title: First-line XELOX plus bevacizumab followed by XELOX plus bevacizumab or single-agent bevacizumab as maintenance therapy in patients with metastatic colorectal cancer: the phase III MACRO TTD study.
abstract: OBJECTIVE
  The aim of this phase III trial was to compare the efficacy and safety of bevacizumab alone with those of bevacizumab and capecitabine plus oxaliplatin (XELOX) as maintenance treatment following induction chemotherapy with XELOX plus bevacizumab in the first-line treatment of patients with metastatic colorectal cancer (mCRC).
  
  
  METHODS
  Patients were randomly assigned to receive six cycles of bevacizumab, capecitabine, and oxaliplatin every 3 weeks followed by XELOX plus bevacizumab or bevacizumab alone until progression. The primary endpoint was the progression-free survival (PFS) interval; secondary endpoints were the overall survival (OS) time, objective response rate (RR), time to response, duration of response, and safety.
  
  
  RESULTS
  The intent-to-treat population comprised 480 patients (XELOX plus bevacizumab, n = 239; bevacizumab, n = 241); there were no significant differences in baseline characteristics. The median follow-up was 29.0 months (range, 0-53.2 months). There were no statistically significant differences in the median PFS or OS times or in the RR between the two arms. The most common grade 3 or 4 toxicities in the XELOX plus bevacizumab versus bevacizumab arms were diarrhea, hand-foot syndrome, and neuropathy.
  
  
  CONCLUSIONS
  Although the noninferiority of bevacizumab versus XELOX plus bevacizumab cannot be confirmed, we can reliably exclude a median PFS detriment >3 weeks. This study suggests that maintenance therapy with single-agent bevacizumab may be an appropriate option following induction XELOX plus bevacizumab in mCRC patients.
authors.affiliation: Hospital Clínico San Carlos, Prof. Martín Lagos, 28040, Madrid, Spain. ediazrubio.hcsc@salud.madrid.org
authors.forename: Eduardo
authors.initials: E
authors.lastname: Díaz-Rubio
authors.forename: Auxiliadora
authors.initials: A
authors.lastname: Gómez-España
authors.forename: Bartomeu
authors.initials: B
authors.lastname: Massutí
authors.forename: Javier
authors.initials: J
authors.lastname: Sastre
authors.forename: Albert
authors.initials: A
authors.lastname: Abad
authors.forename: Manuel
authors.initials: M
authors.lastname: Valladares
authors.forename: Fernando
authors.initials: F
authors.lastname: Rivera
authors.forename: Maria J
authors.initials: MJ
authors.lastname: Safont
authors.forename: Purificación
authors.initials: P
authors.lastname: Martínez de Prado
authors.forename: Manuel
authors.initials: M
authors.lastname: Gallén
authors.forename: Encarnación
authors.initials: E
authors.lastname: González
authors.forename: Eugenio
authors.initials: E
authors.lastname: Marcuello
authors.forename: Manuel
authors.initials: M
authors.lastname: Benavides
authors.forename: Carlos
authors.initials: C
authors.lastname: Fernández-Martos
authors.forename: Ferrán
authors.initials: F
authors.lastname: Losa
authors.forename: Pilar
authors.initials: P
authors.lastname: Escudero
authors.forename: Antonio
authors.initials: A
authors.lastname: Arrivi
authors.forename: Andrés
authors.initials: A
authors.lastname: Cervantes
authors.forename: Rosario
authors.initials: R
authors.lastname: Dueñas
authors.forename: Amelia
authors.initials: A
authors.lastname: López-Ladrón
authors.forename: Adelaida
authors.initials: A
authors.lastname: Lacasta
authors.forename: Marta
authors.initials: M
authors.lastname: Llanos
authors.forename: Jose M
authors.initials: JM
authors.lastname: Tabernero
authors.forename: Antonio
authors.initials: A
authors.lastname: Antón
authors.forename: Enrique
authors.initials: E
authors.lastname: Aranda
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D000068258:Bevacizumab; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D060828:Induction Chemotherapy; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010071:Oxaloacetates; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; D010071:Oxaloacetates; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000068258:Bevacizumab; D000069287:Capecitabine; D005472:Fluorouracil