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61.
Filippo Pietrantonio Christian Cotsoglou Giovanni Fucà Salvatore Lo Vullo Federico Nichetti Massimo Milione Jorgelina Coppa Marta Vaiani Alessandra Alessi Michele Prisciandaro Michele Droz-Dit Busset Federica Morano Salvatore Corallo Silvia Lazzati Maria Antista Alessia Mennitto Giovanni Randon Alessandra Raimondi Vincenzo Mazzaferro 《Clinical colorectal cancer》2019,18(1):34-43.e6
Background
In colorectal cancer liver metastases (CRCLM), bevacizumab-based neoadjuvant strategies provide increased pathologic response. We aimed at assessing the activity of perioperative capecitabine, oxaliplatin, irinotecan, and bevacizumab (COI-B regimen) in patients with potentially resectable CRCLM, and investigating biomarkers for early prediction of pathologic response.Patients and Methods
This was a single-center phase II study enrolling patients with liver-limited, borderline resectable disease and/or high-risk features. Patients received 5 preoperative and 4 postoperative cycles of biweekly COI-B (irinotecan 180 mg/m2 and bevacizumab 5 mg/Kg on day 1, oxaliplatin 85 mg/m2 on day 2, and capecitabine 1000 mg/m2 twice a day on days 2 to 6). The primary endpoint was pathologic response rate in the intention-to-treat population. A Simon 2-stage design was adopted to detect an increase from 30% to 50% with a power of 90%. Dynamic imaging biomarkers (early tumor shrinkage [ETS], deepness of response, maximum standardized uptake volume [SUVmax]/regression index) and next generation sequencing data were explored as surrogates.Results
From June 2013 to March 2017, 46 patients were enrolled. Pathologic response was achieved in 63% patients (endpoint met), and responders achieved significantly better survival outcomes with respect to non-responders. The most frequent grade 3/4 adverse events were diarrhea and neutropenia (8.7%) in the preoperative phase and thromboembolic events (5.9%) in the postoperative phase. ETS and lower SUV-2 were significantly associated with pathologic response.Conclusion
The COI-B regimen is a feasible and highly active perioperative strategy in patients with molecularly unselected, potentially resectable CRCLM. ETS and SUV-2 have a promising role as imaging-based biomarkers for pathologic response. 相似文献62.
摘 要 目的:探讨黄芪汤加减治疗慢性阻塞性肺疾病急性加重期(AECOPD)的临床疗效。方法:采用随机数字表法将166例AECOPD患者随机分为常规组和观察组各83例。常规组采用常规西医方法治疗,观察组在常规组的基础上给予黄芪汤加减治疗。观察两组治疗前后第1秒用力呼气量(FEV1)、用力肺活量(FVC)、FEV1占FVC的百分比(FEV1/FVC%)、动脉血氧分压(PaO2)、动脉血二氧化碳分压(PaCO2)、肿瘤坏死因子 α(TNF α)、白细胞介素 1β(IL 1β)、白细胞介素 6(IL 6)水平。结果:两组治疗后FEV1、FEV1/FVC、PaO2水平与治疗前相比较均显著升高(P<0.05),且观察组与同期常规组相比较均显著升高(P<0.05);两组治疗后PaCO2、TNF α、IL 1β、IL 6水平与治疗前相比较均显著降低(P<0.05),且观察组与同期常规组相比较均显著降低(P<0.05)。结论:黄芪汤加减治疗AECOPD可降低患者炎症反应水平,改善动脉血气和肺功能,提高治疗效果,值得临床应用。 相似文献
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64.
《Clinical breast cancer》2020,20(2):e173-e180
BackgroundIn PALOMA-2, palbociclib + letrozole significantly prolonged progression-free survival (PFS) versus placebo + letrozole in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2−) advanced breast cancer (ABC). We investigated clinical outcomes of patients who achieved or did not achieve a confirmed objective response (OR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (data cutoff: May 31, 2017).Patients and MethodsPostmenopausal patients untreated for ER+/HER2− ABC were randomized 2:1 to palbociclib + letrozole or placebo + letrozole. Median PFS, median duration of OR, baseline characteristics, and palbociclib exposure were compared in patients with or without OR by treatment arm.ResultsIn the intent-to-treat population, OR was achieved by 194 (44%) of 444 and 77 (35%) of 222 patients in the palbociclib and placebo arms, respectively (odds ratio, 1.5; 95% confidence interval [CI], 1.0-2.1; P = .0156). Regardless of treatment, more OR than non-OR patients had de novo metastatic disease (47%-50% and 28%-31%, respectively) and no prior endocrine therapy (55% and 35%-37%, respectively). Rates of palbociclib dose reduction owing to adverse events were similar regardless of OR (41% and 38%, respectively). Among the patients with OR during the study, approximately 50% achieved OR within the first 3 months regardless of treatment. The median PFS was significantly prolonged with palbociclib + letrozole versus placebo + letrozole in patients with measurable disease in both OR (37.2 months; 95% CI, 28.1 months to not estimable vs. 27.4 months; 95% CI, 22.2-31.1 months; hazard ratio, 0.66; 95% CI, 0.47-0.94; P = .009) and non-OR groups (10.9 months; 95% CI, 8.2-11.2 months vs. 5.6 months; 95% CI, 5.3-8.3 months; hazard ratio, 0.72; 95% CI, 0.54-0.97; P = .016).ConclusionsPalbociclib + letrozole provided significant clinical benefit versus placebo + letrozole to patients with ER+/HER2− ABC regardless of achieving RECIST-defined OR.Pfizer; ClinicalTrials.gov: NCT01740427 相似文献
65.
《Clinical Lymphoma, Myeloma & Leukemia》2020,20(9):596-601
BackgroundPrevious reports have suggested that a higher bone marrow plasma-cell percentage (BMPC%) is associated with worse outcomes. However, it is unknown whether BMPC% is an independent predictor because genetic information was not available at that time. Currently the impact of BMPC% at diagnosis of multiple myeloma (MM) is not well described.Patients and MethodsWe evaluated the prognostic impact of BMPC% ≥ 60% versus < 60% in 1426 newly diagnosed MM patients. All patients had an estimation of their BMPC% at diagnosis, and the highest percentage was used. Progression-free survival (PFS) and overall survival (OS) analyses were performed by the Kaplan-Meier method. Univariate and multivariate analyses for PFS and OS using the Cox proportional hazards model were performed for age, Revised International Staging System (R-ISS) score, creatinine level, and BMPC%.ResultsBMPC% ≥ 60% was found in 562 patients (39%), and the median PFS was shorter for these patients compared to BMPC% < 60% (22.6 vs. 32.1 months; P < .0001). Also, for OS, the median was shorter for the higher BMPC% group (53.4 vs. 75.4 months; P < .0001). On the multivariate analysis for PFS, age ≥ 65 years (hazard ratio [HR], 1.46; P < .0001), R-ISS (1-2 vs. 3) (HR, 0.49; P < .0001), and BMPC% ≥ 60% (HR, 1.23; P = .015) were predictive. On the multivariate analysis for OS, age ≥ 65 years (HR, 2.23; P < .001), R-ISS (1-2 vs. 3) (HR, 0.41; P < .0001), and BMPC% ≥ 60% (HR, 1.24; P = .02) were also predictive.ConclusionBMPC% ≥ 60% at diagnosis is predictive for PFS and OS, even in a multivariate analysis that included known prognostic factors for MM. 相似文献
66.
67.
目的:探讨养阴利咽饮与玉液散吹喉对阴虚肺燥型慢性咽炎患者血清炎性因子的影响。方法:将2015年8月至2017年3月山东省淄博市第四人民医院收治的慢性咽炎患者118例作为研究对象,按治疗方法不同分为对照组和观察组,每组59例。对照组用常规西药治疗,观察组用养阴利咽饮与玉液散吹喉治疗,均连续治疗30 d。比较2组临床疗效,观察并比较治疗前后2组患者主要临床症状改善情况,唾液中分泌型免疫球蛋白A(SIgA)、血清炎性因子水平及生命质量变化。结果:治疗后观察组总有效率为91.53%,高于对照组的76.27%(P<0.05)。治疗后2组咽痛、干咳、咽黏膜充血水肿临床症状积分低于治疗前,且观察组低于对照组(P<0.01)。与治疗前比较,治疗后2组患者唾液中SIgA水平均明显升高,血清肿瘤坏死因子-α(TNF-α)及C-反应蛋白(CRP)水平均明显降低,且2组比较差异均有统计学意义(均P<0.01)。治疗后2组患者SF-36各项评分均明显高于治疗前,且观察组高于对照组(P<0.05或P<0.01)。结论:养阴利咽饮与玉液散吹喉联用可降低阴虚肺燥型慢性咽炎患者血清TNF-α、CRP水平,升高唾液中SIgA含量,改善患者临床症状,提高患者生命质量。 相似文献
68.
69.
70.
Ewelina Kazimierczyk Andrzej Eljaszewicz Paula Zembko Ewa Tarasiuk Malgorzata Rusak Agnieszka Kulczynska-Przybik Marta Lukaszewicz-Zajac Karol Kaminski Barbara Mroczko Maciej Szmitkowski Milena Dabrowska Bozena Sobkowicz Marcin Moniuszko Agnieszka Tycinska 《Pharmacological reports : PR》2019,71(1):73-81