Original Article

Cancer Chemotherapy and Pharmacology

, Volume 52, Issue 2, pp 147-152

Gemcitabine and vinorelbine as second-line treatment in patients with metastatic breast cancer: a phase II study

  • Michela DonadioAffiliated withOncologia Medica, Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette Email author 
  • , Mara ArdineAffiliated withOncologia Medica, Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette
  • , Alfredo BerrutiAffiliated withOncologia Medica, Azienda Ospedaliera San Luigi
  • , Giuliana RitortoAffiliated withOncologia Medica, Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette
  • , Elena FeaAffiliated withOncologia Medica, Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette
  • , Marinella MistrangeloAffiliated withOncologia Medica, Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette
  • , Zaira CoccorulloAffiliated withOncologia Medica, Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette
  • , Paola BergnoloAffiliated withOncologia Medica, Ospedale Gradenigo
  • , Alessandro ComandoneAffiliated withOncologia Medica, Ospedale Gradenigo
    • , Oscar BertettoAffiliated withOncologia Medica, Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette

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Abstract

Background

To evaluate the feasibility and activity of gemcitabine and vinorelbine as a second/third-line approach in patients with advanced breast cancer.

Methods

Entered into the study were 51 consecutive patients. All had been previously treated with anthracyclines. Of these 51 patients, 36 had experienced failure or relapse after one chemotherapy line for advanced disease, and 15 after two chemotherapy lines. The dominant sites of involvement were brain in 4 patients (7.8%), liver in 22 (43.2%), lung in 10 (19.6%), bone in 10 (19.6), and soft-tissue in 5 (9.8%). Treatment consisted of vinorelbine 25 mg/m2 and gemcitabine 1000 mg/m2 administered on days 1 and 8 every 21 days.

Results

The scheme was well tolerated. Grade 3/4 neutropenia was observed in 11% of patients. Grade 3 nausea and vomiting occurred in 6%, and grade 2 neurotoxicity in 6%. No patients experienced grade 3/4 alopecia. The median relative dose intensity was 94.6% (49.7–100%) and 90.0% (23.1–100%) for vinorelbine and gemcitabine, respectively. Two patients (3.9%) were not evaluable for disease response, 4 (7.8%) attained a clinical complete response, 13 (25.5%) a partial response (for an overall response rate of 33.3%, 95% coefficient interval 20.0–46.0%), 23 (45.2%) showed stable disease, and 9 (17.6%) progressed. The median time to progression of responding patients was 10.8 months, and the median overall survival of the entire population was 17.8 months.

Conclusions

Vinorelbine and gemcitabine is a manageable scheme with moderate activity in pretreated patients with advanced breast cancer.

Keywords

Gemcitabine Vinorelbine Second-line treatment Metastatic breast cancer Phase II