Article
Finaly analyzes of biweekly schedule of pegylated liposomal doxorubicin (PLD) in 64 heavily pretreated patients with relapsed ovarian cancer (ROC)
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Authors
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Jalid Sehouli
- Universitätsklinikum, Jena, Berlin, Deutschland
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Guelten Oskay-Oezcelik
- Charité Universitätsklinikum, Berlin
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Joshua Kuehne
- Charité Universitätsklinikum, Berlin
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Hans Huindenburg
- NOGGO, Berlin
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Peter Klare
- NOGGO, Berlin
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Georg Heinrich
- NOGGO, Berlin
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Barbara Schmalfeldt
- Technische Universität, München
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Heinrich Mertens
- NOGGO, Berlin
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Oumar Camara
- Universitätsklinikum, Jena
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Werner Lichtenegger
- Charité Universitätsklinikum, Berlin
| Published: | March 20, 2006 |
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Outline
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Objectives: Pegylated liposomal doxorubicin (PLD) formulation has been approved for the treatment of recurrent ovarian cancer (ROC). Toxic skin reactions were reported as being the dose-limiting toxicity and have an impact on patients' quality of life (QoL). The primary aim of this study was to optimise the toxicity profile by choosing a biweekly schedule of PLD Furthermore, QoL was investigated. Secondary objective of this study was to evaluate the response rates of this new regimen.
Methods: We performed a multi-institutional phase-II study to analyze the toxicity profile of PLD (20mg/m²/q 14d) in heavily pretreated patients with ROC. Eligibility criteria: ROC, prior treatment with platinum- and taxan, ECOG status 0-2, organ function within normal range. Statistic: 2-Step-Design, in case of a positive first step (n=26): >2 response + < 6 events of PPE (CTC Grade III/IV), a total number of 60 patients must be recruited; power: 80%, p<0.05, based on a 10% reduction of PPE (95%CI).
Results: A total of 64 patients were recruited (10/2001-02/2004). 553 courses (median: 7, range: 1-35) were evaluable. Median age was 59 years (range, 38-81). Patients were generally heavily pretreated: Only 13 of the patients have been in second-line, most of the patients were in third- or fourth-line of chemotherapy. Heamatologic toxicity profile was favourable: only in three patients anaemia grade III and in one patient thrombocytopenia grade III was observed. Ten patients were in fifth-line. Overall, the treatment was well tolerated. 30 patients developed skin toxicities: 18 patients with grade I, 9 with grade II and only 3 patients with grade III. These side effects occurred after a median of 5 courses. Clinical responses were evaluable with radiologic measurements. Two patients achieved complete responses, further five patients achieved partial response and 13 stable disease and 24 progression disease as best response criteria. The progression-free survival for these heavily pretreated patients was median 4.3 months (range, 0.5-22.3 months) The overall survival was median 18.2 months (range, 1.4-34 months).
Conclusions: Based on our results the new biweekly schedule seems to be an effective and well tolerated regime for patients with heavily pretreated relapsed ovarian cancer.
