Composite scoring combining OncotypeDX risk with circulating tumor cell status improves prognostication.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e12577-e12577
Author(s):  
Nadeem Bilani ◽  
Leah Elson ◽  
Elizabeth Blessing Elimimian ◽  
Hong Liang ◽  
Zeina A. Nahleh
Keyword(s):  
High Risk ◽  
Tumor Cell ◽  
Prognostic Value ◽  
Early Stage ◽  
Scoring Systems ◽  
Circulating Tumor Cell ◽  
Low Risk ◽  
Intermediate Risk ◽  
Hormone Receptor Positive ◽  
Her2 Breast Cancer

e12577 Background: Genomic assays, such as the 21-gene OncotypeDX (ODX) and the 70-gene MammaPrint (MP) panels, can be used to personalize treatment for women with early-stage, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer (BC). We previously showed that 1) circulating tumor cell (CTC) status has prognostic and predictive value in BC, and that 2) there is no clear association between ODX risk and CTCs. We, hereby, assess the prognostic value of composite scoring combining ODX and CTC data. Methods: This analysis of the 2004-2017 National Cancer Database registry includes patients with early-stage (AJCC I-II), HR+/HER- BC, as well as ODX, MP, and CTC data. A composite model was created with ODX and CTC data: low-risk escalated to intermediate-risk, or intermediate- to high-risk, if positive for CTCs. The association between a) ODX, b) ODX-CTC composite, or c) MP and overall survival (OS) was examined using Cox regressions, controlling for age (50-70); and stratifying by race (White vs. Black) and tumor histology (ductal vs. lobular). Prognostic value was evaluated using Harrell’s C-index (i.e. area under ROC curve) for each model. Results: N = 841,716 patients with early-stage, HR+/HER2- BC were identified. N = 271,416 (32.2%) had ODX data, n = 12,417 (1.5%) had MP data, and n = 1,141 (0.14%) had both ODX and CTC data. Due to CTC-positivity, n = 46 patients were upstaged from low- to intermediate-risk (23.1% of all low-risk), while n = 63 patients were upstaged from intermediate- to high-risk (20.5% of all intermediate-risk) in the composite ODX-CTC model. All 3 prognostic scoring systems were associated (p < 0.05) with OS as per Cox regressions. As indicated by a C-index closer to 1, MP appears superior to ODX alone at differentiating high- from low-risk based on OS (0.597 versus 0.565) patients. However, composite ODX-CTC scoring was superior to MP alone (0.673 versus 0.597). This model could not be validated in Black patients (versus White) or those with lobular histology (compared to ductal) due to limited ODX-CTC data in these groups. Conclusions: Composite ODX-CTC risk scoring appears superior to MP alone. If confirmed, this prognostic model would more accurately identify early-stage, HR+/HER2- patients requiring escalated systemic therapy including chemotherapy compared to low-risk BC. More data is needed in ethnic minorities and patients with atypical histology to validate these promising results.[Table: see text]

scholarly journals Risk Evaluation of Early-stage Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer Patients: a Population-based Study From Taiwan

2021 ◽  
Author(s):  
Lei Lei ◽  
Han-Ching Chan ◽  
Tzu-Pin Lu ◽  
Hung-Chun Skye Cheng
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Prognostic Value ◽  
Risk Group ◽  
Early Stage ◽  
Growth Factor Receptor ◽  
Risk Groups ◽  
Low Risk ◽  
Hormone Receptor Positive ◽  
Epidermal Growth

Abstract PURPOSE: To assess the prognostic value of the Dutch criteria for patients with early-stage hormone receptor-positive and human epidermal growth factor receptor 2-negative breast cancer from the Taiwan Cancer Database. PATIENTS AND METHODS:We included 8,295 patients with early-stage node-negative breast cancer who underwent surgery during January 2008–December 2012. Patients were stratified into low- and high-risk groups based on the Dutch criteria. The Kaplan–Meier method and log-rank test were used to estimate the difference in breast cancer-specific survival (BCSS) and overall survival (OS) between groups. Multivariable analysis was used to evaluate the prognostic value of the Dutch criteria.RESULTS: Overall, the low-risk and high-risk groups comprised 5,375 and 2,920 patients, respectively. In the low- and high-risk groups, the 5-year BCSS rate was 99.6% and 98.2% (P<0.0001) and the 5-year OS rate was 98.3% and 96.8% (P<0.0001), respectively. The hazard ratio for BCSS was 4.18 (95% confidence interval [CI], 2.63–6.63, P<0.0001), and the hazard ratio for OS was 1.94 (95% CI, 1.48–2.55); both were significantly poorer in the high-risk group than in the low-risk group. In the low-risk group, the 5-year BCSS and OS of patients who did and did not receive adjuvant chemotherapy were similar (99.5% versus 99.6% [P=0.927] and 98.8% and 98.1% [P=0.0683], respectively). CONCLUSIONS: The prognosis of low-risk patients as classified using the Dutch criteria is excellent with or without adjuvant chemotherapy. The benefit of multi-gene testing for chemotherapy decision-making might be minimal in these patients.

Value of clinical treatment score post-5 years (CTS5) for late relapse risk assessment in patients with early-stage HER2+ breast cancer (BC) in the north central cancer treatment group (NCCTG) N9831 (Alliance) trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 529-529
Author(s):  
Tanmayi Pai ◽  
Angelica Gil ◽  
Yaohua Ma ◽  
Zhuo Li ◽  
Pooja Advani ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Tumor Size ◽  
Cox Regression ◽  
Early Stage ◽  
Low Risk ◽  
Late Relapse ◽  
Intermediate Risk ◽  
Relapse Risk ◽  
Significant Difference

529 Background: Multiple prognostic models exist to predict late relapse risk in early stage hormone receptor-positive (HR+) breast cancer (BC). The CTS5 is one such model that has been validated in HR+ HER2-negative BC. The value of this model in HR+ HER2+ has not been established. Here, we assessed CTS5 in patients (pts) with early stage HER2+ BC treated in the NCCTG N9831 (Alliance) trial. Methods: Pts with stage I-III HER2+ HR+ BC who survived ≥ 5 years were included. The online CTS5 calculator was used to determine CTS5 score and risk group (low, intermediate, and high) based on age, tumor size, grade, and number of involved nodes. Kaplan-Meier (KM) estimates, Cox regression models, and C index were used for analysis. Results: From 3,130 pts, 1,204 pts met the criteria and were included. Median age was 49 (22-79) years and median tumor size was 2.4 (0.1-12) cm. 63.6% had grade 3 tumors, 33.6% grade 2, and 2.8% grade 1. Median follow up was 10.89 (5.01-15.32) years. Based on CTS5, 821 (68.2%) pts were classified as high risk, 289 (24%) as intermediate risk, and 94 (7.8%) as low risk. Overall, using univariate Cox regression analysis, there was no statistically significant difference in recurrence free survival (RFS) among pts with intermediate vs. low (HR 0.47 95%CI 0.18-1.22, p = 0.12) and high vs. low (HR1.23 95%CI0.57-2.67, p = 0.6) with the C index of 0.58. Among pts who received concurrent trastuzumab (H) with HR+ BC, there was also no statistical difference in RFS between high vs. low (HR 0.68 95%CI0.24-1.97, p = 0.48) with the C index of 0.55. Paradoxically, pts with intermediate risk had better RFS than low risk (HR 0.18 95%CI0.03-0.97, p = 0.05). As a continuous variable, there is also no significant improvement in RFS per 1 unit increase in CTS5 score (HR 1.19 95%CI 0.73-1.96, p = 0.49) with the C index of 0.54. After 5 years, 7.06% (n = 30/425) of HR+ pts treated with concurrent H recurred. Conclusions: The CTS5 model is not prognostic in pts with early stage HR+ HER2+ BC receiving adjuvant H. While most HR+ HER2+ pts are classified as high risk by CTS5, the recurrence between years 5-10 was low in pts who received adjuvant H. This study highlights the need to develop a new predictive model for risk of late relapse in this specific group of pts to enable clinicians to determine which pts would benefit from extended adjuvant endocrine therapy. Support: BCRF-19-161, U10CA180821, Genentech. https://acknowledgments.alliancefound.org Clinical trial information: NCT00005970 .

scholarly journals Development and validation of prediction scores for nosocomial infections, reoperations, and adverse events in the daily clinical setting of neurosurgical patients with cerebral and spinal tumors

2020 ◽  
pp. 1-11
Author(s):  
Sebastian Lohmann ◽  
Tobias Brix ◽  
Julian Varghese ◽  
Nils Warneke ◽  
Michael Schwake ◽  
...  
Keyword(s):  
High Risk ◽  
Adverse Events ◽  
Nosocomial Infections ◽  
Scoring Systems ◽  
Low Risk ◽  
Risk Scores ◽  
Spinal Tumors ◽  
Intermediate Risk ◽  
Development And Validation

OBJECTIVEVarious quality indicators are currently under investigation, aiming at measuring the quality of care in neurosurgery; however, the discipline currently lacks practical scoring systems for accurately assessing risk. The aim of this study was to develop three accurate, easy-to-use risk scoring systems for nosocomial infections, reoperations, and adverse events for patients with cerebral and spinal tumors.METHODSThe authors developed a semiautomatic registry with administrative and clinical data and included all patients with spinal or cerebral tumors treated between September 2017 and May 2019. Patients were further divided into development and validation cohorts. Multivariable logistic regression models were used to develop risk scores by assigning points based on β coefficients, and internal validation of the scores was performed.RESULTSIn total, 1000 patients were included. An unplanned 30-day reoperation was observed in 6.8% of patients. Nosocomial infections were documented in 7.4% of cases and any adverse event in 14.5%. The risk scores comprise variables such as emergency admission, nursing care level, ECOG performance status, and inflammatory markers on admission. Three scoring systems, NoInfECT for predicting the incidence of nosocomial infections (low risk, 1.8%; intermediate risk, 8.1%; and high risk, 26.0% [p < 0.001]), LEUCut for 30-day unplanned reoperations (low risk, 2.2%; intermediate risk, 6.8%; and high risk, 13.5% [p < 0.001]), and LINC for any adverse events (low risk, 7.6%; intermediate risk, 15.7%; and high risk, 49.5% [p < 0.001]), showed satisfactory discrimination between the different outcome groups in receiver operating characteristic curve analysis (AUC ≥ 0.7).CONCLUSIONSThe proposed risk scores allow efficient prediction of the likelihood of adverse events, to compare quality of care between different providers, and further provide guidance to surgeons on how to allocate preoperative care.

Prognostic Value of Molecular Markers for Guiding Post-Remission Therapy in Patients with De Novo Acute Myeloid Leukemia (AML) and Intermediate-Risk Cytogenetics

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2522-2522
Author(s):  
Marta Pratcorona ◽  
Mireia Camós ◽  
Montserrat Torrebadell ◽  
Maria Rozman ◽  
Ana Carrió ◽  
...  
Keyword(s):  
High Risk ◽  
Prognostic Value ◽  
De Novo ◽  
Low Risk ◽  
High Dose ◽  
Intermediate Risk ◽  
Hematopoietic Stem ◽  
Allogeneic Hsct ◽  
Molecular Features ◽  
Mutational Status

Abstract The heterogeneous prognosis of patients with intermediate-risk cytogenetics AML (AML-IR) can be partially clarified by screening of NPM1 mutations (NPMmut) and internal tandem duplication of FLT3 (FLT3-ITD). Nonetheless, additional factors might influence the prognostic effect of these molecular lesions, such as the FLT3-ITD mutant level. Moreover, the optimal post-remission strategy might differ depending on the underlying molecular lesion. In this regard, we analyzed the outcome, according to NPM1 and FLT3 mutations and post-remission therapy given, of a series of patients diagnosed with de novo AML-IR in a single institution who received intensive chemotherapy. Patients were treated following 4 sequential protocols of CETLAM group during the period 1994–2006, consisting of 1 or 2 cycles of standard induction chemotherapy and 1 course of high-dose cytarabine-based consolidation therapy. Thereafter, patients underwent hematopoietic stem cell transplantation (HSCT) according to donor availability and presumed risk (protocols LAM 99 & 2003). NPM1 mutations and FLT3-ITD were screened in diagnostic DNA by PCR amplification followed by Genescan analysis. The ratio between FLT3-ITD and wildtype FLT3 alleles (ITD/wt ratio) was calculated using the area under the peak of corresponding alleles. Overall, 134 patients (51% male; median age, 53; range: 17–70) with AML-IR (normal karyotype, 66%) were studied. NPM1mut and FLT3-ITD were found in 45% and 37% of patients, respectively, with a median ITD/wt ratio of 0.59 (0.045–5.5). After induction regimen, 109 patients (81%) achieved complete response (CR). The only variables predictive of a favorable response were NPMmut (90% vs. 75%; p=0.01) and age &lt;60 (85% vs. 72.5%; p=0.05). After a median follow-up of 69 months, relapse risk (RR) at 5 years was 54% (±5%). RR was higher in patients presenting with hyperleukocytosis (&gt;50 × 109/L), NPMwt, and FLT3-ITD. Interestingly, the prognostic value of FLT3-ITD depended on the relative mutant level, and detection of FLT3-ITD with a low ITD/wt ratio (i.e.,&lt;0.3) did not increase the risk conferred by underlying NPM1 mutational status. In accordance, a composite variable based on NPMmut and quantitative FLT3-ITD was created defining 2 prognostic categories: a low-risk group (LOWmol), constituted by patients with NPMmut and either absence of FLT3-ITD or low ITD/wt ratio, and a high-risk subset (HIGHmol), defined by the absence of NPMmut and/or high ITD/wt ratio. This molecular stratification showed independent prognostic value for RR (5-year RR: 24%±10% vs. 81%±7 in LOWmol vs. HIGHmol patients, respectively; p&lt;0.001), and survival (OS; relative risk: 2.8, 95% CI:1.6-5, p&lt;0.001; figure Moreover, the effect of post-remission therapy varied in both molecular-defined subgroups. Thus, among patients with an age ≤60, 5-year survival in LOWmol patients with a planned autologous HSCT (autoHSCT) was 83%±9%, not differing significantly from that of patients undergoing allogeneic HSCT (intention-to-treat analysis; figure On the other hand, 5-year OS of HIGHmol patients who underwent allogeneic HSCT in first CR was 73%±13, which compared favorably with other post-remission strategies (5-yr OS: 27%±7%; p=0.019). In conclusion, in patients with intermediate-risk AML, the combined assessment of NPM1 mutations and quantitative estimation of FLT3-ITD allows the distinction of 2 categories of patients with different prognosis. Thus, whereas autoHSCT arises as an effective postremission therapy in patients harboring low-risk molecular features, allogeneic HSCT in first CR seems to overcome adverse prognosis of patients with high-risk disease. Nonetheless, the validity of this molecularly-based therapeutic algorithm warrants confirmation in other studies. Figure Figure

scholarly journals Effectiveness in Predicting the Response and Outcome with Three Prognostic Scoring Systems in Pediatric CML CP on Upfront Imatinib

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4549-4549
Author(s):  
Ganta Ranga Raman ◽  
Srividya Nasaka ◽  
Sadashivudu Gundeti ◽  
Vijay Gandhi Linga ◽  
Narendra Anukonda ◽  
...  
Keyword(s):  
High Risk ◽  
Risk Score ◽  
Scoring Systems ◽  
Risk Groups ◽  
Cytogenetic Response ◽  
Low Risk ◽  
P Value ◽  
Intermediate Risk ◽  
Hematological Response ◽  
Prognostic Scoring Systems

Abstract Introduction: The Sokal and Hasford (Euro) scores were developed in the chemotherapy and interferon era and are widely used as prognostic indicators in patients with chronic myeloid leukemia (CML).Recently, European Treatment and Outcome Study (EUTOS) scoring system was introduced. Data on risk stratification in pediatric CML population was lacking due to its rarity [<3%]. Objective: To study the effectiveness in predicting the response and outcome with three prognostic scores in pediatric CML-chronic phase patients on front line Imatinib. Materials and methods: We retrospectively analyzed the hospital records of newly diagnosed CML CP patients [aged ≤18 years] from 2004 to 2010 for their risk score, cytogenetic response and outcome at the end of 4 years. Outcome was measured in terms of event free survival (EFS) at the end of 48 months. Events include loss of hematological response, loss of cytological response, progression to accelerated/ blast phase (AP/BC). All received free Imatinib under Gleevac international patient assistance program. Results: Data of 106 children was analyzed with median age of 13.5 years [ranged 5-18 years] and male preponderance [M:F =1.14:1]. The distribution of children was 63%, 32% and 5% in Sokal low, intermediate and high risk respectively, 50%, 43% and 5% in Hasford/Euro low, intermediate and high risk respectively, 71% and 29% in EUTOS low and high risk respectively. The overall cumulative complete hematological response at the end of 3 month was 94%, and complete cytogenetic response at 18 months was 75%. The CCyR at 18 month was seen in 72%,76% and 100% among Sokal low, intermediate and high risk groups respectively, 74%, 73% and 100% among Hasford/Euro low, intermediate and high risk groups respectively, 81% and 86% EUTOS low and high risk groups respectively. The EFS at the end of 48 months was seen in 72%,64% and 83% among Sokal low, intermediate and high risk groups respectively; 70%, 63% and 83% among Hasford/Euro low, intermediate and high risk groups respectively; 73% and 66% EUTOS low and high risk groups respectively. Conclusion: None of the scoring systems predicted the response and outcome effectively in children with CML CP. Children with EUTOS low risk score had better EFS than high risk score but not statistically significant. These age group CML patients need to be studied and new prognostic scoring systems are needed to risk startify. Limitation of the study: small sample size, not a prospective study Table 1EventsEUTOS low risk n=76 (71%)EUTOS high risk n=30 (29%)p value (Fishers test)CHR at 3mon72/76 (94%)26/30 (86%)0.21CCyR at 12mon58/76 (76%)22/30 (73%)0.8CCyR at 18mon62/76 (81%)26/30 (86%)0.77EFS at 4 yrs56/76 (73%)20/30 (66%)0.48 Table 2 Events Sokal low risk n=66 (63%) Sokal intermediate risk n=34 (32%) Sokal high risk n=6 (5%) p value (Fishers test) CHR at 3mon 60/66 (100%) 34/34 (100%) 6/6 (100%) 0.18 CCyR at 12mon 32/66 (48%) 20/34 (58%) 5/6 (83%) 0.23 CCyR at 18mon 48/66 (72%) 26/34 (76%) 6/6 (100%) 0.4 EFS at 4 yrs 48/66 (72%) 22/34 (64%) 5/6 (83%) 0.6 Table 3 Events Euro low risk n=54 (50%) Euro intermediate risk n=46 (43%) Euro high risk n=6 (5%) p value (Fishers test) CHR at 3 mon 50/54 (92%) 46/46 (100%) 6/6 (100%) 0.16 CCyR at 12 mon 36/54 (66%) 26/46 (56%) 5/6 (83%) 0.36 CCyR at 18 mon 40/54 (74%) 34/46 (73%) 6/6 (100%) 0.46 EFS at 4 yrs 38/54 (70%) 30/46 (63%) 5/6 (83%) 0.94 Disclosures No relevant conflicts of interest to declare.

scholarly journals Chemotherapy Costs and 21-Gene Recurrence Score Genomic Testing Among Medicare Beneficiaries With Early-Stage Breast Cancer, 2005 to 2011

2019 ◽  
Vol 17 (3) ◽  
pp. 245-254 ◽  
Author(s):  
Michaela A. Dinan ◽  
Lauren E. Wilson ◽  
Shelby D. Reed
Keyword(s):  
High Risk ◽  
Early Stage ◽  
Recurrence Score ◽  
Low Risk ◽  
Genomic Testing ◽  
Intermediate Risk ◽  
Medicare Beneficiaries ◽  
Primary Analysis ◽  
High Risk Disease ◽  
Risk Patients

Background: This study examined whether associations between 21-gene recurrence score (RS) genomic testing and lower costs among patients with early-stage, estrogen receptor–positive breast cancer are observable in real-world data from the Medicare population. Methods: A retrospective cohort study was conducted using SEER-Medicare data for a nationally representative sample of Medicare beneficiaries diagnosed from 2005 through 2011. The main outcomes were associations between RS testing and overall and chemotherapy-specific costs. The primary analysis was restricted to patients aged 66 to 75 years. Results: The primary analysis comprised 30,058 patients. Mean costs 1 year after diagnosis were $35,940 [SD, $28,894] overall, $51,127 [33,386] for clinically high-risk disease, $33,225 [$27,711] for intermediate-risk disease, and $26,695 [$19,532] for low-risk disease. Chemotherapy-specific costs followed similar trends. In multivariable analyses, RS testing was associated with significantly lower costs among high-risk patients in terms of both relative costs (cost ratio, 0.88; 99% CI, 0.82–0.94) and absolute costs ($6,606; 99% CI, $39,223–$9,290). Higher costs among low-risk and intermediate-risk patients were mainly caused by higher noncancer costs. In sensitivity analyses that included all patients aged ≥66 years (N=64,996), associations between RS testing and costs among high-risk patients were similar but less pronounced because of lower overall use of chemotherapy. Conclusions: RS testing was associated with lower overall and chemotherapy-related costs in patients with high-risk disease, consistent with lower chemotherapy use among these patients. Higher overall costs for patients with intermediate-risk and low-risk disease were driven largely by non–treatment-related costs.

scholarly journals Survival outcomes of low-risk and intermediate-risk stage IB1 cervical cancer patients

2019 ◽  
Vol 13 (1) ◽  
pp. 27-32
Author(s):  
Asama Vanichtantikul ◽  
Patou Tantbirojn ◽  
Tarinee Manchana
Keyword(s):  
Cervical Cancer ◽  
High Risk ◽  
Prognostic Factor ◽  
Cancer Patients ◽  
Early Stage ◽  
Low Risk ◽  
Survival Outcomes ◽  
Intermediate Risk ◽  
Early Stage Cervical Cancer ◽  
Risk Patients

Abstract Background Survival for patients with early stage cervical cancer without any high-risk factors treated with radical hysterectomy is excellent. However, there are few data on the survival outcomes for low-risk and intermediate-risk early stage cervical cancer patients. Objective To determine survival outcomes and prognostic factors of low-risk and intermediate-risk stage IB1 cervical cancer patients. Methods Stage IB1 cervical cancer patients with radical hysterectomy and pelvic lymphadenectomy were retrospectively reviewed. Patients with positive pelvic nodes, parametrial involvement, and positive margin who are classified as high-risk patients were excluded. Patients with squamous cell carcinoma or grade 1–2 adenocarcinoma, tumor size less than 2 cm, no lymphovascular space invasion (LVSI), and depth of stromal invasion (DSI) less than 10 mm were defined as low-risk patients. Survival was evaluated using the Kaplan–Meier method and compared by the log-rank test. Multivariate analysis was performed using Cox proportional-hazards regression. Results There were 82 (42.3%) low-risk patients and 112 (57.7%) intermediate-risk patients. More patients in intermediate risk received adjuvant treatment (3.6% and 14.3%, P = 0.07). Three (3.6%) low-risk patients and 18 (16.1%) intermediate-risk patients had recurrent disease (P = 0.004). At median follow-up of 86 months, 1.2% of low-risk patients and 8.9% of intermediate-risk had cancer-related deaths (P = 0.02). Low-risk patients had significantly better 5-year disease-free survival (98.2% vs 91.1%, P = 0.01) and estimated 5-year overall survival (98.5% vs 91.1%, P = 0.01). DSI more than 10 mm and presence of LVSI were significantly associated with recurrence. However, LVSI was an independent prognostic factor. Conclusion Stage IB1 cervical cancer patients had excellent survival. Low-risk patients had significantly better survival. Presence of LVSI was an independent prognostic factor.

scholarly journals International prognostic score for asymptomatic early-stage chronic lymphocytic leukemia

Blood ◽  
2020 ◽  
Vol 135 (21) ◽  
pp. 1859-1869 ◽  
Author(s):  
Adalgisa Condoluci ◽  
Lodovico Terzi di Bergamo ◽  
Petra Langerbeins ◽  
Manuela A. Hoechstetter ◽  
Carmen D. Herling ◽  
...  
Keyword(s):  
High Risk ◽  
Chronic Lymphocytic Leukemia ◽  
Risk Score ◽  
Early Stage ◽  
Prognostic Score ◽  
Lymphocytic Leukemia ◽  
Low Risk ◽  
Intermediate Risk ◽  
Early Stage Disease ◽  
International Prognostic Score

Abstract Most patients with chronic lymphocytic leukemia (CLL) are diagnosed with early-stage disease and managed with active surveillance. The individual course of patients with early-stage CLL is heterogeneous, and their probability of needing treatment is hardly anticipated at diagnosis. We aimed at developing an international prognostic score to predict time to first treatment (TTFT) in patients with CLL with early, asymptomatic disease (International Prognostic Score for Early-stage CLL [IPS-E]). Individual patient data from 11 international cohorts of patients with early-stage CLL (n = 4933) were analyzed to build and validate the prognostic score. Three covariates were consistently and independently correlated with TTFT: unmutated immunoglobulin heavy variable gene (IGHV), absolute lymphocyte count higher than 15 × 109/L, and presence of palpable lymph nodes. The IPS-E was the sum of the covariates (1 point each), and separated low-risk (score 0), intermediate-risk (score 1), and high-risk (score 2-3) patients showing a distinct TTFT. The score accuracy was validated in 9 cohorts staged by the Binet system and 1 cohort staged by the Rai system. The C-index was 0.74 in the training series and 0.70 in the aggregate of validation series. By meta-analysis of the training and validation cohorts, the 5-year cumulative risk for treatment start was 8.4%, 28.4%, and 61.2% among low-risk, intermediate-risk, and high-risk patients, respectively. The IPS-E is a simple and robust prognostic model that predicts the likelihood of treatment requirement in patients with early-stage CLL. The IPS-E can be useful in clinical management and in the design of early intervention clinical trials.

Secondary Invasive Breast Events among Patients with Hormone-Positive Breast Cancer and High-Risk Oncotype DX Recurrence Scores 26–30 and ≥31

Oncology ◽  
2021 ◽  
pp. 1-4
Author(s):  
Natalie F. Berger ◽  
Brittney S. Zimmerman ◽  
Serena Tharakan ◽  
Kelly Suchman ◽  
Krystal P. Cascetta ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Endocrine Therapy ◽  
Risk Group ◽  
Early Stage ◽  
Low Risk ◽  
Oncotype Dx ◽  
Intermediate Risk ◽  
Ovarian Suppression ◽  
Significant Difference

<b><i>Background:</i></b> The Oncotype DX Recurrence Score (ODx RS) is the most widely adopted genomic assay used to guide treatment for patients with early-stage, hormone-positive (HR+) breast cancer (BC), with higher scores predicting greater risk of recurrence and benefit from chemotherapy. Patients with ODx RS &#x3e;25 typically recieve adjuvant chemotherapy; however, data regarding efficacy of chemotherapy for reducing recurrence in this population have been mixed. <b><i>Objectives:</i></b> This study aimed to evaluate outcomes of patients with early-stage HR+ BC with high-risk ODx RS (26–30 and ≥31) in order to assess treatment patterns and outcomes. We hypothesized that the benefit of chemotherapy in these groups may be minimal and that select patients may forgo chemotherapy in favor of more aggressive endocrine therapy and ovarian suppression. <b><i>Methods:</i></b> We performed a retrospective analysis of 515 patients with early-stage, HR+ BC with high-risk ODx RS 26–30 and ≥31 treated between 2006 and 2018. Patients were stratified by RS: low-risk (≤10), intermediate-risk (11–25), and high-risk (≥26). The Kaplan-Meier method was used to estimate the time to secondary invasive breast events (SIBE) or distributions overall and among different RS groups with the log rank test used to compare distributions between groups. <b><i>Results:</i></b> Rates of chemotherapy administration were 7% among the low-risk group, 18% among the intermediate-risk group, and 83% among high-risk patients with 41 SIBE (8%) reported. When stratified by ODx RS, 5-year rates of SIBE were 4%, 6%, and 16% for low-risk, intermediate-risk, and high-risk RS, respectively. Among the 27 lymph node (LN)-negative patients with ODx RS 26–30, 74% received chemotherapy. The 5-year rate of SIBE was 25% among patients who received chemotherapy and 33% among those who did not (<i>p</i> = 0.5489). Among the 23 LN-negative patients with ODx RS ≥31, 91% of patients received chemotherapy. The 5-year rate of SIBE was 0% both with and without chemotherapy. <b><i>Conclusions:</i></b> There was no statistically significant difference in SIBE for patients with high-risk ODx RS based on chemotherapy treatment. More aggressive endocrine therapy with ovarian suppression has become an alternative to chemotherapy among patients with intermediate-risk ODx RS (16–25). This approach may be useful among patients with high-risk ODx RS, with additional studies needed in this patient population.

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