Comparison of standard-dose and half-dose sorafenib therapy on clinical outcome in patients with unresectable hepatocellular carcinoma in field practice: A propensity score matching analysis

Nishikawa, Hiroki; Osaki, Yukio; Endo, Masatsugu; Takeda, Haruhiko; Tsuchiya, Kaoru; Joko, Kouji; Ogawa, Chikara; Taniguchi, Haruhito; Orito, Etsuro; Uchida, Yasushi; Izumi, Namiki

doi:10.3892/ijo.2014.2654

Cited by 28 publications

(28 citation statements)

References 26 publications

(68 reference statements)

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“…Comparison of discriminative ability using 6 months and 1-year concordance index (c-index) among five prognostic systems. for Japanese HCC patients with a relatively lower body weight compared with Western populations remains unclear (21) and further investigation is required. We acknowledge several limitations to the present analysis.…”

Section: Discussionmentioning

confidence: 99%

“…Subjects participating in clinical trials of novel molecular targeted agents or sequential or combination therapies with TACE and sorafenib were excluded from the present analysis. Sorafenib therapy was indicated in patients with unresectable HCC determined by dynamic computed tomography (CT): i) Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2; ii) presence of extrahepatic metastases; iii) HCC refractory to previous therapies, such as TACE; iv) unsuitability for TACE due to anatomical reasons; or v) vascular invasion, such as tumor thrombus in the portal vein (19,21).…”

Section: Methodsmentioning

confidence: 99%

“…Sorafenib therapy was continued until disease progression, unacceptable drug-related toxicity, or the patient's wish to discontinue treatment. After discontinuation of sorafenib therapy for any reason, any additional therapies, such as TACE or systemic chemotherapy, were allowed based on the status of each patient (19,21).…”

Section: Methodsmentioning

confidence: 99%

“…As regards the initial dose of sorafenib, for patients without risk factors, we introduced the recommended initial dose of 400 mg twice a day (800 mg/day) of sorafenib (16,17,19,21,25,26). 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).…”

Section: Methodsmentioning

confidence: 99%

“…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%

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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: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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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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Effect of sorafenib starting dose and dose intensity on survival in patients with hepatocellular carcinoma: Results from a Canadian Multicenter Database

et al. 2020

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Background Sorafenib has been shown to improve survival in patients with advanced hepatocellular carcinoma (HCC), however, full dose can be difficult to tolerate. The aim of this study was to determine whether sorafenib starting dose and mean dose intensity affect survival. Methods Patients treated with sorafenib for HCC from January 2008 to July 2016 in several Canadian provinces were included and retrospectively analyzed. The primary end point was overall survival (OS) of patients starting on sorafenib full dose compared to reduced dose. Secondary analysis compared OS with different mean dose‐intensity groups. Survival outcomes were assessed with Kaplan‐Meier curves and Cox proportional hazards models. A propensity score analysis was performed to account for treatment bias and confounding. Results Of 681 patients included, sorafenib was started at full dose in 289 patients (42%). Median survival for starting full and reduced dose was 9.4 months and 8.9 months ( P = .15) respectively. After propensity score matching and adjusting for potential confounders there was still no difference in survival (HR 0.8, 95% CI, 0.61‐1.06, P = .12). Almost half of the patients (45%) received a dose intensity < 50%. Median survival for mean dose intensity > 75%, 50%‐75%, and < 50% were 9.5 months, 12.9 months, and 7.1 months ( P = .005) respectively. In multivariable models, starting dose(HR 1.16, 95% CI 0.93‐1.44, P = .180) and mean dose intensity were not associated with survival. Conclusions Starting HCC patients on a reduced dose of sorafenib compared to full dose may not compromise survival. Mean dose‐intensity of sorafenib may also not affect survival.

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Dosing, efficacy and safety of lenvatinb in the real‐world treatment of hepatocellular carcinoma: Results from a Canadian database

Amaro

Allen

Knox

et al. 2022

Liver Cancer International

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Background and Aims A phase 3 trial showed lenvatinib to be effective and safe in the treatment of unresectable hepatocellular carcinoma (HCC), however, its performance in the real world and effect of dosing on survival are unclear. Methods From July 2018 to June 2020, HCC patients treated with lenvatinib from 10 Canadian cancer centres were included. Overall survival (OS) and progression‐free survival (PFS) were retrospectively analysed and compared across first‐ and later lines use of lenvatinib. In patients receiving lenvatinib first‐line, OS between different mean dose intensities and starting doses were compared. Results A total of 220 patients were included, of which 79% received lenvatinib as first‐line therapy. For first‐line versus later line treatment, median OS was 12.5 versus 11.8 months (P = .83) and median PFS was 7.6 versus 4.6 months (P = .27) respectively. Of patients receiving lenvatinib first‐line, 54% started at full dose according to their weight. Median OS for patients starting lenvatinib at full‐ and reduced‐dose was 12.3 and 15.8 months (P = .75) respectively. Median OS for patients with a mean dose intensity >66.7% compared ≤66.7% was 13.7 and 7.7 months (P = .01). In the multivariate analysis, dose intensity (>66.7 vs ≤66.7%) did not predict for OS [HR 0.70, 95% CI 0.42–1.18; P = .18]. The most common side effects were fatigue (59%), hypertension (41%) and decreased appetite (25%). Conclusions Lenvatinib appears to be effective in real‐world practice regardless of the line of therapy. Dose modifications at the start or during treatment did not appear to significantly affect survival.

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Comparison of standard-dose and half-dose sorafenib therapy on clinical outcome in patients with unresectable hepatocellular carcinoma in field practice: A propensity score matching analysis

Abstract: Abstract. The aims of the present study were to examine whether unresectable hepatocellular carcinoma (HCC)

Cited by 28 publications

References 26 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

Effect of sorafenib starting dose and dose intensity on survival in patients with hepatocellular carcinoma: Results from a Canadian Multicenter Database

Dosing, efficacy and safety of lenvatinb in the real‐world treatment of hepatocellular carcinoma: Results from a Canadian database

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