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首页> 美国卫生研究院文献>Neuro-Oncology >OS11.1 Temozolomide (TMZ) 1 week on/1 week off as initial treatment for high risk low grade oligodendroglial tumors: a phase II AINO (Italian Association for Neuro-Oncology) study
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OS11.1 Temozolomide (TMZ) 1 week on/1 week off as initial treatment for high risk low grade oligodendroglial tumors: a phase II AINO (Italian Association for Neuro-Oncology) study

机译：OS11.1替莫唑胺（TMZ）1周/ 1周休假作为高风险低度轻度少突胶质细胞瘤的初始治疗：II期AINO（意大利神经肿瘤协会）研究

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>Introduction: The efficacy of dose-dense temozolomide (TMZ, 1 week on/1 week off) in grade II gliomas is not well known, and the impact could depend on the molecular subtype. In this regard prospective data are still missing. PATIENTS AND METHODS: Between 2006 and 2010 a single arm phase II study on 60 evaluable patients with grade II oligodendroglial tumors (WHO 2007) was performed. Inclusion criteria were as follows: 1) age ≥ 18 years; 2) KPS ≥ 70; 3) biopsy-proven grade II oligodendroglioma or oligoastrocytoma according to WHO 2007; 4) presence of a measurable residual tumor after surgery. The primary endpoint of the study was tumor response on MRI according to RANO criteria, while the secondary endpoints were progression-free survival (PFS), overall survival (OS), and seizure control according to Engel classification. Most patients (65%) had an active epilepsy at the time of start of chemotherapy. Molecular factors were available in 49/60 patients (81.7%): 21/60 (35%) patients were IDH1-2 mutated/1p19q codeleted, 4/60 (6.7%) were IDH1-2 mutated/1p19q non-codeleted and 24/60 (40%) were IDH1-2 wild-type. The median number of cycles of dose-dense TMZ was 11 (range 2–18). Median follow up was 64 months (range 7–112). RESULTS: Overall, response rate following dose-dense TMZ was as follows: PR in 21/60 (35%) patients, minor PR (mPR) in 14/60 (23%), SD in 21/60 (35%) and PD in 4/60 (7%). Most patients achieved the best tumor response within 6 months after the start of TMZ. Among patients with mPR and PR, 15/49 (30.6%) were IDH1-2 mutated/1p19q codeleted and 11/49 (22.4%) were IDH1-2 wild-type. PFS was 71.4% at 36 months and 28.6% at 60 months with a median value of 46 months in the IDH1-2 mutated/1p19q codeleted subgroup, while PFS was 45.8% at 36 months and 25% at 60 months with a median value of 34 months in the IDH1-2 wild-type subgroup. OS was 90.5% at 36 months and 66.7% at 60 months with a median value of 76 months in the IDH1-2 mutated/1p19q codeleted subgroup, while OS was 66.7% at 36 months and 50% at 60 months with a median value of 60 months in the IDH1-2 wild-type subgroup. The number of patients with IDH1-2 mutated but not 1p/19q codeleted tumors was too small to allow meaningful correlations with response and survival. Seizure improvement was achieved in 29/34 patients (85%) following TMZ: 17/33 (52%) patients at 12 months and 18/29 (62.1%) at 24 months were seizure-free (Engel class I). The time of maximal seizure response was earlier than that observed on MRI (3 months vs 6 months). CONCLUSIONS: Dose-dense TMZ has shown a significant activity in terms of tumor and seizure control, especially in IDH1-2 mutated/1p19q codeleted patients. Seizure reduction could represent an early indicator of response to chemotherapy and maybe predict the duration of response.
机译：>简介：剂量密集的替莫唑胺（TMZ，1周开/ 1周停）在II级神经胶质瘤中的疗效尚不清楚，其影响可能取决于分子亚型。在这方面，仍然缺少预期数据。患者与方法：2006年至2010年间，对60例可评估的II级少突胶质细胞瘤患者进行了单臂II期研究（WHO 2007）。纳入标准如下：1）年龄≥18岁； 2）KPS≥70; 3）根据WHO的规定，经活检证明为II级少突胶质细胞瘤或少星形胶质细胞瘤; 4）手术后存在可测量的残留肿瘤。这项研究的主要终点是根据RANO标准进行的MRI肿瘤反应，次要终点是根据Engel分类的无进展生存期（PFS），总生存期（OS）和癫痫发作控制。开始化疗时，大多数患者（65％）患有活动性癫痫病。分子因素可用于49/60患者（81.7％）：21/60（35％）患者是IDH1-2突变/ 1p19q编码的，4/60（6.7％）患者是IDH1-2突变/ 1p19q非编码的和24 / 60（40％）为IDH1-2野生型。剂量密集型TMZ的中位循环数为11（范围2–18）。中位随访时间为64个月（范围7-112）。结果：总体上，剂量密集型TMZ的缓解率如下：21/60（35％）患者的PR，14/60（23％）的轻微PR（mPR），21/60（35％）的SD和PD为4/60（7％）。大多数患者在TMZ开始后的6个月内达到了最佳的肿瘤反应。在患有mPR和PR的患者中，IDH1-2突变的/ 1p19q编码为15/49（30.6％），IDH1-2野生型的编码为11/49（22.4％）。在IDH1-2突变的/ 1p19q小码分组中，PFS在36个月时为71.4％，在60个月时为28.6％，中值为46个月，而在36个月时PFS为45.8％，在60个月时为25％，中值为IDH1-2野生型亚组中的34个月。 IDH1-2突变/ 1p19q编码亚组的OS在36个月时为90.5％，在60个月时为66.7％，中值为76个月，而在36个月时OS为66.7％，在60个月时OS为60％，中值为IDH1-2野生型亚组中的60个月。 IDH1-2突变但不是1p / 19q编码肿瘤的患者人数太少，无法与反应和生存率进行有意义的关联。 TMZ术后29/34例患者（85％）癫痫发作有所改善：12个月时17/33（52％）患者和24个月时18/29（62.1％）患者无癫痫发作（Engel I级）。最大癫痫发作反应时间早于MRI观察的时间（3个月对6个月）。结论：剂量密集型TMZ在肿瘤和癫痫发作控制方面表现出显着的活性，尤其是在IDH1-2突变的/ 1p19q编码患者中。癫痫发作的减少可能代表对化学疗法有反应的早期指标，并可能预测反应的持续时间。

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