Joaquín Gavilá

Fundación Instituto Valenciano de Oncología

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Aleix Prat

Hospital Clínic de Barcelona

Antonio Llombart‐Cussac

Hospital Arnau de Vilanova

Tomás Pascual

Hospital Clínic de Barcelona

Montserrat Muñoz

Consorci Institut D'Investigacions Biomediques August Pi I Sunyer

Vicente Guillém

Fundación Instituto Valenciano de Oncología

Laia Paré

Oryzon Genomics (Spain)

Patricia Villagrasa

Oryzon Genomics (Spain)

Mafalda Oliveira

Universidade Estadual de Feira de Santana

Aña Lluch

INCLIVA Health Research Institute

Núria Chic

Hospital Clínic de Barcelona

Cooperative Institutions

GEICAM – Spanish Breast Cancer Group

156

Fundación Instituto Valenciano de Oncología

102

Centro de Investigación Biomédica en Red de Cáncer

Hospital Clínic de Barcelona

Dana-Farber Cancer Institute

Instituto de Salud Carlos III

Institut Català d'Oncologia

Vall d'Hebron Hospital Universitari

Solti

Universitat Autònoma de Barcelona

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Correction: ER+ Breast Cancers Resistant to Prolonged Neoadjuvant Letrozole Exhibit an E2F4 Transcriptional Program Sensitive to CDK4/6 Inhibitors

Clinical Cancer Research (2019)

Ángel Guerrero-Zotano Thomas Stricker Luigi Formisano Katherine E. Hutchinson Daniel G. Stover

In the original version of this article (1), the stated disclosure of the author Carlos L. Arteaga is incorrect. The error has been corrected in the latest online HTML and PDF versions of the article. The authors regret this error.

Letrozole

10.1158/1078-0432.ccr-18-4270

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Citations (1)

Figure S3 from ER+ Breast Cancers Resistant to Prolonged Neoadjuvant Letrozole Exhibit an E2F4 Transcriptional Program Sensitive to CDK4/6 Inhibitors

Ángel Guerrero-Zotano Thomas Stricker Luigi Formisano Katherine E. Hutchinson Daniel G. Stover

Distribution of clinically actionable mutations according to PEPI score, PCNA proliferation signature and breast cancer subtypes

Letrozole

10.1158/1078-0432.22464816.v1

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Figure S4 from ER+ Breast Cancers Resistant to Prolonged Neoadjuvant Letrozole Exhibit an E2F4 Transcriptional Program Sensitive to CDK4/6 Inhibitors

Ángel Guerrero-Zotano Thomas Stricker Luigi Formisano Katherine E. Hutchinson Daniel G. Stover

E2F4 gene signature modulation and association with overall survival in ER+/HER2- breast cancer treated with endocrine therapy. a) E2F4 gene signature expression at baseline (pre) and after 2-weeks of aromatase inhibitor treatment (post), data from ACOSOGZ1031b study. Tumors were divided according to the E2F4 score at baseline in high, medium or low tertiles. After two-weeks of aromatase inhibitor treatment, there was a decrease in the E2F4 score in all groups. However, the proportion of tumors still expressing a high post-treatment E2F4 score was greater in patients with a high E2F4 score at baseline (60%) than the other groups. b) Overall survival in patients with ER+ breast cancer treated with adjuvant endocrine therapy in the METABRIC database (n=1498) according to E2F4 signature score tertiles. c) Overall survival in patients with ER+ tumors from METABRIC according to E2F4 score tertiles in Luminal A and d) Luminal B tumors.

Letrozole

Aromatase inhibitor

10.1158/1078-0432.22464813

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Supplementary Data from Independent Validation of the PAM50-Based Chemo-Endocrine Score (CES) in Hormone Receptor–Positive HER2-Positive Breast Cancer Treated with Neoadjuvant Anti–HER2-Based Therapy

Tomás Pascual Aranzazu Fernandez-Martinez Maki Tanioka Maria Vittoria Dieci Sònia Pernas

Supplementary Data

Neoadjuvant Therapy

10.1158/1078-0432.22481012.v1

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Abstract OT2-06-01: Solti-1903 HOPE: Real-world clinical practice study to assess the impact of using genomic data on the next treatment decision making-choice in patients with locally advanced or metastatic breast cancer in Spain

Cancer Research (2022)

Ana Casas Eva Ciruelos Mafalda Oliveira Cristina Saura Meritxell Bellet

Abstract BACKGROUND: Metastatic breast cancer (mBC) remains an incurable disease and is the cause of nearly all deaths related to BC. Next-generation sequencing technologies are allowing the application of personalized targeted molecular therapies, thereby improving outcomes in breast cancer patients. However, they are not routinely used in the clinic and their cost could be a cause of disparity. One strategy to overcome the barriers of implementing NGS in the clinic is to promote the active participation of patients with mBC in the management of their disease and offering free access to these tests. With this in mind, we designed HOPE (SOLTI-1903), a Spanish real-world study where patients lead their inclusion, participation, and follow-up through a digital tool (DT) that guides them in every step of the journey. The ultimate objective of HOPE is to gather real-world data on the utilization of molecular information in the management of mBC and to empower these patients. TRIAL DESIGN: Patients diagnosed with locally advanced or mBC can be included. Basic demographic data, disease characteristics, treatment history and quality of life data are collected by patients through a DT. The study is complemented by a patient empowerment program including informative workshops and precision medicine video-tutorials. Patients are encouraged to involve their physicians in HOPE. A total of 600 patients will be included in Spain. PATIENT JOURNEY: Once patients request participation through the DT, a dedicated team in SOLTI assists them in the subsequent steps while validating that eligibility criteria are met according to patient-provided data. Then, patients receive instructions from SOLTI’s team to attend the nearest partner local laboratory, where they sign the study informed consent form. A metastatic (preferably) or primary archival tumor sample is requested from the patient’s reference hospital and analyzed by FoundationOne®CDx. Patients that are in progression or not receiving active systemic chemo- or radiotherapy undergo a blood draw to receive a Guardant360 analysis. These two NGS tests are offered to all patients, and the blood test is performed even if no tissue is available. The results from the molecular analyses are regularly reviewed by a Molecular Advisory Board (MAB). The MAB, based on its joint experience in clinical oncology, genomics, bioethics, and pathology, may add some advice to these reports via DT, making comments about detected molecular alterations and adding further recommendations for specific treatment options or available CT with targeted therapies and/or additional genetic tests such as germline validation of potentially significant findings. From that moment, patients are requested to record their disease evolution in the DT every 3 months for 2 years. The primary objective is to assess the real-world clinical practice integrating molecular profiling in the Standard of Care management of patients with mBC connected through a DT. Secondary objectives include to i) describe the genetic mutational profile of mBC, ii) estimate the enrollment rate in CT of patients engaged in a patient-centered strategy for molecular tumor assessment, iii) assessing Progression Free Survival, Overall Survival and Quality of Life status among patients enrolled in CT according to the tumor’s genomic profile and iv) evaluate the logistic feasibility of the study. Recruitment started on October 2020. By June 2021, 362 patients had been enrolled. ACKNOWLEDGEMENTS: This study is sponsored by SOLTI and financially supported by Novartis and three non-profit organizations: Asociación Cáncer de Mama Metastásico, Asociación Saray and Fundación Actitud frente al Cáncer. Roche and Guardant Health provide their tests for all patients. Citation Format: Ana Casas, Eva Ciruelos, Mafalda Oliveira, Cristina Saura, Meritxell Bellet, Sonia Pernas, Joaquín Gavilá, Montserrat Muñoz, Maria Vidal, Blanca González-Farré, Juan M. Cejalvo, Rafael López, Ana Vivancos, Marcos Malumbres, Javier Salvador Bofill, Isabel Blancas, Emilio Alba, Valentina Boni, Susana De la Cruz, Elena Galve, Antonia Perelló, Mireia Margelí, Meritxell Soler, Rubén Olivera-Salguero, Helena Masanas, Rosa Olmos, Marga Forns, Pilar Fernández Pascual, Elia Seguí, Tomas Pascual, Aleix Prat. Solti-1903 HOPE: Real-world clinical practice study to assess the impact of using genomic data on the next treatment decision making-choice in patients with locally advanced or metastatic breast cancer in Spain [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT2-06-01.

10.1158/1538-7445.sabcs21-ot2-06-01

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Safety profile of trastuzumab deruxtecan in advanced breast cancer: Expert opinion on adverse event management

Clinical & Translational Oncology (2024)

Eva Ciruelos José Á. García-Sáenz Joaquín Gavilá Miguel Martín César A. Rodríguez

Abstract Trastuzumab deruxtecan (T-DXd) is an antibody–drug conjugate that targets human epidermal growth factor receptor 2 (HER2) and has shown promising results in the treatment of advanced/metastatic breast cancer. The objective of this report is to provide guidance on the prophylaxis, monitoring, and management of adverse events (AEs) in patients with breast cancer treated with T-DXd, and to emphasize that proper management of AEs is needed to optimize the effectiveness of T-DXd treatment and reduce the number of discontinuations. The article covers various aspects of T-DXd treatment, including its clinical efficacy, safety profile, and dosing considerations, and provides practical recommendations for managing AEs, such as nausea/vomiting, interstitial lung disease, and hematologic toxicity. Although there are still many knowledge gaps about the cause and incidence of AEs in real-world patients, this document may serve as a valuable resource for clinicians who are involved in the care of breast cancer patients receiving T-DXd treatment.

Safety profile

10.1007/s12094-024-03383-x

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Palbociclib and ribociclib in breast cancer: consensus workshop on the management of concomitant medication

Therapeutic Advances in Medical Oncology (2019)

Meritxell Bellet Faten Ahmad Rafael Villanueva-Vázquez Carolina Valdivia Julian Palomino‐Doza

Drug-drug interactions are of significant concern in clinical practice in oncology, particularly in patients receiving Cyclin-dependent kinase (CDK) 4/6 inhibitors, which are typically exposed to long-term regimens. This article presents the highlights from the 'First Workshop on Pharmacology and Management of CDK4/6 Inhibitors: Consensus about Concomitant Medications'. The article is structured into two modules. The educational module includes background information regarding drug metabolism, corrected QT (QTc) interval abnormalities, management of psychotropic drugs and a comprehensive review of selected adverse effects of palbociclib and ribociclib. The collaborative module presents the conclusions of the five working groups, each of which comprised five experts from different fields. From these conclusions positive lists of drugs for treating common comorbid conditions that can be safely administered concomitantly with palbociclib and/or ribociclib were developed.

Palbociclib

Concomitant

10.1177/1758835919833867

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Citations (49)

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)

Marco Colleoni Weixiu Luo Per Karlsson Jacqueline Chirgwin Stefan Aebi

503 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. 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 analyses. SOLE required 4800 pts for 80% power to detect a 20% DFS hazard reduction with 2-sided α = 0.05 using a stratified log rank test. Analysis is by intention-to-treat. Results: At 60 mos median follow-up, 5 yr DFS from randomization was 85.8% vs 87.5% for patients assigned intermittent vs continuous letrozole (HR = 1.08; 95% CI 0.93-1.26; P = 0.31). Similar outcome was observed for breast cancer-free interval (HR = 0.98; 95% CI 0.81-1.19), distant recurrence-free interval (HR = 0.88; 95% CI 0.71-1.09), and overall survival (HR = 0.85; 95% CI 0.68-1.07). AEs of grade > 3 were reported for 43.5% vs 41.6% of pts assigned intermittent vs continuous letrozole. Overall 24% pts discontinued letrozole early in both groups. Conclusions: Among postmenopausal women with HR+ BC, extended intermittent letrozole did not improve DFS vs continuous letrozole. The similar observed outcomes and incidence of AEs provides clinically relevant information on the intermittent administration of extended letrozole for patients who could benefit from temporary treatment breaks. Clinical trial information: NCT00553410.

Letrozole

Clinical endpoint

Interim analysis

Aromatase inhibitor

10.1200/jco.2017.35.15_suppl.503

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Everolimus (EVE) plus exemestane (EXE) in elderly patients (pts) with hormone receptor-positive (HR+), human epidermal growth receptor-2 negative (HER2-) advanced breast cancer (ABC) progressing on prior nonsteroidal aromatase inhibitors (NSAIs) : Insights on safety form BALLET (CRAD001YIC04)

Patrick Neven Daniele Generali Eva Ciruelos I. Láng Joaquín Gavilá

Exemestane

Everolimus

Aromatase inhibitor

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Abstract P2-13-04: Impact of the adjuvant treatment with trastuzumab in HER2 positive breast cancer in the real-world setting. Analysis of two cohorts (1997-2005/2006-2015) in 1970 patients

Cancer Research (2019)

CA Rodríguez Jesús García-Gómez Nuria Ribelles Joaquín Gavilá Sònia Pernas

Abstract INTRODUCTION: Although large randomized trials assessing the benefit of adjuvant trastuzumab in HER2-positive (HER2+) breast cancer have clearly demonstrated a significant improvement in long-term survival, it is necessary to know the impact of the use of trastuzumab adjuvant in the real life population, which includes patients frequently excluded from clinical trials, such as those with very small tumors without node involvement, or advanced age. The objective of this study is to describe the outcomes of women who received adjuvant trastuzumab for HER2+ cáncer since it was approved in 2006, compared with a previous cohort of HER2+ patients not treated with trastuzumab in 7 Spanish centers. METHODS: Women with newly diagnosed stage I-III, HER2+ breast cancer, between 1997 and 2015 were included in the study. Two cohorts were considered: The No-Trastuzumab cohort (No-T), between 1997 and 2005, and the Trastuzumab cohort (T) with trastuzumab-treated women between 2006 and 2015. Kaplan-Meier estimates were used to evaluate DFS and OS. Additionally, cohorts were analyzed by pathologic tumour size, lymph node involvement and hormonal receptor status to stratify outcome measures. RESULTS: A total of 2134 patients were identified. In 164 cases, data were insufficient or the follow-up incomplete. Therefore, the final analysis included 1970 patients, of whom 539 belong to the "No-T" cohort and 1431 to the "T" cohort. The median follow-up was 81 months. Median age: 53 years [22-98]. A total of 699 patients had T1 tumors [43% in the "No-T" cohort vs 33% in the "T" cohort]. 55% of the cases were N0 [58% and 54% in the "No-T" and "T" cohorts respectively]. The status of the hormonal receptors was well balanced between groups [36% ER negative in both]. Regarding the type of adjuvant treatment administered, in the "T" cohort more patients received adjuvant chemotherapy [65% vs 97%] and also in the “T” group combinations of taxanes and anthracyclines were more frequent [14% vs 72%]. The proportion of adjuvant endocrine therapy was similar in both groups [37% vs 34%]. In the “T” cohort, median Disease Free Survival (DFS) was not-reached, compared with 149 months in the “No-T” group. 5-year DFS was 83% vs 65% respectively [p<0.001]. 5-year DFS was also superior and statistically significant in all the subgroups analyzed, including patients with T1 tumors (87% vs 57%), N0 (87% vs 78%), patients T1N0 (88% vs 74%) and HR positive (86% vs 71%) or negative (78% vs 50%). Similarly, Overall Survival (OS) was increased in patients treated with Trastuzumab (median: 224 months vs not-reached, 5-year OS: 92% vs 75% [p <0.001].) 5-year OS was also statistically superior in the T1 subgroup (92% vs 72%), and N0 (95% vs 88%). [p<0.001 in all subanalysis]. CONCLUSIONS: Adjuvant treatment with Trastuzumab under conditions of real clinical practice in HER2+ early breast cancer, shows a highly significant benefit in terms of DFS and OS, regardless of the stage of the disease or other clinical variables. A very important benefit was reached in patients with small tumors, node-negative disease, or both conditions (T1N0). The benefit was also obtained regardless of the expression of hormonal receptors. Citation Format: Rodriguez CA, Garcia-Gomez J, Ribelles N, Gavila J, Pernas S, Rodriguez-Lescure A, Urrutikoetxea A, Pernaut C, Lopez A, Garcia-Mata J. Impact of the adjuvant treatment with trastuzumab in HER2 positive breast cancer in the real-world setting. Analysis of two cohorts (1997-2005/2006-2015) in 1970 patients [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P2-13-04.

10.1158/1538-7445.sabcs18-p2-13-04

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