Breast Cancer Research and Treatment

, Volume 151, Issue 3, pp 597–606 | Cite as

Pegylated liposomal doxorubicin plus cyclophosphamide followed by paclitaxel as primary chemotherapy in elderly or cardiotoxicity-prone patients with high-risk breast cancer: results of the phase II CAPRICE study

  • Miguel J. Gil-Gil
  • M. Bellet
  • S. Morales
  • B. Ojeda
  • L. Manso
  • C. Mesia
  • E. Garcia-Martínez
  • N. Martinez-Jáñez
  • M. Melé
  • A. Llombart
  • S. Pernas
  • P. Villagrasa
  • C. Blasco
  • J. Baselga
Clinical Trial


Anthracycline and taxane-based primary chemotherapy (PCT) is the standard treatment for high-risk breast cancer (HRBC). However, conventional anthracyclines are not commonly used in elderly patients or those prone to cardiotoxicity. Pegylated liposomal doxorubicin, (PLD) has comparable efficacy, but less cardiotoxicity than conventional anthracyclines. We conducted a phase II single-arm trial to assess the efficacy and safety of PCT based on PLD followed by paclitaxel (PTX) in a HRBC population usually undertreated. Fifty patients with stage II–IIIB breast cancer and at least one risk factor for developing cardiotoxicity initiated PLD 35 mg/m2 plus cyclophosphamide 600 mg/m2 every 4 weeks for four cycles, followed by 80 mg/m2 weekly PTX for 12. Close cardiac monitoring was performed. Primary endpoint was the pathological complete response rate (pCR) in the breast. Treatment delivery and toxicities were assessed. Eighty-four per cent of patients were older than 65 years, 64 % suffered from hypertension, and 10 % had prior cardiac disease. In an intention-to-treat analysis, breast pCR was 32 % (95 % CI 19.5–46.7 %) and pCR in breast and axilla was 24 % (95 % CI 12.1–35.8 %). At diagnosis only, 26 % of patients were candidates for breast conservative surgery, which increased to 58.7 % after PCT. No significant decrease in left ventricular ejection fraction was seen. PLD followed by PTX was feasible in a fragile population of patients who were not candidates for conventional doxorubicin. Moreover, it achieved a pCR similar to standard therapy and could therefore be an option for elderly patients or cardiotoxicity-prone who present HRBC.


Cardiotoxicity Elderly Neoadjuvant chemotherapy Pegylated liposomal doxorubicin Breast cancer Phase II study 



Breast conserving surgery rate




Congestive heart failure






High-risk breast cancer


Hand–foot syndrome


Intention to treat


Left ventricular ejection fraction


Magnetic resonance image


Estrogen receptor


Overall response rate


Overall survival




Pathologic complete response


Pegylated liposomal doxorubicin


Primary chemotherapy


Progression-free survival





This work was supported by the Schering Plough and Merck Sharp and Dohme. The results of this study were presented in part at SABCS 2011.

Conflict of interest

The authors declare that they have no conflict of interest.

Compliance with Ethical Standards

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in this study.


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Copyright information

© Springer Science+Business Media New York 2015

Authors and Affiliations

  • Miguel J. Gil-Gil
    • 1
  • M. Bellet
    • 2
  • S. Morales
    • 3
  • B. Ojeda
    • 4
  • L. Manso
    • 5
  • C. Mesia
    • 1
  • E. Garcia-Martínez
    • 6
  • N. Martinez-Jáñez
    • 7
  • M. Melé
    • 8
  • A. Llombart
    • 3
    • 10
  • S. Pernas
    • 1
  • P. Villagrasa
    • 9
  • C. Blasco
    • 9
  • J. Baselga
    • 2
    • 11
  1. 1.Department of Medical Oncology, Institut Català d’Oncologia-IDIBELLL’Hospitalet de LlobregatBarcelonaSpain
  2. 2.Department of Medical Oncology, Vall d’Hebron Institute of Oncology and HospitalUniversitari Vall d’HebronBarcelonaSpain
  3. 3.Department of Medical OncologyHospital Arnau de VilanovaLleidaSpain
  4. 4.Department of Medical OncologyHospital de Sant PauBarcelonaSpain
  5. 5.Department of Medical OncologyHospital 12 de OctubreMadridSpain
  6. 6.Department of Medical OncologyHospital JM Morales MesseguerMurciaSpain
  7. 7.Department of Medical OncologyHospital Ramón y CajalMadridSpain
  8. 8.Department of Medical OncologyHospital Sant JoanReusSpain
  9. 9.SOLTI Breast Cancer Research GroupBarcelonaSpain
  10. 10.H. Arnau de VilanovaValenciaSpain
  11. 11.Memorial Sloan Kettering Cancer CenterNew YorkUSA

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