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Susan Fineberg - One of the best experts on this subject based on the ideXlab platform.
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comparison of local Recurrence Risk estimates after breast conserving surgery for dcis dcis nomogram versus refined oncotype dx breast dcis score
Annals of Surgical Oncology, 2019Co-Authors: Emily C Zabor, Rosemarie Di Donato, Bryan E Harmon, Monica Morrow, Hiram S Cody, Susan FinebergAbstract:A ductal carcinoma in situ (DCIS) Nomogram integrating 10 clinicopathologic/treatment factors and a Refined DCIS Score (RDS) that incorporates a genomic assay and three clinicopathologic factors (Oncotype DX DCIS Score) are available to estimate DCIS 10-year local Recurrence Risk (LRR). This study compared these estimates. Patients 50 years of age or older with DCIS size 2.5 cm or smaller and a genomic assay available were identified. An RDS within 1–2% of the range of Nomogram LRR estimates obtained by assuming use and non-use of endocrine therapy (Nomogram ± ET) was defined as concordant. Assuming a 10-year Risk threshold of 10% for recommending radiation, Nomogram ± ET and RDS estimates were compared, and threshold concordance was determined. For 54 (92%) of 59 patients, the RDS and Nomogram ± ET LRR estimates were concordant. For the remaining 5 (8%) of the 59 patients, the RDS LRR estimates were lower than the Nomogram + ET estimates, with an absolute difference of 3–8%, and thus were discordant. For these five patients, the RDS estimates of 10-year LRR were lower than 10% (range 5–8%) and the Nomogram + ET estimates were 10% or higher (range 11–14%). These five patients with both discordant and threshold-discordant estimates all had close margins (≤ 2 mm). Among 92% of women 50 years of age or older with DCIS size 2.5 cm or smaller, free-of-charge online Nomogram 10-year LRR estimates were concordant with those obtained using the commercially available RDS (> $4600). Among the 8% with discordant Risk estimates, the RDS appeared to underestimate the LRR and may lead to inappropriate omission of radiotherapy. Unless other data show a clinically significant advantage of the RDS (Oncotype DX DCIS Score), the study data suggest that for women 50 years of age or older with DCIS size 2.5 cm or smaller, its use is not warranted.
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can features evaluated in the routine pathologic assessment of lymph node negative estrogen receptor positive stage i or ii invasive breast cancer be used to predict the oncotype dx Recurrence score
Archives of Pathology & Laboratory Medicine, 2010Co-Authors: Jena Auerbach, Susan FinebergAbstract:Abstract Context.—Oncotype DX is a multigene reverse transcription–polymerase chain reaction assay used to quantify Recurrence Risk in patients with stage I or II estrogen receptor–positive, lymph ...
Fl Baehner - One of the best experts on this subject based on the ideXlab platform.
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a population based validation study of the dcis score predicting Recurrence Risk in individuals treated by breast conserving surgery alone
Breast Cancer Research and Treatment, 2015Co-Authors: Refik Saskin, Fl Baehner, E Rakovitch, Steven M Butler, Sharon Nofechmozes, Wedad Hanna, Alan B. TuckAbstract:Validated biomarkers are needed to improve Risk assessment and treatment decision-making for women with ductal carcinoma in situ (DCIS) of the breast. The Oncotype DX® DCIS Score (DS) was shown to predict the Risk of local Recurrence (LR) in individuals with low-Risk DCIS treated by breast-conserving surgery (BCS) alone. Our objective was to confirm these results in a larger population-based cohort of individuals. We used an established population-based cohort of individuals diagnosed with DCIS treated with BCS alone from 1994 to 2003 with validation of treatment and outcomes. Central pathology assessment excluded cases with invasive cancer, DCIS < 2 mm or positive margins. Cox model was used to determine the relationship between independent covariates, the DS (hazard ratio (HR)/50 Cp units (U)) and LR. Tumor blocks were collected for 828 patients. Final evaluable population includes 718 cases, of whom 571 had negative margins. Median follow-up was 9.6 years. 100 cases developed LR following BCS alone (DCIS, N = 44; invasive, N = 57). In the primary pre-specified analysis, the DS was associated with any LR (DCIS or invasive) in ER+ patients (HR 2.26; P < 0.001) and in all patients regardless of ER status (HR 2.15; P < 0.001). DCIS Score provided independent information on LR Risk beyond clinical and pathologic variables including size, age, grade, necrosis, multifocality, and subtype (adjusted HR 1.68; P = 0.02). DCIS was associated with invasive LR (HR 1.78; P = 0.04) and DCIS LR (HR 2.43; P = 0.005). The DCIS Score independently predicts and quantifies individualized Recurrence Risk in a population of patients with pure DCIS treated by BCS alone.
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abstract s5 04 a large prospectively designed study of the dcis score predicting Recurrence Risk after local excision for ductal carcinoma in situ patients with and without irradiation
Cancer Research, 2015Co-Authors: Refik Saskin, Fl Baehner, E Rakovitch, Steven M Butler, Sharon Nofechmozes, Wedad Hanna, Alan B. TuckAbstract:Background: DCIS patients need better tools to align the aggressiveness of treatment with the aggressiveness of their disease. The DCIS Score (DS) was validated as a predictor of ipsilateral breast Recurrence (IBR; DCIS or invasive) in 327 E5194 patients treated by breast-conserving surgery (BCS) without radiation (RT) (Solin,2013). This Ontario population based DCIS study of 3335 women with DCIS from 1994 to 2003 (Rakovitch,2013) was conducted to test the DCIS Score as a predictor of Recurrence Risk in patients treated with BCS alone and in patients treated with BCS+RT. Methods: REMARK guidelines were followed. Breast pathologists centrally reviewed all HE 718 received BCS without RT (N=571 with CM) and 846 received BCS+RT (N=689 with CM). Median follow-up was 9.4 years. Among 1260 pts with CM, 100 pts treated with BCS alone had an IBR (DCIS, N=44; invasive, N=57); 86 pts treated with BCS+RT had an IBR (DCIS, N=32; invasive, N=55). In the primary analysis, among 571 patients treated by BCS alone with CM the continuous DS was significantly associated with IBR in ER+ patients (HR 2.26; 95%CI 1.41,3.59; P=0.001) and in all patients (HR 2.15; 95%CI 1.43,3.22; P= Conclusions: DCIS Score quantifies Recurrence Risk for DCIS patients treated by BCS with or without RT. Integrating the DCIS Score with established Risk factors, such as multifocality, age, and tumor size, can help identify DCIS patients treated with BCS alone with low 10 year Risk ( Citation Format: Eileen Rakovitch, Sharon Nofech-Mozes, Wedad Hanna, Frederick L Baehner, Refik Saskin, Steven M Butler, Alan Tuck, Sandip Sengupta, Leela Elavathil, Prashant A Jani, Michel Bonin, Martin C Chang, Elzbieta Slodkowska, Joseph M Anderson, Farid Jamshidian, Diana B Cherbavaz, Steven Shak, Lawerence Paszat. A large prospectively-designed study of the DCIS score: Predicting Recurrence Risk after local excision for ductal carcinoma in situ patients with and without irradiation [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr S5-04.
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a multigene expression assay to predict local Recurrence Risk for ductal carcinoma in situ of the breast
Journal of the National Cancer Institute, 2013Co-Authors: Lawrence J Solin, Fl Baehner, Steven M Butler, Robert Gray, Lorie L Hughes, Carl Yoshizawa, Diana B Cherbavaz, Steven Shak, David L PageAbstract:The treatment of ductal carcinoma in situ (DCIS; intraductal carcinoma) of the breast is variable, with concerns about both overtreatment and undertreatment (1–4). DCIS is commonly detected on screening mammography in the asymptomatic woman. Most women with newly diagnosed DCIS are eligible for breast conservation surgery (ie, excision or lumpectomy), either with or without radiation treatment. Randomized clinical trials have demonstrated that adding radiation treatment after surgical excision reduces the Risk of developing local Recurrence and invasive local Recurrence by approximately 50% (5–14). However, most patients will not develop local Recurrence if treated using surgical excision without radiation, and many patients are treated in contemporary practice using surgical excision alone (3,5–12,14–17). Several studies have used clinical and pathologic features to attempt to define patients at low Risk after surgical excision without radiation, including a prospective trial conducted by the Eastern Cooperative Oncology Group (ECOG) E5194 (18–21). However, reproducible and reliable methods using clinical and pathologic factors to select patients for surgical excision alone have not been established. The 2009 National Institutes of Health State-of-the-Science Conference included the research recommendation to develop and validate Risk stratification models for identifying patients who may be managed with less therapeutic intervention (1). This study was performed to determine whether the prospectively defined, 12-gene Oncotype DX DCIS Score (hereafter referred to as the DCIS Score) quantifies local Recurrence Risk and provides Risk information independent of traditional clinical and pathologic characteristics.
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s4 6 a quantitative multigene rt pcr assay for predicting Recurrence Risk after surgical excision alone without irradiation for ductal carcinoma in situ dcis a prospective validation study of the dcis score from ecog e5194
Cancer Research, 2011Co-Authors: L J Solin, Fl Baehner, Steven M Butler, Lorie L Hughes, Steven Shak, R Gray, Sunil Badve, C Yoshizawa, G W Sledge, Nancy E DavidsonAbstract:Background: We have previously reported the results of surgical excision without irradiation for selected patients with DCIS in ECOG E5194, where the 5-year rates of local Recurrence varied with age, grade, and lesion size (Hughes et al. J Clin Oncol 27:5319, 2009). New methods are needed to provide more accurate and reproducible assessment of Recurrence Risk. Methods: ECOG E5194 included 670 eligible patients with DCIS treated with surgical excision (≥ 3 mm negative margins) without irradiation, 228 of whom received tamoxifen. Patients had low or intermediate grade DCIS ≤ 2.5 cm, or high grade DCIS ≤ 1 cm. The Oncotype DX® assay was performed by quantitative RT-PCR using formalin fixed paraffin embedded tumor specimens from 327 patients (49% of the parent study). Recurrence Score® (RS) was calculated using the published algorithm. A new, prespecified DCIS Score™ was designed to predict Recurrence using an optimized gene expression algorithm. The primary objective was to determine whether there was a significant association between the Risk of an ipsilateral breast event (IBE) and the continuous DCIS Score in Cox models. 46 patients had an IBE (defined as ipsilateral local Recurrence of DCIS [n=20] or invasive cancer [n=26]). Median follow-up was 8.8 years. Results: The 10-year IBE rates were 15.4% for low/intermediate grade DCIS and 15.1% for high-grade DCIS (as determined by central pathology review), and for invasive IBE, 5.6% and 9.8%, respectively. Comparison between local and expert grading showed substantial disagreement. Continuous DCIS Score was significantly associated with IBE (HR 2.34 per 50 units; 95% CI 1.15, 4.59; p=0.02) when adjusted for tamoxifen use (prespecified primary analysis) and with invasive IBE (HR 3.73; CI 1.34, 9.82; p=0.01). DCIS Score was significantly associated with outcome when evaluated by the prespecified Risk groups (see Table). Similar results were observed with and without adjustment for tamoxifen use or for negative margin width. Features associated with IBE in multivariate models included menopausal status (HR 0.49; 95% CI 0.27, 0.90; p=0.02), tumor size (HR 1.52 per 5 mm; 95% CI 1.11, 2.01; p=0.01), and continuous DCIS Score (HR 2.41; 95% CI 1.15, 4.89; p=0.02). The standard RS, which is calculated using thresholding of many genes unlike the DCIS Score, was not associated with IBE or invasive IBE (p > 0.6). Conclusions: We have prospectively validated a multigene assay that quantifies Recurrence Risk and complements traditional clinical and pathologic factors in selected patients with DCIS treated with surgical excision without irradiation. The DCIS Score provides a new clinical tool for individualized selection of treatment for patients with DCIS. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr S4-6.
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validation study of a quantitative multigene reverse transcriptase polymerase chain reaction assay for assessment of Recurrence Risk in patients with stage ii colon cancer
Journal of Clinical Oncology, 2011Co-Authors: Richard Gray, Fl Baehner, Carl Yoshizawa, P Quirke, Kelly Handley, Margarita Lopatin, Laura Magill, C Beaumont, Kim M Clarklangone, Mark A LeeAbstract:Purpose We developed quantitative gene expression assays to assess Recurrence Risk and benefits from chemotherapy in patients with stage II colon cancer. Patients and Methods We sought validation by using RNA extracted from fixed paraffin-embedded primary colon tumor blocks from 1,436 patients with stage II colon cancer in the QUASAR (Quick and Simple and Reliable) study of adjuvant fluoropyrimidine chemotherapy versus surgery alone. A Recurrence score (RS) and a treatment score (TS) were calculated from gene expression levels of 13 cancer-related genes (n = 7 Recurrence genes and n = 6 treatment benefit genes) and from five reference genes with prespecified algorithms. Cox proportional hazards regression models and log-rank methods were used to analyze the relationship between the RS and Risk of Recurrence in patients treated with surgery alone and between TS and benefits of chemotherapy. Results Risk of Recurrence was significantly associated with RS (hazard ratio [HR] per interquartile range, 1.38; 95%...
Mary Anne Rossing - One of the best experts on this subject based on the ideXlab platform.
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breast cancer Recurrence Risk in relation to antidepressant use after diagnosis
Breast Cancer Research and Treatment, 2008Co-Authors: Jessica Chubak, Diana S M Buist, Denise M Boudreau, Mary Anne RossingAbstract:Background While laboratory data suggest that antidepressants may promote mammary tumor growth, there has been little research investigating whether antidepressant use after breast cancer diagnosis is associated with the Risk of breast cancer Recurrence. Methods We conducted a retrospective cohort study within Group Health, an integrated healthcare delivery system in Washington state. Women diagnosed with a first primary invasive, stage I, IIA, or IIB, unilateral breast carcinoma between 1990–1994 (aged ≥65 years) and 1996–1999 (aged ≥18 years) were eligible for the study (N = 1306). Recurrence within 5-year of diagnosis was ascertained by medical chart review. We used the pharmacy database to identify antidepressant dispensings from Group Health pharmacies. We used multiple Cox regression to estimate the hazard ratio for Recurrence and breast cancer mortality, comparing users and non-users of antidepressant medications. Results for Recurrence were examined separately in users and non-users of tamoxifen. Results We did not observe an association between antidepressant use after breast cancer diagnosis and the Risk of Recurrence either in general (hazard ratio for any antidepressant use: 0.8; 95% confidence interval: 0.5–1.4) or for specific types of antidepressant medication. Risk of death from breast cancer did not differ between non-users and users of antidepressants. Conclusions The results of this study suggest that women who use antidepressants after breast cancer diagnosis do not have an increased Risk of Recurrence or mortality.
Jessica Chubak - One of the best experts on this subject based on the ideXlab platform.
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breast cancer Recurrence Risk in relation to antidepressant use after diagnosis
Breast Cancer Research and Treatment, 2008Co-Authors: Jessica Chubak, Diana S M Buist, Denise M Boudreau, Mary Anne RossingAbstract:Background While laboratory data suggest that antidepressants may promote mammary tumor growth, there has been little research investigating whether antidepressant use after breast cancer diagnosis is associated with the Risk of breast cancer Recurrence. Methods We conducted a retrospective cohort study within Group Health, an integrated healthcare delivery system in Washington state. Women diagnosed with a first primary invasive, stage I, IIA, or IIB, unilateral breast carcinoma between 1990–1994 (aged ≥65 years) and 1996–1999 (aged ≥18 years) were eligible for the study (N = 1306). Recurrence within 5-year of diagnosis was ascertained by medical chart review. We used the pharmacy database to identify antidepressant dispensings from Group Health pharmacies. We used multiple Cox regression to estimate the hazard ratio for Recurrence and breast cancer mortality, comparing users and non-users of antidepressant medications. Results for Recurrence were examined separately in users and non-users of tamoxifen. Results We did not observe an association between antidepressant use after breast cancer diagnosis and the Risk of Recurrence either in general (hazard ratio for any antidepressant use: 0.8; 95% confidence interval: 0.5–1.4) or for specific types of antidepressant medication. Risk of death from breast cancer did not differ between non-users and users of antidepressants. Conclusions The results of this study suggest that women who use antidepressants after breast cancer diagnosis do not have an increased Risk of Recurrence or mortality.
Steven Shak - One of the best experts on this subject based on the ideXlab platform.
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a multigene expression assay to predict local Recurrence Risk for ductal carcinoma in situ of the breast
Journal of the National Cancer Institute, 2013Co-Authors: Lawrence J Solin, Fl Baehner, Steven M Butler, Robert Gray, Lorie L Hughes, Carl Yoshizawa, Diana B Cherbavaz, Steven Shak, David L PageAbstract:The treatment of ductal carcinoma in situ (DCIS; intraductal carcinoma) of the breast is variable, with concerns about both overtreatment and undertreatment (1–4). DCIS is commonly detected on screening mammography in the asymptomatic woman. Most women with newly diagnosed DCIS are eligible for breast conservation surgery (ie, excision or lumpectomy), either with or without radiation treatment. Randomized clinical trials have demonstrated that adding radiation treatment after surgical excision reduces the Risk of developing local Recurrence and invasive local Recurrence by approximately 50% (5–14). However, most patients will not develop local Recurrence if treated using surgical excision without radiation, and many patients are treated in contemporary practice using surgical excision alone (3,5–12,14–17). Several studies have used clinical and pathologic features to attempt to define patients at low Risk after surgical excision without radiation, including a prospective trial conducted by the Eastern Cooperative Oncology Group (ECOG) E5194 (18–21). However, reproducible and reliable methods using clinical and pathologic factors to select patients for surgical excision alone have not been established. The 2009 National Institutes of Health State-of-the-Science Conference included the research recommendation to develop and validate Risk stratification models for identifying patients who may be managed with less therapeutic intervention (1). This study was performed to determine whether the prospectively defined, 12-gene Oncotype DX DCIS Score (hereafter referred to as the DCIS Score) quantifies local Recurrence Risk and provides Risk information independent of traditional clinical and pathologic characteristics.
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s4 6 a quantitative multigene rt pcr assay for predicting Recurrence Risk after surgical excision alone without irradiation for ductal carcinoma in situ dcis a prospective validation study of the dcis score from ecog e5194
Cancer Research, 2011Co-Authors: L J Solin, Fl Baehner, Steven M Butler, Lorie L Hughes, Steven Shak, R Gray, Sunil Badve, C Yoshizawa, G W Sledge, Nancy E DavidsonAbstract:Background: We have previously reported the results of surgical excision without irradiation for selected patients with DCIS in ECOG E5194, where the 5-year rates of local Recurrence varied with age, grade, and lesion size (Hughes et al. J Clin Oncol 27:5319, 2009). New methods are needed to provide more accurate and reproducible assessment of Recurrence Risk. Methods: ECOG E5194 included 670 eligible patients with DCIS treated with surgical excision (≥ 3 mm negative margins) without irradiation, 228 of whom received tamoxifen. Patients had low or intermediate grade DCIS ≤ 2.5 cm, or high grade DCIS ≤ 1 cm. The Oncotype DX® assay was performed by quantitative RT-PCR using formalin fixed paraffin embedded tumor specimens from 327 patients (49% of the parent study). Recurrence Score® (RS) was calculated using the published algorithm. A new, prespecified DCIS Score™ was designed to predict Recurrence using an optimized gene expression algorithm. The primary objective was to determine whether there was a significant association between the Risk of an ipsilateral breast event (IBE) and the continuous DCIS Score in Cox models. 46 patients had an IBE (defined as ipsilateral local Recurrence of DCIS [n=20] or invasive cancer [n=26]). Median follow-up was 8.8 years. Results: The 10-year IBE rates were 15.4% for low/intermediate grade DCIS and 15.1% for high-grade DCIS (as determined by central pathology review), and for invasive IBE, 5.6% and 9.8%, respectively. Comparison between local and expert grading showed substantial disagreement. Continuous DCIS Score was significantly associated with IBE (HR 2.34 per 50 units; 95% CI 1.15, 4.59; p=0.02) when adjusted for tamoxifen use (prespecified primary analysis) and with invasive IBE (HR 3.73; CI 1.34, 9.82; p=0.01). DCIS Score was significantly associated with outcome when evaluated by the prespecified Risk groups (see Table). Similar results were observed with and without adjustment for tamoxifen use or for negative margin width. Features associated with IBE in multivariate models included menopausal status (HR 0.49; 95% CI 0.27, 0.90; p=0.02), tumor size (HR 1.52 per 5 mm; 95% CI 1.11, 2.01; p=0.01), and continuous DCIS Score (HR 2.41; 95% CI 1.15, 4.89; p=0.02). The standard RS, which is calculated using thresholding of many genes unlike the DCIS Score, was not associated with IBE or invasive IBE (p > 0.6). Conclusions: We have prospectively validated a multigene assay that quantifies Recurrence Risk and complements traditional clinical and pathologic factors in selected patients with DCIS treated with surgical excision without irradiation. The DCIS Score provides a new clinical tool for individualized selection of treatment for patients with DCIS. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr S4-6.
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Risk of Recurrence and chemotherapy benefit for patients with node negative estrogen receptor positive breast cancer Recurrence score alone and integrated with pathologic and clinical factors
Journal of Clinical Oncology, 2011Co-Authors: Gong Tang, Steven Shak, Jack Cuzick, Joseph P Costantino, Mitch Dowsett, John F Forbes, Michael Crager, Eleftherios P Mamounas, Norman WolmarkAbstract:Purpose The 21-gene breast cancer assay Recurrence score (RS) is widely used for assessing Recurrence Risk and predicting chemotherapy benefit in patients with estrogen receptor (ER) –positive breast cancer. Pathologic and clinical factors such as tumor size, grade, and patient age also provide independent prognostic utility. We developed a formal integration of these measures and evaluated its prognostic and predictive value. Patients and Methods From the National Surgical Adjuvant Breast and Bowel (NSABP) B-14 and translational research cohort of the Arimidex, Tamoxifen Alone or in Combination (TransATAC) studies, we included patients who received hormonal monotherapy, had ER-positive tumors, and RS and traditional clinicopathologic factors assessed (647 and 1,088, respectively). Individual patient Risk assessments from separate Cox models were combined using meta-analysis to form an RS-pathology-clinical (RSPC) assessment of distant Recurrence Risk. Risk assessments by RS and RSPC were compared in node...