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

Krajnak, Slavomir; Decker, Thomas; Schollenberger, Lukas; Rosé, Christian; Ruckes, Christian; Fehm, Tanja; Thomssen, Christoph; Harbeck, Nadia; Schmidt, Marcus

doi:10.1007/s00432-021-03599-2

Cited by 7 publications

(3 citation statements)

References 36 publications

(55 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Despite the availability of Phase 1 trial data [ 40 ], which, for VNR, suggested a recommended dose of 50 mg thrice a week when used as a single agent, some trials tested alternative schedules, such as 30 mg/day, without interruptions. This schedule was studied in a multicentre, open-label, single-arm study which enrolled nine patients and was closed early due to one Grade 5 toxicity (febrile neutropenia) [ 41 ].…”

Section: Resultsmentioning

confidence: 99%

Metronomic Chemotherapy for Metastatic Breast Cancer Treatment: Clinical and Preclinical Data between Lights and Shadows

Cazzaniga

Capici²,

Cordani

et al. 2022

JCM

View full text Add to dashboard Cite

Metronomic chemotherapy (mCHT), defined as continuous administration of low-dose chemotherapeutic agents with no or short regular treatment-free intervals, was first introduced to the clinic in international guidelines in 2017, and, since then, has become one of the available strategies for the treatment of advanced breast cancer (ABC). Despite recent successes, many unsolved practical and theoretical issues remain to be addressed. The present review aims to identify the “lights and shadows” of mCHT in preclinical and clinical settings. In the preclinical setting, several findings indicate that one of the most noticeable effects of mCHT is on the tumor microenvironment, which, over the last twenty years, has been demonstrated to be pivotal in supporting tumor cell survival and proliferation. On the other hand, the direct effects on tumor cells have been less well-defined. In addition, critical items to be addressed are the lack of definition of an optimal biological dose (OBD), the method of administration of metronomic schedules, and the recognition and validation of predictive biomarkers. In the clinical context—where mCHT has mainly been used in a metastatic setting—low toxicity is the most well-recognised light of mCHT, whereas the type of study design, the absence of randomised trials and uncertainty in terms of doses and drugs remain among the shadows. In conclusion, growing evidence indicates that mCHT is a suitable treatment option for selected metastatic breast cancer (MBC) patients. Moreover, given its multimodal mechanisms of action, its addition to immunological and targeted therapies might represent a promising new approach to the treatment of MBC. More preclinical data are needed in this regard, which can only be obtained through support for translational research as the key link between basic science and patient care.

show abstract

Section: Resultsmentioning

confidence: 99%

Metronomic Chemotherapy for Metastatic Breast Cancer Treatment: Clinical and Preclinical Data between Lights and Shadows

Cazzaniga

Capici²,

Cordani

et al. 2022

JCM

View full text Add to dashboard Cite

show abstract

“…It is therefore difficult to interpret the presented data and the exact role of MCT in terms of current recommendations for MBC treatment. Parts of the clinical data from our MCT cohort were already published elsewhere [ 16 , 31 , 32 ]. In this study, MCT patients were included regardless of the active agent, and OS data were presented for the first time.…”

Section: Discussionmentioning

confidence: 99%

Real-World Experience of Metronomic Chemotherapy in Metastatic Breast Cancer: Results of a Retrospective Unicenter Study

Krajnak¹,

Krajňáková²,

Anić³

et al. 2023

Breast Care

Self Cite

View full text Add to dashboard Cite

Introduction: Metronomic chemotherapy (MCT) is increasingly used in oncology due to its favorable therapeutic index. There is still a lack of evidence for MCT in metastatic breast cancer (MBC). In this retrospective unicenter study we demonstrated real-word data on MCT in MBC. Methods: MBC patients who received metronomic oral cyclophosphamide (CTX) (50 mg daily) and methotrexate (MTX) (2.5 mg every other day), CTX and capecitabine (CAPE) (500 mg thrice daily), CTX or vinorelbine (VRL) (30 mg daily) alone for at least 4 weeks between 2009 and 2021 were included. The primary endpoint was disease control rate (DCR) ≥ 24 weeks. Secondary endpoints were progression-free survival (PFS) and overall survival (OS). Patient characteristics and therapy response were analyzed using Chi-square test. For survival analyses Kaplan–Meier estimator and Log-rank test were used. Results: 72 patients were identified. 62 patients received CTX/MTX, three CTX/CAPE, two CTX and five VRL. Median age at diagnosis MBC and at start of MCT was 59.0 years and 64.5 years, respectively. 72.2% tumors were hormone receptor-positive and 27.8% were triple-negative. 54.2% patients had more than two different metastases. 80.6% patients showed visceral involvement. 31.9% patients achieved DCR ≥ 24 weeks. Median PFS was 17.0 weeks (95% CI 14.5–19.5) and median OS was 58.0 weeks (95% CI 29.0–87.0). MCT showed similar DCR ≥ 24 weeks and clinically meaningful but not statistically significant shorter median PFS compared to prior therapy [31.9% vs. 32.8% (p=0.570) and 17.0 weeks vs. 20.0 weeks (p=0.093), respectively], and statistically significant higher DCR ≥ 24 weeks and longer median PFS compared to subsequent therapy [31.9% vs. 17.4% (p=0.038) and 17.0 weeks vs. 12.0 weeks (p=0.006), respectively]. Three (4.2%) patients terminated MCT because of toxicity. Conclusion: In this real-world retrospective study, MCT was effective and well tolerated, and may thus represent a valuable treatment option in selected MBC patients.

show abstract

“…Clinical benefits were obtained in the majority of patients and a number of complete responses were achieved. No treatment related death was reported, and the toxicity appeared manageable [ 28 , 29 •, 30 – 32 ].…”

Section: Metronomic Chemotherapy In Elderly Breast Cancer Patientsmentioning

confidence: 99%

Metronomic Chemotherapy in Elderly Patients

Bandini,

Calabrò,

Banchi

et al. 2024

Curr Oncol Rep

View full text Add to dashboard Cite

Purpose of Review This review describes the most relevant studies found in the scientific literature regarding metronomic chemotherapy (MCT) in the geriatric oncology population to support its use as a feasible treatment of care in the frail elderly patients. Recent Findings Recent years have seen a reevaluation of cancer chemotherapeutic drugs and MCT is an emerging schedule in phase II and III clinical trials. Summary Ageing is one of the risk factors for the development of cancer, the incidence of whom increases dramatically in people who live longer. To date, standard oncological protocols involve chemotherapeutic drugs in short cycles of therapy at the maximum tolerated dose (MTD). Although these therapeutic regimens may be successful, they can cause important adverse drug reactions, especially in elderly or frail patients. MCT is a different modality of delivery of chemotherapeutic drugs (frequent low dose for prolonged time) and it looks at the overcoming of the limitations and disadvantages of MTD, in particular the toxicity aspect. We reviewed the experience of clinicians who have used MCT in clinical trials enrolling elderly patients with different cancer types.

show abstract

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

Cited by 7 publications

References 36 publications

Metronomic Chemotherapy for Metastatic Breast Cancer Treatment: Clinical and Preclinical Data between Lights and Shadows

Metronomic Chemotherapy for Metastatic Breast Cancer Treatment: Clinical and Preclinical Data between Lights and Shadows

Real-World Experience of Metronomic Chemotherapy in Metastatic Breast Cancer: Results of a Retrospective Unicenter Study

Metronomic Chemotherapy in Elderly Patients

Contact Info

Product

Resources

About