Paclitaxel and carboplatin vs gemcitabine and vinorelbine in patients with adeno- or undifferentiated carcinoma of unknown primary: a randomised prospective phase II trial
Research output: Contribution to journal › Research article › Contributed › peer-review
Contributors
- Department of internal Medicine I
- Westpfalz-Klinikum GmbH
- TUD Dresden University of Technology
- KEM | Evang. Kliniken Essen-Mitte
- Helios Hospital Group
- Technical University of Munich
- Krankenhaus Nordwest, Frankfurt am Main
- Leibniz University Hannover (LUH)
- University of Tübingen
- University of Regensburg
- University Hospital of Saarland
- Ludwigshafen Hospital
- Johannes Gutenberg University Mainz
- St. Bernward Hospital
Abstract
Platinum/taxane combinations are widely used in patients with carcinoma of unknown primary (CUP), yielding response rates of 30% and median overall survival of 9-11 months in selected patients. Yet these combinations have not been subject to a randomised trial to overcome selection bias, a major problem in CUP. We randomised 92 patients to either paclitaxel/carboplatin (arm A) or the non-platinum non-taxane regimen gemcitabine/vinorelbine (arm B). The primary endpoint was rate of practicability as defined: application of >or=2 cycles of therapy (1) with a maximal delay of 1 week (2) and survival of >or=8 months (3). Practicability was shown in 52.4% (95% CI 36-68%) in arm A and in 42.2% (95% CI 28-58%) in arm B, respectively. The median overall survival, 1-year survival -rate and response rate of patients treated in arm A was 11.0 months, 38, and 23.8%, arm B 7.0 months, 29, and 20%. In conclusion, the paclitaxel/carboplatin regimen showed clinically meaningful activity in this randomised trial (Clinical trial registration number 219, 'Deutsches KrebsStudienRegister', German Cancer Society.)
Details
Original language | English |
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Pages (from-to) | 44-49 |
Number of pages | 6 |
Journal | British Journal of Cancer |
Volume | 100 |
Issue number | 1 |
Publication status | Published - 13 Jan 2009 |
Peer-reviewed | Yes |
External IDs
Scopus | 58149263066 |
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PubMedCentral | PMC2634671 |
WOS | 000262267700008 |
PubMed | 19066607 |
ORCID | /0000-0002-9321-9911/work/142251934 |
Keywords
Sustainable Development Goals
Keywords
- Anti-neoplastic-combined chemotherapy protocols, clinical trial, phase II, Medical oncology, Neoplasms, Randomized controlled trial, Unknown primary