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Phase II Study Evaluating PegLiposomal Doxorubicin and Carboplatin Combination Chemotherapy in Gynecologic Sarcomas and Mixed Epithelial-Mesenchymal Tumors A Phase II Protocol of the Arbeitsgemeinschaft Gynaekologische Onkologie Study Group (AGO-GYN 7)
  1. Philipp Harter, MD,
  2. Jalid Sehouli, MD, PhD,
  3. Alexander Reuss, MSc,
  4. Klaus Baumann, MD, PhD,
  5. Lars Hanker, MD,
  6. Rainer Kimmig, MD, PhD,
  7. Willibald Schröder, MD, PhD,
  8. Alexander Burges, MD,
  9. Martina Gropp-Meier, MD,
  10. Christian Kurzeder, MD, PhD,
  11. Sven Mahner, MD, PhD,
  12. Ulrich Canzler, MD,
  13. Hans-Joachim Lück, MD, PhD,
  14. Werner Meier, MD, PhD,
  15. Tanja Fehm, MD, PhD and
  16. Andreas du Bois, MD, PhD
  1. * Department of Gynecology & Gynecologic Oncology, Kliniken Essen-Mitte, Essen;
  2. Department of Gynecology, Charité Medical University of Berlin, Berlin;
  3. Coordinating Center for Clinical Trials, University Marburg;
  4. § Department of Gynecology, Gynecologic Endocrinology and Oncology, Philipps University Marburg, Marburg;
  5. Department of Obstetrics and Gynecology, Johann Wolfgang Goethe-University, Frankfurt;
  6. Department of Obstetrics and Gynecology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck;
  7. # Department of Obstetrics and Gynecology, University of Duisburg-Essen, Essen;
  8. ** Department of Gynecologic Oncology and Gynecology, Gynaekologicum Bremen, Bremen;
  9. †† Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, München;
  10. ‡‡ Department of Obstetrics and Gynecology, Oberschwabenklinik Hospital St. Elisabeth Ravensburg, Ravensburg;
  11. §§ Department of Obstetrics and Gynecology, University Hospital Ulm, Ulm;
  12. ∥∥ Department of Gynecology and Gynecologic Oncology, University Medical Center Hamburg-Eppendorf, Hamburg;
  13. ¶¶ Department of Obstetrics and Gynecology, Carl Gustav Carus Technische University Dresden, Dresden;
  14. ## Gynecology Hannover, Hannover;
  15. *** Department of Obstetrics and Gynecology, Ev. Hospital Düsseldorf, Düsseldorf;
  16. ††† Department of Obstetrics and Gynecology, University of Tübingen, Tübingen; and
  17. ‡‡‡ Department of Obstetrics and Gynecology, University of Düsseldorf, Düsseldorf, Germany.
  1. Address correspondence and reprint requests to: Philipp Harter, MD, Department of Gynecology & Gynecologic Oncology, Kliniken Essen Mitte, Evang. Huyssens-Stiftung/Knappschaft GmbH, Henricistr 92, 45136 Essen, Germany. E-mail: p.harter{at}kliniken-essen-mitte.de.

Abstract

Background Gynecologic sarcomas are rare diseases with still undefined optimal treatment. Platinum and anthracyclines were reported as active agents in gynecologic sarcoma and carcinosarcoma. So far, data regarding the combination of carboplatin and pegylated liposomal doxorubicin for this patient population are missing.

Methods This prospective single-arm multicenter phase II trial evaluated the efficacy of carboplatin AUC 6 in combination with pegylated liposomal doxorubicin 40 mg/m2 q28 in 40 patients with newly diagnosed or recurrent gynecologic sarcoma or carcinosarcoma.

Results Twenty patients with carcinosarcoma and 20 patients with leiomyosarcoma or endometrial stromal sarcoma were included. The percentage of patients with grade 3/4 neutropenia was 50%, but we did not observe any febrile neutropenia. The rates of grade 1 and 2 palmo-plantar erythema were moderate with 25% and 10%, respectively. Response rate was 33.3%. The 12-month progression-free and overall survival times were 32.5% and 77.0%, respectively.

Conclusions The combination of carboplatin and pegylated liposomal doxorubicin is feasible and has activity within the investigated study cohort.

  • Uterine sarcoma
  • Uterine leiomyosarcoma
  • Endometrial stromal sarcoma
  • Uterine carcinosarcoma
  • Chemotherapy
  • Carboplatin
  • Pegylated liposomal doxorubicin

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Footnotes

  • The authors declare no conflicts of interest.

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