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Colleen A Lawton - One of the best experts on this subject based on the ideXlab platform.
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sequence of Hormonal Therapy and radioTherapy field size in unfavourable localised prostate cancer nrg rtog 9413 long term results of a randomised phase 3 trial
Lancet Oncology, 2018Co-Authors: Mack Roach, Colleen A Lawton, Kenneth L Zeitzer, Jennifer Moughan, Adam P Dicker, Elizabeth Gore, Young Kwok, Michael J Seider, Ichow Hsu, Alan C HartfordAbstract:Summary Background The NRG/RTOG 9413 study showed that whole pelvic radioTherapy (WPRT) plus neoadjuvant Hormonal Therapy (NHT) improved progression-free survival in patients with intermediate-risk or high-risk localised prostate cancer compared with prostate only radioTherapy (PORT) plus NHT, WPRT plus adjuvant Hormonal Therapy (AHT), and PORT plus AHT. We provide a long-term update after 10 years of follow-up of the primary endpoint (progression-free survival) and report on the late toxicities of treatment. Methods The trial was designed as a 2 × 2 factorial study with Hormonal sequencing as one stratification factor and radiation field as the other factor and tested whether NHT improved progression-free survival versus AHT, and NHT plus WPRT versus NHT plus PORT. Eligible patients had histologically confirmed, clinically localised adenocarcinoma of the prostate, an estimated risk of lymph node involvement of more than 15% and a Karnofsky performance status of more than 70, with no age limitations. Patients were randomly assigned (1:1:1:1) by permuted block randomisation to receive either NHT 2 months before and during WPRT followed by a prostate boost to 70 Gy (NHT plus WPRT group), NHT 2 months before and during PORT to 70 Gy (NHT plus PORT group), WPRT followed by 4 months of AHT (WPRT plus AHT group), or PORT followed by 4 months of AHT (PORT plus AHT group). Hormonal Therapy was combined androgen suppression, consisting of goserelin acetate 3·6 mg once a month subcutaneously or leuprolide acetate 7·5 mg once a month intramuscularly, and flutamide 250 mg twice a day orally for 4 months. Randomisation was stratified by T stage, Gleason Score, and prostate-specific antigen concentration. NHT was given 2 months before radioTherapy and was continued until radioTherapy completion; AHT was given at the completion of radioTherapy for 4 months. The primary endpoint progression-free survival was analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00769548. The trial has been terminated to additional follow-up collection and this is the final analysis for this trial. Findings Between April 1, 1995, and June 1, 1999, 1322 patients were enrolled from 53 centres and randomly assigned to the four treatment groups. With a median follow-up of 8·8 years (IQR 5·07–13·84) for all patients and 14·8 years (7·18–17·4) for living patients (n=346), progression-free survival across all timepoints continued to differ significantly across the four treatment groups (p=0·002). The 10-year estimates of progression-free survival were 28·4% (95% CI 23·3–33·6) in the NHT plus WPRT group, 23·5% (18·7–28·3) in the NHT plus PORT group, 19·4% (14·9–24·0) in the WPRT plus AHT group, and 30·2% (25·0–35·4) in the PORT plus AHT group. Bladder toxicity was the most common grade 3 or worse late toxicity, affecting 18 (6%) of 316 patients in the NHT plus WPRT group, 17 (5%) of 313 in the NHT plus PORT group, 22 (7%) of 317 in the WPRT plus AHT group, and 14 (4%) of 315 in the PORT plus AHT group. Late grade 3 or worse gastrointestinal adverse events occurred in 22 (7%) of 316 patients in the NHT plus WPRT group, five (2%) of 313 in the NHT plus PORT group, ten (3%) of 317 in the WPRT plus AHT group, and seven (2%) of 315 in the PORT plus AHT group. Interpretation In this cohort of patients with intermediate-risk and high-risk localised prostate cancer, NHT plus WPRT improved progression-free survival compared with NHT plus PORT and WPRT plus AHT at long-term follow-up albeit increased risk of grade 3 or worse intestinal toxicity. Interactions between radioTherapy and Hormonal Therapy suggests that WPRT should be avoided without NHT. Funding National Cancer Institute.
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effect of long term Hormonal Therapy vs short term Hormonal Therapy a secondary analysis of intermediate risk prostate cancer patients treated on nrg oncology rtog 9202
International Journal of Radiation Oncology Biology Physics, 2013Co-Authors: Amin Mirhadi, David J Grignon, Qiang Zhang, Gerald E Hanks, Herbert Lepor, Christopher A Peters, Seth A Rosenthal, Kenneth L Zeitzer, John S Radwan, Colleen A LawtonAbstract:Purpose NRG Oncology RTOG 9202 was a randomized trial testing long-term adjuvant androgen deprivation (LTAD) versus initial androgen deprivation only (STAD) with external beam radiation Therapy (RT) in mostly high-risk and some intermediate-risk prostate cancer patients. RTOG 9408 found an overall survival (OS) advantage in patients with cT1b-T2b disease and prostate-specific antigen (PSA) Methods and Materials An analysis was performed for all patients enrolled in RTOG 9202 defined as intermediate-risk (cT2 disease, PSA or cT2 disease, PSA 10-20 ng/mL, and Gleason score Results With over 11 years of median follow-up, 39 STAD patients were alive and 33 LTAD patients were alive. There was no difference in OS (10-year estimates, 61% STAD vs 65% LTAD; P =.53), DSS (10-year DSS, 96% vs 97%; P =.72), or PSAF (10-year PSAF, 53% vs 55%; P =.99) between groups. Conclusion LTAD did not confer a benefit in terms of OS, DSS, or PSAF rates in the intermediate-risk subset in this study. Whereas the subset was relatively small, treatment assignment was randomly applied, and a trend in favor of LTAD would have been of interest. Given the small number of disease-specific deaths observed and lack of benefit with respect to our endpoints, this secondary analysis does not suggest that exploration of longer Hormonal Therapy is worth testing in the intermediate-risk prostate cancer subset.
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predicting long term survival and the need for Hormonal Therapy a meta analysis of rtog prostate cancer trials
International Journal of Radiation Oncology Biology Physics, 2000Co-Authors: Mack Roach, Michael V Pilepich, S O Asbell, Mohammed Mohuidden, Roger Terry, David J Grignon, Colleen A Lawton, William U Shipley, James D CoxAbstract:Abstract Purpose: To assess the impact of short-term and long-term androgen suppression on the disease-specific and overall survival of 2200 men treated with radioTherapy on one of 5 prospective randomized trials when stratified by prognostic risk groups. Methods and Materials: Between 1975 and 1992, 2742 men were treated for clinically localized prostate cancer on one of 5 consecutive prospective Phase III randomized trials. Patients were selected for this analysis if they were deemed evaluable and eligible for the trial, and if follow-up information was available. For this analysis patients were stratified into four previously described prognostic risk groups: Group 1 patients had a Gleason score (GS) = 2–6, and T1–2Nx; Group 2: GS=2–6, T3Nx; or GS=2–6, N+, or GS=7, T1–2Nx; Group 3: T3Nx, GS=7; or N+, GS=7, or T1–2Nx, GS=8–10; and Group 4 patients were T3Nx, GS=8–10, or N+, GS=8–10. The median pretreatment prostate-specific antigen (PSA) was 25 ng/ml for the 434 evaluable patients for whom this information was available. The median follow-up times for patients treated on early studies exceeded 11 years, and for more recent studies 6 years. Results: Risk group 2 patients with "bulky" or T3 disease appeared to have a disease-specific survival benefit at 8 years with the addition of 4 months of goserelin and flutamide. Group 3 and 4 patients were noted to have an approximately 20% higher survival at 8 years with the addition of long-term Hormonal Therapy ( p ≤ 0.0004). Conclusions: Based on this meta-analysis of RTOG trials, subsets of patients can be identified who either do not appear to benefit from the use of Hormonal Therapy, benefit from short-term Hormonal Therapy, or who benefit only from long-term Hormonal Therapy. These observations should be confirmed by prospective randomized trials before they can be considered conclusive. In the meantime, however, these observations provide rational guidelines for deciding who should receive Hormonal Therapy and for how long.
Mack Roach - One of the best experts on this subject based on the ideXlab platform.
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sequence of Hormonal Therapy and radioTherapy field size in unfavourable localised prostate cancer nrg rtog 9413 long term results of a randomised phase 3 trial
Lancet Oncology, 2018Co-Authors: Mack Roach, Colleen A Lawton, Kenneth L Zeitzer, Jennifer Moughan, Adam P Dicker, Elizabeth Gore, Young Kwok, Michael J Seider, Ichow Hsu, Alan C HartfordAbstract:Summary Background The NRG/RTOG 9413 study showed that whole pelvic radioTherapy (WPRT) plus neoadjuvant Hormonal Therapy (NHT) improved progression-free survival in patients with intermediate-risk or high-risk localised prostate cancer compared with prostate only radioTherapy (PORT) plus NHT, WPRT plus adjuvant Hormonal Therapy (AHT), and PORT plus AHT. We provide a long-term update after 10 years of follow-up of the primary endpoint (progression-free survival) and report on the late toxicities of treatment. Methods The trial was designed as a 2 × 2 factorial study with Hormonal sequencing as one stratification factor and radiation field as the other factor and tested whether NHT improved progression-free survival versus AHT, and NHT plus WPRT versus NHT plus PORT. Eligible patients had histologically confirmed, clinically localised adenocarcinoma of the prostate, an estimated risk of lymph node involvement of more than 15% and a Karnofsky performance status of more than 70, with no age limitations. Patients were randomly assigned (1:1:1:1) by permuted block randomisation to receive either NHT 2 months before and during WPRT followed by a prostate boost to 70 Gy (NHT plus WPRT group), NHT 2 months before and during PORT to 70 Gy (NHT plus PORT group), WPRT followed by 4 months of AHT (WPRT plus AHT group), or PORT followed by 4 months of AHT (PORT plus AHT group). Hormonal Therapy was combined androgen suppression, consisting of goserelin acetate 3·6 mg once a month subcutaneously or leuprolide acetate 7·5 mg once a month intramuscularly, and flutamide 250 mg twice a day orally for 4 months. Randomisation was stratified by T stage, Gleason Score, and prostate-specific antigen concentration. NHT was given 2 months before radioTherapy and was continued until radioTherapy completion; AHT was given at the completion of radioTherapy for 4 months. The primary endpoint progression-free survival was analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00769548. The trial has been terminated to additional follow-up collection and this is the final analysis for this trial. Findings Between April 1, 1995, and June 1, 1999, 1322 patients were enrolled from 53 centres and randomly assigned to the four treatment groups. With a median follow-up of 8·8 years (IQR 5·07–13·84) for all patients and 14·8 years (7·18–17·4) for living patients (n=346), progression-free survival across all timepoints continued to differ significantly across the four treatment groups (p=0·002). The 10-year estimates of progression-free survival were 28·4% (95% CI 23·3–33·6) in the NHT plus WPRT group, 23·5% (18·7–28·3) in the NHT plus PORT group, 19·4% (14·9–24·0) in the WPRT plus AHT group, and 30·2% (25·0–35·4) in the PORT plus AHT group. Bladder toxicity was the most common grade 3 or worse late toxicity, affecting 18 (6%) of 316 patients in the NHT plus WPRT group, 17 (5%) of 313 in the NHT plus PORT group, 22 (7%) of 317 in the WPRT plus AHT group, and 14 (4%) of 315 in the PORT plus AHT group. Late grade 3 or worse gastrointestinal adverse events occurred in 22 (7%) of 316 patients in the NHT plus WPRT group, five (2%) of 313 in the NHT plus PORT group, ten (3%) of 317 in the WPRT plus AHT group, and seven (2%) of 315 in the PORT plus AHT group. Interpretation In this cohort of patients with intermediate-risk and high-risk localised prostate cancer, NHT plus WPRT improved progression-free survival compared with NHT plus PORT and WPRT plus AHT at long-term follow-up albeit increased risk of grade 3 or worse intestinal toxicity. Interactions between radioTherapy and Hormonal Therapy suggests that WPRT should be avoided without NHT. Funding National Cancer Institute.
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defining biochemical failure following radioTherapy with or without Hormonal Therapy in men with clinically localized prostate cancer recommendations of the rtog astro phoenix consensus conference
International Journal of Radiation Oncology Biology Physics, 2006Co-Authors: Mack Roach, William U Shipley, Gerald E Hanks, Howard D Thames, Paul F Schellhammer, Gerald H Sokol, Howard M SandlerAbstract:In 1996 the American Society for Therapeutic Radiology and Oncology (ASTRO) sponsored a Consensus Conference to establish a definition of biochemical failure after external beam radioTherapy (EBRT). The ASTRO definition defined prostate specific antigen (PSA) failure as occurring after three consecutive PSA rises after a nadir with the date of failure as the point halfway between the nadir date and the first rise or any rise great enough to provoke initiation of Therapy. This definition was not linked to clinical progression or survival; it performed poorly in patients undergoing Hormonal Therapy (HT), and backdating biased the Kaplan-Meier estimates of event-free survival. A second Consensus Conference was sponsored by ASTRO and the Radiation Therapy Oncology Group in Phoenix, Arizona, on January 21, 2005, to revise the ASTRO definition. The panel recommended: (1) a rise by 2 ng/mL or more above the nadir PSA be considered the standard definition for biochemical failure after EBRT with or without HT; (2) the date of failure be determined "at call" (not backdated). They recommended that investigators be allowed to use the ASTRO Consensus Definition after EBRT alone (no Hormonal Therapy) with strict adherence to guidelines as to "adequate follow-up." To avoid the artifacts resulting from short follow-up, the reported date of control should be listed as 2 years short of the median follow-up. For example, if the median follow-up is 5 years, control rates at 3 years should be cited. Retaining a strict version of the ASTRO definition would allow comparisons with a large existing body of literature.
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predicting long term survival and the need for Hormonal Therapy a meta analysis of rtog prostate cancer trials
International Journal of Radiation Oncology Biology Physics, 2000Co-Authors: Mack Roach, Michael V Pilepich, S O Asbell, Mohammed Mohuidden, Roger Terry, David J Grignon, Colleen A Lawton, William U Shipley, James D CoxAbstract:Abstract Purpose: To assess the impact of short-term and long-term androgen suppression on the disease-specific and overall survival of 2200 men treated with radioTherapy on one of 5 prospective randomized trials when stratified by prognostic risk groups. Methods and Materials: Between 1975 and 1992, 2742 men were treated for clinically localized prostate cancer on one of 5 consecutive prospective Phase III randomized trials. Patients were selected for this analysis if they were deemed evaluable and eligible for the trial, and if follow-up information was available. For this analysis patients were stratified into four previously described prognostic risk groups: Group 1 patients had a Gleason score (GS) = 2–6, and T1–2Nx; Group 2: GS=2–6, T3Nx; or GS=2–6, N+, or GS=7, T1–2Nx; Group 3: T3Nx, GS=7; or N+, GS=7, or T1–2Nx, GS=8–10; and Group 4 patients were T3Nx, GS=8–10, or N+, GS=8–10. The median pretreatment prostate-specific antigen (PSA) was 25 ng/ml for the 434 evaluable patients for whom this information was available. The median follow-up times for patients treated on early studies exceeded 11 years, and for more recent studies 6 years. Results: Risk group 2 patients with "bulky" or T3 disease appeared to have a disease-specific survival benefit at 8 years with the addition of 4 months of goserelin and flutamide. Group 3 and 4 patients were noted to have an approximately 20% higher survival at 8 years with the addition of long-term Hormonal Therapy ( p ≤ 0.0004). Conclusions: Based on this meta-analysis of RTOG trials, subsets of patients can be identified who either do not appear to benefit from the use of Hormonal Therapy, benefit from short-term Hormonal Therapy, or who benefit only from long-term Hormonal Therapy. These observations should be confirmed by prospective randomized trials before they can be considered conclusive. In the meantime, however, these observations provide rational guidelines for deciding who should receive Hormonal Therapy and for how long.
Alfred I Neugut - One of the best experts on this subject based on the ideXlab platform.
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nonadherence to medications for chronic conditions and nonadherence to adjuvant Hormonal Therapy in women with breast cancer
JAMA Oncology, 2016Co-Authors: Alfred I Neugut, Jason D Wright, Xiaobo Zhong, Melissa K Accordino, Jingyan Yang, Dawn L HershmanAbstract:Importance While adjuvant Hormonal Therapy (HT) reduces mortality for women with nonmetastatic breast cancer, nonadherence to HT is common. Objective We investigated the association between patterns of prior nonadherence to medications for chronic conditions with HT nonadherence. Design, Setting, and Participants For this retrospective cohort study, the MarketScan database was scanned for women 18 years and older who had been diagnosed with nonmetastatic breast cancer between January 1, 2010, and December 31, 2012, and who filled 2 or more prescriptions for tamoxifen and/or an aromatase inhibitor. Main Exposures and Outcomes Nonadherence to medications for 6 chronic conditions (hypertension, hyperlipidemia, gastroesophageal reflux disease, thyroid disease, diabetes, osteoporosis) in the 12 months before diagnosis was defined as a medication possession ratio (MPR) less than 80%. Nonadherence to HT was defined as an MPR less than 80% between the first and last prescription for HT up to 2 years. Analysis Multivariable logistic regression was used to determine the association between prior medication nonadherence and HT nonadherence. Results Of 21 255 women treated with adjuvant HT, 3314 (15.6%) were nonadherent, and age ( Conclusions and Relevance We found that nonadherence to medications for chronic conditions prior to HT was associated with greater nonadherence to oral HT in patients with breast cancer. Medication nonadherence history may play an important role in determining patients at risk for nonadherence to a subsequent medication for a different illness, such as HT, and a potential target for future interventions.
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household net worth racial disparities and Hormonal Therapy adherence among women with early stage breast cancer
Journal of Clinical Oncology, 2015Co-Authors: Dawn L Hershman, Jennifer Tsui, Jason D Wright, Ellie J Coromilas, Weiyann Tsai, Alfred I NeugutAbstract:Purpose Nonadherence to adjuvant Hormonal Therapy is common and is associated with increased prescription copayment amount and black race. Studies suggest that household wealth may partly explain racial disparities. We investigated the impact of net worth on disparities in adherence and discontinuation. Patients and Methods We used the OptumInsight insurance claims database to identify women older than age 50 years diagnosed with early breast cancer, from January 1, 2007, to December 31, 2011, who were using Hormonal Therapy. Nonadherence was defined as a medication possession ratio of ≤ 80% of eligible days over a 2-year period. We evaluated the association of demographic and clinical characteristics, annual household income, household net worth ( $750,000), insurance type, and copayments ( $20) with adherence to Hormonal Therapy. Logistic regression analyses were conducted by sequentially adding sociodemographic and financial variables to race...
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racial ethnic differences in initiation of adjuvant Hormonal Therapy among women with hormone receptor positive breast cancer
Breast Cancer Research and Treatment, 2012Co-Authors: Jennifer C Livaudais, Alfred I Neugut, Dawn L Hershman, Laurel A Habel, Lawrence H Kushi, Scarlett Lin Gomez, Louis Fehrenbacher, Beti Thompson, Gloria D CoronadoAbstract:Mortality after breast cancer diagnosis is known to vary by race/ethnicity even after adjustment for differences in tumor characteristics. As adjuvant Hormonal Therapy decreases risk of recurrence and increases overall survival among women with hormone receptor-positive tumors, treatment disparities may play a role. We explored racial/ethnic differences in initiation of adjuvant Hormonal Therapy, defined as two or more prescriptions for tamoxifen or aromatase inhibitor filled within the first year after diagnosis of hormone receptor-positive localized or regional-stage breast cancer. The sample included women diagnosed with breast cancer enrolled in Kaiser Permanente Northern California (KPNC). Odds ratios [OR] and 95% confidence intervals [CI] compared initiation by race/ethnicity (Hispanic, African American, Chinese, Japanese, Filipino, and South Asian vs. non-Hispanic White [NHW]) using logistic regression. Covariates included age and year of diagnosis, area-level socioeconomic status, co-morbidities, tumor stage, histology, grade, breast cancer surgery, radiation and chemoTherapy use. Our sample included 13,753 women aged 20–79 years, diagnosed between 1996 and 2007, and 70% initiated adjuvant Hormonal Therapy. In multivariable analysis, Hispanic and Chinese women were less likely than NHW women to initiate adjuvant Hormonal Therapy ([OR] = 0.82; [CI] 0.71–0.96 and [OR] = 0.78; [CI] 0.63–0.98, respectively). Within an equal access, insured population, lower levels of initiation of adjuvant Hormonal Therapy were found for Hispanic and Chinese women. Findings need to be confirmed in other insured populations and the reasons for under-initiation among these groups need to be explored.
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association between prescription co payment amount and compliance with adjuvant Hormonal Therapy in women with early stage breast cancer
Journal of Clinical Oncology, 2011Co-Authors: Alfred I Neugut, Milayna Subar, Elizabeth T Wilde, Scott Stratton, Corey H Brouse, Grace Clarke Hillyer, Victor R Grann, Dawn L HershmanAbstract:Purpose Noncompliance with adjuvant Hormonal Therapy among women with breast cancer is common. Little is known about the impact of financial factors, such as co-payments, on noncompliance. Patients and Methods
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early discontinuation and nonadherence to adjuvant Hormonal Therapy in a cohort of 8 769 early stage breast cancer patients
Journal of Clinical Oncology, 2010Co-Authors: Dawn L Hershman, Lawrence H Kushi, Scarlett Lin Gomez, Louis Fehrenbacher, Weiyann Tsai, Theresa Shao, Donna Buono, Aaron Kershenbaum, Sunita Miles, Alfred I NeugutAbstract:Purpose While studies have found that adjuvant Hormonal Therapy for hormone-sensitive breast cancer (BC) dramatically reduces recurrence and mortality, adherence to medications is suboptimal. We investigated the rates and predictors of early discontinuation and nonadherence to Hormonal Therapy in patients enrolled in Kaiser Permanente of Northern California health system. Patients and Methods We identified women diagnosed with hormone-sensitive stage I-III BC from 1996 to 2007 and used automated pharmacy records to identify Hormonal Therapy prescriptions and dates of refill. We used Cox proportional hazards regression models to analyze factors associated with early discontinuation and nonadherence (medication possession ratio 80%) of Hormonal Therapy. Results We identified 8,769 patients with BC who met our eligibility criteria and who filled at least one prescription for tamoxifen (43%), aromatase inhibitors (26%), or both (30%) within 1 year of diagnosis. Younger or older age, lumpectomy (v mastectomy), and comorbidities were associated with earlier discontinuation, while Asian race, being married, earlier year at diagnosis, receipt of chemoTherapy or radioTherapy, and longer prescription refill interval were associated with completion of 4.5 years of Therapy. Of those who continued Therapy, similar factors were associated with full adherence. Women age younger than 40 years had the highest risk of discontinuation (hazard ratio, 1.51; 95% CI, 1.23 to 1.85). By 4.5 years, 32% discontinued Therapy, and of those who continued, 72% were fully adherent. Conclusion Only 49% of patients with BC took adjuvant Hormonal Therapy for the full duration at the optimal schedule. Younger women are at high risk of nonadherence. Interventions to improve adherence and continuation of Hormonal Therapy are needed, especially for younger women. J Clin Oncol 28:4120-4128. © 2010 by American Society of Clinical Oncology
Dawn L Hershman - One of the best experts on this subject based on the ideXlab platform.
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nonadherence to medications for chronic conditions and nonadherence to adjuvant Hormonal Therapy in women with breast cancer
JAMA Oncology, 2016Co-Authors: Alfred I Neugut, Jason D Wright, Xiaobo Zhong, Melissa K Accordino, Jingyan Yang, Dawn L HershmanAbstract:Importance While adjuvant Hormonal Therapy (HT) reduces mortality for women with nonmetastatic breast cancer, nonadherence to HT is common. Objective We investigated the association between patterns of prior nonadherence to medications for chronic conditions with HT nonadherence. Design, Setting, and Participants For this retrospective cohort study, the MarketScan database was scanned for women 18 years and older who had been diagnosed with nonmetastatic breast cancer between January 1, 2010, and December 31, 2012, and who filled 2 or more prescriptions for tamoxifen and/or an aromatase inhibitor. Main Exposures and Outcomes Nonadherence to medications for 6 chronic conditions (hypertension, hyperlipidemia, gastroesophageal reflux disease, thyroid disease, diabetes, osteoporosis) in the 12 months before diagnosis was defined as a medication possession ratio (MPR) less than 80%. Nonadherence to HT was defined as an MPR less than 80% between the first and last prescription for HT up to 2 years. Analysis Multivariable logistic regression was used to determine the association between prior medication nonadherence and HT nonadherence. Results Of 21 255 women treated with adjuvant HT, 3314 (15.6%) were nonadherent, and age ( Conclusions and Relevance We found that nonadherence to medications for chronic conditions prior to HT was associated with greater nonadherence to oral HT in patients with breast cancer. Medication nonadherence history may play an important role in determining patients at risk for nonadherence to a subsequent medication for a different illness, such as HT, and a potential target for future interventions.
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household net worth racial disparities and Hormonal Therapy adherence among women with early stage breast cancer
Journal of Clinical Oncology, 2015Co-Authors: Dawn L Hershman, Jennifer Tsui, Jason D Wright, Ellie J Coromilas, Weiyann Tsai, Alfred I NeugutAbstract:Purpose Nonadherence to adjuvant Hormonal Therapy is common and is associated with increased prescription copayment amount and black race. Studies suggest that household wealth may partly explain racial disparities. We investigated the impact of net worth on disparities in adherence and discontinuation. Patients and Methods We used the OptumInsight insurance claims database to identify women older than age 50 years diagnosed with early breast cancer, from January 1, 2007, to December 31, 2011, who were using Hormonal Therapy. Nonadherence was defined as a medication possession ratio of ≤ 80% of eligible days over a 2-year period. We evaluated the association of demographic and clinical characteristics, annual household income, household net worth ( $750,000), insurance type, and copayments ( $20) with adherence to Hormonal Therapy. Logistic regression analyses were conducted by sequentially adding sociodemographic and financial variables to race...
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racial ethnic differences in initiation of adjuvant Hormonal Therapy among women with hormone receptor positive breast cancer
Breast Cancer Research and Treatment, 2012Co-Authors: Jennifer C Livaudais, Alfred I Neugut, Dawn L Hershman, Laurel A Habel, Lawrence H Kushi, Scarlett Lin Gomez, Louis Fehrenbacher, Beti Thompson, Gloria D CoronadoAbstract:Mortality after breast cancer diagnosis is known to vary by race/ethnicity even after adjustment for differences in tumor characteristics. As adjuvant Hormonal Therapy decreases risk of recurrence and increases overall survival among women with hormone receptor-positive tumors, treatment disparities may play a role. We explored racial/ethnic differences in initiation of adjuvant Hormonal Therapy, defined as two or more prescriptions for tamoxifen or aromatase inhibitor filled within the first year after diagnosis of hormone receptor-positive localized or regional-stage breast cancer. The sample included women diagnosed with breast cancer enrolled in Kaiser Permanente Northern California (KPNC). Odds ratios [OR] and 95% confidence intervals [CI] compared initiation by race/ethnicity (Hispanic, African American, Chinese, Japanese, Filipino, and South Asian vs. non-Hispanic White [NHW]) using logistic regression. Covariates included age and year of diagnosis, area-level socioeconomic status, co-morbidities, tumor stage, histology, grade, breast cancer surgery, radiation and chemoTherapy use. Our sample included 13,753 women aged 20–79 years, diagnosed between 1996 and 2007, and 70% initiated adjuvant Hormonal Therapy. In multivariable analysis, Hispanic and Chinese women were less likely than NHW women to initiate adjuvant Hormonal Therapy ([OR] = 0.82; [CI] 0.71–0.96 and [OR] = 0.78; [CI] 0.63–0.98, respectively). Within an equal access, insured population, lower levels of initiation of adjuvant Hormonal Therapy were found for Hispanic and Chinese women. Findings need to be confirmed in other insured populations and the reasons for under-initiation among these groups need to be explored.
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association between prescription co payment amount and compliance with adjuvant Hormonal Therapy in women with early stage breast cancer
Journal of Clinical Oncology, 2011Co-Authors: Alfred I Neugut, Milayna Subar, Elizabeth T Wilde, Scott Stratton, Corey H Brouse, Grace Clarke Hillyer, Victor R Grann, Dawn L HershmanAbstract:Purpose Noncompliance with adjuvant Hormonal Therapy among women with breast cancer is common. Little is known about the impact of financial factors, such as co-payments, on noncompliance. Patients and Methods
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early discontinuation and nonadherence to adjuvant Hormonal Therapy in a cohort of 8 769 early stage breast cancer patients
Journal of Clinical Oncology, 2010Co-Authors: Dawn L Hershman, Lawrence H Kushi, Scarlett Lin Gomez, Louis Fehrenbacher, Weiyann Tsai, Theresa Shao, Donna Buono, Aaron Kershenbaum, Sunita Miles, Alfred I NeugutAbstract:Purpose While studies have found that adjuvant Hormonal Therapy for hormone-sensitive breast cancer (BC) dramatically reduces recurrence and mortality, adherence to medications is suboptimal. We investigated the rates and predictors of early discontinuation and nonadherence to Hormonal Therapy in patients enrolled in Kaiser Permanente of Northern California health system. Patients and Methods We identified women diagnosed with hormone-sensitive stage I-III BC from 1996 to 2007 and used automated pharmacy records to identify Hormonal Therapy prescriptions and dates of refill. We used Cox proportional hazards regression models to analyze factors associated with early discontinuation and nonadherence (medication possession ratio 80%) of Hormonal Therapy. Results We identified 8,769 patients with BC who met our eligibility criteria and who filled at least one prescription for tamoxifen (43%), aromatase inhibitors (26%), or both (30%) within 1 year of diagnosis. Younger or older age, lumpectomy (v mastectomy), and comorbidities were associated with earlier discontinuation, while Asian race, being married, earlier year at diagnosis, receipt of chemoTherapy or radioTherapy, and longer prescription refill interval were associated with completion of 4.5 years of Therapy. Of those who continued Therapy, similar factors were associated with full adherence. Women age younger than 40 years had the highest risk of discontinuation (hazard ratio, 1.51; 95% CI, 1.23 to 1.85). By 4.5 years, 32% discontinued Therapy, and of those who continued, 72% were fully adherent. Conclusion Only 49% of patients with BC took adjuvant Hormonal Therapy for the full duration at the optimal schedule. Younger women are at high risk of nonadherence. Interventions to improve adherence and continuation of Hormonal Therapy are needed, especially for younger women. J Clin Oncol 28:4120-4128. © 2010 by American Society of Clinical Oncology
Maryellen Taplin - One of the best experts on this subject based on the ideXlab platform.
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second line Hormonal Therapy for men with chemoTherapy naive castration resistant prostate cancer american society of clinical oncology provisional clinical opinion
Journal of Clinical Oncology, 2017Co-Authors: Katherine S Virgo, Maryellen Taplin, Ethan Basch, Andrew D Loblaw, Thomas K Oliver, Bryan R Rumble, Michael A Carducci, Luke T Nordquist, Eric Winquist, Eric A SingerAbstract:Purpose ASCO provisional clinical opinions (PCOs) offer direction to the ASCO membership after publication or presentation of potential practice-changing data. This PCO addresses second-line Hormonal Therapy for chemoTherapy-naive men with castration-resistant prostate cancer (CRPC) who range from being asymptomatic with only biochemical evidence of CRPC to having documented metastases but minimal symptoms. Clinical Context The treatment goal for CRPC is palliation. Despite resistance to initial androgen deprivation Therapy, most men respond to second-line Hormonal therapies. However, guidelines have neither addressed second-line Hormonal Therapy for nonmetastatic CRPC nor provided specific guidance with regard to the chemoTherapy-naive population. Recent Data Six phase III randomized controlled trials and expert consensus opinion inform this PCO. Provisional Clinical Opinion For men with CRPC, a castrate state should be maintained indefinitely. Second-line Hormonal Therapy (eg, antiandrogens, CYP17 inhibitors) may be considered in patients with nonmetastatic CRPC at high risk for metastatic disease (rapid prostate-specific antigen doubling time or velocity) but otherwise is not suggested. In patients with radiographic evidence of metastases and minimal symptoms, enzalutamide or abiraterone plus prednisone should be offered after discussion with patients about potential harms, benefits, costs, and patient preferences. Radium-223 and sipuleucel-T also are options. No evidence provides guidance about the optimal order of Hormonal therapies for CRPC beyond second-line treatment. Prostate-specific antigen testing every 4 to 6 months is reasonable for men without metastases. Routine radiographic restaging generally is not suggested but can be considered for patients at risk for metastases or who exhibit symptoms or other evidence of progression. Additional information is available at www.asco.org/genitourinary-cancer-guidelines and www.asco.org/guidelineswiki .
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the evolving paradigm of second line Hormonal Therapy options for castration resistant prostate cancer
Current Opinion in Oncology, 2012Co-Authors: Kevin D Courtney, Maryellen TaplinAbstract:Purpose of review The review examines recent advances in second-line Hormonal Therapy for the treatment of castrate-resistant prostate cancer (CRPC). Recent findings Recent data highlight the continued importance of androgen signaling in CRPC. These findings have spurred the development of novel inhibitors of adrenal and intra-tumoral androgen synthesis and novel androgen signaling inhibitors with activity in CRPC. In the past year abiraterone acetate, a CYP17 (17α-hydroxylase/17, 20 lyase) inhibitor, received US FDA approval for use in the treatment of metastatic CRPC in patients previously treated with docetaxel. Additionally, the novel androgen signaling inhibitor MDV3100 has been reported to confer a survival advantage compared to placebo in the same patient population. Here we review the scientific rationale for targeting androgen signaling in CRPC and the recent pivotal trials that support the use of novel second-line Hormonal therapies. Additionally, we summarize ongoing preclinical and clinical efforts to ascertain and overcome mechanisms of resistance. Summary Novel inhibitors of extra-gonadal androgen synthesis and androgen receptor function demonstrate the continued importance of androgen signaling in CRPC. These agents have improved clinical outcomes for patients with metastatic CRPC.
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efficacy of nilutamide as secondary Hormonal Therapy in androgen independent prostate cancer
BJUI, 2005Co-Authors: Mari Nakabayashi, Meredith M Regan, Deborah Lifsey, Philip W Kantoff, Maryellen Taplin, Oliver SartorAbstract:OBJECTIVE To evaluate the activity of nilutamide as secondary Hormonal Therapy in patients with androgen-independent prostate cancer (AIPC), as treatment options are limited for these patients and secondary Hormonal Therapy with antiandrogens has advantages, including low toxicity, oral administration and high patient acceptance. PATIENTS AND METHODS We retrospectively identified 45 patients with AIPC who were treated with nilutamide as secondary Hormonal Therapy in two institutions. The decrease in prostate-specific antigen (PSA) levels, side-effects of treatment, and the relationship between baseline characteristics, type and duration of previous Therapy and response to nilutamide were assessed. Most patients received oral nilutamide at 150 mg/day. RESULTS Eighteen of 45 evaluable patients (40%) had a PSA level decrease of ≥ 50%. Responders (PSA decline ≥ 50%) had a median (range) time to progression of 4.4 (0.31–44.7) months. There were responses to nilutamide whether used as the second to fifth line of Hormonal Therapy. There were no differences in response to nilutamide based on clinical stage, type of local Therapy, PSA level at diagnosis or initiation of nilutamide, or type of previous antiandrogen Therapy. Responders were more likely to have received monoTherapy with luteinizing hormone-releasing hormone analogues or orchidectomy as first-line Hormonal treatment (P = 0.02). The most common reversible adverse effects were mild to moderate visual adaptation effects, reported in 20% of patients. CONCLUSIONS Nilutamide appears to be an effective secondary Hormonal Therapy in patients with AIPC and is associated with a mild toxicity profile.
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efficacy of nilutamide as secondary Hormonal Therapy in androgen independent prostate cancer aipc
Journal of Clinical Oncology, 2005Co-Authors: Mari Nakabayashi, Meredith M Regan, Deborah Lifsey, Philip W Kantoff, Maryellen Taplin, Carolyn Evan, Oliver SartorAbstract:4683 Background: Treatment options are limited for patients with androgen independent prostate cancer (AIPC). Secondary Hormonal Therapy with antiandrogens has advantages, including low toxicity, o...