title: Radical treatment of non-small-cell lung cancer patients with synchronous oligometastases: long-term results of a prospective phase II trial (Nct01282450).
abstract: BACKGROUND
  Stage IV non-small-cell lung cancer (NSCLC) patients with oligometastases (< 5 metastatic lesions) may experience long-term survival when all macroscopic tumor sites are treated radically, but no prospective data on NSCLCs with synchronous oligometastases are available.
  
  
  METHODS
  A prospective single-arm phase II trial was conducted. The main inclusion criteria were pathologically proven NSCLC stage IV with less than five metastases at primary diagnosis, amendable for radical local treatment (surgery or radiotherapy). The study is listed in clinicaltrials.gov, number NCT01282450.
  
  
  RESULTS
  Forty patients were enrolled, 39 of whom were evaluable (18 men, 21 women); mean age was 62.1 ± 9.2 years (range, 44-81). Twenty-nine (74%) had local stage III; 17 (44%) brain, seven (18%) bone, and four (10%) adrenal gland metastases. Thirty-five (87%) had a single metastatic lesion. Thirty-seven (95%) of the patients received chemotherapy as part of their primary treatment. Median overall survival (OS) was 13.5 months (95% confidence interval 7.6-19.4); 1-, 2-, and 3-year OS was 56.4%, 23.3%, and 17.5%, respectively. Median progression-free survival (PFS) was 12.1 months (95% confidence interval 9.6-14.3); 1-year PFS was 51.3%, and both 2- and 3-year PFS was 13.6%. Only two patients (5%) had a local recurrence. No patient or tumor parameter, including volume and F-deoxyglucose uptake was significantly correlated with OS or PFS. The treatment was well tolerated.
  
  
  CONCLUSIONS
  In this phase II study, long-term PFS was found in a subgroup of NSCLC patients with synchronous oligometastases when treated radically. Identification of this favorable subgroup before therapy is needed.
authors.affiliation: Department of Radiation Oncology (MAASTRO clinic), GROW-School for Oncology and Developmental Biology, University Medical Centre Maastricht, Maastricht, The Netherlands. dirk.deruysscher@uzleven.be
authors.forename: Dirk
authors.initials: D
authors.lastname: De Ruysscher
authors.forename: Rinus
authors.initials: R
authors.lastname: Wanders
authors.forename: Angela
authors.initials: A
authors.lastname: van Baardwijk
authors.forename: Anne-Marie C
authors.initials: AM
authors.lastname: Dingemans
authors.forename: Bart
authors.initials: B
authors.lastname: Reymen
authors.forename: Ruud
authors.initials: R
authors.lastname: Houben
authors.forename: Gerben
authors.initials: G
authors.lastname: Bootsma
authors.forename: Cordula
authors.initials: C
authors.lastname: Pitz
authors.forename: Linda
authors.initials: L
authors.lastname: van Eijsden
authors.forename: Wiel
authors.initials: W
authors.lastname: Geraedts
authors.forename: Brigitta G
authors.initials: BG
authors.lastname: Baumert
authors.forename: Philippe
authors.initials: P
authors.lastname: Lambin
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000556:secondary / Q000628:therapy; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018287:Carcinoma, Large Cell / Q000401:mortality / Q000556:secondary / Q000628:therapy; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000556:secondary / Q000628:therapy*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000556:secondary / Q000628:therapy; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000473:pathology / Q000628:therapy; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D016634:Radiosurgery; D012307:Risk Factors; D015996:Survival Rate; D013997:Time Factors