title: Phase II study of carboplatin, docetaxel and bevacizumab for chemotherapy-naïve patients with advanced non-squamous non-small cell lung cancer.
abstract: OBJECTIVE
  To evaluate a 3-drug combination of carboplatin, docetaxel and bevacizumab as a front-line chemotherapy for patients with advanced non-squamous non-small cell carcinoma (NSCLC), a single arm phase II study was conducted.
  
  
  METHODS
  Patients with stage IIIB/IV or postoperative recurrent non-squamous NSCLC were treated with carboplatin (targeted area under the curve of 6 mg h/L), docetaxel (60 mg/m(2)), and bevacizumab (15 mg/kg) on day 1, repeated every 3 weeks for 4 to 6 cycles, followed by maintenance with bevacizumab every 3 weeks until disease progression or occurrence of predefined toxicity. The planned patient number was 40, and the primary endpoint was progression free survival (PFS) as assessed by independent reviewers.
  
  
  RESULTS
  One patient refused the treatment after enrollment; thus, 39 patients were treated and analyzed. The 3-drug therapy was delivered for a median of 4 cycles, and 54 % of the patients proceeded to the maintenance therapy for a median of 4 cycles. The overall response rate was 74.4 % (29/39), with a 95 % confidence interval (CI) of 60.0 to 88.7 %. The median PFS and overall survival (OS) were 6.2 months (95 % CI, 4.8-8.5 months) and 22.4 months (95 % CI, 11.3-26.2 months), respectively. Toxicities of grade 3 or higher included neutropenia in 71.8 %, febrile neutropenia in 23.1 %, and hypertension in 38.5 % of the patients, but they were transient and manageable.
  
  
  CONCLUSIONS
  The primary endpoint was met. The regimen yielded promising results with an excellent overall response rate, PFS, and OS for chemotherapy-naïve patients with advanced non-squamous NSCLC. Further studies are warranted.
authors.affiliation: Department of Medical Oncology, Graduate School of Medicine, Chiba University, 1-8-1, Inohana, Chuo-ku, Chiba, 260-8670, Japan, takiguchi@faculty.chiba-u.jp.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Takiguchi
authors.forename: Shunichiro
authors.initials: S
authors.lastname: Iwasawa
authors.forename: Koichi
authors.initials: K
authors.lastname: Minato
authors.forename: Yosuke
authors.initials: Y
authors.lastname: Miura
authors.forename: Akihiko
authors.initials: A
authors.lastname: Gemma
authors.forename: Rintaro
authors.initials: R
authors.lastname: Noro
authors.forename: Kozo
authors.initials: K
authors.lastname: Yoshimori
authors.forename: Masato
authors.initials: M
authors.lastname: Shingyoji
authors.forename: Mitsunori
authors.initials: M
authors.lastname: Hino
authors.forename: Masahiro
authors.initials: M
authors.lastname: Ando
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Okamoto
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D000068258:Bevacizumab; D016190:Carboplatin