title: A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Combination of Bevacizumab (NSC-704865) in Patients With Inoperable Locally Advanced Stage III Non-Small-Cell Lung Cancer: SWOG S0533.
abstract: BACKGROUND
  The aim of this trial was to determine feasibility of incorporating bevacizumab (B) into concurrent chemoradiotherapy (CRT) for locally advanced non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Patients with unresectable stage III NSCLC, performance status of 0 to 1, and adequate organ function were accrued in 2 strata, low- and high-risk (squamous histology, hemoptysis, tumor with cavitation and/or adjacent to a major vessel). Cohort 1 patients received cisplatin 50 mg/m(2) days (d) 1 and 8, etoposide 50 mg/m(2) (d 1-5) for 2 cycles concurrent with radiotherapy (64.8 Gy) followed by docetaxel (D) 75 mg/m(2) and B 15 mg/kg for 3 cycles. If safety was established, then accrual would continue to cohort 2 (B, d 15, 36, 57) and then subsequently to cohort 3 (B, d 1, 22, 43).
  
  
  RESULTS
  Twenty-nine patients (17 low- and 12 high-risk) registered to cohort 1. Twenty-six patients (including 4 squamous, 1 adenosquamous) were assessable. Twenty-five completed CRT. Grade 3/4 toxicities during CRT included acceptable rates of hematologic toxicity, esophagitis, and pneumonitis. Of 21 assessable for safety with D/B consolidation, major adverse events were pneumonitis (2 Grade 3) and 2 episodes of fatal hemoptysis in the high-risk group, resulting in closure of this stratum. The low-risk stratum subsequently closed because of slow accrual. Median overall survival was 46 months for low-risk and 17 months for high-risk strata.
  
  
  CONCLUSIONS
  Bevacizumab was not safely integrated into CRT for stage III NSCLC in patients considered at high risk for hemoptysis. In lower risk patients, data are insufficient to determine safety or efficacy.
authors.affiliation: Wayne State University/Karmanos Cancer Institute, Detroit, MI. Electronic address: wozniakt@karmanos.org.
authors.forename: Antoinette J
authors.initials: AJ
authors.lastname: Wozniak
authors.affiliation: SWOG Statistical Center, Seattle, WA.
authors.forename: James
authors.initials: J
authors.lastname: Moon
authors.affiliation: Oregon Health and Sciences University/Knight Cancer Institute, Portland, OR.
authors.forename: Charles R
authors.initials: CR
authors.lastname: Thomas
authors.affiliation: University of California at Davis, Sacramento, CA.
authors.forename: Karen
authors.initials: K
authors.lastname: Kelly
authors.affiliation: University of California at Davis, Sacramento, CA.
authors.forename: Philip C
authors.initials: PC
authors.lastname: Mack
authors.affiliation: University of Colorado School of Medicine, Aurora, CO.
authors.forename: Laurie E
authors.initials: LE
authors.lastname: Gaspar
authors.affiliation: University of Colorado School of Medicine, Aurora, CO.
authors.forename: David
authors.initials: D
authors.lastname: Raben
authors.affiliation: Quality Assurance Review Center, Lincoln, RI.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Fitzgerald
authors.affiliation: University of Rochester/James P. Wilmot Cancer Center, Rochester, NY.
authors.forename: Kishan J
authors.initials: KJ
authors.lastname: Pandya
authors.affiliation: University of California at Davis, Sacramento, CA.
authors.forename: David R
authors.initials: DR
authors.lastname: Gandara
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage; D015331:Cohort Studies; D003131:Combined Modality Therapy; D000077143:Docetaxel; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010865:Pilot Projects; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D000068258:Bevacizumab; D005047:Etoposide; D002945:Cisplatin
keywords: Bevacizumab; Cisplatin/etoposide; Concurrent chemoradiotherapy; Locally advanced NSCLC; Non–small-cell lung cancer