PMID- 33259244
OWN - NLM
STAT- MEDLINE
DCOM- 20210818
LR  - 20210818
IS  - 1651-226X (Electronic)
IS  - 0284-186X (Linking)
VI  - 60
IP  - 2
DP  - 2021 Feb
TI  - Metronomic treatment of vinorelbine with oral capecitabine is tolerable in the 
      randomized Phase 2 study XeNa including patients with HER2 non-amplified 
      metastatic breast cancer.
PG  - 157-164
LID - 10.1080/0284186X.2020.1851045 [doi]
AB  - BACKGROUND: Metronomic treatment is hypothesized to be less toxic and more 
      effective as compared to standard maximal tolerable dosing treatment in 
      metastatic cancer disease. MATERIAL AND METHODS: We tested the metronomic 
      treatment principle with vinorelbine in a randomized phase 2 setting combined 
      with standard capecitabine treatment in the XeNa trial with Clinical Trials.gov 
      identifier number: NCT0141771. 120 patients with disseminated HER2 non-amplified 
      breast cancer were included. Randomization was between Arm A: vinorelbine 
      60 mg/m(2) day 1 + day 8 in the first cycle followed by 80 mg/m(2) day 1 + day 8 
      in the following cycles or Arm B: vinorelbine 50 mg three times a week. 
      Capecitabine 1000 mg/m(2) twice a day for days 1-14 was administered in both 
      arms. RESULTS: The treatment was generally well-tolerated. The response rate (RR) 
      was 24% (arm A) versus 29% (arm B) (p = .67). The clinical benefit rate (CBR) 
      46.8% (arm A) versus 51.7% (arm B) (p = .72). We found a median progression-free 
      survival (PFS) of 7.1 months (95% confidence interval [CI] 3.9-10.3) in arm A and 
      6.3 months (95% CI 4.1-8.5) in arm B (p = .25) whereas median overall survival 
      (OS) was 23.3 months (95% CI 20.2-26.4) in arm A and 22.3 months (95% CI 
      14.3-30.3) in arm B (p = .76). CONCLUSIONS: We confirmed that the combination of 
      vinorelbine and capecitabine was well tolerated. Metronomic treatment can be used 
      with acceptable adverse events (AEs), but we did not find significant difference 
      in the effect compared to the standard treatment.
FAU - Brems-Eskildsen, Anne Sofie
AU  - Brems-Eskildsen AS
AD  - Department of Oncology, University Hospital of Aarhus, Aarhus, Denmark.
FAU - Linnet, Soren
AU  - Linnet S
AD  - Department of Oncology, Region Hospital of West Jutland, Herning, Denmark.
FAU - Dano, Hella
AU  - Dano H
AD  - Department of Oncology, Region Hospital in Hilleroed, Hillerod, Denmark.
FAU - Luczak, Adam
AU  - Luczak A
AD  - Department of Oncology, University Hospital of Aalborg, Aalborg, Denmark.
FAU - Vestlev, Peter Michael
AU  - Vestlev PM
AD  - Department of Oncology, Roskilde Hospital, Roskilde, Denmark.
FAU - Jakobsen, Erik Hugger
AU  - Jakobsen EH
AD  - Department of Oncology, Region Hospital in Esbjerg, Esbjerg, Denmark.
FAU - Neimann, Jeppe
AU  - Neimann J
AD  - Department of Oncology, University Hospital of Aarhus, Aarhus, Denmark.
FAU - Jensen, Charlotte Buch
AU  - Jensen CB
AD  - Department of Oncology, University Hospital of Aarhus, Aarhus, Denmark.
FAU - Dongsgaard, Trine
AU  - Dongsgaard T
AD  - Department of Oncology, Region Hospital of West Jutland, Herning, Denmark.
FAU - Langkjer, Sven Tyge
AU  - Langkjer ST
AD  - Department of Oncology, University Hospital of Aarhus, Aarhus, Denmark.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20201201
PL  - Sweden
TA  - Acta Oncol
JT  - Acta oncologica (Stockholm, Sweden)
JID - 8709065
RN  - 5V9KLZ54CY (Vinblastine)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - Q6C979R91Y (Vinorelbine)
SB  - IM
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - *Breast Neoplasms/drug therapy
MH  - Capecitabine/therapeutic use
MH  - Female
MH  - Humans
MH  - Neoplasm Metastasis
MH  - Receptor, ErbB-2
MH  - Treatment Outcome
MH  - Vinblastine
MH  - Vinorelbine
OTO - NOTNLM
OT  - Breast cancer
OT  - metronomic treatment
OT  - randomized trial
EDAT- 2020/12/02 06:00
MHDA- 2021/08/19 06:00
CRDT- 2020/12/01 17:08
PHST- 2020/12/02 06:00 [pubmed]
PHST- 2021/08/19 06:00 [medline]
PHST- 2020/12/01 17:08 [entrez]
AID - 10.1080/0284186X.2020.1851045 [doi]
PST - ppublish
SO  - Acta Oncol. 2021 Feb;60(2):157-164. doi: 10.1080/0284186X.2020.1851045. Epub 2020 
      Dec 1.