通络活血法外用治疗化疗性手足综合征临床研究

目的：观察通络活血法外用治疗化疗性手足综合征的临床疗效和安全性。方法：选取卡培他滨化疗后出现手足综合征不良反应者为观察对象,2：1随机分为试验组与对照组,纳入患者共102例,分别给予通络活血法或安慰剂外用（洗/浸）,温浴（35～38℃）,20 min/次,每日2次,连用7天为1个观察周期。结果：手足综合征分级的疗效总有效率试验组与对照组分别为87.88%、20.59%,试验组治疗起效时间为（3.80±0.20）天;疼痛缓解有效率试验组与对照组分别为90.91%、41.18%,治疗前后的NRS评分试验组为5.89±1.97和2.12±2.20、对照组为5.91±1.76和4.88±2.38;组间差异有统计学意义。结论：通络活血法外用能够减轻化疗性手足综合征的疼痛程度、有效降低分级、改善患者的生活质量,且安全性良好。     

卡培他滨辅助化疗联合TP方案同步放化疗对中晚期食管癌患者免疫功能及炎性因子的影响

目的探讨卡培他滨辅助化疗联合紫杉醇+顺铂(TP方案)同步放化疗对中晚期食管癌患者免疫功能和炎性因子水平的影响。方法根据治疗方案的不同,将160例中晚期食管癌患者分为对照组(n=76)和观察组(n=84),对照组患者接受TP方案同步放化疗,观察组患者在此基础上联合卡培他滨辅助化疗。比较两组患者治疗前和治疗后6个月血清免疫球蛋白[免疫球蛋白A(IgA)、免疫球蛋白M(IgM)、免疫球蛋白G(IgG)]水平和炎性因子[肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)和白细胞介素-8(IL-8)]水平。结果治疗前,两组患者血清免疫球蛋白和炎性因子水平比较,差异均无统计学意义(P﹥0.05)。治疗后,观察组患者IgA、IgG和IgM水平均明显高于本组治疗前和对照组患者(P<0.01);治疗后,两组患者血清TNF-α、IL-6和IL-8水平均明显低于本组治疗前,且观察组患者血清TNF-α、IL-6和IL-8水平均明显低于对照组患者,差异均有统计学意义(P<0.01)。结论卡培他滨辅助化疗联合TP方案同步放化疗治疗食管癌,可有效恢复患者免疫功能,改善机体炎性状态,提高临床疗效。     

三维适形放疗同步卡培他滨化疗治疗老年胃癌

目的:研究三维适形放疗同步卡培他滨化疗治疗老年胃癌患者的疗效、生存时间和不良反应。方法:本院收治的45例老年胃癌患者随机分为卡培他滨单药化疗组（21例）和三维适形放疗同步卡培他滨化疗组（24例）。PTV剂量1.8Gy/(25f·5w),放疗开始同步卡培他滨化疗。比较两组患者的疗效、生存时间和不良反应。结果:卡培他滨单药化疗组客观缓解率61.9%,三维适形放疗同步卡培他滨化疗组客观缓解率87.5%,有显著统计学差异(P＜0.05)。两组不良反应、生活质量无显著差异。卡培他滨单药化疗组2年生存率23.8%,三维适形放疗同步卡培他滨化疗组2年生存率50.0%,有显著统计学差异(P＜0.05)。结论:三维适形放疗同步卡培他滨化疗治疗老年胃癌可以有效提高患者的治疗效果,改善预后,不良反应可以耐受,是一种安全有效的治疗方案。     

Capecitabine Pattern of Usage,Rate of Febrile Neutropaenia and Treatment Related Death in Asian Cancer Patients in Clinical Practice

Background: Oral capecitabine is increasingly replacing intravenous 5-fluorouracil in many chemotherapyregimens. However, data on the risk of febrile neutropaenia (FN) and treatment related death (TRD) with thedrug remain sparse outside of clinical trial settings despite its widespread usage. This study aimed to determinethese rates in a large cohort of patients treated in the University of Malaya Medical Centre (UMMC). Materialsand Methods: We reviewed the clinical notes of all patients prescribed with oral capecitabine chemotherapyfor any tumour sites in University Malaya Medical Centre (UMMC) from 1st January 2009 till 31st June 2010.Information collected included patient demographics, histopathological features, treatment received including thedifferent chemotherapy regimens and intent of treatment whether the chemotherapy was given for neoadjuvant,concurrent with radiation, adjuvant or palliative intent. The aim of this study is to establish the pattern of usage,FN and TRD rates with capecitabine in clinical practice outside of clinical trial setting. FN is defined as an oraltemperature >38.5°C or two consecutive readings of >38.0°C for 2 hours and an absolute neutrophil count <0.5 x109/L, or expected to fall below 0.5 x 109/L (de Naurois et al., 2010). Treatment related death was defined as deathoccurring during or within 30 days of last chemotherapy treatment. Results: Between 1st January 2009 and 30thJune 2010, 274 patients were treated with capecitabine chemotherapy in UMMC. The mean age was 58 years(range 22 to 82 years). Capecitabine was used in 14 different tumour sites with the colorectal site predominatingwith a total of 128 cases (46.7%), followed by breast cancer (35.8%). Capecitabine was most commonly usedin the palliative setting accounting for 63.9% of the cases, followed by the adjuvant setting (19.7%). The mostcommon regimen was single agent capecitabine with 129 cases (47.1%). The other common regimens were XELOX(21.5%) and ECX (10.2%). The main result of this study showed an overall FN rate of 2.2% (6/274). The overallTRD rate was 5.1% (14/274). The FN rate for the single agent capecitabine regimen was 1.6% (2/129) and theTRD rate was 5.4% (7/129). All the TRDs were with single agent capecitabine regimen were used for palliativeintent. Conclusions: Oral capecitabine is used widely in clinical practice in a myriad of tumour sites and bearsa low risk of febrile neutropaenia. However, capecitabine like any other intravenous chemotherapeutic agentcarries a significant risk of treatment related death.     

An Updated Meta-analysis and System Review:is emcitabine+Fluoropyrimidine in Combination a Better herapy Versus Gemcitabine Alone for Advanced and Unresectable Pancreatic Cancer?

Background: Pancreatic cancer ranks fourth in deaths caused by cancers throughout the world. Gemcitabinechemotherapy is the primary method of treatment of advanced pancreatic cancer, and in asco2014, it is still firstlinechemotherapy. Howeve,r gemcitabine+fluorouracil regimens are also licensed and widely used worldwide.Clinical trials are the best way to evaluate drug efficacy. In this study, we performed a systematic reviewand a meta-analysis of randomized controlled trials (RCTs) to assess whether gemcitabine+fluoropyrimidinecombination therapy improves the prognosis of unresectable pancreatic cancer compared with gemcitabinetreatment alone. Materials and Methods: A quantitative up-to-date meta-analysis was undertaken to investigatethe efficacy of gemcitabine-based combination treatment compared with gemcitabine monotherapy for locallyadvanced or metastatic pancreatic cancer. Inclusion was limited to high-quality randomized clinical trials.Results: A total of 12 studies were included in the present analysis, with a total of 3,038 patients recruited.The studies were divided into three subgroups including 5-FU / CAP / S-1 combined with gemcitabine. For theprimary endpoint of overall survival (OS), gemcitabine-based combination therapy demonstrated significantlybetter outcome (HR, 0.88; 95% CI, 0.81-0.95) than gemcitabine monotherapy. The analysis of progression freesurvival (PFS) also provided a significant result for the combined therapy in a total of 8 trials (2,130 patients)(HR, 0.74; 95% CI, 0.63-0.86). With subgroup analysis according to the method of dosing delivery, we foundthat in the injection group with 3 trials (889 patients), a negative result was found (HR, 0.93; 95% CI, 0.77-1.12);while a positive result was observed in the oral group with 9 trials (2,149 patients) (HR, 0.87; 95% CI, 0.80-0.95).Conclusions: Gemcitabine combination therapy provides a modest improvement of survival, but is associatedwith more toxicity compared with gemcitabine monotherapy.     

卡培他滨维持化疗治疗晚期胃癌和术后复发转移胃癌的安全性及预后分析

目的:研究晚期胃癌、术后复发转移胃癌患者应用卡培他滨不同方案治疗的临床效果。方法:回顾分析我院自2010年8月至2013年8月以来,于我科治疗的120例胃癌患者临床资料,依据治疗方案将其分为奥沙利铂组、多西紫杉醇组、对照组,每组40例,奥沙利铂组予以奥沙利铂、卡培他滨联合治疗,多西紫杉醇组予以多西紫杉醇、卡培他滨联合治疗,对照组予以卡培他滨单独治疗,观察对比治疗14d后三组的临床疗效、DCR（疾病控制率）,三组血清CEA、CA50、CA199、CA125改变情况,三组生存质量及不良反应等情况。结果:奥沙利铂组RR为80.0%,与多西紫杉醇组（70.0%）、对照组（50.0%）相较,均呈明显差异（P＜0.05）。奥沙利铂组DCR为90.0%,与多西紫杉醇组（85.0%）相较,无统计学差异（P＞0.05）,与对照组（65.0%）相较,呈明显差异（P＜0.05）。奥沙利铂组、多西紫杉醇组治疗后血清CEA、CA50、CA199、CA125与对照组相较,均存在明显差异（P＜0.05）,但奥沙利铂组与多西紫杉醇组相较,无统计学差异（P＞0.05）。奥沙利铂组、多西紫杉醇组治疗后生活质量评分与对照组相较,呈明显差异（P＜0.05）,奥沙利铂组与多西紫杉醇组相较,呈明显差异（P＜0.05）。三组各项不良反应发生率相较,无统计学差异（P＞0.05）。结论:晚期胃癌、术后复发转移胃癌患者应用奥沙利铂、卡培他滨联合治疗,可以提高治疗的有效率和疾病控制率,而且可以改善预后生存质量,优化血清CEA、CA50、CA199、CA125水平,无额外的不良反应,安全稳定,效果显著,应予推广。     

周剂量紫杉醇联合顺铂、卡培他滨治疗晚期胃癌的临床研究

目的观察周剂量紫杉醇联合顺铂、卡培他滨方案治疗晚期胃癌的客观疗效、疾病进展时间和不良反应。方法77例晚期胃癌患者随机分为2组,治疗组39例晚期胃癌患者接受周剂量紫杉醇75 mg/m^2（d1、d8、d15）,顺铂25 mg/m2（d1、d8、d15）,卡培他滨每日1 250 mg/m^2,分2次口服,d1-d14,28 d为1周期,疗程2-6周期。对照组38例晚期胃癌患者接受奥沙利铂85 mg/m^2,d1,亚叶酸钙200 mg/m^2（2 h静脉输注）d1-d2,而后5-氟尿嘧啶（5-Fu）400 mg/m^2（10 min静脉推注）及5-Fu 600 mg/m^2（持续静脉泵入22 h）,d1-d2,每14天重复,2次为1周期。结果治疗组有效率显著高于对照组（59.0%vs 47.4%,P〈0.05）,TTP治疗组较对照组显著延长（6.8个月vs 5.8个月,P〈0.05）。治疗组手足综合征发生率显著高于对照组（P〈0.01）,其他不良反应按分级比较2组无显著性差异（P〉0.05）。Karnofsky评分治疗组改善率较对照组显著增高（P〈0.05）。结论周剂量紫杉醇联合顺铂、卡培他滨化疗方案治疗晚期胃癌近期疗效显著,耐受性较好。     

Costs associated with complications are lower with capecitabine than with 5‐fluorouracil in patients with colorectal cancer

BACKGROUND:

Capecitabine, an oral alternative to 5‐fluorouracil (5‐FU) in patients with colorectal cancer (CRC), has equal clinical efficacy and a favorable safety profile; however, its use may be limited because of unit cost concerns. In this study, the authors measured the cost of chemotherapy‐related complications during treatment with capecitabine‐ and 5‐FU–based regimens.

METHODS:

Patients with CRC who received at least 1 administration of capecitabine or 5‐FU during 2004 and 2005 were identified from the Thomson MarketScan research databases. Monthly frequency and cost for 23 complications were recorded. Logistic regression was used to predict complication probability. General linear models were used to predict monthly complication cost and total monthly expenditure.

RESULTS:

In total, 4973 patients with CRC met the inclusion criteria for this analysis. Although the most frequently observed complications were the same between capecitabine and 5‐FU (nausea and vomiting, infection, anemia, neutropenia, diarrhea), each was observed with greater frequency in 5‐FU–based regimens. The mean predicted monthly complication cost was significantly higher (by 136%) with 5‐FU monotherapy than with capecitabine monotherapy (difference, $601; 95% confidence interval [95% CI], $469‐$737). In addition, the mean predicted monthly complication cost for 5‐FU+oxaliplatin was higher than the cost with capecitabine plus oxaliplatin (difference, $1165; 95% CI, $892‐$1595). When acquisition, administration, and complication costs were taken into consideration, there were no significant differences in the total cost between capecitabine regimens and 5‐FU regimens.

CONCLUSIONS:

Capecitabine compared well with 5‐FU–based therapy in patients with CRC and was associated with lower complication rates and associated costs. Cancer 2009. © 2009 American Cancer Society.     

低位直肠癌术前调强放疗同步加量并同步口服卡培他滨化疗的初步研究

目的探讨低位直肠癌调强放射治疗（IMRT）同步加量并同步口服卡培他滨化疗的毒副作用,并初步分析其疗效。方法回顾性分析16例接受术前IMRT同步加量放疗同时口服希罗达化疗,临床诊断为T_（2～4）和/或N_（1～2）的低位直肠腺癌患者,放射治疗采用5野IMRT技术,共25次5周,全盆腔45～50Gy,肿瘤及其周围2cm范围同步加量至55～60Gy。同时口服卡培他滨625mg/m~2,每日2次,应用2周后休息1周,再继续口服至放疗结束。手术于放疗结束后8～10周进行。记录分析所有病例的毒副作用及远近期疗效。结果所有病例顺利完成治疗,无治疗中断者。有11例患者（68.8%）出现Ⅲ度皮肤反应,无Ⅲ度以上腹泻、血液学及泌尿系统毒副作用,仅1例患者（6.3%）出现晚期Ⅱ度胃肠道毒副作用。放疗后评估临床完全缓解7例（43.8%）,部分缓解8例（50%）。12例（75%）患者保肛,其中手术并保肛7例,肿物消失拒绝手术5例。2年总生存率85.7%,无病生存率76.6%,局部复发率6.3%。结论低位直肠癌调强放射治疗（IMRT）同步加量并同步口服卡培他滨化疗有一定效果且患者耐受良好,值得进一步探索研究。     

Low Incidence of the DPD IVS14+1G>A Polymorphism in Jordanian Breast and Colorectal Cancer patients

Background: Dihydropyrimidine dehydrogenase (DPD) is a crucial enzyme in the catabolism of 5-fluorouracil (5-FU), a drug that is frequently used in cancer therapy. Patients with deficient DPD activity are at risk of developing severe 5-FU–associated toxicity. One possible cause of deficiency is genetic polymorphisms in the DPD gene, such as IVS14+1G>A. Aim: The present study was conducted to screen for the IVS14+1G>A polymorphism in cancer patients receiving 5-FU and a control group. Methods: A total of 40 cancer patients (30 colorectal cancer (CRC) and 10 breast cancer patients) were enrolled in this study. One hundred healthy controls were also tested using polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). DNA sequence analysis was carried out to confirm the presence of the IVSI14+1G>A polymorphism. Results: Only one CRC patient showed heterozygous IVS14+1G>A polymorphism in the DPD gene. Conclusion: The results of this study demonstrated a very low frequency of the IVS14+1G>A polymorphism among Jordanian patients with colorectal and breast cancer.