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العنوان
Value of Drug -Related Adverse Events in predicting Efficacy of Sorafenib Therapy for advanced stage Hepatocellular Carcinoma /
المؤلف
Elshaer, Mahasen Akram.
هيئة الاعداد
باحث / محاسن اكرم الشاعر
مشرف / امام عبد اللطيف واكد
مشرف / ايمان احمد رويشة
مشرف / اسماء ابراهيم السيد
الموضوع
Hepatitis, Viral - Treatment. Liver - Cancer - Prevention. Carcinoma, Hepatocellular - prevention & control.
تاريخ النشر
2015.
عدد الصفحات
120 p. :
اللغة
الإنجليزية
الدرجة
ماجستير
التخصص
الكبد
تاريخ الإجازة
1/4/2015
مكان الإجازة
جامعة المنوفية - كلية الطب - طب الكبد
الفهرس
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Abstract

sorafenib was approved as an appropriate treatment in patients with
advanced HCC: the Sorafenib Hepatocarcinoma Assessment Randomized
Protocol (SHARP) study pointed out how the median survival time and
time to radiologic progression were nearly 3 months longer for patients
treated with sorafenib than for those in the placebo group.
Sorafenib seems to be
reported are diarrhea, nausea,
toxicities, including HF SR,
hemorrhage. The severity of H
well tolerated: the principal side effects
fatigue, hypertension, and dermatological
alopecia, stomatitis, erythema, and
FSR is dose related, and depends on the
duration, dosage, and accumulation of the drug (Llovet et al., 2008).
The acneiform rash (most often acne-like) usually occurs a few day
weeks from the start of treatment. Histologically, HFSR is after
administration of sorafenib, and reaches a maximum after 2-3
characterized by thick, well-defined hyperkeratotic lesions frequent
affecting digit flexural locations: this peculiar characteristic led to the
term HFSR. Although sorafenib-induced HFSR is usually not a lifethreatening
side effect, it affects quality of life in a significant manner
and can be complicated by infection, pain, and limitation of activities of
daily living. In addition, it represents a dose-limiting toxicity, and may
compromise the efficacy of the treatment because dose reduction
The Current study included 30 patients who fulfilled the pre
designed inclusion criteria which were ( adult patients at least 18 years
ago Patients must have histologically or cytologically confirmed or
radiologically confirmed (according to AASLD criteria) advanced
(unresectable, and/or metastatic) HCC not eligible for local ablation or
TACE.
All the Studied cases were subjected to the following:
Thorough history taking including patient name, age, gender,
occupation, smoking index, duration of liver disease, history of DM or
hypertension , Complete Clinical examination Complete blood count.
Liver function tests: ALT & AST, serum bilirubin, serum albumin ,
prothrombin time. Coagulation profile .Renal function tests. Amylase and
1ipase.Alfa Fetoprotein (AFP). Serum electrolytes.Radiological
investigations:Pelvi-Abdominal U1trasound.Triphasic CT of abdomen and
pelvis CT of chest
In the present study there was a male predominance as males
constituted 96.6 % of all patients and the mean of their age was 53.62 *
5.46. All patients had HCV related, Child-Pugh A chronic liver disease.
Twenty one patients (70%) were BCLC C and 9 patients (30%)
patients were BCLC B.
Also our study revealed that there is longer median survival time
in BCLC B (llmonth) than patients with BCLC C @month), but did not
reach statistically significance.
As regard adverse effects and their timing in our study, the
overall incidene was 100%. Mostly (88%) were early timing during first
three months and 15% were grade 3 to 4.
The most common adverse event reported in this study was liver
dysfuction which was found in 85% of patients. Constitutional
symptoms were found in 48% of patients.
Dermatological adverse effects were reported in 3 1% of patients.
Gastrointestinal symptoms adverse events were found in 21% of
patients. Moreover, abdonimal pain was noticed in 21% of patients. Only
3 (1 0%) patients developed hypertension
The overall median survival of the entire cohort was 9 months in
this study with 95% CI of 4.1 -14.0. The one and two year probability of
survival was 44% and 39% respectively.
In the present study, all patients who developed specific type
adverse events had less median survival time and less TTP than those
who did not experience this type of adverse events, although slight better
tumour control was noticed except with thrombocytopenia. However, all
these relations did not reach statistically significance.
Patients who developed dermatological AE had less median
survival time and less TTP than those who did not develop
dermatological AE in this study although slight better tumour control.
The median OS was 7 months in the group of patients with skin toxicity
versus 11 months in those without skin toxicity. The median TTP was 7.5
months in the group of patients with skin toxicity versus 11.7 months in
those without skin toxicity. The tumor control rate was 55.6% in patients
with dermatological AE, versus 55% in patients without dermatological
side effects.