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Maintenance treatment with Pegylated liposomal doxorubicin versus observation following induction chemotherapy for metastatic breast cancer: GEICAM 2001-01 study

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Abstract

This randomized multicenter phase III trial evaluated the role of maintenance therapy with pegylated liposomal doxorubicin (PLD) after induction chemotherapy in patients with metastatic breast cancer (MBC). Patients without disease progression following first-line induction chemotherapy consisting of three cycles of doxorubicin (75 mg/m2) followed by three cycles of docetaxel (100 mg/m2) both every 21 days, were randomized to PLD (40 mg/m2) every 28 days for six cycles or to observation. Time to progression (TTP) was the primary endpoint. 288 patients were enrolled and received induction first-line chemotherapy. One hundred and fifty-five achieved response or stable disease and were randomized to maintenance PLD (n = 78) or observation (n = 77). With a median follow-up of 20 months from randomization (range 1–56), disease progression occurred in 94% of patients. PLD significantly improved TTP by 3.3 months (8.4 vs. 5.1 months; hazard ratio [HR] = 0.54, 95% CI: 0.39 to 0.76, P = 0.0002) compared with observation. Overall survival was not significantly prolonged with PLD (24.8 vs. 22.0 months, respectively; HR = 0.86, 95% CI: 0.58–1.27, P = 0.44). PLD-induced toxicity was mild and manageable with up to 5% of patients experiencing grade 3/4 non-hematologic events (fatigue, mucositis, palmar-plantar erythrodysesthesia). Grade 3/4 neutropenia occurred in 12% of patients; two patients developed febrile neutropenia. This phase III trial demonstrated that maintenance chemotherapy with PLD is well tolerated and offers improved TTP in patients with MBC following first-line chemotherapy.

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Acknowledgements

The author thanks Andrés Hernando for his help in the conduction of the trial, Maribel Casas and Maria José Escudero for the statistical analyses and Dra. Eva Carrasco and Dr. Peter R. Turner for the editorial assistance. This work was research supported by Spanish Breast Cancer Research Group (GEICAM) and this study was supported in part by Schering Plough Corporation.

Conflict of interest statement

None of the co-authors has any involvement that can be construed as a conflict of interest. The funding bodies were not involved in the collection and interpretation of the data, or in the decision to publish.

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Authors and Affiliations

  1. Department of Medical Oncology, Hospital Clínico Universitario Virgen de la Victoria, Colonia Santa Inés s/n, 29010, Malaga, Spain

    Emilio Alba, Nuria Ribelles & Antonia Márquez

  2. Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain

    Manuel Ruiz-Borrego, Elisa Calvo & David Vicente

  3. Department of Medical Oncology, Hospital Universitario Germans Trias I Pujol, Badalona, Barcelona, Spain

    Mireia Margelí

  4. Department of Medical Oncology, Hospital General de Elche, Elche, Alicante, Spain

    Álvaro Rodríguez-Lescure

  5. Department of Medical Oncology, Complejo Hospitalario de Jaén, Jaén, Spain

    Pedro Sánchez-Rovira

  6. Department of Medical Oncology, Instituto Valenciano de Oncología, Valencia, Spain

    Amparo Ruiz

  7. Department of Medical Oncology, Complejo Hospitalario Xeral Calde, Lugo, Spain

    Jose Ramón Mel-Lorenzo

  8. Department of Medical Oncology, Centro Oncológico de Galicia, A Coruña, Spain

    Manuel Ramos-Vázquez

  9. Department of Medical Oncology, Hospital Clínico Universitario San Carlos, Madrid, Spain

    Antonio Casado, José Angel García-Sáenz & Miguel Martín

Authors
  1. Emilio Alba
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  2. Manuel Ruiz-Borrego
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  3. Mireia Margelí
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  4. Álvaro Rodríguez-Lescure
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  5. Pedro Sánchez-Rovira
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  6. Amparo Ruiz
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  7. Jose Ramón Mel-Lorenzo
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  8. Manuel Ramos-Vázquez
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  9. Nuria Ribelles
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  10. Elisa Calvo
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  11. Antonio Casado
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  12. Antonia Márquez
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  13. David Vicente
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  14. José Angel García-Sáenz
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  15. Miguel Martín
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Corresponding author

Correspondence to Emilio Alba.

Additional information

This study was conducted on behalf of the Spanish Breast Cancer Research Group (GEICAM)

Appendix

Appendix

See Table 5.

Table 5 List of participating centers and investigators
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Alba, E., Ruiz-Borrego, M., Margelí, M. et al. Maintenance treatment with Pegylated liposomal doxorubicin versus observation following induction chemotherapy for metastatic breast cancer: GEICAM 2001-01 study. Breast Cancer Res Treat 122, 169–176 (2010). https://doi.org/10.1007/s10549-010-0860-9

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  • DOI: https://doi.org/10.1007/s10549-010-0860-9

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