Safety of everolimus plus exemestane in patients with hormone-receptor-positive, HER2-negative locally advanced or metastatic breast cancer: results of phase IIIb BALLET trial in Spain

  • E. Ciruelos
  • M. Vidal
  • E. Martínez de Dueñas
  • N. Martínez-Jáñez
  • Y. Fernández
  • J. A. García-Sáenz
  • L. Murillo
  • F. Carabantes
  • A. Beliera
  • R. Fonseca
  • J. Gavilá
Research Article

Abstract

Background

Everolimus with exemestane has shown promising activity in patients with hormone-receptor (HR)-positive HER2-negative endocrine-resistant advanced breast cancer. It is necessary, therefore, to characterize the safety profile of this new combination in the real-world clinical setting and in the broadest possible population.

Patients and methods

Post-menopausal women with HR-positive HER2-negative advanced breast cancer progressing after prior non-steroidal aromatase inhibitors (NSAIs) were included. The objectives of this analysis were to evaluate the safety profile of this combination in a subset of Spanish patients in the BALLET trial and to characterize grade 3 and 4 adverse events (AEs) in routine clinical practice in Spain.

Results

Between September 2012 and July 2013, 429 patients (20% of the overall study population) were included in the BALLET study in 52 hospitals in Spain, of whom 100 (23%) were ≥ 70 years. The median treatment duration was 3.14 and 3.03 months for exemestane and everolimus, respectively. The most common reasons for discontinuation of treatment were local reimbursement of everolimus (43%), followed by disease progression (31%) and the incidence of AEs (15%). The most frequent AEs causing permanent discontinuation were pneumonitis (4%), asthenia (2%) and stomatitis (2%). Overall, 87% of patients experienced at least one AE of any grade, 30% of patients at least one grade 3 AE and 2% of patients a grade 4 AE.

Conclusion

The safety profile in Spanish patients of the BALLET trial is consistent with the results obtained in the overall population of the trial, as well as in previous clinical trials.

Keywords

Aromatase inhibitors Breast neoplasm Endocrine therapy Post-menopausal women Targeted therapy 

Notes

Acknowledgements

The authors wish to thank Dr. Beatriz Gil-Alberdi from HealthCo Comunicación y Contenidos en Salud S. L. (Madrid, Spain) for her help in the preparation of the first draft of this manuscript. Novartis Spain provided financial support for medical writing services. The authors acknowledge the participation of the following oncologists in this study: Dr. Eva Ciruelos Gil, Hospital Universitario 12 de Octubre; Dr. Francisco Lobo Semper, Fundación Jiménez Díaz; Dra. Noelia Martínez Jañez, Hospital Universitario Ramón y Cajal; Dra. Pilar Zamora Auñón, Hospital Universitario La Paz; Dr. Álvaro Rodríguez-Lescure, Hospital Universitario de Elche; Dr. Francisco Ayala de la Peña, Hospital Morales Meseguer; Dr. José Ponce Lorenzo, Hospital Universitario de Alicante; Dr. Ignacio Chacón López-Muñiz, Hospital Virgen de la Salud; Dra. Aurelia Bustos Moreno, Hospital San Juan de Alicante; Dra. Mireia Margeli Vila, Hospital Germans Trials i Pujol; Dra. Sonia del Barco Berrón, Hospital Doctor Josep Trueta; Dr. Ignasi Tusquets Trías de Bes, Hospital del Mar; Dr. Joaquín Gavilá Gregori, Instituto Valenciano de Oncología; Dr. Diego Pérez Martín, Hospital Costa del Sol; Dra. Antonia Perelló Martorell, Hospital Son Espases; Dr. Jesús García Mata, Complejo Hospitalario de Ourense; Dr. Eduardo Martínez Dueñas, Hospital Provincial de Castellón; Dra. Silvia Antolín Novoa, Complejo Hospitalario A Coruña; Dr. Rafael López López, Complejo Hospitalario de Santiago; Dr. Antonio Antón Torres, Hospital Universitario Miguel Servet; Dra. Elena Galve Calvo, Hospital de Basurto; Dr. José Juan Illaramendi Mañas, Centro Hospitalario de Navarra; Dra. Isabel Álvarez, Hospital de Donostia; Dra. María García González, Hospital Universitario de Burgos; Dr. Francisco Carabantes Ocon, Hospital Carlos Haya; Dr. Rubén del Toro Salas, Hospital de Jerez; Dr. Juan Lucas Bayo Calero, Hospital Juan Ramón Jiménez; Dra. Pilar López Álvarez, Hospital Virgen de la Candelaria; Dra. María Lomas Garrido, Centro Hospitalario de Jaén; Dr. Norberto Batista López, Hospital Universitario de Canarias; Dr. Miguel Ángel Seguí, Hospital Parc Taulí; Blanca Cantos Sánchez, Hospital Puerta de Hierro; Dra. Montserrat Muñoz Mateu, Hospital Clinic de Barcelona; Dr. Agustí Barnadas i Molins, Hospital Sant Pau i Santa Creu; Dr. Miguel Martín Jiménez, Hospital Gregorio Marañón; Dr. Manuel Codes de Villena, Hospital Virgen de la Macarena; Dr. José Manuel Baena Cañada, Hospital Puerta del Mar; Dra. Vega Iranzo González Cruz, Hospital General de Valencia; Dr. José Ángel García Sáenz, Hospital Clínico San Carlos; Dra. Yolanda Fernández Pérez, Hospital Central de Asturias; Dra. Laura Murillo Jaso, Hospital Clínico Lozano Blesa; Dr. Santos Enrech, Hospital Universitario de Getafe; Dr. Juan de la Haba Rodríguez, Hospital Universitario Reina Sofía; Dr. Serafín Morales Murillo, Hospital Universitario Arnau de Vilanova; Dr. José Luis García Puche, Hospital Universitario San Cecilio; Dra. Isaura Fernández Pérez, Complejo Hospitalario de Vigo; Dra. Maria Vidal, Hospital Universitari Vall d’Hebron; Dr. Manuel Ramos Vázquez, Centro Oncológico de Galicia; Dra. Isabel Garau Llinàs, Hospital Son Llàtzer; Dra. Ana Miguel, Xarxa Assistencial de Manresa; Dra. Victoria Castellón Rubio, Hospital de Torrecárdenas; Dr. Miguel Ángel Lara, Hospital Infanta Leonor; Dra. Ana Lluch, Hospital Clínico de Valencia; Dra. Catalina Falo, Hospital Universitari de Bellvitge; Dra. Esperanza Blanco, Hospital Infanta Cristina; Dra. Susana Martínez Peralta, Hospital de Mataró.

Compliance with ethical standards

Conflict of interest

The authors declare that they do not have any conflict of interest that may inappropriately influence this work.

Ethical statement

The study has been performed in accordance with the ethical standards of the Declaration of Helsinki and its later amendments.

Informed consent

Informed consent was obtained from all individual participants of this study.

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Copyright information

© Federación de Sociedades Españolas de Oncología (FESEO) 2017

Authors and Affiliations

  • E. Ciruelos
    • 1
  • M. Vidal
    • 2
    • 3
  • E. Martínez de Dueñas
    • 4
  • N. Martínez-Jáñez
    • 5
  • Y. Fernández
    • 6
  • J. A. García-Sáenz
    • 7
  • L. Murillo
    • 8
  • F. Carabantes
    • 9
  • A. Beliera
    • 10
  • R. Fonseca
    • 10
  • J. Gavilá
    • 11
  1. 1.Departamento de Oncología MédicaHospital Universitario 12 de OctubreMadridSpain
  2. 2.Vall d’Hebron University HospitalBarcelonaSpain
  3. 3.Clinic HospitalBarcelonaSpain
  4. 4.General University Hospital of CastellónCastelló de la PlanaSpain
  5. 5.Ramón y Cajal University HospitalMadridSpain
  6. 6.Central University Hospital of AsturiasOviedoSpain
  7. 7.San Carlos University HospitalMadridSpain
  8. 8.Lozano Blesa University HospitalZaragozaSpain
  9. 9.Carlos Haya University HospitalMálagaSpain
  10. 10.Novartis OncologyMadridSpain
  11. 11.Instituto Valenciano de OncologíaValenciaSpain

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