title: Primary chemotherapy for newly diagnosed nonsmall cell lung cancer patients with synchronous brain metastases compared with whole-brain radiotherapy administered first : result of a randomized pilot study.
abstract: BACKGROUND
  This randomized pilot trial investigated whether primary chemotherapy was feasible in terms of efficacy, survival, toxicity profile, and quality of life compared with whole-brain radiotherapy (WBRT) given first in chemotherapy-naive patients nonsmall cell lung cancer (NSCLC) with synchronous brain metastasis when neurologic symptoms or signs are absent or controlled by supportive care.
  
  
  METHODS
  After stratification by Eastern Cooperative Oncology Group performance status (ECOG PS) (0-1 vs 2), the number of intracranial metastases (<3 vs 3< or =), and the presence of extrathoracic extracranial metastasis, eligible patients were randomized to the primary chemotherapy arm or the WBRT-first arm. World Health Organization (WHO) response criteria, National Cancer Institute Common Toxicity Criteria (NCI-CTC; version 2.0), and the European Organization for Research and Treatment of Cancer (EORTC) C-30/LC-13 questionnaire were used.
  
  
  RESULTS
  A total of 48 patients were enrolled between August 2002 and November 2005. The response rate of chemotherapy and survival outcomes in the primary chemotherapy arm were not statistically different from those in the WBRT-first arm (overall response rate, 28.0% vs 39.1%; progression-free survival, 3.6 months vs 4.4 months; overall survival, 9.1 months vs 9.9 months). There was close correlation noted between intracranial and extracranial tumor responses (k = 0.82). However, in the WBRT-first arm, grade 3 of 4 neutropenia was more frequent (79% vs 40%) during chemotherapy and 4 patients (17.4%) did not receive further chemotherapy because of early death or poor performance after WBRT. Cognitive function appeared to deteriorate during primary chemotherapy, but was also found to deteriorate after WBRT.
  
  
  CONCLUSIONS
  Primary chemotherapy is more feasible and can be an appropriate option for patients with synchronous brain metastasis when neurologic symptoms or signs are absent or controlled. The role and timing of WBRT should be defined in further studies in this clinical setting.
authors.affiliation: Research Institute and Hospital, National Cancer Center, Goyang, Gyeonggi, Korea. jslee@ncc.re.kr
authors.forename: Dae Ho
authors.initials: DH
authors.lastname: Lee
authors.forename: Ji-Youn
authors.initials: JY
authors.lastname: Han
authors.forename: Heung Tae
authors.initials: HT
authors.lastname: Kim
authors.forename: Sung Jin
authors.initials: SJ
authors.lastname: Yoon
authors.forename: Hong Ryull
authors.initials: HR
authors.lastname: Pyo
authors.forename: Kwan Ho
authors.initials: KH
authors.lastname: Cho
authors.forename: Sang-Hoon
authors.initials: SH
authors.lastname: Shin
authors.forename: Heon
authors.initials: H
authors.lastname: Yoo
authors.forename: Seung-Hoon
authors.initials: SH
authors.lastname: Lee
authors.forename: Jin Soo
authors.initials: JS
authors.lastname: Lee
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000532:radiotherapy / Q000556:secondary*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003131:Combined Modality Therapy; D016371:Cranial Irradiation; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011788:Quality of Life; D016019:Survival Analysis