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6. Correction to: Efficacy of fulvestrant in the treatment of postmenopausal women with endocrine-resistant advanced breast cancer in routine clinical practice

Author

Blancas, I., Fontanillas, M., Conde, V., Lao, J., Martínez, E., Sotelo, M. J., Jaen, A., Bayo, J. L., Carabantes, F., Illarramendi, J. J., Gordon, M. M., Cruz, J., García-Palomo, A., Mendiola, C., Pérez-Ruiz, E., Bofill, J. S., Baena-Cañada, J. M., Jáñez, N. M., Esquerdo, G., and Ruiz-Borrego, M.

Published
2018
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7. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study

Author

Rugo, H S, O'Shaughnessy, J, Boyle, F, Toi, M, Broom, R, Blancas, I, Gumus, M, Yamashita, T, Im, Y-H, Rastogi, P, Zagouri, F, Song, C, Campone, M, San Antonio, B, Shahir, A, Hulstijn, M, Brown, J, Zimmermann, A, Wei, R, Johnston, S R D, Reinisch, M, Tolaney, S M, and monarchE Committee Members

Subjects
safety, Diarrhea, Receptor, ErbB-2, HER2 negative, Aminopyridines, HR positive, Breast Neoplasms, Hematology, abemaciclib, monarchE, Oncology, Antineoplastic Combined Chemotherapy Protocols, Quality of Life, Humans, Benzimidazoles, Female, Patient Reported Outcome Measures, early breast cancer, Neoplasm Recurrence, Local
Abstract

In monarchE, abemaciclib plus endocrine therapy (ET) as adjuvant treatment of hormone receptor-positive, human epidermal growth factor 2-negative, high-risk, early breast cancer (EBC) demonstrated a clinically meaningful improvement in invasive disease-free survival versus ET alone. Detailed safety analyses conducted at a median follow-up of 27 months and key patient-reported outcomes (PROs) are presented. The safety population included all patients who received at least one dose of study treatment (n = 5591). Safety analyses included incidence, management, and outcomes of common and clinically relevant adverse events (AEs). Patient-reported health-related quality of life, ET symptoms, fatigue, and side-effect burden were assessed. The addition of abemaciclib to ET resulted in higher incidence of grade ≥3 AEs (49.7% versus 16.3% with ET alone), predominantly laboratory cytopenias [e.g. neutropenia (19.6%)] without clinical complications. Abemaciclib-treated patients experienced more serious AEs (15.2% versus 8.8%). Discontinuation of abemaciclib and/or ET due to AEs occurred in 18.5% of patients, mainly due to grade 1/2 AEs (66.8%). AEs were managed with comedications (e.g. antidiarrheals), abemaciclib dose holds (61.7%), and/or dose reductions (43.4%). Diarrhea was generally low grade (grade 1/2: 76%); grade 2/3 events were highest in the first month (20.5%), most were short-lived (≤7 days) and did not recur. Venous thromboembolic events (VTEs) were higher with abemaciclib + ET (2.5%) versus ET (0.6%); in the abemaciclib arm, increased VTE risk was observed with tamoxifen versus aromatase inhibitors (4.3% versus 1.8%). PROs were similar between arms, including being 'bothered by side-effects of treatment', except for diarrhea. At ≥3 months, most patients reporting diarrhea reported 'a little bit' or 'somewhat'. In patients with high-risk EBC, adjuvant abemaciclib + ET has an acceptable safety profile and tolerability is supported by PRO findings. Most AEs were reversible and manageable with comedications and/or dose modifications, consistent with the known abemaciclib toxicity profile.

Published
2022

10. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study

Author

Rugo, H.S. O'Shaughnessy, J. Boyle, F. Toi, M. Broom, R. Blancas, I. Gumus, M. Yamashita, T. Im, Y.-H. Rastogi, P. Zagouri, F. Song, C. Campone, M. San Antonio, B. Shahir, A. Hulstijn, M. Brown, J. Zimmermann, A. Wei, R. Johnston, S.R.D. Reinisch, M. Tolaney, S.M. monarchE Committee Members

Abstract

BACKGROUND: In monarchE, abemaciclib plus endocrine therapy (ET) as adjuvant treatment of hormone receptor-positive, human epidermal growth factor 2-negative, high-risk, early breast cancer (EBC) demonstrated a clinically meaningful improvement in invasive disease-free survival versus ET alone. Detailed safety analyses conducted at a median follow-up of 27 months and key patient-reported outcomes (PROs) are presented. PATIENTS AND METHODS: The safety population included all patients who received at least one dose of study treatment (n = 5591). Safety analyses included incidence, management, and outcomes of common and clinically relevant adverse events (AEs). Patient-reported health-related quality of life, ET symptoms, fatigue, and side-effect burden were assessed. RESULTS: The addition of abemaciclib to ET resulted in higher incidence of grade ≥3 AEs (49.7% versus 16.3% with ET alone), predominantly laboratory cytopenias [e.g. neutropenia (19.6%)] without clinical complications. Abemaciclib-treated patients experienced more serious AEs (15.2% versus 8.8%). Discontinuation of abemaciclib and/or ET due to AEs occurred in 18.5% of patients, mainly due to grade 1/2 AEs (66.8%). AEs were managed with comedications (e.g. antidiarrheals), abemaciclib dose holds (61.7%), and/or dose reductions (43.4%). Diarrhea was generally low grade (grade 1/2: 76%); grade 2/3 events were highest in the first month (20.5%), most were short-lived (≤7 days) and did not recur. Venous thromboembolic events (VTEs) were higher with abemaciclib + ET (2.5%) versus ET (0.6%); in the abemaciclib arm, increased VTE risk was observed with tamoxifen versus aromatase inhibitors (4.3% versus 1.8%). PROs were similar between arms, including being 'bothered by side-effects of treatment', except for diarrhea. At ≥3 months, most patients reporting diarrhea reported 'a little bit' or 'somewhat'. CONCLUSIONS: In patients with high-risk EBC, adjuvant abemaciclib + ET has an acceptable safety profile and tolerability is supported by PRO findings. Most AEs were reversible and manageable with comedications and/or dose modifications, consistent with the known abemaciclib toxicity profile. Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.

Published
2022

11. 332TiP SOLTI-1907 ATREZZO: Targeting hormonal receptor negative (HR-) or PAM50 non-luminal disease with atezolizumab in combination with trastuzumab and vinorelbine in HER2+ metastatic breast cancer (MBC)

Author

Ciruelos, E.M., primary, Pernas, S., additional, Perelló, A., additional, Lopez, A., additional, Salvador Bofill, F.J., additional, Cejalvo, J.M., additional, Blancas, I., additional, Ponce Lorenzo, J., additional, Servitja, S., additional, Perez, M., additional, Cruz, J., additional, Albacar, C., additional, Escrivá-de-Romaní, S.I., additional, Guerra, J.A., additional, González-Santiago, S., additional, Sanfeliu, E., additional, Rodriguez, C., additional, Tolosa, P., additional, Ferrero-Cafiero, J.M., additional, and Prat, A., additional

Published
2021
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12. 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

Author

Casas, A, Ciruelos, E, Oliveira, M, Saura, C, Bellet, M, Pernas, S, Gavila, J, Munoz, M, Vidal, M, Farre, BG, Cejalvo, JM, Lopez, R, Vivancos, A, Scaltriti, M, Bofill, JS, Blancas, I, Alba, E, Boni, V, De la Cruz, S, Galve, E, Perello, A, Margeli, M, Canes, J, Celiz, P, Masanas, H, Olmos, R, Fonts, M, Fernandez-Pascual, P, Villagrasa, P, and Prat, A

Published
2021

17. Usefulness of NT-ProBNP as a biomarker of cardiotoxicity in breast cancer patients treated with trastuzumab

Author

Blancas, I., primary, Martín, C., additional, Martín-Pérez, F.J., additional, Legerén, M., additional, Martos, M., additional, Sequero, S., additional, Carnenero, S., additional, Pérez-García, M.E., additional, Rodríguez-González, C.J., additional, Jurado, J.M., additional, Delgado, M., additional, González-Astorga, B., additional, González-Cebrián, I., additional, Garrido, J.M., additional, Prieto, C., additional, Bayo-Martin, V., additional, Fernández-Gutiérrez, M.I., additional, Ayala-Carbonero, G., additional, Reyes-Larzategui, S., additional, and Rodríguez-Serrano, F., additional

Published
2019
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18. Analysis of the efficacy of naloxegol in a real-world 12 weeks of follow-up study, in patients with cancer and opioid-induced constipation with laxative-inadequate response

Author

Cobo Dols, M., primary, Beato Zambrano, M.D.C., additional, Cabezón Gutiérrez, L., additional, Chicas Sett, R., additional, Blancas, I., additional, García Navalón, F.J., additional, Firvida Pérez, J.L., additional, Serrano Bermúdez, G., additional, Togores Torres, P., additional, Delgado Mingorance, I., additional, Giraldo Marín, A., additional, Librán Oriol, A., additional, Paredes Lario, A., additional, Sánchez Mauriño, P., additional, Higuera Gomez, O., additional, Moreno Muñoz, D., additional, Jiménez López, A.J., additional, Huerta González, I., additional, Sanz Yagüe, A., additional, and Soler López, B., additional

Published
2019
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20. Real-world data on the efficacy and safety of weekly oral vinorelbine in breast cancer patients previously treated with anthracycline or taxane-based regimens

Author

Blancas, I., primary, Aguirre, E., additional, Morales, S., additional, Gonzálvez, M. L., additional, Servitja, S., additional, Díaz, N., additional, del Barco, S., additional, Barnadas, A., additional, Margelí, M., additional, García Carbonero, I., additional, and Llombart, A., additional

Published
2018
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21. Analysis of stroma and immune-related gene expression patterns during breast cancer (BC) progression

Author

Molinero, L., primary, Albanell, J., additional, Koeppen, H., additional, Martinez de Dueñas, E., additional, Halligan, D., additional, Guerrero, A., additional, Chacón López-Muñiz, J.I., additional, Perez, R., additional, Antolin, S., additional, Blancas, I., additional, Muñoz, M., additional, Oltra, A., additional, LÓpez de Ceballos, M.H., additional, Sánchez-Aragó, M., additional, Caballero, R., additional, Carrasco, E., additional, González-Angulo, A.M., additional, Lluch, A., additional, Mittendorff, E.A., additional, and Rojo, F., additional

Published
2017
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22. 1821P - Analysis of the efficacy of naloxegol in a real-world 12 weeks of follow-up study, in patients with cancer and opioid-induced constipation with laxative-inadequate response

Author

Cobo Dols, M., Beato Zambrano, M.D.C., Cabezón Gutiérrez, L., Chicas Sett, R., Blancas, I., García Navalón, F.J., Firvida Pérez, J.L., Serrano Bermúdez, G., Togores Torres, P., Delgado Mingorance, I., Giraldo Marín, A., Librán Oriol, A., Paredes Lario, A., Sánchez Mauriño, P., Higuera Gomez, O., Moreno Muñoz, D., Jiménez López, A.J., Huerta González, I., Sanz Yagüe, A., and Soler López, B.

Published
2019
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23. 216P - Usefulness of NT-ProBNP as a biomarker of cardiotoxicity in breast cancer patients treated with trastuzumab

Author

Blancas, I., Martín, C., Martín-Pérez, F.J., Legerén, M., Martos, M., Sequero, S., Carnenero, S., Pérez-García, M.E., Rodríguez-González, C.J., Jurado, J.M., Delgado, M., González-Astorga, B., González-Cebrián, I., Garrido, J.M., Prieto, C., Bayo-Martin, V., Fernández-Gutiérrez, M.I., Ayala-Carbonero, G., Reyes-Larzategui, S., and Rodríguez-Serrano, F.

Published
2019
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24. Abstract P6-05-02: Intrinsic subtype and gene expression changes between primary and metastatic breast cancer

Author

Prat, A, primary, Martínez de Dueñas, E, additional, Galván, P, additional, Garcia, S, additional, Burgués, O, additional, Paré, L, additional, Antolín, S, additional, Martinello, R, additional, Blancas, I, additional, Adamo, B, additional, Guerrero, Á, additional, Muñoz, M, additional, Nuciforo, P, additional, Vidal, M, additional, Pérez, RM, additional, Chacón, JI, additional, Caballero, R, additional, Gascón, P, additional, Carrasco, E, additional, Rojo, F, additional, Perou, CM, additional, Cortés, J, additional, Adamo, V, additional, Albanell, J, additional, and Lluch, A, additional

Published
2016
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27. Assessment of Treatment Response with Fulvestrant (F) 500 Mg in Standard Clinical Practice Through a Retrospective Study: Nct01509625

Author

Blancas, I., primary, Fontanillas, M., additional, Conde Herrero, V., additional, Lao, J., additional, Martinez de Dueñas, E., additional, Sotelo Lezama, M., additional, JaÉn-Morago, A., additional, Bayo, J.L., additional, Carabantes, F., additional, Illaramendi, J.J., additional, Gordón, M., additional, Ruiz-Borrego, M., additional, Cruz, J., additional, García-Palomo, A., additional, Mendiola, C., additional, Perez-Ruiz, E., additional, Cañada, J.M. Baena, additional, Martínez, N., additional, Esquerdo, G., additional, and Bofill, J. Salvador, additional

Published
2014
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28. Final results of a phase II study of paclitaxel, bevacizumab, and gemcitabine as first-line therapy for patients with HER2-negative metastatic breast cancer

Author

Salvador, J., primary, Manso, L., additional, de la Haba, J., additional, Jaen, A., additional, Ciruelos, E., additional, de Villena, M. C., additional, Gil, M., additional, Murias, A., additional, Galan, A., additional, Jara, C., additional, Bayo, J., additional, Baena, J. M., additional, Casal, J., additional, Mel, J. R., additional, Blancas, I., additional, and Sanchez Rvira, P., additional

Published
2014
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29. P1-14-03: AVALUZ Study: First Line with Bevacizumab in Combination with Paclitaxel (P) and Gemcitabine (G) in Patients with HER-2 Negative Recurrent or Metastatic BC: PFS Analysis.

Author

Salvador, J, primary, Ciruelos, E, additional, Codes, de Villena M, additional, Jaen, A, additional, Gil, M, additional, Galan, A, additional, Murias, A, additional, Jara, C, additional, de, la Haba J, additional, Baena, JM, additional, Villanueva, MJ, additional, Bayo, J, additional, Blancas, I, additional, Gonzalez, E, additional, Perez, D, additional, Mel, JR, additional, and Manso, L, additional

Published
2011
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31. P2-12-17: Prospective Evaluation of the Conversion Rate of HER2, ER and PR between Primary Tumors and Corresponding Metastases. CONVERTHER/GEICAM 2009–03 Study.

Author

Martinez, de Dueñas E, primary, Lluch, A, additional, Guerrero, A, additional, Chacon, JI, additional, Perez, R, additional, Antolin, S, additional, Blancas, I, additional, Ferrer-Lozano, J, additional, Burgues, O, additional, Lopez, A, additional, and Gonzalez-Angulo, AM, additional

Published
2011
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32. Prognostic value of a high level of circulating endothelial cells in patients with HER2-recurrent or metastatic breast cancer treated with bevacizumab in combination with paclitaxel and gemcitabine as first-line therapy

Author

Manso, L, primary, Ciruelos, E, additional, Codes, M, additional, De la Haba, J, additional, Galan, A, additional, Baena, J, additional, Jaen, A, additional, Gil, M, additional, Murias, A, additional, Blancas, I, additional, Gonzalez, E, additional, Perez, D, additional, Bayo, JL, additional, Mel, J, additional, Garcia-Martinez, E, additional, Cubedo, R, additional, and Salvador, J, additional

Published
2011
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33. Clinical value of circulating epithelial tumor cells and circulating endothelial cells (CTCs/CECs) in patients with HER2-negative recurrent or metastatic breast cancer treated with bevacizumab in combination with paclitaxel (P) and gemcitabine (G) as first-line therapy.

Author

Manso, L., primary, Ciruelos, E. M., additional, Codes, M., additional, De la Haba, J. R., additional, Galan, A., additional, Baena, J. M., additional, Jaen, A., additional, Gil, M., additional, Murias, A., additional, Blancas, I., additional, Gonzalez, E., additional, Perez, D., additional, Bayo, J. L., additional, Mel, J. R., additional, Garcia-Martinez, E., additional, Cubedo, R., additional, and Salvador, J., additional

Published
2011
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34. Final analysis of dose density with zoledronic acid treatment in metastatic breast cancer patients: ZARAS study.

Author

De la Haba, J., primary, Rodriguez-Lescure, A., additional, Baena, J. M., additional, Martin Liberal, J., additional, Morales, S., additional, Chacon, J. I., additional, Lopez-Vega, J. M., additional, Fernandez, I., additional, Aguiar, D., additional, Garcia-Palomo, A., additional, Llorente, R. M., additional, Barea, J. L., additional, Alvarez, E., additional, Blancas, I., additional, Fernandez, Y., additional, Sanchez Rovira, P., additional, and Vinyes, G., additional

Published
2011
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35. First line with bevacizumab in combination with paclitaxel (P) and gemcitabine (G) in patients with HER2-negative or recurrent mBC: First PFS analysis.

Author

Salvador, J., primary, Jaen, A., additional, Ciruelos, E. M., additional, Codes, M., additional, Gil, M., additional, Murias, A., additional, Galan, A., additional, De la Haba, J. R., additional, Jara, C., additional, Bayo, J. L., additional, Baena, J. M., additional, Casal, J., additional, Mel, J. R., additional, Blancas, I., additional, Gonzalez, E., additional, Perez, D., additional, and Manso, L., additional

Published
2011
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36. Abstract P2-16-13: Phase II Open Label Trial Bevacizumab in Combination with Paclitaxel and Gemcitabine as First Line in Patients with HER-2 Negative Recurrent or Metastatic Breast Cancer (AVALUZ): First Analysis

Author

Salvador, J, primary, Jaen, A, additional, Ciruelos, E, additional, Codes de Villena, M, additional, Gil, M, additional, Murias, A, additional, Galan, A, additional, de la Haba, J, additional, Jara, C, additional, Bayo, J, additional, Baena, JM, additional, Casal, J, additional, Mel, JR, additional, Blancas, I, additional, Gonzalez, E, additional, Perez, D, additional, and Manso, L., additional

Published
2010
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37. Abstract P3-02-11: First Analysis of the Value of Circulating Epithelial Tumor Cells and Circulating Endothelial Cells (CTCs/CECs) in Patients with HER-2 Negative Recurrent or Metastatic Breast Cancer Treated with Bevacizumab in Combination with Paclitaxel and Gemcitabine as First Line Therapy (AVALUZ Trial)

Author

Manso, L, primary, Ciruelos, E, additional, Codes de Villena, M, additional, de la Haba, J, additional, Galán, A, additional, Baena, JM, additional, Jaen, A, additional, Gil, M, additional, Murias, A, additional, Blancas, I, additional, Gonzalez, E, additional, Perez, D, additional, Bayo, J, additional, Mel, JR, additional, Garcia, E, additional, Cubedo, R, additional, and Salvador, J., additional

Published
2010
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46. 362P - Assessment of Treatment Response with Fulvestrant (F) 500 Mg in Standard Clinical Practice Through a Retrospective Study: Nct01509625

Author

Blancas, I., Fontanillas, M., Conde Herrero, V., Lao, J., Martinez de Dueñas, E., Sotelo Lezama, M., JaÉn-Morago, A., Bayo, J.L., Carabantes, F., Illaramendi, J.J., Gordón, M., Ruiz-Borrego, M., Cruz, J., García-Palomo, A., Mendiola, C., Perez-Ruiz, E., Cañada, J.M. Baena, Martínez, N., Esquerdo, G., and Bofill, J. Salvador

Published
2014
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47. Efficacy and safety of aflibercept in metastatic colorectal cancer pretreated with bevacizumab: A report of five cases

Author

Margarita Garrido, Teresa Pereda, Isabel Blancas, José Miguel Jurado, Marta Legerén, José Luis García, Mayte Delgado, Julia Alcaide, María J. Sánchez, Antonio Rueda, Jorge López, [Alcaide,J, Rueda,A] Oncology Department, Costa del Sol Hospital, Marbella, Málaga, Spain. [Delgado,M, Legerén,M, Jurado,JM, Blancas,I, Sánchez,MJ, García,JL] Oncology Department, San Cecilio Clinical Hospital, Granada, Andalucía, Spain. [Pereda,T, López,J] Pathology Department, Costa del Sol Hospital, Marbella, Málaga, Spain. [Garrido,M] Pharmacy and Nutrition Department, Costa del Sol Hospital, Marbella, Málaga, Spain., [Alcaide, Julia] Costa Sol Hosp, Dept Oncol, Malaga 29603, Spain, [Rueda, Antonio] Costa Sol Hosp, Dept Oncol, Malaga 29603, Spain, [Delgado, Mayte] San Cecilio Clin Hosp, Dept Oncol, Dr Oloriz Ave, Granada 18014, Andalucia, Spain, [Legeren, Marta] San Cecilio Clin Hosp, Dept Oncol, Dr Oloriz Ave, Granada 18014, Andalucia, Spain, [Jurado, Jose Miguel] San Cecilio Clin Hosp, Dept Oncol, Dr Oloriz Ave, Granada 18014, Andalucia, Spain, [Blancas, Isabel] San Cecilio Clin Hosp, Dept Oncol, Dr Oloriz Ave, Granada 18014, Andalucia, Spain, [Sanchez, Maria J.] San Cecilio Clin Hosp, Dept Oncol, Dr Oloriz Ave, Granada 18014, Andalucia, Spain, [Garcia, Jose L.] San Cecilio Clin Hosp, Dept Oncol, Dr Oloriz Ave, Granada 18014, Andalucia, Spain, [Pereda, Teresa] Costa Sol Hosp, Dept Pathol, Malaga 29603, Spain, [Lopez, Jorge] Costa Sol Hosp, Dept Pathol, Malaga 29603, Spain, [Garrido, Margarita] Costa Sol Hosp, Pharm & Nutr Dept, Malaga 29603, Spain, and Sanofi Spain (Barcelona, Spain)

Subjects
0301 basic medicine, Oncology, Cancer Research, Colorectal cancer, Leucovorin, Chemicals and Drugs::Heterocyclic Compounds::Alkaloids::Camptothecin [Medical Subject Headings], Ras mutations, Targeted therapy, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], angiogenesis, 1st progression, 0302 clinical medicine, Neoplasias colorrectales, Camptotecina, Ensayos de Uso compasivo, Aflibercept, Proteínas recombinantes de fusión, Metastatic colorectal cancer, Chemicals and Drugs::Organic Chemicals::Organometallic Compounds::Organoplatinum Compounds [Medical Subject Headings], metastatic colorectal cancer, aflibercept, Articles, targeted therapy, VEGF, Humanos, Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Recombinant Proteins::Recombinant Fusion Proteins [Medical Subject Headings], Proteinuria, 030220 oncology & carcinogenesis, Chemicals and Drugs::Macromolecular Substances::Polymers::Polyesters [Medical Subject Headings], Combination, Diseases::Hemic and Lymphatic Diseases::Hematologic Diseases::Leukocyte Disorders::Leukopenia::Agranulocytosis::Neutropenia [Medical Subject Headings], Fluorouracil, Compuestos organoplatinos, medicine.drug, medicine.medical_specialty, Phenomena and Processes::Genetic Phenomena::Genetic Variation::Mutation [Medical Subject Headings], Bevacizumab, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Therapies, Investigational::Compassionate Use Trials [Medical Subject Headings], Chemicals and Drugs::Enzymes and Coenzymes::Enzymes::Transferases::Phosphotransferases::Phosphotransferases (Alcohol Group Acceptor)::Protein Kinases::Protein-Tyrosine Kinases::Receptor Protein-Tyrosine Kinases::Receptors, Vascular Endothelial Growth Factor [Medical Subject Headings], Guidelines, Neutropenia, Irinotecan, Association, Xenograft models, 03 medical and health sciences, VEGFR, Diseases::Cardiovascular Diseases::Vascular Diseases::Hypertension [Medical Subject Headings], Internal medicine, Hipertensión, medicine, Chemotherapy, Supervivencia sin enfermedad, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Disease-Free Survival [Medical Subject Headings], Mutación, business.industry, Diseases::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Intestinal Neoplasms::Colorectal Neoplasms [Medical Subject Headings], Receptores de Factores de crecimiento endotelial vascular, medicine.disease, Oxaliplatin, Surgery, Clinical trial, Regimen, Diseases::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Urological Manifestations::Proteinuria [Medical Subject Headings], 030104 developmental biology, Angiogenesis, Poliésteres, business
Abstract

Journal Article; Aflibercept is a recombinant fusion protein that acts by inhibiting tumoural angiogenesis. Efficacy data obtained in the VELOUR randomised study has contributed to the approval of aflibercept as a second-line metastatic colorectal cancer (mCRC) treatment following an oxaliplatin-based regimen. The present study reports a case series of five patients with mCRC, who were treated in two centres since 2011 in the Compassionate Use Program for aflibercept. All patients had a KRAS mutation and previously received palliative fluoropyrimidine-oxaliplatin-based chemotherapy with bevacizumab. A doublet with irinotecan combined with aflibercept was administered until progression of disease. The majority of patients received a greater number of aflibercept cycles than the median reported in the VELOUR study (12 vs. 7 cycles), with manageable and reversible toxicity. The most frequent adverse events observed were diarrhoea, neutropenia, fatigue, proteinuria and hypertension. Most cases obtained a progression-free survival greater than the median reported in the VELOUR study (11 vs. 6.9 months) and, in a subgroup of patients previously treated with bevacizumab, and a median survival time of ~47 months was reached from the initial treatment of the disease. The present study contrasts the efficacy and safety results obtained from the pivotal VELOUR trial, and confirms that aflibercept, used in routine clinical practice outside of the clinical trial environment, is active and well-tolerated following bevacizumab treatment. Medical writing assistance, supported financially by Sanofi Spain (Barcelona, Spain). Yes

Published
2016

48. Temsirolimus in overtreated metastatic renal cancer with subsequent use of sunitinib: A case report

Author

Marta Legerén, José Luis García-Puche, Isabel Blancas, Irene Zarcos, José Miguel Jurado, Mayte Delgado, [Jurado,JM, Zarcos,I, Delgado,M, Blancas,I, Legerén,M, and García Puche,JL] Oncology Department, Hospital Clínico Universitario San Cecilio, Granada, Spain.

Subjects
Oncology, Temsirolimus, Cancer Research, Diseases::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Urologic Neoplasms::Kidney Neoplasms [Medical Subject Headings], Neoplasias renales, Diseases::Respiratory Tract Diseases::Pleural Diseases::Pleural Effusion [Medical Subject Headings], Case Report, Disease, Diseases::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Body Temperature Changes::Fever [Medical Subject Headings], Chemicals and Drugs::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Peptide Hormones::Pituitary Hormones::Pituitary Hormones, Anterior::Thyrotropin [Medical Subject Headings], Masculinos, Matástasis, Inhibidores de la angiogénesis, Hipercolesterolemia, Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Amino Acids::Amino Acids, Cyclic::Amino Acids, Aromatic::Thyroxine [Medical Subject Headings], Adulto, Sunitinib, Hipotiroidismo, Anemia, metastatic renal carcinoma, Leucopenia, Diseases::Respiratory Tract Diseases::Lung Diseases [Medical Subject Headings], Relación dosis-respuesta a droga, Tomografía computarizada por rayos X, Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Growth Substances::Growth Inhibitors::Angiogenesis Inhibitors [Medical Subject Headings], Diseases::Endocrine System Diseases::Thyroid Diseases::Hypothyroidism [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Imaging::Image Interpretation, Computer-Assisted::Tomography, X-Ray Computed [Medical Subject Headings], Diseases::Hemic and Lymphatic Diseases::Hematologic Diseases::Anemia [Medical Subject Headings], Tyrosine kinase, medicine.drug, mTOR inhibitors, medicine.medical_specialty, Antiinflamatorios, Check Tags::Male [Medical Subject Headings], Carcinoma renal, Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Inflammatory Agents [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Techniques, Radioisotope::Radionuclide Imaging::Tomography, Emission-Computed [Medical Subject Headings], Diseases::Hemic and Lymphatic Diseases::Hematologic Diseases::Leukocyte Disorders::Leukopenia [Medical Subject Headings], Internal medicine, temsirolimus, Named Groups::Persons::Age Groups::Adult [Medical Subject Headings], medicine, mThor inhibitors, Adverse effect, Hipertrigliceridemia, business.industry, Phenomena and Processes::Physiological Phenomena::Pharmacological Phenomena::Dose-Response Relationship, Drug [Medical Subject Headings], Carcinoma, Therapeutic effect, Metastatic renal, Cancer, Diseases::Nutritional and Metabolic Diseases::Metabolic Diseases::Lipid Metabolism Disorders::Dyslipidemias::Hyperlipidemias::Hypertriglyceridemia [Medical Subject Headings], medicine.disease, Molecular medicine, Diseases::Nutritional and Metabolic Diseases::Metabolic Diseases::Lipid Metabolism Disorders::Dyslipidemias::Hyperlipidemias::Hypercholesterolemia [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Urogenital Surgical Procedures::Urologic Surgical Procedures::Nephrectomy [Medical Subject Headings], Immunology, business, Fiebre
Abstract

JOURNAL ARTICLE During the last decade, we have been developing new therapeutic strategies for the treatment of renal cancer, based on knowledge derived from molecular biology. We report a case of long-term renal metastatic cancer progression despite therapy with sunitinib and interleukin, which are the most active drugs in renal cancer. Disease stabilization for 58 weeks was achieved upon sequential use of temsirolimus, following the occurrence of disease progression during angiogenic therapy. The patient demonstrated excellent tolerance without marked symptoms for 10 months. Hypothyroidism and mumps-related adverse events were present. The survival time from diagnosis to lung metastasis was 8 years. Thus, this case demonstrates promising therapeutic effects of the sequential use of tyrosine kinase inhibitors (TKIs) and mammalian target of rapamycin (mTOR) inhibitors during different stages of the disease. Yes

Published
2013

49. HER2/neu 655 polymorphism, trastuzumab-induced cardiotoxicity, and survival in HER2-positive breast cancer patients.

Author

Blancas I, Linares-Rodríguez M, Martín-Bravo C, Gómez-Peña C, and Rodríguez-Serrano F

Subjects
Humans, Female, Middle Aged, Adult, Aged, Genotype, Survival Rate, Prognosis, Trastuzumab adverse effects, Trastuzumab therapeutic use, Breast Neoplasms drug therapy, Breast Neoplasms genetics, Breast Neoplasms mortality, Receptor, ErbB-2 genetics, Receptor, ErbB-2 metabolism, Cardiotoxicity etiology, Cardiotoxicity genetics, Antineoplastic Agents, Immunological adverse effects, Antineoplastic Agents, Immunological therapeutic use, Polymorphism, Single Nucleotide
Abstract

Purpose: HER2 overexpression in breast cancer correlates with poor outcomes. The incorporation of Trastuzumab into the treatment regimen has notably improved patient prognoses. However, cardiotoxicity emerges in approximately 20% of patients treated with the drug. This study aims to investigate the association between the HER2 655 A > G polymorphism, Trastuzumab-induced cardiotoxicity, and patient survival., Methods: The study involved 88 patients treated with Trastuzumab. Cardiotoxicity, defined as a reduction in left ventricular ejection fraction (LVEF) from baseline or the emergence of clinical signs of congestive heart failure, was identified during treatment follow-up. Genotyping of HER2 655 A > G employed TaqMan SNP technology., Results: Genotype frequencies of HER2/neu 655 (53 AA, 32 AG, and 3 GG) were consistent with Hardy-Weinberg equilibrium. No significant differences were observed in mean baseline LVEF between patients who developed cardiotoxicity and those who did not. Within these groups, neither AA nor AG genotypes showed an association with changes in mean baseline or reduced LVEF levels. Logistic regression analysis, adjusted for hormonal status and anthracycline treatment, revealed that AG genotype carriers face a significantly higher risk of cardiotoxicity compared to AA carriers (OR = 4.42; p = 0.037). No association was found between the HER2/neu 655 A > G polymorphism and disease-free or overall survival, regardless of whether the data was adjusted for stage or not., Conclusion: HER2 655 A > G polymorphism is significantly linked to an increased risk of Trastuzumab-induced cardiotoxicity but does not correlate with variations in disease-free survival or overall survival rates., (© 2024. The Author(s).)

Published
2024
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50. Novel Genetic Variants Explaining Severe Adverse Drug Events after Clinical Implementation of DPYD Genotype-Guided Therapy with Fluoropyrimidines: An Observational Study.

Author

Díaz-Villamarín X, Martínez-Pérez M, Nieto-Sánchez MT, Ruiz-Tueros G, Fernández-Varón E, Torres-García A, González Astorga B, Blancas I, Iáñez AJ, Cabeza-Barrera J, and Morón R

Abstract

Fluoropyrimidines (FPs) are commonly prescribed in many cancer streams. The EMA and FDA-approved drug labels for FPs recommend genotyping the DPYD *2A (rs3918290), *13 (rs55886062), *HapB3 (rs56038477), alleles, and DPYD rs67376798 before treatment starts. We implemented the DPYD genotyping in our daily clinical routine, but we still found patients showing severe adverse drug events (ADEs) to FPs. We studied among these patients the DPYD rs1801265, rs17376848, rs1801159, rs1801160, rs1801158, and rs2297595 as explanatory candidates of the interindividual differences for FP-related toxicities, examining the association with the response to FPs . We also studied the impact of DPYD testing for FP dose tailoring in our clinical practice and characterized the DPYD gene in our population. We found a total acceptance among physicians of therapeutic recommendations translated from the DPYD test, and this dose tailoring does not affect the treatment efficacy. We also found that the DPYD *4 (defined by rs1801158) allele is associated with a higher risk of ADEs (severity grade ≥ 3) in both the univariate (O.R. = 5.66; 95% C.I. = 1.35-23.67; p = 0.014) and multivariate analyses (O.R. = 5.73; 95% C.I. = 1.41-28.77; p = 0.019) among FP-treated patients based on the DPYD genotype. This makes it a candidate variant for implementation in clinical practice.

Published
2024
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