沙利度胺联合利妥昔单抗治疗CLL/SLL的近期疗效

目的探讨沙利度胺联合利妥昔单抗治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤(CLL/SLL)的临床疗效及安全性。方法对25例CLL患者进行前瞻性研究,采用简单随机分组法,分为沙利度胺联合利妥昔单抗方案(TR)治疗组12例,利妥昔单抗联合氟达拉滨+环磷酰胺方案(FCR)对照组13例,评估患者的近期疗效和不良反应。结果经2个疗程、4个疗程治疗后,FCR组ORR明显高于TR组(P<0.05);在第6个疗程后,TR组与FCR组ORR率差异无统计学意义。TR组总体不良反应发生率明显低于FCR组(P<0.05)。结论沙利度胺联合利妥昔单抗治疗CLL/SLL,起效时间长,但近期疗效理想,不良反应轻。     

沙利度胺联合紫杉醇在晚期卵巢癌维持治疗中的临床应用

目的评价沙利度胺联合紫杉醇在晚期卵巢癌维持治疗中的临床疗效、不良反应及对生活质量的影响。方法回顾性分析经手术及一线化疗(紫杉醇联合卡铂)后达到临床完全缓解的晚期卵巢癌患者30例的临床资料,Karnofsky评分(KPS评分)≥70。沙利度胺组16例,给予紫杉醇及沙利度胺治疗;对照组14例,单纯给予紫杉醇治疗,观察患者临床疗效、不良反应及对生活质量的影响。结果 2组2年无进展生存(PFS)比较差异有统计学意义(P<0.05),2组3年生存率比较差异无统计学意义(P>0.05)。沙利度胺组患者KPS评分增加者比率、进食增加者比率高于对照组(P<0.05)。沙利度胺组的胃肠道不良反应发生率(恶心、呕吐)明显低于对照组(P<0.05)。沙利度胺组的中性粒细胞减少及神经毒性发生率与对照组比较差异无统计学意义(P>0.05),不良反应大多数可耐受。结论与单纯给予紫杉醇治疗相比,紫杉醇联合沙利度胺维持治疗经手术及一线化疗(紫杉醇联合卡铂)后达到临床完全缓解的晚期卵巢癌可延长无疾病生存期,改善生活质量,减轻不良反应,患者耐受性和依从性好。     

西妥昔单抗与放化疗联合治疗方案对进展期鼻咽癌患者预后的影响

目的:探讨西妥昔单抗与放化疗联合治疗方案对进展期鼻咽癌患者预后的影响。方法:收集2009年5月—2011年2月间诊治的进展期鼻咽癌患者64例,根据治疗方案将其分为观察组(n=36)和对照组(n=28),观察组患者给予西妥昔单抗与放化疗联合治疗方案治疗,对照组患者给予单纯放化疗治疗,分析两组患者的近期疗效、不良反应及3年内生存情况。结果:观察组患者治疗的总有效率66.67%高于对照组42.86%(P<0.05);两组患者不良反应发生情况经比较其差异无统计学意义(P>0.05);观察组患者3年内总生存率88.88%高于对照组67.86%(P<0.05)。结论:西妥昔单抗与放化疗联合治疗对进展期鼻咽癌患者的疗效较显著,未增加与放化疗相关的不良反应,安全性良好,有利于延长患者生存期。     

利妥昔单抗联合化疗对高龄弥漫大B细胞性非霍奇金淋巴瘤的疗效探究

目的探究利妥昔单抗联合化疗对高龄弥漫大B细胞性非霍奇金淋巴瘤(diffuse large B cell lymphoma,DLBCL)的疗效。方法 2005年1月~2009年8月厦门大学附属第一医院接收的高龄DLBCL患者34例,其中10例采用单纯的CEOP化疗方案,24例采用利妥昔单联合化疗的R-CEOP治疗方案。比较2种治疗方案下患者近期疗效、长期随访生存率、不良反应和血清中免疫球蛋白的变化。结果采用R-CEOP治疗方案的患者近期总有效率为66.7%(16/24)、长期随访生存率第1、2、3年为87.5%、75.0%、54.0%,显著高于CEOP组[近期总有效率50.0%(5/10),第1、2、3年长期随访生存率为81.8%、60.0%、40.0%],差异有统计学意义(P<0.05);不良反应发生率(66.7%)及严重程度低于CEOP组(80.0%),血清中Ig G、Ig A、Ig M发生降低变化的百分比(72.7%、77.3%、72.7%)高于CEOP组(20.0%、30.0%、30.0%),两两比较差异有统计学意义(P<0.05)。结论利妥昔单抗联合化疗对高龄DLBCL疗效确切,高龄DLBCL患者对大部分不良反应可以耐受,但利妥昔单抗易使高龄DLBCL患者血清中免疫球蛋白降低而发生感染。     

利妥昔单抗联合CTOP方案治疗弥漫大B细胞淋巴瘤的临床观察

目的观察利妥昔单抗(Rituximab)联合CTOP方案治疗弥漫大B细胞淋巴瘤的临床疗效及不良反应。方法 36例弥漫大B细胞淋巴瘤(diffuse large B-cell lymphoma,DLBCL)患者分为联合组和CTOP组。联合组18例,采用CTOP方案(环磷酰胺加吡喃阿霉素加长春新碱加泼尼松)加利妥昔单抗(375mg/m2,于每周期化疗前1d静脉滴注1次)治疗;CTOP组18例,单用CTOP方案化疗。两组均每21d为一个周期,6周期后评价的疗效及不良反应,随访观察生存情况。结果联合组完全缓解率(CR)为55.6%,总有效率为88.9%;CTOP组分别为38.9%,61.1%,两组疗效差异有统计学意义(P<0.05).联合组1年总生存率(OS)为83.5%,2年OS为71.3%;CTOP组分别为78.3%,41.2%;两组患者的2年OS有显著性差异(P<0.05)。两组患者不良反应主要为轻中度骨髓抑制和胃肠道反应,不良反应发生率相近(P>0.05),均可耐受。结论利妥昔单抗联合化疗治疗弥漫型大B细胞淋巴瘤的临床缓解率较高,患者耐受良好且生存时间较长,应推荐作为首选方案。     

小剂量利妥昔单抗注射液联合环孢素A治疗难治性ITP的临床观察

目的:探讨小剂量利妥昔单抗注射液(通用名为利妥昔单抗注射液)联合环孢素A治疗难治性特发性血小板减少性紫癜(简称难治性ITP)的疗效。方法:38例诊断为难治性ITP患者随机分为观察组和对照组,观察组采用小剂量利妥昔单抗注射液联合环孢素A治疗,对照组采用大剂量地塞米松冲击联合硫唑嘌呤治疗,并评估两组患者的近期及远期疗效和副作用。结果:观察组的近期及远期疗效优于对照组,2组间差异有显著性(P<0.05),除肝功能方面,不良反应的其他指标的比较,2组间差异无显著性(P>0.05)。结论:小剂量利妥昔单抗注射液联合环孢素A可作为难治性ITP的有效治疗手段之一。     

利妥昔单抗联合CHOP方案治疗NHL的临床疗效评价

目的:探讨利妥昔单抗联合环磷酰胺、阿霉素、长春新碱、强的松(CHOP)方案治疗非霍奇金淋巴瘤(NHL)的疗效及安全性。方法:62例NHL患者,其中32例接受利妥昔单抗联合CHOP方案治疗者为治疗组;30例接受CHOP方案治疗者为对照组。每周期21d,共进行6个疗程。结果:治疗组与对照组总有效率分别为75.00%、60.00%(P<0.05);2组毒副作用基本相似(P>0.05);治疗组的生活质量改善情况明显高于对照组(P<0.05)。结论:利妥昔单抗联合CHOP方案对NHL患者有较好疗效,且化疗药物的毒副作用未见增加。     

利妥昔单抗联合化疗治疗回盲部弥漫大B细胞淋巴瘤的临床分析

目的探讨利妥昔单抗(美罗华)联合化疗治疗回盲部弥漫大B细胞淋巴瘤的疗效及毒副作用。方法 6例经病理检查证实为回盲部弥漫大B细胞淋巴瘤患者,5例采用利妥昔单抗联合CTNP方案化疗,1例采用CTNP方案化疗,每21天为1个周期,观察治疗前后的毒副作用及疗效。结果 5例利妥昔单抗联合化疗治疗的患者有4例达完全缓解,1例达部分缓解;另1例单纯化疗患者死于疾病进展。结论利妥昔单抗联合化疗治疗回盲部弥漫大B细胞淋巴瘤可取得较好疗效,对于高龄患者利妥昔单抗无需减量,但需注意调整化疗剂量,并监测不良反应。     

利妥昔单抗辅助化疗治疗淋巴瘤的临床应用及预后分析

目的研究利妥昔单抗辅助化疗治疗淋巴瘤的临床应用及预后分析。方法回顾性收集2017年4月至2018年2月本院住院治疗的淋巴癌患者109例为研究对象,分为对照组(n=52)和观察组(n=57),对照组采用CHOP方案(环磷酰胺+表柔比星+长春新碱+地塞米松);观察组采用CHOP方案联合利妥昔单抗治疗,比较两组的临床疗效的不良反应发生情况。结果治疗后,观察组患者的总有效率(89.47%)与对照组(55.77%)比较,观察组患者临床疗效优于对照组,两组患者差异具有统计学意义(P<0.05);治疗后,观察组不良反应发生率(17.54%)与对照组(40.38%)相比,差异无统计学意义(P>0.05)。结论在CHOP化疗方案的基础上给予利妥昔单抗治疗淋巴瘤,临床效果较单用CHOP方案效果显著,降低不良反应发生率。     

大剂量甲氨喋呤联合利妥昔单抗治疗原发性中枢神经系统淋巴瘤的效果

目的探讨分析大剂量甲氨喋呤联合利妥昔单抗治疗原发性中枢神经系统淋巴瘤的效果。方法选取本院2015年1月至2016年1月收治的原发性中枢神经系统淋巴瘤患者50例作为本次研究的对象,采用数字表格法随机分为对照组和观察组,每组各25例。对照组患者采用全脑放射治疗联合大剂量甲氨喋呤进行治疗,观察组患者采用大剂量甲氨喋呤联合利妥昔单抗进行治疗,观察比较两组的治疗效果及平均无进展存活期。结果观察组患者治疗总有效率为84.00%,明显高于对照组的60.00%(P<0.05)。观察组患者的不良反应发生率明显低于对照组(P<0.05)。观察组患者平均无进展存活期为28个月,对照组患者的平均无进展存活期为11个月(P<0.05)。结论大剂量甲氨喋呤联合利妥昔单抗治疗原发性中枢神经系统淋巴瘤具有非常显著的治疗效果,其治疗效果及平均无进展存活期均高于常规治疗,而治疗后的不良反应发生率要低于常规治疗。     

弥漫性大B细胞淋巴瘤化疗后沙利度胺维持治疗疗效

目的比较中高危、高危弥漫性大B细胞淋巴瘤（IPI≥3）化疗后加与不加口服沙利度胺维持治疗的疗效。方法经病理学证实的弥漫性大B细胞淋巴瘤行CHOPE21或CHOPl4方案化疗6周期后完全缓解（CR）40例,随机分为口服沙利度胺维持组（n：20）与观察组（n=20）。主要观察终点为无进展生存（PFS）,次要观察终点为总生存（OS）和不良反应。结果维持组中位PFS为10．6个月,观察组为6．7个月（P=0．036）。维持组1、2、3年0s分别为80％、55％、45％,观察组分别为75％、45％、40％（P分别为0．705、0．527、0．749）。维持组仅有轻微血液学毒性。结论中高危、高危弥漫性大B细胞淋巴瘤（IPI≥3）化疗后予口服沙利度胺维持治疗可以延长PFS,但不能提高生存率,能否改善长期生存有待临床进一步加以研究。     

Rituximab maintenance in relapsed or refractory follicular non-Hodgkin's lymphoma: the evidence of its therapeutic value

INTRODUCTION: Non-Hodgkin's lymphoma (NHL) is the sixth most common malignancy, and follicular lymphoma (FL) is the second most common form of NHL. FL is generally considered to be incurable, and is characterized by periods of remission followed by episodes of relapse, with median survival of 8-10 years. Maintenance treatment is aimed at improving quality of life and survival. AIMS: To review the current evidence for maintenance rituximab in patients with FL. EVIDENCE REVIEW: Two randomized studies of rituximab maintenance or observation after induction therapy with single-agent rituximab, which were performed mainly in patients with relapsed/refractory disease, have demonstrated a two- to three-fold improvement in median progression-free survival (PFS) in the maintenance arm. Two further studies of rituximab maintenance or observation following induction chemotherapy with or without rituximab performed in patients with relapsed/refractory FL have shown a two- to four-fold increase in median PFS in the maintenance arm. In one of these studies an overall survival benefit has also been demonstrated. An additional study, this time in previously untreated patients, has demonstrated a four-fold improvement in median PFS as well as a significant overall survival benefit with rituximab maintenance following induction with chemotherapy alone. PLACE IN THERAPY: Currently rituximab maintenance can be considered to be appropriate therapy for patients with relapsed/refractory disease who have not received rituximab previously and who are not suitable for autologous stem cell transplantation, and for patients who receive first-line therapy with chemotherapy without rituximab.     

Rituximab: as first-line maintenance therapy following rituximab-containing therapy for follicular lymphoma

Rituximab is a recombinant chimeric murine/human monoclonal IgG(1-κ) antibody. It binds specifically to the CD20 antigen on normal and malignant B lymphocytes and produces complement-dependent and antibody-dependent cytotoxicity and induces apoptosis in these cells. Prolonged treatment with rituximab in patients with follicular lymphoma results in a sustained reduction in circulating B lymphocytes. Two years of single-agent maintenance therapy with rituximab significantly prolonged progression-free survival (primary endpoint) compared with observation in patients with follicular lymphoma who were responsive to first-line induction therapy with rituximab plus chemotherapy. Furthermore, maintenance therapy with rituximab significantly delayed the time to the next antilymphoma treatment and the next chemotherapy compared with observation in these patients. Rituximab had an acceptable tolerability profile as single-agent maintenance therapy in patients with follicular lymphoma with no new or unexpected adverse events compared with induction therapy.     

肿瘤细胞周期相关蛋白在肾移植术后弥漫大 B细胞淋巴瘤中的表达及与预后的关系

目的探讨肿瘤细胞周期相关蛋白( CREPT)在肾移植术后弥漫大 B细胞淋巴瘤( DLBCL)中的表达及与预后的关系研究。方法选择 2013年 2月至 2019年 8月海南医学院第一附属医院、海南省肿瘤医院、海南医学院第二附属医院收治的 40例肾移植术后发生 DLBCL的病人作为研究对象，以病灶组织作为病例组；另外选择 50例增生性淋巴结炎组织作为对照组。采用免疫组化方法检测组织 CREPT表达情况，收集肾移植术后 DLBCL病人的临床资料，分析临床资料、治疗效果、预后与 CREPT表达的关系。结果 CREPT定位于细胞核或细胞质， 40例肾移植术后发生 DLBCL病人中 CREPT高表达者 23例( 57.50%)50例增生性淋巴结炎组织中高表达者 5例( 10.00%)(P<0.05)。 CREPT高表达组 EB活化率高于低表达组，高 Ann Arboe分期病人，比例高于 CREPT低表达组( P<0.05)。达到有效标准病人 36例，多因素分析示， Ann Arboe分期是治疗效果的影响因素( P<     

Cost-effectiveness analysis of the addition of rituximab to CHOP in young patients with good-prognosis diffuse large-B-cell lymphoma

BACKGROUND and objective: Diffuse large-B-cell lymphoma (DLBCL) is an aggressive form of lymphoma. It accounts for 30-40% of all new cases of non-Hodgkin's lymphoma and is the subtype with the highest overall incidence. Before the development of monoclonal antibodies, the standard treatment of newly diagnosed DLBCL was based on combination therapy with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP). Current treatment consists of the combination of CHOP and the monoclonal antibody rituximab (R-CHOP regimen), with recovery rates of 70%. The aim of this study was to compare the efficacy (survival) and direct medical costs of two chemotherapy regimens, R-CHOP and CHOP, in the treatment of DLBCL in young patients with a good prognosis. METHODS: A decision-analysis model with tree structure was used to compare R-CHOP and CHOP in the treatment of young patients with DLBCL from the perspective of the Italian National Health Service. Patients entered at the root of the tree and followed one of the six possible therapeutic pathways. After receiving one of the two chemotherapy treatments (R-CHOP or CHOP) for 5 months, patients could have a complete response or not. In the presence of no response, patients underwent rescue therapy. In the case of relapse after 3 years' follow-up (following an initial complete response at 5 months), patients were given rescue therapy. The model provided an estimate of mean survival (life-years gained [LYG]) and mean costs (direct medical costs) over a period of 3 years. Both survival and costs were discounted at a rate of 3%. Costs were in euro, year 2007 values. Several sensitivity analyses were carried out with varying clinical parameters. RESULTS: The LYG with the R-CHOP regimen was higher (2.697 LYG per patient) than with the CHOP regimen (2.517 LYG per patient). When taking into account the cost of rescue therapy, the overall mean treatment cost per patient was lower with the R-CHOP regimen (22,113.44 euro) than with the CHOP regimen (22,831.17 euro). Sensitivity analyses showed that the incremental cost-effectiveness ratios per LYG for complete response at 5 months (16,816.00 euro) and for relapse-free survival at 3 years (11,967.12 euro) were below the internationally accepted threshold (50,000 euro). Furthermore, for survival at 3 years, R-CHOP was confirmed as the dominant therapy (lower expected mean costs, higher number of LYG). CONCLUSIONS: Our study demonstrated the clinical and economic benefits of adding rituximab to a CHOP chemotherapy regimen in young patients who present with DLBCL with good prognosis. The higher costs associated with rituximab were offset by the significantly lower rescue therapy costs. Further studies that include patients with unfavourable prognosis are needed to confirm these findings.     

CD19+CD20−CD27hi IL‐s10‐producing B cells are overrepresented in R‐CHOP‐treated DLBCL patients in complete remission

Treatment of diffuse large B cell lymphoma (DLBCL) with rituximab, an anti‐CD20 monoclonal antibody, has resulted in significantly improved patient responses with longer event‐free intervals and higher overall survival rates. However, since rituximab depletes all CD20‐expressing cells, including noncancerous B cells, the effects of rituximab on the normal immunity of DLBCL patients under remission need to be examined. Here, we observed that DLBCL patients under remission contained significantly lower frequencies of total B cells, with a significantly overrepresented interleukin (IL)‐10‐producing B cell (B10) population in the peripheral blood. Further examination confirmed that a large fraction of B10 cells was CD20^?CD27^hi plasmablasts, possibly explaining the persistence of B10 cells after R‐CHOP treatment. We also observed that the percentage of B10 cells in DLBCL patients in remission gradually reduced during the first year of achieving complete remission, primarily due to the replenishment of non‐B10 B cells. Despite this, the percentage of B10 cells in DLBCL patients after 1 year of achieving complete remission was still higher than that in controls. CD4⁺ and CD8⁺ T cells cocultured with B10‐enriched B cells secreted significantly lower levels of proinflammatory cytokines IFN‐g and TNF‐a, compared to those incubated with B10‐depleted B cells. Together, our data observed a long‐lasting overrepresentation of B10 cells in DLBCL patients under remission. Whether this change could impact on the overall anti‐tumor immunity during remission requires further studies.     

Rituximab: a review of its use in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia

Rituximab (MabThera, Rituxan) is an anti-CD20 monoclonal antibody that induces lysis and apoptosis of normal and malignant human B cells, and sensitises malignant B cells to the cytotoxic effect of chemotherapy. In phase III trials in patients with indolent or aggressive B-cell non-Hodgkin's lymphoma (NHL), intravenous rituximab in combination with chemotherapy was more effective as first- or second-line therapy than chemotherapy alone in providing tumour remission and patient survival. Likewise, in patients with chronic lymphocytic leukaemia (CLL), rituximab in combination with chemotherapy appeared more effective than chemotherapy alone as either first- or second-line treatment. In addition, rituximab maintenance therapy was shown to significantly prolong tumour remission and patient survival in patients with indolent B-cell NHL or CLL. The combination of rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) was cost effective as first-line therapy for advanced-stage diffuse large B-cell NHL compared with CHOP alone. Rituximab, either alone or in combination with chemotherapy, was generally well tolerated in patients with NHL or CLL. Overall, rituximab in combination with chemotherapy, is a valuable option for first- and second-line therapy in patients with advanced-stage indolent or aggressive B-cell NHL, and possibly those with B-cell CLL, and is included in current treatment guidelines for these indications. The drug is also potentially useful as maintenance therapy in patients with indolent B-cell NHL or CLL.     

Aggressive lymphoma: improving treatment outcome with rituximab

The standard therapy for patients with aggressive lymphoma is cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) chemotherapy, which achieves a complete response in more than 60% of patients but is curative in only about 40-50%. More aggressive and/or dose-intensified chemotherapy regimens have failed to provide significant survival advantages compared with CHOP, and may have higher toxicity. Rituximab, a chimeric monoclonal antibody to the CD20 antigen, is effective as monotherapy in aggressive lymphoma and in combination with chemotherapy has demonstrated high response rates in phase II trials. A scheduled interim analysis of a randomized, prospective trial comparing rituximab plus CHOP with CHOP alone in elderly patients with untreated diffuse large B-cell lymphoma has shown significantly better response rates and survival with rituximab plus CHOP compared with CHOP alone. These results represent the first significant improvement in overall survival over CHOP in aggressive lymphoma for over 20 years. The addition of rituximab was not associated with significant additional toxicity over that seen with CHOP alone. Ongoing studies are underway to establish whether the survival benefit of rituximab plus CHOP is seen in younger patient populations. Rituximab in combination with chemotherapy is also being evaluated as salvage treatment for patients who relapse after initial chemotherapy. In a preliminary analysis of a study in 50 patients with refractory or relapsed aggressive lymphoma, rituximab plus etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin (EPOCH) chemotherapy has demonstrated promising results when used as sole salvage therapy and as an induction therapy prior to autologous stem-cell transplantation, again without significant additional toxicity.     

利妥昔单抗联合化疗治疗弥漫性大B细胞淋巴瘤的临床观察

目的：评价利妥昔单抗联合化疗治疗弥漫性大B细胞淋巴瘤（DLBCL）的疗效及安全性.方法：116例DLBCL患者接受利妥昔单抗联合化疗方案,中位治疗4.73个疗程.初治DLBCL患者112例,其中R-CHOP 87例,R-CHOP样29例;26例在化疗中进展.采用Cheson标准及WHO标准评估疗效及不良反应.结果：116例患者全部进行疗效评价,总体客观有效率为75％ （87/116）,CR ＋CRu为34例（29.31％）,PR为53例（45.69％）,SD为12例（10.34％）,PD为17例（14.66％）.其中1例患者在挽救方案获得缓解后,接受自体干细胞支持下的超大剂量化疗.主要不良反应为骨髓抑制,消化道反应,轻度肝损伤,首次输注反应2例.中位随访52.3（3.2～86.5）月,6例死于肿瘤进展,2例死于骨髓抑制后合并重度感染.中位生存期60.54月（3.2～86.5）,其中1、3、5年总生存率分别为81％、63％、52％,无病生存期1、3、5年总生存率分别为76％、52％、47％.在影响疗效相关因素分析中,IPI评分Ann、Arbor分期和LDH水平为影响患者化疗效果的相关因素（P＜0.05）.结论：利妥昔单抗联合治疗DLBCL的疗效确切,不良反应可以耐受,效果与文献报道一致.     

Sorafenib: in hepatocellular carcinoma

Sorafenib is an orally active multikinase inhibitor with anti-tumour activity. It was recently approved in the US and the EU for the treatment of patients with hepatocellular carcinoma. Oral sorafenib 400 mg twice daily significantly improved survival in patients with advanced hepatocellular carcinoma in the randomized, double-blind, multicentre, phase III SHARP trial (n = 602); the median duration of survival was 10.7 months with sorafenib and 7.9 months with placebo. In addition, the median time to progression was significantly longer in patients receiving sorafenib than in those receiving placebo (5.5 vs 2.8 months). Combination therapy with oral sorafenib 400 mg twice daily and intravenous doxorubicin has potential in the treatment of patients with advanced hepatocellular carcinoma, according to the results of a randomized, double-blind, phase II study (n = 96). Although the addition of sorafenib to doxorubicin did not significantly delay the time to progression, the median durations of overall survival and progression-free survival were significantly longer with sorafenib plus doxorubicin than with doxorubicin alone. Monotherapy with oral sorafenib 400 mg twice daily was generally well tolerated in patients with advanced hepatocellular carcinoma, with a manageable adverse event profile.