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Abstract：
We report the analysis involving patients treated on the initial CODEL design.
Adults (>18) with newly diagnosed 1p/19q World Health Organization (WHO) grade III oligodendroglioma were randomized to radiotherapy (RT; 5940 centigray ) alone (arm A); RT with concomitant and adjuvant temozolomide (TMZ) (arm B); or TMZ alone (arm C). Primary endpoint was overall survival (OS), arm A versus B. Secondary comparisons were performed for OS and progression-free survival (PFS), comparing pooled RT arms versus TMZ-alone arm.
Thirty-six patients were randomized equally. At median follow-up of 7.5 years, 83.3% (10/12) TMZ-alone patients progressed, versus 37.5% (9/24) on the RT arms. PFS was significantly shorter in TMZ-alone patients compared with RT patients (hazard ratio [HR] = 3.12; 95% CI: 1.26, 7.69; P = 0.014). Death from disease progression occurred in 3/12 (25%) of TMZ-alone patients and 4/24 (16.7%) on the RT arms. OS did not statistically differ between arms (comparison underpowered). After adjustment for isocitrate dehydrogenase (IDH) status (mutated/wildtype) in a Cox regression model utilizing IDH and RT treatment status as covariables (arm C vs pooled arms A + B), PFS remained shorter for patients not receiving RT (HR = 3.33; 95% CI: 1.31, 8.45; P = 0.011), but not OS ((HR = 2.78; 95% CI: 0.58, 13.22, P = 0.20). Grade 3+ adverse events occurred in 25%, 42%, and 33% of patients (arms A, B, and C). There were no differences between arms in neurocognitive decline comparing baseline to 3 months.
TMZ-alone patients experienced significantly shorter PFS than patients treated on the RT arms. The ongoing CODEL trial has been redesigned to compare RT + PCV versus RT + TMZ.
Adults (>18) with newly diagnosed 1p/19q World Health Organization (WHO) grade III oligodendroglioma were randomized to radiotherapy (RT; 5940 centigray ) alone (arm A); RT with concomitant and adjuvant temozolomide (TMZ) (arm B); or TMZ alone (arm C). Primary endpoint was overall survival (OS), arm A versus B. Secondary comparisons were performed for OS and progression-free survival (PFS), comparing pooled RT arms versus TMZ-alone arm.
Thirty-six patients were randomized equally. At median follow-up of 7.5 years, 83.3% (10/12) TMZ-alone patients progressed, versus 37.5% (9/24) on the RT arms. PFS was significantly shorter in TMZ-alone patients compared with RT patients (hazard ratio [HR] = 3.12; 95% CI: 1.26, 7.69; P = 0.014). Death from disease progression occurred in 3/12 (25%) of TMZ-alone patients and 4/24 (16.7%) on the RT arms. OS did not statistically differ between arms (comparison underpowered). After adjustment for isocitrate dehydrogenase (IDH) status (mutated/wildtype) in a Cox regression model utilizing IDH and RT treatment status as covariables (arm C vs pooled arms A + B), PFS remained shorter for patients not receiving RT (HR = 3.33; 95% CI: 1.31, 8.45; P = 0.011), but not OS ((HR = 2.78; 95% CI: 0.58, 13.22, P = 0.20). Grade 3+ adverse events occurred in 25%, 42%, and 33% of patients (arms A, B, and C). There were no differences between arms in neurocognitive decline comparing baseline to 3 months.
TMZ-alone patients experienced significantly shorter PFS than patients treated on the RT arms. The ongoing CODEL trial has been redesigned to compare RT + PCV versus RT + TMZ.
摘要：
我们报告了涉及初始CODEL设计治疗的患者的分析。
新诊断为1p/19q世界卫生组织（WHO）III级少突胶质细胞瘤的成年人（>18）被随机分为单纯放疗（RT;5940centgrey）（A组）；RT合并替莫唑胺和辅助替莫唑胺（TMZ）（B组）；或单纯TMZ（C组）。主要终点是总生存期（OS），A组与B组比较，对OS和无进展生存期（PFS）进行次要比较，比较合并的RT组和TMZ单独组。
36例患者被平均随机分组。在中位随访7.5年时，83.3%(10/12)TMZ单药患者进展，与RT臂的37.5％（9/24）。与单纯放疗患者相比，单纯TMZ患者的PFS显著缩短（风险比[HR]=3.12；95%CI：1.26，7.69；P=0.014）。3/12（25％）的TMZ单独患者和4/24（16.7％）的RT组患者发生疾病进展死亡。两组之间的OS没有统计学差异(比较能力不足)。在Cox回归模型中调整了异柠檬酸脱氢酶（IDH）状态（突变/野生型）后，利用IDH和RT治疗状态作为协变量（C组与合并的A组B组），未接受RT的患者的PFS仍然较短(HR=3.33;95%CI:1.31,8.45;P=0.011),而非OS((HR=2.78；95%CI：0.58，13.22，P=0.20)。3级+不良事件发生率为25%，42%,和33%的患者(A组，B,andC).与基线至3个月相比，两组之间的神经认知能力下降没有差异。
单纯TMZ患者的PFS明显短于接受RT治疗的患者。正在进行的CODEL试验已重新设计，以比较RT+PCV与RT+TMZ。
新诊断为1p/19q世界卫生组织（WHO）III级少突胶质细胞瘤的成年人（>18）被随机分为单纯放疗（RT;5940centgrey）（A组）；RT合并替莫唑胺和辅助替莫唑胺（TMZ）（B组）；或单纯TMZ（C组）。主要终点是总生存期（OS），A组与B组比较，对OS和无进展生存期（PFS）进行次要比较，比较合并的RT组和TMZ单独组。
36例患者被平均随机分组。在中位随访7.5年时，83.3%(10/12)TMZ单药患者进展，与RT臂的37.5％（9/24）。与单纯放疗患者相比，单纯TMZ患者的PFS显著缩短（风险比[HR]=3.12；95%CI：1.26，7.69；P=0.014）。3/12（25％）的TMZ单独患者和4/24（16.7％）的RT组患者发生疾病进展死亡。两组之间的OS没有统计学差异(比较能力不足)。在Cox回归模型中调整了异柠檬酸脱氢酶（IDH）状态（突变/野生型）后，利用IDH和RT治疗状态作为协变量（C组与合并的A组B组），未接受RT的患者的PFS仍然较短(HR=3.33;95%CI:1.31,8.45;P=0.011),而非OS((HR=2.78；95%CI：0.58，13.22，P=0.20)。3级+不良事件发生率为25%，42%,和33%的患者(A组，B,andC).与基线至3个月相比，两组之间的神经认知能力下降没有差异。
单纯TMZ患者的PFS明显短于接受RT治疗的患者。正在进行的CODEL试验已重新设计，以比较RT+PCV与RT+TMZ。
