gms | German Medical Science

27th German Cancer Congress Berlin 2006

German Cancer Society (Frankfurt/M.)

22. - 26.03.2006, Berlin

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Combination therapy with pegliposomal doxorubicin and carboplatin in malignant gynecologic tumours. A prospective multicenter phase-II trial of the AGO-OVAR and the AGO Kommission Uterus

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  • corresponding author presenting/speaker Philipp Harter - HSK, Wiesbaden, Deutschland
  • Jacobus Pfisterer - Universitätsklinikum, Kiel
  • Nicole Burchardi - KKS, Marburg
  • Sibylle Loibl - Universitätsklinikum, Frankfurt
  • Jens Huober - Universitätsklinikum, Tuebingen
  • Pauline Wimberger - Universitätsklinikum, Essen
  • Alexander Burges - Klinikum Großhadern, Muenchen
  • Anne Staehle - St.-Vincentius-Krankenhaus, Karlsruhe
  • Heinz Koelbl - Universitätsklinikum, Mainz
  • Andreas du Bois - HSK, Wiesbaden

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocPO349

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/dkk2006/06dkk459.shtml

Published: March 20, 2006

© 2006 Harter et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

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Background: To determine the toxicity and efficacy of combination therapy with pegliposomal doxorubicin and carboplatin in patients with malignant gynecologic tumours.

Methods: Patients with recurrent or advanced uterine sarcomas, endometrial, cervical or vaginal cancer or with recurrent platinum-sensitive ovarian cancer were treated with pegliposomal doxorubicin 40mg/m² and carboplatin AUC 6, q28 over 6 cycles (up to 10 cycles allowed). Primary and secondary endpoints were tolerability and efficacy. Efficacy was measured according to RECIST and/or CA- 125 GCIG criteria.

Results: 67 pts with recurrent ovarian cancer, 11 pts with uterine sarcomas, 31 pts with endometrial cancer, and 31 pts with cervical or vaginal cancer have been recruited (total 140 pts, 87 pts evaluable for response). Grade 3 or 4 hematologic toxicities occured in 7.8% for anemia, 14.1% for thrombocytopenia, 23% for leukopenia, and 24.6% for neutropenia of whom 1.7% developped febrile neutropenia. Non-hematologic Grade 3 or 4 toxicities have been observed in more than 5% of all patients for the following items: asthenia: 14%, pain: 10.3%, dyspnea: 8.9%, palmo-plantar-erythema: 7.4%, nausea and vomiting: 6.6%, diarrhea: 5.2%. The median dose intensity was 93.9% for pegliposomal doxorubicin and 97% for carboplatin. 76% of all non-progressing patients received at least 5 cycles. The overall response rate (complete + partial response) was 55.6% in ovarian cancer, 42.9% in uterine sarcomas, 43.5% in endometrial cancer, and 14.3% in cervical and vaginal cancer.

Conclusions: The combination of pegliposmal doxorubicin and carboplatin was well tolerated, even in pretreated patients. This preliminary analysis showed remarkable efficacy in patients with uterine sarcomas, endometrial cancer, and ovarian cancer which merits further evaluation. However, the regimen had limited efficacy in cervical and vaginal cancer. A prospective randomised trial in recurrent ovarian cancer patients comparing carboplatin/pegliposomal doxorubicin with paclitaxel/carboplatin has already been started within the international study group network (AGO-OVAR 2.9; CALYPSO-trial).