Worse outcome of sorafenib therapy associated with ascites and <scp>C</scp>hild‐<scp>P</scp>ugh score in advanced hepatocellular carcinoma

Kim, Hwi Young; Park, Joong-Won; Joo, Jungnam; Kim, Hyoseok; Woo, Sang Myung; Lee, Woojin; Kim, Chang Min

doi:10.1111/jgh.12310

Cited by 44 publications

(37 citation statements)

References 25 publications

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“…It plays an important role in prognostic score for a variety of tumors, such as Gleason score for prostate cancer [6], Child-pugh classification for hepatocellular carcinoma [7], SBR, WHO score for breast cancer [8], but the prognostic effect of histopathology has never been reported in gastric cancer. Moreover, there is not any effective way to identify the prognosis of early gastric cancer.…”

Section: Introductionmentioning

confidence: 99%

Histopathology-based prognostic score is independent prognostic factor of gastric carcinoma

et al. 2014

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BackgroundThe aim of our study was to evaluate the histological characteristics and prognosis of gastric cancer.MethodsClinicopathlogical variables of 932 patients with gastric carcinoma admitted to the Department of Surgical Oncology at the First Hospital of China Medical University were analyzed retrospectively. Different histological characteristics of gastric cancer were summarized and assigned score according to the malignancy defined by WHO classification, the scores were stratified into 4 stage, the prognosis of different stages were analyzed by Kaplan-Meier analysis and cox regression.ResultsAmong the 932 patients, 246 (26.39%) had mixed histology type of gastric cancer. Compared to the pure histological type, mixed histological type of gastric cancer was significant associated with tumor size, lymph node metastasis and depth of invasion (all P < 0.05). The 5-year survival rates of advanced and early gastric cancer patients with mixed type were 40.8% and 83.5% respectively, which were lower than those with pure type (50.0% and 95.8%, P < 0.01). Statistically significant difference with stratification of early and advanced stage could be observed between patients with the histological grading score. The data showed that the histological score could be the independent factor of prognosis.ConclusionsThe histological score is an independent factor of gastric cancer, it exerts an excellent ability to classify survival of patients with gastric carcinoma. It also provides a new strategy and parameter for evaluating the biological behavior and prognosis of gastric cancer.

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Section: Introductionmentioning

confidence: 99%

Histopathology-based prognostic score is independent prognostic factor of gastric carcinoma

et al. 2014

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“…In conclusion, it was recently demonstrated that ideal therapeutic results were not achieved by sorafenib in patients with advanced HCC with CP class B (9). In such patients, we identified a subgroup exhibiting a better clinical outcome when treated with the split-dose FMP chemotherapeutic regimen, simply by assessing the AFP level and/or the GALNT14 genotype.…”

Section: Discussionmentioning

confidence: 89%

GALNT14 genotype, α-fetoprotein and therapeutic side effects predict post-chemotherapy survival in patients with advanced hepatocellular carcinoma

Lin

Hsu

Chen

et al. 2014

Molecular and Clinical Oncology

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Abstract. In addition to targeted agents, chemotherapy is currently considered to be a treatment option for patients with advanced hepatocellular carcinoma (HCC); however, it is associated with severe side effects that may limit its clinical use. UDP-N-acetyl-α-D-galactosamine:polypep tide N-acetyl-galactosaminyltransferase 14 (GALNT14) genotype was previously identified as a prognostic marker for HCC patients receiving 5-fluorouracil, mitoxantrone and cisplatin (FMP) combination chemotherapy. The present study aimed to assess clinical parameters and on-treatment side effects as effective predictors for favorable prognosis. A total of 118 patients with HCC receiving split-dose FMP were retrospectively enrolled. The clinical parameters, side effects and GALNT14 genotype were analyzed. The independent predictors for time-to-progression (TTP) and overall survival (OS) were assessed using Cox proportional hazards models. Following categorization, the Kaplan-Meier method was used to compare survival outcomes. Pretreatment α-fetoprotein (AFP) ≤2,800 ng/ml (median level), GALNT14 'TT' genotype, on-treatment leukopenia and absence of vomiting were identified as independent predictors of a favorable TTP (P= 0.001, 0.035, 0.008 and 0.009, respectively) and OS (P= 0.028, 0.006, 0.027 and 0.013, respectively). A total of 59 patients with AFP ≤2,800 ng̸ml exhibited longer median TTP and OS (3.11 vs. 1.75 months, P<0.001; and 8.14 vs. 3.79 months, P<0.001, respectively). A total of 30 patients with the GALNT14 'TT' genotype exhibited longer median TTP and OS (3.11 vs. 2.11 months, P= 0.014; and 5.75 vs. 3.93 months, P=0.001, respectively). Finally, 9 patients (9/118; 7.6%) with all four favorable factors exhibited the longest median TTP and OS (10.64 vs. 2.07 months, P= 0.002; and 25.50 vs. 4.50 months, P<0.001, respectively). In conclusion, the AFP level and the GALNT genotype may be considered as pre-therapeutic predictors of a favorable response. When combined with on-treatment leukopenia and absence of vomiting, a subgroup of patients with excellent outcome may be identified.

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“…[39, 40] A real world cohort reported significantly decreased overall survival with sorafenib in Child-Pugh B compared to Child-Pugh A cirrhotics. [41] Likewise, post-marketing studies in entecavir for chronic HBV infection show lower proportions of ALT normalization than was shown in registration trials. [42]…”

Section: Discussionmentioning

confidence: 99%

Limited Generalizability of Registration Trials in Hepatitis C: A Nationwide Cohort Study

et al. 2016

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BackgroundApproval of drugs in chronic hepatitis C is supported by registration trials. These trials might have limited generalizability through use of strict eligibility criteria. We compared effectiveness and safety of real world hepatitis C patients eligible and ineligible for registration trials.MethodsWe performed a nationwide, multicenter, retrospective cohort study of chronic hepatitis C patients treated in the real world. We applied a combined set of inclusion and exclusion criteria of registration trials to our cohort to determine eligibility. We compared effectiveness and safety in eligible vs. ineligible patients, and performed sensitivity analyses with strict criteria. Further, we used log binomial regression to assess relative risks of criteria on outcomes.ResultsIn this cohort (n = 467) 47% of patients would have been ineligible for registration trials. Main exclusion criteria were related to hepatic decompensation and co-morbidity (cardiac disease, anemia, malignancy and neutropenia), and were associated with an increased risk for serious adverse events (RR 1.45–2.31). Ineligible patients developed significantly more serious adverse events than eligible patients (27% vs. 11%, p< 0.001). Effectiveness was decreased if strict criteria were used.ConclusionsNearly half of real world hepatitis C patients would have been excluded from registration trials, and these patients are at increased risk to develop serious adverse events. Hepatic decompensation and co-morbidity were important exclusion criteria, and were related to toxicity. Therefore, new drugs should also be studied in these patients, to genuinely assess benefits and risk of therapy in the real world population.

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Worse outcome of sorafenib therapy associated with ascites and Child‐Pugh score in advanced hepatocellular carcinoma

Abstract: CP score was more important than CP class in predicting the outcome of sorafenib therapy in patients with advanced HCC. Among the CP score components, presence of ascites was a significant prognostic factor, especially in CPB7 patients.

Cited by 44 publications

References 25 publications

Histopathology-based prognostic score is independent prognostic factor of gastric carcinoma

Histopathology-based prognostic score is independent prognostic factor of gastric carcinoma

GALNT14 genotype, α-fetoprotein and therapeutic side effects predict post-chemotherapy survival in patients with advanced hepatocellular carcinoma

Limited Generalizability of Registration Trials in Hepatitis C: A Nationwide Cohort Study

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