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We observed a significant difference in OS among our patients with low-risk aaIPI 0-1 (45%, median OS 44 months) in comparison to patients with high-risk aaIPI 2-3 (10% - median OS 6 months).
Many factors might cause significant heterogeneity, such as different induction therapy, second-line treatment regimens, rituximab administration protocols, aaIPI and ASCT.
The prognostic value of the following variables was assessed by multivariate analyses: BMI (overweight versus normal and underweight versus normal), gender (male versus female), age ([greater than or equal to] 60 years versus <60 years), and aaIPI score (2-3 = high score versus 0-1 = low score).
Patients from the LNH03-2B study were younger and exhibited lower aaIPI scores.
The ages, BMI, gender, and aaIPI scores for the patients in the pooled analysis are shown in Table 1(b).
High aaIPI score, age older than 60 years, and male gender were associated with a shorter PFS; the median PFS was 118 months for patients with low aaIPI scores versus 41 months for patients with high score (P < 0.0001, HR = 1.97, 95% CI (1.62-2.38)) and 111 months for females versus 59 months for males (P = 0.0262, HR = 1.24, 95% CI (1.025-1.493)) (Figures 2(a) and 2(b)).
High aaIPI score and age were the two factors significantly associated with shorter OS; the median OS was 83 months for aaIPI > 1 versus not reached for aaIPI of 0-1 (P < 0.0001, HR = 2.41, 95% CI (1.92-3.01)), and the median OS was 108 months versus not reached (P < 0.0001, HR = 2.021, 95% CI (1.409-2.898)) for patients older or younger than 60 years, respectively.
In a Cox regression analysis including gender, BMI, age, aaIPI score, and interaction between gender and BMI as variables, a high aaIPI score was the strongest factor independently associated with shorter OS and shorter PFS (P < 0.0001, HR = 2.287 and P < 0.0001, HR = 1.926 for OS and PFS, resp.).
To our knowledge, this is the largest study evaluating the impact of gender and BMI independently of aaIPI score and age in patients with DLBCL who were prospectively treated with R-CHOP in phase III trials.
In multivariate analysis, gender was not anymore a relevant prognostic factor for PFS and OS (even the difference was almost significant for OS, P = 0.07), and aaIPI remained the strongest prognostic factor for both OS and PFS.
The strongest prognostic factor impacting OS and PFS remains the aaIPI score.
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