PMID- 23100174
OWN - NLM
STAT- MEDLINE
DCOM- 20130226
LR  - 20201209
IS  - 1432-0843 (Electronic)
IS  - 0344-5704 (Linking)
VI  - 71
IP  - 1
DP  - 2013 Jan
TI  - XELOX and bevacizumab followed by single-agent bevacizumab as maintenance therapy 
      as first-line treatment in elderly patients with advanced colorectal cancer: the 
      boxe study.
PG  - 257-64
LID - 10.1007/s00280-012-2004-x [doi]
AB  - PURPOSE: The addition of bevacizumab to oxaliplatin-based chemotherapy 
      significantly improved progression-free survival (PFS) in patients with 
      metastatic colorectal cancer (CRC). An increased risk of arterial thromboembolic 
      events has been observed in some trials in older patients, and the potential 
      benefit of a maintenance therapy with bevacizumab alone has not been clearly 
      demonstrated. This phase II study was designed to evaluate the efficacy and 
      safety of XELOX (capecitabine plus oxaliplatin) plus bevacizumab followed by 
      bevacizumab alone in elderly patients with advanced CRC. METHODS: Treatment 
      consisted of bevacizumab 7.5 mg/kg and oxaliplatin 130 mg/m(2) on day 1, plus 
      capecitabine 1,000 mg/m(2) twice daily on days 1-14, every 3 weeks up to a 
      maximum of 8 cycles. Patients then received maintenance therapy consisting of 
      bevacizumab alone (7.5 mg/kg) once every 3 weeks up to disease progression. The 
      primary study end-points were safety and response rate. RESULTS: A total of 44 
      patients were recruited. In an intention-to-treat analysis, the overall response 
      rate was 52% [95% confidence interval (CI) 37 to 68%], with 86% of patients 
      achieving disease control. Median PFS and overall survival were 11.5 months (95% 
      CI 10.0-12.9 months) and 19.3 months (95% CI 16.5-22.1 months), respectively. In 
      all, 10 patients (23%) had grade 3/4 adverse events (AEs), the most common being 
      diarrhea (9%), neutropenia (7%), peripheral neuropathy (7%), and stomatitis (7%). 
      No patients died because of treatment-related AEs. The rate of 
      bevacizumab-related AEs (hypertension, thromboembolic events, and 
      gastrointestinal perforation) was consistent with that reported earlier in the 
      general CRC population. CONCLUSION: The combination of XELOX and bevacizumab is 
      effective and has a manageable tolerability profile when administered to elderly 
      patients with advanced CRC. Maintenance therapy with single-agent bevacizumab may 
      be considered to extend PFS in this setting of patients.
FAU - Rosati, Gerardo
AU  - Rosati G
AD  - Medical Oncology Unit, S. Carlo Hospital, Potenza, Italy. oncogerry@yahoo.it
FAU - Avallone, Antonio
AU  - Avallone A
FAU - Aprile, Giuseppe
AU  - Aprile G
FAU - Butera, Alfredo
AU  - Butera A
FAU - Reggiardo, Giorgio
AU  - Reggiardo G
FAU - Bilancia, Domenico
AU  - Bilancia D
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20121026
PL  - Germany
TA  - Cancer Chemother Pharmacol
JT  - Cancer chemotherapy and pharmacology
JID - 7806519
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Oxaloacetates)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 2S9ZZM9Q9V (Bevacizumab)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - U3P01618RT (Fluorouracil)
RN  - XELOX
SB  - IM
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal, Humanized/administration & dosage
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Bevacizumab
MH  - Capecitabine
MH  - Colorectal Neoplasms/*drug therapy/pathology
MH  - Deoxycytidine/administration & dosage/adverse effects/analogs & 
      derivatives/therapeutic use
MH  - Disease-Free Survival
MH  - Drug Administration Schedule
MH  - Fluorouracil/administration & dosage/adverse effects/analogs & 
      derivatives/therapeutic use
MH  - Humans
MH  - Male
MH  - Oxaloacetates
MH  - Survival Rate
MH  - Treatment Outcome
EDAT- 2012/10/27 06:00
MHDA- 2013/02/27 06:00
CRDT- 2012/10/27 06:00
PHST- 2012/07/28 00:00 [received]
PHST- 2012/10/10 00:00 [accepted]
PHST- 2012/10/27 06:00 [entrez]
PHST- 2012/10/27 06:00 [pubmed]
PHST- 2013/02/27 06:00 [medline]
AID - 10.1007/s00280-012-2004-x [doi]
PST - ppublish
SO  - Cancer Chemother Pharmacol. 2013 Jan;71(1):257-64. doi: 
      10.1007/s00280-012-2004-x. Epub 2012 Oct 26.