We are analyzing https://link.springer.com/article/10.1007/s00535-016-1173-5.

Title:
Safety and effectiveness of sorafenib in Japanese patients with hepatocellular carcinoma in daily medical practice: interim analysis of a prospective postmarketing all-patient surveillance study | Journal of Gastroenterology
Description:
Sorafenib was approved for treatment of unresectable hepatocellular carcinoma (HCC) in Japan in 2009. A prospective postmarketing all-patient surveillance (PMS) study was requested by Japanese authorities to confirm safety and effectiveness of sorafenib in Japanese HCC population. Patients with unresectable HCC treated with sorafenib were followed up for 12 months. Data on patient demographic characteristics, treatment status, clinical outcome, and adverse events (AEs) were collected. This interim analysis included 1109 and 1065 patients evaluable for safety and effectiveness, respectively. Most patients (83.4 %) received the recommended initial dose of 400 mg twice daily. After a follow-up of 12-months, 89.8 % had discontinued treatment, most because of AEs (44.5 %) or progression (33.8 %). The most common drug-related adverse events (DRAE) were hand-foot skin reaction (51.4 %), liver dysfunction (26.4 %), diarrhea (25.1 %), and hypertension (21.6 %). The median overall survival (OS) was 348 days [95 % confidence interval (CI) 299–389 days], and the median duration of treatment was 87 days (95 % CI 78–98 days). Multivariate analyses identified baseline prognostic factors for longer OS, including female sex, low Child-Pugh score, Eastern Cooperative Oncology Group performance status 0, tumor stage I/II/III, low aspartate aminotransferase level, high hemoglobin level, hepatitis C and history of surgical resection. In general, the safety and effectiveness findings in this PMS were consistent with findings from previous clinical studies. Sorafenib was well tolerated and clinically useful for Japanese patients. Clinical trial registration number: NCT01411436
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Keywords {🔍}

patients, sorafenib, study, treatment, article, drae, pubmed, hepatocellular, carcinoma, japan, google, scholar, hcc, liver, safety, analysis, cas, factors, data, clinical, handfoot, skin, cancer, reaction, days, pms, results, advanced, japanese, median, baseline, childpugh, therapy, status, dose, dysfunction, previous, reported, initiation, unresectable, survival, score, phase, randomized, based, table, pharma, medical, surveillance, events,

Topics {✒️}

jp/reg_stat/statistics/dl/index article download pdf hand-foot skin reaction hand-foot skin reactions large-scale surveillance study transcatheter arterial embolization/chemoembolization raf/mek/erk pathway good performance status low child-pugh score central registration system baseline child-pugh score baseline child-pugh class half-dose sorafenib therapy full size table drug-related adverse events real-life clinical practice cr + pr + stable disease c-kit protein baseline ecog ps rcc xenograft models medical oncology/hematology open-label study phase iii trial kyorin university school patient demographic/disease data therapeutic-effect-related factors ecog ps score half-dose sorafenib treatment phase iii randomized lyo inuyama privacy choices/manage cookies retrospective pooled analysis randomized controlled trial log-rank test asia–pacific region asia pacific region asia-pacific region phase iii multinational phase iii randomised adverse drug reactions inhibits tumor growth article kaneko additional marketing authorization skin-related events full access randomized controlled trials table 1 baseline demographic randomized clinical trials independent prognosis factor patient surveillance study

Schema {🗺️}

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         headline:Safety and effectiveness of sorafenib in Japanese patients with hepatocellular carcinoma in daily medical practice: interim analysis of a prospective postmarketing all-patient surveillance study
         description:Sorafenib was approved for treatment of unresectable hepatocellular carcinoma (HCC) in Japan in 2009. A prospective postmarketing all-patient surveillance (PMS) study was requested by Japanese authorities to confirm safety and effectiveness of sorafenib in Japanese HCC population. Patients with unresectable HCC treated with sorafenib were followed up for 12 months. Data on patient demographic characteristics, treatment status, clinical outcome, and adverse events (AEs) were collected. This interim analysis included 1109 and 1065 patients evaluable for safety and effectiveness, respectively. Most patients (83.4 %) received the recommended initial dose of 400 mg twice daily. After a follow-up of 12-months, 89.8 % had discontinued treatment, most because of AEs (44.5 %) or progression (33.8 %). The most common drug-related adverse events (DRAE) were hand-foot skin reaction (51.4 %), liver dysfunction (26.4 %), diarrhea (25.1 %), and hypertension (21.6 %). The median overall survival (OS) was 348 days [95 % confidence interval (CI) 299–389 days], and the median duration of treatment was 87 days (95 % CI 78–98 days). Multivariate analyses identified baseline prognostic factors for longer OS, including female sex, low Child-Pugh score, Eastern Cooperative Oncology Group performance status 0, tumor stage I/II/III, low aspartate aminotransferase level, high hemoglobin level, hepatitis C and history of surgical resection. In general, the safety and effectiveness findings in this PMS were consistent with findings from previous clinical studies. Sorafenib was well tolerated and clinically useful for Japanese patients. Clinical trial registration number: NCT01411436
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            Postmarketing surveillance
            Molecular targeted therapy
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            Abdominal Surgery
            Colorectal Surgery
            Surgical Oncology
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      headline:Safety and effectiveness of sorafenib in Japanese patients with hepatocellular carcinoma in daily medical practice: interim analysis of a prospective postmarketing all-patient surveillance study
      description:Sorafenib was approved for treatment of unresectable hepatocellular carcinoma (HCC) in Japan in 2009. A prospective postmarketing all-patient surveillance (PMS) study was requested by Japanese authorities to confirm safety and effectiveness of sorafenib in Japanese HCC population. Patients with unresectable HCC treated with sorafenib were followed up for 12 months. Data on patient demographic characteristics, treatment status, clinical outcome, and adverse events (AEs) were collected. This interim analysis included 1109 and 1065 patients evaluable for safety and effectiveness, respectively. Most patients (83.4 %) received the recommended initial dose of 400 mg twice daily. After a follow-up of 12-months, 89.8 % had discontinued treatment, most because of AEs (44.5 %) or progression (33.8 %). The most common drug-related adverse events (DRAE) were hand-foot skin reaction (51.4 %), liver dysfunction (26.4 %), diarrhea (25.1 %), and hypertension (21.6 %). The median overall survival (OS) was 348 days [95 % confidence interval (CI) 299–389 days], and the median duration of treatment was 87 days (95 % CI 78–98 days). Multivariate analyses identified baseline prognostic factors for longer OS, including female sex, low Child-Pugh score, Eastern Cooperative Oncology Group performance status 0, tumor stage I/II/III, low aspartate aminotransferase level, high hemoglobin level, hepatitis C and history of surgical resection. In general, the safety and effectiveness findings in this PMS were consistent with findings from previous clinical studies. Sorafenib was well tolerated and clinically useful for Japanese patients. Clinical trial registration number: NCT01411436
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         Molecular targeted therapy
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         Abdominal Surgery
         Colorectal Surgery
         Surgical Oncology
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            address:
               name:Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan
               type:PostalAddress
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      email:[email protected]
      name:Kenji Ikeda
      affiliation:
            name:Toranomon Hospital
            address:
               name:Department of Hepatology, Toranomon Hospital, Tokyo, Japan
               type:PostalAddress
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      name:Yasushi Matsuzaki
      affiliation:
            name:Tokyo Medical University Ibaraki Medical Center
            address:
               name:Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokyo Medical University Ibaraki Medical Center, Ibaraki, Japan
               type:PostalAddress
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      name:Junji Furuse
      affiliation:
            name:Kyorin University School of Medicine
            address:
               name:Department of Medical Oncology, Kyorin University School of Medicine, Tokyo, Japan
               type:PostalAddress
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      name:Hironobu Minami
      affiliation:
            name:Kobe University Graduate School of Medicine
            address:
               name:Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe, Japan
               type:PostalAddress
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            name:Bayer Yakuhin, Ltd.
            address:
               name:Pharmacovigilance, Medical Affairs, Bayer Yakuhin, Ltd., Osaka, Japan
               type:PostalAddress
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      name:Toshiyuki Sunaya
      affiliation:
            name:Bayer Yakuhin, Ltd.
            address:
               name:Clinical Statistics, Product Development, Bayer Yakuhin, Ltd., Osaka, Japan
               type:PostalAddress
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      name:Yuichiro Ito
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            name:Bayer Yakuhin, Ltd.
            address:
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               type:PostalAddress
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      name:Lyo Inuyama
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            name:Bayer Yakuhin, Ltd.
            address:
               name:Pharmacovigilance, Medical Affairs, Bayer Yakuhin, Ltd., Osaka, Japan
               type:PostalAddress
            type:Organization
      name:Kiwamu Okita
      affiliation:
            name:Shimonoseki Kosei Hospital
            address:
               name:Shimonoseki Kosei Hospital, Yamaguchi, Japan
               type:PostalAddress
            type:Organization
PostalAddress:
      name:Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan
      name:Department of Hepatology, Toranomon Hospital, Tokyo, Japan
      name:Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokyo Medical University Ibaraki Medical Center, Ibaraki, Japan
      name:Department of Medical Oncology, Kyorin University School of Medicine, Tokyo, Japan
      name:Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe, Japan
      name:Pharmacovigilance, Medical Affairs, Bayer Yakuhin, Ltd., Osaka, Japan
      name:Clinical Statistics, Product Development, Bayer Yakuhin, Ltd., Osaka, Japan
      name:Medical Affairs Oncology and Hematology, Bayer Yakuhin, Ltd., Osaka, Japan
      name:Pharmacovigilance, Medical Affairs, Bayer Yakuhin, Ltd., Osaka, Japan
      name:Shimonoseki Kosei Hospital, Yamaguchi, Japan

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