title: Efficacy and safety of vinorelbine-capecitabine oral metronomic combination in elderly metastatic breast cancer patients: VICTOR-1 study.
abstract: OBJECTIVE
  Elderly patients with metastatic breast cancer are expected to derive similar benefits from chemotherapy as younger patients, but are more likely to experience therapy-related toxicity. Data from the VICTOR-1 study showed that metronomic therapy with vinorelbine and capecitabine was effective and well tolerated in patients with metastatic breast cancer. This analysis determined the efficacy and safety of the metronomic combination of oral vinorelbine and capecitabine in a subgroup of VICTOR-1 study patients aged ≥70 years.
  
  
  METHODS
  Eighteen of the 32 patients enrolled in VICTOR-1 were aged ≥70 years. Objective response and clinical benefit rates were calculated and toxicity was determined using the NCI-CTCAE criteria.
  
  
  RESULTS
  All patients had at least 1 comorbidity (4 had 2 comorbidities), and 77.7% were taking concomitant medication. Eight patients (44%) had received ≥1 chemotherapy regimens for metastatic disease and most (78%) had ≥2 metastatic sites. Grade 1-2 adverse events occurred in 45.8% of cycles, whereas the incidence of grade 3 and grade 4 events was very low (1.5% and 0.7%, respectively). Median time to progression was 10.5 months (range 1-40). The objective response rate was 33% and the clinical benefit rate was 67%.
  
  
  CONCLUSIONS
  The all-oral metronomic combination of vinorelbine and capecitabine had an acceptable efficacy profile and appears to be better tolerated than standard treatment schedules in elderly metastatic breast cancer patients (age ≥70 years).
authors.affiliation:  Oncology Department, San Gerardo Hospital, Monza - Italy.
authors.forename: Marina E
authors.initials: ME
authors.lastname: Cazzaniga
authors.affiliation:  Oncology Unit, Mario Negri Institute, Milan - Italy.
authors.forename: Valter
authors.initials: V
authors.lastname: Torri
authors.affiliation:  Oncology Department, San Gerardo Hospital, Monza - Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Riva
authors.affiliation:  Oncology Unit, Mario Negri Institute, Milan - Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Porcu
authors.affiliation:  Oncology Department, San Gerardo Hospital, Monza - Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Cicchiello
authors.affiliation:  Oncology Department, San Gerardo Hospital, Monza - Italy.
authors.forename: Serena
authors.initials: S
authors.lastname: Capici
authors.affiliation:  Oncology Department, San Gerardo Hospital, Monza - Italy.
authors.forename: Diego
authors.initials: D
authors.lastname: Cortinovis
authors.affiliation:  Oncology Department, San Gerardo Hospital, Monza - Italy.
authors.forename: Nunzio
authors.initials: N
authors.lastname: Digiacomo
authors.affiliation:  Oncology Department, San Gerardo Hospital, Monza - Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Bidoli
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine / Q000008:administration & dosage; D005260:Female; D006801:Humans; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D000069287:Capecitabine; D000077235:Vinorelbine