Gliadel® wafer in initial surgery for malignant glioma:: long-term follow-up of a multicenter controlled trial
Gliadel® wafer in initial surgery for malignant glioma:: long-term follow-up of a multicenter controlled trial
复制标题
DOI：
10.1007/s00701-005-0707-z
复制
发表时间：
2006-03-01
影响因子：
2.4
通讯作者：
Bortey, E
中科院分区：
文献类型：
--
作者：
Westphal, M;Ram, Z;Bortey, E
客观的。辅助全身化疗可延长原发性恶性胶质瘤患者 12-18 个月的生存期。唯一批准用于恶性神经胶质瘤的间质化疗治疗是在手术时将含有卡莫司汀 (BCNU) 的 Gliadel(R) 晶片放置在切除腔中。 Westphal 及其同事 (n = 240) 进行的一项大型试验分析显示，在 30 个月的试验过程中，BCNU 晶圆处理组的风险降低了 29% (P = 0.03)。对这些患者进行长期随访以确定 2 年和 3 年的生存获益。方法。通过 Kaplan-Meier 方法估计了 56 个月研究中安慰剂组和治疗组的生存率。使用 Cox 比例风险模型的多重回归分析包括年龄、KPS 和肿瘤类型的预后因素。对 207 名 GBM 患者进行了二次分析。结果。在 59 名可进行长期随访的患者中，11 名患者在 56 个月时仍存活：9 名接受了 BCNU 晶片，2 名接受了安慰剂晶片。使用 BCNU 晶片治疗的患者的中位生存期为 13.8 个月，而安慰剂治疗的患者的中位生存期为 11.6 个月 (P = 0.017)，风险比为 0.73 (P = 0.018)，风险显着降低 27%。这种生存优势在 1 年、2 年和 3 年均得以维持，并且在 3 年时具有统计学意义（P = 0.01）。 207 名 GBM 患者中的两名在随访期结束时仍存活，均属于 BCNU 晶片治疗组。结论。与安慰剂相比，在初次手术时接受 BCNU 晶片联合放射治疗的恶性神经胶质瘤患者在 2 年和 3 年的随访中显示出与安慰剂相比的生存优势。
Objective. Adjuvant systemic chemotherapy increases survival of primary malignant glioma patients beyond 12-18 months. The only interstitial chemotherapy treatment approved for malignant glioma is Gliadel((R)) wafer containing carmustine (BCNU) placed in the resection cavity at surgery. Analysis of a large trial by Westphal and colleagues (n = 240) showed a 29% risk reduction (P = 0.03) in the BCNU wafer-treated group over the course of the 30-month trial. Long-term follow-up of these patients was undertaken to determine the survival benefit at 2 and 3 years.Methods. Survival proportions for the placebo and treatment groups over the 56-month study were estimated by the Kaplan-Meier method. Multiple-regression analyses using the Cox proportional hazards model included prognostic factors of age, KPS, and tumor type. A secondary analysis was conducted for 207 GBM patients.Results. Of the 59 patients available for long-term follow-up, 11 were alive at 56 months: 9 had received BCNU wafers and 2 had received placebo wafers. Median survival of patients treated with BCNU wafers was 13.8 months vs 11.6 months in placebo-treated patients (P = 0.017) with a hazard ratio of 0.73 (P = 0.018), representing a 27% significant risk reduction. This survival advantage was maintained at 1, 2, and 3 years and was statistically significant (P = 0.01) at 3 years. Two of 207 GBM patients remained alive at the end of the follow-up period, both in the BCNU wafer-treated group.Conclusion. Malignant glioma patients treated with BCNU wafers at the time of initial surgery in combination with radiation therapy demonstrated a survival advantage at 2 and 3 years follow-up compared with placebo.