title: Lung stereotactic body radiation therapy (SBRT) delivered over 4 or 11 days: a comparison of acute toxicity and quality of life.
abstract: OBJECTIVE
  The optimal duration over which lung SBRT should be delivered is unknown. We conducted a randomized pilot study in patients treated with four fractions of lung SBRT delivered over 4 or over 11 days.
  
  
  METHODS
  Patients with a peripheral solitary lung tumor (NSCLC or pulmonary metastasis) ≤ 5 cm were eligible. For NSCLC lung tumors ≤ 3 cm, a dose of 48 Gy in 4 fractions was used, otherwise 52 Gy in 4 fractions was delivered. Patients were randomized to receive treatment over 4 consecutive days or over 11 days. The primary end-point was acute grade ≥ 2 toxicity. Secondary end-points included quality of life (QOL) assessed using the EORTC QLQ-C30 and QLQ-LC13 questionnaires.
  
  
  RESULTS
  Fifty four patients were enrolled. More patients in the 11 day group had respiratory symptoms at baseline. 55.6% patients treated over 4 days and 33.3% of patients treated over 11 days experienced acute grade ≥ 2 toxicity (p=0.085). Dyspnea, fatigue and coughing domains were worse in the 11 day group at baseline. At 1 and 4 months, more patients in the 4 day group experienced a clinically meaningful worsening in the dyspnea QOL domain compared to the 11 day group (44.5% vs 15.4%, p=0.02; 38.5% vs 12.0%, p=0.03, respectively). However, raw QOL scores were not different at these time-points between treatment groups.
  
  
  CONCLUSIONS
  Grade 2 or higher acute toxicity was more common in the 4 day group, approaching statistical significance. More patients treated on 4 consecutive days reported a clinically meaningful increase in dyspnea, although interpretation of these results is challenging due to baseline imbalance between treatment groups. Larger studies are required to validate these results.
authors.affiliation: Centre for Cancer Research and Cell Biology, Queens University Belfast, United Kingdom.
authors.forename: Suneil
authors.initials: S
authors.lastname: Jain
authors.forename: Ian
authors.initials: I
authors.lastname: Poon
authors.forename: Hany
authors.initials: H
authors.lastname: Soliman
authors.forename: Brian
authors.initials: B
authors.lastname: Keller
authors.forename: Anthony
authors.initials: A
authors.lastname: Kim
authors.forename: Fiona
authors.initials: F
authors.lastname: Lochray
authors.forename: Latifa
authors.initials: L
authors.lastname: Yeung
authors.forename: Patrick
authors.initials: P
authors.lastname: Cheung
mesh_terms: D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D004307:Dose-Response Relationship, Radiation; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness / Q000473:pathology; D009367:Neoplasm Staging; D010865:Pilot Projects; D011183:Postoperative Complications / Q000453:epidemiology / Q000473:pathology / Q000503:physiopathology; D011788:Quality of Life; D011829:Radiation Dosage; D011832:Radiation Injuries / Q000453:epidemiology / Q000473:pathology* / Q000503:physiopathology; D016634:Radiosurgery / Q000009:adverse effects* / Q000379:methods; D018570:Risk Assessment; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
keywords: Acute toxicity; Lung cancer; Lung metastases; Quality of life; SABR; SBRT; Stereotactic