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Article

A randomized phase II non-comparative study of pemetrexed‑carboplatin and gemcitabine‑vinorelbine in anthracycline- and taxane-pretreated advanced breast cancer patients

  • Authors:
    • Dino Amadori
    • Eva Carrasco
    • Siegfried Roesel
    • Roberto Labianca
    • Beatrice Uziely
    • Victoria Soldatenkova
    • Valerie Moreau
    • Durisala Desaiah
    • Thomas Bauknecht
    • Miguel Martin
  • View Affiliations / Copyright

    Affiliations: Romagnolo Scientific Institute for the Study and Treatment of Cancer, Meldola, Italy, Spanish Breast Cancer Research Group (GEICAM), Madrid, Spain, Gütersloh Oncology Practice, Gütersloh, Germany, Riuniti Hospital, Bergamo, Italy, Hadassah-Hebrew University Medical Center, Jerusalem, Israel, Lilly Deutschland, Bad Homburg, Germany, Lilly France, Paris, France, Eli Lilly and Company, Indianapolis, IN, USA, Gregorio Marañón University Hospital Research Institute, Complutense University, Madrid, Spain
  • Pages: 1778-1785
    |
    Published online on: March 28, 2013
       https://doi.org/10.3892/ijo.2013.1869
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Abstract

Pemetrexed-carboplatin and gemcitabine‑vinorelbine combination therapies were efficacious in phase II and phase III studies as first-line breast cancer treatment. Thus, Arm A and Arm B combinations were investigated in patients pretreated with anthracycline and taxanes. Women with advanced breast cancer, with ≥1 measurable lesion per RECIST, were stratified by line of treatment (1st, 2nd), visceral disease (yes/no), ECOG PS (0-1 vs. 2) and randomized 1:1 to Arm A (pemetrexed 600 mg/m2, D1 i.v. q21; carboplatin, AUC 5, D1 i.v. q21) or Arm B (gemcitabine 1,200 mg/m2 D1, D8 i.v. q21; vinorelbine 30 mg/m2 D1, D8 i.v. q21). Treatment continued until progression. The primary endpoint was objective response rate (RR). Secondary endpoints were duration of response (DoR), time-to-response (TTR), time-to-progressive disease (TTPD), time-to-treatment failure (TTTF) and safety. A two-stage design was employed independently for each arm. Of 135 randomized patients, 125 (Arm A, n=64; Arm B, n=61) qualified for tumor-response analysis. The mean (standard deviation) number of cycles administered was 6.3 (4.13) in Arm A and 6.2 (4.39) in Arm B. Efficacy in Arm A and Arm B were: RR (95% CI), 26.6 (16.3-39.1) and 29.5 (18.5-42.6); time-to-events (months), DoR 7.7 and 7.5; TTPD, 5.1 and 5.6; TTR, 1.8 and 1.8; TTTF, 4.8 and 5.1; respectively. Most common grade 3/4 adverse events possibly related to study-drug were neutropenia, thrombocytopenia, anemia and leucopenia in Arm A and neutropenia, leucopenia and fatigue in Arm B. In this study, both combinations showed moderate activity as predefined RR was not reached and were well tolerated.
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Copy and paste a formatted citation
Spandidos Publications style
Amadori D, Carrasco E, Roesel S, Labianca R, Uziely B, Soldatenkova V, Moreau V, Desaiah D, Bauknecht T, Martin M, Martin M, et al: A randomized phase II non-comparative study of pemetrexed‑carboplatin and gemcitabine‑vinorelbine in anthracycline- and taxane-pretreated advanced breast cancer patients. Int J Oncol 42: 1778-1785, 2013.
APA
Amadori, D., Carrasco, E., Roesel, S., Labianca, R., Uziely, B., Soldatenkova, V. ... Martin, M. (2013). A randomized phase II non-comparative study of pemetrexed‑carboplatin and gemcitabine‑vinorelbine in anthracycline- and taxane-pretreated advanced breast cancer patients. International Journal of Oncology, 42, 1778-1785. https://doi.org/10.3892/ijo.2013.1869
MLA
Amadori, D., Carrasco, E., Roesel, S., Labianca, R., Uziely, B., Soldatenkova, V., Moreau, V., Desaiah, D., Bauknecht, T., Martin, M."A randomized phase II non-comparative study of pemetrexed‑carboplatin and gemcitabine‑vinorelbine in anthracycline- and taxane-pretreated advanced breast cancer patients". International Journal of Oncology 42.5 (2013): 1778-1785.
Chicago
Amadori, D., Carrasco, E., Roesel, S., Labianca, R., Uziely, B., Soldatenkova, V., Moreau, V., Desaiah, D., Bauknecht, T., Martin, M."A randomized phase II non-comparative study of pemetrexed‑carboplatin and gemcitabine‑vinorelbine in anthracycline- and taxane-pretreated advanced breast cancer patients". International Journal of Oncology 42, no. 5 (2013): 1778-1785. https://doi.org/10.3892/ijo.2013.1869
Copy and paste a formatted citation
x
Spandidos Publications style
Amadori D, Carrasco E, Roesel S, Labianca R, Uziely B, Soldatenkova V, Moreau V, Desaiah D, Bauknecht T, Martin M, Martin M, et al: A randomized phase II non-comparative study of pemetrexed‑carboplatin and gemcitabine‑vinorelbine in anthracycline- and taxane-pretreated advanced breast cancer patients. Int J Oncol 42: 1778-1785, 2013.
APA
Amadori, D., Carrasco, E., Roesel, S., Labianca, R., Uziely, B., Soldatenkova, V. ... Martin, M. (2013). A randomized phase II non-comparative study of pemetrexed‑carboplatin and gemcitabine‑vinorelbine in anthracycline- and taxane-pretreated advanced breast cancer patients. International Journal of Oncology, 42, 1778-1785. https://doi.org/10.3892/ijo.2013.1869
MLA
Amadori, D., Carrasco, E., Roesel, S., Labianca, R., Uziely, B., Soldatenkova, V., Moreau, V., Desaiah, D., Bauknecht, T., Martin, M."A randomized phase II non-comparative study of pemetrexed‑carboplatin and gemcitabine‑vinorelbine in anthracycline- and taxane-pretreated advanced breast cancer patients". International Journal of Oncology 42.5 (2013): 1778-1785.
Chicago
Amadori, D., Carrasco, E., Roesel, S., Labianca, R., Uziely, B., Soldatenkova, V., Moreau, V., Desaiah, D., Bauknecht, T., Martin, M."A randomized phase II non-comparative study of pemetrexed‑carboplatin and gemcitabine‑vinorelbine in anthracycline- and taxane-pretreated advanced breast cancer patients". International Journal of Oncology 42, no. 5 (2013): 1778-1785. https://doi.org/10.3892/ijo.2013.1869
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