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Clinical Trial
. 2009 Jan 13;100(1):44-9.
doi: 10.1038/sj.bjc.6604818. Epub 2008 Dec 9.

Paclitaxel and carboplatin vs gemcitabine and vinorelbine in patients with adeno- or undifferentiated carcinoma of unknown primary: a randomised prospective phase II trial

G Huebner  1 , H Link, C H Kohne, M Stahl, A Kretzschmar, S Steinbach, G Folprecht, H Bernhard, S E Al-Batran, P Schoffski, C Burkart, F Kullmann, B Otremba, M Menges, M Hoffmann, U Kaiser, A Aldaoud, A Jahn; German CUP Study Group
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Clinical Trial

Paclitaxel and carboplatin vs gemcitabine and vinorelbine in patients with adeno- or undifferentiated carcinoma of unknown primary: a randomised prospective phase II trial

G Huebner et al. Br J Cancer. .

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.)

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Figures

Figure 1
Figure 1
Trial profile, CONSORT diagram.
Figure 2
Figure 2
Overall survival.
Figure 3
Figure 3
Progression-free survival.
See this image and copyright information in PMC

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