Single-Agent Oral Vinorelbine as First-Line Chemotherapy for Endocrine-Pretreated Breast Cancer With Bone Metastases and No Visceral Involvement: NORBREAST-228 Phase II Study

Steger, Guenther G.; Dominguez, Adriana; Dobrovol'skaya, N Yu; Giotta, Francesco; Tubiana-Mathieu, Nicole; Pecherstorfer, Martin; Ardizzoia, Antonio; Błasińska-Morawiec, Maria; Espinosa, Enrique; Villanova, G.

doi:10.1016/j.clbc.2017.05.012

Cited by 10 publications

(13 citation statements)

References 18 publications

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“…Metronomic vinorelbine in patients with metastatic breast cancer months, oral weekly VRL is considered as an active oral alternative to intravenous CT in the rst-line CT treatment of MBC(Blancas et al 2019;Freyer et al 2003;Steger et al 2018). It is noteworthy that these results are similar to the results of metronomic VRL regimens.…”

mentioning

confidence: 90%

“…Among available agents, vinorelbine (VRL) represents a standard treatment option in this situation, as it provides proven e cacy and a good safety pro le (Fumoleau et al 1993;Terenziani et al 1996). Oral administration of VRL shows a level of e cacy comparable to the intravenous treatment, while providing a favourable safety pro le and the additional advantages of an oral treatment (Aapro et al 2019;Blancas et al 2019;Freyer et al 2003;Steger et al 2018). 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).…”

Section: Introductionmentioning

confidence: 99%

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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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mentioning

confidence: 90%

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

View full text Add to dashboard Cite

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“…Oral vinorelbine was well tolerated with 8.2 months median progression-free survival (PFS) and 35.2 months OS. 35 – 37 ○ Replacing IV etoposide with oral etoposide was studied in several hematological and solid malignancies. The reduced bioavailability (∼50%) of the oral formulation warrants doubling the dose oral etoposide when switching from IV to oral etoposide.…”

Section: Recommendation # 3 Switching From Intravenous Chemotherapy mentioning

confidence: 99%

“…Oral vinorelbine was well tolerated with 8.2 months median progression-free survival (PFS) and 35.2 months OS. 35 – 37 …”

Section: Recommendation # 3 Switching From Intravenous Chemotherapy mentioning

confidence: 99%

Practical strategies to manage cancer patients during the COVID-19 pandemic: Saudi Oncology Pharmacy Assembly Experts recommendations

Alshamrani

Alharbi

Alkhudair

et al. 2020

J Oncol Pharm Pract

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Purpose During COVID-19 pandemic, cancer patients are considered one of the most vulnerable to infection since they tend to have advanced age, multiple comorbidities, and are often immunosuppressed by their cancer or therapy. Hence, the Saudi Oncology Pharmacy Assembly has issued recommendations to reduce the frequency of cancer patients’ visits to oncology centers during the pandemic while maintaining the access to cancer therapy and minimize the risk of exposure to coronavirus disease. Materials and methods A qualitative methodological approach was conducted in April 2020 using a virtual panel discussion for collection of recommendations. Results A total of 12 expert oncology pharmacy practitioners shared their knowledge and experiences in managing oncology patients during the COVID-19 pandemic. The participants recognized many fundamental recommendations that were already applied in many cancer centers since the start of the COVID-19 outbreak. On that basis, the panelists developed eight practice-related recommendations for action, with a main focus on cancer treatment modification. Conclusions In conclusion, delivering cancer care during the COVID-19 pandemic carries significant challenges. This paper addressed suggestions to properly manage cancer patients during difficult times. Implementing changes in practice mandates a national collaborative effort from different sectors to guarantee the quality and continuity of care. The SOPA expert panel developed these recommendations, to ultimately contribute in maintaining access to cancer therapy while minimizing the risk of COVID-19 exposure.

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“…Among available agents, vinorelbine (VRL) represents a standard treatment option in this situation, as it provides proven efficacy and a good safety profile (Fumoleau et al 1993;Terenziani et al 1996). Oral administration of VRL shows a level of efficacy comparable to the intravenous treatment, while providing a favourable safety profile and the additional advantages of an oral treatment (Aapro et al 2019;Blancas et al 2019;Freyer et al 2003;Steger et al 2018). 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).…”

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

View full text Add to dashboard Cite

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.

show abstract

Single-Agent Oral Vinorelbine as First-Line Chemotherapy for Endocrine-Pretreated Breast Cancer With Bone Metastases and No Visceral Involvement: NORBREAST-228 Phase II Study

Cited by 10 publications

References 18 publications

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

Practical strategies to manage cancer patients during the COVID-19 pandemic: Saudi Oncology Pharmacy Assembly Experts recommendations

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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