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Clinical Trial
. 2016 Dec;160(3):501-509.
doi: 10.1007/s10549-016-4009-3. Epub 2016 Oct 17.

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  1 , L Cortesi  2 , A Ferzi  3 , L Scaltriti  4 , F Cicchiello  5 , M Ciccarese  6 , S Della Torre  7 , F Villa  8 , M Giordano  9 , C Verusio  10 , M Nicolini  11 , A R Gambaro  12 , L Zanlorenzi  13 , E Biraghi  14 , L Legramandi  15 , E Rulli  15 ; VICTOR Study Group
Collaborators, Affiliations
Clinical Trial

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 et al. Breast Cancer Res Treat. 2016 Dec.

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.

Keywords: Breast cancer; Capecitabine; Metronomic chemotherapy; Vinorelbine.

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Conflict of interest statement

The authors have declared no conflicts of interest. Informed consent The study was conducted in accordance with the 1987 Declaration of Helsinki and adhered to Good Clinical Practice guidelines. Approval of the protocol was obtained from the local ethics committee for each participating center; all patients were required to give written informed consent before enrolment and to comply with the protocol for the duration of the study.

Figures

Fig. 1
Fig. 1
Study population
Fig. 2
Fig. 2
Progression-free survival according to treatment line and hormone receptor status
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References

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