HPV status to predict outcome for anal cancer treated with radiochemotherapy.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4065-4065
Author(s):  
Sabine Kathrin Mai ◽  
Miriam Reuschenbach ◽  
Martine Ottstadt ◽  
Grit Welzel ◽  
Marcus Trunk ◽  
...  

4065 Background: Evaluation of the HPV infection- and transformation-status as a predictor of the response to definitive radio-chemotherapy for anal cancer. Methods: 80 patients (54 fm, 26 m) with histologically confirmed anal cancer and known HPV-Infection- (determined by PCR) and p16-expression-status (determined by immunohistochemistry) were analyzed. All pts. were treated with definitive radio-chemotherapy (RCT) with 5-FU/MMC, median age 60ys (35–86), median follow up 54mo (4–180). 41 pts. were HPV+ and p16+ (group 1), 10 pts. were HPV-/p16+ (group 2), 9 pts. were HPV+/p16- (group 3) and 17 pts. were HPV+/p16- (group 4). Endpoints were local control (LC) at 5ys and overall survival (OS) at 5ys. In addition to HPV/p16 status, the influence of T-stage and tumor localization (canal vs. margin) was analyzed. Results: More women than men were HPV+ (fm 77% vs. m 33%) while gender was evenly distributed among HPV-pts. (fm 48% vs. m 53%). Upon univariate analysis, gender, HPV+ and p16+ were significant predictors of both LC and OS (p<0.05) while T-Stage was predictive for LC (p<0.05). Upon multivariate analysis, gender and T-Stage significantly influenced LC (w85.2% vs. m54.9%, p=0.028; <T3 84.2% vs ≥ T3 48,1%, p=0,019). OS was significantly influenced by gender (w95% vs. m59.2%, p=0.005), while the influence of HPV/p16-status did not reach significance when all four groups were analyzed simultaneously in this moderately sized cohort. Upon direct univariate comparison of HPV+/p16+ und HPV-/p16-pts, both gender and combined HPV/p16-positivity had a significant influence on LC and OS. Upon multivariate analysis, combined HPV/p16-positivity resulted in better LC (HPV+/p16+: 85% vs. HPV-/p16-: 38.7%, p=0.003), while, as a consequence of moderate patient numbers, only gender significantly predicted OS (fm93.7% vs. m62.6%, p=0.015). Viral status, however, showed a trend for significance. Conclusions: The data from one of the largest monocentric series treated with a uniform treatment regimen suggest that HPV-status predicts response to RCT in pts. with anal cancer. Patients with tumors not associated with HPV whatsoever (HPV-/P16-) have both inferior LC and a clear trend for inferior OS and might require an intensified treatment regimen.

2019 ◽  
Vol 25 (9) ◽  
pp. 877-886 ◽  
Author(s):  
Mu Li ◽  
Nitin Trivedi ◽  
Chenyang Dai ◽  
Rui Mao ◽  
Yuning Wang ◽  
...  

Objective: Differentiated thyroid cancer (DTC), the most common subtype of thyroid cancer, has a relatively good prognosis. The 8th edition of the American Joint Committee on Cancer (AJCC) pathologic tumor-node-metastasis (T [primary tumor size], N [regional lymph nodes], M [distant metastasis]) staging system did not take the T stage into consideration in stage IV B DTC patients. We evaluated the prognostic value of the T stage for advanced DTC survival. Methods: DTC cases that were considered stage IV B in the AJCC 8th edition were extracted from the Surveillance, Epidemiology, and End Results database. T stage (AJCC 6th standard) was categorized into T0–2, T3 and T4. We analyzed overall survival (OS) and cancer specific survival (CSS) in the overall group as well as in pathologic subgroups. We used the Kaplan-Meier method and log-rank test for univariate analysis and the Cox regression model for multivariate analysis. Results: A total of 519 cases were extracted. Patients with earlier T stages showed significantly better OS and CSS in univariate analysis. T stage was an independent prognostic factor for both OS and CSS in multivariate analysis. Subgroup analysis in papillary and follicular thyroid cancer showed that T4 was an independent prognostic factor for both OS and CSS. Conclusion: AJCC 8 stage IV B DTC patients could be further stratified by T stage. Further studies with larger samples and AJCC 8 T stage information are necessary. Abbreviations: AJCC = American Joint Committee on Cancer; CI = confidence interval; CSS = cancer specific survival; DTC = differentiated thyroid cancer; FTC = follicular thyroid cancer; FVPTC = follicular variant of papillary thyroid carcinoma; HR = hazard ratio; OS = overall survival; PTC = papillary thyroid cancer; SEER = surveillance, epidemiology, and end results database


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3956-3956
Author(s):  
Murtadha K. Al-Khabori ◽  
Mark Minden ◽  
Vikas Gupta ◽  
Aaron D. Schimmer ◽  
Andre C. Schuh ◽  
...  

Abstract T cell acute lymphoblastic leukemia (T-ALL) accounts for 14–22% of adult ALL. No prospective comparisons between different chemotherapy protocols have been done. Since 2000 a modified DFCI protocol (Silverman et al, Blood2001;97:121–1218) has been used as standard treatment for all newly diagnosed patients with T-ALL at Princess Margaret Hospital (PMH). This protocol includes a remission induction phase, a CNS prophylaxis phase with intrathecal chemotherapy and 12 Gy cranial irradiation, a 30-week intensification phase including weekly asparaginase, and a 72-week maintenance phase. We compared outcomes using this regimen to previous results for all newly diagnosed T-ALL from 1990 – 2000 at PMH using the standard institutional protocol in use at the time. Between 1990–2000, 44 patients (Group 1) were treated with a variety of protocols, including 9203ALL PMH protocol (11 patients), L10 (2 pts), Protocol C (7 pts), HyperCVAD (15 pts) and ECOG E2993 (9 pts). From 2000–2007, 33 T-ALL patients were treated with modified DFCI protocol (Group 2). The median age for all patients was 31 years (range 14–69 years). There was no significant difference between the two groups with respect to age at diagnosis, presenting WBC (median or percent &gt; 100 ×109/L), CSF positivity, or cytogenetics. More patients from Group 1 underwent allogeneic stem cell transplantation (BMT) in CR-1 (54%) as compared to those in Group 2 (54% vs. 14%, P = 0.001), primarily due to a change in BMT policy in 2002. The median follow up was 23 months (range 1–161 months) for the entire group and 53 months (range 14–161 months) for the surviving patients. Sixty-nine patients (90%) achieved complete remission, and 37 patients have relapsed. The CR rates were not significantly different between the two groups. The 3-year failure-free survival (FFS) was significantly higher in Group 2 (DFCI protocol) as compared with Group 1 (other protocols) (89% vs. 27%, P = 0.0001). Multivariate analysis using Cox proportional hazard model showed only the treatment regimen received (DFCI vs. others) to have a statistically significant impact on FFS (P = 0.0001). The 3-year overall survival (OS) was significantly higher in the DFCI group compared to the group receiving the other protocols (81% vs. 45%, P = 0.0006). On multivariate analysis, only the treatment regimen received (P=0.001) and the CSF status (P=0.014) had a significant impact on OS; BMT did not have a significant impact on OS. When patients were censored at the time of transplant, the FFS and OS analyses still showed statistically significant benefit for patients treated on DFCI protocol (P = 0.0001 and 0.03, respectively). In summary, treatment outcomes have markedly improved from 2000 onward as compared to the previous decade. Although improvements in supportive care and reduced use of allogeneic BMT may have been factors, it is likely that the institution of the DFCI pediatric protocol was the primary factor in the improved outcome. These results support the use of such pediatric asparaginase-intensive pediatric protocols for adult T-ALL.


2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 40-40
Author(s):  
R. D. Tendulkar ◽  
K. L. Stephans ◽  
C. A. Reddy ◽  
K. Martires ◽  
A. R. Patel ◽  
...  

40 Background: The percentage of positive cores (PPC) on biopsy for prostate cancer has been identified as a predictor of outcome following definitive local treatment. We aim to identify whether this observation holds true for a modern cohort of patients (pts) treated at Cleveland Clinic with permanent prostate brachytherapy (PB) or external beam radiation therapy (EBRT). Methods: We retrospectively reviewed pathology reports of pts treated with either PB or EBRT from our IRB-approved prospective prostate cancer registry. No pts underwent both PB and EBRT. The number of biopsy cores sampled, number of cores positive for prostate cancer, and maximum length of any core positive for prostate cancer were collected. Cox proportional hazards regression was used to analyze biochemical relapse free survival (bRFS) using the nadir + 2 ng/ml definition. Results: We identified 1253 PB and 879 EBRT pts with complete pathology and clinical information. Among PB pts, 46% were low risk, 40% intermediate risk, and 14% high risk, while 78% had <50% PPC, and 22% had >=50% PPC. The 5-year bRFS for PB was 92.0% for <50% PPC, vs. 83.1% for >=50% PPC (HR 2.1, p=0.0005). For PB pts, significant predictors of bRFS on univariate analysis included: PPC, clinical T stage, PSA, biopsy Gleason score, androgen deprivation, and frequency of PSA testing. On multivariate analysis, only PPC, biopsy Gleason score, and PSA frequency remained significant predictors following PB. Among EBRT pts, 11% were low risk, 36% intermediate risk, and 53% high risk, while 55% had <50% PPC, and 45% had >=50% PPC. The 5-year bRFS for EBRT was 85.6% for <50% PPC, vs. 77.1% for >=50% PPC (HR 1.8, p<0.0001). For EBRT pts, significant predictors of bRFS on univariate analysis included: PPC, clinical T stage, PSA, biopsy Gleason score, androgen deprivation, EBRT dose, and frequency of PSA testing. On multivariate analysis, only PPC, biopsy Gleason score, and PSA frequency remained significant predictors following EBRT. Conclusions: Following PB or EBRT, the percent of positive cores for prostate cancer was a significant predictor of bRFS on multivariate analysis, more so than conventional predictors such as T stage and PSA. No significant financial relationships to disclose.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6019-6019
Author(s):  
Benjamin H. Kann ◽  
Michael Buckstein ◽  
Todd J. Carpenter ◽  
Ava Golchin ◽  
Richard Lorne Bakst ◽  
...  

6019 Background: Pathologic ECE (pECE) of tumor through lymph node (LN) is a poor prognosticator for OPC and typically diagnosed upon surgical LN removal. At our institution, experienced radiologists routinely identify ECE on pretreatment CT. The prognostic value of radiographic ECE (rECE) is less clear and may prove clinically useful. In this study, we evaluate rECE as an independent prognosticator in OPC. Methods: Retrospective review of 185 patients with locally advanced OPC treated in our department from 2006-2012. 109 patients had accessible pretreatment CT reports clearly stating the presence or absence of rECE. Patients were treated with definitive concurrent chemoradiation therapy (CCRT) (30%), induction chemo then CCRT (47%), or surgery with adjuvant CCRT (14%) or RT (9%). Kaplan-Meier survival analysis compared these cohorts for locoregional control (LRC), distant control (DC), and progression-free (PFS) and overall survival (OS); log-rank tests were performed for significance. Multivariate analysis was conducted via cox-regression. Results: Median follow-up of the 109 patients was 31 months (range: 1-80 months). 61 patients had rECE(+) and 48 had rECE(-) scans. There was no significant difference between the cohorts in terms of median age, stage, treatment type, smoking history, or tumor HPV status. There was a difference in nodal stage with 83% of rECE(+) patients having N2-3 disease versus 67% of rECE(-) patients (p=0.02). On univariate analysis, there were differences between the rECE(-) versus rECE(+) cohorts in OS (4yr: 92% vs 72%, p=0.01), PFS (4yr: 92% vs 62%, p=0.002), and DC (4yr: 98% vs 76%, p=0.006), with no difference in LRC (4yr: 95% vs 91%, p=0.35). On multivariate analysis factoring in age, smoking history, stage, and treatment type, rECE presence was a negative predictor of OS (hazard ratio, 0.26; 95% CI, 0.07 to 0.95) and PFS (hazard ratio, 0.23; 95% CI, 0.06 to 0.81), with DC approaching significance (hazard ratio, 0.13; 95% CI, 0.02 to 1.05). Conclusions: While pECE is an established risk factor for locally advanced OPC, this study suggests that rECE may be an independent poor prognosticator of PFS, OS and DC with potential importance in guiding clinical management.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6048-6048 ◽  
Author(s):  
Samer Alsidawi ◽  
Gustavo Figueiredo Marcondes Westin ◽  
Ashish V. Chintakuntlawar ◽  
Scott H. Okuno ◽  
Katharine Andress Rowe Price

6048 Background: The role of Human Papilloma Virus (HPV) infection in non-oropharyngeal squamous cell carcinoma (non-OPSCC) of the head and neck is unknown. Current available studies have yielded conflicting results due to limited number of patients. We present a large analysis from the National Cancer Database (NCDB) evaluating HPV-positive non-OPSCC. Methods: Using the NCDB registry, we included adults diagnosed with non-OPSCC from 2004-2012 with available HPV status. A cohort of patients with OPSCC was analyzed for HPV prevalence comparison. Survival analysis was performed using Kaplan-Meier method and stratified using HPV-status. The prognostic effect of variables was studied using Cox proportional hazards models. The JMP software was used for statistical analysis. Results: A total of 8726 non-OPSCC patients were identified and primary sites included the oral cavity (50%), larynx (41%) and hypopharynx (9%). 11% of non-OPSCC patients had evidence of infection with high-risk HPV strains compared to 61% of OPSCC patients. HPV-positive non-OPSCC patients presented at slightly younger age, had more advanced stage and higher tumor grade compared to HPV-negative patients (P < 0.01). HPV-positive non-OPSCC patients had better survival than HPV-negative patients (HR 0.82, 95% CI 0.72-0.93, P < 0.01) and this was most pronounced in patients with locally advanced disease (5-year survival 50% versus 40%, HR 0.69, 95% CI 0.6-0.8, P < 0.01). A univariate and multivariate analysis were performed adjusting for age, sex, race, stage, primary site, Charlson/Deyo comorbidity score, financial income, tumor grade, surgery, radiation and chemotherapy administration. Smoking history was unavailable. HPV positivity was an independent predictor of better survival in non-OPSCC in multivariate analysis (HR 0.69, 95% CI 0.59-0.8, P < 0.01). Conclusions: HPV infection is seen in a subset of patients with non-OPSCC head and neck cancer and these present with more advanced tumors. The survival of patients with HPV-positive non-OPSCC is significantly better than HPV-negative tumors. Routine HPV testing and enrollment in treatment de-intensification clinical trials similar to OPSCC might be appropriate for this patient population.


2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 251-251
Author(s):  
J. Wang ◽  
C. C. Hsu ◽  
C. D. Fuller ◽  
T. M. Pawlik ◽  
R. C. Miller ◽  
...  

251 Background: To assess the effect of adjuvant therapy in gallbladder adenocarcinoma (GBC). Methods: Retrospective review was conducted at five institutions to identify pts who had surgery for confirmed dx of GBC from 1985-2008 (N = 189). Pts were excluded if they had chemo alone (N = 8), path other than adenoca (N= 7), carcinoma in situ (N=1), < 30 days of follow-up (N = 2), or missing data (N=14). Of the remaining 156 pts, 58 received surgery only and 98 received adj RT ± chemo. Kaplan-Meier was used for overall survival (OS) and Cox proportional hazards to compare risk factors. Results: Median age of dx was 64.4, 68.0% were female, 37.9% had ≥ stage 2b, 37.2% had + nodes, and 32.1% had + margins. Overall, 35.9% of the patients had simple cholecystectomy (SC) only and 64.1% had radical resection (ER). mOS for pts treated with surgery alone was 49.7 months (95% CI: 24.8 to Inf). On univariate analysis, + margins (HR 2.72, p<0.001) was associated with worse OS, whereas ER compared to SC improved survival in both univariate (HR 0.46, p<0.001) and multivariate (HR 0.53, p=0.033) analyses after adjusting for node/margins, T-stage, adj RT, age, gender, and institution. mOS for the entire cohort vs. adj RT (median 50.4 Gy) ± chemo was 30.7 months (95% CI: 19.2 to 46.9) vs. 26.9 months (95% CI: 15.5 to 39.1). But, compared to surgery alone, the adj group was more likely to have had node +, margin +, or T-stage 3+ (all p<0.001). The adj RT group was also less likely than surgery alone pts to have undergone ER (p = 0.007). On multivariate analysis, decreased OS was also found for node + (HR 2.09, p=0.004), margin + (HR 1.84, p=0.043), and T3/T4 disease (HR 2.37, p=0.002). After adjusting for surgical extent, node, margin, T stage, age, gender, and institution, there was improved OS with adj therapy (HR: 0.43, p = 0.020). When stratified by surgical extent, the risk estimate for adj RT improved OS among those with SC (n=56; HR 0.20, p=0.135) and ER (n=100; HR 0.46, p=0.067), but was not statistically significant. Conclusions: ER was associated with improved OS, whereas node/margin+ and T-stage 3+ were associated with worse survival. In multivariate analysis, adj RT improved OS after surgery. Given the poor prognosis of GBC patients with advanced disease, consideration of adj therapy is appropriate. No significant financial relationships to disclose.


2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 34-34
Author(s):  
Naruhiko Ikoma ◽  
Elena Elimova ◽  
Mariela A. Blum ◽  
Jaffer A. Ajani ◽  
Y. Sabrina Chiang ◽  
...  

34 Background: Because gastric cancers stage ≥ T2 or ≥ N1 are considered for neoadjuvant treatment, accuracy of preoperative staging is critical. The purpose of this study was to identify preoperative staging accuracies of computed tomography scan (CT) and endoscopic ultrasound (EUS) in gastric cancer and their utilities in selecting patients for neoadjuvant therapy. Methods: Medical records of 8,260 patients with gastric or gastroesophageal adenocarcinoma (presented 1995-2013) were reviewed to identify those who underwent gastrectomy but not neoadjuvant treatment. We reviewed preoperative EUS reports and CT images to identify detailed T stage (based on AJCC 7thedition) and lymph node positivity (short axis diameter ≥ 6mm). T stage and N status were compared with those from the surgical pathology report. Clinicopathologic variables associated with incorrect preoperative staging were also examined. Results: We identified 187 patients who underwent preoperative staging by EUS (n = 145) and/or CT (n = 134) for gastrectomy. The accuracy, sensitivity, and specificity of EUS in distinguishing T1 from more advanced tumors were 82%, 78%, and 85%, respectively. In univariate analysis, tumor location and lymphovascular invasion were associated with incorrect EUS T staging. In multivariate analysis, variables associated with underestimation of EUS T stage was lymphovascular invasion (OR 7.51, 95% CI 1.91-29.5, p < 0.01) and Caucasian race (OR 3.75, 95% CI 1.31-10.75, p = 0.01). The accuracies, sensitivities, and specificities for N status were, respectively, 65%, 49%, and 79% with CT and 66%, 29%, and 95% with EUS. In univariate analysis, poor differentiation and lymphovascular invasion were associated with incorrect diagnosis of CT N status. In multivariate analysis, lymphovascular invasion was associated with false-negative (OR 3.79, 95% CI 1.34-10.7, p = 0.01), and differentiated histology was associated with false-positive CT N status (OR 7.14, 95% CI 2.00-25.44, p < 0.01). Conclusions: EUS has reasonable accuracy in T stage, while both CT and EUS have low sensitivities and high specificities in N status. These accuracies should be considered when selecting patients for neoadjuvant treatment.


2014 ◽  
Vol 90 (1) ◽  
pp. S31-S32 ◽  
Author(s):  
S.K. Mai ◽  
M. Reuschenbach ◽  
M. Ottstadt ◽  
G. Welzel ◽  
S. Severa ◽  
...  

1996 ◽  
Vol 82 (6) ◽  
pp. 554-559 ◽  
Author(s):  
Antoni Ribas ◽  
Joaquim Bellmunt ◽  
Joan Albanell ◽  
Inés De Torres ◽  
Begoña Bermejo ◽  
...  

Aims and Background Several reports on prognostic factors for infiltrating bladder cancer have given controversial results. We assessed the prognostic value of p53 nuclear overexpression together with known prognostic factors for survival in patients with invasive T2-4 NO MO bladder cancer treated with neoadjuvant chemotherapy. Study Design Thirty-five paraffi-nized tumor samples from initial transurethral resection of patients with bladder cancer were analyzed immunohistochemi-cally to detect overexpression of p53 protein. Patients were treated with 3 to 4 cycles of neoadjuvant methotrexate, carboplatin, and vinblastine (M-CAVI) and then underwent radical cystectomy. Prechemotherapy, treatment, and postchemotherapy factors were analyzed for correlation with survival by univariate and multivariate analysis. Fifty-seven percent of tumors were positive for p53 protein, 71.5% had grade III-IV tumors, and 72% had organ-confined disease. The median follow-up was 20 months (range 5-71+). Results By univariate analysis, the significant pretreatment factors were initial tumor (T) stage ( P <0.0001) and the male sex ( P = 0.03). Five postchemotherapy variables were found significant: surgery performed according to protocol ( P = 0.003), overall clinical ( P = 0.004), and overall pathologic ( P = 0.02) response to therapy, postchemotherapy pathologic stage ( P = 0.0002), and tumor status after surgery ( P = 0.0006). By multivariate analysis, the initial prechemotherapy T stage was the only factor that demonstrated independent significance. Conclusions Although the median follow-up of the study is still too short, in this group of patients treated with a neoadjuvant carboplatin-based regimen, a classical variable (prechemotherapy T stage) rather than p53 nuclear overexpression was an independent prognostic factor for survival. Further follow-up will be required to assess the value of p53 overexpression as a prognostic factor in invasive bladder cancer patients treated with neoadjuvant carboplatin-based chemotherapy.


Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5018-5018 ◽  
Author(s):  
William G. Wierda ◽  
X. Wang ◽  
S. OBrien ◽  
S. Faderl ◽  
A. Ferrajoli ◽  
...  

Abstract Prognostic factors are tools to address heterogeneity in clinical behavior and survival in patients with disease. They are particularly relevant for patients with malignancy, including chronic lymphocytic leukemia (CLL). There is striking heterogeneity in overall survival (OS) of patients with CLL as well as in response to treatment, time to treatment failure (TTF), and time to progression (TTP) following response. Serum β2 microglobulin (β2M) has previously been reported to correlate with OS and TTP in patients with CLL. We performed a retrospective analysis of 659 Rx-naïve and 1062 previously treated patients with CLL enrolled on clinical trials from 5/74 to 7/05 at MD Anderson Cancer Center evaluating for predictors for response to treatment, amount of treatment given, incidence of myelosuppression, TTF, TTP in responders, and OS. Univariate analysis was performed, then significant factors were used to develop multivariate models for these endpoints. Groups were analyzed separately. The clinical factors evaluated included: age, Rai stage, # nodal sites, liver and spleen size, β2M, WBC, ALC, HGB, PLT, serum LDH, Cr, ALB, CD38 expression, and serum Ig levels, and refractoriness to alkylating agents and fludarabine and # prior treatments for previously treated patients. In the Rx-naïve group, characteristics (median and range) were as follows: age=57 yrs(17–86); β2M=3.3 mg/L(1.1–16.4); WBC=74.7k/μL(2.1–552); ALC= 63k/μL(1–512); HGB=12.7 g/dL(5.7–18.7); PLT=156 k/μL(8–450); LDH=545 IU/L(103–3600); and IgG=754 mg/dL(45–5000). Patients with Rai stage 0=28; Rai I-II=402; and Rai III-IV=196. In the previously treated group, characteristics (median and range) were as follows: age=61 yrs(25–83); β2M= 4.4 mg/L(1.4–59.4); WBC= 43 k/μL(.6–953); ALC=36 k/μL(0–829); HGB=11.4 g/dL(3.8–17.6); PLT= 121 k/μL(2–703); LDH=597 IU/L(21–4739); and IgG=586 mg/dL(14–5000). Patients with Rai stage 0=37; Rai I-II=392; and Rai III-IV=563. Multivariate models identified the following predictors (p&lt;.05) for response to treatment for Rx-naive patients: β2M, PLT, ALC, age, and treatment regimen; for previously treated patients they were β2M, PLT, HGB, age, # prior Rx, and treatment regimen. TTF was correlated in multivariate analysis (p&lt;.05) with β2M, age, extent of bone marrow (BM) involvement, and treatment regimen for Rx-naïve patients and with β2M, HGB, IgM, # prior Rx, and treatment regimen for previously treated patients. TTP for responders correlated (p&lt;.05) in multivariate analysis with treatment regimen and BM involvement for Rx-naïve and with # prior Rx and treatment regimen for previously treated patients. Finally, Cox proportinal hazards model for OS identified the following predictors in Rx-naïve patients: β2M, age, treatment regimen; and for previously treated patients they included β2M, # prior Rx, age, treatment regimen, IgM, HGB, and PLT. Therefore, β2M and treatment regimen were consistent and significant independent predictors of outcome. In Rx-naïve patients, β2M level rose prior to initiating treatment, decreased with response to treatment for responders, and rose again with relapse in those patients with serial β2M determinations. β2M is a powerful prognostic factor for patients with CLL predicting for multiple clinical endpoints. We are currently incorporating it into our risk-stratification for clinical trials and it should be incorporated into the routine evaluation of patients with CLL.


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