title: Paclitaxel and carboplatin vs gemcitabine and vinorelbine in patients with adeno- or undifferentiated carcinoma of unknown primary: a randomised prospective phase II trial.
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.)
authors.affiliation: Westpfalz-Klinikum, Hellmut-Hartert-Str 1, 67655 Kaiserslautern, Germany. lghuebner@web.de
authors.forename: G
authors.initials: G
authors.lastname: Huebner
authors.forename: H
authors.initials: H
authors.lastname: Link
authors.forename: C H
authors.initials: CH
authors.lastname: Kohne
authors.forename: M
authors.initials: M
authors.lastname: Stahl
authors.forename: A
authors.initials: A
authors.lastname: Kretzschmar
authors.forename: S
authors.initials: S
authors.lastname: Steinbach
authors.forename: G
authors.initials: G
authors.lastname: Folprecht
authors.forename: H
authors.initials: H
authors.lastname: Bernhard
authors.forename: S E
authors.initials: SE
authors.lastname: Al-Batran
authors.forename: P
authors.initials: P
authors.lastname: Schoffski
authors.forename: C
authors.initials: C
authors.lastname: Burkart
authors.forename: F
authors.initials: F
authors.lastname: Kullmann
authors.forename: B
authors.initials: B
authors.lastname: Otremba
authors.forename: M
authors.initials: M
authors.lastname: Menges
authors.forename: M
authors.initials: M
authors.lastname: Hoffmann
authors.forename: U
authors.initials: U
authors.lastname: Kaiser
authors.forename: A
authors.initials: A
authors.lastname: Aldaoud
authors.forename: A
authors.initials: A
authors.lastname: Jahn
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D066246:ErbB Receptors / Q000037:antagonists & inhibitors; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009382:Neoplasms, Unknown Primary / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D016016:Proportional Hazards Models; D011446:Prospective Studies; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D014747:Vinblastine; D016190:Carboplatin; D066246:ErbB Receptors; D017239:Paclitaxel; D000077235:Vinorelbine; D000093542:Gemcitabine