title: Metronomic chemotherapy with oral vinorelbine (mVNR) and capecitabine (mCAPE) in advanced HER2-negative breast cancer patients: is it a way to optimize disease control? Final results of the VICTOR-2 study.
abstract: The VICTOR-1 study demonstrated that the all-oral metronomic combination of vinorelbine and capecitabine is highly active and well tolerated in hormone receptor-positive/HER2-negative patients. The VICTOR-2 study was designed to confirm these results.
  
  
  
  Patients received mVNR 40 mg three times a week and mCAPE 500 mg three times a day, continuously. The primary endpoint was the clinical benefit rate (CBR); secondary endpoints were toxicity, objective response rate (ORR), and progression-free survival (PFS).
  
  
  
  Eighty patients were evaluable for the primary efficacy analysis. Median age was 65.3 years; most patients had HR-positive tumors (65 %). The CBR was 45.7 % (95 % CI 28.8-63.4) and 51.1 % (95 % CI 35.8-66.3) in first- and ≥ second-line therapy, respectively. The ORR was 35.5 % in first-line (95 % CI 19.2-54.6) and 25.6 % in ≥second-line (95 % CI 13.5-41.2). The median duration of response was 11.3 and 6.4 months and PFS rates at 1 year were 24.3 and 22.2 %, respectively. In triple-negative breast cancer patients (N = 28, 35 %) a lower, but clinically relevant CBR (35.7, 95 % CI 18.6-55.9) was observed. The main toxicities per cycle were non-febrile neutropenia (1.1 %), hand-foot syndrome (1.0 %), nausea and vomiting (1.0 %), leucopenia (0.8 %), fatigue (0.7 %), and diarrhea (0.4 %).
  
  
  
  The VICTOR-2 study confirms the clinical activity of mVNR and mCAPE in HER2-negative breast cancer patients, suggesting that the easy schedule of administration, which requires monthly blood tests and limits patients' dependence on hospitals, and the low cost of the drugs are valuable elements, even for countries with limited access to innovative or expensive drugs.
authors.affiliation: Oncology Unit, ASST Monza, Via Pergolesi, 33 20900, Monza, MB, Italy. marina.cazzaniga@asst-monza.it.
authors.forename: M E
authors.initials: ME
authors.lastname: Cazzaniga
authors.affiliation: Haematology and Oncology Unit, Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Cortesi
authors.affiliation: Oncology Unit, ASST Ovest Milanese, Ospedale di Legnano, Legnano, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Ferzi
authors.affiliation: Oncology Day Hospital Unit, Ospedale Civile di Guastalla, Guastalla, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Scaltriti
authors.affiliation: Oncology Unit, ASST Monza, Via Pergolesi, 33 20900, Monza, MB, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Cicchiello
authors.affiliation: Oncology Unit, Ospedale Vito Fazzi, Lecce, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Ciccarese
authors.affiliation: Oncology Unit, ASST Rhodense-Presidio di Garbagnate Milanese e Presidio di Rho, Garbagnate, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Della Torre
authors.affiliation: Oncology Unit, ASST, Lecco, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Villa
authors.affiliation: Oncology Unit, ASST Lariana, Como, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Giordano
authors.affiliation: Oncology Unit, ASST della Valle Olona, Saronno, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Verusio
authors.affiliation: Oncology Day Hospital Unit, Azienda USL Romagna, Cattolica, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Nicolini
authors.affiliation: Oncology Unit, ASST Fatebenefratelli-Sacco, Milan, Italy.
authors.forename: A R
authors.initials: AR
authors.lastname: Gambaro
authors.affiliation: Oncology Unit, ASST della Valle Olona, Busto Arsizio, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Zanlorenzi
authors.affiliation: Oncology Unit, ASST Melegnano e Martesana, Gorgonzola, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Biraghi
authors.affiliation: Methodology for Clinical Research Laboratory, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Legramandi
authors.affiliation: Methodology for Clinical Research Laboratory, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Rulli
mesh_terms: D059250:Administration, Metronomic; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality / Q000473:pathology*; D000069287:Capecitabine / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D019233:Retreatment; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000069287:Capecitabine; D018719:Erb-b2 Receptor Tyrosine Kinases; D014747:Vinblastine; D000077235:Vinorelbine
keywords: Breast cancer; Capecitabine; Metronomic chemotherapy; Vinorelbine