf, Stephen H.
中科院分区：
文献类型：
--
作者：
Blumenthal, Deborah T.;Rankin, Cathryn;Petersdorf, Stephen H.
背景。据报道，高级别胶质瘤患者的预后不良表明需要开发多模式治疗方法。添加化疗对提高生存率有不同的贡献。当前研究（西南肿瘤学组 [SWOG] 9016）的目的是确定是否可以在合作组环境中安全地给予卡莫司汀和顺铂组合的同步放疗和化疗。其他目标包括估计缓解率、疾病稳定率和 1 年生存概率。方法。 SWOG 9016 研究纳入了 59 名符合条件的 III 级或 IV 级星形细胞瘤患者，他们在卡莫司汀/顺铂化疗的同时接受了放疗。患者需要患有可测量或可评估的疾病。治疗终点包括完全缓解（CR）、部分缓解（PR）或疾病进展（PD）。 结果。 6 名患者获得 CR（CR 率为 10%；95% 置信区间 [95% CI]，4-21%），4 名患者获得 PR（PR 率为 7%；95% CI，2-16%），2 名患者 (3%) 出现未经证实的缓解。 24 名患者（41%；95% CI，28-54%）疾病稳定，10 名患者（17%）表现出 PD。总体疾病稳定率（CR + PR + 疾病稳定，排除未经证实的缓解）为 58%（95% CI，44-70%）。结论。尽管存在一组长期幸存者，但当前研究的结果似乎并不支持额外的研究或常规使用顺铂和卡莫司汀。
BACKGROUND. The poor prognosis reported for patients with high-grade glial neoplasms indicates a need for the development of multimodality therapeutic approaches. The addition of chemotherapy has contributed variably to increased survival. The objective of the current study (Southwest Oncology Group [SWOG] 9016) was to determine whether concurrent radiotherapy and chemotherapy with the combination of carmustine and cisplatin could be given safely in a cooperative group setting. Additional objectives included the estimation of response rate, the rate of disease stabilization, and the probability of 1-year survival.METHODS. SWOG 9016 study included 59 eligible patients with grade III or IV astrocytoma who received radiotherapy concurrently with carmustine/cisplatin chemotherapy. Patients were required to have either measurable or evaluable disease. The therapeutic endpoints were comprised of complete response (CR), partial response (PR), or progressive disease (PD).RESULTS. Six patients achieved a CR (CR rate of 10%; 95% confidence interval [95% CI], 4-21%), 4 achieved a PR (PR rate of 7%; 95% CI, 2-16%), and 2 patients (3%) experienced an unconfirmed response. Twenty-four patients (41%; 95% CI, 28-54%) had stable disease and 10 patients (17%) demonstrated PD. The overall disease stabilization rate (CR + PR + stable disease, excluding unconfirmed response) was 58% (95% CI, 44-70%).CONCLUSIONS. Despite the presence of a cohort of long-term survivors, the results of the current study do not appear to support the additional study or routine use of concurrent cisplatin and carmustine.