Nadia Harbeck, Steffen Saupe, Elke Jäger, Marcus Schmidt, Rolf Kreienberg, Lothar Müller, Burkhard Otremba, Dirk Waldenmaier, Julia Dorn, Mathias Warm, Michael Scholz, Michael Untch, Maike de Wit, Jana Barinoff, Hans-Joachim Lück, Philipp Harter, Doris Augustin, Paul Harnett, Matthias Wilhelm Beckmann, Salah-Eddin al- Batran
- Purpose: The PELICAN trial evaluates for the first time efficacy and safety of pegylated liposomal doxorubicin (PLD) versus capecitabine as first-line treatment of metastatic breast cancer (MBC).
Methods: This randomized, phase III, open-label, multicenter trial enrolled first-line MBC patients who were ineligible for endocrine or trastuzumab therapy. Cumulative adjuvant anthracyclines of 360 mg/m2 doxorubicin or equivalent were allowed. Left ventricular ejection fraction of >50 % was required. Patients received PLD 50 mg/m2 every 28 days or capecitabine 1250 mg/m2 twice daily for 14 days every 21 days. The primary endpoint was time-to-disease progression (TTP).
Results: 210 patients were randomized (n = 105, PLD and n = 105, capecitabine). Adjuvant anthracyclines were given to 37 % (PLD) and 36 % (capecitabine) of patients. No significant difference was observed in TTP [HR = 1.21 (95 % confidence interval, 0.838–1.750)]. Median TTP was 6.0 months for both PLD and capecitabine. Comparing patients with or without prior anthracyclines, no significant difference in TTP was observed in the PLD arm (log-rank P = 0.64). For PLD versus capecitabine, respectively, overall survival (median, 23.3 months vs. 26.8 months) and time-to-treatment failure (median, 4.6 months vs. 3.7 months) were not statistically significantly different. Compared to PLD, patients on capecitabine experienced more serious adverse events (P = 0.015) and more cardiac events among patients who had prior anthracycline exposure (18 vs. 8 %; P = 0.31).
Conclusion: Both PLD and capecitabine are effective first-line agents for MBC.
MetadatenAuthor: | Nadia HarbeckORCiDGND, Steffen Saupe, Elke Jäger, Marcus Schmidt, Rolf Kreienberg, Lothar Müller, Burkhard Otremba, Dirk Waldenmaier, Julia Dorn, Mathias Warm, Michael Scholz, Michael UntchORCiDGND, Maike de Wit, Jana Barinoff, Hans-Joachim LückORCiDGND, Philipp HarterORCiDGND, Doris Augustin, Paul Harnett, Matthias Wilhelm BeckmannORCiDGND, Salah-Eddin al- BatranORCiDGND |
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URN: | urn:nbn:de:hebis:30:3-452287 |
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DOI: | https://doi.org/10.1007/s10549-016-4033-3 |
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ISSN: | 0167-6806 |
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ISSN: | 1573-7217 |
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Pubmed Id: | https://pubmed.ncbi.nlm.nih.gov/27798749 |
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Parent Title (English): | Breast cancer research and treatment |
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Publisher: | Springer Science + Business Media B.V. |
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Place of publication: | Dordrecht [u. a.] |
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Document Type: | Article |
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Language: | English |
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Year of Completion: | 2016 |
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Date of first Publication: | 2016/10/31 |
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Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
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Creating Corporation: | PELICAN Investigators |
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Release Date: | 2017/12/12 |
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Tag: | Capecitabine; Metastatic breast cancer; PELICAN; Pegylated liposomal doxorubicin |
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Volume: | 161 |
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Issue: | 1 |
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Page Number: | 10 |
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First Page: | 63 |
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Last Page: | 72 |
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Note: | Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://crea tivecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
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HeBIS-PPN: | 428681921 |
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Institutes: | Medizin / Medizin |
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Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Sammlungen: | Universitätspublikationen |
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Licence (German): | Creative Commons - Namensnennung 4.0 |
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