Annals of Oncology Advance Access published online on April 6, 2006
Annals of Oncology, doi:10.1093/annonc/mdl079
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1 Department of Gynecology and Obstetrics, Charité University Medical Center, Berlin
* To whom correspondence should be addressed. Background: The obvious benefit of pegylated liposomal doxorubicin (PLD) for tumour control in recurrent ovarian cancer is frequently offset by severe palmar-plantar erythrodysesthesia (PPE). There is evidence that dose reduction from 50 to 40 mg/m2 reduces the incidence of PPE without compromising cytotoxic activity. We set out to investigate whether biweekly application further improves the therapeutic index of PLD. Patients and methods: Patients with recurrent ovarian cancer after surgery and adjuvant chemotherapy with platinum and taxane compounds were eligible to participate in this multi-institutional phase II study. PLD was administered at a dose of 20 mg/m2 every two weeks. Eligible patients had ECOG performance status of Results: Between October 2001 and February 2004, 64 patients with median age of 59 (range 38-81) years were recruited onto this trial. We evaluated 553 (median 7, range 1-25) courses of PLD treatment. Most patients were in their third or fourth line of chemotherapy. PPE was noted in 30 patients (47.6%), but only three participants progressed to grade 3 severity (4.7%, 95% confidence interval 1.0-13.1%). Partial response, stable disease, and tumour progression were observed in 5, 13, and 24 patients, respectively. Median overall and progression-free survival were 18.2 (range, 1.4-34.0) and 4.3 (range 0.5-22.3) months. Conclusions: Biweekly PLD may reduce the incidence of PPE while retaining efficacy in relapsed ovarian cancer. Our data support the need for a randomized trial to strengthen these assumptions.
Received December 8, 2005
Revised February 1, 2006
Accepted March 3, 2006
original article
Biweekly pegylated liposomal doxorubicin in patients with relapsed ovarian cancer: results of a multicenter phase-II trial
J. Sehouli 1 *,
G. Oskay-Özcelik 1,
J. Kühne 1,
D. Stengel 2,
H.-J. Hindenburg 3,
P. Klare 3,
G. Heinrich 4,
B. Schmalfeldt 5,
Heinrich Mertens 6,
O. Camara 7,
W. Lichtenegger 1,
and
Ovarian Cancer Study Group of the Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie (NOGGO)
2 Center for Clinical Research, Unfallkrankenhaus Berlin
3 Private Practice, Berlin
4 Private Practice, Fürstenwalde
5 Department of Gynecology and Obstetrics, Klinikum Rechts der Isar, University of Munich
6 Department of Gynecology and Obstetrics, St. Josef Krankenhaus GmbH Moers
7 Department of Gynecology and Obstetrics, Friedrich-Schiller-University of Jena, Germany
J. Sehouli, E-mail: sehouli{at}aol.com
Abstract 
2, and sufficient organ function. We employed an optimized two-stage design to test the hypothesis that biweekly application of PLD reduces the frequency of grade III and IV PPE from 25% to 10%. Response and survival were addressed descriptively.
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