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Therapeutic Advances in Medical Oncology 2022The role of bevacizumab combined with paclitaxel and carboplatin in the first-line treatment of advanced non-squamous non-small-cell lung cancer (NSCLC) has been...
Efficacy and safety of adding bevacizumab biosimilar or original drug to platinum-based chemotherapy as first-line treatment in patients with advanced NSCLC: a systematic review and meta-analysis.
INTRODUCTION
The role of bevacizumab combined with paclitaxel and carboplatin in the first-line treatment of advanced non-squamous non-small-cell lung cancer (NSCLC) has been supported by a large number of data. However, whether bevacizumab biosimilars have the same efficacy and safety as the original drug is still controversial. This meta-analysis was designed to evaluate whether bevacizumab biosimilars have the same clinical efficacy and safety as the original drug in patients with advanced non-squamous NSCLC.
METHODS
Electronic databases (PubMed, Embase, Cochrane, CNKI, Wanfang, and VIP) and the ClinicalTrail.gov website were extensively searched using relevant search criteria. We included phase III randomized controlled trials (RCTs) to compare the efficacy and safety of marketed biosimilars and Avastin in the first-line treatment of patients with advanced NSCLC. The risk of bias of the included studies was assessed using the RoB 2 assessment scale, and the RevMan 5.4 statistical software was used for meta-analysis.
RESULTS
A total of 6360 patients were included in 11 RCTs. There was no statistical difference between the experimental group and the control group in terms of effectiveness [objective response rate (at week 18), disease control rate (at week 18), median duration of response, median progression-free survival, median overall survival (OS), and OS after 12 months]. In terms of safety [treatment-emergent adverse events (grade ⩾3) and treatment-related adverse events (grade ⩾3)], there was also no significant difference between biosimilars and Avastin.
CONCLUSIONS
The efficacy and safety of bevacizumab biosimilars in the treatment of advanced non-squamous NSCLC are highly similar to those of the original drug combined with paclitaxel and carboplatin, respectively.
PubMed: 36312816
DOI: 10.1177/17588359221130501 -
Heliyon Nov 2023The efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) in advanced non-small cell lung cancer (NSCLC) have yielded inconsistent findings.
Efficacy and safety of nanoparticle albumin-bound paclitaxel in advanced non-small cell lung cancer: A systematic review and meta-analysis of clinical trials and observational studies.
BACKGROUND
The efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) in advanced non-small cell lung cancer (NSCLC) have yielded inconsistent findings.
MATERIALS AND METHODS
We conducted a systematic review and meta-analysis, including comparative and noncomparative trials and cohort studies, to assess the efficacy and safety of nab-paclitaxel in advanced NSCLC. The search covered PubMed, CENTRAL, Scopus, and ClinicalTrials.gov until October 2022. Efficacy outcomes (OR, PR, progressive disease, OS, and PFS) and safety outcomes (neutropenia, leukopenia, thrombocytopenia, anemia, and sensory neuropathy) were analyzed.
RESULTS
Our meta-analysis included data from 35 studies (9 RCTs, 2 cohort studies, and 24 noncomparative studies). Nab-paclitaxel significantly improved OR rate (RR 1.35 [95% CI 1.19, 1.53], I = 36.6%; RR 1.67 [95% CI 1.30, 2.14], I = 4.3%) and PR rate (RR 1.34 [95% CI 1.18, 1.53], I = 38.8%; RR 1.59 [95% CI 1.22, 2.07], I = 19.4%) compared to the control group. It further demonstrated more pronounced benefits in squamous cell carcinoma and as a second-line treatment. Pooled evidence from the RCTs also indicated improved OS (HR 0.90 [95% CI 0.81, 0.99], I = 9.2%) and PFS (HR 0.84 [95% CI 0.76, 0.93], I = 14.5%) However, evidence on the reduction of adverse events with nab-paclitaxel treatment was insufficient, and biases in study selection and detection may have influenced the results.
CONCLUSIONS
Nab-paclitaxel enhances OR, PR, PFS, and marginally improves OS in advanced NSCLC, particularly in patients with prior chemotherapy. Further research is needed to establish its safety advantages.
PubMed: 38027982
DOI: 10.1016/j.heliyon.2023.e21903 -
Annals of Palliative Medicine Jul 2022Long-term benefit of nanoparticle-albumin-bound paclitaxel (Nab-P) over conventional taxanes in breast cancer patients is still controversial. We conducted a systematic... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Long-term benefit of nanoparticle-albumin-bound paclitaxel (Nab-P) over conventional taxanes in breast cancer patients is still controversial. We conducted a systematic review of studies to identify the optimal taxanes for selection in clinical practice.
METHODS
We enrolled studies if they enrolled adults (age ≥18) with breast cancer, compared Nab-P (at any dose) to conventional paclitaxel or docetaxel, provided information on survival data, the response rate, or adverse events, were randomized controlled trials, case-control studies, or cohort studies, and were published in English (including those published online, ahead of the print publication). Cochrane Collaboration tool and Newcastle-Ottawa scale were used for bias-risk assessment. Grading of recommendations assessment, development, and evaluation approach were adopted for the quality of evidence evaluation. The outcomes included the overall response rate, pathological complete response rate, progression-free survival, overall survival, allergic reaction, leukopenia, neutropenia, and sensory neuropathy.
RESULTS
A total of 20 eligible clinical studies comprising 11,046 patients were included in the analysis. No significant publication bias was observed based on a visual inspection of the funnel plots for progressionfree survival (PFS), and overall survival (OS). Compared to the conventional taxanes group (n=2,743), the Nab-P group (n=1,680) had a significantly higher ORR (RR =1.21, 95% CI: 1.07-1.37; P=0.003) and pCR (RR =1.33, 95% CI: 1.17-1.51; P<0.001). The Nab-P group also had a lower risk of disease progression and death than the conventional taxanes group (HR =0.89, P=0.269). Additionally, the Nab-P group had fewer treatment-related allergic reactions (RR =0.74, 95% CI: 0.59-0.93; P=0.009) and less grade ≥4 neutropenia (RR =0.39, 95% CI: 0.20-0.77; P=0.007) than the conventional taxanes group. The incidence of any-grade of neutropenia and sensory neuropathy were significantly higher in the Nab-P group than the conventional taxanes group (P=0.009 and P<0.001, respectively).
DISCUSSION
The Nab-P in all stages of breast cancer patients had significantly better efficacy and tolerance than the conventional taxanes. Moreover, preventive strategies for reducing the incidence of Nab-P induced sensory neuropathy should be explored in future studies.
Topics: Adult; Albumin-Bound Paclitaxel; Breast Neoplasms; Female; Humans; Nanoparticles; Neutropenia; Paclitaxel; Randomized Controlled Trials as Topic; Taxoids
PubMed: 35927773
DOI: 10.21037/apm-22-690 -
Translational Cancer Research Jun 2022Bevacizumab (Avastin), a monoclonal antibody targeting vascular endothelial growth factor (VEGF)-A, is widely used in treating a variety of malignant tumors. Several...
BACKGROUND
Bevacizumab (Avastin), a monoclonal antibody targeting vascular endothelial growth factor (VEGF)-A, is widely used in treating a variety of malignant tumors. Several biosimilars of bevacizumab have been developed and marketed with the expiration of bevacizumab's patent. The objective of this study was to collate available data from head-to-head randomized controlled trials (RCTs) and evaluate the efficacy and safety of biosimilar bevacizumab compared with the bevacizumab (Avastin) in patients with non-squamous non-small cell lung cancer (NSCLC).
METHODS
Literature search of Web of Science, PubMed, Cochrane Library, EMBASE, and ClinicalTrials.gov was performed from inception until October 15, 2021. The efficacy outcome indicators were objective response rate (ORR), progression-free survival (PFS) and overall survival (OS). The occurrence of adverse events (AEs) was evaluated for safety outcome.
RESULTS
Ten RCTs recruiting 6,416 patients with non-squamous NSCLC were included. All RCTs studies included the biosimilar bevacizumab group as the experimental group and the original bevacizumab group as the control group. The patients in the experimental group and control group received the same dose and duration of chemotherapy combined with carboplatin and paclitaxel. The results of meta-analysis showed that there were no significant differences in ORR [risk ratio (RR): 0.97, 95% confidence interval (95% CI): 0.93-1.02. P=0.841, I=0], PFS (RR: 1.04, 95% CI: 0.98-1.10, P=0.235, I=0) and OS (RR: 1.05, 95% CI: 1.00-1.10, P=0.692, I=0) between the biomarker and original groups. The P values of ORR, PFS and OS were 0.533, 0.970 and 0.916 respectively as shown by Egger's test, suggesting that there was no publication bias. Subgroup analysis showed no significant differences in ORR, PFS, and OS between the Chinese and multicenter trials. The pooled incidence rate of AEs between two groups was similar, and there was also no significant difference between the two groups.
DISCUSSION
This is the first study to independently report biosimilar bevacizumab in a meta-analysis on NSCLC treatment. The results showed that biosimilar bevacizumab had similar efficacy and safety compared with the original bevacizumab.
TRIAL REGISTRATION
PROSPERO registration No. CRD42021276991.
PubMed: 35836506
DOI: 10.21037/tcr-22-71 -
Thorax Apr 2015Our aim was to evaluate the clinical effectiveness of chemotherapy treatments currently licensed in Europe and recommended by the National Institute for Health and Care... (Meta-Analysis)
Meta-Analysis Review
Our aim was to evaluate the clinical effectiveness of chemotherapy treatments currently licensed in Europe and recommended by the National Institute for Health and Care Excellence (NICE) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). A systematic search of MEDLINE, EMBASE and the Cochrane Library for randomised controlled trials (RCTs) published from 2001 to 2010 was carried out. Relative treatment effects for overall survival (OS) and progression-free survival (PFS) were estimated using standard meta-analysis and mixed treatment comparison methodology. A total of 23 RCTs were included: 18 trials compared platinum-based chemotherapy, two compared pemetrexed and three compared gefitinib. There are no statistically significant differences in OS between any of the four third-generation chemotherapy regimens. There is statistically significant evidence that pemetrexed+platinum increases OS compared with gemcitabine+platinum. There are no statistically significant differences in OS between gefitinib and docetaxel+platinum or between gefitinib and paclitaxel+platinum. There is a statistically significant improvement in PFS with gefitinib compared with docetaxel+platinum and gefitinib compared with paclitaxel+platinum. Due to reduced generic pricing, third-generation chemotherapy regimens (except vinorelbine) are still competitive options for most patients. This research provides a comprehensive evidence base, which clinicians and decision-makers can use when deciding on the optimal first-line chemotherapy treatment regimen for patients diagnosed with locally advanced or metastatic NSCLC.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Cell Lung; Cost-Benefit Analysis; Drug Costs; Humans; Lung Neoplasms; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 25661113
DOI: 10.1136/thoraxjnl-2014-205914 -
Frontiers in Medicine 2023This meta-analysis was exerted in assessing the anticancer efficacy and safety of nab-paclitaxel (nab-P) when combined with platinum compound agents for therapy in...
PURPOSE
This meta-analysis was exerted in assessing the anticancer efficacy and safety of nab-paclitaxel (nab-P) when combined with platinum compound agents for therapy in patients with non-small cell lung cancer (NSCLC).
METHOD
We systematically searched the following seven electronic databases: PubMed, Cochrane Library, Web of Science, Embase, CNKI, Wan Fang, and China Science and Technology Journal Data. Randomized comparative clinical [randomized controlled clinical trial (RCT)] studies on nab-P plus platinum and carboplatin or cisplatin in combination with conventional chemotherapy agents or traditional paclitaxel were searched.
RESULTS
A total of 19 RCT studies involving 6,011 patients were analyzed. The primary outcome includes the overall response rate (ORR), overall survival (OS), and progression-free survival (PFS). The secondary outcome includes adverse events (AEs). Nab-P combined with platinum (carboplatin/cisplatin) had a better ORR [odds ratio (OR) = 1.66, 95% confidence interval (CI) (1.34, 2.05), < 0.001] and improved PFS [hazard ratio (HR) = 0.84, 95% CI: (0.74, 0.94), = 0.01] and OS [HR = 0.86, 95% CI: (0.78, 0.96), = 0.008] in NSCLC patients. ORR [OR = 2.18, 95% CI: (1.07, 4.43)], PFS [HR = 0.62, 95% CI: (0.40, 0.97)], and OS [HR = 0.63, 95% CI: (0.49, 0.81)] were significantly improved among patients aged >70 years, and ORR [OR = 1.80, 95% CI: (1.20, 2.70)] and PFS [HR = 0.74, 95% CI: (0.56, 0.97)] were significantly elevated with SCC rate ≥65% in NSCLC patients (all > 0.05). Among the adverse effects, the prevalence of neutropenia, neuralgia, and arthralgia/myalgia (≥ grade 3) compared to that of the control group. On the other hand, the prevalence of anemia and thrombocytopenia was higher in the nab-P plus platinum (carboplatin/cisplatin) compared to that of controls. It is worth noting that fatigue did not show statistical significance.
CONCLUSION
Nab-P in combination with carboplatin/cisplatin regimen improves efficacy and tolerability in patients with NSCLC.
SYSTEMATIC REVIEW REGISTRATION
http://www.crd.york.ac.uk/PROSPERO/, identifier: CRD42022288499.
PubMed: 37554498
DOI: 10.3389/fmed.2023.1139248 -
Cancers Apr 2019The tumor microenvironment plays an important role in the initiation and progression of pancreatic adenocarcinoma (PDAC). In this systematic review, we provide an... (Review)
Review
The tumor microenvironment plays an important role in the initiation and progression of pancreatic adenocarcinoma (PDAC). In this systematic review, we provide an overview of clinical trials with stroma-targeting agents. We systematically searched MEDLINE/PubMed and the EMBASE database, using the PRISMA guidelines, for eligible clinical trials. In total, 2330 records were screened, from which we have included 106 articles. A meta-analysis could be performed on 51 articles which describe the targeting of the vascular endothelial growth factor (VEGF) pathway, and three articles which describe the targeting of hyaluronic acid. Anti-VEGF therapies did not show an increase in median overall survival (OS) with combined hazard ratios (HRs) of 1.01 (95% confidence interval (CI) 0.90-1.13). Treatment with hyaluronidase PEGPH20 showed promising results, but, thus far, only in combination with gemcitabine and nab-paclitaxel in selected patients with hyaluronic acid (HA) tumors: An increase in median progression free survival (PFS) of 2.9 months, as well as a HR of 0.51 (95% CI 0.26-1.00). In conclusion, we found that anti-angiogenic therapies did not show an increased benefit in median OS or PFS in contrast to promising results with anti-hyaluronic acid treatment in combination with gemcitabine and nab-paclitaxel. The PEGPH20 clinical trials used patient selection to determine eligibility based on tumor biology, which underlines the importance to personalize treatment for pancreatic cancer patients.
PubMed: 31035512
DOI: 10.3390/cancers11050588 -
Immunotherapy Apr 2022This paper presents the reported dermatological adverse events (AEs) associated with approved combinations of immunotherapy with drugs of the same class, or in... (Review)
Review
This paper presents the reported dermatological adverse events (AEs) associated with approved combinations of immunotherapy with drugs of the same class, or in combination with targeted therapy or chemotherapy. PubMed was used as an electronic database, and a total of 29 articles were reviewed which reported dermatological AEs following combination therapies with nivolumab, ipilimumab, axitinib, pembrolizumab, lenvatinib, avelumab, atezolizumab, carboplatin, etoposide, paclitaxel, bevacizumab, pemetrexed, cisplatin and durvalumab. The dermatological AEs reported were mutually inclusive and the highest incidence of specific AEs was seen in the following combinations: rash in the nivolumab/ipilimumab and lenvatinib/pembrolizumab combinations, pruritus in the atezolizumab/nab-paclitaxel combination, dry skin and palmar-plantar erythrodysesthesia in the axitinib/pembrolizumab combination, and alopecia and severe skin reactions in the pembrolizumab/carboplatin/paclitaxel combination. Knowledge of such side effects is of benefit when choosing an optimal treatment regimen and should be integrated into the monitoring and follow-up phases of treatment.
Topics: Axitinib; Carboplatin; Humans; Immune Checkpoint Inhibitors; Ipilimumab; Nivolumab; Paclitaxel
PubMed: 35232283
DOI: 10.2217/imt-2021-0244 -
Annals of Vascular Surgery Sep 2022Recent evidence raised the concern that paclitaxel-containing therapy was associated with an increased risk of mortality in patients with peripheral artery diseases... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Recent evidence raised the concern that paclitaxel-containing therapy was associated with an increased risk of mortality in patients with peripheral artery diseases (PADs). However, it is unclear whether drug-eluting stent (DES) versus drug-coated balloon (DCB) have a different effect on mortality of PAD patients. Our study aimed to systematically review current literature comparing clinical outcomes of patients treated with DES versus DCB for PAD.
METHODS
MEDLINE and Embase were searched for eligible studies from January 2000 to December 31, 2020. Randomized controlled trials (RCTs) or cohort studies that reported outcomes of DES versus DCB were included in our study. The primary outcome was 12-month all-cause mortality. A random-effect model was used to pool the odds ratios (ORs) and related 95% confidence intervals (CIs).
RESULTS
Our review included 7 studies, involving 2 RCTs and 5 cohort studies. A total of 4,237 patients with DES and 9,234 patients with DCB were analyzed. All included cohort studies were of high quality with Newcastle-Ottawa scores from 7 to 8. No significant difference in 12-month all-cause mortality was found between DES and DCB without significant heterogeneity (OR 1.02, 95% CI 0.91-1.14, I = 0%). As for primary patency, no significant difference between treatments was observed (OR 1.27, 95% CI 0.75-2.15, I = 55%). Similar results were observed for freedom from target lesion revascularization (OR 0.94, 95% CI 0.64-1.40, I = 0%).
CONCLUSIONS
This systematic review and meta-analysis suggest that no significant difference in 12-month all-cause mortality was found between DES and DCB. Primary patency and freedom from target lesion revascularization of lower extremity PAD were also comparable between the 2 groups.
Topics: Angioplasty, Balloon; Coated Materials, Biocompatible; Drug-Eluting Stents; Femoral Artery; Humans; Lower Extremity; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 35561891
DOI: 10.1016/j.avsg.2022.04.039 -
Oncology Research and Treatment 2021FOLFIRINOX, gemcitabine/nab-paclitaxel (gem-nab/P), and gemcitabine-capecitabine (gem-cap) demonstrated superiority over gemcitabine monotherapy for pancreatic cancer...
OBJECTIVES
FOLFIRINOX, gemcitabine/nab-paclitaxel (gem-nab/P), and gemcitabine-capecitabine (gem-cap) demonstrated superiority over gemcitabine monotherapy for pancreatic cancer (PC). It is still unclear which chemotherapy regimen is the most optimal. This study aimed to conduct a systematic review (SR) and indirect comparison to compare safety and efficacy of FOLFIRINOX versus gem-nab/P and gem-cap in PC.
METHODS
An SR was conducted in several databases from inception to November 2020. RCTs investigating resectable or advanced PC were included. Primary outcomes including overall survival (OS), disease-free survival (DFS)/progression-free survival (PFS)/relapse-free survival (RFS), and grade 3/4 adverse events (AEs) were pooled using a random effects model. Indirect comparisons were done to compare FOLFIRINOX versus gem-cap and gem-nab/P. Heterogeneity was evaluated using Cochran's Q test and I2 statistics.
RESULTS
Nine studies were identified involving 6,564 patients. Indirect comparisons showed FOLFIRINOX had significantly better OS (resectable: HR 0.78 [0.61-0.99]; advanced: HR 0.71 [0.60-0.85]) and RFS/DFS/PFS (resectable: HR 0.67 [0.55-0.82]; advanced: HR 0.65 [0.57-0.74]) compared to gem-cap as well as OS (resectable: HR 0.78 [0.61-1.00]; advanced: HR 0.73 [0.54-0.98]) and DFS/PFS (resectable: HR 0.66 [0.53-0.82]; advanced: HR 0.64 [0.49-0.83]) compared to gem-nab/P. FOLFIRINOX increased grade 3/4 AE risk compared to gem-cap and gem-nab/P.
CONCLUSIONS
FOLFIRINOX is associated with significant survival benefits compared to gem-nab/P and gem-cap. However, it is important to consider the increased grade 3/4 AE risk associated with FOLFIRINOX.
Topics: Albumins; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Survival; Humans; Paclitaxel; Pancreatic Neoplasms
PubMed: 34315166
DOI: 10.1159/000517409