title: Bevacizumab + capecitabine as maintenance therapy after initial bevacizumab + XELOX treatment in previously untreated patients with metastatic colorectal cancer: phase III 'Stop and Go' study results--a Turkish Oncology Group Trial.
abstract: OBJECTIVE
  It was the aim of this study to evaluate maintenance therapy with bevacizumab + capecitabine following induction with bevacizumab + capecitabine + oxaliplatin (XELOX) versus bevacizumab + XELOX until progression as first-line therapy in metastatic colorectal cancer (mCRC).
  
  
  METHODS
  Patients received either bevacizumab (7.5 mg/kg) + XELOX (capecitabine 1,000 mg/m(2) twice daily on days 1-14 + oxaliplatin 130 mg/m(2) on day 1 every 3 weeks) until disease progression (arm A) or the same doses of bevacizumab + XELOX for 6 cycles followed by bevacizumab + capecitabine until disease progression (arm B). The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), objective response rate (ORR) and safety.
  
  
  RESULTS
  One hundred and twenty-three patients were randomized. Treatment compliance was similar in both groups. Median PFS was significantly longer for arm B than for arm A (11.0 vs. 8.3 months; p = 0.002). There was no significant difference between the two arms for ORR (66.7 vs. 59.0%; p = 0.861) or median OS (23.8 vs. 20.2 months; p = 0.100). Tolerability was acceptable in both treatment arms; the most frequent grade 3/4 treatment-related adverse events (arm B vs. arm A) were fatigue (6.6 vs. 16.1%), diarrhoea (3.3 vs. 11.3%), anorexia (3.3 vs. 11.3%), and neuropathy (1.6 vs. 8.1%).
  
  
  CONCLUSIONS
  Maintenance therapy with bevacizumab + capecitabine can be considered an appropriate option following induction bevacizumab + XELOX in patients with mCRC instead of continuation of bevacizumab + XELOX.
authors.affiliation: Institute of Cancer, Hacettepe University, Ankara, Turkey.
authors.forename: Suayib
authors.initials: S
authors.lastname: Yalcin
authors.forename: Ruchan
authors.initials: R
authors.lastname: Uslu
authors.forename: Faysal
authors.initials: F
authors.lastname: Dane
authors.forename: Ugur
authors.initials: U
authors.lastname: Yilmaz
authors.forename: Nurullah
authors.initials: N
authors.lastname: Zengin
authors.forename: Evin
authors.initials: E
authors.lastname: Buyukunal
authors.forename: Suleyman
authors.initials: S
authors.lastname: Buyukberber
authors.forename: Celalettin
authors.initials: C
authors.lastname: Camci
authors.forename: Orhan
authors.initials: O
authors.lastname: Sencan
authors.forename: Sadettin
authors.initials: S
authors.lastname: Kilickap
authors.forename: Fatih
authors.initials: F
authors.lastname: Ozdener
authors.forename: Duygu
authors.initials: D
authors.lastname: Cevik
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010071:Oxaloacetates
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D010071:Oxaloacetates; D003841:Deoxycytidine; D000068258:Bevacizumab; D000069287:Capecitabine; D005472:Fluorouracil