M. Bergamino

Hospital Universitari Germans Trias i Pujol

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Silvia Vázquez

Institut Català d'Oncologia

Catalina Falo

Institut Català d'Oncologia

Agostina Stradella

Universitat de Barcelona

Sònia Pernas

Institut Català d'Oncologia

Miguel Gil‐Gil

Institut Català d'Oncologia

V. Navarro

Instituto Cajal

Aleix Prat

Hospital Clínic de Barcelona

Tomás Pascual

Hospital Clínic de Barcelona

E. Vilajosana

Institut Català d'Oncologia

Patricia Galván

Consorci Institut D'Investigacions Biomediques August Pi I Sunyer

Cooperative Institutions

Institut Català d'Oncologia

103

Duran i Reynals Hospital

Institut d'Investigació Biomédica de Bellvitge

Universitat de Barcelona

Bellvitge University Hospital

Hospital Clínic de Barcelona

Institut Català d'Ornitologia

Consorci Institut D'Investigacions Biomediques August Pi I Sunyer

GEICAM – Spanish Breast Cancer Group

Solti

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SUN-P091: Evolution of Nutritional Status in Locally Advanced Head and Neck (LAHNC) Patients Treated with Bioradiotherapy (BRT)

Clinical Nutrition (2016)

L. Hurtós Marc Oliva M. Bergamino Antonio Rullan Miren Taberna

10.1016/s0261-5614(16)30434-4

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Citations (0)

Long-Term Cardiac Safety and Survival Outcomes of Neoadjuvant Pegylated Liposomal Doxorubicin in Elderly Patients or Prone to Cardiotoxicity and Triple Negative Breast Cancer. Final Results of the Multicentre Phase II CAPRICE Study

Frontiers in Oncology (2021)

Miguel Gil‐Gil Meritxell Bellet M. Bergamino Serafín Morales Agustí Barnadas

The CAPRICE trial was designed to specifically evaluate neoadjuvant pegylated liposomal doxorubicin (PLD) in elderly patients or in those with other cardiovascular risk factors in whom conventional doxorubicin was contraindicated. The primary analysis of the study showed a pathological complete response (pCR) of 32% and no significant decreases in LVEF during chemotherapy. Here, we report important secondary study objectives: 5-year cardiac safety, disease-free survival (DFS), overall survival (OS) and breast cancer specific survival (BCSS).In this multicentre, single-arm, phase II trial, elderly patients or those prone to cardiotoxicity and high risk stage II-IIIB breast cancer received PLD (35 mg/m2) plus cyclophosphamide (600 mg/m2) every 4 weeks for 4 cycles, followed by paclitaxel for 12 weeks as neoadjuvant chemotherapy (NAC). Left ventricular ejection fraction (LVEF) monitorization, electrocardiograms and cardiac questionnaires were performed at baseline, during treatment and at 9, 16, 28 and 40 weeks thereafter. The primary endpoint was pCR and 5-year cardiac safety, DFS, BCSS and OS were also analyzed.Between Oct 2007, and Jun 2010, 50 eligible patients were included. Median age was 73 (35-84) years, 84% were older than 65; 64% of patients suffered from hypertension, and 10% had prior cardiac disease. Most of tumors (88%) were triple negative. No significant decreases in LVEF were observed. The mean baseline LVEF was 66.6% (52-86) and after a median follow-up of 5 years, mean LVEF was 66 (54.5-73). For intention to treat population, 5-year DFS was 50% (95% CI 40.2-68.1) and 5-year OS was 56% (95%CI 41.2-68.4). There were 8 non-cancer related deaths, achieving a 5 years BCSS of 67.74% (CI 95%:54.31%- 81.18%).At 5-year follow-up, this PLD-based NAC regimen continued to be cardiac-safe and effective in a population of very high-risk breast cancer patients. This scheme should be considered as an option in elderly patients or in those with other risks of developing cardiotoxicity.ClinicalTrials.gov reference NCT00563953.

Cardiotoxicity

Clinical endpoint

10.3389/fonc.2021.645026

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Citations (8)

Validation and comparison of Breast Graded Prognostic Assessment scores in patients with breast cancer and brain metastases

Clinical & Translational Oncology (2021)

Carles Fabregat-Franco Agostina Stradella V. Navarro Jenniffer Linares M. Galdeano

Triple-negative breast cancer

10.1007/s12094-021-02577-x

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Citations (4)

Does hyper-progression exist among head and neck cancer patients treated with immunotherapy?

Annals of Oncology (2017)

A. Ortega Franco Nieves Plana Irene Braña M. Taberna Sanz M. Oliva Bernal

Discontinuation

Tumor progression

Progression-free survival

Squamous cell cancer

10.1093/annonc/mdx374.015

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Citations (3)

KRAS mutations as a prognostic factor after metastasectomy in colorectal cancer patients

Annals of Oncology (2018)

M. Domenech Viñolas Cristina Santos Javier Pérez Mar Varela M. Martínez Villacampa

Metastasectomy

10.1093/annonc/mdy281.059

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Residual cancer burden as a prognostic factor in a large series of neoadjuvant chemotherapy. Subgroup analysis per molecular surrogated subtypes

Annals of Oncology (2019)

Catalina Falo Sara Gutiérrez Fernández Elena García‐Garrigós Ángela Casado Silvia Vázquez

Univariate analysis

10.1093/annonc/mdz240.065

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Citations (1)

Abstract PO3-19-08: A phase 2 randomized pre-operative,window of opportunity trial investigating the effect of elacestrant with/without triptorelin in premenopausal patients with HR+/HER2- breast cancer – SOLTI-2104-PremiÈRe trial

Cancer Research (2024)

Meritxell Bellet Ezquerra Cristina Hernándo Pablo Tolosa María Vidal Yolanda Fernández

Abstract Background. Premenopausal women diagnosed with HR+/HER2- breast cancer (BC) often have a different biology and worse prognosis. The SOFT and TEXT studies demonstrated an increase diseasefree survival (DFS) with ovarian function suppression (OFS) plus tamoxifen or exemestane compared to tamoxifen alone. Of note, high-risk clinicopathologic features, adjuvant chemotherapy, or aged ≤35 years correlated with greater OFS benefit. However, adding OFS in this context has intrinsic issues as higher toxicity, which led to treatment discontinuation (20% in SOFT trial), and suboptimal OFS was found in around 25% of patients (pts) with exemestane plus monthly triptorelin (SOFT-EST sub-study). Thus, new effective ET options without OFS are needed for premenopausal patients (pts). Elacestrant is the first oral, non-steroidal, selective estrogen receptor degrader (SERD) to demonstrate improved efficacy to SOC treatments and specifically compared to fulvestrant in postmenopausal pts with HR+/HER2- metastatic BC at the phase III EMERALD trial. In menopausal patients with HR+/HER2- early BC, the window of opportunity SOLTI-1905 ELIPSE trial (NCT04797728), showed that elacestrant was associated with a 27.3% rate of Complete Cell Cycle Arrest (CCCA) and a statistically significant suppression of Ki-67. Among Luminal A tumors, the CCCA rate was 45% and the average decrease in Ki-67 was 64.6%, while no CCCA was reported and the suppression of Ki-67 was less pronounced (31.7%) in the Luminal B population. There is still a need for investigating elacestrant without OFS in the premenopausal scenario. We hypothesize that elacestrant as a single agent or in combination with triptorelin is an effective and safe treatment regimen in premenopausal pts with HR+/HER2-negative early BC capable of achieving an equivalent CCCA rate as a subrogate of effectiveness regardless the use of OFS Study design. PREMIERE is a parallel, non-comparative, two-arm, randomized 1:1, open-label, multicenter, exploratory study in premenopausal women with primary operable HR+/HER2-negative BC. The study aims to evaluate the biological effects of elacestrant with or without triptorelin. Participants must have histologically confirmed HR+ (≥ 10%) and HER2- operable early BC stage I to stage IIB >1 cm with a Ki-67 between 10-35%. The primary objective is to assess the ability of each treatment arm to induce CCCA determined by central assessment of Ki-67 (% Ki-67 ≤ 2.7%). No formal comparison between treatment arms is intended. Secondary objectives include evaluating the biological activity of elacestrant with or without OFS, antiproliferative activity, changes in gene expression including PAM50 subtype changes, and the effect of optimal vs suboptimal suppression on CCCA . Serum E2 and FSH levels will also be evaluated. Safety and tolerability will be assessed based on adverse events and clinical laboratory test results. Pts will undergo screening and randomization, with stratification by PAM50 subtype (Luminal A vs Non-luminal A). Treatment will be elacestrant 400 mg once daily or elacestrant 400 mg once daily plus triptorelin 3.75 mg days +1 and +29 for 30 (+7) days. Surgery or biopsy will be performed after treatment completion, and a post-surgery visit will mark the end of the active follow-up period. Patients will receive SOC treatment after surgery. 48 patients will be recruited in 9 sites within SOLTI Spanish network in 9 months period. This study is financially supported by Menarini-Stemline. Citation Format: Meritxell Bellet- Ezquerra, Cristina Hernando, Pablo Tolosa, Maria Vidal, Yolanda Fernández, Santiago González-Santiago, Pilar Sanchez, Susana De La Cruz, Vanesa Ortega, Xavier Gonzalez-Farré, Milana Bergamino, Alejandra Espinosa, Tomás Pascual. A phase 2 randomized pre-operative,window of opportunity trial investigating the effect of elacestrant with/without triptorelin in premenopausal patients with HR+/HER2- breast cancer – SOLTI-2104-PremiÈRe trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-19-08.

Triptorelin

Window of opportunity

10.1158/1538-7445.sabcs23-po3-19-08

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Abstract P4-21-32: Treatment of early HER2-positive breast cancer in trastuzumab era in everyday clinical practice: An overview after 10 years of its approval

Cancer Research (2017)

Adela Fernández Ortega Marta Doménech Catalina Falo M. Gil Agostina Stradella

Abstract Introduction: The addition of Trastuzumab(T) to chemotherapy (CT) revolutionized HER2-positive breast cancer(BC) and changed its natural history. We reviewed the efficacy of T outside clinical trials in a cancer comprehensive center. Methods: Ambiespective and descriptive study was conducted in Catalan Institute of Oncology (ICO-Barcelona). Estimates of progression-free survival (PFS) and overall survival (OS) were obtained with the Kaplan-Meier method and compared with LogRank test. The association of clinic-pathological variables and outcome was studied by χ2and Cox proportional hazard analysis. Results: 430 consecutive early HER2-positive BC patients (pts) were treated with adjuvant/neoadjuvant T and CT from Jan 2005 to Dec 2012. Pt basal characteristics are reported in Table 1. Neoadjuvant treatment was administrated in 230pts (54%) and in 200 (46%) in adjuvancy. Pathological complete response (pCR) in breast and nodes (ypT0/isypN0) was achieved in 48% of pts, with higher rates in hormone receptor (HR)-negative pts (62 vs 37% p=0.0005). Median duration of T: 10.6 months (m). 28%pts treated with neoadjuvant T+CT who achieved a pCR did not receive adjuvant T. Treatment discontinuation: 38pts (8.8%): 27pts due to cardiac toxicity and 4 relapsed during adjuvant T. In 87%pts, neoadjuvant CT was based on anthracyclines(A) and taxanes. Adjuvant CT: A and taxanes in 57.4%; 14%pts FAC, 15.4% A-CMF and 12% TCH. At a median follow-up of 70m (3-135), 44pts (10.4%) had relapsed: 33pts with distant M1, 9pts with only loco-regional disease and 2pts contralateral HER2-positive BC. M1 location: 46% visceral, 34% bone/lymph nodes and 20% in central nervous system (CNS). PFS was 23.4m(0-88); median OS was not reached; estimated 10 years-OS was 86.5%. Pts treated with A and taxanes had a significantly better OS compared to those treated with other CT (113 vs 98m, p= 0.009). Kaplan-Meier curve showed numerically higher relapses at 10 years in HR-positive pts (83 vs 90% p=0.8). Pts with pCR had significantly better OS (113 vs 104m, p=0.006). Pts with CNS-metastases had a significantly worse OS (13 vs 26m,p=0,02) and those with HR-negative (49 vs 24m, p= 0.033). Conclusion: In everyday clinical practice, recurrences after adjuvant/neoadjuvant trastuzumab in HER2-positive BC were less than described in the T-pivotals trials, with 10% of recurrences at a median of FU of 70m. In our series, estimated 10 years-OS was 86.5%. Pts treated with A and taxanes had a significantly better OS as well as those pts who achieved a pCR. On the contrary, pts with CNS M1 and those with HR-negative had worse prognosis. Table 1Median age51.9y (27-83)Stage I/II/III106 (25%)/ 226 (52%)/ 97 (23%)HR Positive/ Negative249 (58%)/181 (42%) Citation Format: Ortega A, Domenech M, Falo C, Gil M, Stradella A, Fernandez A, Morilla I, Villanueva R, Castany R, Vazquez S, Molina K, Bergamino M, Navarro V, Pernas S. Treatment of early HER2-positive breast cancer in trastuzumab era in everyday clinical practice: An overview after 10 years of its approval [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P4-21-32.

Neoadjuvant Therapy

Log-rank test

10.1158/1538-7445.sabcs16-p4-21-32

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Comorbidity and nutritional factors influence on bioradiotherapy (BRT) outcome in head and neck squamous cell carcinoma (HNSCC) patients

Annals of Oncology (2016)

Marc Oliva Miren Taberna Adriana Iriarte M. Bergamino Aleix Rovira

10.1093/annonc/mdw376.29

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Recurrence pattern and its prognostic impact following definitive chemo-radiotherapy in stage III non-small cell lung cancer