Reference : Randomized multicenter phase II study of larotaxel (XRP9881) in combination with cisp...
Scientific journals : Article
Human health sciences : Cardiovascular & respiratory systems
Human health sciences : Oncology
Randomized multicenter phase II study of larotaxel (XRP9881) in combination with cisplatin or gemcitabine as first-line chemotherapy in nonirradiable stage IIIB or stage IV non-small cell lung cancer.
Zatloukal, Petr [> > > >]
Gervais, Radj [> > > >]
Vansteenkiste, Johan [> > > >]
Bosquee, Léon mailto [Centre Hospitalier Universitaire de Liège - CHU > > Pneumologie-Allergologie >]
Sessa, Christiana [> > > >]
Brain, Etienne [> > > >]
Dansin, Eric [> > > >]
Urban, Thierry [> > > >]
Dohollou, Nadine [> > > >]
Besenval, Michele [> > > >]
Quoix, Elisabeth [> > > >]
Journal of Thoracic Oncology
Lippincott Williams & Wilkins
Yes (verified by ORBi)
[en] Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Carcinoma, Non-Small-Cell Lung/drug therapy/pathology ; Cisplatin/administration & dosage ; Deoxycytidine/administration & dosage/analogs & derivatives ; Female ; Humans ; Lung Neoplasms/drug therapy/pathology ; Male ; Maximum Tolerated Dose ; Middle Aged ; Neoplasm Staging ; Prognosis ; Survival Rate ; Taxoids/administration & dosage
[en] INTRODUCTION: This randomized phase II study investigated the efficacy and safety of a new taxane, larotaxel (XRP9881), in combination with either cisplatin or gemcitabine in the first-line treatment of patients with nonirradiable stage IIIB or stage IV non-small cell lung cancer to select the combination having the most promising antitumor activity. METHODS: Patients received either larotaxel (50 mg/m) as a 1-hour infusion, followed by a 1-hour infusion of cisplatin (75 mg/m), every 3 weeks (arm A), or gemcitabine (800 mg/m) as a 30 minute infusion, on days 1 and 8, and larotaxel (60 mg/m) as a 1-hour infusion, on day 8 (following gemcitabine), every 3 weeks (arm B). The primary end point was the objective response rate (per-protocol population). RESULTS: Thirty-two patients were randomized to arm A and 30 to arm B. The response rate was higher in arm A compared with arm B in both the per-protocol (26.7% versus 18.2%) and intention-to-treat (28.1% versus 13.3%) populations. In the intention-to-treat population, median progression-free survival for arm A versus arm B was 4.7 versus 3.3 months and median overall survival was 8.6 versus 7.3 months, respectively. Fifty percent of patients in arm A and 66.7% in arm B experienced at least one National Cancer Institute common toxicity criteria grade 3/4 adverse event and grade 3/4 neutropenia was observed in 46.9% and 41.4% of patients, respectively. CONCLUSIONS: Both larotaxel combinations were effective and manageable, however all measured efficacy parameters (response rate, progression free survival, and survival) seemed to favor the combination with cisplatin.

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