title: Concomitant treatment of brain metastasis with whole brain radiotherapy [WBRT] and temozolomide [TMZ] is active and improves quality of life.
abstract: BACKGROUND
  Brain metastases (BM) represent one of the most frequent complications related to cancer, and their treatment continues to evolve. We have evaluated the activity, toxicity and the impact on Quality of Life (QoL) of a concomitant treatment with whole brain radiotherapy (WBRT) and Temozolomide (TMZ) in patients with brain metastases from solid tumors in a prospective Simon two stage study.
  
  
  METHODS
  Fifty-nine patients were enrolled and received 30 Gy WBRT with concomitant TMZ (75 mg/m2/day) for ten days, and subsequently TMZ (150 mg/m2/day) for up to six cycles. The primary end points were clinical symptoms and radiologic response.
  
  
  RESULTS
  Five patients had a complete response, 21 patients had a partial response, while 18 patients had stable disease. The overall response rate (45%) exceeded the target activity per study design. The median time to progression was 9 months. Median overall survival was 13 months. The most frequent toxicities included grade 3 neutropenia (15%) and anemia (13%), and only one patient developed a grade 4 thrombocytopenia. Age, Karnofsky performance status, presence of extracranial metastases and the recursive partitioning analysis (RPA) were found to be predictive factors for response in patients. Overall survival (OS) and progression-free survival (PFS) were dependent on age and on the RPA class.
  
  
  CONCLUSIONS
  We conclude that this treatment is well tolerated, with an encouraging objective response rate, and a significant improvement in quality of life (p < 0.0001) demonstrated by FACT-G analysis. All patients answered the questionnaires and described themselves as 'independent' and able to act on their own initiatives. Our study found a high level of satisfaction for QoL, this provides useful information to share with patients in discussions regarding chemotherapy treatment of these lesions.
authors.affiliation: Oncology Department, S. Giovanni di Dio Hospital, ASL Napoli3 Via Giovanni XXIII 80028 Frattaminore, Naples, Italy. lelloaddeo@alice.it
authors.forename: Raffaele
authors.initials: R
authors.lastname: Addeo
authors.forename: Michele
authors.initials: M
authors.lastname: Caraglia
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Faiola
authors.forename: Elena
authors.initials: E
authors.lastname: Capasso
authors.forename: Bruno
authors.initials: B
authors.lastname: Vincenzi
authors.forename: Liliana
authors.initials: L
authors.lastname: Montella
authors.forename: Rosario
authors.initials: R
authors.lastname: Guarrasi
authors.forename: Luigi
authors.initials: L
authors.lastname: Caserta
authors.forename: Salvatore
authors.initials: S
authors.lastname: Del Prete
mesh_terms: D000368:Aged; D001921:Brain / Q000528:radiation effects; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy* / Q000556:secondary; D003131:Combined Modality Therapy; D016371:Cranial Irradiation; D003606:Dacarbazine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D015996:Survival Rate; D000077204:Temozolomide
chemical_list: D003606:Dacarbazine; D000077204:Temozolomide