Phase III trial of chemotherapy plus radiotherapy compared with radiotherapy alone for pure and mixed anaplastic oligodendroglioma: Intergroup Radiation Therapy Oncology Group Trial 9402
Phase III trial of chemotherapy plus radiotherapy compared with radiotherapy alone for pure and mixed anaplastic oligodendroglioma: Intergroup Radiation Therapy Oncology Group Trial 9402
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DOI：
10.1200/jco.2005.04.3414
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发表时间：
2006-06-20
影响因子：
45.3
通讯作者：
Curran, Walter
中科院分区：
文献类型：
--
作者：
Cairncross, Gregory;Berkey, Brian;Curran, Walter
目的间变性少突神经胶质瘤 (AO) 和间变性少突星形细胞瘤 (AOA) 在诊断时接受手术和放疗 (BT) 治疗，但它们也对丙卡巴肼、洛莫司汀和长春新碱 (PCV) 有反应，这增加了早期化疗提高生存率的可能性。此外，AO 的更好结果与 1 p 和 19q 等位基因丢失相关。 患者和方法 AO 和 AOA 患者被随机分配接受 PCV 化疗，然后接受 RT 与单纯术后 RT。主要终点是总生存期。通过荧光原位杂交评估 1 p 和 19q 等位基因的状态。结果 289 名符合条件的患者被随机分配接受 PCV 加 RT (n = 147) 或单独 RT (n = 142)。在疾病进展时，80% 随机分配接受放疗的患者接受了化疗。对大多数患者进行 3 年随访后，中位生存时间相似（PCV 加 RT 后 4.9 年 vs 单独 RT 后 4.7 年；风险比 [HR] = 0.90；95% Cl，0.66 至 1.24；P =.26）。无进展生存时间有利于 PCV 加 RT（2.6 年 vs 单独 RT 1.7 年；HR = 0.69；95% CI，0.52 至 0.91；P =.004），但 65% 的患者出现 3 或 4 级毒性，并有 1 名患者死亡。与不缺乏 1p 和 19q 的肿瘤相比，缺乏 1p 和 19q 的肿瘤患者 (46%) 的中位生存时间更长（分别 > 7 年和 2.8 年；P
PurposeAnaplastic oligodendroglioma (AO) and anaplastic oligoastrocytoma (AOA) are treated with surgery and radiotherapy (BT) at diagnosis, but they also respond to procarbazine, lomustine, and vincristine (PCV), raising the possibility that early chemotherapy will improve survival. Furthermore, better outcomes in AO have been associated with 1 p and 19q allelic loss.Patients and MethodsPatients with AO and AOA were randomly assigned to PCV chemotherapy followed by RT versus postoperative RT alone. The primary end point was overall survival. The status of 1 p and 19q alleles was assessed by fluorescence in situ hybridization.ResultsTwo hundred eighty-nine eligible patients were randomly assigned to either PCV plus RT (n = 147) or RT alone (n = 142). At progression, 80% of patients randomly assigned to RT had chemotherapy. With 3-year follow-up on most patients, the median survival times were similar (4.9 years after PCV plus RT v 4.7 years after RT alone; hazard ratio [HR] = 0.90; 95% Cl, 0.66 to 1.24; P =.26). Progression-free survival time favored PCV plus RT (2.6 years v 1.7 years for RT alone; HR = 0.69; 95% CI, 0.52 to 0.91; P =.004), but 65% of patients experienced grade 3 or 4 toxicity, and one patient died. Patients with tumors lacking 1p and 19q (46%) compared with tumors not lacking 1 p and 19q had longer median survival times (> 7 v 2.8 years, respectively; P