Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma: Subanalyses of a phase III trial

Bruix, Jordi; Raoul, Jean‐Luc; Sherman, Morris; Mazzaferro, Vincenzo; Bolondi, Luigi; Craxı̀, Antonio; Galle, Peter R.; Santoro, Armando; Beaugrand, Michel; Sangiovanni, A.; Porta, Camillo; Gerken, Guido; Marrero, Jorge A.; Nadel, Andrea; Shan, Minghua; Moscovici, M.; Voliotis, D.; Llovet, Josep M.

doi:10.1016/j.jhep.2012.06.014

Cited by 742 publications

(616 citation statements)

References 40 publications

(50 reference statements)

Supporting

Mentioning

570

Contrasting

Unclassified

Order By: Relevance

“…However, this statement requires strong qualification in light of the clinical evidence. In the SHARP trial, 11 sorafenib was associated with a median overall survival of 14.5 months among 54 patients with intermediate-stage HCC-only 3.1 months longer than the median survival of 11.4 months reported for the 51 patients in the placebo group. In addition, the GIDEON study 12 observed that sorafenib therapy was associated with adverse events in 69% and 66% of patients with intermediate-stage and advanced-stage disease, respectively; the correspond ing rates of serious adverse events were 32% and 38%.…”

Section: Correspondencementioning

confidence: 76%

Intermediate-stage HCC—upfront resection can be feasible

Zhong

Wang

et al. 2015

Nat Rev Clin Oncol

View full text Add to dashboard Cite

Section: Correspondencementioning

confidence: 76%

Intermediate-stage HCC—upfront resection can be feasible

Zhong

Wang

et al. 2015

Nat Rev Clin Oncol

View full text Add to dashboard Cite

“…Sorafenib got approval for advanced HCC based on pivotal randomized phase III trials, however the majority of the patients in these trials were in good ECOG PS and most had Child Pugh A status, which is not the case in routine general practice. 21,22 Kostner et al in their retrospective study of sorafenib in HCC, noted median OS of only 1.8 months of patients in PS 2-3. 23 In our study, 66% of our patients had PS≥2.…”

Section: Tumor Characteristicsmentioning

confidence: 99%

Clinical profile of hepatocellular carcinoma and experience with sorafenib from a tertiary cancer centre in Southern India

et al. 2017

View full text Add to dashboard Cite

Background: Hepatocellular carcinoma is a major health problem and a major cause of cancer mortality in India. There are no reports published on experience with sorafenib in advanced HCC from India. We analyzed the clinical presentation, possible etiological factors, tumor characteristics, outcomes and tolerability of sorafenib in the patients presenting to present cancer center.Methods: Retrospective chart review of 53 patients was done. 53 patients (male 37, female 16; median age 52 years, range 7-80 years) fulfilling the diagnostic criteria were analyzed for clinical characteristics, hematological and biochemical investigations, tumor characteristics, treatment taken and outcome.Results: 53 patients were diagnosed to have HCC between 2012-2015. Hepatitis B virus infection was the most common underlying etiologic factor (22.6%). Heavy alcohol intake was seen in 5 patients. PS ≥2 was noted in 66% of patients. 68% of the patients had BCLC stage C. Sorafenib was well tolerated with median OS of 3 months in patients taking sorafenib.Conclusions: Most of the patients had advanced inoperable HCC. Majority of the patients presented with BCLC Stage C and D. Hepatitis B infection was the most common underlying etiology. Sorafenib was well tolerated. More prospective studies are required for getting a clearer and correct picture of HCC and experience with sorafenib in Indian scenario.

show abstract

“…Those results have been prospectively confirmed in different clinical trials in which sorafenib was the control arm (93)(94)(95)(96)(97) as well as in multiple prospective studies in real life clinical practice (98-100). Furthermore, sorafenib is able to maintain its efficacy despite the etiology of liver disease, the baseline status of neoplasm, the presence or absence of cancer related symptoms or previous therapies (101). Despite the success of sorafenib at advanced stage, there are still many aspects to be clarified.…”

Section: Improvements In the Treatment Of Intermediate-advanced Hccmentioning

confidence: 99%

New challenges in clinical research on hepatocellular carcinoma

Díaz-González¹,

Forner²,

C³

et al. 2015

Rev Esp Enferm Dig

View full text Add to dashboard Cite

This is an updated review of screening, early diagnosis and treatment of hepatocellular carcinoma, focusing on the advancements occurred in the last years and highlighting the challenges in clinical research.Hepatocellular carcinoma (HCC) is nowadays the sixth most frequent cancer worldwide with up to 740,000 new cases diagnosed each year, and it is the third most prevalent cause of cancer-relateddeath worldwide (1). This neoplasm usually appears linked to an underlying liver disease, being one of the most relevant causes of death in patients diagnosed of liver cirrhosis (2,3). In the last years, important advancements in terms of diagnosis, staging and treatment of HCC, improving the management and outcome of the disease, have been made (4-7). Despite the fact that these improvements have absolutely changed natural history of HCC, there are several areas that still need further advancements.The aim of this document is to discuss some controversial aspects, which in our opinion constitute real challenges in clinical research of HCC.Key words: Hepatocellular carcinoma. Hepatic oncology. Sorafenib. Transarterial chemoembolization. AFP. IMPROVING EARLY DIAGNOSISFrom the basis that the only possibility to offer and apply treatments with curative intention is being able to diagnose HCC at early stages, when there are not cancer related symptoms. Since this option is only feasible if screening is performed in population at risk, scientific guidelines recommend performing abdominal ultrasonography (US) in every patient with liver cirrhosis. Despite the recommendation of HCC screening by the Spanish guidelines (4), one registry study performed in Spain which included 62 centers and 705 patients diagnosed of HCC within a period of time of 4 months showed that just 47% of HCC patients were diagnosed in the setting of surveillance and less than a half were diagnosed at early stage (8).This data shows that early diagnosis, a key issue to be able to significantly reduce HCC-related mortality, is one of the most relevant issues that deserve further efforts from scientific community. Aiming to evaluate which were the causes of screening program fail in the United States of America, Singal et al. evaluated 1,005 patients included in the HALT-C prospective study. A third part of patients did not adhere to an adequate screening program and, in 70% of cases that were diagnosed at an advanced stage, the main reason was the absence of detection in US (9).With the aim of improving detection rate, it is crucial to establish formative programs in order to certify the capability of being able to carry on this activity and it is necessary to use up-to-date ultrasonography scans in order to perform an optimal liver exploration. Tumor markers could be a useful tool to overcome theoretical limitations of US: its evaluation is not subjective, does not depend on the operator and it may be reproducible, as well as it is relatively cheap and a tool easy to access in areas with low monetary income. Regrettably, different tumor markers ev...

show abstract

Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma: Subanalyses of a phase III trial

Abstract: These exploratory subgroup analyses showed that sorafenib consistently improved median OS and DCR compared with placebo in patients with advanced HCC, irrespective of disease etiology, baseline tumor burden, performance status, tumor stage, and prior therapy.

Cited by 742 publications

References 40 publications

Intermediate-stage HCC—upfront resection can be feasible

Intermediate-stage HCC—upfront resection can be feasible

Clinical profile of hepatocellular carcinoma and experience with sorafenib from a tertiary cancer centre in Southern India

New challenges in clinical research on hepatocellular carcinoma

Contact Info

Product

Resources

About