Safety and efficacy study of metronomic vinorelbine, cyclophosphamide plus capecitabine in metastatic breast cancer: A phase II trial

Montagna, Emilia; Palazzo, Antonella; Maisonneuve, Patrick; Cancello, Giuseppe; Iorfida, Monica; Sciandivasci, Angela; Espósito, Angela; Cardillo, Anna; Mazza, M.; Munzone, Elisabetta; Lai, A.; Goldhirsch, Aron; Colleoni, Marco

doi:10.1016/j.canlet.2017.01.027

Cited by 39 publications

(35 citation statements)

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“…However, all patients will eventually progress, with a mTTP of 5-7 months [8,9,10,11]. In this setting, palliation is the primary goal of treatment, and life expectancy is limited.…”

Section: Discussionmentioning

confidence: 99%

“…This approach significantly reduces toxicities and the need for growth factor support to accelerate recovery from myelosuppression. The metronomic combination of capecitabine, vinorelbine, and cyclophosphamide (VEX regimen) was recently investigated in a phase II trial of patients with endocrine-responsive MBC [8]. Treatment with the VEX regimen showed activity, and the rate of toxicities was low.…”

Section: Introductionmentioning

confidence: 99%

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Metronomic Chemotherapy for First-Line Treatment of Metastatic Triple-Negative Breast Cancer: A Phase II Trial

et al. 2018

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Background: Few data are available on the benefit of metronomic cyclophosphamide, capecitabine, and vinorelbine as first-line therapy in patients with metastatic triple-negative breast cancer. Methods: This phase II study assessed the safety and efficacy of metronomic oral chemotherapy with vinorelbine 40 mg orally 3 times a week, cyclophosphamide 50 mg daily, and capecitabine 500 mg 3 times a day (VEX regimen) in untreated metastatic triple-negative breast cancer patients. The biopsy of the metastatic site had to be triple-negative, independent of the hormone receptor expression of the primary tumor. The primary endpoint was time to progression (TTP). Secondary endpoints included assessment of safety and clinical benefit (objective response rate plus stable disease rate at ≥24 weeks). Results: 25 patients were included, and 22 were evaluable for both efficacy and toxicities (median age, 66 years). Median TTP was 6.4 months (95% confidence interval 3.6-12.6). The most common grade 1-2 toxicities were nausea, diarrhea, leuko-/neutropenia, and reversible liver enzyme alteration. Grade 3 events included hand and foot syndrome (9%). Conclusion: The VEX regimen demonstrated activity and was relatively well tolerated when given as first-line therapy in selected metastatic breast cancer patients with triple-negative disease.

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“…However, all patients will eventually progress, with a mTTP of 5-7 months [8,9,10,11]. In this setting, palliation is the primary goal of treatment, and life expectancy is limited.…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Metronomic Chemotherapy for First-Line Treatment of Metastatic Triple-Negative Breast Cancer: A Phase II Trial

et al. 2018

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“…In another study with metastatic hormone receptor positive patients, metronomic combination of CP with vinorelbine and capecitabine was evaluated for both naïve and pretreated patients. Naïve patients had a TTP of 25.1 months, while pretreated patients' median TTP was 11.2 months [57]. Zhang et al evaluated addition of metronomic CP to docetaxel in non-triple-negative patients as a first-line treatment compared to docetaxel alone.…”

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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“…However, we have shown that LDMC can also be a treatment option for younger patients. Based on previous data from phase II studies, LDMC regimens provide promising results in the first-line setting with a clinical benefit rate (CBR) of up to 78% and a median time to progression (TTP) of up to 22 months [17][18][19]. Among the non-heavily pretreated subgroup, 33.3% LDMC patients and 26.2% CCT patients showed DCR (p = 0.568).…”

Section: Discussionmentioning

confidence: 99%

Low-dose metronomic chemotherapy as an efficient treatment option in metastatic breast cancer—results of an exploratory case–control study

Krajnak

Schnatz

Almstedt

et al. 2020

Breast Cancer Res Treat

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Purpose There is growing interest in low-dose metronomic chemotherapy (LDMC) in metastatic breast cancer (MBC). In this retrospective case-control analysis, we compared the efficacy of LDMC and conventional chemotherapy (CCT) in MBC. Methods Each LDMC patient receiving oral cyclophosphamide (CTX) (50 mg daily) and methotrexate (MTX) (2.5 mg every other day) was matched with two controls who received CCT. Age, number of chemotherapy lines and metastatic sites as well as hormone receptor (HR) status were considered as matching criteria. Primary endpoint was disease control rate longer than 24 weeks (DCR). Secondary endpoints were progression-free survival (PFS), duration of response (DoR) and subgroup analyses using the matching criteria. Results 40 cases and 80 controls entered the study. 30.0% patients with LDMC and 22.5% patients with CCT showed DCR (p = 0.380). The median PFS was 12.0 weeks in both groups (p = 0.218) and the median DoR was 31.0 vs. 20.5 weeks (p = 0.383), respectively. Among younger patients, DCR was 40.0% in LDMC vs. 25.0% in the CCT group (p = 0.249). DCR was achieved in 33.3% vs. 26.2% non-heavily pretreated patients (p = 0.568) and in 36.0% vs. 18.0% patients without multiple metastases (p = 0.096), respectively. In the HR-positive group, 30.0% LDMC vs. 28.3% CCT patients showed DCR (p = 1.000). Among triple-negative patients, DCR was achieved in 30.0% LDMC and 5.0% CCT patients (p = 0.095). Conclusions We demonstrated a similar efficacy of LDMC compared to CCT in the treatment of MBC. Thus, LDMC may be a valuable treatment option in selected MBC patients.

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Safety and efficacy study of metronomic vinorelbine, cyclophosphamide plus capecitabine in metastatic breast cancer: A phase II trial

Cited by 39 publications

References 32 publications

Metronomic Chemotherapy for First-Line Treatment of Metastatic Triple-Negative Breast Cancer: A Phase II Trial

Metronomic Chemotherapy for First-Line Treatment of Metastatic Triple-Negative Breast Cancer: A Phase II Trial

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

Low-dose metronomic chemotherapy as an efficient treatment option in metastatic breast cancer—results of an exploratory case–control study

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