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  • 1
    Keywords: CANCER ; GROWTH-FACTOR ; INHIBITOR ; SURVIVAL ; tumor ; COMBINATION ; Germany ; PROSTATE ; TOXICITY ; DEATH ; DISEASE ; DRUG ; PATIENT ; primary ; ANTIGEN ; ENTRY ; NO ; prostate cancer ; PROSTATE-CANCER ; COMPONENT ; chemotherapy ; SAFETY ; PHARMACOKINETICS ; PHASE-II ; ONCOLOGY ; END ; overall survival ; SOLID TUMORS ; PHASE ; EVENTS ; CRITERIA ; docetaxel ; EVALUATE ; ENGLAND ; SET ; MITOXANTRONE PLUS PREDNISONE ; RAF KINASE ; anticancer drug ; prostate-specific antigen ; NOV ; POINT ; PROGRESSION-FREE SURVIVAL ; clinical study ; REGIMEN ; phase II study ; BAY-43-9006 ; bid ; DAYS ON/7 DAYS ; FACTOR RECEPTOR INHIBITOR ; hormone-refractory ; sorafenib
    Abstract: Sorafenib is a multi-kinase inhibitor with antiangiogenic and antiproliferative activity. The activity of sorafenib in progressive hormone-refractory prostate cancer (HRPC) patients was investigated in a phase II clinical study. Progressive HRPC patients received sorafenib 400 mg bid p.o. continuously. Only patients with no prior chemotherapy, and either one-unidimensional measurable lesion according to RECIST-criteria or increasing prostate-specific antigen (PSA) values reflecting a hormone-refractory situation, were eligible for study entry. The primary study objective was the rate of progression-free survival of 〉= 12 weeks (PFS 12). Secondary end points were overall response, overall survival, and toxicity. Fifty-seven patients with PC were enrolled. Two patients had to be withdrawn from the set of eligible patients. According to RECIST criteria, 4 patients out of 55 evaluable patients showed stable disease (SD). According to PSA-response, we saw 11 patients with SD PSA and 2 patients were responders at 12 weeks (PFS12 = 17/55 = 31%). Among the 257 adverse events, 15 were considered drug related of maximum CTC-grade 3. Twenty-four serious adverse events occurred in 14 patients (14/55 = 26%). Seven of them were determined to be drug related. No treatment-related death was observed. Sorafenib has antitumour activity in HRPCP when evaluated for RECIST-and PSA-based response. Further investigation as a component of combination regimens is necessary to evaluate its definite or overall clinical benefit for HRPCP
    Type of Publication: Journal article published
    PubMed ID: 18040273
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  • 2
    Keywords: PHASE ; PHASE-III ; - ; advanced breast cancer ; III TRIAL ; THERAPY ; CANCER ; BREAST-CANCER ; BREAST ; breast cancer ; TRIAL ; chemotherapy ; ONCOLOGY ; THERAPIES
    Type of Publication: Meeting abstract published
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  • 3
    Publication Date: 2006-04-21
    Keywords: ddc: 610
    Language: English
    Type: conferenceObject
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  • 4
    Electronic Resource
    Electronic Resource
    Springer
    Supportive care in cancer 2 (1994), S. 205-206 
    ISSN: 1433-7339
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Type of Medium: Electronic Resource
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  • 5
    ISSN: 1433-7339
    Keywords: Cancer pain ; Cancer pain management ; Opiates ; Prescribing practices ; Morphine
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Following clinical observations showing that opiates are sometimes not consistently administered for chronic cancer pain, a survey was conducted among 1200 physicians in the German-speaking part of Switzerland. Their opium-prescribing habits were assessed by means of a postal questionnaire. The results indicate that, among the majority of physicians completing the questionnaire, established guidelines and basic principles of pain control with opiates in cancer patients are largely understood. Oral morphine is chosen by 89% to initiate treatment of chronic cancer pain, and the correct use of slow-release morphine is known to 87% of the responding physicians. Unfortunately, an important minority of physicians does not follow established guidelines in the treatment of cancer pain, and up to 20% still feel that the danger of addiction, respiratory depression and other side-effects are important reasons for withholding opiates in this patients population. The results and their implications are discussed and compared with the current literature on cancer pain management.
    Type of Medium: Electronic Resource
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  • 6
    ISSN: 1433-7339
    Keywords: Asthenia ; Assessment ; Cancer ; Cytokines
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Asthenia is a very common symptom of patients with advanced cancer, but its investigation is hindered by a lack of suitable validated measuring instruments. The goal of the present study was to construct and validate a questionnaire for the study of asthenia in cancer patients, as well as to establish correlations with other symptoms and physiological and biochemical parameters. A group of 31 patients with advanced cancer and a control group of 30 healthy volunteers were examined. The proposed questionnaire, based on visual analogue scales, questions with categorical anwers and on the hospital anxiety and depression scale was validated by comparing results of the patient and control groups, by the test/retest method and by comparison with the evaluation of an observer. Correlation with various physiological and biochemical parameters was performed. The questionnaire distinguished well among the patients and control groups. VAS of asthenia proved quite stable over a period of 5 days. Correlations of asthenia with lack of appetite, the hospital anxienty and depression scale, weight, heart rate and serum cortisol levels could be established. No significant correlation between asthenia and various serum markers of inflammation and cytokines, including C-reactive protein, tumour necrosis factor, interleukin-1, and interleukin-2 receptors, could be found. The proposed questionnaire for evaluation of asthenia could be validated in a patient sample of limited size and a simplified questionnaire based on visual analogue scales is being developed for further investigations.
    Type of Medium: Electronic Resource
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  • 7
    ISSN: 1433-7339
    Keywords: Pamidronate ; Osteolytic bone disease ; Pain ; Dose effect ; Breast cancer ; Myeloma
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract In a prospective dose-escalation study tolerability and effectiveness of repeated infusions with intravenous pamidronate were investigated. A total of 80 patients with proven malignancy and pain due to osteolytic bone disease were enrolled. Doses of 30 mg, 45 mg, 60 mg and 90 mg pamidronate, given every 4 weeks, 3 weeks or 2 weeks were tested. Thus dose intensity was increased by giving higher doses and/or by shortening the intervals. A combined palliation score on the bases of pain score (WHO), analgesic score (WHO) and improvement of performance status (SAKK/ECOG) was rated by the physician on a six-point scale. Regression analysis showed a close correlation between dose intensity and effect (Pearson's R=0.7: P〈0.0001). A statistically significantly different palliative score for patients treated with low (below 15 mg/week), medium (16–30 mg/week) and high doses (above 31 mg/week) of pamidronate was found (P=〈0.01). A dose intensity below 10 mg pamidronate/week and single doses of 30 mg had no clinically relevant benefit, whereas dose intensities of 25–45 mg/week showed a significant palliative effect. We conclude that pamidronate should be given in a close intensity of 20 mg per week or more in patients with far advanced osteolytic bone disease. Best results are obtained with high doses of 60 mg or 90 mg pamidronate. Further investigations by prospective randomized trials are needed to determine the optimal dose and schedule of pamidronate infusions.
    Type of Medium: Electronic Resource
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  • 8
    ISSN: 1433-7339
    Keywords: Transdermal fentanyl ; Cancer pain ; Drug titration
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract All communications on the use of transdermal fentanyl as well as the recommendations of the manufacturer include the direction that patients should be titrated with a short-acting narcotic to control their cancer pain before they are converted to a fentanyl transdermal therapeutic system (TTS). We investigated the possibility of avoiding this titration phase by immediate fentanyl TTS therapy in patients with uncontrolled cancer pain. Dose finding was performed by direct titration of fentanyl TTS according to clinical necessity on a day-to-day basis. Morphine solution for rescue medication was available. Short-term follow-up was 28 days, and 20 patients (10 in- and 10 outpatients) were evaluable. On the average, sufficient pain control [visual analogue scale (VAS) 〈35 mm] was reached within 48 h of the start of fentanyl TTS. The mean VAS values before and during fentanyl TTS therapy were 53 mm (before), 27 mm (week 1), 21 mm (week 2), 18 mm (week 3) and 21 mm (week 4). There were statistically significant lower VAS values at all follow-up times compared to pretreatment values (e.g. pretreatment to day 1:P=0.019; pretreatment to day 28:P=0.002, Wilcoxon sign-rank test). The mean fentanyl TTS doses were 70 μg/h (week 1), 98 μg/h (week 2), 107 μg/h (week 3) and 116 μg/h (week 4). The differences of mean fentanyl TTS doses were significantly different between days 1 and 7 (P〈0.001) and between days 8 and 14 (P=0.006), but not between days 15 and 21 and days 22 and 28. Mean morphine doses as rescue medication were steadily decreasing from 11 mg/day in week 1 to 3 mg/day in week 4 of treatment, but no statistically significant differences between these amounts could be found. Our results indicate that the titration phase with a short-acting narcotic prior to the conversion to fentanyl TTS is not necessary. Fentanyl TTS can be titrated safely and effectively on a day-to-day basis according to clinical necessity if the patients are well monitored, thus simplifying pain therapy with fentanyl TTS.
    Type of Medium: Electronic Resource
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  • 9
    ISSN: 1432-1440
    Keywords: Idiopathic hypereosinophilic syndrome ; Cardiomyopathy ; Capillary endothelial cell ; Echocardiography ; Vitamin B12-binding proteins (transcobalamin I/III) ; Prednisone therapy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary A female patient is described in whom the diagnosis of idiopathic hypereosinophilic syndrome (HES) with heart disease and peripheral neuropathy was made at the age of 32 years. Although prednisone induced a prompt and longstanding complete hematological remission, progressive and eventually intractable heart failure developed, and the patient died 6 years later. Endomyocardial biopsy at diagnosis showed infiltration with intact and disintegrated eosinophils and Charcot-Leyden crystals. Echocardiographic follow-up (including Doppler-Echocardiography) revealed mitral regurgitation with thickening and impaired motility of the posterior mitral leaflet, as well as progressive dilated cardiomyopathy. At autopsy, a diffuse interstitial fibrosis with patchy prominence in an eccentric hypertrophic and highly dilated heart was found. There were no significant endocardial thickening and no mural thrombi. In contrast to the findings of the initial endomyocardial biopsy, autopsy revealed no eosinophilic infiltrate. In this case, eosinophil-induced heart disease manifested as dilated cardiomyopathy, without endocardial fibrosis as originally described by Löffler. We speculate, that eosinophils have been deposited predominantly in the myocard at an early stage of disease, and — activated locally — secreted their granule proteins producing an initial damage to capillary endothelial cells and myocytes. After prednisone-induced clearance of eosinophils from blood and tissues, progressive, self-perpetuating interstitial fibrosis of the myocard and loss of myocytes eventually resulted in end-stage dilated cardiomyopathy.
    Type of Medium: Electronic Resource
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  • 10
    ISSN: 1569-8041
    Keywords: camptothecin analogue ; phase II ; second-line treatment ; small-cell lung cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:GI147211, a 10,11-ethylenedioxy substituted analogueof camptothecin (CPT), was brought into clinical development because of itshigher water solubility and greater potency as compared to topotecan (TPT).The antitumor activity of GI147211 as second-line therapy in small-cell lungcancer (SCLC) was assessed after stratification of patients in refractory (noresponse to initial treatment or relapse within three months from last cycle)and chemosensitive (relapse more than three months from last cycle). Patients and methods:Sixty-seven patients were entered in thestudy and sixty-two were evaluable for response, twenty-eight in therefractory and thirty-four in the chemosensitive group. All patients hadreceived 1 line of chemotherapy; radiation had also been given in 29 cases,6 in the refractory and 23 in the chemosensitive group. GI147211 wasadministered at 1.2 mg/m2/day as 30-min infusion for fiveconsecutive days every three weeks. Results:The overall response rate was 16.6% (11 of 66patients; 95% confidence interval (95% CI):8.5%–27.5%), 10.3% (3 of 29 patients; 95%CI: 2.2%–27%) in the refractory and 21.1% (8 of 37patients; 95% CI: 9.5%–37%) in the chemosensitivegroup. Only partial responses (PR) were observed with a median duration of PRof 4.8 months (5.7 months in the refractory and 5.2 in the chemosensitivegroup). Hematological toxicity consisted mainly of neutropenia (grades3–4 in 25% of cycles) and thrombocytopenia (grades 3–4 in23% of cycles); non-hematological toxicity was mild to moderate andconsisted of nausea (22% of cycles), vomiting (11%), malaise(34%). Conclusions:At the dose and schedule tested GI147211 is an activenew agent for second-line treatment of SCLC; the antitumor activity andtoxicity profile are comparable to those observed with TPT which remains theleading CPT analogue for salvage treatment. Interest has been renewed in theclinical development of GI147211 by preclinical data with the liposomalformulation showing an increased therapeutic index.
    Type of Medium: Electronic Resource
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