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Urologic Oncology Apr 2024Nanocarriers (NCs) are a form of nanotechnology widely investigated in cancer treatment to improve the safety and efficacy of systemic therapies by increasing tumor... (Review)
Review
Nanocarriers (NCs) are a form of nanotechnology widely investigated in cancer treatment to improve the safety and efficacy of systemic therapies by increasing tumor specificity. Numerous clinical trials have explored the use of NCs in urologic cancers since the approval of the first NCs for cancer treatment over 20 years ago. The objective of this systematic review is to examine the effectiveness and safety of NCs in treating urological cancers. This paper summarizes the state of the field by investigating peer-reviewed, published results from 43 clinical trials involving the use of NCs in bladder, prostate, and kidney cancer patients with a focus on safety and efficacy data. Among the 43 trials, 16 were phase I, 20 phase II, and 4 phase I/II. No phase III trials have been reported. While both novel and classic NCs have been explored in urologic cancers, NCs already approved for the treatment of other cancers were more widely represented. Trials in prostate cancer and mixed trials involving both urologic and non-urologic cancer patients were the most commonly reported trials. Although NCs have demonstrable efficacy with adequate safety in non-urologic cancer patient populations, current clinical stage NC options appear to be less beneficial in the urologic cancer setting. For example, nab-paclitaxel and liposomal doxorubicin have proven ineffective in the treatment of urologic cancers despite successes in other cancers. However, several ongoing pre-clinical studies using targeted and locally applied improved NCs may eventually improve their utility.
Topics: Male; Humans; Urologic Neoplasms; Prostatic Neoplasms
PubMed: 38161104
DOI: 10.1016/j.urolonc.2023.11.022 -
Cardiovascular Revascularization... Jun 2015Coronary atherosclerosis often involves small-caliber coronaries, yet the safety and efficacy of 2.25-mm DES have been poorly defined, with a general lack of separation... (Review)
Review
BACKGROUND
Coronary atherosclerosis often involves small-caliber coronaries, yet the safety and efficacy of 2.25-mm DES have been poorly defined, with a general lack of separation of 2.25 with 2.5-mm performance. No randomized head-to-head 2.25 mm DES studies have been reported. There are several single-arm prospective studies, and we aim to systematically review all published specific 2.25-mm data to estimate composite DES-specific performance and highlight current knowledge gaps.
METHODS
We performed a systematic literature search of PubMed, EMBASE, Web of Science and Cochrane database for clinical trials of 2.25-mm DES. Angiographic and composite clinical outcomes were compared with descriptive statistics.
RESULTS
2.25 mm-Paclitaxel (PES), sirolimus (SES), everolimus (EES) and platinum chromium EES DES-specific outcomes have been reported. Death at 12 months for SES, PES, EES and platinum chromium EES was 1.3%, 3.0%, 1.5%, and 4.4%. Rates of target vessel revascularization at 12 months for SES, PES, EES and platinum chromium EES were 5.7%, 13.3%, 8.8%, and 3.3%. Angiographic outcomes at 9 months to one year were as follows: mean late lumen loss (LLL) for SES, PES, and EES was 0.15 ± 0.11-mm, 0.28 ± 0.11-mm, and 0.16 ± 0.41-mm and mean diameter restenosis for SES, PES, and EES were 29.5 ± 6.2%, 34.7 ± 4.2%, and 20.9 ± 22.5%. Reported stent thrombosis rates for 2.25-mm DES were low ranging from 0% to 2.2% in up to 24-months of follow-up.
CONCLUSIONS
This systematic review summarizes and tabulates all available specific data on 2.25-mm DES. Based on our descriptive analysis, 2.25-mm DESs have a favorable safety and efficacy profile for the treatment of very small coronary lesions.
Topics: Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Paclitaxel; Sirolimus
PubMed: 25976630
DOI: 10.1016/j.carrev.2015.03.008 -
European Journal of Cancer (Oxford,... Dec 2019Although a myriad of novel treatments entered the treatment paradigm for advanced melanoma, there is lack of head-to-head evidence. We conducted a network meta-analysis... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Although a myriad of novel treatments entered the treatment paradigm for advanced melanoma, there is lack of head-to-head evidence. We conducted a network meta-analysis (NMA) to estimate each treatment's relative effectiveness and safety.
METHODS
A systematic literature review (SLR) was conducted in Embase, MEDLINE and Cochrane to identify all phase III randomised controlled trials (RCTs) with a time frame from January 1, 2010 to March 11, 2019. We retrieved evidence on treatment-related grade III/IV adverse events, progression-free survival (PFS) and overall survival (OS). Evidence was synthesised using a Bayesian fixed-effect NMA. Reference treatment was dacarbazine. In accordance with RCTs, dacarbazine was pooled with temozolomide, paclitaxel and paclitaxel plus carboplatin. To increase homogeneity of the study populations, RCTs were only included if patients were not previously treated with novel treatments.
RESULTS
The SLR identified 28 phase III RCTs involving 14,376 patients. Nineteen and seventeen treatments were included in the effectiveness and safety NMA, respectively. For PFS, dabrafenib plus trametinib (hazard ratio [HR] PFS: 0.21) and vemurafenib plus cobimetinib (HR PFS: 0.22) were identified as most favourable treatments. Both had, however, less favourable safety profiles. Five other treatments closely followed (dabrafenib [HR PFS: 0.30], nivolumab plus ipilimumab [HR PFS: 0.34], vemurafenib [HR PFS: 0.38], nivolumab [HR PFS: 0.42] and pembrolizumab [HR PFS: 0.46]). In contrast, for OS, nivolumab plus ipilimumab (HR OS: 0.39), nivolumab (HR OS: 0.46) and pembrolizumab (HR OS: 0.50) were more favourable than dabrafenib plus trametinib (HR OS: 0.55) and vemurafenib plus cobimetinib (HR OS: 0.57).
CONCLUSIONS
Our NMA identified the most effective treatment options for advanced melanoma and provided valuable insights into each novel treatment's relative effectiveness and safety. This information may facilitate evidence-based decision-making and may support the optimisation of treatment and outcomes in everyday clinical practice.
Topics: Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Azetidines; Benzimidazoles; Cancer Vaccines; Carboplatin; Dacarbazine; Humans; Hydrazines; Imidazoles; Interleukin-2; Ipilimumab; Lenalidomide; Melanoma; Network Meta-Analysis; Nitrosourea Compounds; Nivolumab; Organophosphorus Compounds; Oximes; Paclitaxel; Piperidines; Progression-Free Survival; Proportional Hazards Models; Pyridones; Pyrimidinones; Skin Neoplasms; Sorafenib; Survival Rate; Temozolomide; Treatment Outcome; Vemurafenib; gp100 Melanoma Antigen
PubMed: 31670077
DOI: 10.1016/j.ejca.2019.08.032 -
Journal of Clinical Oncology : Official... Aug 2016To provide evidence-based recommendations to oncologists and others for the treatment of patients with metastatic pancreatic cancer. (Review)
Review
PURPOSE
To provide evidence-based recommendations to oncologists and others for the treatment of patients with metastatic pancreatic cancer.
METHODS
American Society of Clinical Oncology convened an Expert Panel of medical oncology, radiation oncology, surgical oncology, gastroenterology, palliative care, and advocacy experts to conduct a systematic review of the literature from April 2004 to June 2015. Outcomes were overall survival, disease-free survival, progression-free survival, and adverse events.
RESULTS
Twenty-four randomized controlled trials met the systematic review criteria.
RECOMMENDATIONS
A multiphase computed tomography scan of the chest, abdomen, and pelvis should be performed. Baseline performance status and comorbidity profile should be evaluated. Goals of care, patient preferences, treatment response, psychological status, support systems, and symptom burden should guide decisions for treatments. A palliative care referral should occur at first visit. FOLFIRINOX (leucovorin, fluorouracil, irinotecan, and oxaliplatin; favorable comorbidity profile) or gemcitabine plus nanoparticle albumin-bound (NAB) -paclitaxel (adequate comorbidity profile) should be offered to patients with Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1 based on patient preference and support system available. Gemcitabine alone is recommended for patients with ECOG PS 2 or with a comorbidity profile that precludes other regimens; the addition of capecitabine or erlotinib may be offered. Patients with an ECOG PS ≥ 3 and poorly controlled comorbid conditions should be offered cancer-directed therapy only on a case-by-case basis; supportive care should be emphasized. For second-line therapy, gemcitabine plus NAB-paclitaxel should be offered to patients with first-line treatment with FOLFIRINOX, an ECOG PS 0 to 1, and a favorable comorbidity profile; fluorouracil plus oxaliplatin, irinotecan, or nanoliposomal irinotecan should be offered to patients with first-line treatment with gemcitabine plus NAB-paclitaxel, ECOG PS 0 to 1, and favorable comorbidity profile, and gemcitabine or fluorouracil should be offered to patients with either an ECOG PS 2 or a comorbidity profile that precludes other regimens. Additional information is available at www.asco.org/guidelines/MetPC and www.asco.org/guidelineswiki.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Pancreatic Ductal; Communication; Evidence-Based Medicine; Humans; Pain Management; Palliative Care; Pancreatic Neoplasms; Patient Care Planning; Patient Care Team; Symptom Assessment
PubMed: 27247222
DOI: 10.1200/JCO.2016.67.1412 -
Journal of Vascular Surgery Dec 2020The comparison between paclitaxel-coated balloon (PCB) angioplasty and plain balloon angioplasty (PBA) for hemodialysis (HD) access stenosis or occlusion has not been... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The comparison between paclitaxel-coated balloon (PCB) angioplasty and plain balloon angioplasty (PBA) for hemodialysis (HD) access stenosis or occlusion has not been well investigated. The objectives of this systematic review and meta-analysis were to compare all-cause mortality, HD access primary patency, and circuit primary patency after endovascular maintenance procedures using PCB angioplasty vs PBA.
METHODS
MEDLINE, Embase, and Cochrane Databases were systematically searched to identify all the relevant studies on paclitaxel-coated devices for stenosis or thrombosis of HD access. A random effects model was applied to pool the effect measures. Dichotomous data were presented using an odds ratio (OR). Effect data were presented using pooled hazard ratio (HR) with 95% confidence interval (CI).
RESULTS
A total of 16 studies were included in this meta-analysis, 12 randomized controlled trials and 4 cohort studies involving 1086 patients who underwent endovascular treatment for HD access stenosis or occlusion. All-cause mortality rates at 6, 12, and 24 months after intervention were similar between the PCB and PBA groups (6 months: OR, 1.06 [95% CI, 0.38-2.96; P = .907; I = 19.2%]; 12 months: OR, 1.20 [95% CI, 0.66-2.16; P = .554; I = 0%]; 24 months: OR, 1.43 [95% CI, 0.83-2.45; P = .195; I = 0%]). There was a significant improvement of primary patency in the PCB group compared with the PBA group (HR, 0.47; 95% CI, 0.33-0.69; P < .001; I = 67.3%). This benefit was consistent with the analysis of randomized controlled trials, whereas cohort studies were excluded. Further subgroup analysis of target lesions demonstrated that primary patency was significantly higher in the PCB group than in the PBA group, not only for arteriovenous fistula (HR, 0.54; 95% CI, 0.30-0.98; P = .041; I = 76.8%) but also for central venous stenosis (HR, 0.39; 95% CI, 0.22-0.71; P = .002; I = 0%). The PCB group was associated with higher 6-month (OR, 0.40; 95% CI, 0.27-0.59; P < .001) and 24-month lesion primary patency (OR, 0.28; 95% CI, 0.11-0.72; P = .009) than PBA and was marginally associated with 12-month lesion primary patency (OR, 0.52; 95% CI, 0.26-1.03; P = .06). Circuit primary patency analysis showed a marginal trend toward better outcome in the PCB group (HR, 0.63; 95% CI, 0.40-1.00) but no statistical significance (P = .052).
CONCLUSIONS
This systematic review and meta-analysis demonstrated that PCB angioplasty is associated with significantly improved primary patency of arteriovenous fistula and central venous stenosis for HD access maintenance, with no evidence of increasing all-cause mortality based on short-term and midterm follow-up. Further large cohort study is needed to investigate long-term mortality.
Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Paclitaxel; Recurrence; Renal Dialysis; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency
PubMed: 32540324
DOI: 10.1016/j.jvs.2020.04.525 -
BMC Cancer Feb 2021To compare the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and solvent-based taxanes (sb-taxanes) as neoadjuvant therapy in the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
To compare the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and solvent-based taxanes (sb-taxanes) as neoadjuvant therapy in the treatment of breast cancer.
METHODS
We systematically searched the PubMed, Embase, and Cochrane Central Register databases. Randomized controlled trials (RCTs) and cohort studies, published in English, about the comparison between nab-paclitaxel and sb-taxanes as neoadjuvant therapy in patients with breast cancer were searched up to September 2019.
RESULTS
The primary outcome was the proportion of patients with pathological complete response (pCR, defined as ypT0 ypN0 or ypT0/is ypN0). Other main outcomes included long-term survival and adverse events (AEs). Seven studies (five RCTs and two cohorts) and 2949 patients were included. Neoadjuvant nab-paclitaxel improved pCR compared with sb-taxanes (ypT0 ypN0: OR = 1.52, 95%CI: 1.27-1.83, P < 0.001; ypT0/is ypN0: OR = 1.40, 95%CI: 1.17-1.68, P < 0.001). The benefits of nab-paclitaxel on pCR were persistent in HER2-negative, hormone receptor (HR)-positive breast cancer (OR = 1.53, 95%CI: 1.07-2.19, P = 0.020), triple-negative breast cancer (weekly/every 2 weeks regimen; OR = 2.95, 95%CI: 1.54-5.67, P < 0.001), and tumors with Ki-67 > 20% (OR = 1.63, 95%CI: 1.26-2.12, P < 0.001). Patients treated with nab-paclitaxel had better event-free survival (EFS; HR = 0.69, 95%CI: 0.57-0.85, P < 0.001) than with sb-taxanes. There were no differences in most of grade > 3 AEs between nab-paclitaxel and sb-taxanes (all P > 0.05), besides of any grade hypersensitivity (OR = 0.29, 95%CI: 0.11-0.72, P = 0.008), any grade (OR = 2.10, 95%CI: 1.37-3.23, P = 0.001) and grade > 3 (OR = 4.01, 95%CI: 2.51-6.41, P < 0.001) neuropathy.
CONCLUSION
Nab-paclitaxel is effective for the treatment of non-metastatic breast cancer in the neoadjuvant setting. Nab-paclitaxel could improve pCR rate and EFS compared with sb-taxanes and with reasonable toxicities.
Topics: Albumins; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Female; Humans; Paclitaxel; Prognosis; Randomized Controlled Trials as Topic; Solvents; Taxoids
PubMed: 33541289
DOI: 10.1186/s12885-021-07831-7 -
Journal of Vascular and Interventional... Feb 2024To provide an updated systematic review and meta-analysis of safety and effectiveness outcomes with paclitaxel-containing devices. (Review)
Review
Mortality, Safety, and Effectiveness of Paclitaxel-Containing Balloons and Stents in the Femoropopliteal Artery: Systematic Review and Meta-Analysis of Randomized Controlled Trials since 2018.
PURPOSE
To provide an updated systematic review and meta-analysis of safety and effectiveness outcomes with paclitaxel-containing devices.
MATERIALS AND METHODS
A systematic review and meta-analysis of randomized controlled trials (RCTs) investigating paclitaxel-containing balloons or stents in the treatment of femoropopliteal disease was performed. Pooled risk ratio (RR) was calculated using the inverse-variance, random-effects model in the assessment of primary patency, all-cause mortality, target limb major amputation, target lesion revascularization (TLR), and thrombosis.
RESULTS
In total, 19 RCTs were included comprising 4,284 participants. All-cause mortality rates did not differ significantly between the 2 arms at 12 months (RR, 1.06; 95% confidence interval [CI], 0.66-1.72; P = .80), 24 months (RR, 0.92; 95% CI, 0.56-1.50; P = .73), 36 months (RR, 1.21; 95% CI, 0.65-2.25; P = .55), or 48-60 months (RR, 0.95; 95% CI, 0.66-1.39; P = .81) after intervention. Primary patency was significantly higher at 12 months in the paclitaxel-containing arm: 80.92% (1,438/1,777) versus 57.48% (607/1,056) in the control arm (RR, 1.44; 95% CI, 1.30-1.59; P < .00001).
CONCLUSIONS
The present study demonstrates no statistically significant difference in all-cause mortality, target limb major amputation, or thrombosis with paclitaxel drug-eluting therapy to the femoropopliteal region. Additionally, improved and durable patency rates with a statistically significantly lower risk of clinically driven TLR with paclitaxel drug-eluting therapy have been demonstrated.
PubMed: 38428483
DOI: 10.1016/j.jvir.2023.12.574 -
Current Pharmaceutical Design 2021Background and Introduction: Peripheral neuropathy is one of the most common dose-limiting side effects of solvent-based paclitaxel. Paclitaxel poliglumex (PPX) and... (Meta-Analysis)
Meta-Analysis
UNLABELLED
Background and Introduction: Peripheral neuropathy is one of the most common dose-limiting side effects of solvent-based paclitaxel. Paclitaxel poliglumex (PPX) and NK105 were developed to overcome the paclitaxel induced peripheral neuropathy. However, the incidence of peripheral neuropathy induced by PPX and NK105 was reported higher than solvent-based paclitaxel, but evidence remains inconsistent.
METHODS
The article was reported in accordance with PRISMA Guidelines (Registration number: CRD42021245313). We conducted a meta-analysis to compare the incidence and severity of peripheral neuropathy between solvent-based paclitaxel, PPX and NK105 mono-chemotherapy.
RESULTS
Results revealed that no significant difference exists between the incidence of all grade peripheral neuropathy among the solvent-based paclitaxel, PPX and NK105 treated groups. While, the incidence of high grade peripheral neuropathy induced by NK105 was lower than two other groups. Moreover, the overall survival was not improved in PPX compared with other groups. However, NK105 demonstrated significant longer overall survival in patients with cancer.
CONCLUSION
Current evidence suggests more attention should be paid to the paclitaxel poliglumex re-formulation.
Topics: Antineoplastic Agents, Phytogenic; Humans; Paclitaxel; Peripheral Nervous System Diseases; Polyglutamic Acid; Solvents
PubMed: 32940171
DOI: 10.2174/1381612826666200917145551 -
Clinical and Translational Science Oct 2022Taxane-based chemotherapy regimens are used as first-line treatment for breast cancer. Neurotoxicity, mainly taxane-induced peripheral neuropathy (TIPN), remains the... (Meta-Analysis)
Meta-Analysis
Taxane-based chemotherapy regimens are used as first-line treatment for breast cancer. Neurotoxicity, mainly taxane-induced peripheral neuropathy (TIPN), remains the most important dose-limiting adverse event. Multiple genes may be associated with TIPN; however, the strength and direction of the association remain unclear. For this reason, we systematically reviewed observational studies of TIPN pharmacogenetic markers in breast cancer treatment. We conducted a systematic search of terms alluding to breast cancer, genetic markers, taxanes, and neurotoxicity in Ovid, ProQuest, PubMed, Scopus, Virtual Health, and Web of Science. We assessed the quality of evidence and bias profile. We extracted relevant variables and effect measures. Whenever possible, we performed random-effects gene meta-analyses and examined interstudy heterogeneity with meta-regression models and subgroup analyses. This study follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and STrengthening the REporting of Genetic Association Studies (STREGA) reporting guidance. A total of 42 studies with 19,431 participants were included. These evaluated 262 single-nucleotide polymorphisms (SNPs) across 121 genes. We conducted meta-analyses on 23 genes with 60 SNPs (19 studies and 6246 participants). Thirteen individual SNPs (ABCB1-rs2032582, ABCB1-rs3213619, BCL6/-rs1903216, /CAND1-rs17781082, CYP1B1-rs1056836, CYP2C8-rs10509681, CYP2C8-rs11572080, EPHA5-rs7349683, EPHA6-rs301927, FZD3-rs7001034, GSTP1-rs1138272, TUBB2A-rs9501929, and XKR4-rs4737264) and the overall SNPs' effect in four genes (CYP3A4, EphA5, GSTP1, and SLCO1B1) were statistically significantly associated with TIPN through meta-analysis. In conclusion, through systematic review and meta-analysis, we found that polymorphisms, and particularly 13 SNPs, are associated with TIPN, suggesting that genetics does play a role in interindividual predisposition. Further studies could potentially use these findings to develop individual risk profiles and guide decision making.
Topics: Female; Humans; Breast Neoplasms; Cytochrome P-450 CYP2C8; Cytochrome P-450 CYP3A; Genetic Markers; Liver-Specific Organic Anion Transporter 1; Neurotoxicity Syndromes; Paclitaxel; Peripheral Nervous System Diseases; Pharmacogenetics; Polymorphism, Single Nucleotide; Taxoids
PubMed: 35892315
DOI: 10.1111/cts.13370 -
Frontiers in Pharmacology 2023In the last few decades, there has been a rapid development in cancer therapies and improved detection strategies, hence the death rates caused by cancer have...
In the last few decades, there has been a rapid development in cancer therapies and improved detection strategies, hence the death rates caused by cancer have decreased. However, it has been reported that cardiovascular disease has become the second leading cause of long-term morbidity and fatality among cancer survivors. Cardiotoxicity from anticancer drugs affects the heart's function and structure and can occur during any stage of the cancer treatments, which leads to the development of cardiovascular disease. To investigate the association between anticancer drugs for non-small cell lung cancer (NSCLC) and cardiotoxicity as to whether: different classes of anticancer drugs demonstrate different cardiotoxicity potentials; different dosages of the same drug in initial treatment affect the degree of cardiotoxicity; and accumulated dosage and/or duration of treatments affect the degree of cardiotoxicity. This systematic review included studies involving patients over 18 years old with NSCLC and excluded studies in which patients' treatments involve radiotherapy only. Electronic databases and registers including Cochrane Library, National Cancer Institute (NCI) Database, PubMed, Scopus, Web of Science, ClinicalTrials.gov and the European Union Clinical Trials Register were systematically searched from the earliest available date up until November 2020. A full version protocol of this systematic review (CRD42020191760) had been published on PROSPERO. A total of 1785 records were identified using specific search terms through the databases and registers; 74 eligible studies were included for data extraction. Based on data extracted from the included studies, anticancer drugs for NSCLC that are associated with cardiovascular events include bevacizumab, carboplatin, cisplatin, crizotinib, docetaxel, erlotinib, gemcitabine and paclitaxel. Hypertension was the most reported cardiotoxicity as 30 studies documented this cardiovascular adverse event. Other reported treatment-related cardiotoxicities include arrhythmias, atrial fibrillation, bradycardia, cardiac arrest, cardiac failure, coronary artery disease, heart failure, ischemia, left ventricular dysfunction, myocardial infarction, palpitations, and tachycardia. The findings of this systematic review have provided a better understanding of the possible association between cardiotoxicities and anticancer drugs for NSCLC. Whilst variation is observed across different drug classes, the lack of information available on cardiac monitoring can result in underestimation of this association. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020191760, identifier PROSPERO CRD42020191760.
PubMed: 37383708
DOI: 10.3389/fphar.2023.1137983