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

M. E. Cazzaniga, L. Cortesi, A. Ferzi, L. Scaltriti, F. Cicchiello, M. Ciccarese, S. Della Torre, F. Villa, M. Giordano, C. Verusio, M. Nicolini, A. R. Gambaro, L. Zanlorenzi, E. Biraghi, L. Legramandi, E. Rulli, behalf of VICTOR Study Group On behalf of VICTOR Study Group, Francesca Riva, Pelizzoni Davide, Isabella MarchiElena Collovà, Giuseppe Prati, Antonio Ardizzoia, Davide Toniolo, Palma Pugliese, Claudia Pogliani, Abbondanza Gambino, Lucia Stocchi, Andrea Colombo, Cinzia Fasola, Raffaele Venezia, Fabio Galli, Valter Torri

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Purpose: 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. Methods: 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). Results: 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 %). Conclusion: 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.

Original languageEnglish
Pages (from-to)501-509
Number of pages9
JournalBreast Cancer Research and Treatment
Volume160
Issue number3
DOIs
Publication statusPublished - Dec 1 2016

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Breast Neoplasms
Drug Therapy
Disease-Free Survival
Hand-Foot Syndrome
Triple Negative Breast Neoplasms
Hospital Costs
Leukopenia
Hematologic Tests
vinorelbine
Capecitabine
Neutropenia
Pharmaceutical Preparations
Nausea
Vomiting
Fatigue
Diarrhea
Appointments and Schedules
Survival Rate
Hormones
Neoplasms

Keywords

  • Breast cancer
  • Capecitabine
  • Metronomic chemotherapy
  • Vinorelbine

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

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. / Cazzaniga, M. E.; Cortesi, L.; Ferzi, A.; Scaltriti, L.; Cicchiello, F.; Ciccarese, M.; Della Torre, S.; Villa, F.; Giordano, M.; Verusio, C.; Nicolini, M.; Gambaro, A. R.; Zanlorenzi, L.; Biraghi, E.; Legramandi, L.; Rulli, E.; On behalf of VICTOR Study Group, behalf of VICTOR Study Group; Riva, Francesca; Davide, Pelizzoni; Marchi, Isabella; Collovà, Elena; Prati, Giuseppe; Ardizzoia, Antonio; Toniolo, Davide; Pugliese, Palma; Pogliani, Claudia; Gambino, Abbondanza; Stocchi, Lucia; Colombo, Andrea; Fasola, Cinzia; Venezia, Raffaele; Galli, Fabio; Torri, Valter.

In: Breast Cancer Research and Treatment, Vol. 160, No. 3, 01.12.2016, p. 501-509.

Research output: Contribution to journalArticle

Cazzaniga, ME, Cortesi, L, Ferzi, A, Scaltriti, L, Cicchiello, F, Ciccarese, M, Della Torre, S, Villa, F, Giordano, M, Verusio, C, Nicolini, M, Gambaro, AR, Zanlorenzi, L, Biraghi, E, Legramandi, L, Rulli, E, On behalf of VICTOR Study Group, BOVICTORSG, Riva, F, Davide, P, Marchi, I, Collovà, E, Prati, G, Ardizzoia, A, Toniolo, D, Pugliese, P, Pogliani, C, Gambino, A, Stocchi, L, Colombo, A, Fasola, C, Venezia, R, Galli, F & Torri, V 2016, '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', Breast Cancer Research and Treatment, vol. 160, no. 3, pp. 501-509. https://doi.org/10.1007/s10549-016-4009-3
Cazzaniga, M. E. ; Cortesi, L. ; Ferzi, A. ; Scaltriti, L. ; Cicchiello, F. ; Ciccarese, M. ; Della Torre, S. ; Villa, F. ; Giordano, M. ; Verusio, C. ; Nicolini, M. ; Gambaro, A. R. ; Zanlorenzi, L. ; Biraghi, E. ; Legramandi, L. ; Rulli, E. ; On behalf of VICTOR Study Group, behalf of VICTOR Study Group ; Riva, Francesca ; Davide, Pelizzoni ; Marchi, Isabella ; Collovà, Elena ; Prati, Giuseppe ; Ardizzoia, Antonio ; Toniolo, Davide ; Pugliese, Palma ; Pogliani, Claudia ; Gambino, Abbondanza ; Stocchi, Lucia ; Colombo, Andrea ; Fasola, Cinzia ; Venezia, Raffaele ; Galli, Fabio ; Torri, Valter. / 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. In: Breast Cancer Research and Treatment. 2016 ; Vol. 160, No. 3. pp. 501-509.
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abstract = "Purpose: 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. Methods: 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). Results: 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 {\%}). Conclusion: 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.",
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TY - JOUR

T1 - Metronomic chemotherapy with oral vinorelbine (mVNR) and capecitabine (mCAPE) in advanced HER2-negative breast cancer patients

T2 - is it a way to optimize disease control? Final results of the VICTOR-2 study

AU - Cazzaniga, M. E.

AU - Cortesi, L.

AU - Ferzi, A.

AU - Scaltriti, L.

AU - Cicchiello, F.

AU - Ciccarese, M.

AU - Della Torre, S.

AU - Villa, F.

AU - Giordano, M.

AU - Verusio, C.

AU - Nicolini, M.

AU - Gambaro, A. R.

AU - Zanlorenzi, L.

AU - Biraghi, E.

AU - Legramandi, L.

AU - Rulli, E.

AU - On behalf of VICTOR Study Group, behalf of VICTOR Study Group

AU - Riva, Francesca

AU - Davide, Pelizzoni

AU - Marchi, Isabella

AU - Collovà, Elena

AU - Prati, Giuseppe

AU - Ardizzoia, Antonio

AU - Toniolo, Davide

AU - Pugliese, Palma

AU - Pogliani, Claudia

AU - Gambino, Abbondanza

AU - Stocchi, Lucia

AU - Colombo, Andrea

AU - Fasola, Cinzia

AU - Venezia, Raffaele

AU - Galli, Fabio

AU - Torri, Valter

PY - 2016/12/1

Y1 - 2016/12/1

N2 - Purpose: 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. Methods: 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). Results: 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 %). Conclusion: 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.

AB - Purpose: 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. Methods: 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). Results: 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 %). Conclusion: 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.

KW - Breast cancer

KW - Capecitabine

KW - Metronomic chemotherapy

KW - Vinorelbine

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