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Efficacy and safety of apatinib alone or apatinib plus paclitaxel/docetaxel versus paclitaxel/docetaxel in the treatment of advanced non-small cell lung cancer: A meta-analysis.
Li, Z, Liu, Z, Wu, Y, Li, H, Sun, Z, Han, C, Zhang, X, Zhang, J
Thoracic cancer. 2021;(21):2838-2848
Abstract
BACKGROUND To investigate the efficacy and safety of apatinib alone or apatinib plus paclitaxel/docetaxel versus paclitaxel/docetaxel in the treatment of advanced non-small cell lung cancer (NSCLC) through pooling of open published data. METHODS The electronic databases of Medline (1960-2021.5), Cochrane central register of controlled trials (CENTRAL), EMBASE(1980-2021.5) and Wan fang (1986-2021.5) were systematically searched by two reviewers to identify the relevant clinical trials related to the above subject. The objective response rate (ORR), disease control rate (DCR) and drug relevant adverse reactions were pooled and demonstrated by risk ratio (RR) and 95% confidence interval (95% CI). The statistical heterogeneity across studies was assessed by I-square test. The publication bias was evaluated by Egger's line regression test and demonstrated by Begg's funnel plot. RESULTS Eleven prospective studies were included in the meta-analysis. The pooled results indicated that the ORR (RR = 1.62, 95% CI: 1.32-2.00, p < 0.05) and DCR (RR = 1.29, 95% CI: 1.18-1.41, p < 0.05) of apatinib alone or apatinib plus paclitaxel/docetaxel was significantly higher than that of the paclitaxel/docetaxel group for advanced NSCLC, respectively. The drug-related adverse reaction was not statistically different between apatinib alone or apatinib plus paclitaxel/docetaxel with regard to the hand-foot syndrome, gastrointestinal reaction, thrombocytopenia, anemia and leukocytopenia (pall > 0.05) except for hypertension (RR = 3.60, 95% CI: 1.26-10.31, p < 0.05). Subgroup analysis also indicated that the hypertension and hand-foot syndrome in apatinib + paclitaxel/docetaxel were higher than that of the paclitaxel/docetaxel group with a statistical difference (p < 0.05). CONCLUSIONS Apatinib alone or apatinib plus paclitaxel/docetaxel was superior to paclitaxel/docetaxel for ORR and DCR. However, combined treatment with apatinib appears to increase the risk of a patient developing an adverse reaction, especially hypertension and hand-foot syndrome.
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Efficacy and safety of paclitaxel with or without targeted therapy as second-line therapy in advanced gastric cancer: A meta-analysis.
Zheng, T, Jin, J, Zhang, Y, Zhou, L
Medicine. 2020;(25):e20734
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Abstract
BACKGROUD Paclitaxel (PTX) has become a widely used second-line therapy for advanced gastric cancer. There exists controversy whether targeted therapy combined with PTX can provide additional benefit over PTX alone. Therefore, a meta-analysis was carried out to evaluate the efficacy and safety of the two therapy regimes. METHODS We searched systematically for studies from the databases of PubMed, Embase, Web of Science and the Cochrane Library published between January 2000 and August 2019. Only randomized controlled trials were eligible. Statistical analysis was performed by meta-analysis. The primary end points were progression-free survival and overall survival, objective response rate and adverse events were the secondary end points. RESULTS A total of 4 randomized controlled trials with 1574 patients (PTX + targeted therapy, n = 786; PTX, n = 788) were included for the final analysis. As compared with PTX monotherapy, PTX + targeted therapy significantly improved progression-free survival (hazard ratio = 0.88, 95% confidence interval [CI] 0.84-0.92, P < .001), overall survival (hazard ratio = 0.90, 95% CI: 0.86-0.95, P < .001) and was associated with a better objective response rate (RR = 1.80; 95% CI: 1.45-2.24; P < .001). PTX+targeted therapy group significantly increased incidences of grade 3 to 5 neutropenia, fatigue and neuropathy (P < .05). No statistically significant differences were observed in the incidences of grade 3 to 5 anemia, decreased appetite, nausea, diarrhea and abdominal pain between the two treatments (P >.05). CONCLUSIONS Second-line PTX+targeted therapy is a more effective treatment option with tolerable safety profile for advanced gastric cancer as a result of improved survival, though with additional toxicity.
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Efficacy and safety evaluation of paclitaxel-loaded metal stents in patients with malignant biliary obstructions.
Yuan, T, Zhu, Y, Wang, X, Cui, W, Cao, J
European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology. 2019;(5):816-819
Abstract
Paclitaxel-eluting covered metal stents (PECMSs) and metallic stents covered with a paclitaxel-incorporated membrane (MSCPMs) have been developed to increase stent patency by preventing tumor ingrowth. However, few studies have compared their efficacy and safety compared with conventional covered metal stents (CMSs). This study aimed to compare differences in efficacy and safety between PECMS/MSCPM and CMS by meta-analysis. A search of PubMed and Embase was conducted for randomized controlled trials of PECMS/MSCPM and CMS in patients with malignant biliary obstructions published between January 1966 and August 2017. A meta-analysis was performed to compare clinical outcomes and complications between stent types. A total of 221 patients from three studies were included. There were no significant differences between PECMS/MSCPM and CMS in stent patency duration (P = 0.128) or survival time (P = 0.363). Risk did not differ between PECMS/MSCPM and CMS for stent malfunction (hazard ratio [HR]: 1.13, 95% confidence interval [CI]: 0.63-2.02, P = 0.677 for all stent malfunction; HR: 1.39, 95% CI: 0.68-2.85, P = 0.362 for stent occlusion caused by tumor ingrowth; HR: 0.80, 95% CI: 0.34-1.91, P = 0.617 for stent occlusion caused by distal stent migration or sludge impaction), or complications (HR: 1.54, 95% CI: 0.70-3.39, P = 0.280 for all complications; HR: 0.42, 95% CI: 0.14-1.30, P = 0.131 for pancreatitis). The exception was cholangitis-like symptoms, the risk for which was higher in PECMS/MSCPM compared with CMS (HR: 3.93, 95% CI: 1.08-14.29, P = 0.038). Although PECMS/MSCPM may be associated with higher risk of cholangitis-like symptoms, the overall results were similar between PECMS/MSCPM and CMS. Further studies are warranted in larger populations of patients.
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Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon.
Schneider, PA, Laird, JR, Doros, G, Gao, Q, Ansel, G, Brodmann, M, Micari, A, Shishehbor, MH, Tepe, G, Zeller, T
Journal of the American College of Cardiology. 2019;(20):2550-2563
Abstract
BACKGROUND Five years of prospective clinical trials confirm that the paclitaxel drug-coated balloon (DCB) (IN.PACT Admiral, Medtronic, Dublin, Ireland) is safe and effective to treat femoropopliteal artery disease. A recent meta-analysis of heterogeneous trials of paclitaxel-based balloons and stents reported that they are associated with increased mortality and that higher doses are linked to higher mortality from 2 to 5 years. OBJECTIVES The purpose of this study was to determine if there is a correlation between paclitaxel exposure and mortality by conducting an independent patient-level meta-analysis of 1,980 patients with up to 5-year follow-up. METHODS Data from 2 single-arm and 2 randomized independently adjudicated prospective studies of a paclitaxel DCB (n = 1,837) and uncoated percutaneous transluminal angioplasty (PTA) (n = 143) were included. Analyses of baseline, procedure, and follow-up data of individual patients were performed to explore correlations of paclitaxel dose with long-term mortality. Survival time by paclitaxel dose tercile was analyzed with adjustment of inverse probability weighting to correct baseline imbalances and study as random effect. A standard cohort was defined to compare DCB- and PTA-treated patients with similar characteristics by applying criteria from pivotal studies (n = 712 DCB, n = 143 PTA). RESULTS A survival analysis stratified nominal paclitaxel dose by low, mid, and upper terciles; mean doses were 5,019.0, 10,007.5, and 19,978.2 μg, respectively. Rates of freedom from all-cause mortality between the 3 groups through 5 years were 85.8%, 84.2%, and 88.2%, respectively (p = 0.731). There was no significant difference in all-cause mortality between DCB and PTA through 5 years comparing all patients (unadjusted p = 0.092) or patients with similar characteristics (adjusted p = 0.188). CONCLUSIONS This independent patient-level meta-analysis demonstrates that this paclitaxel DCB is safe. Within DCB patients, there was no correlation between level of paclitaxel exposure and mortality. (Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I], NCT01175850; IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II], NCT01566461; MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery [MDT-2113 SFA], NCT01947478; The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population, NCT02118532; and IN.PACT Global Clinical Study, NCT01609296).
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Clinical efficacy and safety of Aidi injection plus paclitaxel-based chemotherapy for advanced non-small cell lung cancer: A meta-analysis of 31 randomized controlled trials following the PRISMA guidelines.
Xiao, Z, Wang, C, Zhou, M, Hu, S, Jiang, Y, Huang, X, Li, N, Feng, J, Tang, F, Chen, X, et al
Journal of ethnopharmacology. 2019;:110-122
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE As an important Chinese herb injection, Aidi injection is composed of the extracts from Astragalus, Eleutherococcus senticosus, Ginseng, and Cantharis. Aidi injection plus paclitaxel-based chemotherapy is often used to in the treatment of non-small cell lung cancer (NSCLC) in China. AIM OF THE STUDY The objective of this study is to further confirm whether Aidi injection can improve the tumor responses and survivals, and reveal its safety, optimal usage and combination with paclitaxel. MATERIALS AND METHODS A meta-analysis was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. All randomized controlled trials (RCTs) concerning the Aidi injection plus paclitaxel-based chemotherapy for NSCLC were selected. Main outcomes were objective response rate (ORR), disease control rate (DCR), survivals, quality of life (QOL) and adverse drug reactions (ADRs). All data were extracted by using a standard data extraction form and synthesized through meta-analysis. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used for rating the quality of evidence. RESULTS Thirty-one RCTs involving 2058 patients were included, and most trials had an unclear methodological bias risk. The risk ratio (RR) and 95% confidence intervals (CI) of ORR, DCR, QOL, neutropenia, thrombocytopenia, gastrointestinal toxicity and liver injury were as following: 1.32 (1.20-1.46), 1.14 (1.09-1.20), 1.89 (1.66-2.16), 0.61 (0.51-0.74), 0.62 (0.45-0.87), 0.59 (0.49-0.72) and 0.52 (0.36-0.75). Compared to chemotherapy alone, all differences were statistically significant. Subgroup analysis showed that only with the TP, Aidi injection could increase the ORR and DCR. Treatment with 100 ml, 80 ml or 50 ml/time, and 14 days/2 cycles or 21 days/2-4 cycles, Aidi injection could increase the ORR and DCR, respectively. Sensitivity analysis showed that the results had good robustness. None of the trials reported the overall survivals (OS), progression free survival (PFS). The quality of evidences was moderate. CONCLUSIONS Current moderate evidence revealed that Aidi injection plus paclitaxel-based chemotherapy, especially TP can significantly improve the clinical efficacy and QOL for patients with stage III/IV NSCLC. Aidi injection can relieve the risk of hematotoxicity, gastrointestinal toxicity and liver injury in patient with NSCLC receiving paclitaxel-based chemotherapy. The optimal usage may be 50 ml/time and 14 days/2 cycles.
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Does nab-paclitaxel have a higher incidence of peripheral neuropathy than solvent-based paclitaxel? Evidence from a systematic review and meta-analysis.
Guo, X, Sun, H, Dong, J, Feng, Y, Li, H, Zhuang, R, Wang, P, Cai, W, Zhou, Y
Critical reviews in oncology/hematology. 2019;:16-23
Abstract
Paclitaxel-induced peripheral neuropathy is a common reason for dose reduction or early cessation of therapy. Nab-paclitaxel was developed to provide additional clinical benefits and overcome the safety drawbacks of solvent-based paclitaxel. However, the incidence of peripheral neuropathy induced by nab-paclitaxel was reported higher than solvent-based paclitaxel but evidence remains inconsistent. Therefore, we conducted a meta-analysis to compare the incidence and severity of peripheral neuropathy between nab-paclitaxel and solvent-based paclitaxel mono-chemotherapy. In total, 24 articles were included in this meta-analysis. Results revealed the incidence of peripheral neuropathy induced by nab-paclitaxel was higher than solvent-based paclitaxel. The dosage and assessment method could influence the comparison of the incidence and severity of peripheral neuropathy between nab-paclitaxel and solvent-based paclitaxel. Current evidence suggests the incidence of peripheral neuropathy induced by nab-paclitaxel was higher than solvent-based paclitaxel among cancer patients received mono-chemotherapy. When received nab-paclitaxel, more attention should be paid to peripheral neuropathy.
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Triple negative breast cancer and platinum-based systemic treatment: a meta-analysis and systematic review.
Pandy, JGP, Balolong-Garcia, JC, Cruz-Ordinario, MVB, Que, FVF
BMC cancer. 2019;(1):1065
Abstract
BACKGROUND Triple negative breast cancer (TNBC) represents 15-20% of breast cancers. Due to its heterogeneity and high rates of relapse, there is a need to optimize treatment efficacy. Platinum chemotherapy is still controversial and currently not recommended as first-line treatment for TNBC. Recent studies have shown promising activity of this regimen. This study was done to evaluate the effect of platinum chemotherapy on pathologic complete response (pCR) after neoadjuvant treatment for early TNBC and progression-free survival (PFS) in metastatic TNBC. METHODS A systematic search of Pubmed, Embase, Cochrane, Clinical trials databases and hand search were done to identify randomized controlled trials (RCTs) investigating the use of platinum-based chemotherapy in adults with TNBC. Studies were appraised using the Cochrane Collaboration tool. Using the random effects model, pooled Odds ratios (ORs) with 95% confidence intervals (CI) for pCR, and Hazard Ratios (HRs) with 95%CI for PFS were analyzed. RESULTS Eleven RCTs were included (N = 2946). Platinum-based chemotherapy showed pCR benefit of 40%vs27% (OR1.75,95% CI 1.46-2.62,p < 0.0001) in the neo-adjuvant setting. Subgroup analysis showed increased pCR rates (44.6%vs27.8%) with platinum plus taxane regimen (p < 0.0001). In metastatic TNBC, three RCTs were analyzed (N = 531), platinum treatment did not show PFS advantage (HR1.16,95%CI 0.90-1.49,p = 0.24). CONCLUSION Platinum chemotherapy is associated with increased pCR rates in TNBC, hence it is a viable option for patients in the neoadjuvant setting. Subgroup analysis showed that the combination of platinum and taxanes (Carboplatin/Paclitaxel) improved pCR. However, no PFS advantage was seen in metastatic TNBC. Given the current conflicting data in metastatic TNBC, further exploration with additional powered studies is needed.