We thank Dr Gupta for his letter on our study “A Phase II Randomized, Multicenter, Open-Label Trial of Continuing Adjuvant Temozolomide Beyond 6 Cycles in Patients with Glioblastoma (GEINO 14-01).” The main issue addressed by our trial was whether patients will benefit from continuing adjuvant temozolomide further than the 6 standard cycles. Our patient randomization may seem unbalanced at first glance. However, neurologic symptoms included motor and language disorders, partial anopsias, memory deficits, and mild instability, all of which were grades 1–2 and stable. More patients had mild motor aphasia in the experimental than in the control arm (8 [10%] vs 4 [5.1%]), which could have affected Mini-Mental State Examination scores. Nevertheless, KPS (P = 0.68) and the need for dexamethasone (P = 0.67) were similar in the 2 arms, suggesting a correct randomization according to clinical factors.

中文翻译：

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回复：“新诊断的胶质母细胞瘤中的延长佐剂替莫唑胺：是多是少？”

我们感谢 Gupta 博士就我们的研究“在胶质母细胞瘤患者中持续辅助替莫唑胺超过 6 个周期的 II 期随机、多中心、开放标签试验（GEINO 14-01）”的来信。我们的试验解决的主要问题是患者是否会从超过 6 个标准周期的持续辅助替莫唑胺中获益。乍一看，我们的患者随机化似乎不平衡。然而，神经系统症状包括运动和语言障碍、部分失明、记忆障碍和轻度不稳定，所有这些都是 1-2 级且稳定。与对照组相比，实验组出现轻度运动性失语症的患者更多（8 [10%] 对 4 [5.1%]），这可能会影响简易精神状态检查分数。尽管如此，KPS ( P = 0.68) 和地塞米松的需要 ( P= 0.67) 在 2 个组中相似，表明根据临床因素进行了正确的随机化。