Oral vinorelbine and capecitabine as first-line therapy in metastatic breast cancer: a retrospective analysis

A retrospective analysis of 70 patients with triple-negative or hormone-resistant advanced breast carcinoma who had not previously received chemotherapy was carried out. Patients received oral vinorelbine 60 mg/m2 on day 1 and 8, plus capecitabine 1000 mg/m2 bid for 14 consecutive days every 3 weeks. Overall response rate was 53% with a 9% complete response rate. Stable disease was recorded in 27% of the cases. Median progression-free survival was 7.9 months and median overall survival was 29.2 months. Toxicity was generally mild and easily manageable. These data demonstrate that this combination is feasible, safe and active as first-line treatment of triple-negative fully hormone-resistant advanced breast carcinoma patients.

Metronomic chemotherapy with oral Navelbine produces clinical benefit and low toxicity in metastatic breast cancer in K Hospital

Background: The metronomic concept emerged more than 20 year sago, however, a significant development in various solidtumors was noticed in the past 10 years. There are potentially several mechanisms of action against tumor cells including inhibition of angiogenesis. This study aims to assess the efficacy and the safety of ametronomic schedule of oral Vinorelbine (Navelbine) in treatment of metastatic breast cancer. Methods: For the duration from January 2020 to June 2021 there were 30 metastatic breast cancer patients at the median age of 53 years (range 34 - 72), were treated with a metronomic schedule of oral Vinorelbine (VNR). Oral VNR was administered 40 mg three times weekly, continuously. Patients took oral VNR continuously on days 1, 3 and 5 of the week until the disease progression or unacceptable side effects. The difference between before and after 9 weeks treatment was conducted via the matched t - tests to discern the quality - of - life indicator (p < 0.05 was considered significant). Progression - free survival analysis was performed using Kaplan Maier. Results: All 30 patients received at least 9 weeks of therapy and were evaluated. 7 achieved partial responses (23.3%) and 13 achieved stable disease responses (43.4%). Median progression - free survival entailed 6.9 months. The quality of life was notified significantly. A good result was found in our metastatic breast cancer patients, who were given with a Metronomic Vinorelbine (mVNR) administration. Conclusions: As a result of our latest study indicated that themetronomic vinorelbine might become a potential treatment for metastatic breast cancer patients via the reduction of adverse effects and improvement of life quality and sets the stage for future extensive clinical trials.

Clinical case of the use of oral metronomic vinorelbin in patient with metastatic Her2 negative breast cancer

Endocrine therapy in combination with inhibitors of cyclin-dependent kinases 4/6 in first lines is the current standard of treatment of metastatic ER positive Her2 negative breast cancer. After progression on several lines of endocrine therapy according to current principles we apply sequential lines of monochemotherapy. If possible non-toxic agents are prefered in order to maintain high quality of life. The special role in this context may play oral agents, when regular visits in clinic and intravenous injection are not needed. The efficacy of oral vinorelbine is well explored, unfortunately the standard dosage regimen сan have quite high especially hematologic toxicity. The metronomic dosing regimen is believed to be as effective as the standard, but is less toxic. In addition, the anti-angiogenic properties of the metronomic mode are described. Taking into account the increasing use of combination of endocrine therapy with CDK4/6 inhibitors in first treatment lines, it is extremely important to study the efficacy and tolerability of various regimens and drugs after progression on combined endocrine therapy. In this article, we represent a clinical case of the use of oral vinorelbine in the metronomic mode in the patient after progression on combination of fulvestrant and palbociclib. Long-term disease control with satisfactory quality of life has been demonstrated.

Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine in Patients With Previously Treated HER2-Positive Metastatic Breast Cancer: A Multicenter, Retrospective Study

BackgroundPyrotinib is a newly-developed irreversible pan-ErbB (erythroblastic leukemia viral oncogene homolog) receptor oral tyrosine kinase inhibitor (TKI) with promising efficacy in the human epidermal growth factor receptor-2 (HER2) positive breast cancer. The phase III PHOEBE study proved that pyrotinib plus capecitabine exceeded lapatinib plus capecitabine (LX) in PFS (p &lt; 0.001). Oral vinorelbine is commonly used in combination with anti-HER2 treatment. However, no evidence was reported in terms of the real-world pattern, safety, and efficacy of pyrotinib plus vinorelbine (NP) compared with LX.MethodsMedical records were retrospectively evaluated for all HER2-positive metastatic breast cancer (MBC) patients who experienced progression on prior trastuzumab-containing regimens (advanced setting) and taxane (any setting) and received NP or LX therapy from 2015 to 2021 in five institutions.ResultsA total of 224 patients were enrolled and evaluated, of which 132 (58.9%) patients received LX and 92 (41.1%) patients received NP. The median progression-free survival (mPFS) of NP group was significantly longer than that in LX group (8.3 vs 5.0 months, HR = 0.47 95% CI 0.34–0.65, p &lt; 0.001). The advantage of NP over LX was seen both in patients with trastuzumab resistance (p &lt; 0.001) and refractoriness (p = 0.004). The NP group had more diarrhea cases (23.9%) compared to the LX group (8.3%). Discontinuation rates in the two groups were similar.ConclusionsThis trial revealed the clinical practice of NP and LX treatment among HER2+ MBC patients pretreated with trastuzumab in China. More patients received LX than NP in real-world while the efficacy of NP exceeded LX in terms of PFS regardless of resistant status of trastuzumab. Although the NP group had more diarrhea cases, toxicities in both groups were acceptable.

Single-Agent Oral Vinorelbine in the Treatment of Pediatric Progressive Optic Pathway Glioma: A Single Institutional Experience

Purpose: The vinca alkaloids’ activity against pediatric low-grade glioma (PLGG) is well established. The goal of the present study is to describe our experience with oral vinorelbine in patients with progressive optic pathway glioma (OPG), not only regarding the clinical response, but also the cost benefit using an oral medication. Methods: Patients under 21 years of age with unresectable and/or progressive OPG were eligible. Oral vinorelbine was administered at a dose of 90mg/m2 daily on days 0, 8 and 22, in a scheme of 4 weekly cycles for a total of 18 cycles (54 doses). Results: From 2013 to 2018, sixteen patients were enrolled onto the study, with a median age of 9,1 years (range 4,6-17,8y). The most common histology was pilocytic astrocytoma (88,8%). Best response to chemotherapy was reviewed with a response rate (complete, partial, or minor response) of 30% for the patients treated exclusively with the oral drug. Five-year event-free survival (EFS) rate was 43.4%. Six patients had to change to intravenous vinorelbine due to gastrointestinal toxicity, vomiting grade III. None of the patients showed neurotoxicity. The total cost including drug acquisition, administration and toxicity management was lower with the oral formulation comparing to IV one. Conclusion: Single-agent oral vinorelbine seems to have some clinical activity in the management of recurrent or refractory pediatric OPG, being an interesting and cost-effective option, minding that gastrointestinal toxicity may be limiting and a combination of antiemetics should be considered in this treatment regimen.

Metronomic oral vinorelbine doublet chemotherapy with carboplatin in treatment of advanced lung cancer: a feasibility and safety study

Background: Non-small cell lung cancer (NSCLC) is globally one of the most common forms of cancer. Palliative treatment is a delicate balance against toxicity and survival. Using small frequent doses of chemotherapy, metronomic regimens have been hypothesized to maintain or even improve efficacy while achieving a lower treatment-related toxicity. The mechanism is thought to result from a more continuous exposure of the tumour cells to the drugs. Treating NSCLC, this study addresses the feasibility and tolerability of carboplatin in combination with 12 weeks of daily metronomic vinorelbine. Method: Patients were included over a period of ten months. All patients had biopsy-verified incurable NSCLC and were candidates for first line chemotherapy (PD-L1<50% and no targetable mutations). This open label, non-randomized prospective safety and feasibility study was investigator initiated. Patients received up-to four cycles of standard dose carboplatin AUC 5 every third week in combination with 12 weeks of metronomic oral daily Navelbine® (20/30 mg). Patients were evaluated by CT scans after end of treatment and then every 8 weeks (+/- 1 week) until progression. Results: A total of 20 patients were included. Male/female-ratio was 4/16. Age ranged from 49-83 with a median of 70.5 years. Majority had adenocarcinoma (95%). Two patients withdrew their consent within a week. 18 patients were included in safety analysis. 13 received all four cycles. Grade 1/2 toxicity was frequently seen and included fatigue 13 (72%), diarrhoea 13 (72%), constipation/congestion 13 (72%). Grade 3 toxicities were dyspnoea 2 (11%), nausea 3 (17%) and fatigue 3 (17%). Two (11%) had grade 4 toxicity with neutropenic fever, both recovered. No grade 5 toxicity was detected. Conclusion: In treatment of NSCLC this study is the first addressing the regimen of carboplatin in combination with daily metronomic vinorelbine. We conclude that doublet chemotherapy with daily vinorelbine is safe and feasible.