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17.10.2016 | Clinical trial | Ausgabe 3/2016 Open Access

Breast Cancer Research and Treatment 3/2016

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

Zeitschrift:
Breast Cancer Research and Treatment > Ausgabe 3/2016
Autoren:
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, On behalf of VICTOR Study Group
Wichtige Hinweise
The remaining members of the VICTOR Study Group are listed in the Appendix 1.
A comment to this article is available at http://​dx.​doi.​org/​10.​1007/​s10549-016-4055-x.

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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