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

被引：50

作者：

Huebner, G. ^{[1
]}

Link, H. ^{[1
]}

Kohne, C. H. ^{[2
]}

Stahl, M. ^{[3
]}

Kretzschmar, A. ^{[4
]}

Steinbach, S. ^{[1
]}

Folprecht, G. ^{[2
]}

Bernhard, H. ^{[5
]}

Al-Batran, S. E. ^{[6
]}

Schoffski, P. ^{[7
]}

Burkart, C. ^{[8
]}

Kullmann, F. ^{[9
]}

Otremba, B.

Menges, M. ^{[10
]}

Hoffmann, M. ^{[11
]}

Kaiser, U. ^{[12
]}

Aldaoud, A.

Jahn, A. ^{[13
]}

机构：

[1] Westpfalz Klinikum, D-67655 Kaiserslautern, Germany

[2] Univ Hosp Carl Gustav Carus, D-01307 Dresden, Germany

[3] Kliniken Essen Mitte, D-45136 Essen, Germany

[4] Helios Klinikum Berlin Buch, D-13125 Berlin, Germany

[5] Univ Hosp Rechts Isar, D-81675 Munich, Germany

[6] Klinikum Frankfurt Nordwest, D-60488 Frankfurt, Germany

[7] Hannover Med Sch, D-30623 Hannover, Germany

[8] Eberhard Karls Univ Hosp, D-72076 Tubingen, Germany

[9] Univ Hosp, D-93042 Regensburg, Germany

[10] Saarland Univ Hosp, D-66421 Homburg, Germany

[11] Klinikum Stadt Ludwigshafen, D-67063 Ludwigshafen, Germany

[12] St Bernward Hosp, D-31334 Hildesheim, Germany

[13] Johannes Gutenberg Univ Mainz, D-55131 Mainz, Germany

来源：

BRITISH JOURNAL OF CANCER | 2009年 / 100卷 / 01期

关键词：

neoplasms; unknown primary; randomized controlled trial; clinical trial; phase II; medical oncology; anti-neoplastic-combined chemotherapy protocols; CANCER-RESEARCH-NETWORK; CELL LUNG-CANCER; PRIMARY SITE; PRIMARY TUMORS; CHEMOTHERAPY; EPIDEMIOLOGY; COMBINATION; CISPLATIN; ETOPOSIDE; DOCETAXEL;

D O I：

10.1038/sj.bjc.6604818

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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 >= 2 cycles of therapy ( 1) with a maximal delay of 1 week ( 2) and survival of >= 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.)

引用

页码：44 / 49

页数：6

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