Breast Cancer In Spain Research Articles

Cost-Utility Analysis of Adjuvant Olaparib for Germline BRCA1/2-Mutated, High-Risk HER2-Negative Early Breast Cancer in Spain.

Here we estimate the cost-effectiveness of olaparib in the Spanish National Health Service (SNHS) as adjuvant treatment of early germline mutations in the BRCA1/2 genes (gBRCAm) HER2-negative (HER2neg) breast cancer (BC) with high risk of recurrence. A semi-Markov model was adapted to the Spanish healthcare setting, using the perspective of the SNHS, and a lifetime horizon. Two scenarios were compared: receiving olaparib versus standard of care (SoC) treatment. The model comprised five health states and included the clinical results of the OlympiA trial, along with the direct healthcare costs associated with the use of early BC and subsequent treatment resources (€2023). A discount rate of 3% was applied for future cost and quality-of-life outcomes. A probabilistic sensitivity analysis (PSA) was carried out. The introduction of olaparib as adjuvant treatment for patients with early gBRCAm HER2neg BC with high risk of recurrence could involve an incremental cost of €44,273 and €50,164, with an improvement of 1.14 and 1.28 quality-adjusted life years (QALYs) for hormone receptor-positive (HR+) and triple-negative (TN) patients, respectively. Therefore, adjuvant olaparib could be cost-effective for early gBRCAm HER2neg BC, with an incremental cost-effectiveness ratio of €38,839/QALY and €39,084/QALY for HR+ and TN patients, respectively. The results from the PSA showed that 75.7% and 82.2% of the simulations fell below the €60,000/QALY threshold. Olaparib as adjuvant treatment could be cost-effective in gBRCAm patients with early HER2neg BC in Spain.

Management of early-stage HER2-positive breast cancer and attitudes towards HER2DX test in Spain: insights from a nationwide survey

PurposeThis study aimed to investigate the current therapeutic management of patients with early-stage HER2-positive (HER2+) breast cancer in Spain, while also exploring the perceptions surrounding HER2DX in terms of its credibility, clinical relevance, and impact on therapeutic decision-making. Understanding these aspects is crucial for optimizing treatment strategies and enhancing patient outcomes in the context of HER2+ breast cancer.MethodsAn online questionnaire was conducted by an independent third-party between April and May 2022 across 70 medical oncologists highly specialized in breast cancer management in Spain. The survey included 37 questions regarding treatment decision making in HER2+ early breast cancer.ResultsThe management of patients with HER2+ early breast cancer exhibited a high degree of heterogeneity. Among the interviewed oncologists, 53% would recommend upfront surgery for node negative tumors measuring 1 cm or less. Interestingly, 69% and 56% of interviewers were open to deescalate the duration of adjuvant trastuzumab in pT1a and pT1b N0 tumors, respectively. Certain clinicopathological characteristics, such as high grade, high Ki-67, and young age, influenced the decision to prescribe neoadjuvant treatment for patients with clinical stage 1 disease. In cases where neoadjuvant treatment was prescribed for cT1-2 N0 tumors, there was a wide variation in the choice of chemotherapeutic and anti-HER2 regimens. Regarding the use of adjuvant trastuzumab emtansine (T-DM1) in patients with residual disease after neoadjuvant therapy, there was diversity in practice, and a common concern emerged that T-DM1 might be overtreating some patients. HER2DX, as a diagnostic tool, was deemed trustworthy, and the reported scores were considered clinically useful. However, 86% of interviewees believed that a prospective trial was necessary before fully integrating the test into routine clinical practice.ConclusionIn the context of early-stage HER2+ breast cancer in Spain, a notable diversity in therapeutic approaches was observed. The majority of interviewed medical oncologists acknowledged HER2DX as a clinically valuable test for specific patients, in line with the 2022 SEOM-GEICAM-SOLTI clinical guidelines for early-stage breast cancer. To facilitate the full integration of HER2DX into clinical guidelines, conducting prospective studies to further validate its efficacy and utility was recommended.

EE528 Analysis of Non-Pharmacological Cost Savings Derived from the Use of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection in Patients with HER2-Positive Breast Cancer in Spain

EE528 Analysis of Non-Pharmacological Cost Savings Derived from the Use of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection in Patients with HER2-Positive Breast Cancer in Spain

Perfil sociodemográfico y descripción del síntoma de presentación en mujeres con cáncer de mama en un estudio de base poblacional: implicaciones y papel de las enfermeras

ObjectiveTo describe the frequency and typology of the presenting symptom of women diagnosed of breast cancer in Spain and their socio-demographic profile. MethodsDescriptive study nested in a population epidemiological study (MCC-SPAIN) in 10 Spanish provinces. Between 2008 and 2012, 836 histologically confirmed incident cases of breast cancer were recruited who reported some symptom prior to diagnosis in a direct computerized interview. For the comparison of 2 discrete variables, the Pearson Chi square test was used. ResultsThe most frequent presenting symptom among women who reported at least one symptom was noticing a «lump in the breast» (73%), followed far behind by noticing «changes in the breast» (11%). The frequency of the presenting symptom showed some geographic heterogeneity as well as with menopausal status. No association was observed between the type of presenting symptom and the rest of the sociodemographic variables explored, except for the educational level in which women with a higher educational level tended to proportionally report other symptoms different from the «lump in the breast» more frequently than less educated. Postmenopausal women reported noticing changes in the breast (13%) more frequently than premenopausal women (8%), although without reaching statistical significance (P=.056). ConclusionsThe most frequent presenting symptom is «breast lump», followed by «breast changes». There could be sociodemographic heterogeneity in the type of presenting symptom to be taken into account by nurses in their socio-sanitary interventions.

Sociodemographic profile and description of the presenting symptom in women with breast cancer in a population-based study: Implications and role for nurses

ObjectiveTo describe the frequency and typology of the presenting symptom of women diagnosed of breast cancer in Spain and their socio-demographic profile. MethodsDescriptive study nested in a population epidemiological study (MCC-SPAIN) in 10 Spanish provinces. Between 2008 and 2012, 836 histologically confirmed incident cases of breast cancer were recruited who reported some symptom prior to diagnosis in a direct computerized interview. For the comparison of 2 discrete variables, the Pearson Chi square test was used. ResultsThe most frequent presenting symptom among women who reported at least one symptom was noticing a “lump in the breast” (73%), followed far behind by noticing “changes in the breast” (11%). Geographic heterogeneity was observed in the frequency of the presenting symptom, as well as with menopausal status. No association was observed between the type of presenting symptom and the rest of the sociodemographic variables explored, except for the educational level in which women with a higher educational level tended to proportionally report other symptoms different from the “lump in the breast” more frequently than less educated. Postmenopausal women reported noticing changes in the breast (13%) more frequently than premenopausal women (8%), although without reaching statistical significance (P = .056). ConclusionsThe most frequent presenting symptom is “breast lump”, followed by “breast changes”. There could be sociodemographic heterogeneity in the type of presenting symptom to be taken into account by nurses in their socio-sanitary interventions.

Hospital Incidence and Medical Costs of Female Breast Cancer in Spain: A Retrospective Multicenter Study

Background: Breast cancer is the most prevalent cancer in women worldwide, causing the greatest number of cancer-related deaths. This study aimed to evaluate the use of healthcare resources associated with female breast cancer in Spain, to analyze trends in hospitalization and death rates, and the related direct medical costs Methods: A retrospective multicenter study analyzed records of hospital and ambulatory visits of women diagnosed with breast cancer in Spanish hospitals between 1st January 2005 and 31st December 2018. Results: In total, 353,080 admission files were reviewed, mainly inpatient hospital admissions, corresponding to 299,585 individual patients. The median patient age was 59 years, 12.7% of admissions registered the presence of metastatic tumors, and 15.7% registered unspecified secondary tumors. The mean in-hospital death rate was 3.0% for patients without a metastatic disease and 10.5% for patients with metastatic disease, decreasing significantly over the study period. The total age adjusted hospitalization rate increased between 2005 and 2011 and decreased after 2012. The mean direct medical cost was €3824 per outpatient visit, €3995 per hospital admission up to 3 days and €5001 per hospital admission over 3 days. Admission costs increased in patients with metastatic disease and those deceased during hospitalization Conclusion: This study supports previous findings regarding the relative increase in breast cancer incidence that could be attributed to the intensive screening and the reduction in the death rate. Mean direct medical cost in this study varied greatly with the length of stay, presence of metastatic tumors and disease fatality.

183 (PB-096) Poster - Abemaciclib for treating patients with HR+, HER2- advanced/metastatic breast cancer in Spain: a real-world study

Background: We report the demographic and clinical characteristics, treatment patterns, and treatment outcomes of female patients with hormone receptor positive (HR+), human epidermal growth factor 2 negative (HER2-) advanced/metastatic breast cancer (ABC/MBC) treated with abemaciclib in a real-world setting in Spain.

Thematic analysis of illness narratives as an example of an approach to better understand the lived experience of women diagnosed with breast cancer in Spain

ObjectiveTo explore the lived experience of women diagnosed with breast cancer through the analysis of illness narratives, as an example of a narrative-based medicine approach.SettingSpain.ParticipantsNine narratives stemming from non-fiction books,...

Adherence of long-term breast cancer survivors to follow-up care guidelines: a study based on real-world data from the SURBCAN cohort

PurposeTo identify adherence to follow-up recommendations in long-term breast cancer survivors (LTBCS) of the SURBCAN cohort and to identify its determinants, using real-world data.MethodsWe conducted a retrospective study using electronic health records from 2012 to 2016 of women diagnosed with incident breast cancer in Spain between 2000 and 2006 and surviving at least 5 years. Adherence to basic follow-up recommendations, adherence according to risk of recurrence, and overall adherence were calculated based on attendance at medical appointments and imaging surveillance, by year of survivorship. Logistic regression models were fitted to depict the association between adherence and its determinants.ResultsA total of 2079 LTBCS were followed up for a median of 4.97 years. Of them, 23.6% had survived ≥ 10 years at baseline. We estimated that 79.5% of LTBCS were overall adherent to at least one visit and one imaging test. Adherence to recommendations decreased over time and no differences were found according to recurrence risk. Determinants of better overall adherence were diagnosis in middle age (50–69 years old), living in a more-deprived area, having fewer years of survival, receiving primary treatment, and being alive at the end of follow-up.ConclusionWe identified women apparently not complying with surveillance visits and tests. Special attention should be paid to the youngest and eldest women at diagnosis and to those with longer survival.

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

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.

Abstract P4-07-10: Patient profiles, management and treatment patterns in HR+, HER2- early breast cancer in a real-world setting in Spain

Abstract Background: Hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) is the most prevalent breast cancer (BC) subtype(≈60% of all BC in Spain), 95% of which are diagnosed in early stage. Despite several treatment options, approximately 20%-25% of them will experience metastatic relapse. Early and accurate identification of patients at high risk of recurrence is critical to improve patient outcomes. It would be relevant to know how high risk patients are identified and managed in Spain. The primary objective was to describe the current approaches to patient management and standards of care for patients with early stage (I-IIIc) HR+/HER2- BC in a real world setting in Spain.Methods: Real-world data were drawn from the Adelphi Early BC I Disease Specific Program. Data included physicians´ (medical oncologists) subjective perceptions such as factors used to determine patient´s risks of recurrence, and objective variables relating to the next 8 consecutive patients with HR+ HER2- BC they consulted and completed patient record forms for, such as demographic, clinical and gene expression profiles. Data were collected between June and October 2019. The sample was analyzed to identify patients similar to those meeting the high risk of recurrence criteria used in the monarchE (mE) trial: ≥4 positive nodes, OR 1-3 positive nodes AND [grade 3 or tumor ≥5 cm or Ki-67 ≥20%]. Those not meeting the criteria were categorised as Low/moderate (L/M) risk. Results: 50 oncologists provided data on 400 consecutive patients, of which 81 (20%) were categorized as high risk. Patients´ mean age was 58 years old at diagnosis and initiated first adjuvant treatment (AT) within four months of diagnosis. 19% had family history of BC, their disease stage was predominantly II (50%), 57% had grade 2 tumors and 74% had a tumor size of 1-3cm. 50 patients (13%) met high risk clinical pathologic criteria (≥4 positive nodes, OR 1-3 positive nodes AND [grade 3 or tumor ≥5 cm]) and an additional 31 patients (8%) met high risk mE criteria based on having a Ki-67 expression of ≥20%.At diagnosis, high risk patients compared to L/M tended to be younger (mean 54,3 vs 58,5 years), with higher likelihood of BC family history (32% vs 16%), more advanced disease at diagnosis (99% vs 59% stage II or III), more likely to have grade 3 tumors (41% vs 14%) and tumors >3cm (32% vs 14%). The most common biomarker/genetic tests at diagnosis were ER, PgR and Ki67, used in over 95% of patients.Genomic assays of the tumors were performed in 35% of patients, of which the most common were Oncotype Dx (58%) and MammaPrint (22%). High risk patients were less likely to have genomic assays (15% vs 40% received any). Genomic assays were more often conducted prior to starting AT therapy (66%) than at initial diagnosis (38%).Neoadjuvant and first adjuvant treatments are described in table 1. Factors frequently considered by oncologists (>45% of respondents) to evaluate risk of recurrence were tumor stage, size and grade, nodal, HER2 and HR status, genomic assays and Ki-67 expression level. Conclusion: One in five patients were classified as high risk according to mE criteria, although oncologists considered additional factors to categorize patients as high risk level in their daily practice. Consequently, many patients of L/M risk according to mE criteria could still be considered as high risk by their physicians, as suggested by nearly half of patients receiving ChT treatment as adjuvant therapy. Proportion of patients that were prescribed each class in each setting (not mutually exclusive)ChemotherapyAnthracyclineTaxaneEndocrine therapyAromatase inhibitorTamoxifenTargeted therapyTotal sampleNeoadjuvant therapy n (%)n (%)n (%)n (%)n (%)n (%)n (%)n (%)Overall (n=400)75 (19)69 (92)60 (80)64 (85)28 (37)22 (29)6 (8)-High risk (n=81)17 (21)16 (94)15 (88)16 (94)8 (47)7 (41)1 (6)-L/M risk (n=319)58 (18)53 (91)45 (78)48 (83)20 (34)15 (26)5 (9)-Total sampleFirst adjuvant n (%)n (%)n (%)n (%)n (%)n (%)n (%)n (%)Overall (n=400)400 (100)217 (54)129 (32)132 (33)256 (64)177 (44)79 (20)1 (0)High risk (n=81)81 (100)66 (81)56 (69)50 (62)27 (33)18 (22)9 (11)1 (1)L/M risk (n=319)319 (100)151 (47)73 (23)82 (26)229 (72)159 (50)70 (22)- Citation Format: Miguel Martín, Jose Ángel García Sáenz, Isabel Blancas, Alberto Molero, Manuel Atienza, Jose Manuel Cervera, Jacqueline Brown, Alex Rider, Rhys Williams, Emilio Alba. Patient profiles, management and treatment patterns in HR+, HER2- early breast cancer in a real-world setting 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 P4-07-10.

Depressive Symptoms and Quality of Life Associated With the Use of Monoclonal Antibodies in Breast Cancer Treatment.

To assess the relationship between (a) chemotherapy and monoclonal antibody (mAb) treatments and (b) depressive symptoms and quality of life (QOL) in patients with breast cancer. 182 women with breast cancer in Spain who were undergoing chemotherapy with or without mAbs. An observational, cross-sectional study was carried out. The European Organisation for Research and Treatment of Cancer (EORTC) QOL Questionnaire-Core 30 and the EORTC QOL Questionnaire-Breast Cancer were used to assess QOL. Patients were screened for depressive symptoms using the Beck Depression Inventory-II. No relationship was found between the use of mAbs with chemotherapy and QOL, except for incidence of diarrhea. However, depressive symptoms had a negative and highly significant influence on the majority of the QOL parameters. The presence of depressive symptoms negatively affects QOL. Used concurrently, mAbs and chemotherapy do not negatively influence QOL, but some adverse effects, such as diarrhea, are common.

Cost-utility of talazoparib monotherapy treatment for locally advanced or metastatic breast cancer in Spain

Breast cancer is one of the most frequent malignancies. The aim of the article is to analyse the cost-utility ratio and budgetary impact of talazoparib treatment for patients with locally advanced or metastatic gBRCA + breast cancer from the perspective of the Spanish National Health System. Analyses were based on the EMBRACA clinical trial and the model was constructed according to “partitioned survival analysis”. Two scenarios were considered in order to compare talazoparib with the alternatives of capecitabine, vinorelbine and eribulin: 1. Chemotherapy in patients pre-treated with anthracyclines/taxanes and, 2. A second- and subsequent-line treatment option. Treatment types following relapse were recorded in the mentioned clinical trial. The effectiveness measure used was quality-adjusted life years (QALY). The average health cost of patients treated at 43 months with talazoparib was 84,360.86€, whilst current treatment costs were 26,683.90€. The effectiveness of talazoparib was 1.93 years of survival (1.09 QALY) relative to 1.58 years (0.83 QALY) in the treatment group. The incremental cost-utility ratio was 252,420.04€/QALY. This represents the additional cost required to earn an additional QALY when changing from regular treatment to talazoparib. Regarding budgetary impact, the number of patients susceptible to receiving treatment with between 94 and 202 talazoparib was estimated, according to scenario and likelihood. The 3-year cost difference was between 6.9 and 9 million euros. The economic evaluation conducted shows an elevated incremental cost-utility ratio and budgetary impact. Taking these results into account, the price of talazoparib would have to be lower than that taken as a reference to reach the cost-utility thresholds.

Abstract OT-17-01: Solti-1903 hope: Real-world clinical practice study to assess the impact of using comprehensive genomic data on the next treatment decision making-choice in patients with locally advanced or metastatic breast cancer in Spain

Abstract BACKGROUND: Metastatic breast cancer (mBC) remains an incurable disease and is the cause of nearly all deaths from breast cancer. Targeted molecular therapies and the evolving role of next-generation sequencing (NGS) technologies are increasing and may improve outcomes in breast cancer patients. However, they are not being routinely used in the clinic. One strategy to overcome the barriers of implementing NGS in the clinic is to promote the active participation of mBC patients in the management of their disease. With this in mind, we designed HOPE (SOLTI-1903), a national real-world study where patients lead their inclusion, participation and follow-up in the study through a digital tool that will guide them in every step of the journey. Our objective is empowering mBC patients and gather real-world data about the utilization of molecular information in the management of mBC. TRIAL DESIGN: Patients diagnosed with mBC who are receiving, have just received, or will receive standard treatment or treatment in a clinical trial (CT) can be included. Demographic data, disease characteristics, treatment history and quality of life data will be collected through a digital tool (DT) by the patient. Patients are encouraged to involve their physician`s in the study journey. The study is complemented by a patient empowerment program including informative workshops and precision medicine video-tutorials. A total of 600 patients will be included in Spain. Patient Journey Once patients request to participate in HOPE through the DT, a dedicated team from SOLTI will assist them in the following steps while validating that eligibility criteria are met according to data introduced by themselves. Then, patients will receive instructions via DT to go to the nearest partner local laboratory, where they will sign the study consent form. A metastatic (preferably) or primary archival tumor sample will be requested to the patient’s reference hospital and analyzed by FoundationOne®CDx. Also, a blood sample will be collected and analyzed by Guardant360. For all patients, two NGS tests will be offered (If no tissue available, only blood test will be performed). Both molecular analyses results will be reviewed during regular meetings by a Molecular Advisory Board (MAB). The MAB, based on their joint experience in clinical oncology, genomics, molecular biology, 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. From that moment, patients will record their disease evolution in the DT each 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 mBC patients connected through a DT. Secondary objectives include to describe genetic mutational profile of mBC, to evaluate the enrollment rate in CT of patients engaged in a patient-centered strategy for molecular tumor assessment, to asses Progression Free Survival, Overall Survival and Quality of life status among patients enrolled in CT according to the tumor’s genomic profile and those receiving standard treatment and to describe logistic feasibility of the study. This study is sponsored by SOLTI and financially supported by Novartis and two non-profit organizations: Asociación Cáncer de Mama Metastásico y Fundación Actitud frente al Cáncer. Roche and Guardant Health provide their test for all patients. Citation Format: Ana Casas, Eva Ciruelos, Mafalda Oliveira, Cristina Saura, Meritxell Bellet, Sonia Pernas, Joaquín Gavilá, Montserrat Muñoz, María Vidal, Blanca Gonzalez Farré, Juan M. Cejalvo, Rafael Lopez, Ana Vivancos, Maurizio Scaltriti, Javier S. Bofill, Isabel Blancas, Emilio Alba, Valentina Boni, Susana De la Cruz, Elena Galve, Antonia Perelló, Mireia Margelí, Jordi Canes, Pamela Céliz, Helena Masanas, Rosa Olmos, Marga Fonts, Pilar Fernandez-Pascual, Patricia Villagrasa, Aleix Prat. Solti-1903 hope: Real-world clinical practice study to assess the impact of using comprehensive 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 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 OT-17-01.

PCN78 Costs of Recurrence in Patients with HER2+ Breast Cancer in Spain

Previous studies estimated the cost of recurrences in HER2+ breast cancer (BC) patients in Spain. Considering the advances in the management of the disease, the aim of this study is to update and describe the costs of recurrences in patients with HER2+ BC in Spain. The average cost of a HER2+ BC recurrence was estimated considering direct and indirect costs of local and metastatic relapses (up to 5 lines in the metastatic setting) weighted by the proportion of patients reaching each treatment line according to published literature and validated by an expert panel. Unit costs were obtained from literature and national databases and were updated to €2020. Direct cost estimates included pharmacological treatments and other medical resources (visits, tests, hospitalizations, local treatments [surgery and radiotherapy], adverse events management and treatment of localized metastases) and were validated by an expert panel. Indirect costs were estimated using the human capital approach. In local relapses, direct costs were €36,367 whereas indirect costs were €20,210. In metastatic relapses, direct costs ranged between €124,657 (patients receiving one treatment line) and €243,853 (patients receiving five treatment lines), and indirect costs ranged between €14,510 and €44,525, respectively. The average cost of the recurrence per patient weighting both local and metastatic relapses was €196,078 (86% direct costs, of which 84% were pharmacological treatments and 16% other medical resources). The average cost of the recurrence per patient weighting only metastatic relapses was €204,753 (87% direct costs, of which 85% were pharmacological treatments). HER2+ BC recurrences continue posing a high economic burden on the Spanish National Healthcare System and the society. Tackling the disease at an early stage reducing the risk of recurrences remains a paramount priority in the management of the disease.

Quality of Life in a Cohort of 1078 Women Diagnosed with Breast Cancer in Spain: 7-Year Follow-Up Results in the MCC-Spain Study.

Breast cancer is the most frequent cause of tumors and net survival is increasing. Achieving a higher survival probability reinforces the importance of studying health-related quality of life (HR-QoL). The main aim of this work is to test the relationship between different sociodemographic, clinical and tumor-intrinsic characteristics, and treatment received with HR-QoL measured using SF-12 and the FACT/NCCN (National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy) Breast Symptom Index (FBSI). Women with breast cancer recruited between 2008 and 2013 and followed-up until 2017–2018 in a prospective cohort answered two HR-QoL surveys: the SF-12 and FBSI. The scores obtained were related to woman and tumor characteristics using linear regression models. The telephone survey was answered by 1078 women out of 1685 with medical record follow-up (64%). Increases in all three HR-QoL scores were associated with higher educational level. The score differences between women with university qualifications and women with no schooling were 5.43 for PCS-12, 6.13 for MCS-12 and 4.29 for FBSI. Histological grade at diagnosis and recurrence in the follow-up displayed a significant association with mental and physical HR-QoL, respectively. First-line treatment received was not associated with HR-QoL scores. On the other hand, most tumor characteristics were not associated with HR-QoL. As breast cancer survival is improving, further studies are needed to ascertain if these differences still hold in the long run.

The economic burden of metastatic breast cancer in Spain

ObjectivesThe study aimed to estimate the burden of metastatic breast cancer (mBC) in Spain over 5 years.MethodsAn incidence-based cost-of-illness model was developed in which a cohort of patients with mBC...

Evolution of older patients diagnosed with early breast cancer in Spain between 1998 and 2001 included in El Alamo III project.

An increase in the number of cancer cases is expected in the near future. Breast cancer (BC) mortality rates increase with age even when adjusted for other variables. Here we analyzed BC disease-free survival (BCDFS) and BC specific survival (BCSS) in the El Alamo III BC registry of GEICAM Spanish Breast Cancer Group. El Alamo III is a retrospective registry of BC patients diagnosed between 1998 and 2001. Patients with stage I-III invasive BC of age groups 55-64years (y), 70-74years and ≥ 75 years were included. Patients and tumors characteristics, treatments and recurrences and deaths were analyzed. 4343 patients were included within the following age intervals: 2288 (55-64years), 960 (70-74years), and 1095 (≥ 75years). Older patients (≥ 70years) were diagnosed with more advanced tumors (stage III) than younger patients (21.5% versus 13.4%, p < 0.0001). Mastectomies were performed more on older patients and they received less chemotherapy than younger patients (66.6% versus 43.1%, p < 0.00001 and 30.8% versus 71.6%, p < 0.0001, respectively). With a median follow-up of 5.9years, 17.7% patients had BCDFS events in the younger group and 19.8% in the older group (p < 0.0001). A decrease in BCSS was also observed in older patients, either when analyzing patients ≥ 70y (p < 0.0001) and when differentiating by the two older groups (p < 0.0001). Our study suggests that older BC patients have worse outcomes what can be a consequence of receiving inadequate adjuvant treatments. Specific trials for these patients are warranted to allow us to treat them with the same scientific rigor than younger patients.

Contribution of trastuzumab to the prognostic improvement of HER2-positive early breast cancer in Spain: an estimation of life years and disease-free life years gained since its approval.

Introduction: Trastuzumab has become the standard treatment for both HER2-positive early and metastatic breast cancer (HER2+ eBC or mBC) since its approval. The objective of the study is to estimate the benefit of adjuvant trastuzumab in the treatment of patients with HER2+ eBC in terms of life years gained (LYG) and disease-free life years gained (DFLYG) since its approval in Spain in 2006.Results: 35,851 women make up the cohorts from 2006 to 2017. In the T (trastuzumab)+CT (chemotherapy) scenario, the sum of life years was 605,358 (525,964 disease-free) versus 564,137 (489,916 disease-free) in the CT scenario, resulting in 41,221 LYG (36,048 disease-free) due to trastuzumab. The general population for the same age range would have generated 704,331 LY. The estimated incremental cost was 880.43 million€ (€24,558.13 per patient) from 2006 to 2035. The incremental cost-effectiveness ratios obtained were €20,644 and €23,960 per LYG and DFLYG, respectively.Methods: An epidemiological model was developed with a time horizon until 2035 and a 3% discount rate. The model compared two scenarios, with and without trastuzumab as adjuvant therapy. The effectiveness data to model the survival curves were obtained from BCIRG 006 study and direct costs were included.Conclusions: Adjuvant trastuzumab has substantially improved the survival of patients with HER2+ eBC, contributing over 41,000 LYG to Spanish society (over 36,000 DFLYG) in a cost-effective manner. However, the sum of LYG with trastuzumab is still far from the LY estimated for the general population, supporting the need of further advances in HER2+ eBC.

Cost-effectiveness analysis of ribociclib versus palbociclib in the first-line treatment of HR+/HER2- advanced or metastatic breast cancer in Spain.

PurposeThe aim of this study was to evaluate the cost-effectiveness of ribociclib compared to palbociclib, both in combination with letrozole, in the first-line treatment of postmenopausal women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced or metastatic breast cancer (ABC) from the perspective of the Spanish National Health System (NHS).Patients and methodsDisease progression was simulated with a partitioned survival model developed from the parameterization and extrapolation of survival curves of postmenopausal women with HR+/HER2− ABC from clinical trials with ribociclib or palbociclib, both in combination with letrozole. The model was structured on the basis of three health states (progression-free, progressed disease, and death), with a 1-month cycle length and inclusion of subsequent treatments administered for disease progression, over a time horizon of 15 years. Clinical, economic, and quality of life parameters were drawn from clinical trials and the literature. The use of resources and clinical practice in the Spanish setting was validated by a panel of experts. The Spanish NHS perspective was adopted, taking into account exclusively direct health costs from 2017 expressed in Euros. Drug prices used were the reported ex-factory prices. Uncertainty of the parameters and robustness of the results were evaluated using deterministic and probabilistic sensitivity analyses (2,000 iterations).ResultsThis cost-effectiveness analysis showed a greater benefit (0.437 and 0.285 life-years gained [LYGs] and quality-adjusted life years [QALYs] gained, respectively) and a slightly higher cost (€439.86) for ribociclib+letrozole compared to palbociclib+letrozole. The resulting incremental cost-effectiveness and cost-utility ratios were €1,007.69 per LYG and €1,543.62 per QALY gained, respectively. The results of the multiple sensitivity analyses showed limited dispersion of the outcomes, thus corroborating their robustness.ConclusionFrom the NHS perspective, considering the most commonly established willingness-to-pay thresholds in the Spanish setting, ribociclib+letrozole would represent a cost-effective therapeutic option compared to palbociclib+letrozole in the first-line treatment of HR+/HER2− ABC in postmenopausal women.