Metronomic chemotherapy for advanced breast cancer patients in the real world practice: Final results of the VICTOR-6 study

Cazzaniga, Marina Elena; Pinotti, Graziella; Montagna, Emilia; Amoroso, Domenico; Berardi, Rossana; Butera, Alfredo; Cagossi, Katia; Cavanna, Luigi; Ciccarese, Mariangela; Cinieri, Saverio; Cretella, Elisabetta; Conciliis, Enrico De; Febbraro, Antonio; Ferraú, Francesco; Ferzi, A.; Fiorentini, G.; Fontana, A.; Gambaro, Anna; Garrone, Ornella; Gebbia, Vittorio; Generali, Daniele; Gianni, Luca; Giovanardi, Filippo; Grassadonia, A.; Leonardi, V.; Marchetti, Paolo; Melegari, Elisabetta; Musolino, Antonino; Nicolini, M.; Putzu, Carlo; Riccardi, Ferdinando; Santini, Daniele; Saracchini, Silvana; Sarobba, Maria Giuseppa; Schintu, M. G.; Scognamiglio, Giovanni; Spadaro, P.; Taverniti, C.; Toniolo, D.; Tralongo, Paolo; Turletti, Anna; Valenza, Roberto; Valerio, Maria Rosaria; Vici, Patrizia; Clivio, Luca; Torri, Valter

doi:10.1016/j.breast.2019.07.006

Cited by 44 publications

(51 citation statements)

References 14 publications

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“…The VICTOR‐6 study [20] aiming at summarizing the data of mCHT in Italy has provided the real‐world effectiveness of vinorelbine, capecitabine, CTX, and MTX in treating advanced breast cancer. However, the percentage of patients treated with CTX or MTX in this study composed less than 25% of the study cohort.…”

Section: Introductionmentioning

confidence: 99%

Metronomic chemotherapy of cyclophosphamide plus methotrexate for advanced breast cancer: Real‐world data analyses and experience of one center

Lee

et al. 2020

Cancer Communications

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Section: Introductionmentioning

confidence: 99%

Metronomic chemotherapy of cyclophosphamide plus methotrexate for advanced breast cancer: Real‐world data analyses and experience of one center

Lee

et al. 2020

Cancer Communications

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“…Metronomic chemotherapy (MCT), describing the administration of low doses on a continuous and high administration frequency basis, has been shown to mediate good tumour control and maintain an excellent safety profile (Cazzaniga et al 2019a;Krajnak et al 2020;Liu et al 2017;Orlando et al 2020). This therapy option generally represents an approach of high interest in the treatment of solid tumours, as it offers the advantage of exposing the tumour to a significant amount of drug while improving safety for the patients (Cazzaniga et al 2019b). It provides for fractionated, frequent, long-term administration of single doses of medication without pauses until disease progression or unacceptable toxicity (Gennari et al 2011;Liu et al 2017).…”

Section: Introductionmentioning

confidence: 99%

Phase II study of metronomic treatment with daily oral vinorelbine as first-line chemotherapy in patients with advanced/metastatic HR+/HER2− breast cancer resistant to endocrine therapy: VinoMetro—AGO-B-046

Krajnak¹,

Decker²,

Schollenberger

et al. 2021

J Cancer Res Clin Oncol

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Purpose Metronomic chemotherapy (MCT) is an increasingly used treatment option in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced/metastatic breast cancer (MBC) after failure of endocrine-based therapies. Methods VinoMetro was a multicentre, open-label, single-arm, phase II study of metronomic oral vinorelbine (VRL; 30 mg/day) as a first-line chemotherapy (CT) in patients with HR+/HER2− MBC after endocrine failure. The primary endpoint was the clinical benefit rate (CBR) at 24 weeks. Results Between January 2017 and April 2019, nine patients were enrolled. The CBR was 22.2% (90% confidence interval [CI] 4.1–55.0), p = 0.211. The median progression-free survival (PFS) was 12.0 weeks (95% CI 11.3–12.7). Grade 3–4 adverse events (AEs) occurred in 22.2% of patients. One patient died of febrile neutropenia. Conclusion VinoMetro (AGO-B-046) was closed early after nine patients and occurrence of one grade 5 toxicity in agreement with the lead institutional review board (IRB). Metronomic dosing of oral VRL in HR+/HER2− MBC as first-line CT after failure of endocrine therapies showed only limited benefit in this population. Trial registration number and date of registration ClinicalTrials.gov Identifier: NCT03007992; December 15, 2016.

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“…Metronomic chemotherapy (MCT), describing the administration of low doses on a continuous and high administration frequency basis, has been shown to mediate good tumour control and maintain an excellent safety pro le (Cazzaniga et al 2019a; Krajnak et al 2020;Liu et al 2017;Orlando et al 2020). This therapy option generally represents an approach of high interest in the treatment of solid tumours, as it offers the advantage of exposing the tumour to a signi cant amount of drug while improving safety for the patients (Cazzaniga et al 2019b). It provides for fractionated, frequent, long-term administration of single doses of medication without pauses until disease progression or unacceptable toxicity (Gennari et al 2011;Liu et al 2017).…”

Section: Introductionmentioning

confidence: 99%

Phase II Study of Metronomic Treatment With Daily Oral Vinorelbine as First-line Chemotherapy in Patients With Advanced/metastatic HR+/HER2- Breast Cancer Resistant to Endocrine Therapy: VinoMetro – AGO-B-046

Krajnak¹,

Decker²,

Schollenberger³

et al. 2021

Preprint

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PurposeMetronomic chemotherapy (MCT) is an increasingly used treatment option in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced/metastatic breast cancer (MBC) after failure of endocrine-based therapies. MethodsVinoMetro was a multicentre, open-label, single-arm, phase II study of metronomic oral vinorelbine (VRL; 30 mg/day) as a first-line chemotherapy (CT) in patients with HR+/HER2- MBC after endocrine failure. The primary endpoint was the clinical benefit rate (CBR) at 24 weeks. ResultsBetween January 2017 and April 2019, 9 patients were enrolled. The CBR was 22.2% (90% confidence interval [CI] 4.1–55.0), p=0.211. The median progression-free survival (PFS) was 12.0 weeks (95% CI 11.3–12.7). Grade 3-4 adverse events (AEs) occurred in 22.2% of patients. One patient died of febrile neutropenia.ConclusionVinoMetro (AGO-B-046) was closed early after 9 patients and occurrence of one grade 5 toxicity in agreement with the lead institutional review board (IRB). Metronomic dosing of oral VRL in HR+/HER2- MBC as first-line CT after failure of endocrine therapies showed only limited benefit in this population.Trial registration number and date of registrationClinicalTrials.gov Identifier: NCT03007992; December 15, 2016

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Metronomic chemotherapy for advanced breast cancer patients in the real world practice: Final results of the VICTOR-6 study

Cited by 44 publications

References 14 publications

Metronomic chemotherapy of cyclophosphamide plus methotrexate for advanced breast cancer: Real‐world data analyses and experience of one center

Metronomic chemotherapy of cyclophosphamide plus methotrexate for advanced breast cancer: Real‐world data analyses and experience of one center

Phase II study of metronomic treatment with daily oral vinorelbine as first-line chemotherapy in patients with advanced/metastatic HR+/HER2− breast cancer resistant to endocrine therapy: VinoMetro—AGO-B-046

Phase II Study of Metronomic Treatment With Daily Oral Vinorelbine as First-line Chemotherapy in Patients With Advanced/metastatic HR+/HER2- Breast Cancer Resistant to Endocrine Therapy: VinoMetro – AGO-B-046

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