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American Society of Clinical Oncology... 2017On the basis of several randomized trials and meta-analyses, adjuvant chemotherapy is the accepted standard of care for certain patients with early-stage non-small cell... (Review)
Review
On the basis of several randomized trials and meta-analyses, adjuvant chemotherapy is the accepted standard of care for certain patients with early-stage non-small cell lung cancer (NSCLC). Patients with stage II, IIIA, or large (≥ 4 cm) IB tumors are candidates for adjuvant chemotherapy. The survival improvement with adjuvant chemotherapy is approximately 5% at 5 years, though certain trials have suggested that it can be 8% to 10%. Neoadjuvant chemotherapy also has shown a survival advantage, though the volume of data with this approach is far less than that of adjuvant chemotherapy. The combination of cisplatin and vinorelbine is the most well-studied regimen, but current consensus is to use four cycles of any of the platinum-based chemotherapy regimens commonly used as front-line therapy for patients with advanced-stage NSCLC. Trials to define biomarkers that can predict benefit from adjuvant chemotherapy have not been successful, but results of other such trials are still awaited. On the basis of the benefit observed with targeted agents in patients with advanced-stage disease and driver genetic alterations in their tumors, ongoing trials are evaluating the utility of these targeted agents as adjuvant therapy. Similarly, clinical benefit observed with checkpoint inhibitors has prompted assessment of these drugs in patients with early-stage NSCLC. It is very likely, in the future, that factors other than the anatomy of the tumor will be used to select patients with early-stage NSCLC for systemic therapy and that the choice of systemic therapy will extend beyond platinum-based chemotherapy.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Cell Lung; Chemotherapy, Adjuvant; Cisplatin; Humans; Neoplasm Staging; Vinblastine; Vinorelbine
PubMed: 28561669
DOI: 10.1200/EDBK_175188 -
The Oncologist Dec 2020Desmoid tumors (DT) are rare collagen-forming tumors that can exhibit locally aggressive patterns of behavior. The aim of this study was to evaluate the efficacy and...
INTRODUCTION
Desmoid tumors (DT) are rare collagen-forming tumors that can exhibit locally aggressive patterns of behavior. The aim of this study was to evaluate the efficacy and safety of treatment of DT with single-agent oral vinorelbine.
MATERIALS AND METHODS
A retrospective review of patients treated with vinorelbine 90 mg orally on days 1, 8, and 15 of a 28-day cycle from January 2004 to July 2019 was performed. Response was assessed using RECIST version 1.1. Descriptive statistics were employed.
RESULTS
A total of 29 patients were included. Response rate was 20.7% (6/29), and clinical benefit rate (response by RECIST 1.1 and/or clinical symptom improvement) was 65.5% (19/29). No patient experienced grade 3 or above toxicity. Common toxicities were grade 1-2 nausea (14/26, 48.3%), fatigue (9/26, 31.0%), and diarrhea (4/26, 13.8%).
CONCLUSION
Single-agent oral vinorelbine is an effective, safe, and well-tolerated treatment for DT. It represents a new oral alternative for management of DT.
Topics: Administration, Oral; Antineoplastic Combined Chemotherapy Protocols; Fibromatosis, Aggressive; Humans; Retrospective Studies; Treatment Outcome; Vinblastine; Vinorelbine
PubMed: 32918789
DOI: 10.1002/ONCO.13516 -
Pharmacological Research Mar 2020The Aidi injection contains multiple active ingredients, including astragaloside (Re, Rb1, and Rg1), ginsenoside, cantharidin, elentheroside E, and syringin, and it is... (Meta-Analysis)
Meta-Analysis
Clinical efficacy and safety of aidi injection combination with vinorelbine and cisplatin for advanced non-small-cell lung carcinoma: A systematic review and meta-analysis of 54 randomized controlled trials.
The Aidi injection contains multiple active ingredients, including astragaloside (Re, Rb1, and Rg1), ginsenoside, cantharidin, elentheroside E, and syringin, and it is administered with vinorelbine and cisplatin (NP) to treat non-small-cell lung carcinoma (NSCLC). In this study, we performed a systematic review and meta-analysis to determine the clinical efficacy and safety of the Aidi injection with NP, and the optimal threshold and treatment regimen to produce the desired responses. We collected all studies regarding the Aidi injection with NP for NSCLC from Chinese and English databases (up to April 2019). Risk of methodological bias was evaluated for each study. Data for analysis were extracted using a standard data extraction form. Evidence quality was assessed following the Grading of Recommendations Assessment, Development and Evaluation approach. We included 54 trials containing 4,053 patients for analysis. Combining the Aidi injection with NP significantly increased the objective response rate (odds ratio [OR], 1.32; confidence interval [CI], 1.23, 1.42), disease control rate (OR, 1.14; CI, 1.11, 1.18), and quality of life (OR, 1.80; CI, 1.61, 1.98), with decreased risks of myelosuppression, neutropenia, thrombocytopenia, anemia, gastrointestinal reaction, and liver dysfunction. For patients with a Karnofsky Performance Status score of ≥60, the Aidi injection (50 mL/day, two weeks/cycle, with two to three cycles) treatment with vinorelbine (25 mg/m) and cisplatin (30-35 mg/m or 40-50 mg/m) might be the optimal regimen for producing the desired tumor response and achieving a good safety level. Most results were robust, and their quality was moderate. The results suggest that administration of the Aidi injection and concomitant NP is beneficial to NSCLC, and provide evidence for the optimal threshold and treatment regimen that may improve tumor response with a good safety level.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Cell Lung; Cisplatin; Drugs, Chinese Herbal; Humans; Injections; Lung Neoplasms; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome; Vinorelbine
PubMed: 31935454
DOI: 10.1016/j.phrs.2020.104637 -
Pediatric Hematology and Oncology May 2021
Topics: Antineoplastic Combined Chemotherapy Protocols; Child; Cyclophosphamide; Humans; Infusions, Intra-Arterial; Male; Meningeal Neoplasms; Positron-Emission Tomography; Rhabdomyosarcoma; Sirolimus; Vinorelbine
PubMed: 33439069
DOI: 10.1080/08880018.2020.1871138 -
Journal of Healthcare Engineering 2022We aimed to explore the epidemiological characteristics and changes of lung cancer and the clinical medication in England from 2001 to 2019. We searched related research...
We aimed to explore the epidemiological characteristics and changes of lung cancer and the clinical medication in England from 2001 to 2019. We searched related research using search engine systems such as MEDLINE, PubMed, and PsychINFO. Lung cancer is a serious disease and the prognosis is usually very poor. The overall mortality rate of lung cancer decreased year by year in England from 2001 to 2019, but men, the elderly, and people exposed to polluted air are still more likely to be infected with lung cancer or die as a result, the prevalence and mortality rate of lung cancer in the north of England is significantly higher than that in the south, and the gap is increasing year by year. Lung cancer has changeable risk factors such as quitting smoking and improving air quality, which can effectively reduce the related risk. Paclitaxel, docetaxel, gemcitabine, and vinorelbine are the main drugs for the treatment of lung cancer in England and the treatment of these drugs is beneficial to the survival and quality of life of patients. Men and the elderly are at high risk of lung cancer, which means that lung cancer has obvious gender inequality and age inequality. At the same time, based on the statistical data of lung cancer risk in different regions, it can be concluded that lung cancer also has strong geographical and economic inequality. Changing risk factors and using drugs can effectively reduce the risk of lung cancer and provide effective treatment.
Topics: Aged; Epidemiologic Studies; Humans; Lung Neoplasms; Male; Quality of Life; Smoking; Vinorelbine
PubMed: 35368924
DOI: 10.1155/2022/3577312 -
Cancer Research Feb 2021Checkpoint inhibitors (CI) instigate anticancer immunity in many neoplastic diseases, albeit only in a fraction of patients. The clinical success of cyclophosphamide...
Checkpoint inhibitors (CI) instigate anticancer immunity in many neoplastic diseases, albeit only in a fraction of patients. The clinical success of cyclophosphamide (C)-based haploidentical stem-cell transplants indicates that this drug may re-orchestrate the immune system. Using models of triple-negative breast cancer (TNBC) with different intratumoral immune contexture, we demonstrate that a combinatorial therapy of intermittent C, CI, and vinorelbine activates antigen-presenting cells (APC), and abrogates local and metastatic tumor growth by a T-cell-related effect. Single-cell transcriptome analysis of >50,000 intratumoral immune cells after therapy treatment showed a gene signature suggestive of a change resulting from exposure to a mitogen, ligand, or antigen for which it is specific, as well as APC-to-T-cell adhesion. This transcriptional program also increased intratumoral Tcf1 stem-like CD8 T cells and altered the balance between terminally and progenitor-exhausted T cells favoring the latter. Overall, our data support the clinical investigation of this therapy in TNBC. SIGNIFICANCE: A combinatorial therapy in mouse models of breast cancer increases checkpoint inhibition by activating antigen-presenting cells, enhancing intratumoral Tcf1 stem-like CD8 T cells, and increasing progenitor exhausted CD8 T cells.
Topics: Animals; Antigen-Presenting Cells; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; CD8-Positive T-Lymphocytes; Cell Adhesion; Cyclophosphamide; Female; Hepatocyte Nuclear Factor 1-alpha; Immune Checkpoint Inhibitors; Immunity, Cellular; Mice; Mice, Inbred BALB C; Programmed Cell Death 1 Receptor; Transcriptome; Triple Negative Breast Neoplasms; Vinorelbine
PubMed: 33268528
DOI: 10.1158/0008-5472.CAN-20-1818 -
Journal of Clinical Oncology : Official... Dec 2022JCO The randomized, open-label, phase II EVAN study investigated the efficacy (disease-free survival [DFS] and 5-year overall survival [OS]) and safety of erlotinib... (Randomized Controlled Trial)
Randomized Controlled Trial
Updated Overall Survival and Exploratory Analysis From Randomized, Phase II EVAN Study of Erlotinib Versus Vinorelbine Plus Cisplatin Adjuvant Therapy in Stage IIIA Epidermal Growth Factor Receptor+ Non-Small-Cell Lung Cancer.
JCO The randomized, open-label, phase II EVAN study investigated the efficacy (disease-free survival [DFS] and 5-year overall survival [OS]) and safety of erlotinib versus vinorelbine/cisplatin as adjuvant chemotherapy after complete resection (R0) for stage III epidermal growth factor receptor () mutation+ non-small-cell lung cancer. We describe the updated results at the 43-month follow-up. In EVAN, patients were randomly assigned (1:1) to erlotinib (n = 51) or vinorelbine/cisplatin (n = 51). The median follow-up was 54.8 and 63.9 months in the erlotinib and chemotherapy arms, respectively. With erlotinib, the respective 5-year DFS by Kaplan-Meier analysis was 48.2% (95% CI, 29.4 to 64.7) and 46.2% (95% CI, 27.6 to 62.9) in the intention-to-treat and per-protocol populations. The median OS was 84.2 months with erlotinib versus 61.1 months with chemotherapy (hazard ratio, 0.318; 95% CI, 0.151 to 0.670). The 5-year survival rates were 84.8% and 51.1% with erlotinib and chemotherapy, respectively. In whole-exome sequencing analysis, frequent genes with variants co-occurring at baseline were , , , , and . With erlotinib, a single-nucleotide polymorphism mutation in was associated with significantly worse DFS ( = .01). To our knowledge, this study is the first to demonstrate clinically meaningful OS improvement with adjuvant erlotinib compared with chemotherapy in R0 stage III EGFR+ non-small-cell lung cancer.
Topics: Humans; Carcinoma, Non-Small-Cell Lung; Erlotinib Hydrochloride; Vinorelbine; Cisplatin; Lung Neoplasms; Protein Kinase Inhibitors; Antineoplastic Combined Chemotherapy Protocols; Neoplasm Staging; ErbB Receptors; Disease-Free Survival; Mutation; Axonemal Dyneins
PubMed: 36027483
DOI: 10.1200/JCO.22.00428 -
Current Cancer Drug Targets 2024This study aimed to observe the efficacy and safety of inetetamab and pyrotinib in combination with vinorelbine in second-line therapy and beyond in HER2-positive...
The Efficacy and Safety of Inetetamab and Pyrotinib in Combination with Vinorelbine for Second-line Therapy and Beyond in HER2-positive Metastatic Breast Cancer: A Single-institution Clinical Experience.
BACKGROUND AND OBJECTIVES
This study aimed to observe the efficacy and safety of inetetamab and pyrotinib in combination with vinorelbine in second-line therapy and beyond in HER2-positive metastatic breast cancer (MBC).
METHODS
Patients with HER2-positive MBC admitted to our hospital from January 2016 to December 2021 were selected. For patients who could not receive antibody‒drug conjugates (ADCs) during second-line (2-line) or third-line and beyond (≥ 3-line) anti-HER2 therapy, inetetamab + pyrotinib + vinorelbine was used for treatment until unacceptable adverse events occurred or the disease progressed, as evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 every 2 cycles. The progression-free survival (PFS), objective response rate (ORR), clinical benefit rate (CBR), and adverse reactions were recorded. Multivariate Cox regression analysis was performed to explore the prognostic factors influencing the curative effect.
RESULTS
Overall, 52 patients were included; 13 patients received 2-line treatment, and 39 patients received ≥ 3-line treatment. The median PFS (mPFS) for all patients treated with inetetamab + pyrotinib + vinorelbine was 7 months. The mPFS of the 2-line subgroup was significantly better than that of the ≥ 3-line subgroup (17 vs. 5 months, P = 0.001). The mPFS of the subgroups that received trastuzumab (H) or trastuzumab and pertuzumab (HP) only was significantly better than that of the H or HP and tyrosine kinase inhibitor (TKI) subgroups (8 vs. 5 months, P = 0.030). The mPFS of the HER2 resistance subgroup was better than that of the HER2 refractoriness subgroup (14 vs. 7 months, P = 0.025). Cox regression analysis showed that the treatment line (2-line more so than ≥ 3-line) was an independent prognostic factor for PFS. In addition, the ORR and CBR of 2-line patients were significantly higher than those of ≥ 3-line patients (69.2% vs. 30.8% and 92.3% vs. 64.1%, respectively). The most common hematological toxicities were leukopenia and neutropenia, and the most common nonhematological toxicity was diarrhea.
CONCLUSION
Inetetamab and pyrotinib in combination with vinorelbine have good efficacy in ≥ 2-line treatment of HER2-positive MBC with controllable toxicity, and the combination is a new treatment option, especially for patients who cannot use ADCs in 2-line treatment.
Topics: Humans; Vinorelbine; Female; Breast Neoplasms; Middle Aged; Antineoplastic Combined Chemotherapy Protocols; Receptor, ErbB-2; Aged; Adult; Acrylamides; Progression-Free Survival; Retrospective Studies; Aminoquinolines
PubMed: 37916639
DOI: 10.2174/0115680096248592231016065117 -
Leukemia Research Sep 2019Salvage regimens in relapsed/refractory Hodgkin's lymphoma (HL) differ in their efficacy and toxicity profiles. Gemcitabine (G), vinorelbine (V) and liposomal...
BACKGROUND
Salvage regimens in relapsed/refractory Hodgkin's lymphoma (HL) differ in their efficacy and toxicity profiles. Gemcitabine (G), vinorelbine (V) and liposomal doxorubicin (GVDoxil) is one regimen with high response rates but has high toxicity and cost. We devised a regimen of GVDex by substituting the more expensive liposomal doxorubicin with the cheaper high-dose dexamethasone (Dex).
PATIENTS AND METHODS
We analyzed the data of 48 adult and paediatric patients of relapsed/refractory HL who received GVDex as salvage therapy. GVDex was delivered as outpatient once in 3 weeks (Q3 weekly) (G 1000 mg/m IV over 30 min on D1, 8; V 25 mgm IV fast infusion on D1, 8; Dex40 mg PO D1-4) for 2-3 cycles. We present the overall response rate, toxicity, progression-free (PFS) and overall survival (OS) from the time of start of GVDex.
RESULTS
Forty-eight patients [median age: 24 years (5-63)] received GVDex [(median cycles:3(1-6)] in this period. Median time from diagnosis to the first relapse was 18.9 (2-119) months. Overall response rate [ORR = complete (CR)+partial (PR)] was 63%. Eleven (23%) patients developed febrile neutropenia. After a median follow-up of 20 months, the Kaplan-Meier estimates of patients alive and progression-free at 24 months were 60% and 49%, respectively.
CONCLUSIONS
The response rates with GVDex were comparable to those reported with GVDoxil when used as a first-line salvage regimen in relapsed/refractory HL. It was an effective regimen even in patients who failed 2 lines of therapy for HL.
Topics: Adolescent; Adult; Antineoplastic Combined Chemotherapy Protocols; Child; Child, Preschool; Deoxycytidine; Dexamethasone; Female; Hodgkin Disease; Humans; Male; Middle Aged; Recurrence; Retreatment; Salvage Therapy; Treatment Outcome; Vinorelbine; Young Adult; Gemcitabine
PubMed: 31325732
DOI: 10.1016/j.leukres.2019.106188 -
Breast (Edinburgh, Scotland) Apr 2024Single-agent oral vinorelbine is a standard of care for hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer... (Randomized Controlled Trial)
Randomized Controlled Trial
Single-agent metronomic versus weekly oral vinorelbine as first-line chemotherapy in patients with HR-positive/HER2-negative advanced breast cancer: The randomized Tempo Breast study.
INTRODUCTION
Single-agent oral vinorelbine is a standard of care for hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC) that has progressed on endocrine therapy. Metronomic administration may offer a better balance of efficacy and safety than standard regimens, but data from previous trials are scarce.
METHODS
In this open-label, multicenter, phase II trial, patients were randomized to oral vinorelbine administered on a metronomic (50 mg three times weekly) or weekly (60 mg/m in cycle 1, increasing to 80 mg/m if well tolerated) schedule. Treatment was continued until disease progression or intolerance. The primary endpoint was disease control rate (DCR, the proportion of patients with a best overall confirmed response of CR, PR, or stable disease lasting 6 months or more).
RESULTS
One-hundred sixty-three patients were randomized and treated. The DCR was 63.4% (95% confidence interval [CI]: 52.0-73.8) with metronomic vinorelbine and 72.8% (95% CI: 61.8-82.1) with weekly vinorelbine. Weekly vinorelbine was also associated with longer progression-free survival (5.6 vs 4.0 months) and overall survival (26.7 vs 22.3 months) than metronomic vinorelbine, but was associated with more adverse events.
CONCLUSIONS
In this randomized phase II trial, single-agent metronomic oral vinorelbine was effective and well tolerated as first-line chemotherapy for patients with HR-positive/HER2-negative ABC. Formal comparisons are not done in this phase II study and one can simply observe that confidence intervals of all endpoints overlap. When deciding for a chemotherapy after failure of endocrine therapy and CDK 4/6 inhibitors, oral vinorelbine might be an option to be given with either schedule.
CLINICAL TRIAL REGISTRATION NUMBER
EudraCT 2014-003860-19.
Topics: Humans; Female; Vinorelbine; Breast Neoplasms; Breast; Receptor, ErbB-2; Progression-Free Survival; Administration, Metronomic; Antineoplastic Combined Chemotherapy Protocols; Treatment Outcome; Vinblastine
PubMed: 38377732
DOI: 10.1016/j.breast.2024.103681