Safety and efficacy study of oral metronomic vinorelbine combined with trastuzumab (mNH) in HER2-positive metastatic breast cancer: a phase II trial

Wang, Zijing; Liu, Jiaxuan; Ma, Fei; Wang, Jiayu; Luo, Yang; Fan, Ying; Yuan, Peng; Zhang, Pin; Li, Qing; Li, Qiao; Xu, Binghe

doi:10.1007/s10549-021-06216-5

Cited by 14 publications

(9 citation statements)

References 21 publications

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“…Other authors [ 53 ] investigated the combination of mCHT (VNR 40 mg thrice a week), in combination with trastuzumab, reporting very few adverse events, the most important being neutropenia, which was observed in 10% of the patients.…”

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

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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.

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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

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“…Long-term metronomic treatment may result in anticancer drug cumulative toxicity, which might lead to secondary illnesses. [8][9][10] The toxicity profile of metronomic chemotherapy in geriatric cancer patients was studied in a few Indian researches. The study's goal is to determine the toxicity profile of metronomic chemotherapy, as well as the pattern of ADRs and drug-drug interactions (DDIs) in geriatric cancer patients receiving metronomic chemotherapy in South Indian populations.…”

Section: Introductionmentioning

confidence: 99%

“…Long-term metronomic treatment may result in anticancer drug cumulative toxicity, which might lead to secondary illnesses. 8–10…”

Section: Introductionmentioning

confidence: 99%

Toxicity profile, adverse drug reactions and drug-drug interactions among geriatric cancer patients under metronomic chemotherapy in a South Indian tertiary care hospital

Sureshkumar

Srinivasan

Lingeshwaran

et al. 2022

J Oncol Pharm Pract

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Objective The study aims to examine the toxicity profile, pattern of adverse drug reactions (ADRs) and drug-drug interactions (DDIs) in geriatric cancer patients receiving metronomic chemotherapy. Patients and Methods Patients were followed after each cycle till 12 weeks. Haematological parameters such as complete blood count, liver function test and renal function test were recorded from the baseline to the final visit. The Common Terminology Criteria for Adverse Events (CTCAE) scale was used to characterise the toxicity profile. ADRs that the patients had were documented and assessed for its causality, severity and preventability. The Lexicomp drug interaction checker was used to grade DDIs. Results Of 129 patients, according to CTCAE grading, haemoglobin indicated grade 1 toxicity, while other haematological parameters revealed no toxicity. Although there was a statistically significant difference in ALT, alkaline phosphate, serum creatinine and potassium ( p < 0.05), it was not clinically significant. A total of 226 ADRs were documented. Anaemia was the most frequently occurred ADR (14%) and Capecitabine caused the highest number of ADRs. Assessments of causality showed that the majority of cases are “possible” (63%). In evaluating the severity of ADRs, 99% ADRs were “mild” and 61% of ADRs were “probably” preventable. Upon assessing the DDIs, 82% of the prescriptions had “no known interaction”. Conclusion Metronomic chemotherapy in geriatric cancer patients exhibited grade 1 toxicity for haemoglobin. Anemia was the most common ADRs. The majority of cases were “possible” in causality, “mild” in severity, and “probably” preventable. The majority of the prescriptions have no known DDIs.

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“…The long-term outcome data [ 38 ] from this trial recently presented a median follow-up of 54.0 months and demonstrated metronomic chemotherapy-based dual blockade as an active and relatively well-tolerated treatment option in the older or frail population. A single-arm phase II clinical trial carried out by Wang et al [ 39 ] firstly verified the antitumor potency and well-tolerated toxicity of TZM and metronomic vinorelbine combination treatment in HER2-positive metastatic breast cancer patients. An ORR of 20.0% and a CBR of 75.0% were identified.…”

Section: Clinical Trials and Practice In Various Breast Cancer Subtypesmentioning

confidence: 99%

Current Research Status of Metronomic Chemotherapy in Combination Treatment of Breast Cancer

Liu

Wang

et al. 2022

Oncol Res Treat

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Background: Metronomic chemotherapy (MCT), termed sustained low-dose administration with minimal toxicity, is a new modality of conventional chemotherapy, a verified therapy alternative, and has acquired significant recognition and interest in oncology. Numerous clinical trials of MCT in combination with other treatments, including targeted therapies, biologics, and endocrine therapy, are in progress to obtain better results. Summary: We systematically reviewed the most recent clinical data from Pubmed/Medline, ClinicalTrials.gov, and the European Clinical Trials Database. We comprehensively described the clinical benefits of MCT in combination with other treatments in different molecular subtypes of breast cancer and assessed the feasibility of its adoption in varying phases of treatment. Key message: MCT, in combination with other therapeutic interventions, will fully exploit the benefits of this strategy, ushering in a new paradigm in oncology treatment and driving the transformation of cancer into a more manageable chronic disease using newly developed treatment approaches.

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Safety and efficacy study of oral metronomic vinorelbine combined with trastuzumab (mNH) in HER2-positive metastatic breast cancer: a phase II trial

Cited by 14 publications

References 21 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

Toxicity profile, adverse drug reactions and drug-drug interactions among geriatric cancer patients under metronomic chemotherapy in a South Indian tertiary care hospital

Current Research Status of Metronomic Chemotherapy in Combination Treatment of Breast Cancer

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