Abstract
Purpose
Pegylated liposomal doxorubicin (PLD, CAELYX®) has demonstrated activity in several phase-III trials and has been approved for the therapy of relapsed ovarian cancer after platinum treatment. Aim of this observational study was to analyze the efficacy and toxicity profile of PLD under routine clinical conditions and without the general restrictions of defined inclusion and exclusion criteria of clinical trials.
Methods
Between 2003 and 2005, a total of 190 patients with relapsed ovarian cancer were enrolled. 183 patients were available for evaluation; dose-intensity, modifications, treatment duration, toxicities and response were systematically analyzed.
Results
The median patient age was 62 years (range 23–86 years). 45.4% of the patients received PLD as second-line therapy and a median of four courses per patient were administered. The median dose of PLD was 40 mg/m2, most frequently used every 4 weeks (68.8%). Grade 3 Leucopenia (1.6%) and grade 3 and 4 thrombocytopenia (0.5%) were the most frequent hematological toxicities. The most frequent non-hematological toxicities were skin toxicity, pain and nausea, which were observed in 38.8, 41 and 45.9% of the patients, respectively. Twenty-seven percent of the patients showed a response to therapy with 6.9% achieving complete remission and 20.1% achieving partial remission. 37.7% achieved a stable disease. The median duration of response for all patients was 4.8 months (range 0–51.8 months). Median progression-free interval and overall survival were 5.8 months (95% CI 5.1–6.6 months) and 16.6 months (95% CI 13.9–22.6 months), respectively.
Conclusions
PLD is safe and effective in patients with relapsed ovarian cancer, even after numerous previous treatment regimens. A dose of 40 mg/m2 every 28 days seems to be an effective and well-tolerated therapeutic option in advanced ovarian cancer with a low incidence of hematological toxicities and acceptable non-hematological toxicities.
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Abbreviations
- BfArM:
-
German Federal Institute for Drugs and Medical Devices
- CI:
-
Confidence interval
- CR:
-
Complete remission
- CTCAE:
-
Common Terminology Criteria for Adverse Events
- ECOG:
-
Eastern Cooperative Oncology Group
- nd:
-
Not determined
- NOGGO:
-
North-Eastern German Society of Gynecological Oncology
- PD:
-
Progressive disease
- PLD:
-
Pegylated liposomal doxorubicin
- PPE:
-
Palmar-plantar erythrodysesthesia
- PR:
-
Partial remission
- SAE:
-
Serious adverse events
- SD:
-
Stable disease
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Acknowledgments
The authors gratefully acknowledge all of the many patients and their families, as well as clinical investigators and their study center trial facility staff who supported this trial. Without their enthusiastic collaboration this work would not have been possible. Furthermore, we would like to thank the following institutions for their contributions to this trial: Medical Practice Dr. Prechtl (München), Medical Practice Dr. Neise (Krefeld), Medical Practice Dr. Nusch (Velbert), Medical Practice Dr. Kurbacher (Bonn), Medical Practice Dr. Göhler (Dresden), Medical Practice Dr. Lerchenmüller (Münster), Medical Practice Dr. Reschke (Oldenburg), Department of Gynecology and Obstetrics—Hospital Augsburg Prof. Wischnik, Medical Practice Dr. Fett (Wuppertal), Medical Practice Dr. Selbach (Duisburg), Medical Practice Dr. Bittrich (Erfurt), Medical Practice Dr. Hempel (Rehling), Department of Gynecology and Obstetrics—Hospital Heidelberg Prof. Bastert, Medical Practice Dr. Busch (Mühlhausen), Medical Practice Dr. Steffen (Gera), Medical Practice Dr. Rohrberg (Halle), Medical Practice Dr. Kasper (Hof), Department of Gynecology and Obstetrics—Hospital Krefeld Prof. Baltzer, Medical Practice Dr. Hälbig (Eisenach), Medical Practice Dr. Wiegand (Moers), Medical Practice Dr. Mainz (Würselen), Medical Practice Dr. Schardt Gelsenkirchen, Medical Practice Dr. Tessen Goslar, Medical Practice Dr. Heinrich (Fürstenwalde), Medical Practice Dr. Mittermüller (Germering), Medical Practice Dr. Schick (München), Medical Practice Dr.Wierick (Weißkollm), Medical Practice Dr. Blumenstengel (Eisenach), Medical Practice Dr. Perker (Weilheim), Medical Practice Dr. Stauch (Kronach), Medical Practice Dr. Schneider (Neusäß), Medical Practice Dr. Tummes (Aachen), Medical Practice Dr. Weinberg (Aachen), Medical Practice Dr. Schlag (Würzburg), Medical Practice Dr. Schwindt (Bonn).
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Sehouli, J., Camara, O., Schmidt, M. et al. Pegylated liposomal doxorubicin (CAELYX®) in patients with advanced ovarian cancer: results of a German multicenter observational study. Cancer Chemother Pharmacol 64, 585–591 (2009). https://doi.org/10.1007/s00280-008-0909-1
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DOI: https://doi.org/10.1007/s00280-008-0909-1