Paclitaxel and carboplatin vs gemcitabine and vinorelbine in patients with adeno- or undifferentiated carcinoma of unknown primary: a randomised prospective phase II trial
Publikation: Beitrag in Fachzeitschrift › Forschungsartikel › Beigetragen › Begutachtung
Beitragende
- Medizinische Klinik und Poliklinik I
- Westpfalz-Klinikum GmbH
- Technische Universität Dresden
- KEM | Evang. Kliniken Essen-Mitte gGmbH
- Helios Kliniken Gruppe
- Technische Universität München
- Krankenhaus Nordwest, Frankfurt am Main
- Leibniz Universität Hannover (LUH)
- Eberhard Karls Universität Tübingen
- Universität Regensburg
- Universitätsklinikum des Saarlandes
- Ludwigshafen Hospital
- Johannes Gutenberg-Universität Mainz
- St. Bernward Krankenhaus
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
Originalsprache | Englisch |
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Seiten (von - bis) | 44-49 |
Seitenumfang | 6 |
Fachzeitschrift | British Journal of Cancer |
Jahrgang | 100 |
Ausgabenummer | 1 |
Publikationsstatus | Veröffentlicht - 13 Jan. 2009 |
Peer-Review-Status | Ja |
Externe IDs
Scopus | 58149263066 |
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PubMedCentral | PMC2634671 |
WOS | 000262267700008 |
PubMed | 19066607 |
ORCID | /0000-0002-9321-9911/work/142251934 |
Schlagworte
Ziele für nachhaltige Entwicklung
Schlagwörter
- Anti-neoplastic-combined chemotherapy protocols, clinical trial, phase II, Medical oncology, Neoplasms, Randomized controlled trial, Unknown primary