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Liposomal pegylated doxorubicin plus vinorelbine combination as first-line chemotherapy for metastatic breast cancer in elderly women ≥65 years of age

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Abstract

Purpose

No standard chemotherapy has been so far definitely settled for elderly patients with metastatic breast cancer (MBC). In order to identify a regimen with acceptable efficacy and low burden of non-overlapping toxic effects, a combination consisting of liposomal pegilated doxorubicin (PLD) with alternating oral and intravenous vinorelbine (NVB) has been investigated in a phase II study.

Methods

Thirty-four consecutive patients (median age 71 years; range 65–82) with MBC have been enrolled. Based on 4-weekly cycles, PLD 40 mg/m2 plus NVB 25 mg/m2 i.v., have been administered intravenously on day 1 and oral NVB 60 mg/m2 on day 15.

Results

All patients were assessable for safety and efficacy. In all, 17 responses were documented with three complete responses (CR) and 14 partial responses, with an overall response rate of 50% (95% CI 36–66). Median overall survival time was 13 months and the median time to progression 8 months. Interestingly, all the patients with CR are still alive with a disease-free survival of more than 1 year. The main toxicity was neutropenia: grade 3 in 15% and grade 4 in 11% of patients, respectively. Febrile neutropenia was recorded in three patients not requiring dose reduction. Other frequently reported adverse events included: anemia, nausea, vomiting, stomatitis, all rarely severe. The evaluation of quality of life (QoL) did not show any significant change during the study.

Conclusions

Our data suggest that this combination is active and well tolerated in elderly patients with MBC and could represent another efficacious chance for the management of this population.

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Acknowledgments

The authors thank Alessandro Ottaiano for the support, revision and helpful suggestions.

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Authors and Affiliations

  1. Oncology Unit, U.O.C. Oncology, “S.Giovanni di Dio” Hospital, ASL Napoli 3, Via Giovanni XXIII, 80028, Frattaminore, Naples, Italy

    Raffaele Addeo, Vincenzo Faiola, Rosario Guarrasi, Liliana Montella, Elena Capasso, Gregorio Cennamo & Salvatore Del Prete

  2. Section of Oncology, Campus Biomedico University, Rome, Italy

    Bruno Vincenzi

  3. Department of Experimental and Clinical Medicine, University Magna Grǽcia of Catanzaro and Oncology Center “T. Campanella”, Catanzaro, Italy

    Maria Saveria Rotundo & Pierosandro Tagliaferri

  4. Experimental Pharmacology Unit, INT Pascale, National Institute of Tumours of Naples, Via Mariano Semmola, 80131, Naples, Italy

    Michele Caraglia

Authors
  1. Raffaele Addeo
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  2. Vincenzo Faiola
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  3. Rosario Guarrasi
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  4. Liliana Montella
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  5. Bruno Vincenzi
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  6. Elena Capasso
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  8. Maria Saveria Rotundo
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  10. Michele Caraglia
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  11. Salvatore Del Prete
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Correspondence to Raffaele Addeo or Michele Caraglia.

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Addeo, R., Faiola, V., Guarrasi, R. et al. Liposomal pegylated doxorubicin plus vinorelbine combination as first-line chemotherapy for metastatic breast cancer in elderly women ≥65 years of age. Cancer Chemother Pharmacol 62, 285–292 (2008). https://doi.org/10.1007/s00280-007-0605-6

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  • DOI: https://doi.org/10.1007/s00280-007-0605-6

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