Abstract：
BACKGROUND: We investigated the prognostic value of baseline positron emission tomography (PET) parameters for patients with treatment-naïve follicular lymphoma (FL) in the phase III RELEVANCE trial, comparing the immunomodulatory combination of lenalidomide and rituximab (R2) versus R-chemotherapy (R-chemo), with both regimens followed by R maintenance therapy.
METHODS: Baseline characteristics of the entire PET-evaluable population (n = 406/1032) were well balanced between treatment arms. The maximal standard uptake value (SUVmax) and the standardized maximal distance between tow lesions (SDmax) were extracted, the standardized distance between two lesions the furthest apart, were extracted. The total metabolic tumor volume (TMTV) was computed using the 41% SUVmax method.
RESULTS: With a median follow-up of 6.5 years, the 6-year progression-free survival (PFS) was 57.8%, the median TMTV was 284 cm3, SUVmax was 11.3 and SDmax was 0.32 m-1, with no significant difference between arms. High TMTV (>510 cm3) and FLIPI were associated with an inferior PFS (P = 0.013 and P = 0.006, respectively), whereas SUVmax and SDmax were not (P = 0.08 and P = 0.12, respectively). In multivariable analysis, follicular lymphoma international prognostic index (FLIPI) and TMTV remained significantly associated with PFS (P = 0.0119 and P = 0.0379, respectively). These two adverse factors combined stratified the overall population into three risk groups: patients with no risk factors (40%), with one factor (44%), or with both (16%), with a 6-year PFS of 67.7%, 54.5%, and 41.0%, respectively. No significant interaction between treatment arms and TMTV or FLIPI (P = 0.31 or P = 0.59, respectively) was observed. The high-risk group (high TMTV and FLIPI 3-5) had a similar PFS in both arms (P = 0.45) with a median PFS of 68.4% in the R-chemo arm versus 71.4% in the R2 arm.
CONCLUSIONS: Baseline TMTV is predictive of PFS, independently of FLIPI, in patients with advanced FL even in the context of antibody maintenance.
METHODS: Baseline characteristics of the entire PET-evaluable population (n = 406/1032) were well balanced between treatment arms. The maximal standard uptake value (SUVmax) and the standardized maximal distance between tow lesions (SDmax) were extracted, the standardized distance between two lesions the furthest apart, were extracted. The total metabolic tumor volume (TMTV) was computed using the 41% SUVmax method.
RESULTS: With a median follow-up of 6.5 years, the 6-year progression-free survival (PFS) was 57.8%, the median TMTV was 284 cm3, SUVmax was 11.3 and SDmax was 0.32 m-1, with no significant difference between arms. High TMTV (>510 cm3) and FLIPI were associated with an inferior PFS (P = 0.013 and P = 0.006, respectively), whereas SUVmax and SDmax were not (P = 0.08 and P = 0.12, respectively). In multivariable analysis, follicular lymphoma international prognostic index (FLIPI) and TMTV remained significantly associated with PFS (P = 0.0119 and P = 0.0379, respectively). These two adverse factors combined stratified the overall population into three risk groups: patients with no risk factors (40%), with one factor (44%), or with both (16%), with a 6-year PFS of 67.7%, 54.5%, and 41.0%, respectively. No significant interaction between treatment arms and TMTV or FLIPI (P = 0.31 or P = 0.59, respectively) was observed. The high-risk group (high TMTV and FLIPI 3-5) had a similar PFS in both arms (P = 0.45) with a median PFS of 68.4% in the R-chemo arm versus 71.4% in the R2 arm.
CONCLUSIONS: Baseline TMTV is predictive of PFS, independently of FLIPI, in patients with advanced FL even in the context of antibody maintenance.
摘要：
背景：我们在3期相关性试验中研究了基线PET参数对初治滤泡性淋巴瘤（FL）患者的预后价值，比较来那度胺和利妥昔单抗（R2）与R-化疗（R-chemo）的免疫调节组合，两种方案均采用R维持治疗。
方法:整个PET可评价群体(n=406/1032)的基线特征在治疗组之间很好地平衡。SUVmax和SDmax，提取相距最远的两个病变之间的标准化距离。使用41%SUVmax方法计算总代谢肿瘤体积(TMTV)。
结果：中位随访时间为6.5年，6y-PFS为57.8%，中位TMTV为284cm3,SUVmax为11.3,SDmax为0.32m-1,组间无显著差异.高TMTV（>510cm3）和FLIPI与较差的PFS相关（p=0.013和p=0.006），而SUVmax和SDmax没有（p=0.08和p=0.12）。在多变量分析中，FLIPI和TMTV仍然与PFS显著相关(p=0.0119和p=0.0379)。这两个不利因素组合将总体人群分为3个风险组：无风险因素患者（40％），只有一个因素(44%)，或两者(16%)，6y-PFS为67.7%，分别为54.5%和41.0%。未观察到治疗组与TMTV或FLIPI之间的显著相互作用(p=0.31和p=0.59)。高风险组（高TMTV和FLIPI3-5）在两组中的PFS相似（p=0.45），R化疗组的中位PFS为68.4％，R2组的中位PFS为71.4％。
结论：基线TMTV可预测PFS，独立于FLIPI,即使在抗体维持的情况下，晚期FL患者也是如此。
方法:整个PET可评价群体(n=406/1032)的基线特征在治疗组之间很好地平衡。SUVmax和SDmax，提取相距最远的两个病变之间的标准化距离。使用41%SUVmax方法计算总代谢肿瘤体积(TMTV)。
结果：中位随访时间为6.5年，6y-PFS为57.8%，中位TMTV为284cm3,SUVmax为11.3,SDmax为0.32m-1,组间无显著差异.高TMTV（>510cm3）和FLIPI与较差的PFS相关（p=0.013和p=0.006），而SUVmax和SDmax没有（p=0.08和p=0.12）。在多变量分析中，FLIPI和TMTV仍然与PFS显著相关(p=0.0119和p=0.0379)。这两个不利因素组合将总体人群分为3个风险组：无风险因素患者（40％），只有一个因素(44%)，或两者(16%)，6y-PFS为67.7%，分别为54.5%和41.0%。未观察到治疗组与TMTV或FLIPI之间的显著相互作用(p=0.31和p=0.59)。高风险组（高TMTV和FLIPI3-5）在两组中的PFS相似（p=0.45），R化疗组的中位PFS为68.4％，R2组的中位PFS为71.4％。
结论：基线TMTV可预测PFS，独立于FLIPI,即使在抗体维持的情况下，晚期FL患者也是如此。
