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Paclitaxel-induced sensory peripheral neuropathy is associated with an ABCB1 single nucleotide polymorphism and older age in Japanese.
Tanabe, Y, Shimizu, C, Hamada, A, Hashimoto, K, Ikeda, K, Nishizawa, D, Hasegawa, J, Shimomura, A, Ozaki, Y, Tamura, N, et al
Cancer chemotherapy and pharmacology. 2017;(6):1179-1186
Abstract
PURPOSE Whether age and inter-individual variability of pharmacogenetics are risk factors for paclitaxel-induced peripheral neuropathy (PIPN) is inconclusive. This study was conducted to evaluate the influence of previously investigated single nucleotide polymorphisms (SNPs) and age, using genotype data from a prospective study of paclitaxel-related toxicity in Japanese patients with breast cancer. METHODS Peripheral blood mononuclear cells from 127 Japanese women with breast cancer who received weekly adjuvant paclitaxel were used to genotypes SLCO1B3 T334G (rs4149117), CYP2C8 A1196G (rs10509681), ABCB1 C1236T (rs1128503), ABCB1 G2677T/A (rs2032582), and ABCB1 C3435T (rs1045642). Genotypic and clinical factors were investigated for associations with PIPN. RESULTS Of the five SNPs evaluated, no SNPs were significantly associated with grade 2 or higher PIPN. However, ABCB1 1236 TT showed a trend to associate with grade 2 or higher PIPN compared to ABCB1 CT/CC (odds ratio 2.1, 95% CI 0.991-4.548, p = 0.051). In subgroup analysis, patients ≥60 years old with an ABCB1 1236 TT had a higher incidence of ≥grade 2 PIPN compared to patients with CT or CC genotype (p = 0.027). On multivariable analysis, age ≥60 years and the ABCB1 1236 TT showed a significant association with ≥grade 2 PIPN (p = 0.005 and p = 0.034, respectively). CONCLUSIONS ABCB1 1236 TT genotype and older age might be a predictor of PIPN, which diminishes quality of life of cancer survivors.
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Serial Morphological and Functional Assessment of the Paclitaxel-coated Balloon for de Novo Lesions.
Ann, SH, Her, AY, Singh, GB, Okamura, T, Koo, BK, Shin, ES
Revista espanola de cardiologia (English ed.). 2016;(11):1026-1032
Abstract
INTRODUCTION AND OBJECTIVES There is limited data on the serial morphological and functional assessment of paclitaxel-coated balloon treatment using coronary angiography, optical coherence tomography, and fractional flow reserve. METHODS In this prospective, single-center observational study, patients with de novo lesions were treated with the paclitaxel-coated balloon. Serial angiographic, optical coherence tomography and fractional flow reserve measurements were performed before and after plain old balloon angioplasty, as well as at 9-month follow-up. RESULTS Twenty patients (21 lesions) were enrolled in this study. The reference vessel diameter was 2.68±0.34mm and late luminal loss was 0.01±0.21mm. The median changes in the minimal lumen area between pre- and postplain old balloon angioplasty, and postplain old balloon angioplasty and follow-up were an increase of 75.2% [interquartile range of 37.2 to 164.7] and 50.0% [interquartile range of 1.1% to 64.5%], respectively. Intimal dissections were seen in all postprocedural optical coherence tomography images, and 66.6% of them were sealed on follow-up optical coherence tomography (median 278 days). The fractional flow reserve distal to the target lesion was 0.71±0.14 predilatation, 0.87±0.04 postdilatation, and 0.83±0.08 at follow-up. CONCLUSIONS The paclitaxel-coated balloon restores coronary blood flow by means of plaque modification, causing an increment in minimal lumen area. At 9-month follow-up, coronary flow was sustained and the luminal patency was the result of suppressed luminal narrowing progression from local drug effects on the de novo coronary lesions.
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Vinorelbine Plus Platinum in Patients with Metastatic Triple Negative Breast Cancer and Prior Anthracycline and Taxane Treatment.
Li, M, Fan, Y, Li, Q, Zhang, P, Yuan, P, Ma, F, Wang, J, Luo, Y, Cai, R, Chen, S, et al
Medicine. 2015;(43):e1928
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Abstract
Currently, there is no preferred standard chemotherapy regimen available for patients with metastatic triple negative breast cancer (mTNBC) and no cohort studies on the efficacy of vinorelbine plus platinum (NP) regimen in patients with mTNBC who failed to anthracyclines and/or taxanes have been reported. We present the single-center, retrospective experience of NP regimen in a total of 41 patients with mTNBC.All patients were treated with NP regimen, main combination used was vinorelbine-cisplatin in 34 patients (82.9%).The median follow-up was 36.8 months. Objective response rate was 34.1% (n = 14) in the whole study group. Three patients experienced complete response (7.3%), 11 patients acquired partial response (26.8%), stable disease was observed in 14 patients (34.1%), and 10 patients (24.4%) had progressive disease. Response evaluation was not applicable in 3 patients who received the treatment of NP regimen after surgical removal of the metastatic lesions. The median overall survival and progression-free survival were 18.9 months (95% confidence interval, 15.6-22.1 months) and 6.7 months (95% confidence interval, 2.9-10.5 months), respectively. The main adverse events were grade 3/4 neutropenia (n = 20, 48.8%) and grade 1/2 gastrointestinal toxicity (n = 20, 48.8%).NP regimen is active and tolerable in patients with mTNBC pretreated with anthracyclines and/or taxanes. Therefore, among other chemotherapy regimens, NP combination may provide a rational treatment option for this patient subset.
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Coronary artery treatment with paclitaxel-coated balloon using a BTHC excipient: clinical results of the international real-world DELUX registry.
Toelg, R, Merkely, B, Erglis, A, Hoffman, S, Bruno, H, Kornowski, R, Slagboom, T, Naber, C, Witzenbichler, B, Graf, K, et al
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2014;(5):591-9
Abstract
AIMS: Safety and efficacy of percutaneous coronary interventions using the Pantera Lux paclitaxel-coated balloon have been demonstrated in the PEPPER first-in-man trial. This prospective, multicentre, clinical registry aims to evaluate its safety and efficacy in an international real-world setting in a larger cohort of patients. METHODS AND RESULTS Between April 2010 and April 2011, 1,064 patients were treated for predominantly diffuse and proliferative in-stent restenosis of bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR), or for de novo lesions. Clinical device success was obtained in 98.2% of the patients. The study endpoint was major adverse cardiac events (MACE), defined as a composite of all-cause mortality, non-fatal myocardial infarction and clinically driven target vessel revascularisation, and was 8.5% in the overall, 6.0% in the BMS-ISR, 11.5% in the DES-ISR and 7.0% in the de novo population at six months, and 15.1%, 11.6%, 20.6% and 9.4% at 12 months, respectively. Definitive stent thrombosis occurred in 0.4% of the patients within 12 months. CONCLUSIONS Safety and efficacy of the Pantera Lux paclitaxel-coated balloon was confirmed in a real-world setting with low major adverse cardiac event rates in patients with in-stent restenosis or de novo lesions. (ClinicalTrials.gov: NCT01081366).