Lourdes Calvo

Complexo Hospitalario Universitario A Coruña

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Research Trends

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Document Type

Co-Authors

Eva Carrasco

GEICAM – Spanish Breast Cancer Group

Emilio Alba

Instituto de Investigación Biomédica de Málaga

Juan de la Haba-Rodríguez

GEICAM – Spanish Breast Cancer Group

Miguel Martín

Hospital General Universitario Gregorio Marañón

José Ignacio Chacón

Centro de Cirugía de Mínima Invasión Jesús Usón

Antonio Llombart‐Cussac

Hospital Arnau de Vilanova

Begoña Bermejo

Hospital Clínico Universitario de Valencia

Aña Lluch

INCLIVA Health Research Institute

Joan Albanell

Hospital Del Mar

Silvia Antolín

Complexo Hospitalario Universitario A Coruña

Cooperative Institutions

GEICAM – Spanish Breast Cancer Group

233

Complexo Hospitalario Universitario A Coruña

127

Centro de Investigación Biomédica en Red de Cáncer

117

Universidade da Coruña

Instituto de Salud Carlos III

Institut Català d'Oncologia

Hospital Universitario Ramón y Cajal

Centro de Investigación Biomédica en Red

Dana-Farber Cancer Institute

Servicio Gallego de Salud

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P3-14-15: Non-Randomized, Open Label Phase II Trial Evaluating the Safety and Efficacy of Taxotere (T) Followed by Myocet (M) + Cyclophosphamide (C) as First-Line Treatment for HER2−Negative Breast Cancer (BC).

Cancer Research (2011)

Jesús García-Mata Lourdes Calvo R. López López M. Ramos Jorge Castellanos

Abstract Background Breast cancer is the most common malignancy in females in Europe and is the most common cause of cancer mortality in women, with doxorubicin playing an important role in chemotherapy (CT) regimens used in this setting but limited by cardiotoxicity. Liposomal encapsulated doxorubicin was designed to minimize healthy tissue distribution by altering pharmacokinetics thus reducing cardiotoxicity while preserving antitumor efficacy. The current study was developed to assess the pathologic complete response (pCR), response rate and safety of treatment with taxotere (T), non-pegylated liposomal doxorubicin (M) and cyclophosphamide (C) in previously untreated patients with BC. Methods: Patients (pts) with HER2−negative BC receiving 1st-line CT were eligible. On Day 1 of each 21-day cycle for a total of 4 cycles, pts received T 75 mg/m2 IV, followed sequentially by M 60 mg/m2 and C 600 mg/m2 IV every 3 wks for 4 cycles. Breast conserving surgery (BCS) was considered if the response was deemed satisfactory, otherwise mastectomy was performed and pCR was evaluated. Pts must have had LVEF ≥50% at the time of enrolment and had regular cardiac evaluation throughout the study (MUGA or ECHO). Results: A total of 74 pts (50 stages II and 24 IIIA) over a 30-month period in six centres were accrued with clinical/pathological responses available for 51. The median age was 46 yrs (range 23–75). Histology: lobular 7/ductal 67. Grade I/II/III: 6/27/30. ER+/PR+: 43; ER+/ PR-: 13. Triple negative: 18. 50 pts had pre-op CT cycles and were subjected to surgery. No clinically significant change in LVEF was noticed (Pre-CT LVEF 68.5% [CI95%: 66.7−70.4]; post-CT LVEF 68.9% [CI95%: 66.0−71.7]). On an intention to treat analysis, an objective clinical response was observed for 38 pts: 6 complete (12%) and 32 partial (63 %). In addition, 12 pts (23%) demonstrated stable disease and only one progressed (2%).The proportion of patients requiring mastectomy and BCS were 14 (28%) and 36 (72%), respectively. On 33 pts with an axillary dissection, 25 (76%) had involved nodes. After pathological review, 18/50 pts (36 %) were devoid of any tumor cells in both breast and lymph nodes according to Miller & Payne's classification. Median number of positive lymph nodes following CT was 3 (IQR 2–6). All patients were included for toxicity assessment. Grade 3–4 neutropenia and febrile neutropenia was seen in 23% and 10% pts, respectively. Principal non-hematologic grade 3–4 toxicities included allergic reaction/hypersensitivity in 6% pts, and asthenia, diarrhoea and vomiting in 1%. No pts developed symptomatic CHF. Ten pts discontinued treatment: 5 due to taxane-hypersensitivity reaction, 3 due to disease progression and 2 due to protocol violation. Conclusions: This multi-centre phase II trial clearly demonstrates significant activity (pCR 36%) for neoadjuvant taxane sequentially followed by non-pegylated liposomal doxorubicin and cyclophosphamide regimen in a HER-2 negative BC population. Overall the treatment regimen was well tolerated. Sequential T→MC is safe and not associated with changes in LVEF. An updated evaluation of efficacy and toxicity profile analysis will be presented. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P3-14-15.

Cardiotoxicity

10.1158/0008-5472.sabcs11-p3-14-15

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Citations (2)

Supplementary Figure S3 from Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial

Joan Albanell José Manuel Pérez-García Miguel Gil‐Gil Giuseppe Curigliano Manuel Ruíz-Borrego

The level of mutant and wild-type circulating DNA in baseline plasma samples by patient.

Palbociclib

10.1158/1078-0432.22489437

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Citations (0)

Supplemental Material from A PAM50-Based Chemoendocrine Score for Hormone Receptor–Positive Breast Cancer with an Intermediate Risk of Relapse

Aleix Prat Aña Lluch Arran Turnbull Anita K. Dunbier Lourdes Calvo

Supplemental Methods, Tables and Figures Tables Table S1. CES association with chemotherapy sensitivity (measured as pCR) in the MDACC-based dataset. Table S2. CES association with chemotherapy sensitivity (measured as Residual Cancer Burden [RCB]) in the MDACC-based dataset. Model A. Table S3. CES association with chemotherapy sensitivity (measured as Residual Cancer Burden [RCB]) in the MDACC-based dataset. Model B. Table S4. Univariate association of CES and various signatures with chemotherapy sensitivity in HR+/HER2-negative disease from the MDACC-based dataset. Table S5. Association of CES and PAM50 Proliferation Signature with chemotherapy sensitivity in HR+/HER2-negative disease from the MDACC-based dataset. Table S6. Association of CES and CHEMOPRED Signature with chemotherapy sensitivity in HR+/HER2-negative disease from the MDACC-based dataset. Table S7. Association of CES and the proliferation component of the Genomic Health Index (GHI; OncotypeDX Recurrence Score) with chemotherapy sensitivity in HR+/HER2- negative disease from the MDACC-based dataset. Table S8. Association of CES and Genomic Grade Index (GGI) Signature with chemotherapy sensitivity in HR+/HER2-negative disease from the MDACC-based dataset. Table S9. Association of CES and SET index Signature with chemotherapy sensitivity in HR+/HER2-negative disease from the MDACC-based dataset. Table S10. Association of CES and RCBPRED Signature with chemotherapy sensitivity in HR+/HER2-negative disease from the MDACC-based dataset. Table S11. Association of CES and DLDA30 Signature with chemotherapy sensitivity in HR+/HER2-negative disease from the MDACC-based dataset. Table S12. Association of CES and ROR-P Signature with chemotherapy sensitivity in HR+/HER2-negative disease from the MDACC-based dataset. Table S13. Association of CES and Ki67 by IHC with chemotherapy sensitivity in HR+/HER2-negative disease of the Malaga cohort. 7 Table S14. Association of CES and PAM50 ROR with chemotherapy sensitivity in HR+/HER2-negative disease of the Malaga cohort. Table S15. CES association with endocrine sensitivity in the Marsden dataset (n=103). Table S16. CES association with endocrine sensitivity in the Marsden dataset within HER2-negative disease (n=89). Figures Fig. S1. Association of CES with Miller-Payne following chemotherapy in HR+/HER2- negative disease from the Malaga-based cohort. Fig. S2. CES association with endocrine sensitivity in the Edinburgh dataset (n=120). (A) Tumor volume changes of each patient and response classification. (B) Association of CES and other variables with response (defined as at least 70% reduction by 90 days) in the overall population. (C) Association of CES and other variables with response within HER2-negative disease. Fig. S3. Association of CES with pCR in the combined dataset from the MDACC- and Malaga-based cohorts.

Table (database)

10.1158/1078-0432.22463336.v1

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Citations (0)

Data from Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial

Joan Albanell José Manuel Pérez-García Miguel Gil‐Gil Giuseppe Curigliano Manuel Ruíz-Borrego

<div>AbstractPurpose:To assess the efficacy and exploratory biomarkers of continuing palbociclib plus endocrine therapy (ET) beyond progression on prior palbociclib-based regimen in patients with hormone receptor–positive/HER2-negative (HR+/HER2−) advanced breast cancer (ABC).Patients and Methods:The multicenter, open-label, phase II BioPER trial included women who had experienced a progressive disease (PD) after having achieved clinical benefit on the immediately prior palbociclib plus ET regimen. Palbociclib (125 mg, 100 mg, or 75 mg daily orally for 3 weeks and 1 week off as per prior palbociclib-based regimen) plus ET of physician's choice were administered in 4-week cycles until PD or unacceptable toxicity. Coprimary endpoints were clinical benefit rate (CBR) and percentage of tumors with baseline loss of retinoblastoma (Rb) protein expression. Additional endpoints included safety and biomarker analysis.Results:Among 33 patients enrolled, CBR was 34.4% [95% confidence interval (CI), 18.6–53.2; P < 0.001] and 13.0% of tumors (95% CI, 5.2–27.5) showed loss of Rb protein expression, meeting both coprimary endpoints. Median progression-free survival was 2.6 months (95% CI, 1.8–6.7). No new safety signals were reported. A signature that included baseline mediators of therapeutic resistance to palbociclib and ET (low Rb score, high cyclin E1 score, ESR1 mutation) was independently associated with shorter median progression-free survival (HR, 22.0; 95% CI, 1.71–282.9; P = 0.018).Conclusions:Maintaining palbociclib after progression on prior palbociclib-based regimen seems to be a reasonable, investigational approach for selected patients. A composite biomarker signature predicts a subset of patients who may not derive a greater benefit from palbociclib rechallenge, warranting further validation in larger randomized controlled trials.</div>

Palbociclib

Regimen

Clinical endpoint

10.1158/1078-0432.c.6532953

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Citations (0)

Abstract CT219: Neoadjuvant letrozole and palbociclib in stage II-IIIB HR[+]/HER2[-] breast cancer with Oncotype DX Recurrence Score® (RS) 18-25 or 26-100. Analysis of RS changes at surgery (DxCARTES trial)

Cancer Research (2019)

Antonio Llombart‐Cussac José Manuel Pérez-García Ángel Guerrero Begoña Bermejo Miguel Gil‐Gil

Abstract BACKGROUND: The combination of a CDK4/6 inhibitor (palbociclib, abemaciclib, or ribociclib) with an aromatase inhibitor (AI) significantly reduces Ki67 compared to single-agent AI in the neoadjuvant setting, but the rates of pathological complete response (pCR) or residual cancer burden (RCB) 0-I remain modest. Despite this inadequate pathological downstaging, to date, there is no data about the efficacy of this treatment in terms of molecular downstaging detected by a more refined genomic signature than Ki67, such as the Oncotype DX Breast Recurrence Score® (RS) test. The aim of this trial is to validate the ability of neoadjuvant palbociclib plus letrozole to modify two initial intermediate or high RS tumor cohorts. TRIAL DESIGN: This is an international, multicenter, open-label, non-comparative, phase II trial. Main selection criteria include: (1) Pre- or post-menopausal women with treatment-naïve, centrally assessed, HR-positive/HER2-negative, Ki67 ≥ 20%, and stage II-IIIB breast cancer; (2) Pre-treatment RS result ≥ 18; (3) Patients agree to collect tissue samples at screening, at Cycle 1 Day 14 of treatment, and at surgery. Patients will be allocated, according to the pre-treatment RS result, either to Cohort A (RS 18-25) or Cohort B (RS 26-100) and will receive treatment with palbociclib (125 mg QD, 3/1 schedule) in combination with letrozole (2.5 mg QD, every 28-day cycle), ± LHRH analogs if pre-menopausal status, for 24 weeks. Definitive breast surgery will be performed within 7 days after completion of 6 treatment cycles. The primary objective of the study is to explore the ability of palbociclib in combination with letrozole to induce global molecular changes, measured by either the post-treatment RS result at surgery, or pCR. Secondary objectives include: (1) Concordance rate among post-treatment RS result and RCB, Ki67, and preoperative endocrine prognostic index (PEPI) score; (2) Overall response rate; (3) Safety-related outcome as per Common Terminology Criteria for Adverse Events v. 5.0. Patients will be accrued in a Simon’s two-stage design trial: optimal design in Cohort A and minimax design in Cohort B. With a unilateral type one error (alpha) set at 0.025 and a 0.8 power (type two error beta = 0.2), the required number of evaluable patients are 28. Considering a drop-out rate no lower than 10%, a sample size of 33 patients in each cohort will be needed. First Patient First Visit: Expected on April 2019. Citation Format: Antonio Llombart Cussac, José Pérez-García, Ángel Guerrero, Begoña Bermejo, Miguel Gil, Vicente Carañana, Serafín Morales, Juan de la Haba, María Fernández, Emilio Alba, Ander Urruticoechea, Lourdes Calvo, Mireia Margeli, Antonio Antón, Manuel Ruíz Borrego, Joan Albanell, Pedro Sánchez Rovira, Meritxell Bellet, Sofia Braga, Passos Coelho, Miguel Abreu, Javier Cortés. Neoadjuvant letrozole and palbociclib in stage II-IIIB HR[+]/HER2[-] breast cancer with Oncotype DX Recurrence Score® (RS) 18-25 or 26-100. Analysis of RS changes at surgery (DxCARTES trial) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT219.

Palbociclib

Letrozole

Neoadjuvant Therapy

Aromatase inhibitor

10.1158/1538-7445.am2019-ct219

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Citations (7)

Clinical and Sociodemographic Determinants of Adherence to World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) Recommendations in Breast Cancer Survivors—Health-EpiGEICAM Study

Cancers (2022)

Virginia Lope Ángel Guerrero-Zotano Emma Ruiz Begoña Bermejo Silvia Antolín

Breast cancer (BC) survivors are advised to follow the WCRF/AICR cancer prevention recommendations, given their high risk of developing a second tumour. We aimed to explore compliance with these recommendations in BC survivors and to identify potentially associated clinical and sociodemographic factors. A total of 420 BC survivors, aged 31-80, was recruited from 16 Spanish hospitals. Epidemiological, dietary and physical activity information was collected through questionnaires. A 7-item score to measure compliance with the recommendations was built according to the 2018 WCRF/AICR scoring criteria. Standardized prevalences and standardized prevalence ratios of moderate and high compliance across participant characteristics were estimated using multinomial and binary logistic regression models. The mean score was 3.9 (SD: 1.0) out of 7 points. Recommendations with the worst adherence were those of limiting consumption of red/processed meats (12% of compliance, 95% CI: 8.2-15.0) and high fibre intake (22% of compliance, 95% CI: 17.6-27.0), while the best compliance was observed for the consumption of fruits and vegetables (73% of compliance, 95% CI: 69.2-77.7). Overall, adherence was worse in women with university education and in those with first-degree relatives with BC. This information may be of interest to design and implement personalized preventive measures adapted to the characteristics of these patients.

Limiting

Cancer Prevention

10.3390/cancers14194705

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Citations (4)

Prognostic role for derived neutrophil-to-lymphocyte ratio in early breast cancer

Annals of Oncology (2016)

Alberto Ocaña Arnoud J. Templeton María Isabel Casas María Sánchez‐Aragó Rosalía Caballero

Inflammatory breast cancer

Clinical endpoint

10.1093/annonc/mdw364.02

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