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Carboplatin and Nonpegylated Liposomal Doxorubicin in Primary Advanced or Recurrent Endometrial Cancer: A Phase 2 Trial Conducted by AGO Austria
  1. Birgit Volgger, MD*,,
  2. Alain G. Zeimet, PhD*,
  3. Alexander Reinthaller, PhD,
  4. Edgar Petru, MD§,
  5. Christian Schauer, MD,
  6. Michaela Klein, MD,
  7. Ursula Sevelda-Schwarzgruber, MD#,
  8. Gerhard Bogner, MD**,
  9. Gerhard Wolfram, MD, and
  10. Christian Marth, PhD*,
  1. *Department of Obstetrics and Gynecology, and
  2. Study Center of AGO (Arbeitsgemeinschaft für Gynäkologisch Onkologie) Austria, Innsbruck Medical University, Innsbruck;
  3. Department of Gynecology and Gynecologic Oncology, Medical University of Vienna, Vienna;
  4. §Department of Obstetrics and Gynecology, Medical University of Graz;
  5. Department of Gynecology, Krankenhaus der Barmherzigen Brüder Graz, Graz;
  6. Department of Obstetrics and Gynecology, Krankenhaus Oberpullendorf, Oberpullendorf;
  7. #Department of Obstetrics and Gynecology, Wilhelminenspital Wien, Vienna;
  8. **Department of Obstetrics and Gynecology, KH der Kreuzschwestern Wels, Wels; and
  9. ††Department of Obstetrics and Gynecology, KH Ried i.I. Schloßberg 1, Ried im Innkreis, Austria.
  1. Address correspondence and reprint requests to Christian Marth, PhD, Department of Obstetrics and Gynecology, Innsbruck Medical University, Anichstraße 35, 6020 Innsbruck, Austria. E-mail: christian.marth{at}uki.at.

Abstract

Objective Recurrent/advanced endometrial carcinoma carries a poor prognosis. Chemotherapy usually consists of cisplatin/doxorubicin and paclitaxel or the doublet of carboplatin and paclitaxel.

We report on final results of the Austrian phase 2 AGO trial of nonpegylated doxorubicin citrate and carboplatin in 39 patients with primary advanced or relapsed endometrial cancer. The main primary end point is response rate, and the main secondary end point is feasibility.

Methods Thirty-nine patients received 60 mg/m2 nonpegylated doxorubicin citrate and carboplatin (area under the curve, 5) every 3 weeks for 6 to 9 cycles or until progression. Best response during therapy, progression-free survival, and the toxicity profile were recorded.

Results Thirteen patients (33%) had primary advanced disease, and 26 patients (67%) had recurrent disease. Seventy-five percent of the tumors were adenocarcinomas, 15% were serous carcinomas, and 5% were clear cell and mixed müllerian carcinomas. We observed 1 complete response (3%) and 16 partial responses (41%) in the intention-to-treat population. The median progression-free survival was 7.2 months, and the median overall survival was 14.7 months. Overall, 177 cycles were administered; the mean number of cycles per patient was 4.5. Ten percent of patients received 9 cycles of chemotherapy, and 44% of patients received 6 cycles of chemotherapy. Grade 3/4 neutropenia occurred in 17%, grade 3/4 anemia in 5%, and grade 3/4 thrombopenia in 12% of the cycles. In 6% of the cycles, febrile neutropenia was noticed. Grade 3/4 nausea was seen in 5% of cycles. One patient (3%) experienced cardiac toxicity and had a reduction in the left ventricular ejection fraction to below 50%.

Conclusions The reported combination demonstrates considerable activity and should be evaluated further.

  • Advanced endometrial cancer
  • Chemotherapy
  • Carboplatin
  • Nonpegylated liposomal doxorubicin

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Footnotes

  • All patients gave written informed consent according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - Good Clinical Practice rules before study entry. The protocol was approved by the ethics committee of the Innsbruck Medical University, Austria, and registered at the European Trial Database (EudraCT number 2007-004060-40). The study was conducted and sponsored by the AGO (Arbeitsgemeinschaft für Gynäkologisch Onkologie) Austria. The study center is located at the Innsbruck Medical University.

  • The authors declare no conflicts of interest.

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