title: Phase II study of sunitinib as maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer.
abstract: This open-label, phase II study evaluated the antitumor activity and safety of sunitinib monotherapy as maintenance treatment following first-line chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Following treatment with standard doublet chemotherapy (paclitaxel and carboplatin), patients received oral sunitinib (starting dose 50mg/day) in 6-week cycles (Schedule 4/2: 4 weeks on treatment, 2 weeks off treatment) until disease progression, unacceptable toxicity or withdrawal of consent. The primary endpoint was probability of survival at 1 year ≥55%. Of 84 patients who received first-line chemotherapy, 66 (79%) received sunitinib maintenance therapy (median sunitinib cycles started: 2 [range 1-20]). Probability of survival at 1 year was 40.5% (95% confidence interval [CI]: 29.8, 51.0). Median overall survival was 10.4 months (95% CI: 8.0, 12.2). The objective response rate was 27.4% (95% CI: 18.2, 38.2). The most frequently reported all-causality adverse events of any grade during sunitinib maintenance therapy were fatigue/asthenia (55%), diarrhea (36%), and nausea (32%). These data suggest that maintenance therapy may have value in NSCLC, although the primary endpoint of the study was not met.
authors.affiliation: Centre François Baclesse, Caen, France.
authors.forename: Radj
authors.initials: R
authors.lastname: Gervais
authors.forename: John D
authors.initials: JD
authors.lastname: Hainsworth
authors.forename: Normand
authors.initials: N
authors.lastname: Blais
authors.forename: Benjamin
authors.initials: B
authors.lastname: Besse
authors.forename: Janessa
authors.initials: J
authors.lastname: Laskin
authors.forename: John T
authors.initials: JT
authors.lastname: Hamm
authors.forename: Allan
authors.initials: A
authors.lastname: Lipton
authors.forename: Kathy S
authors.initials: KS
authors.lastname: Albain
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Masters
authors.forename: Ronald B
authors.initials: RB
authors.lastname: Natale
authors.forename: Paulina
authors.initials: P
authors.lastname: Selaru
authors.forename: Sindy T
authors.initials: ST
authors.lastname: Kim
authors.forename: Richard C
authors.initials: RC
authors.lastname: Chao
authors.forename: Ray D
authors.initials: RD
authors.lastname: Page
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000503:physiopathology; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007211:Indoles / Q000008:administration & dosage* / Q000009:adverse effects; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000503:physiopathology; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011758:Pyrroles / Q000008:administration & dosage* / Q000009:adverse effects; D000077210:Sunitinib; D016019:Survival Analysis
chemical_list: D007211:Indoles; D011758:Pyrroles; D016190:Carboplatin; D017239:Paclitaxel; D000077210:Sunitinib