CTEP CANCER GOV FORMS CTCAEV3 PDF

The article may be redistributed, reproduced, and reused for non-commercial purposes, provided the original source is properly cited. This article has been cited by other articles in PMC. Abstract The standard treatment for advanced hepatocellular carcinoma HCC is sorafenib, a multikinase inhibitor of tumor cell proliferation and angiogenesis. Hyperthermia inhibits angiogenesis and promotes apoptosis. Potential synergic antiangiogenic and proapoptotic effects represent the rationale for combining sorafenib with electro-hyperthermia EHY in HCC.

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The article may be redistributed, reproduced, and reused for non-commercial purposes, provided the original source is properly cited. This article has been cited by other articles in PMC. Abstract The standard treatment for advanced hepatocellular carcinoma HCC is sorafenib, a multikinase inhibitor of tumor cell proliferation and angiogenesis. Hyperthermia inhibits angiogenesis and promotes apoptosis. Potential synergic antiangiogenic and proapoptotic effects represent the rationale for combining sorafenib with electro-hyperthermia EHY in HCC.

A total of 21 patients median age, 64 years; range, 55—73 years with advanced HCC were enrolled in the current study between February and September EHY was achieved by arranging capacitive electrodes with a deep hypothermia radiofrequency field of No complete response was observed. Grade 3 toxicity included fatigue, diarrhea, hand-foot skin reaction and hypertension. In the present study, the sorafenib plus EHY combination was feasible and well tolerated, and no major complications were observed.

The initial findings indicated that this combination offers a promising option for advanced HCC. Keywords: carcinoma, electro-hyperthermia, hepatocellular, sorafenib Introduction Hepatocellular carcinoma HCC is the sixth most common type of neoplasm and the third most frequent cause of cancer-related mortality in Western countries 1.

Sorafenib inhibits tumor cell proliferation and tumor angiogenesis, and increases the rate of apoptosis in a number of tumors 4. Electro-hyperthermia EHY , also known as oncothermia or extracellular hyperthermia, is a method of locoregional hyperthermia, established by the direct absorption of an electric field energy in the extracellular liquid with a subsequent temperature gradient between the extra- and intracellular compartments; this gradient destroys cancer cell membranes, leading to necrosis or apoptosis.

As the conductivity and the dielectric constant of the extracellular matrix in malignant tissue are higher than in the normal tissue, this technique results in selective tumor tissue destruction. For this reason, energy absorption at the applied frequency is significantly increased. Furthermore, malignant cells typically exhibit relatively rigid membranes due to increased phospholipid concentrations, therefore, EHY is likely to selectively destroy malignant cells prior to affecting the healthy cells.

EHY increases apoptosis producing membrane heat shock proteins , blocks further proliferation, terminates tumor cell dissemination re-establishing the adherent connections and increases immunogenicity. EHY is a complementary treatment in various types of tumors, such as brain, soft tissue, liver and abdominal, pancreatic, and head and neck tumors 7. Several pharmacodynamics including the acceleration of the primary mode of action and an increased intracellular drug concentration and pharmacokinetics for example drug uptake, distribution, metabolism and excretion interactions have been described between drugs and temperature.

Conversely, doxorubicin appears to have a defined temperature threshold, whilst the majority of antimetabolites such as 5-fluorouracil , as well as vinca alkaloids and taxanes, show no dependency to hyperthermia 9. In certain animal models, several drugs including KB-R, flavone acetic acid, vinblastine and combretastatin have been observed to induce a temporary reduction in tumor blood, but only in combination with hyperthermia significant tumor responses The potential synergic antiangiogenic and proapoptotic effects are the rationale for combining sorafenib and EHY for the treatment of HCC 11 , Written informed consent was obtained from each patient.

Patients with measurable, histologically confirmed and inoperable HCC who had not received prior systemic treatment for HCC were eligible for enrollment. Treatment and dose modifications Patients received mg sorafenib twice a day and EHY with capacitative electrodes with a deep hypothermia radiofrequency field of Regional hyperthermia and thermal mapping were performed according to the European Society of Hyperthermic Oncology guidelines for quality and safety assurance A large, water-cooled bolus asymmetric electrode 30 cm in diameter was used.

Sorafenib treatment interruptions and dose reductions initially mg twice daily, then reduced to mg once daily were allowed for drug-related toxicity, measured according to the National Cancer Institute Common Toxicity Criteria v 3. A dose delay was introduced for grade 4 hematologic toxicities and grade 3 non-hematologic toxicities, until toxicity was grade 2 or less; patients were then treated at one dose level lower and therapy was discontinued if recovery time was three weeks or longer.

Patients with drug-related grade 4 non-hematologic toxicities were removed from the study. For hand-foot skin reaction HFSR , dose modifications based on prescribing information and consensus panel recommendations were used Treatment was continued until disease progression PD or unacceptable drug-related toxicities.

Response assessment Bidimensional tumor measurements were performed at baseline and every eight weeks one cycle , according to RECIST, by computed tomography or magnetic resonance imaging.

Throughout the study, the lesions were measured at baseline and evaluated using the same technique. Overall tumor response was scored as a complete response CR , partial response PR or stable disease SD if the response was confirmed at least four weeks later.

Patient visits were scheduled every three weeks and at the end of treatment to monitor safety, compliance and determine side effects. The safety assessment included documentation of the adverse events, clinical laboratory tests hematological and biochemical analyses , physical examination and measurement of vital signs.

Statistical analysis This was an uncontrolled mono-institutional phase II trial. The primary endpoint of this trial was the progression-free survival PFS rate at four months. All the analyses were performed using Stata Results Patient characteristics The baseline characteristics of the patients are shown in Table I.

All patients had documented background chronic liver disease and 17 of the 21 patients had a CP classification of A. Table I.

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CTEP CANCER GOV FORMS CTCAEV3 PDF

Felar The price we pay for progress: Publications were limited to trials exploring pharmacologic interventions in patients with solid tumors. December 24, File ctep cancer gov forms ctcaev3 Discussion A careful balance between efficacy ctep cancer gov forms ctcaev3 toxicity is of primary importance in medical interventions. Canncer symptoms Cardiac general Metabolic Hemorrhage. Statistical analysis Results of the ctep cancer gov forms ctcaev3 were summarized by cahcer statistics.

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Please review our privacy policy. Received Nov 20; Accepted Jun Statistical analysis Results of the analysis were summarized ctep cancer gov forms ctcaev3 descriptive statistics. All authors read and approved the final ctep cancer gov forms ctcaev3. Results of the analysis were summarized ctep cancer gov forms ctcaev3 descriptive statistics. Scharf O, Colevas AD.

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