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Gemcitabine combined with cisplatin as first-line treatment in patients 60 years or older with epithelial ovarian cancer: a phase II study
  1. T. Bauknecht*,
  2. A. Hefti,
  3. G. Morack,
  4. C. Villena-Heinsen§,
  5. D. Wallwiener,
  6. D. Elling**,
  7. G. V. Minckwitz,,
  8. K. Mansouri*,
  9. J. Blatter* and
  10. G. P. Breitbach
  1. * Eli Lilly GmbH Deutschland, Bad Homburg v.d.H., Germany
  2. Städtisches Krankenhaus gGmbH, Frauenklinik, Neunkirchen, Germany
  3. Helios Klinikum Berlin Buch, Frauenklinik, Berlin, Germany
  4. § Stadtklinik Baden-Baden, Frauenklinik, Baden-Baden, Germany
  5. Univerität-Frauenklinik, Tübingen, Germany
  6. ** Oskar-Ziethen-Krankenhaus, Berlin; Germany
  7. †† Frauenklinik der Johann-Wolfgang-Goethe-University, Frauenklinik, Frankfurt/Main, Germany
  1. Address correspondence and reprint requests to: Thomas Bauknecht, Lilly Deutschland GmbH, Saalburgstr. 153, 61350 Bad Homburg, Germany. Email: Bauknecht_Thomas{at}Lilly.com.

Abstract

This phase II study evaluated the activity and toxicity of gemcitabine plus cisplatin as first-line treatment of patients with advanced ovarian cancer. Chemonaive patients ≥60-year-old with FIGO stage IIIC or IV epithelial ovarian carcinoma were enrolled. Patients received cisplatin 75 mg/m2 on day 1 and gemcitabine 1250 mg/m2 on day 1 (before cisplatin) and day 8 of a 21-day cycle. Of 44 female patients (median age, 70 years), 72.7% had stage IIIC disease and 67.4% had a Karnofsky performance status ≥80. Of the 37 response-evaluable patients (35 with measurable lesion[s] ≥2 cm), there were seven (18.9%) pathologic complete responses, two (5.4%) pathologic partial responses, two (5.4%) clinical complete responses, and 12 (32.4%) clinical partial responses, for an overall response rate of 62.2% (95% CI, 44.8%–77.5%), and a pathologic response rate of 24.3% (95% CI, 11.8%–41.2%). Median survival was 27.7 months (95% CI, 14.3–40.8 months). Grade 3/4 neutropenia and thrombocytopenia occurred in 59.5% and 30.2% of patients, respectively, with neutropenic fever in one patient. Grade 3 nausea /vomiting and alopecia occurred in 25.6% and 9.5% of patients, respectively. We conclude that gemcitabine plus cisplatin is active and feasible as first-line treatment of advanced epithelial ovarian cancer in patients ≥60 years. Further clinical trials adding gemcitabine to current standard, first-line treatment seem warranted in younger as well as older patients.

  • cisplatin
  • gemcitabine
  • ovarian cancer

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Footnotes

  • Funded by Eli Lilly and Company.

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