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Harold J Burstein - One of the best experts on this subject based on the ideXlab platform.

  • palbociclib with Adjuvant Endocrine Therapy in early breast cancer pallas interim analysis of a multicentre open label randomised phase 3 study
    Lancet Oncology, 2021
    Co-Authors: Erica L Mayer, Kathy D Miller, Amylou C Dueck, Miguel Martin, G Rubovszky, Harold J Burstein, Meritxell Belletezquerra, Nicholas Zdenkowski, Eric P Winer, Georg Pfeiler
    Abstract:

    Summary Background Palbociclib added to Endocrine Therapy improves progression-free survival in hormone-receptor-positive, HER2-negative, metastatic breast cancer. The PALLAS trial aimed to investigate whether the addition of 2 years of palbociclib to Adjuvant Endocrine Therapy improves invasive disease-free survival over Endocrine Therapy alone in patients with hormone-receptor-positive, HER2-negative, early-stage breast cancer. Methods PALLAS is an ongoing multicentre, open-label, randomised, phase 3 study that enrolled patients at 406 cancer centres in 21 countries worldwide with stage II–III histologically confirmed hormone-receptor-positive, HER2-negative breast cancer, within 12 months of initial diagnosis. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance score of 0 or 1. Patients were randomly assigned (1:1) in permuted blocks of random size (4 or 6), stratified by anatomic stage, previous chemoTherapy, age, and geographical region, by use of central telephone-based and web-based interactive response technology, to receive either 2 years of palbociclib (125 mg orally once daily on days 1–21 of a 28-day cycle) with ongoing standard provider or patient-choice Adjuvant Endocrine Therapy (tamoxifen or aromatase inhibitor, with or without concurrent luteinising hormone-releasing hormone agonist), or Endocrine Therapy alone, without masking. The primary endpoint of the study was invasive disease-free survival in the intention-to-treat population. Safety was assessed in all randomly assigned patients who started palbociclib or Endocrine Therapy. This report presents results from the second pre-planned interim analysis triggered on Jan 9, 2020, when 67% of the total number of expected invasive disease-free survival events had been observed. The trial is registered with ClinicalTrials.gov ( NCT02513394 ) and EudraCT (2014-005181-30). Findings Between Sept 1, 2015, and Nov 30, 2018, 5760 patients were randomly assigned to receive palbociclib plus Endocrine Therapy (n=2883) or Endocrine Therapy alone (n=2877). At the time of the planned second interim analysis, at a median follow-up of 23·7 months (IQR 16·9–29·2), 170 of 2883 patients assigned to palbociclib plus Endocrine Therapy and 181 of 2877 assigned to Endocrine Therapy alone had invasive disease-free survival events. 3-year invasive disease-free survival was 88·2% (95% CI 85·2–90·6) for palbociclib plus Endocrine Therapy and 88·5% (85·8–90·7) for Endocrine Therapy alone (hazard ratio 0·93 [95% CI 0·76–1·15]; log-rank p=0·51). As the test statistic comparing invasive disease-free survival between groups crossed the prespecified futility boundary, the independent data monitoring committee recommended discontinuation of palbociclib in patients still receiving palbociclib and Endocrine Therapy. The most common grade 3–4 adverse events were neutropenia (1742 [61·3%] of 2840 patients on palbociclib and Endocrine Therapy vs 11 [0·3%] of 2903 on Endocrine Therapy alone), leucopenia (857 [30·2%] vs three [0·1%]), and fatigue (60 [2·1%] vs ten [0·3%]). Serious adverse events occurred in 351 (12·4%) of 2840 patients on palbociclib plus Endocrine Therapy versus 220 (7·6%) of 2903 patients on Endocrine Therapy alone. There were no treatment-related deaths. Interpretation At the planned second interim analysis, addition of 2 years of Adjuvant palbociclib to Adjuvant Endocrine Therapy did not improve invasive disease-free survival compared with Adjuvant Endocrine Therapy alone. On the basis of these findings, this regimen cannot be recommended in the Adjuvant setting. Long-term follow-up of the PALLAS population and correlative studies are ongoing. Funding Pfizer.

  • Adjuvant Endocrine Therapy for women with hormone receptor positive breast cancer asco clinical practice guideline focused update
    Journal of Clinical Oncology, 2019
    Co-Authors: Harold J Burstein, Clifford A Hudis, Christina Lacchetti, Holly Anderson, Thomas A Buchholz, Nancy E Davidson, Karen A Gelmon, Sharon H Giordano, Alexander J Solky, Vered Stearns
    Abstract:

    PurposeTo update the ASCO clinical practice guideline on Adjuvant Endocrine Therapy based on emerging data about the optimal duration of aromatase inhibitor (AI) treatment.MethodsASCO conducted a s...

  • Adjuvant Endocrine Therapy for women with hormone receptor positive breast cancer asco clinical practice guideline focused update
    Journal of Clinical Oncology, 2019
    Co-Authors: Harold J Burstein, Clifford A Hudis, Christina Lacchetti, Holly Anderson, Thomas A Buchholz, Nancy E Davidson, Karen A Gelmon, Sharon H Giordano, Alexander J Solky, Vered Stearns
    Abstract:

    PurposeTo update the ASCO clinical practice guideline on Adjuvant Endocrine Therapy based on emerging data about the optimal duration of aromatase inhibitor (AI) treatment.MethodsASCO conducted a systematic review of randomized clinical trials from 2012 to 2018. Guideline recommendations were based on the Panel’s review of the evidence from six trials.ResultsThe six included studies of AI treatment beyond 5 years of Therapy demonstrated that extension of AI treatment was not associated with an overall survival advantage but was significantly associated with lower risks of breast cancer recurrence and contralateral breast cancer compared with placebo. Bone-related toxic effects were more common with extended AI treatment.RecommendationsThe Panel recommends that women with node-positive breast cancer receive extended Therapy, including an AI, for up to a total of 10 years of Adjuvant Endocrine treatment. Many women with node-negative breast cancer should consider extended Therapy for up to a total of 10 yea...

  • Adjuvant Endocrine Therapy for women with hormone receptor positive breast cancer american society of clinical oncology clinical practice guideline update on ovarian suppression
    Journal of Clinical Oncology, 2016
    Co-Authors: Harold J Burstein, Clifford A Hudis, Christina Lacchetti, Holly Anderson, Thomas A Buchholz, Nancy E Davidson, Karen A Gelmon, Sharon H Giordano, Alexander J Solky, Vered Stearns
    Abstract:

    PurposeTo update the ASCO Adjuvant Endocrine Therapy guideline based on emerging data concerning the benefits and risks of ovarian suppression in addition to standard Adjuvant Therapy in premenopausal women with estrogen receptor–positive breast cancer.MethodsASCO convened an Update Panel and conducted a systematic review of randomized clinical trials investigating ovarian suppression.ResultsTwo trials investigating the addition of ovarian suppression to tamoxifen did not show an overall clinical benefit for ovarian suppression. Nonetheless, the addition of ovarian suppression to standard Adjuvant Therapy with tamoxifen or with an aromatase inhibitor improved disease-free survival and improved freedom from breast cancer and distant recurrence compared with tamoxifen alone among the subset of patients who were at sufficient risk for recurrence such that Adjuvant chemoTherapy was warranted. Compared with tamoxifen alone, ovarian suppression was associated with a substantial increase in menopausal symptoms, ...

  • Adjuvant Endocrine Therapy for women with hormone receptor positive breast cancer american society of clinical oncology clinical practice guideline focused update
    Journal of Clinical Oncology, 2014
    Co-Authors: Clifford A Hudis, Harold J Burstein, Holly Anderson, Thomas A Buchholz, Nancy E Davidson, Karen A Gelmon, Sharon H Giordano, Sarah Temin, Diana Rowden
    Abstract:

    Purpose To update the ASCO clinical practice guideline on Adjuvant Endocrine Therapy on the basis of emerging data on the optimal duration of treatment, particularly Adjuvant tamoxifen. Methods ASCO convened the Update Committee and conducted a systematic review of randomized clinical trials from January 2009 to June 2013 and analyzed three historical trials. Guideline recommendations were based on the Update Committee’s review of the evidence. Outcomes of interest included survival, disease recurrence, and adverse events. Results This guideline update reflects emerging data on duration of tamoxifen treatment. There have been five studies of tamoxifen treatment beyond 5 years of Therapy. The two largest studies with longest reported follow-up show a breast cancer survival advantage with 10-year durations of tamoxifen use. In addition to modest gains in survival, extended Therapy with tamoxifen for 10 years compared with 5 years was associated with lower risks of breast cancer recurrence and contralateral breast cancer.

Vered Stearns - One of the best experts on this subject based on the ideXlab platform.

  • abstract ps9 58 factors associated with sexual problems during Adjuvant Endocrine Therapy
    Cancer Research, 2021
    Co-Authors: Neha Verma, Vered Stearns, Amanda L Blackford, David Lim, Elissa Thorner, Jennifer Lehman, Claire F Snyder, Caroline A Snyder, Karen L Smith
    Abstract:

    Background: Adjuvant Endocrine Therapy (AET) reduces recurrence and mortality in women with hormone receptor-positive (HR+) breast cancer (BC). Sexual problems are common during AET but are under-reported and under-treated in routine clinical care. Patient reported outcomes (PRO) improve clinician awareness of patient symptoms. We present an analysis of prospectively collected PRO from a clinic-based registry of women with HR+ BC receiving AET with the aim of identifying factors associated with developing or worsening sexual problems. Methods: Women with stage 0-III BC initiating AET were enrolled in a prospective clinic-based registry Mar 2012-Dec 2016. Participants completed PRO surveys at baseline (BL) and 3, 6, 12, 24, 36, 48 and 60 months (mo). Sexual problems were evaluated by the MOS Sexual Problems (MOS-SP) measure (range 0-100; higher scores indicate more sexual problems). Respondents rate severity of problems in 4 domains of sexual function on a 4-point scale (“not a problem”, “a little of a problem”, “somewhat of a problem” and “very much a problem”). We considered participants who responded “somewhat of a problem” or “very much a problem” for ≥1 domain to have a sexual problem at that time point. Based on the empirical rule effect size method, we defined clinically significant developing or worsening sexual problems during AET as an increase in MOS-SP score by ≥8 from BL. Women with MOS-SP score >92 at BL were excluded. Other PRO surveys were the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) scale and NIH PROMIS measures for pain interference, fatigue, depression, anxiety, physical function (PF) and sleep disturbance. We evaluated associations between worsening of PROMIS T-scores in 4-point increments and FACT-ES score in 5-point increments with change in the MOS-SP score by ≥8. Additional covariates were clinical and demographic factors including socioeconomic status (SES). We used neighborhood poverty (NP) rate >15% as a surrogate for low SES based on US census estimates of the % of persons in a zip code below the federal poverty line. We performed logistic regression with generalized estimating equations to account for repeated observations. The final multivariable model was determined with a forward stepwise selection algorithm. Results: Among 300 participants, 195 (65%) were post-menopausal, 252 (84%) white and 30 (10%) black, 134 (45%) on tamoxifen and 166 (55%) on an aromatase inhibitor. Stage distribution was 0: 28 (9%); I: 180 (60%); II-III: 92 (31%). Prior to ET, 132 (44%) had mastectomy, 84 (28%) had chemoTherapy and 199 (66%) had radiation (RT). 40 (13%) were of low SES. Median follow-up is 56 mo. 165 (55%) participants reported ≥1 sexual problem during participation. At BL, median MOS-SP score was 8.32 (range 0-92). There was no significant change in mean MOS-SP score from BL to 48 mo (p=0.74). In univariate analyses, worsening scores on all PRO measures were associated with increase in MOS-SP score by ≥8, however on multivariate analysis, only worsening Endocrine symptoms (OR 1.34, 95% CI 1.21-1.48, p Conclusions: Women receiving AET at risk for developing or worsening sexual problems include those with worsening Endocrine symptoms and worsening PF plus those who have undergone mastectomy or RT. Routine assessment for sexual problems in this population may reduce under-detection and identify women who can benefit from interventions to improve sexual function. Citation Format: Neha Verma, Amanda L. Blackford, David Lim, Elissa Thorner, Jennifer Lehman, Claire Snyder, Caroline A. Snyder, Vered Stearns, Karen L. Smith. Factors associated with sexual problems during Adjuvant Endocrine Therapy [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS9-58.

  • Adjuvant Endocrine Therapy for women with hormone receptor positive breast cancer asco clinical practice guideline focused update
    Journal of Clinical Oncology, 2019
    Co-Authors: Harold J Burstein, Clifford A Hudis, Christina Lacchetti, Holly Anderson, Thomas A Buchholz, Nancy E Davidson, Karen A Gelmon, Sharon H Giordano, Alexander J Solky, Vered Stearns
    Abstract:

    PurposeTo update the ASCO clinical practice guideline on Adjuvant Endocrine Therapy based on emerging data about the optimal duration of aromatase inhibitor (AI) treatment.MethodsASCO conducted a s...

  • Adjuvant Endocrine Therapy for women with hormone receptor positive breast cancer asco clinical practice guideline focused update
    Journal of Clinical Oncology, 2019
    Co-Authors: Harold J Burstein, Clifford A Hudis, Christina Lacchetti, Holly Anderson, Thomas A Buchholz, Nancy E Davidson, Karen A Gelmon, Sharon H Giordano, Alexander J Solky, Vered Stearns
    Abstract:

    PurposeTo update the ASCO clinical practice guideline on Adjuvant Endocrine Therapy based on emerging data about the optimal duration of aromatase inhibitor (AI) treatment.MethodsASCO conducted a systematic review of randomized clinical trials from 2012 to 2018. Guideline recommendations were based on the Panel’s review of the evidence from six trials.ResultsThe six included studies of AI treatment beyond 5 years of Therapy demonstrated that extension of AI treatment was not associated with an overall survival advantage but was significantly associated with lower risks of breast cancer recurrence and contralateral breast cancer compared with placebo. Bone-related toxic effects were more common with extended AI treatment.RecommendationsThe Panel recommends that women with node-positive breast cancer receive extended Therapy, including an AI, for up to a total of 10 years of Adjuvant Endocrine treatment. Many women with node-negative breast cancer should consider extended Therapy for up to a total of 10 yea...

  • Adjuvant Endocrine Therapy for women with hormone receptor positive breast cancer american society of clinical oncology clinical practice guideline update on ovarian suppression
    Journal of Clinical Oncology, 2016
    Co-Authors: Harold J Burstein, Clifford A Hudis, Christina Lacchetti, Holly Anderson, Thomas A Buchholz, Nancy E Davidson, Karen A Gelmon, Sharon H Giordano, Alexander J Solky, Vered Stearns
    Abstract:

    PurposeTo update the ASCO Adjuvant Endocrine Therapy guideline based on emerging data concerning the benefits and risks of ovarian suppression in addition to standard Adjuvant Therapy in premenopausal women with estrogen receptor–positive breast cancer.MethodsASCO convened an Update Panel and conducted a systematic review of randomized clinical trials investigating ovarian suppression.ResultsTwo trials investigating the addition of ovarian suppression to tamoxifen did not show an overall clinical benefit for ovarian suppression. Nonetheless, the addition of ovarian suppression to standard Adjuvant Therapy with tamoxifen or with an aromatase inhibitor improved disease-free survival and improved freedom from breast cancer and distant recurrence compared with tamoxifen alone among the subset of patients who were at sufficient risk for recurrence such that Adjuvant chemoTherapy was warranted. Compared with tamoxifen alone, ovarian suppression was associated with a substantial increase in menopausal symptoms, ...

Claus Kamby - One of the best experts on this subject based on the ideXlab platform.

  • abstract p5 12 01 sole study of letrozole extension a phase 3 randomized clinical trial of continuous vs intermittent letrozole in postmenopausal women who have received 4 6 years of Adjuvant Endocrine Therapy for lymph node positive early breast can
    Cancer Research, 2020
    Co-Authors: Guy Jerusalem, Subrina Farah, Mariepascale Graas, Patrick Neven, Edda Simoncini, Erika Hitre, Jacquie Chirgwin, Per Karlsson, Stefan Aebi, Claus Kamby
    Abstract:

    Background: In animal models of hormone receptor positive (HR+) breast cancer, acquired resistance to continued letrozole was shown to be reversed by estrogen-induced apoptosis. We hypothesized that the rise in estrogen levels during short treatment interruptions would resensitize breast cancer cells to letrozole and improve treatment outcome. SOLE tested the hypothesis that 3 mos treatment-free intervals during extended Adjuvant Therapy will improve disease-free survival (DFS). We previously reported the primary endpoint after 60 mos median follow-up: extended intermittent letrozole did not improve DFS vs extended continuous letrozole. However, only 9% of pts had breast cancer events, justifying updating the analysis with longer follow-up. The dynamic of recovery of estrogen levels after stopping letrozole Therapy has not been previously reported. Methods: SOLE enrolled 4884 postmenopausal women with HR+ lymph node-positive BC who had completed 4-6 yrs of Adjuvant Endocrine Therapy (19% SERM, 43% AI, 38% both; stratification factor). Pts were randomized to an additional 5 yrs continuous letrozole (2.5 mg daily; n=2441) vs 5 yrs intermittent letrozole (taken for the first 9 mos of yrs 1-4, and 12 mos in yr 5; n=2443). We report the final analysis of the SOLE trial after 84 mos median follow-up. In SOLE-EST, levels of estradiol (E2), estrone (E1) and estrone sulphate (E1S) at 0, 9, 10.5 and 12 mos after randomization were determined using a highly sensitive assay in a subgroup of 90 evaluable patients (21 in the continuous and 69 in the intermittent group). Results: There were 923 DFS events. 7 yr DFS was 81.5% in both groups. More pts had distant metastases in the continuous group (8.7% vs 7.5%) while second (non-breast) malignancies were more frequent in the intermittent group (5.5% vs 4.7%). Similar outcomes were observed for breast cancer-free interval (BCFI) (88.6% vs 88.0%), distant recurrence-free interval (DRFI) (91.6% vs 90.4%), and overall survival (OS) (90.6% vs 89.6%) for pts assigned intermittent vs continuous letrozole. In the intermittent group, median E2, E1 and E1S levels more than doubled compared with levels at 9 mos after randomization in the first 6 weeks after stopping letrozole during the treatment free interval while levels were stable for the 21 pts tested in the continuous group. Conclusions: Among postmenopausal women with HR+ BC, extended intermittent letrozole did not improve DFS vs continuous letrozole. Similar outcome was consistently observed for BCFI, DRFI and OS. The SOLE-EST substudy indicates an important increase in estrogen levels as soon as 6 weeks after stopping letrozole Therapy in the intermittent group. Further investigation of prior exposure to aromatase inhibitors in relation with outcome and with E2, E1 and E1S levels in SOLE-EST are underway. Citation Format: Guy Jerusalem, Subrina Farah, Jacquie Chirgwin, Stefan Aebi, Per Karlsson, Patrick Neven, Erika Hitre, Marie-Pascale Graas, Edda Simoncini, Claus Kamby, Alastair Thompson, Sibylle Loibl, Joaquin Gavila, Katsumasa Kuroi, Christian Marth, Bettina Muller, Seamus O9Reilly, Andrea Gombos, Thomas Ruhstaller, Harold Burstein, Manuela Rabaglio, Barbara Ruepp, Giuseppe Viale, Richard D Gelber, Alan S Coates, Angelo Di Leo, Aron Goldhirsch, Meredith Regan, Marco Colleoni. SOLE (study of letrozole extension), a phase 3 randomized clinical trial of continuous vs intermittent letrozole in postmenopausal women who have received 4-6 years of Adjuvant Endocrine Therapy for lymph node-positive, early breast cancer (BC): Final analysis and sole estrogen substudy (SOLE-EST) [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P5-12-01.

  • abstract p5 12 01 sole study of letrozole extension a phase 3 randomized clinical trial of continuous vs intermittent letrozole in postmenopausal women who have received 4 6 years of Adjuvant Endocrine Therapy for lymph node positive early breast can
    Cancer Research, 2020
    Co-Authors: Guy Jerusalem, Subrina Farah, Mariepascale Graas, Patrick Neven, Edda Simoncini, Erika Hitre, Jacquie Chirgwin, Per Karlsson, Stefan Aebi, Claus Kamby
    Abstract:

    Background: In animal models of hormone receptor positive (HR+) breast cancer, acquired resistance to continued letrozole was shown to be reversed by estrogen-induced apoptosis. We hypothesized that the rise in estrogen levels during short treatment interruptions would resensitize breast cancer cells to letrozole and improve treatment outcome. SOLE tested the hypothesis that 3 mos treatment-free intervals during extended Adjuvant Therapy will improve disease-free survival (DFS). We previously reported the primary endpoint after 60 mos median follow-up: extended intermittent letrozole did not improve DFS vs extended continuous letrozole. However, only 9% of pts had breast cancer events, justifying updating the analysis with longer follow-up. The dynamic of recovery of estrogen levels after stopping letrozole Therapy has not been previously reported. Methods: SOLE enrolled 4884 postmenopausal women with HR+ lymph node-positive BC who had completed 4-6 yrs of Adjuvant Endocrine Therapy (19% SERM, 43% AI, 38% both; stratification factor). Pts were randomized to an additional 5 yrs continuous letrozole (2.5 mg daily; n=2441) vs 5 yrs intermittent letrozole (taken for the first 9 mos of yrs 1-4, and 12 mos in yr 5; n=2443). We report the final analysis of the SOLE trial after 84 mos median follow-up. In SOLE-EST, levels of estradiol (E2), estrone (E1) and estrone sulphate (E1S) at 0, 9, 10.5 and 12 mos after randomization were determined using a highly sensitive assay in a subgroup of 90 evaluable patients (21 in the continuous and 69 in the intermittent group). Results: There were 923 DFS events. 7 yr DFS was 81.5% in both groups. More pts had distant metastases in the continuous group (8.7% vs 7.5%) while second (non-breast) malignancies were more frequent in the intermittent group (5.5% vs 4.7%). Similar outcomes were observed for breast cancer-free interval (BCFI) (88.6% vs 88.0%), distant recurrence-free interval (DRFI) (91.6% vs 90.4%), and overall survival (OS) (90.6% vs 89.6%) for pts assigned intermittent vs continuous letrozole. In the intermittent group, median E2, E1 and E1S levels more than doubled compared with levels at 9 mos after randomization in the first 6 weeks after stopping letrozole during the treatment free interval while levels were stable for the 21 pts tested in the continuous group. Conclusions: Among postmenopausal women with HR+ BC, extended intermittent letrozole did not improve DFS vs continuous letrozole. Similar outcome was consistently observed for BCFI, DRFI and OS. The SOLE-EST substudy indicates an important increase in estrogen levels as soon as 6 weeks after stopping letrozole Therapy in the intermittent group. Further investigation of prior exposure to aromatase inhibitors in relation with outcome and with E2, E1 and E1S levels in SOLE-EST are underway. Citation Format: Guy Jerusalem, Subrina Farah, Jacquie Chirgwin, Stefan Aebi, Per Karlsson, Patrick Neven, Erika Hitre, Marie-Pascale Graas, Edda Simoncini, Claus Kamby, Alastair Thompson, Sibylle Loibl, Joaquin Gavila, Katsumasa Kuroi, Christian Marth, Bettina Muller, Seamus O9Reilly, Andrea Gombos, Thomas Ruhstaller, Harold Burstein, Manuela Rabaglio, Barbara Ruepp, Giuseppe Viale, Richard D Gelber, Alan S Coates, Angelo Di Leo, Aron Goldhirsch, Meredith Regan, Marco Colleoni. SOLE (study of letrozole extension), a phase 3 randomized clinical trial of continuous vs intermittent letrozole in postmenopausal women who have received 4-6 years of Adjuvant Endocrine Therapy for lymph node-positive, early breast cancer (BC): Final analysis and sole estrogen substudy (SOLE-EST) [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P5-12-01.

  • sole study of letrozole extension a phase iii randomized clinical trial of continuous vs intermittent letrozole in postmenopausal women who have received 4 6 years of Adjuvant Endocrine Therapy for lymph node positive early breast cancer bc
    Journal of Clinical Oncology, 2017
    Co-Authors: Marco Colleoni, Mariepascale Graas, Patrick Neven, Guy Jerusalem, Edda Simoncini, Erika Hitre, Jacquie Chirgwin, Per Karlsson, Stefan Aebi, Claus Kamby
    Abstract:

    503Background: In animal models of hormone receptor positive (HR+) breast cancer, acquired resistance to continued letrozole was shown to be reversed by estrogen-induced apoptosis. Sensitization to reintroduction of estrogen withdrawal by letrozole was hypothesized to improve treatment outcome. SOLE tested the hypothesis that 3 mos treatment-free intervals during extended Adjuvant Therapy will improve disease-free survival (DFS). Methods: SOLE enrolled 4884 postmenopausal women with HR+ lymph node-positive BC who had completed 4-6 yrs of Adjuvant Endocrine Therapy (19% SERM, 43% AI, 38% both; stratification factor). Pts were randomly assigned to an additional 5 yrs continuous letrozole (2.5 mg daily; n = 2441) vs 5 yrs intermittent letrozole (taken for the first 9 mos of yrs 1-4, and 12 mos in yr 5; n = 2443). The primary endpoint was DFS (randomization until invasive local, regional, distant recurrence or contralateral BC; 2nd malignancy; death). Final analysis was at 665 DFS events, after 2 interim anal...

Albert J Farias - One of the best experts on this subject based on the ideXlab platform.

Nancy E Davidson - One of the best experts on this subject based on the ideXlab platform.

  • Adjuvant Endocrine Therapy for women with hormone receptor positive breast cancer asco clinical practice guideline focused update
    Journal of Clinical Oncology, 2019
    Co-Authors: Harold J Burstein, Clifford A Hudis, Christina Lacchetti, Holly Anderson, Thomas A Buchholz, Nancy E Davidson, Karen A Gelmon, Sharon H Giordano, Alexander J Solky, Vered Stearns
    Abstract:

    PurposeTo update the ASCO clinical practice guideline on Adjuvant Endocrine Therapy based on emerging data about the optimal duration of aromatase inhibitor (AI) treatment.MethodsASCO conducted a s...

  • Adjuvant Endocrine Therapy for women with hormone receptor positive breast cancer asco clinical practice guideline focused update
    Journal of Clinical Oncology, 2019
    Co-Authors: Harold J Burstein, Clifford A Hudis, Christina Lacchetti, Holly Anderson, Thomas A Buchholz, Nancy E Davidson, Karen A Gelmon, Sharon H Giordano, Alexander J Solky, Vered Stearns
    Abstract:

    PurposeTo update the ASCO clinical practice guideline on Adjuvant Endocrine Therapy based on emerging data about the optimal duration of aromatase inhibitor (AI) treatment.MethodsASCO conducted a systematic review of randomized clinical trials from 2012 to 2018. Guideline recommendations were based on the Panel’s review of the evidence from six trials.ResultsThe six included studies of AI treatment beyond 5 years of Therapy demonstrated that extension of AI treatment was not associated with an overall survival advantage but was significantly associated with lower risks of breast cancer recurrence and contralateral breast cancer compared with placebo. Bone-related toxic effects were more common with extended AI treatment.RecommendationsThe Panel recommends that women with node-positive breast cancer receive extended Therapy, including an AI, for up to a total of 10 years of Adjuvant Endocrine treatment. Many women with node-negative breast cancer should consider extended Therapy for up to a total of 10 yea...

  • Adjuvant Endocrine Therapy for women with hormone receptor positive breast cancer american society of clinical oncology clinical practice guideline update on ovarian suppression
    Journal of Clinical Oncology, 2016
    Co-Authors: Harold J Burstein, Clifford A Hudis, Christina Lacchetti, Holly Anderson, Thomas A Buchholz, Nancy E Davidson, Karen A Gelmon, Sharon H Giordano, Alexander J Solky, Vered Stearns
    Abstract:

    PurposeTo update the ASCO Adjuvant Endocrine Therapy guideline based on emerging data concerning the benefits and risks of ovarian suppression in addition to standard Adjuvant Therapy in premenopausal women with estrogen receptor–positive breast cancer.MethodsASCO convened an Update Panel and conducted a systematic review of randomized clinical trials investigating ovarian suppression.ResultsTwo trials investigating the addition of ovarian suppression to tamoxifen did not show an overall clinical benefit for ovarian suppression. Nonetheless, the addition of ovarian suppression to standard Adjuvant Therapy with tamoxifen or with an aromatase inhibitor improved disease-free survival and improved freedom from breast cancer and distant recurrence compared with tamoxifen alone among the subset of patients who were at sufficient risk for recurrence such that Adjuvant chemoTherapy was warranted. Compared with tamoxifen alone, ovarian suppression was associated with a substantial increase in menopausal symptoms, ...

  • perspectives of postmenopausal breast cancer survivors on Adjuvant Endocrine Therapy related symptoms
    Oncology Nursing Forum, 2014
    Co-Authors: G J Van Londen, Nancy E Davidson, Heidi S Donovan, Ellen Burke Beckjord, Alexandra L Cardy, Dana H Bovbjerg, Jennifer Q Morse, Galen E Switzer, Irma Verdonckde M Leeuw, Mary Amanda Dew
    Abstract:

    Purpose/Objectives: To conduct an investigation of women's experiences related to Adjuvant Endocrine Therapy (AET) and managing AET-related symptoms. Research Approach: Qualitative, focus group design. Setting: Main campus of the University of Pittsburgh in Pennsylvania. Participants: 14 breast cancer survivors, aged 50 years or older, with AET-related symptoms. Methodologic Approach: Semistructured discussion guides were used to elicit recollections of conversations with healthcare providers about starting AET, symptom experiences, symptom management, and suggestions for improving management. Audiotaped discussions were transcribed and analyzed to identify themes. Findings: Women reported that, initially, AET was not viewed as a choice, but rather as the necessary next step to save their lives. After starting AET, women experienced difficulties making sense of, communicating about, and managing unanticipated AET-related symptoms. Women who experienced persistently bothersome symptoms began weighing the pros and cons of AET to decide whether to continue treatment. Conclusions: Focus group findings suggest multiple opportunities to better prepare patients for AET and to improve assessment and management of AET-related symptoms. Interpretation: By exploring AET-related symptom experiences, nurses may be able to promote AET adherence in breast cancer survivors.

  • Adjuvant Endocrine Therapy for women with hormone receptor positive breast cancer american society of clinical oncology clinical practice guideline focused update
    Journal of Clinical Oncology, 2014
    Co-Authors: Clifford A Hudis, Harold J Burstein, Holly Anderson, Thomas A Buchholz, Nancy E Davidson, Karen A Gelmon, Sharon H Giordano, Sarah Temin, Diana Rowden
    Abstract:

    Purpose To update the ASCO clinical practice guideline on Adjuvant Endocrine Therapy on the basis of emerging data on the optimal duration of treatment, particularly Adjuvant tamoxifen. Methods ASCO convened the Update Committee and conducted a systematic review of randomized clinical trials from January 2009 to June 2013 and analyzed three historical trials. Guideline recommendations were based on the Update Committee’s review of the evidence. Outcomes of interest included survival, disease recurrence, and adverse events. Results This guideline update reflects emerging data on duration of tamoxifen treatment. There have been five studies of tamoxifen treatment beyond 5 years of Therapy. The two largest studies with longest reported follow-up show a breast cancer survival advantage with 10-year durations of tamoxifen use. In addition to modest gains in survival, extended Therapy with tamoxifen for 10 years compared with 5 years was associated with lower risks of breast cancer recurrence and contralateral breast cancer.