MD Anderson Cancer Center Score Research Articles

Abstract 996: Predicting early mortality in a large ethnically diverse phase I clinical trial program

Abstract Background: Various scoring systems are developed to optimize patient selection for phase I clinical trials. We evaluated the Royal Marsden Hospital (RMH), Princess Margaret Hospital Index (PMHI), and MD-Anderson Cancer Center (MDACC) prognostic scores and compared their power to predict 90-day mortality (90DM) in an ethnically diverse population enrolled in the USC Norris Comprehensive Cancer Center (NCCC) Phase I Program. Methods: We queried our database of patients enrolled in phase I clinical trials at the NCCC from 2015-2022 which includes demographics, treatment details and outcomes. The enrollment occurred at all NCCC sites including the Los Angeles General Medical Center, a safety net hospital. Prognostic scores were calculated: RMH (albumin < 35 g/L, LDH > ULN, > 2 metastatic sites), PMHI (albumin < 35 g/L, ECOG > 0, > 2 metastatic sites), MDACC (albumin < 35 g/L, LDH > ULN, ECOG > 0, > 2 metastatic sites, GI tumor type). Kaplan-Meier analysis was used to calculate median survival in each group. ROC analysis was performed to assess the 90DM prediction. Results: 611 patients (15 breast, 344 GI, 20 GU, 29 GYN, 110 Lung/H&N, 88 other) were accrued to 88 phase I trials. Patients had a median age of 61 (25-87) and a median of 3 prior lines of therapy (0-10). 31.9% of pts were Hispanic, 44.1% non-Hispanic white, 3.7% black, and 20.4% Asian. The 90DM rate was 24.9%. The objective response rate was 8.3%, and 41.5% had stable disease. For all systems, higher scores had shorter survival (p<0.001). The MDACC system had the largest AUC to predict 90DM (AUC: 0.678, p < 0.001). Score of 4-5 (high risk) per MDACC system corresponds to a specificity of 94.5% (91.1-97.2) and positive likelihood ratio of 3.6 (1.8-7.2). Conclusion: In our highly diverse phase I population, higher scores on the RMH, PMHI, and MDACC scoring systems were associated with worse prognosis and 90DM. Careful consideration should be given to potential patients with higher scores prior to enrollment in phase I trials. Characteristics and outcomes of the study participants (N = 611). Variable Median (IQR)/N (%) Scoring system N (%) Median survival days (95% CI) p-Value Age (yr) 61 [54-68] RMH score < 0.001 Female gender 288 (47.1%) 0 151 (36.7%) 505 (378-631) Safety net participant 120 (19.6%) 1 184 (44.8%) 509 (324-693) Non-English speaking 177 (29%) 2 64 (15.6%) 176 (107-244) Performance status ECOG 0 153 (33.3%) 3 12 (2.9%) 44 (12-76) ECOG 1 302 (65.7%) Area under ROC curve (95% CI) 0.650 (0.579-0.721) < 0.001 ECOG 2 5 (1.1%) Number of prior lines 0-2 298 (48.8%) PMHI score < 0.001 >= 3 313 (51.2%) 0 118 (25.7%) 603 (405-800) Tumor type Breast 15 (2.5%) 1 214 (46.5%) 462 (378-545) GI 344 (56.8%) 2 115 (25.0%) 254 (117-390) GU 20 (3.3%) 3 13 (2.8%) 87 (52-122) Gyn 29 (4.8%) Area under ROC curve (95% CI) 0.629 (0.560-0.697) < 0.001 Lung/H&N 110 (18.2%) Others 88 (14.5%) MDACC score < 0.001 Type of trial Chemotherapy 112 (18.3%) 0 (low risk) 26 (7.9%) Not estimated Immunotherapy 227 (37.2%) 1 (low-intermediate risk) 84 (25.5%) 597 (429-768) Targeted therapy 272 (44.5%) 2 (intermediate risk) 116 (35.2%) 471 (115-827) >2 metastatic sites 146 (23.9%) 3 (high-intermediate risk) 75 (22.7%) 297 (142-452) 90-day mortality 152 (24.9%) 4 (high risk) 25 (7.6%) 119 (108-130) Best response by RECIST Stable disease 225 (41.5%) 5 (high risk) 4 (1.2%) Not estimated Partial response 39 (7.2%) Area under ROC curve (95% CI) 0.678 (0.611-0.745) < 0.001 Complete response 6 (1.1%) Progressive disease 272 (50.2%) Citation Format: Hadi Erfani, Sabrina Woll, Austin Luong, Gage Guerra, Anthony Kharrat, Rebecca Umayam, Anastasia Martynova, Laurie Brunette, Lynda Roman, Negeen Izadian, Teshia Bustos, Diana Hanna, Anthony El-Khoueiry, Jacob Thomas. Predicting early mortality in a large ethnically diverse phase I clinical trial program [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 996.

Predictors of survival outcomes in patients (pts) with advanced solid tumors treated with cellular therapies in early clinical trials.

e14532 Background: Treatment strategies utilizing adoptive cell therapies (ACT) have shown promising survival benefits for hematologic malignancies. ACT are also known for the potential high-risk side effects such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Numerous ACT have been tested for solid tumors in phase 1 clinical trials, however no prognostic biomarkers were reported previously. We investigated prognostic markers for toxicities and survival outcomes of pts with solid tumors treated with ACT in a Phase 1 Program. Methods: Pts with advanced or metastatic solid tumors were enrolled in phase 1 ACT trials in the Investigational Cancer Therapeutics Department at The University of Texas MD Anderson Cancer Center. MD Anderson Cancer Center (MDACC) prognosis score was calculated based on the number sites of metastatic sites, lactate dehydrogenase (LDH), albumin, performance status (ECOG) and if gastrointestinal (GI) primary tumors. Clinical and biological characteristics were collected from prospectively maintained electronic medical records and databases. Results: From August 29, 2017 to May 19, 2022, 72 pts received cell therapy in 11 clinical trials. A total of 58% were female (n = 42), 89% white (n = 64) and 26% had GI cancers (n = 19). The median number of prior treatment lines was 3 (interquartile range - IQR = 2) and all pts had received prior chemotherapy. The median baseline MDACC score for all participants was 2 (IQR = 1). The median overall survival (OS) was 7 months (95% CI 5.1-8.8). Day 30+, Day 100+, and Day 365+ mortality rates were 3% (n = 2), 19% (n = 14), and 64% (n = 46), respectively. In total, 64% (n = 46) of pts experienced CRS, with 3 pts having > grade 2, while 13% (n = 9) experienced ICANS, with 1 pt having > grade 2 toxicity. Factors associated with higher rates of mortality at Day 100+ included a diagnosis of GI cancer (37% vs 13%, p = 0.041), more than 2 metastatic sites (37% vs 8.9%, p = 0.003), lung metastasis (29% vs 10.5%, p = 0.043), cardiovascular comorbidity (42% vs 15%, p = 0.048), and MDACC score greater than 1 (33% vs 3%, p = 0.001). Median overall survival (OS) was significantly shorter in pts with GI cancer diagnosis when compared to other cancer types (5 vs 8 months, p = 0.007), no history of prior targeted therapy (7 vs 8 months, p = 0.028), albumin < 3.5 (0 vs 6 months, p < 0.001), hemoglobin < 12 (6 vs 10 months, p = 0.006), and MDACC score > 1 (5 vs 12 months, p = 0.017). Conclusions: MDACC prognosis score of greater than 1 was associated with a reduced OS of pts with advanced solid tumors who received ACT in a phase I clinical trial setting. Further investigation is warranted in larger populations to validate these prognostic factors.

Validation of Prognostic Scores in Patients With Metastatic Urothelial Cancer Enrolling in Phase I Targeted Therapy or Next Generation Immunotherapy Trials.

Enrolling patients with metastatic urothelial carcinoma (mUC) in phase I trials provides an opportunity to identify biological drug activity. Developing prognostic scores may aid in patient selection for phase 1 trials. We analyzed records of patients with mUC who participated in targeted therapy and immunotherapy phase I clinical trials at MD Anderson Cancer Center (MDACC). The Bellmunt and Bajorin scores were calculated as bladder cancer-specific prognostic scores. The Royal Marsden Hospital (RMH) and MDACC scores were calculated as phase I prognostic scores. Hazard ratios (HR) were calculated using the Cox proportional hazard model. The prognostic value of the Bellmunt, Bajorin, RMH, and MDACC scores were assessed using the Likelihood ratio (LR) χ2 test and the c-index. Between 2015 and 2019, 43 patients were enrolled in phase I trials and 12 were enrolled in >I trial leading to a total of 57 trial participants (TPs). Ninty-seven percent of TPs received prior platinum therapy and 60% received a prior checkpoint inhibitor. Median overall survival (OS) and progression-free survival (PFS) were significantly shorter with increasing Bajorin, RMH, or MDACC scores, but not with increasing Bellmunt score. The RMH (c-index=0.658, LR χ2=11.8, P=.008) and MDACC scores (c-index =0.66, LR χ2=12.76, P=.01) outperformed the Bajorin score (c-index=0.522, LR χ2=1.22, P=.5) and the Bellmunt score (c-index=0.537, LR χ2=0.36, P=.9) in predicting overall survivalover. The Bajorin, RMH, and MDACC scores, but not the Bellmunt score, were also predictive of progression-free survival (PFS)prog. The RMH and MDACC scores again outperformed the Bajorin scoreand the Bellmunt score for predicting PFS. The RMH and MDACC phase I prognostic scores accurately predicted survival in patients with mUC and outperformed the bladder cancer-specific scores at time of enrollment on phase 1 clinical trials. The RMH and MDACC scores could optimize selection of patients with mUC for phase I clinical trials.

Comparative analysis of international prognostic index for chronic lymphocytic leukemia, progression-risk score, and MD Anderson Cancer Center 2011 score - a single center experience

Introduction/Objective. Prognostication of chronic lymphocytic leukemia (CLL) has been substantially improved in recent times. Among several prognostic models (PMs) focused on the prediction of time to first treatment (TTFT), progression-risk score (PRS), and MD Anderson Cancer Center score 2011 (MDACC 2011) are the most relevant, while CLL-International Prognostic Index (CLL-IPI), although originally developed to predict overall survival (OS), is also being used to estimate TTFT. The aim of this study was to investigate CLL-IPI, PRS, and MDACC 2011 prognostic values regarding TTFT and OS. Methods. The analyzed cohort included 57 unselected Serbian CLL patients from a single institution, with the basic characteristics reflecting more aggressive disease than in the general de novo CLL population. The eligible patients were assigned investigated PMs, and TTFT and OS analyses were performed. Results. Patients with higher risk scores according to CLL-IPI, PRS, and MDACC 2011 underwent treatment significantly earlier than patients with lower risk scores (p = 0.002, p = 0.019, and p < 0.001, respectively). In multivariate analysis, MDACC 2011 and CLL-IPI retained their significance regarding TTFT (p = 0.001 and p = 0.018, respectively), while PRS did not. CLL-IPI was the only significant predictor of OS both at the univariate (p = 0.005) and multivariate (p = 0.013) levels. Conclusion. CLL-IPI, PRS, and particularly MDACC 2011 are able to predict TTFT even in cohorts with more advanced-disease patients, while for prediction of OS, CLL-IPI is the only applicable among the three PMs. These results imply that PMs should be investigated in more diverse CLL populations, as it is in real-life setting.

Validation of prognostic scoring systems for patients with metastatic renal cell carcinoma enrolled in phase I clinical trials

BackgroundFor patients with metastatic renal cell carcinoma (mRCC) who progress on standard-of-care therapies, there is an unmet need for novel treatments. Phase I clinical trials are designed to test the safety, toxicity and optimal dosing of novel agents. Herein, we analysed the outcomes of patients with mRCC enrolled in phase I trials and assess the utility of prognostic scores.MethodsPatients with all histologies of mRCC were included if they received treatment on a phase I clinical trial at MD Anderson Cancer Center (MDACC). Survival outcomes were calculated using Cox proportional hazard model. Prognostic value of the International Metastatic RCC Database Consortium (IMDC), Royal Marsden Hospital (RMH) and MDACC scores was assessed using the likelihood ratio (LR) χ2 test and the c-index.ResultsAmong 82 patients with mRCC who received treatment, 21 patients participated in more than one trial, resulting in 106 trial participants (TP). Median prior therapies was two. For all TPs, median overall survival (OS) was 31.2 months, progression-free survival (PFS) was 5.9 months and objective response rate was 22%. Median OS and PFS were significantly shorter with increasing IMDC, RMH and MDACC scores. The RMH and MDACC scores outperformed the IMDC score for predicting OS (RMH LR χ2=8.64; MDACC LR χ2=7.74; IMDC LR χ2=2.36) and PFS (RMH LR χ2=17.5; MDACC LR χ2=20.3; IMDC LR χ2=4.28).ConclusionsThe RMH and MDACC prognostic scores can be used to predict OS for patients with mRCC in phase I trials and may guide patient selection. Patients with mRCC should be considered for phase I trials.

Prognostic factors of overall survival in children and adolescents enrolled in dose-finding trials in Europe: An Innovative Therapies for Children with Cancer study

ObjectivesDose-finding trials are fundamental to develop novel drugs for children and adolescents with advanced cancer. It is crucial to maximise individual benefit, whilst ensuring adequate assessment of key study end-points. We assessed prognostic factors of survival in paediatric phase I trials, including two predictive scores validated in adult oncology: the Royal Marsden Hospital (RMH) and the MD Anderson Cancer Center (MDACC) scores. MethodsData of patients with solid tumours aged <18 years at enrolment in their first dose-finding trial between 2000 and 2014 at eight centres of the Innovative Therapies for Children with Cancer European consortium were collected. Survival distributions were compared using log-rank test and Cox regression analyses. ResultsOverall, 248 patients were evaluated: median age, 11.2 years (range 1.0–17.9); 46% had central nervous system (CNS) tumours and 54% extra-CNS tumours. Complete responses were observed in 2.1%, partial responses in 7.2% and stable disease in 25.9%. Median overall survival (OS) was 6.3 months (95% confidence interval, 5.2–7.4). Lansky/Karnofsky ≤80%, no school/work attendance, elevated creatinine and RMH score ≥1 correlated with worse OS in the multivariate analysis. The RMH and MDACC scores correlated with OS in adolescents (12–17 years), p = 0.002, but not in children (2–11 years). ConclusionsPerformance status of 90–100% and school/work attendance at enrolment are strong indicators of longer OS in paediatric phase I trials. Adult predictive scores correlate with survival in adolescents. These findings provide a useful orientation about potential prognosis and could lead in the future to more paediatric-adapted eligibility criteria in early-phase trials.

Validation of prognostic scoring and assessment of clinical benefit for patients with bone sarcomas enrolled in phase I clinical trials.

BackgroundWe sought to validate the Royal Marsden Hospital (RMH) and MD Anderson Cancer Center (MDACC) prognostic scoring systems for the selection of bone sarcoma patients for phase I clinical trials and to identify additional risk factors related to survival.Patients and MethodsWe retrospectively reviewed the baseline characteristics and outcomes of 92 bone sarcoma patients who were referred to MDACC's Phase I Clinical Trials Program.ResultsNinety-two patients with Ewing sarcoma (N = 47), osteosarcoma (N = 22), chondrosarcoma (N = 16), and other tumors (N = 7) were evaluated; 78 were enrolled in at least 1 of 43 different phase I trials. The median overall survival (OS) was 8.8 months (95% confidence interval [CI] = 6.8–13.7 months). Independent factors that predicted shorter survival were male sex, >2 metastatic sites, >3 previous therapies, hemoglobin level <10.5 g/dL, platelet count >200 x103/L, creatinine level ≥1.3 mg/dL, and lactate dehydrogenase level >ULN. Patients with good RMH scores (0-1) had longer OS than patients with poor RMH scores (2-3) (HR = 5.8, 95% CI = 2.9–11.0; P < 0.0001), as did patients with low MDACC scores (0-1) as compared to patients with higher MDACC scores (2–4) (HR = 3.2, 95% CI = 1.9–5.6; P < 0.0001).ConclusionThe RMH prognostic score can be used to predict the OS of bone cancer patients referred for phase I trials. The MDACC score added no value to the RMH score and therefore does not have a role in assessment of patients with bone tumors. Patients with advanced bone sarcomas should be considered for phase I trials.

Exclusion of SERUM Thymidine Kinase Does NOT Reduce the Predictive VALUE of a Comprehensive Prognostic INDEX in Chonic Lymphocytic Leukemia. Results of an External Validation on a Prospective Cohort of Patients with EARLY Disease

▪A comprehensive prognostic index that includes clinical (i.e., age, sex, ECOG performance status), serum (i.e., B2-microglobulin, thymidine kinase) and molecular (i.e., IGVH mutational status, del 17p, del 11q) markers with independent prognostic value and combines them into a single risk score was recently developed by the German CLL Study Group (GCLLSG).We sought to externally validate this novel score in an independent, community-based cohort consisting of 338 patients with early chronic lymphocytic leukemia (CLL) who were registered on a prospective basis during 2006 to 2010 on an observational Italian database (O-CLL1 protocol; clinicaltrial.gov identifier NCT00917540).Because serum thymidine kinase was not available a slightly modified version of the German model based on 6 instead of 7 prognostic variables was used.According to clinical caracteristics of our patients (i.e., all with Binet stage A disease), a point score higher than 5, necessary for inclusion in the high-risk group, was found only in 2 cases. By German prognostic index, 62.9% of patients were scored as having low-risk CLL (score 0-2) whereas 37.1% had intermediate-risk CLL (score 3-5). This stratification translated into a significant difference in the time to first treatment (TTFT). In other words, the higher the score risk the shorter the TTFT [HR = 4.21; 95% C.I. (2.71-6.53) P<0.0001; (Fig 1)]. Interestingly, the prognostic index category remained a predictor of TTFT also when the analysis was restricted to 262 patients with Rai stage 0 disease [HR= 3.12; 95% C.I. (1.84-5.31);P <0.0001]The model proposed in 2007 by investigators at MD Anderson Cancer Center (MDACC) and barely based on traditional clinical parameters (i.e., age, gender, Rai substage, absolute lymphocyte count, number of involved nodal groups and B2-microglobulin) worked in predicting the TTFT [HR = 2,73; 95% C.I. (1.79-4.17); P<0.0001] in our patient cohort. In comparison to the MDACC score the German model provided similar results in terms of sensitivity (German score, 67%; MDACC score, 58.2; P = 0.28). However, both specificity (74% vs 65.4%; P=0.05) and accuracy (72.1% vs 63.5%; P=0.02) were significantly better with the German score.In order to investigate which prognostic model (i.e. German or MDACC score) provided a more accurate prediction of TTFT, a C-statistic analysis, considered a measure of concordance between observed and predicted time-dependent events, was performed. Interestingly, the C-statistic of the German score was 0.71 (range, 0.60-0.82), a value higher than c-statistic observed with MDACC score (c=0.65; range,0.53-0.78).In conclusion, we demonstrated that the German score works in predicting the TTFT of patients with early CLL also when a modified version which does not include serum thymidine kinase is utilized. These changes affected only partially the predictive value of model because C-statistic remained above 0.70, which is considered a necessary threshold of utility at the individual patient level. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

MD Anderson Cancer Center (MDACC) Score Adds Prognostic Information To The Distinction Between High COUNT Monoclonal B-CELL Lymphocytosis (HC-MBL) and RAI STAGE 0 Chronic Lymphocytic Leukemia (CLL)

Immunogenetic characteristics and clinical outcome findings suggest that high-count monoclonal B-cell lymphocytosis (HC-MBL) (i. e, more than 0.5 x 10E9 clonal B cells/L in peripheral blood) and Rai stage 0 CLL (i. e, more than 5.0 x 10E9 clonal B cells/L in peripheral blood) are similar entities. However, it is not clear whether prognostic variables generally useful to forecast the likelihood of transformation to an active phase of disease requiring therapy of patients with early CLL can be applied to subjects with HC-MBL. We therefore analyzed clinical outcome of a multi-institutional, prospective cohort including 94 subjects with HC CLL-like (i.e., CD19-, CD5-, CD23-positivity, and CD20dim expression) MBL and 158 Rai stage 0 CLL patients diagnosed at different Italian hematologic institution between January 2006 and December 2010 (O-CLL1 protocol; clini- caltrial.gov identifier NCT00917540). In this cohort we wondered whether the new prognostic index proposed by MD Anderson Cancer Center (MDACC) which includes either clinical (i.e., number of lymph node sites involved, lymph node size in neck, LDH) or biological (i.e., mutational status of IGHV, presence of 11q or 17p deletion by FISH) variables could add prognostic information to that afforded by distinction between HC-MBL and Rai stage 0.Using time to first treatment (TTFT) as endpoint, we found that likelihood to receive therapy was significantly lower for subject with HC-MBL in comparison to patients in Rai stage 0 (P<0.001). Furthermore, a total point score of 25, used as threshold, identified two different patterns of TTFT among either subjects with HC-MBL (P=0.02) or patients with Rai stage 0 CLL (P<0.001). We then stratified our cohort taking into account either the distinction between HC-MBL and Rai stage 0 or MDACC prognostic index. Accordingly, 4 groups were identified: 1. HC-MBL with MDACC total point score lower than 25 (n=66); 2. HC-MBL with MDACC total point score equal or higher than 25(n=28); 3. Rai stage 0 with MDACC total point score lower than 25 (n=74); 4. Rai stage 0 with MDACC total point score equal or higher than 25 (n=84). The probability of remaining free from therapy at 5 years was 97% for subjects with HC-MBL and MDACC score lower than 25 while it was 20% for patients with Rai stage 0 and score equal or higher than 25. In between there were HC-MBL subjects with MDACC total point scorre equal or higher than 25 and Rai stage 0 patients with MDACC total point score lower than 25. Curves of TTFT of these two groups virtually overlapped and 5-year probability of remaining free from therapy was 68% for both.In conclusion, we demonstrated that MDACC score adds information to the distinction between HC-MLB and Rai stage 0 leading to the identification of three significantly different patterns of TTFT on the basis of objective data of clinical outcome (P<0.0001) (Fig1). These results support the idea that HC-MBL and Rai stage 0 are a mixture of real patients whose clinical outcome is affected by the disease but also of individuals who will never develop clinical signs and symptoms. [Display omitted] Disclosures:No relevant conflicts of interest to declare.

Body composition and survival in the early clinical trials setting

PurposeDelineate the relationships between body composition parameters, 90-day mortality and overall survival, and correlate them with known prognostic factors in an early clinical trials clinic. Patients and methodsWe studied 306 consecutive patients with various tumours; body composition was analysed by computerised tomography images. Survival was measured from the first clinic visit, at 90-day period and until death/last follow-up visit. ResultsMedian patient age was 56years; 159 patients were men. Ninety-day mortality rate was 12%. Median overall survival was 9months. In multivariate analyses, high MD Anderson Cancer Center (MDACC) score (p<0.0001) [lactate dehydrogenase (LDH)>normal, albumin<normal, Eastern Cooperative Oncology Group (ECOG) performance status>1, metastatic sites>2, gastrointestinal (GI) tumours], low skeletal muscle index (SMI) (p=0.0406) and male gender (p=0.0077) were independent predictors of poor survival. If Royal Marsden Hospital (RMH) score (LDH>normal, albumin<normal, metastatic sites>2) was used in lieu of MDACC score, it was also significant (p=0.0003). Including SMI and gender in the MDACC or RMH score improved the accuracy of the original model (p=0.006 and p=0.0037, respectively). ConclusionPatients with low SMI have shorter survival. Gender and SMI strengthens the accuracy of MDACC or RMH scores as prognostic tools. Prospective validation of these findings is warranted.

The utility of two prognostic models for predicting time to first treatment in early chronic lymphocytic leukemia patients: Results of a comparative analysis

The use of both traditional and novel prognostic parameters combined in a statistical model for predicting patient clinical outcome has been recently proposed by both MD Anderson Cancer Center (MDACC) and German chronic lymphocytic leukemia (CLL) group. Using time to first treatment (TTFT) as end-point, we performed a comparative external validation of MDACC score versus a modified version of German score, which excluded thymidine kinase measurement, in a prospective, multicenter, community-based cohort consisting of 328 patients who had asymptomatic, early stage CLL. With both models a significant correlation between higher score and shorter TTFT could be found. As a matter of fact, patients with total point score ≥25 according to MDACC model (HR, 3.27; 95% CI, 2.07–5.18; P<0.0001) or ≥2 according to modified German model (HR, 2.02; 95% CI, 1.29–3.16; P=0.002) were more likely to receive therapy. Both models provided similar results in terms of sensitivity (MDACC score, 61.5%; modified German score, 57.7%; P=0.79), whereas specificity was significantly higher for MDACC score (72.1% versus 63%; P=0.02). The prognostic utility of either MDACC or modified German score was assessed by time-dependent Receiver Operating Characteristic (ROC) analysis. Results of this comparative analysis showed that after the 2nd year area under curve (AUC) for TTFT was higher than 0.60 for both models and kept unmodified this trend over the time. Results of this study suggest that in CLL both MDACC and modified German score group should be considered the benchmarking of comparison for any novel prognostic proposal having as endpoint TTFT in CLL and including both traditional and newer prognostic parameters.