On and off Metronomic Oral Vinorelbine in Elderly Women with Advanced Breast Cancer

Iuliis, Francesca De; Salerno, Gerardo; Taglieri, Ludovica; Lanza, Rosina; Scarpa, Susanna

doi:10.5301/tj.5000207

Cited by 45 publications

(28 citation statements)

References 18 publications

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“…Several phase II studies have investigated metronomic vinorelbine (mVNR) in the treatment of breast cancer [4–8]. mVNR demonstrated long-lasting disease control combined with a good toxicity profile.…”

Section: Introductionmentioning

confidence: 99%

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

Cortesi

Ferzi

et al. 2016

Breast Cancer Res Treat

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PurposeThe 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.MethodsPatients 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).ResultsEighty 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 %).ConclusionThe 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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Section: Introductionmentioning

confidence: 99%

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

Cortesi

Ferzi

et al. 2016

Breast Cancer Res Treat

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“…Vinorelbine was added to bevacizumab in a trial by Saloustras et al but study was closed prematurely due to lack of efficacy (OR was 7.7%) [86]. Another study with an alternative on and off metronomic regimen of vinorelbine was dosed every other day for 4 years with a cumulative dose of 30 mgs; a 50% CB was reported, without grade 3 or 4 toxicity [87].…”

Section: Resultsmentioning

confidence: 99%

Metronomic Chemotherapy: A Systematic Review of the Literature and Clinical Experience

Şimşek

Esin

Yalçın

2019

Journal of Oncology

102

100

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Metronomic chemotherapy, continuous and dose-dense administration of chemotherapeutic drugs with lowered doses, is being evaluated for substituting, augmenting, or appending conventional maximum tolerated dose regimens, with preclinical and clinical studies for the past few decades. To date, the principle mechanisms of its action include impeding tumoral angiogenesis and modulation of hosts’ immune system, affecting directly tumor cells, their progenitors, and neighboring stromal cells. Its better toxicity profile, lower cost, and easier use are main advantages over conventional therapies. The evidence of metronomic chemotherapy for personalized medicine is growing, starting with unfit elderly patients and also for palliative treatment. The literature reviewed in this article mainly demonstrates that metronomic chemotherapy is advantageous for selected patients and for certain types of malignancies, which make it a promising therapeutic approach for filling in the gaps. More clinical studies are needed to establish a solidified role for metronomic chemotherapy with other treatment models in modern cancer management.

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“…Metronomic vinorelbine given orally resulted in good tolerability and safety profile in this elderly population with a satisfactory patient adherence to therapy. 143 Data for single-agent low-dose oral idarubicin are limited, although feasible in women aged ≥65 years. 144 The long plasma half-life of idarubicin and its metabolite make this drug suitable for protracted administration.…”

Section: Metronomics In the Metastatic Settingmentioning

confidence: 99%

“…Metronomic oral vinorelbine was investigated in at least two phase II trials. 90,143 The first trial included 34 elderly patients with metastatic breast cancer (median age 74 years, range 70-84 years) who received oral vinorelbine at 70 mg/m 2 , fractionated on days 1, 3, and 5, for 3 weeks on and 1 week off, every 4 weeks, for a maximum of 12 cycles. Two patients (6%) achieved complete responses and 11 (32%) achieved partial responses.…”

Section: Metronomics In the Metastatic Settingmentioning

confidence: 99%

Clinical overview of metronomic chemotherapy in breast cancer

2015

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Over 15 years ago, low-dose metronomic chemotherapy was shown to induce disease control in patients with advanced-stage breast cancer with a lower incidence of adverse events compared with conventional maximum tolerated dose chemotherapy. Good response rates have been seen in heavily pre-treated patients for whom limited treatment options are available. Most patients prefer oral therapy and metronomic chemotherapy is a convenient alternative in patients with advanced-stage disease in which minimal toxicity and good tumour control are the overall aims of treatment. The addition of metronomic protocols to standard neoadjuvant chemotherapy regimens has produced promising pathological complete response rates. Ongoing trials including the SYSUCC-001 trial in patients with triple-negative breast cancer and the IBCSG 22-00 trial that is assessing a cyclophosphamide-methotrexate maintenance regimen after standard adjuvant therapy in hormone receptor-negative disease, will clarify the value of adding this approach to conventional therapies. The low cost associated with metronomic chemotherapy represents an opportunity for the utilization of this treatment option, especially in developing countries, and poses a challenge for the launch of large trials sponsored by industry. Using breast cancer as the principal example, we discuss the key clinical advances in this area, including new trial design, appropriate patient and end point selection, as well as the evolving rationale for metronomic chemotherapy combinations.

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On and off Metronomic Oral Vinorelbine in Elderly Women with Advanced Breast Cancer

Abstract: The present study demonstrated that metronomic vinorelbine might be a potential treatment in elderly patients by reducing adverse effects and increasing quality of life, setting the stage for future extensive clinical trials.

Cited by 45 publications

References 18 publications

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

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

Metronomic Chemotherapy: A Systematic Review of the Literature and Clinical Experience

Clinical overview of metronomic chemotherapy in breast cancer

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