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.
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.
Cazzaniga ME, Camerini A, Addeo R et al (2016) Metronomic oral vinorelbine in advanced breast cancer and non-small-cell lung cancer: current status and future development. Futur Oncol 12:373–378 CrossRef
Montagna E, Lai A, Palazzo A et al (2015) A phase II study of metronomic oral chemotherapy for metastatic breast cancer patients: Safety and efficacy results of vinorelbine, cyclophosphamide plus capecitabine (VEX) combination. Eur J Cancer Congr 51:S291–S292 CrossRef
Saloustros E, Kalbakis K, Vardakis N et al (2011) Metronomic vinorelbine plus bevacizumab as salvage therapy for patients with metastatic breast cancer. J BUON 16:215–218 PubMed
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- 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
S. Della Torre
A. R. Gambaro
On behalf of VICTOR Study Group
- Springer US
Neu im Fachgebiet Onkologie
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