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

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)177-181
Number of pages5
JournalBreast Care
Volume13
Issue number3
DOIs
Publication statusPublished - Jul 1 2018

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Triple Negative Breast Neoplasms
Drug Therapy
Cyclophosphamide
Hand-Foot Syndrome
Safety
Therapeutics
Neutropenia
Nausea
Diarrhea
Hormones
Confidence Intervals
Breast Neoplasms
Biopsy
Liver
Enzymes
Neoplasms
Capecitabine
vinorelbine

Keywords

  • Breast cancer
  • Metastatic disease
  • Metronomic
  • Treatment strategies

ASJC Scopus subject areas

  • Surgery
  • Oncology

Cite this

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title = "Metronomic Chemotherapy for First-Line Treatment of Metastatic Triple-Negative Breast Cancer: A Phase II Trial",
abstract = "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.",
keywords = "Breast cancer, Metastatic disease, Metronomic, Treatment strategies",
author = "Emilia Montagna and Vincenzo Bagnardi and Giuseppe Cancello and Claudia Sangalli and Eleonora Pagan and Monica Iorfida and Manuelita Mazza and Giovanni Mazzarol and Silvia Dellapasqua and Elisabetta Munzone and Aaron Goldhirsch and Marco Colleoni",
year = "2018",
month = "7",
day = "1",
doi = "10.1159/000487630",
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pages = "177--181",
journal = "Breast Care",
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TY - JOUR

T1 - Metronomic Chemotherapy for First-Line Treatment of Metastatic Triple-Negative Breast Cancer

T2 - A Phase II Trial

AU - Montagna, Emilia

AU - Bagnardi, Vincenzo

AU - Cancello, Giuseppe

AU - Sangalli, Claudia

AU - Pagan, Eleonora

AU - Iorfida, Monica

AU - Mazza, Manuelita

AU - Mazzarol, Giovanni

AU - Dellapasqua, Silvia

AU - Munzone, Elisabetta

AU - Goldhirsch, Aaron

AU - Colleoni, Marco

PY - 2018/7/1

Y1 - 2018/7/1

N2 - 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.

AB - 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.

KW - Breast cancer

KW - Metastatic disease

KW - Metronomic

KW - Treatment strategies

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