title: Treatment of stage I lung cancer in high-risk and inoperable patients: comparison of prospective clinical trials using stereotactic body radiotherapy (RTOG 0236), sublobar resection (ACOSOG Z4032), and radiofrequency ablation (ACOSOG Z4033).
abstract: OBJECTIVE
  The purpose of the present study was to compare the selection criteria and short-term outcomes among 3 prospective clinical trials using stereotactic body radiotherapy (Radiation Therapy Oncology Group [RTOG] trial 0236), sublobar resection (American College of Surgeons Oncology Group [ACOSOG] trial Z4032), and radiofrequency ablation (ACOSOG trial Z4033).
  
  
  METHODS
  The selection criteria and outcomes were compared among RTOG 0236 (n = 55), ACOSOG Z4032 (n = 211), and ACOSOG Z4033 (n = 51). Age, Eastern Cooperative Oncology Group performance status, percentage of predicted forced expiratory volume in 1 second, and percentage of predicted carbon monoxide diffusing capacity of the lung were used to perform a propensity-matched analysis among patients with clinical stage 1A in RTOG 0236 and ACOSOG Z4032.
  
  
  RESULTS
  The patients in ACOSOG Z4033 undergoing radiofrequency ablation were older (75.6 ± 7.5 years) than those in RTOG 0236 (72.5 ± 8.8 years) and ACOSOG Z4032 (70.2 ± 8.5 years; P = .0003). The pretreatment percentage of predicted forced expiratory volume in 1 second was 61.3% ± 33.4% for RTOG 0236, 53.8% ± 19.6% for ACOSOG Z4032, and 48.8% ± 20.3% for ACOSOG Z4033 (P = .15). The pretreatment percentage of predicted carbon monoxide diffusing capacity of the lung was 61.6% ± 30.2% for RTOG 0236, 46.4% ± 15.6% for ACOSOG Z4032, and 43.7% ± 18.0% for ACOSOG Z4033 (P = .001). The overall 90-day mortality for stereotactic body radiotherapy, surgery, and radiofrequency ablation was 0%, 2.4% (5/211), and 2.0% (1/51), respectively (P = .5). Overall, the unadjusted 30-day grade 3+ adverse events were more common with surgery than with stereotactic body radiotherapy (28% vs 9.1%, P = .004), although no difference was between the 2 groups at 90 days. Among the patients with clinical stage IA in ACOSOG Z4032, 29.3% had a more advanced pathologic stage at surgery. A propensity-matched comparison showed no difference between stereotactic body radiotherapy and surgery for 30-day grade 3+ adverse events (odds ratio, 2.37; 95% confidence interval, 0.75-9.90; P = .18).
  
  
  CONCLUSIONS
  Among appropriately matched patients, no difference was seen in early morbidity between sublobar resection and stereotactic body radiotherapy. These results underscore the need for a randomized trial to delineate the relative survival benefit of each modality and to help stratify patients considered high risk.
authors.affiliation: Division of Thoracic Surgery, Washington University School of Medicine, St. Louis, MO 63110, USA. crabtreet@wustl.edu
authors.forename: Traves
authors.initials: T
authors.lastname: Crabtree
authors.forename: Varun
authors.initials: V
authors.lastname: Puri
authors.forename: Robert
authors.initials: R
authors.lastname: Timmerman
authors.forename: Hiran
authors.initials: H
authors.lastname: Fernando
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Bradley
authors.forename: Paul A
authors.initials: PA
authors.lastname: Decker
authors.forename: Rebecca
authors.initials: R
authors.lastname: Paulus
authors.forename: Joe B
authors.initials: JB
authors.lastname: Putnum
authors.forename: Damian E
authors.initials: DE
authors.lastname: Dupuy
authors.forename: Bryan
authors.initials: B
authors.lastname: Meyers
mesh_terms: D000368:Aged; D017115:Catheter Ablation / Q000379:methods* / Q000401:mortality; D002986:Clinical Trials as Topic; D003627:Data Interpretation, Statistical; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D008297:Male; D009367:Neoplasm Staging; D011013:Pneumonectomy / Q000379:methods*; D049268:Positron-Emission Tomography; D057216:Propensity Score; D011446:Prospective Studies; D016634:Radiosurgery / Q000379:methods* / Q000401:mortality; D012129:Respiratory Function Tests; D012189:Retrospective Studies; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome