卡培他滨联合曲妥珠单抗治疗Her-2阳性老年转移性乳腺癌的疗效观察

目的：观察卡培他滨联合曲妥珠单抗治疗Her-2阳性老年转移性乳腺癌的疗效与安全性。方法：32例老年乳腺癌患者（≥65岁）均经病理组织学证实为复发或转移,Her-2阳性,给予卡培他滨1250 mg/m2口服,2次/d,第1~14天;曲妥珠单抗首次负荷剂量8 mg/kg,后续6 mg/kg静点,21 d为一周期,每2周期评价疗效。结果：32例患者均可评价,其中完全缓解（CR）2例（6.2%）,部分缓解（PR）10例（31.3%）,稳定≥6个月（SD）11例（34.4%）,进展（PD）9例（28.1%）,总有效率为37.5%（12/32）,临床获益率（CR＋PR＋SD）为71.9%（23/32）;中位疾病进展时间（TTP）8.5个月;主要的毒副反应为手足综合征、腹泻、口腔炎,均可耐受;1例患者出现症状性心力衰竭,停药后改善;无化疗相关死亡。结论：卡培他滨联合曲妥珠单抗治疗Her-2阳性老年转移性乳腺癌疗效确切,毒副反应轻,耐受性良好,是一种安全有效的姑息治疗方案。     

XELOX versus FOLFOX6 as an adjuvant treatment in colorectal cancer: an economic analysis

ABSTRACT

Objectives: An economic analysis (based on interim data from a long-term, randomised, multi-centre, controlled, clinical trial) to evaluate chemotherapy with XELOX (capecitabine/oxaliplatin) versus FOLFOX6 (5Fluorouracil/leucovorin/oxaliplatin) as an adjuvant treatment for high risk colorectal cancer patients in Greece.

Methods: As survival rate was the same in the two arms, a cost-minimisation analysis was carried out, from the perspectives of the National Health Service (NHS), Social Insurance Funds (SIF) and patients in Greece. Patient data were combined with 2008 unit prices to estimate the total cost of patient care, the patients’ travelling expenditure and their productivity losses. Raw data were bootstrapped 5000 times in order to allow statistical testing.

Results: From an NHS perspective, the mean chemotherapy cost was €8762 with FOLFOX6 and €9713 with XELOX; costs of administration and hospitalisations were €5154 and €1050, respectively. Total treatment cost with FOLFOX6 reached €17?480 and with XELOX €12?525, a difference of €4955 (p?<?0.001) in favour of the latter therapy. From an SIF perspective, the total cost of treatment was €16?240 with FOLFOX6 and €12?617 with XELOX, a reduction of €3623 (p?<?0.001) with the latter therapy. Mean patient travelling cost was €184 with FOLFOX6 and €80 with XELOX, a difference of €104 (p?<?0.001). Mean productivity loss was €100 with FOLFOX6 and €31 with XELOX, a difference of €69 (p?<?0.001).

Conclusions: Chemotherapy combining oral capecitabine and oxaliplatin reduces total treatment cost for the Greek National Health Service and Social Insurance Funds, mainly through a reduction in the cost of administration. From patients’ perspective, it reduces travelling expenditure and productivity losses. Therefore, this combination may be a cost-effective approach for the management of colorectal cancer patients who have had surgery in Greece. This is an analysis alongside a clinical trial, and should be interpreted in this specific context in which it was undertaken.     

卡培他滨联合奥沙利铂或多西他赛治疗晚期胃癌的临床观察

目的观察卡培他滨联合奥沙利铂或多西他赛治疗晚期胃癌的近期疗效和毒副反应。方法选择晚期胃癌患者59例,随机分入XELOX组和DX组。XELOX组30例,DX组29例。XELOX组奥沙利铂130mg／m2,第1天静脉滴注,卡培他滨1000mg／m2,日2次口服,第1～14天,每3周重复给药1次。DX组多西他赛75mg／m2,第1天静脉滴注,卡培他滨用法同前,每3周重复给药1次。2个周期化疗后进行疗效评价。结果所有59例患者均可评价疗效。XELOX组的有效率46．7％,其中CR1例（3．3％）,PR1例（43．3％）,SD8例（26．7％）。DX组的有效率41．4％,其中无CR病例,PR12例（41．4％）,SD7例（24．1％）。两组患者的有效率无统计学差异（P〉0．05）。两组病例主要不良反应为骨髓抑制、胃肠道反应及外周神经毒性,多为Ⅰ-Ⅱ度,耐受良好。结论卡培他滨与奥沙利铂或多西他赛联合治疗方案均是晚期胃癌的有效的化疗方案,两种方案疗效及不良反应类似,患者耐受良好。     

多西他赛联合奥沙利铂卡培他滨治疗晚期胃癌的疗效

目的探讨研究多西他赛联合奥沙利铂、卡培他滨对晚期胃癌患者的治疗效果,总结其不良反应。方法随机选取2010年1月至2012年4月我院晚期胃癌患者70例为研究对象,随机分为两组,对照组患者给予多西他赛联合奥沙利铂及5-氟尿嘧啶治疗,实验组患者给予多西他赛联合奥沙利铂、卡培他滨治疗,对比观察两组疗效。结果实验组患者的有效率高于对照组患者,P<0.05,差异有统计学意义;实验组患者的不良反应与对照组比较差异均不明显,P>0.05,差异无统计学意义。结论使用多西他赛联合奥沙利铂、卡培他滨治疗的效果较好,可以提高治疗效果,且患者耐受性好,是一种较好的治疗晚期胃癌的方法。     

卡培他滨维持性口服治疗宫颈癌的临床研究

目的探讨卡培他滨维持性口服治疗宫颈癌的近期疗效及不良反应。方法将96例宫颈癌患者随机分为高剂量维持组、低剂量维持组及对照组各32例。对照组单纯予以紫杉醇联合顺铂化疗方案治疗。在对照组治疗基础上,高剂量维持组应用卡培他滨1000mg/m2进行维持性治疗,低剂量维持组应用卡培他滨500mg/m2进行维持性治疗。比较3组的临床近期疗效及不良反应。结果高剂量维持组、低剂量维持组及对照组有效率分别为50.0%、46.9%、46.9%,3组间比较差异无统计学意义(P>0.05)。在1年生存率、中位进展时间和中位生存时间方面,均为低剂量维持组>高剂量维持组>对照组(P<0.05)。且低剂量维持组不良反应发生情况优于高剂量维持组,差异有统计学意义(P<0.05)。结论卡培他滨维持性口服治疗晚期宫颈癌疗效佳,且低剂量药物引起的不良反应明显较高剂量轻,临床应用方便,利于长期使用。     

XELOX方案与替吉奥联合奥沙利铂方案治疗老年Ⅳ期胃癌的临床研究

目的观察及比较XELOX方案与替吉奥联合奥沙利铂方案治疗老年Ⅳ期胃癌患者的临床疗效及毒副反应。方法采用随机对照法将70例老年Ⅳ期胃癌患者分为两组,分别采用XELOX方案与替吉奥联合奥沙利铂方案,至少规律化疗2个周期后评价近期疗效、毒副反应和临床获益反应。结果 （1）XELOX组与替吉奥联合奥沙利铂组总有效率（RR,分别为58.8%,57.2%）及疾病控制率（DCR,分别为82.3%,82.9%）比较均无统计学差异（P〉0.05）。（2）两组的骨髓抑制、消化道症状、神经病变等毒副反应比较均无统计学差异（P〉0.05）,而肝脏毒性方面比较有统计学差异,替吉奥组肝毒性明显（P〈0.05）。（3）两组的临床获益率（分别为47.1%和48.6%）无统计学差异（P〉0.05）。（4）两组中位无进展时间（mTTP,分别为5.3个月,5.7个月）及1年生存率（分别为46.9%,51.5%）比较无统计学差异（P〉0.05）。结论 （1）XELOX方案和替吉奥联合奥沙利铂方案治疗Ⅳ期胃癌的疗效显著。（2）毒副反应方面替吉奥联合奥沙利铂组肝毒性较XELOX组明显。（3）两种方案治疗Ⅳ期胃癌有效率及临床获益率较高,安全性好。     

NX方案和GP方案治疗蒽环类及紫杉类药物治疗后复发转移乳腺癌的临床疗效分析

目的:观察长春瑞滨联合卡培他滨(NX)以及吉西他滨联合顺铂(GP)两种方案用于蒽环类和紫杉类药物治疗后复发转移性乳腺癌的有效性和安全性.方法:41例蒽环类和紫杉类药物治疗后复发转移性乳腺癌患者分入NX组和GP组,其中NX组18例,长春瑞滨(Vinorelbine,NVB) 25 mg/m2,第1天和第8天,卡培他滨(Capecitabine,Xeloda) 2000 mg/m2,分两次口服,第1～14天,每21天为一周期;GP组23例,吉西他滨(Gemcitabine,GEM) 1000 mg/m2第1天和第8天,顺铂(Cisplatin,DDP) 20 mg/m2,静脉滴注,第2～5天,21天为一周期.化疗过程中注意观察不良反应,根据不良反应的程度调整药物用量.每两周期评价疗效.结果:41例患者均可评价疗效,NX组CR 1例(5.5％),PR 9例(50％),SD 4例(22.2％),PD 4例(22.2％),RR55.5％,TTP 6.3个月;GP组CR 2例(8.9％),PR 11例(47.8％),SD 5例(21.7％),PD 5例(21.7％),RR 56.5％,TTP 6.5个月.两组间RR及TTP差异无统计学意义(P＞0.05);常见的不良反应主要为骨髓抑制、胃肠道反应、手足综合症、静脉炎等.GP组的血小板下降发生率及消化道反应发生率高于NX组,差异有统计学意义(P＜0.05),NX组的手足综合症发生率明显高于GP组,差异有明显统计学意义(P＜0.01).结论:NX方案和GP方案用于蒽环类及紫杉类药物治疗后复发转移乳腺癌疗效确切,其血液学和非血液学毒性能够耐受.     

XELOX方案治疗晚期胃癌104例

目的探讨奥沙利铂联合卡培他滨（XELOX方案）治疗晚期胃癌的近期疗效和安全性。方法经病理证实的晚期胃癌患者,应用奥沙利铂100～130mg/m2加入5%250ml中静滴2小时;卡培他滨1000mg/m2饭后半小时口服,每日2次,第1～14天;21天为1周期。结果全组患者中CR1例,PR44例,总有效率为43.27%,中位进展时间7.1个月。初治组有效率显著高于复治组（53.57%vs.31.25%,P〈0.05）,转移灶数目1～2个,比≥3个的治疗有效率高（47.27%vs.13.33%,P〈0.05）,肝转移及腹膜后淋巴结转移的有效率相对较低。主要不良反应为骨髓抑制、神经毒性、肝功异常,但以I～II度为主。结论 XELOX方案治疗晚期胃癌有效率较高,毒副反应较低,患者耐受性好。     

Capecitabine-Based Chemoendocrine Combination as First-Line Treatment for Metastatic Hormone-Positive Metastatic Breast Cancer: Phase 2 Study

BackgroundPreclinical studies have suggested a synergistic effect of tamoxifen and capecitabine in estrogen receptor–positive cell lines. We evaluated the safety and efficacy of first-line chemoendocrine treatment in patients with metastatic breast cancer. Biochemical assessment was performed of serum levels of thymidine phosphorylase enzyme (TP), serum tamoxifen, hydroxytamoxifen, and 5-fluorouracil in relationship to efficacy.Patients and MethodsThis prospective phase 2 interventional study studied patients with estrogen receptor-positive, HER2⁻ metastatic breast cancer who received either tamoxifen/capecitabine or letrozole/capecitabine as first-line treatment. The dose of capecitabine provided at 2000 mg per day continuously as a fixed dose.ResultsForty women with a median age of 49.3 years were enrolled. For the whole study group, median progression-free survival (PFS) was 10 months and median overall survival (OS) was 23.3 months. The overall response rate was 60% and the clinical benefit rate 82.5%. Progesterone receptor positivity was associated with significantly longer PFS (12 vs. 7 months, P = .021). The most frequent adverse events were palmar–plantar erythrodysesthesia (62.5%), fatigue (62.5%), diarrhea (30%), abdominal pain (12.5%), and constipation (10%). Changes in serum level of TP were not correlated to response to treatment, PFS, or OS. Higher serum levels of tamoxifen and hydroxytamoxifen were correlated with higher response rates and longer PFS but not OS.ConclusionChemoendocrine treatment is well tolerated, with no evidence of contradictory effects between the combination components. However, the efficacy data need more validation.     

Effects of Proton Pump Inhibitors on FOLFOX and CapeOx Regimens in Colorectal Cancer

Background

First-line adjuvant chemotherapy options for early-stage colorectal cancer (CRC) include CapeOx (capecitabine, intravenous oxaliplatin) and FOLFOX (intravenous 5-fluorouracil, leucovorin, oxaliplatin). Capecitabine is an oral prodrug analog of 5-fluorouracil, and recent studies have suggested that proton pump inhibitors (PPIs) may detrimentally affect capecitabine efficacy. Conversely, some literature suggests that PPIs may negatively affect CRC itself. To gain insight into the nature of PPIs’ effect on capecitabine and CRC, we investigated their effects on effectiveness of CapeOx versus FOLFOX chemotherapy.