In a ‘Real-World’, Clinic-Based Community Setting, Sorafenib Dose of 400 mg/day is as Effective as Standard Dose of 800 mg/day in Patients with Advanced Hepatocellular Carcimona, with Better Tolerance and Similar Survival

Shingina, Alexandra; Hashim, Al Moutaz; Haque, Mazhar; Suen, Michael W.H.; Yoshida, Eric M.; Gill, Sharlene; Donnellan, Fergal; Weiss, Alan

doi:10.1155/2013/170546

Cited by 22 publications

(22 citation statements)

References 12 publications

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“…Considering previous studies on dose reduction of sorafenib, the initial dose was reduced based on clinical factors such as age, body weight, ECOG PS and liver functional reserve (19,21,27). During sorafenib therapy, each attending physician decided to reduce the daily dose of sorafenib according to the grades of adverse events or ECOG PS.…”

Section: Methodsmentioning

confidence: 99%

Comparison of five staging systems in hepatocellular carcinoma treated with sorafenib: A single-center experience

Endo

Nishikawa

Kita

et al. 2016

Molecular and Clinical Oncology

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Abstract. To the best of our knowledge, none of the prognostic staging systems for hepatocellular carcinoma (HCC) patients who underwent sorafenib therapy is universally adopted or preferred. In the present study, we aimed to compare prognostic ability among five prognostic systems, including the Japan Integrated Staging (JIS) system, the Barcelona Clinic Liver Cancer classification system, the tumor-node-metastasis classification system, the Cancer of the Liver Italian Program scoring system and the Chinese University Prognostic Index (CUPI) scoring system for HCC patients who received sorafenib therapy. A total of 143 HCC patients treated with sorafenib were analysed. We compared prognostic ability among the five prognostic systems using the likelihood ratio (LR) χ 2 test, linear trend χ 2 test and concordance index (c-index). Our cohort included 114 men and 29 women. The median patient age was 71 years (range, 45-89 years). A total of 102 patients were classified as Child-Pugh A and 41 as Child-Pugh B, whereas 31 patients (21.7%) had portal vein invasion and 63 (44.1%) extrahepatic metastases. The median survival time was 6.9 months. In the LR χ 2 test, the CUPI scoring system had the highest value (35.804), followed by the JIS system (17.469). In the linear trend χ 2 test, the CUPI scoring system had the highest value (17.523), followed by the JIS system (15.819). In addition, the JIS system had the highest value in the 6-month c-index (0.659) as well as in the 1-year c-index (0.674). However, the CUPI classification system had the lowest value in the 1-year c-index (0.590). In conclusion, the JIS system may be an appropriate staging system for HCC patients undergoing sorafenib therapy.

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Section: Methodsmentioning

confidence: 99%

Comparison of five staging systems in hepatocellular carcinoma treated with sorafenib: A single-center experience

Endo

Nishikawa

Kita

et al. 2016

Molecular and Clinical Oncology

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“…For patients with no risk factors, we introduced the recommended initial dose of sorafenib 400 mg b.i.d.. [2][3][4] Taking previous reports about dose reduction into consideration, the initial dose was reduced by each attending physician according to factors such as bodyweight, age, ECOG-PS and liver function. [17][18][19] During sorafenib treatment, each attending physician decided to reduce the daily dose of sorafenib according to the grades of adverse events or ECOG-PS.…”

Section: Hcc Diagnosis and Sorafenib Therapymentioning

confidence: 99%

Proposal of Japan Red Cross score for sorafenib therapy in hepatocellular carcinoma

Takeda

Nishikawa

Osaki

et al. 2015

Hepatology Research

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Aim: There have been no established predictors of the outcome on sorafenib therapy for hepatocellular carcinoma (HCC) patients. We aimed to establish a new prognostic model suitable for sorafenib in HCC.Methods: Among 465 HCC patients treated with sorafenib in 14 hospitals, we formed a training cohort with 270 patients at seven hospitals located in West Japan and a validation cohort with 167 patients at seven hospitals located in East Japan. In the training cohort, we examined the relationship between overall survival (OS) and pretreatment clinical factors, and structured a new prognostic model. We verified this model in the validation cohort and compared with four existing staging models.Results: Multivariate analysis demonstrated distant metastases, portal invasion, intrahepatic tumor burden of more than 50%, serum α-fetoprotein of 150 ng/dL or more, des-γ-carboxyprothrombin of 1200 mAU/mL or more, albumin of 3.5 g/dL or less and total bilirubin of more than 1.0 mg/dL were significant independent adverse prognostic factors. We calculated a Japan Red Cross (JRC) score with these factors and classified three groups: low-, intermediate-or high-risk. Their median OS were well stratified (18.0, 8.8 and 3.7 months, respectively, P < 0.001) in the training cohort. In the validation cohort, OS were also statistically stratified (23.9, 10.3 and 2.9 months, P < 0.001). C-statistics of the JRC score was 0.755, the highest in the five models, indicating its novel predictability. Conclusion:Our proposed JRC score well predicts the prognosis of sorafenib therapy, and would be useful to plan individualized strategies for unresectable HCC.

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“…Since approval was granted to sorafenib, physicians have accrued a wealth of experience with the fine-tuning of sorafenib in their daily clinical practice, and several 'real-world' studies have continued to investigate the safety and efficacy of sorafenib. Among them is a multinational postmarketing study, GIDEON, and the Italian field-practice study by the Sorafenib Italian Assessment (SOFIA) study group [7][8][9][10][11], as well as a number of other studies in Europe and North America [12][13][14][15] . These real-world experiences have allowed us to assess sorafenib in patients who are not selected by strict clinical trial criteria but by physician judgment, including patients with comorbidities and those receiving concomitant medication.…”

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confidence: 99%

Refining Sorafenib Therapy: Lessons from Clinical Practice

et al. 2014

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AbstrAct:Understanding the best use of sorafenib is essential in order to maximize clinical benefit in hepatocellular carcinoma. Based on Phase III and noninterventional study data, as well as our extensive experience, we discuss dose modification in order to manage adverse events, disease response evaluation and how to maximize treatment benefit. Sorafenib should be initiated at the approved dose (400 mg twice daily) and reduced/ interrupted as appropriate in order to manage adverse events. Dose modification should be considered before discontinuation. Appropriate tumor response assessment is critical. Focusing on radiologic response may result in premature sorafenib discontinuation; symptomatic progression should also be considered. If second-line therapies or trials are unavailable, continuing sorafenib beyond radiologic progression may provide a clinical benefit. Our recommendations enable the maximization of treatment duration, and hence clinical benefit, for patients. Keywords:• adverse event managementIt is well established that hepatocellular carcinoma (HCC) is a complex and heterogeneous disease that is affected by multiple genetic and epigenetic alterations [1]. In the overwhelming majority of patients, liver cirrhosis -another complex disease in its own right -is superimposed on HCC. As a result, the prognostic range for these patients varies considerably and continues to change for each patient at every time point over the clinical course of their disease. A meta-analysis of 30 clinical trials into which HCC patients were enrolled for palliative treatment reflects this heterogeneity. It demonstrated a high variability in survival among untreated patients and concluded that no single patient characteristic alone could predict outcome [2].The prognosis and treatment options for HCC are generally related to tumor stage and liver function at presentation [3,4]. In the west, approximately 30% of all patients with HCC are diagnosed in

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In a ‘Real-World’, Clinic-Based Community Setting, Sorafenib Dose of 400 mg/day is as Effective as Standard Dose of 800 mg/day in Patients with Advanced Hepatocellular Carcimona, with Better Tolerance and Similar Survival

Abstract: In a review of 99 patients in a 'real-world' community setting, a sorafenib dose of 400 mg⁄day was better tolerated and had similar efficacy compared with a sorafenib dose of 800 mg⁄day with respect to survival and outcomes.

Cited by 22 publications

References 12 publications

Comparison of five staging systems in hepatocellular carcinoma treated with sorafenib: A single-center experience

Comparison of five staging systems in hepatocellular carcinoma treated with sorafenib: A single-center experience

Proposal of Japan Red Cross score for sorafenib therapy in hepatocellular carcinoma

Refining Sorafenib Therapy: Lessons from Clinical Practice

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