Exploring the efficacy and safety of single-agent sorafenib in a cohort of Italian patients with hepatocellular carcinoma

This study investigates the effectiveness and safety of sorafenib in a heterogeneous cohort of Child–Pugh A, B and C patients with advanced hepatocellular carcinoma in a clinical-practice scenario. Adult patients with hepatocellular carcinoma and treated with sorafenib 800 mg/day were eligible for this multicentric retrospective observational study. Safety analyses were performed and the effectiveness of sorafenib was assessed in terms of time to progression (TTP) and overall survival (OS). In total, 93 patients were enrolled: 14 were Child–Pugh A, 70 were Child–Pugh B and nine were Child–Pugh C. No differences in the frequency of grade 3 adverse events among different Child–Pugh classes were reported. In the overall cohort, median OS was 12 months (95% CI: 11.7–12.8 months) and TTP was 3 months (95% CI: 2.5–3.4 months). The Child–Pugh score had a statistically significant effect on TTP: 6.6 months in Child–Pugh A, 2.8 months in Child–Pugh B and 2.0 months in Child–Pugh C patients (p = 0.012). To our knowledge, this study includes the largest cohort of Caucasian Child–Pugh B and C patients ever treated with sorafenib. Although the retrospective design of this study does not allow reaching any definite conclusion, the results could lend some preliminary support to the safety and the effectiveness of sorafenib monotherapy in patients with Child–Pugh B and Child–Pugh C liver function.     

The use of single‐agent sorafenib in the treatment of advanced hepatocellular carcinoma patients with underlying Child‐Pugh B liver cirrhosis

BACKGROUND:

This study explored the efficacy, tolerability, and survival benefits of using sorafenib in patients with Child‐Pugh class B (CPB) cirrhosis.

METHODS:

Patients with advanced hepatocellular carcinoma who were treated with sorafenib at Queen Mary Hospital, Hong Kong, China, were analyzed retrospectively. Treatment outcomes were analyzed according to their respective Child‐Pugh status. Patients with CPB disease were further divided into CPB7 (those with a score of 7) and CPB8‐9 (a score of 8 or 9) subgroups.

RESULTS:

The baseline demographic parameters were comparable between 108 patients with Child‐Pugh class A (CPA) disease and 64 CPB patients. Both clinical benefit rate (21.3% vs 32.4% vs 14.8%; P = .23) and progression‐free survival (median: 3.2 months vs 3.2 months vs 2.3 months; P = .26) were similar among CPA, CPB7, and CPB8‐9 groups, respectively. The overall survival was different among these groups (P = .002) and showed a trend toward worse outcome in CPB patients: the median was 6.1, 5.4, and 2.7 months among CPA, CPB7, and CPB8‐9 patients, respectively. The commonest grade 3/4 adverse events were hand‐foot syndrome (13.5%), diarrhea (9.9%), and rash (7.0%). Grade 3/4 leukopenia, thrombocytopenia, and anemia occurred in 2.9%, 5.3%, and 8.8% of the patients, respectively. Overall, the 3 groups of patients experienced similar incidence of most of these adverse events. Nonetheless, CPB patients experienced more anemia (P = .01), gastrointestinal bleeding (P = .02), and hepatic encephalopathy (P = .02).

CONCLUSIONS:

CPA and CPB patients tolerated sorafenib similarly and derived similar clinical and progression‐free survival benefit. Among CPB patients, most benefits were observed in patients with a score of 7. Nevertheless, CPB patients were more susceptible to developing cirrhotic complications, and thus more vigilant surveillance is needed. Cancer 2012. © 2012 American Cancer Society.     

The risk and predictive factors for developing liver cancer among patients with decompensated liver cirrhosis.

Patients with decompensated liver cirrhosis (n 1441) and those with post-transfusion hepatitis (n 343), whose medical expenses were subsidized by the Aichi Prefectural Government, were followed up for three years by record linkage with the Aichi Cancer Registry. During the follow-up period, 122 incident cases of liver cancer were identified. Compared with the general population, patients with decompensated liver cirrhosis were at a 64.9 times greater risk (50.5 times in males and 100.4 times in females) and those with post-transfusion hepatitis were at a 9.4 times greater risk (8.9 times in males and 13.7 times in females) of developing liver cancer. Information on prognostic factors for 1,068 patients with decompensated liver cirrhosis was also collected in a questionnaire survey by the physicians in charge. Patients positive to hepatitis B surface antigen (HBs Ag) and those positive to HBe Ag had a significantly increased risk of subsequent liver cancer. The risk of developing liver cancer was positively associated with base-line levels of GPT and AFP and age and, inversely associated with total alcohol intake and female sex. In multivariate analyses, the associations with HBe Ag, AFP, sex and age remained statistically significant, whereas the associations with GPT, total alcohol intake and HBs Ag were of borderline significance.     

肝癌切除合并脾切除治疗伴有脾功能亢进肝癌的疗效观察

目的探讨肝癌合并脾功能亢进患者肝癌切除合并脾脏切除的临床意义。方法回顾分析2004年3月至2006年1月我科收治的12例患者,分析手术前后肝功能和血小板、白细胞变化情况。结果术后3d患者白细胞由术前的（3.2±1.7）×10^9/L升至（13.5±5.3）×10^9/L,血小板由（52.6±23.7）×10^9/L升至（245.3±94.6）×10^9/L,脾功能亢进消失,肝脏功能术后1周也基本恢复至术前水平。结论肝癌切除合并脾脏切除是治疗肝癌合并脾功能亢进患者的有效方法。     

TACE联合索拉非尼治疗中晚期肝细胞性肝癌的临床研究

目的探讨经导管动脉化疗栓塞（transcatheterarterialchemoembolization,TACE）联合索拉非尼治疗中晚期肝细胞性肝癌（hepatocellularcarcinoma,HCC）的疗效及安全性。方法选择我院70例中晚期HCC患者,其中35例给予TACE联合索拉非尼治疗（观察组）,35例单纯行TACE治疗（对照组）。每4-8周根据实体瘤疗效评估标准（RECIST）行肿瘤应答评价,评估临床疗效及索拉非尼毒副反应,比较两组患者治疗后的中位生存期及中位疾病进展时间。结果观察组和对照组中位0s分别为14_8个月和8．2个月,差异有统计学意义（P〈0．05）,中位TIP分别为10．3个月和5．8个月,差异有统计学意义（P〈0．05）。观察组服用索拉非尼后有27例（77．1％）患者出现毒副反应,经对症治疗后好转。结论TACE联合索拉非尼治疗中晚期HCC疗效好,不良反应可耐受,有望成为中晚期HCC的一种治疗模式。     

索拉非尼治疗晚期原发性肝癌的疗效和影响因素分析

目的 评价索拉非尼治疗晚期原发性肝癌的疗效和不良反应,分析影响疗效的因素。方法 回顾性收集2008年1月至2013年9月在广西医科大学附属肿瘤医院应用索拉非尼治疗的晚期原发性肝癌患者完整的临床资料。计算缓解率和疾病控制率（DCR）并进行Logistic回归分析影响因素,运用Kaplan-Meier法估计总生存期和无疾病进展生存期,并采用Cox风险比例模型分析其影响因素。结果 共收集78 例患者资料,中位随访时间为192 d（95％CI：173~218）。无一例患者获得完全缓解（CR）或部分缓解（PR）,稳定（ＳＤ）48例（61.5%）,进展（ＰＤ）30例（38.5%）。中位生存期（mOS）和中位无疾病进展生存期（mPFS）分别为196 d（95%CI：173~218）和96 d（95%CI：93~98）。不良反应大多数为1~2级,手足皮肤反应是影响索拉非尼治疗的最主要因素。年龄、血清乙型肝炎表面抗原阳性（乙肝病毒感染）是ＤＣＲ的独立影响因素。肝功能（Child-Pugh）分级、既往化疗是影响无疾病进展生存期及总生存期的独立预后因素,美国东部肿瘤协作组活动状态评分（ECOG　PS）是另一个影响总生存期的独立预后因素。结论 索拉非尼治疗晚期原发性肝癌有较好的疾病控制率,安全性较好。ECOG　PS评分、Child-Pugh 分级、既往化疗是影响患者生存的主要因素。     

Phase 2 trial of a novel capecitabine dosing schedule in combination with bevacizumab for patients with metastatic breast cancer

BACKGROUND:

Capecitabine has antitumor activity in metastatic breast cancer (MBC); however, its optimal dose and schedule remain unclear. Mathematical modeling predicts that a capecitabine schedule 7 days of treatment followed by 7 days of rest (7—7) will improve efficacy and minimize toxicity. Bevacizumab has demonstrated the ability to improve outcomes when it is added to chemotherapy, including capecitabine, in the first‐line and second‐line settings.

METHODS:

Patients with measurable MBC received oral capecitabine (2000 mg twice daily; 7—7), and intravenous bevacizumab (10 mg/kg every 2 weeks). The primary endpoint was the response rate. Secondary endpoints included toxicity, the clinical benefit rate, and progression‐free survival (PFS).

RESULTS:

Forty‐one patients were treated. After a median of 7 cycles (range, 1‐32 cycles), partial responses were observed in 20% of patients, and stable disease for ≥6 months was noted in 35% patients. The median PFS was 8 months. The most common treatment‐related toxicities were hand‐foot syndrome (49% grade 2, 20% grade 3/4) hypertension (12% grade 2, 10% grade 3/4), and fatigue (12% grade 2, 2% grade 3/4). Diarrhea (5% grade 2, 0% grade 3/4), nausea (0% grade 2‐4), and vomiting (0% grade 2‐4) were rare.

CONCLUSIONS:

Capecitabine administered for 7 days followed by a 7‐day rest in combination with bevacizumab had modest efficacy and an acceptable toxicity profile in patients with MBC. Gastrointestinal toxicity with this schedule was minimal. Cancer 2011;. © 2011 American Cancer Society.     

大肠癌并肝硬化与大肠癌不并肝硬化发生肝转移癌对照研究

目的 探讨大肠癌并肝硬化患者发生肝转移癌的规律。方法 回顾性分析我院1990年1月～2001年1月10年间诊治的大肠癌856例,均有病理组织学检查确诊。其中大肠癌并肝硬化患者(肝硬化组)74例,伴肝转移癌者2例;其余为不并肝硬化患者(非肝硬化组)782例,伴肝转移癌者168例。结果 肝硬化组肝转移癌发生率为2.7％(2/74);非肝硬化组肝转移癌发生率为21.5％(168/782,P<0.001)。结论 大肠癌不并肝硬化患者的肝转移癌发生率同大肠癌并肝硬化患者的肝转移癌发生率比较,前者肝转移癌发生率明显地高,后者很少发生肝转移癌。     

Phase I trial of everolimus plus sorafenib for patients with advanced renal cell cancer

Background

Everolimus, a mammalian target of rapamycin (mTOR) inhibitor, and sorafenib, a RAF kinase inhibitor, has shown efficacy in renal cell cancer (RCC) as single agents. We conducted a phase I study to evaluate the maximum tolerated dose (MTD) of combining these agents for potential additive or synergistic effects when treating progressive metastatic RCC (mRCC).

Patients and Methods

The 15 patients enrolled in the study had predominantly clear cell RCC (cRCC) and progressive measurable disease with previous treatment that included immunotherapy, tyrosine kinase inhibitors, and/or everolimus. Patients received daily everolimus and twice-daily sorafenib at escalating dose levels of 2.5 mg/400 mg (cohort 1), 5 mg/400 mg (cohort 2), and 10 mg/400 mg (cohort 3), and they were evaluated weekly for toxicity and every 8 weeks for response, using computed tomography/positron emission tomography (CT/PET) and CT at baseline and at first staging.

Results

In cohort 1, 2 of 6 patients experienced dose-limited toxicity (DLT) of thrombocytopenia/leukopenia and pneumonitis. In cohort 2, 1 of 6 patients experienced a DLT of pulmonary embolism, and the 3 patients in cohort 3 experienced no DLTs. The MTD was 10 mg/400 mg. Common adverse events included grade 1/2 hand-foot syndrome. Using Response Evaluation Criteria in Solid Tumors (RECIST), 1 patient achieved a pathologic complete response (CR), 1 patient achieved a radiographic CR, and 1 patient achieved a surgical CR. Seven patients achieved stable disease; 10 patients had decreased fluorine-18 fluorodeoxyglucose uptake. Median progressive-free survival was 5.6 months; overall survival was 7.9 months.

Conclusion

The MTD of daily everolimus 10 mg and twice-daily sorafenib 400 mg is safe and effective for progressive mRCC.     

索拉菲尼治疗中晚期肝癌的临床疗效及安全性

目的探讨索拉菲尼对中晚期肝癌患者的临床疗效。方法选取2014年1月至2015年7月间收治的84例中晚期肝癌患者,随机数表法分为观察组和对照组,每组42例。对照组42例患者采用经导管肝动脉化疗栓塞术(TACE)治疗,观察组42例患者在对照组治疗基础上口服索拉菲尼治疗,比较两组患者治疗的有效性和安全性。结果治疗后,观察组患者总有效率为83.3%,对照组患者为57.1%,差异有统计学意义(P<0.05)。观察组患者血清AFP和Child-Pugh评分均较对照组患者明显改善,差异有统计学意义(P<0.05)。两组患者不良反应症状均较轻,且均经对症处理好转。结论索拉菲尼治疗中晚期肝癌有利于提高患者的生活质量,不会明显增加治疗中不良反应,其疗效显著,且安全可靠,值得临床应用。     

Changes of host immunity in relation to efficacy in liver cirrhosis patients with advanced hepatocellular carcinoma treated by intra-arterial chemotherapy

Purpose  It is known that tumors develop mechanisms to escape from the immune system and to inhibit antitumor responses. The aim of this study was to retrospectively assess changes of host immunity in relation to efficacy in liver cirrhosis (LC) patients with advanced hepatocellular carcinoma (aHCC) treated by combined intra-arterial chemotherapy. Methods  Thirty-seven adult Japanese LC patients with aHCC were treated by intra-arterial combination chemotherapy. The control group was composed of 19 adult Japanese patients with chronic hepatitis C diagnosed by pathological examination of liver biopsy specimens. All control patients were stage 1 according to the fibrosis score of Desment. Results  Ten of the 37 patients (group PR) showed a partial response and 17 of the 37 patients (group SD) showed stable disease, but 10 of the 37 patients (group PD) showed no response. There were no significant differences in the percentage of Th1 cells between any of the groups either before or after chemotherapy. The percentage of Th2 cells was significantly higher in group PD before and after chemotherapy than in the control group (P < 0.05 by Tukey’s test). Although there was no significant difference, the percentage of Th2 cells was higher in group SD than in group PR. Conclusions  The percentage of Th2 cells increased in LC patients with aHCC as the efficacy of intra-arterial combination chemotherapy decreased. These results indicated that intra-arterial chemotherapy might be not useful for patients with aHCC, because it induces Th2 dominant host immunity.     

阿帕替尼治疗多线治疗失败的转移性乳腺癌的疗效观察

目的 观察阿帕替尼治疗难治性乳腺癌的疗效及不良反应.方法 回顾性分析29例经多线治疗失败后进行阿帕替尼化疗的转移性乳腺癌患者的临床资料,分析阿帕替尼单药化疗和阿帕替尼联合化疗患者的无进展生存期(PFS)、客观有效率(ORR)和疾病控制率(DCR).结果 29例患者中,1例死亡,1例由于血小板降低而停止用药,可评价疗效的患者共27例.27例患者的中位PFS为3.1个月(1.0~6.1个月).阿帕替尼联合化疗患者的PFS为3.10个月,阿帕替尼单药化疗患者的中位PFS为3.46个月,差异无统计学意义(P>0.05).治疗后部分缓解3例,疾病稳定12例,疾病进展12例,ORR为11.11%,DCR为55.56%.多因素分析结果显示,既往化疗方案数是影响乳腺癌患者PFS的独立危险因素(P<0.05).化疗后患者的3~4级不良反应包括手足综合征2例(6.90%),高血压2例(6.90%),低血小板血症1例(3.45%).结论 阿帕替尼单药及联合化疗治疗转移性乳腺癌有一定疗效,值得进一步研究.     

对比增强超声与增强CT对诊断肝癌病灶大小可靠性的对比研究

目的 探讨对比增强超声（CEUS）与增强CT（CECT）对中肝癌（最大径3.0～5.0 cm）与非中肝癌（最大径＜3.0 cm或＞5.0 cm）病灶大小诊断的可靠性。方法 回顾性分析2013年6月至2016年6月我院收治的手术并经病理组织学证实的肝癌患者197例,患者均为单发病灶,分为中肝癌组96例和非中肝癌组101例。患者均行CEUS与CECT检查。采用χ2检验比较CEUS与CECT在不同病灶大小肝癌诊断中的差异。结果 CEUS与CECT诊断197例肝癌病灶大小的受试者工作特征（ROC）曲线下面积分别为0.774和0.706,差异无统计学意义（P＞0.05）。96例中肝癌组中,CEUS诊断的特异度为80.6％～85.8％,灵敏度为73.2％～91.6％;CECT诊断的特异度为65.1％～77.2％,灵敏度为63.2％～85.3％。101例非中肝癌组中,CEUS与CECT的诊断准确率分别为92.1%和91.1%,差异无统计学意义（P＞0.05）;96例中肝癌检查组中,两种方法检查的诊断准确率分别为97.9%和89.6%,差异有统计学意义（P＜0.05）。结论 对于肝癌病灶大小的测量尤其是中肝癌,术前优先选择CEUS具有更高的应用价值。     

Clinical efficacy of S-1 in pretreated metastatic breast cancer patients

Background: S-1, an oral fluoropyrimidine carbamate, is an active and well-toleratedagent against solid cancer. However, the clinical efficacy ofS-1 in patients with metastatic breast cancer has not been determined. Methods: We retrospectively evaluated the efficacy of S-1 and identifiedits adverse effects in patients with metastatic breast cancerwho had failed to respond to prior chemotherapy regimens. Allthe patients were treated at the National Cancer Center Hospitaland received S-1 twice daily at a dose of 80 mg/m² for4 weeks, followed by a 2-week rest interval. Results: Between 2003 and 2007, 37 women with metastatic breast cancerreceived S-1 as a third line or greater chemotherapy regimen.All the patients had been previously treated with both anthracyclinesand taxanes prior to S-1 chemotherapy. The median order of S-1administration was as a fifth-line treatment, and 23 patients(62%) received S-1 as their final anticancer drug. One (3%)partial response and two (5%) stable diseases were observed.The median time to progression (TTP) was 84 days. Grade 2 adverseevents, such as diarrhea, stomatitis and neutropenia occurredin 5 (16%), 1 (3%) and 1 (3%) patients, respectively. Conclusions: S-1 was safety administered to heavily treated metastatic breastcancer patients with limited efficacy. Further evaluation ofS-1 is necessary to elucidate its clinical role in breast cancertreatment.     

Continuous administration of sorafenib in combination with transarterial chemoembolization in patients with hepatocellular carcinoma: results of a phase I study

Background and Aim.

It is unknown whether sorafenib can be combined with transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma. This study assesses the safety and tolerability of a continuous regimen of sorafenib combined with TACE.

Methods.

This was an open-label phase I study testing a continuous administration of sorafenib (dose escalation from 200 mg twice daily [bid] to 400 mg bid) starting 7 days prior to TACE with doxorubicin (50 mg).

Results.

Twenty-one patients were screened and 14 received sorafenib combined with TACE. Because there were no dose-limiting toxicities in the first three patients who received sorafenib at a dose of 200 mg bid, subsequent patients received 400 mg bid. Twenty-seven procedures were performed (median, two per patient) and two local therapy–related severe adverse events occurred. The median duration of sorafenib therapy was 246 days (range, 14–547 days). Sorafenib-related adverse events of grade ≥3 were hand–foot skin reaction (n = 3), weight loss (n = 2), diarrhea (n = 1), abdominal pain (n = 1), and thrombocytopenia (n = 3). After treatment with sorafenib and TACE, there was a significant decrease in the concentration of plasma vascular endothelial growth factor (VEGF) from 93 ng/l to 67 ng/l.

Conclusions.

Continuous administration of sorafenib at a dose of 400 mg bid combined with TACE was tolerable. The adverse event profile of this regimen was comparable with that of sorafenib monotherapy with the exception of thrombocytopenia, which may be more frequent. There were no increases in the circulating VEGF levels after TACE with this combined regimen. (Swiss Association for the Study of the Liver study number 25; ClinicalTrials.gov trial identifier, {"type":"clinical-trial","attrs":{"text":"NCT00478374","term_id":"NCT00478374"}}NCT00478374).     

甲孕酮等四联疗法对癌症患者厌食的疗效观察

目的　探索对癌症患者食欲不振确有较好疗效的简便方法。进而为治疗恶病质奠定基础。方法　以孕激素国产甲孕酮、糖皮质激素地塞米松、组胺拮抗剂赛庚啶、胃肠动力剂普瑞博思组成的四联疗法 ,口服 1～ 2周 ,治疗 31例中晚期癌症患者的厌食。结果　食欲改善显效 2 9例 (93 .5 % ) ,有效 1例 (3 .2 % ) ,稳定 1例 (3 .2 % ) ,总有效率 96 .8%。结论　以小剂量甲孕酮为主的四联疗法对癌症患者厌食的疗效高 ,副作用少且价廉 ,简便易行适于各级医院及家庭推广应用。     

西妥昔单抗联合化疗治疗转移性结直肠癌疗效与K-ras状态的关系

背景与目的：随着西妥昔单抗联合化疗在转移性结直肠癌患者中的不断应用,预测其治疗疗效的研究也越来越深入。本文旨在探讨转移性结直肠癌患者肿瘤组织中K—ras基因表达状态（野生型或突变型）及其与西妥昔单抗联合化疗疗效之间的关系。方法：2006年3月02008年6月期间应用西妥昔单抗联合化疗治疗转移性结直肠癌27例。采用聚合酶链反应（PCR）技术和直接测序法检测肿瘤组织中K-ras基因表达状态。分析K—ras基因表达状态与西妥昔单抗联合化疗疗效之间的关系。结果：全组27例患者中,K-ras野生型15例（55．6％）,K—FaS突变型12例（44．4％）。在K—FaS野生型中,西妥昔单抗联合化疗的总有效率（ORR）为66．7％,其中cR2例（13．3％）,PR 8例（53．3％）,中位无进展生存期（PFS）8个月。在K—ras突变型中,总有效率为25．0％,PR3例（25．0％）,中位PFS4个月。在K—ras野生型转移性结直肠癌患者中应用西妥昔单抗联合化疗的疗效明显优于K—ras突变型患者。结论：K-ras野生型是西妥昔单抗联合化疗疗效良好的预测指标。在西妥昔单抗联合化疗前明确患者的K—ras基因状态有助于选择合适的患者,获得最佳疗效。     

早期肠内营养支持在肝癌患者肝移植术后的应用

目的：探讨肝癌患者肝移植术后早期肠内营养（ＥＮ）支持的价值。方法：将６５例肝癌肝移植患者分为两组：２５例术后给予肠外营养（ＰＮ组）,４０例术后早期给予肠内营养（ＥＮ组）。比较两组术后机械通气时间、住ＩＣＵ天数、２８天感染发生率、２８天死亡率及术后１、４、７天肝功能、营养状态、免疫指标。结果：两组性别、年龄、肝功能Ｃｈｉｌｄ分级、供肝热缺血时间、冷缺血时间、无肝期、手术时间、机械通气时间、ＩＣＵ住院天数等比较无差异（Ｐ＞００５）。术后第７天,ＥＮ组较ＰＮ组ＴＢＩＬ、ＤＢＩＬ、ＡＬＴ、ＣＲＰ显著降低（Ｐ＜００５）,Ｐａｂ、ＴＦＮ、ＩｇＡ、ＩｇＭ显著升高（Ｐ＜０.０５）。ＥＮ组较ＰＮ组术后２８天感染率明显降低（Ｐ＜０.０５）。两组２８天内均无死亡病例。ＥＮ组主要并发症为腹胀、腹泻、营养导管堵塞或滑脱。结论：肝癌患者肝移植术后早期ＥＮ比ＰＮ能更有效地改善患者的营养状况,促进患者肝细胞的修复,降低Ｃ反应蛋白水平,提高机体的免疫力,显著减少感染的发生。     

Capecitabine maintenance therapy for XT chemotherapy-sensitive patients with metastatic triple-negative breast cancer

Objective： To investigate the efficacy and safety of capecitabine maintenance therapy（MT） after initial capecitabine plus docetaxel（XT） chemotherapy in patients with metastatic triple-negative breast cancer（m TNBC）.
Methods： Fifty-five m TNBC patients treated with XT chemotherapy between May 2007 and June 2013 were retrospectively analyzed. When initial disease control was achieved by the combination chemotherapy, capecitabine was continued for 32 patients（MT）, while 23 patients remained without any treatment（nonMT）. We compared progression-free survival（PFS） and safety of both groups.
Results： The median PFS of 55 patients was 8.1 months, overall median PFS time of 32 patients in the capecitabine MT group and 23 in the non-MT group was 10.1 vs. 6.7 months（P=0.032）, respectively. When compared PFS time of maintenance treatment, single-agent capecitabine prolonged PFS by 7.1 months, for non-MT patients, the PFS without any treatment was 3.1 months, and this between-group difference was statistically significant（P=0.003）. Adverse events, including of hematologic toxicity, gastrointestinal toxicities, hand-foot syndrome and abnormal liver function were not significantly different between two groups.
Conclusions： After initial disease control was achieved with the XT combination chemotherapy, capecitabine MT can significantly prolong PFS time with a favorable safety profile in m TNBC patients.     

Increased risk of colorectal polyps in patients with non-alcoholic fatty liver disease undergoing liver transplant evaluation

Background

Screening colonoscopy is a standard part of the liver transplant (LT) evaluation process. We aimed to evaluate the yield of screening colonoscopy and determine whether non-alcoholic fatty liver disease (NAFLD) was associated with an increased risk of colorectal neoplasia.

Methods

We retrospectively assessed all patients who completed LT evaluation at our center between 1/2008-12/2012. Patients <50 years old and those without records of screening colonoscopy, or with greater than average colon cancer risk were excluded.

Results

A total of 1,102 patients were evaluated, 591 met inclusion criteria and were analyzed. The mean age was 60 years, 67% were male, 12% had NAFLD and 88% had other forms of chronic liver disease. Overall, 42% of patients had a polyp found on colonoscopy: 23% with adenomas, 14% with hyperplastic polyps and with 1% inflammatory polyps. In the final multivariable model controlling for age, NAFLD [odds ratio (OR) 2.41, P=0.001] and a history of significant alcohol use (OR 1.69, P=0.004) were predictive of finding a polyp on colonoscopy. In addition, NAFLD (OR 1.95, P=0.02), significant alcohol use (OR 1.70, P=0.01) and CTP class C (OR 0.57, P=0.02) were associated with adenoma, controlling for age.

Conclusions

Screening colonoscopy in patients awaiting LT yields a high rate of polyp (43%) and adenoma (22%) detection, perhaps preventing the accelerated progression to carcinoma that can occur in immunosuppressed post-LT patients. Patients with NAFLD may be at a ~2 fold higher risk of adenomas and should be carefully evaluated prior to LT.