Oral Metronomic Vinorelbine (OMV) in elderly or pretreated patients with advanced non small cell lung cancer: outcome and pharmacokinetics in the real world

Pasini, Felice; Barile, Carmen; Caruso, Donatella; Modena, Yasmina; Fraccon, Anna Paola; Bertolaso, Laura; Menon, Daniela; Russa, Francesca La; Crepaldi, Giorgio; Bononi, Antonio; Spezzano, Roberto; Padrini, Roberto; Corona, Giuseppe; Gusella, Milena

doi:10.1007/s10637-018-0631-8

Cited by 13 publications

(19 citation statements)

References 23 publications

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“…MTDs were reached at an oral dose of 60 mg 3 times/week for vinorelbine and 85 mg/m 2 for DDP and ORR was 20.8%. This metronomic strategy was tolerable and effective in patients with NSCLC (21).…”

Section: Clinical Trials Of Mctmentioning

confidence: 90%

“…Later line treatment. Oral metronomic vinorelbine produced non-negligible survival in elderly or pretreated patients and exhibited stable long-term blood concentrations (21,26,27). Daily oral vinorelbine (30 mg/day) for 21 days with an interruption in treatment for 1 week was well tolerated without dose-limiting toxicity (26).…”

Section: Clinical Trials Of Mctmentioning

confidence: 99%

“…A meta-analysis of metronomic oral vinorelbine encompassing 418 patients reported an OS of 8.7 months (95% confidence interval, 7.6-9.5) (20). A schedule of 20-30 mg every other day without interruption demonstrated good tolerance and clinical benefit (21).…”

Section: Clinical Trials Of Mctmentioning

confidence: 99%

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Metronomic chemotherapy in non‑small cell lung cancer (Review)

2020

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Metronomic chemotherapy (MCT) is defined as the rhythmic chemotherapy of low-dose cytotoxic drugs with short or no drug-free breaks over prolonged periods. MCT affects tumor cells and the tumor microenvironment. Particularly, the low-dose schedule impairs the repair process of endothelial cells, resulting in an anti-angiogenesis effect. By stimulating the immune system to eliminate tumor cells, MCT induces immunological activation. Furthermore, combined with targeted therapy, anti-angiogenic drugs enhance the efficacy of MCT. The present review is an overview of phase I, II and III clinical trials focusing on the efficacy, toxicity and mechanism of MCT in patients with non-small cell lung cancer (NSCLC). Furthermore, the prospects of MCT in NSCLC have been discussed. The present review indicated that MCT is an efficacious treatment for selected patients with NSCLC, with acceptable systemic side effects and economic viability for public health. Contents 1. Introduction 2. Preclinical studies of MCT 3. Clinical trials of MCT 4. Mechanism of MCT 5. Conclusion

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Section: Clinical Trials Of Mctmentioning

confidence: 90%

Section: Clinical Trials Of Mctmentioning

confidence: 99%

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Metronomic chemotherapy in non‑small cell lung cancer (Review)

2020

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“…Median PFS was 3.9 months (range 1–13 months) and median OS reached 8.1 months (range 4.0–24.0+ months) with a 12-month survival rate of 22% ( Figure 1 ). These findings are not surprising as other studies failed to identify correlations between patient outcomes and metronomic oral VNR pharmacokinetics [ 21 , 22 ].…”

Section: Discussionmentioning

confidence: 70%

Metronomic oral vinorelbine in patients with advanced non-small cell lung cancer progressing after nivolumab immunotherapy: a retrospective analysis

Gebbia

Aiello

Banna

et al. 2020

ecancer

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Purpose: The availability of immune checkpoint inhibitors has deeply changed the therapeutic scenario of patients with advanced non-small cell lung cancer (NSCLC). Up until now, chemotherapy still represents the first-line treatment for patients with advanced NSCLC not harbouring genetic mutations or lacking high expression of programmed death ligand even if the addition of immunotherapy to first-line chemotherapy has recently been shown to improve clinical outcome. We carried out a multi-institutional retrospective analysis on third-line chemotherapy with metronomic oral vinorelbine (VNR) in a series of patients with metastatic NSCLC pre-treated with first-line chemotherapy and second-line immunotherapy. Patients and methods: Thirty patients with metastatic NSCLC with progressive disease after first-line chemotherapy and subsequent immunotherapy were treated with metronomic oral VNR continuously at the fixed dose of 30 mg three times per week. Results: A partial response was achieved in 4 patients (13.3%), while 10 patients (33.3%) displayed disease stabilisation for an overall disease control rate of 46.7%. Median progression-free survival was 3.9 months (range 1–13 months) and median OS reached 8.1 months (range 4.0–24.0+ months) with a 12-month survival rate of 22%. Conclusion: Oral metronomic VNR appears to be active and safe in patients with metastatic NSCLC in progression after first-line chemotherapy and second-line immunotherapy. The results reported, although from a limited sample, may suggest its use for long-term stabilisation of the disease with good patient compliance.

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“…We know from the literature that mathematical modelling may allow physicians to choose the treatment's regimen which encompasses the timing of administration, based on the evaluation of tolerability and pharmacokinetics [ 31 ]. Recent new trials reported that pharmacokinetics of the aforementioned vinorelbine is stable and the toxicity is associated with high dose of the drug [ 32 ]. Another recent prospective trial explored the activity and feasibility of mVNR 30 mg x 3/wk in selected groups of elderly patients, with advanced disease and poor prognosis owing to the presence of distant metastases and comorbidities.…”

Section: Discussionmentioning

confidence: 99%

Metronomic Chemotherapy with Vinorelbine Produces Clinical Benefit and Low Toxicity in Frail Elderly Patients Affected by Advanced Non-Small Cell Lung Cancer

D’Ascanio

Pezzuto

Fiorentino

et al. 2018

BioMed Research International

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Background Lung cancer is the leading cause of death worldwide. The treatment choice for advanced stage of lung cancer may depend on histotype, performance status (PS), age, and comorbidities. In the present study, we focused on the effect of metronomic vinorelbine treatment in elderly patients with advanced unresectable non-small cell lung cancer (NSCLC). Methods From January 2016 to December 2016, 44 patients affected by non-small cell lung cancer referred to our oncology day hospital were progressively analyzed. The patients were treated with oral vinorelbine 30 mg x 3/wk or 40 mg x 3/wk meaning one day on and one day off. The patients were older than 60, stage IIIB or IV, ECOG PS ≥ 1, and have at least one important comorbidity (renal, hepatic, or cardiovascular disease). The schedule was based on ECOG-PS and comorbidities. The primary endpoint was progression-free survival (PFS). PFS was used to compare patients based on different scheduled dosage (30 or 40 mg x3/weekly) and age (more or less than 75 years old) as exploratory analysis. We also evaluated as secondary endpoint toxicity according to Common Toxicity Criteria Version 2.0. Results Vinorelbine showed a good safety profile at different doses taken orally and was effective in controlling cancer progression. The median overall survival (OS) was 12 months. The disease control rate (DCR) achieved 63%. The median PFS was 9 months. A significant difference in PFS was detected comparing patients aged below with those over 75, and the HR value was 0.72 (p<0.05). Not significant was the difference between groups with different schedules. Conclusions This study confirmed the safety profile of metronomic vinorelbine and its applicability for patients unfit for standard chemotherapies and adds the possibility of considering this type of schedule not only for very elderly patients.

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Oral Metronomic Vinorelbine (OMV) in elderly or pretreated patients with advanced non small cell lung cancer: outcome and pharmacokinetics in the real world

Cited by 13 publications

References 23 publications

Metronomic chemotherapy in non‑small cell lung cancer (Review)

Metronomic chemotherapy in non‑small cell lung cancer (Review)

Metronomic oral vinorelbine in patients with advanced non-small cell lung cancer progressing after nivolumab immunotherapy: a retrospective analysis

Metronomic Chemotherapy with Vinorelbine Produces Clinical Benefit and Low Toxicity in Frail Elderly Patients Affected by Advanced Non-Small Cell Lung Cancer

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