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Regimens, such as paclitaxel, vinorelbine or gemcitabine 17 ; . Single-agent paclitaxel has been reported to give an overall response rate of 2638% Table 3 ; 15 ; . The therapeutic activity of paclitaxel comes through a disruption in the tubulin-microtubular system 18 ; . It binds reversibly and specifically to the -subunit of tubulin, promoting its assembly and stabilizing the microtubules after spindle formation has occurred. These compounds induce the formation of stable microtubule bundles, impairing reorganization of the microtubular skeleton and blocking the cells in the G2-M phase of the cell cycle 1 ; . In 1989, the first study of the administration of paclitaxel to patients with ovarian cancer was reported and soon several reports followed with encouraging results, which led to the approval of paclitaxel in many countries for treating recurrent or metastatic ovarian and breast cancer 8 ; . In 1991, Holmes et al. reported a response rate of 56% 12% complete response, 44% partial response ; with a 9 month duration of response in patients with metastatic breast cancer, which attracted attention to the use of paclitaxel in this disease 19 ; . Paclitaxel causes several treatment-related adverse reactions. Hypersensitivity, neutropenia and thrombocytopenia were common, but could be minimized by moderate dosage with 3 h infusion 8, 11 ; . Furthermore, utilizing a moderate dosage also prevented possible cumulative adverse reactions, such as neuromuscular toxicities and the appearance of hand foot syndrome 20 ; . Fixed doses of paclitaxel of 175 mg m2 were given as our standard treatment and resulted in only 24% grade III bone marrow suppression and 16% grade IIIII hepatotoxicity Table 4 ; . Attention had always been paid to the issue of bone metastases, which appeared in 80% of patients with metastatic breast cancers, and this disease entity usually caused pain and local bone destruction 21 ; . Hortobagyi et al. indicated that cytotoxic chemotherapy played a major role in treatment of metastatic breast cancer patients with bone metastases 22 ; . Concerning the responses for visceral organs and soft tissues, based on our experience on utilizing paclitaxel with metastatic breast cancer patients, we found that patients with lymph node involvement 2 ; were much more sensitive to paclitaxel than patients with lung or liver metastases.
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If one forgets temporarily about data values, and one accepts the duality of present absent signals mapped to true false values, then there is a natural interpretation of synchronous formalisms as synchronous digital circuits at schematic gate level, or "netlists" roughly RTL level with only Boolean variables and registers ; . In turn, such circuits have a straightforward behavioral expansion into Mealy FSMs. The two slight restrictions above are not essential: the adjunction of types and values into digital circuit models has been successfully attempted in a number of contexts, and S R systems can also be seen as contributing to this goal. Meanwhile, the introduction of clocks and presence absence signal status in S R languages departs drastically from the prominent notion of sensitivity list generally used to define the simulation semantics of Hardware Description Languages HDLs ; . We now comment on the opportunities made available through the interpretation of S R systems into Mealy machines or netlists. netlists: we consider here a simple form, as Boolean equation systems defining the values of wires and Boolean registers as a Boolean function of other wires and previous register values. Some wires represent input and output signals with value true indicating signal presence ; , others are internal variables. This type of representation is of special interest because it can provide exact dependency relations between variables, and thus the good representation level to study causality issues with accurate analysis. Notions of "constructive" causality have been the subject of much attention here. They attempt to refine the usual crude criterion for synthesizability, which forbids cyclic dependencies between non-register variables so that a variable seems to depend upon itself in the same instant ; , but does not take into account the Boolean interpretation while it has been established nor the potentially reachable configurations. Consider the equation that is the constant true. Then does not really depend on , since its constant ; value is forced by 's. Constructive causality seeks for the best possible faithful notion of true combinatorial dependency taking the Boolean interpretation of functions into account. For details, see [52]. Another equally important aspect of the mathematical model is that a number of combinatorial and sequential optimization techniques have been developed over the years, in the context of hardware synthesis approaches. The main ones are now embedded in the SIS and MVSIS optimization suites, from UC Berkeley [50, 30]. They come as a great help in allowing programs written in high-level S R formalisms to compile into efficient code, either software or hardware-targeted [51]. Mealy machines: Mealy machines are finite-state automata corresponding strictly to the synchronous assumption. In a given state, provided a certain input valuation a subset of present signals ; , the machine reacts by immediately 3.
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Oncology, Hoffmann-La Roche Inc., Nutley, NJ, U.S.A. of Humoral Immunology, German Rheumatism Research Center.
Marks LB, Garst J, Socinski MA, Sibley G, Blackstock AW, Herndon JE, Zhou S, Shafman T, Tisch A, Clough R, Yu X, Turrisi A, Anscher M, Crawford J, Rosenman J. Carboplatin Paclitaxel or Carboplatin Vinorelbine Followed by Accelerated Hyperfractionated Conformal Radiation Therapy: Report of a Prospective Phase I Dose Escalation Trial From the Carolina Conformal Therapy Consortium, 4329 Marks R, see Shanafelt TD Marlin S, see Reyno L Maroun J, see Benson AB III see Figueredo A Marques R, see Michalkiewicz E Marra P, see Izzo F Marsden JR, see Hancock BW Marshall B, see Atkins MB Marshall GD Jr, see Raut CP Marsiglia H, see Andre F Martelli M, see Zinzani PL Martenson JA, see Gunderson LL Martenson JA Jr, see Benson AB III Martenson JA Jr, Willett CG, Sargent DJ, Mailliard JA, Donohue JH, Gunderson LL, Thomas CR Jr, Fisher B, Benson AB III, Myerson R, Goldberg RM. Phase III Study of Adjuvant Chemotherapy and Radiation Therapy Compared With Chemotherapy Alone in the Surgical Adjuvant Treatment of Colon Cancer: Results of Intergroup Protocol 0130, 3277 Marth C, see Fiegl M Martin C, see Yovine A Martinelli V, see Picardi M Martinez R, see Montalban C Martin G, see Hebert-Croteau N Martin H, see Kiehl MG Martini C, see Caraceni A Martin M, see Colomer R Martin M, see Alba E Martino R, see Lukaschek J Martino S, see Citron ML see Perez EA Marvin V, see Stebbing J Marx A, see Gautschi O see Strobel P Mary-Krause M, Herida M, Costagliola D, Lavole A, Cadranel J. In Reply correspondence ; , 1349 Marymount M, see Campbell AD Massimo L, see Caprino D Massoner A, see Fiegl M Mastrangelo MJ, see Berd D Matakidou A, see Popat S Matejic D, see Steiner HH Materman E, see Raymond E Mather SJ, see Davies AJ Mathew P, Thall PF, Jones D, Perez C, Bucana C, Troncoso P, Kim S-J, Fidler IJ, Logothetis C. Platelet-Derived Growth Factor Receptor Inhibitor Imatinib Mesylate and Docetaxel: A Modular Phase I Trial in Androgen-Independent Prostate Cancer, 3323 Mathews R, see Roberts SS Mathews V, see Hoerr AL Mathias C, see Bruera E Matloff E, see Rebbeck TR Matsubara N, see Nagasaka T Matsui K, see Kubota K Matsukura S, see Nakajima H Matsuo K, see Hotta K Matthay KK, see DuBois SG Matthews B, see Ballen KK Mattke AC, see Schuck A.
Fat mass did not fall significantly during the first 12 weeks of the study P 0.07 ; but was significantly reduced compared with baseline at 24 weeks of GH therapy P 0.02 vs. baseline ; . This reduction was maintained at 36 weeks P 0.02 vs. baseline, P 0.11 vs. 24 weeks ; Table 1 ; . Trunk fat mass decreased significantly at week 24 P 0.02 vs. baseline ; , a change that was maintained at week 36 P 0.02 vs. baseline; P 0.17 vs. week 24 ; Table 1 and viracept.
Witnesses issue, the appellate court explained: Petitioner claims that the witnesses' testimony would have clarified where he was arrested. Petitioner does not establish how this purported testimony would have helped his defense. Moreover, he does not provide declarations from the witnesses as to what they would have testified. Id. For these reasons, the appellate court denied Petitioner his Id. Ex. B at 2.
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Adjuvant Chemotherapy for NonSmall-Cell Lung Cancer -- The Smoke Clears [Pisters] 352 25 ; : 2640-e; [Winton & others] 352 25 ; : 2589-oa Vinorelbine plus Cisplatin vs. Observation in Resected Non Small-Cell Lung Cancer [Winton & others] 352 25 ; : 2589-oa; [Pisters] 352 25 ; : 2640-e and viread.
These include taxol® paclitaxel ; , taxotere, navelbine® vinorelbine ; , gemzar® gemcitabine ; , and camptosar® irinotecan.
50 patients. Reasons for treatment discontinuation were one toxic death, one early death due to progression of disease, 8 non fatal toxicity, 10 progression of disease and one patient refusal. G-CSF support was required in 72 cycles of chemotherapy 22.6% ; . The planned dose intensity of vinorelbine was 20 mg m2 wk and the median dose actually delivered was 15.7 mg m2 wk; therefore the relative dose intensity was 0.79. The planned dose intensity of trastuzumab was 2 mg kg wk and the median dose actually delivered was 1.84 mg kg wk with a relative dose intensity of 0.9. Hematological and non-hematological toxicities are reported in table 2. Grade 34 neutropenia occurred in almost the half of patients 46% ; and 4 patients developed febrile neutropenia. Grade 4 anemia and thrombocytopenia were never observed. The most common non-hematological toxicities were fatigue, constipation and abdominal pain. A toxic death was observed after the first cycle of chemotherapy, due to acute renal failure in a patient with bone metastases who was concomitantly treated with pamidronate. One patient without liver metastases developed grade 3 liver toxicity after the fifth cycle of chemotherapy due to a re-exacerbation of HCV-related hepatitis. Patients were strictly monitored with frequent evaluation of LVEF and a treatment related cardiac event was recognized in four patients. During the period of combined treatment there were three cases of LVEF decline. The first patient presented with tachycardia and an echocardiogram showed a reduction of resting LVEF 20% from baseline value grade 2 according to NCI-CTC ; after the third cycle; she had hypertension and retro-sternal goitre with hyperthyroidism as comorbidity and had received adjuvant epirubicin total dose 480 mg m2 the LVEF reduction was persistent for at least 9 months after treatment. The second event was an asymptomatic grade 2 decline of LVEF after the third cycle, that was persistent three weeks after interruption of treatment; this patient, who had been treated with adjuvant epirubicin for a total dose of 400 mg m2, developed brain metastases and died four months later. The third cardiac event was a grade 1 asymptomatic decline of LVEF after three cycles, in a patient who had not received previous anthracyclines; this patient was taken off from the study because of concomitant grade 2 liver toxicity. One more event of grade 1 LVEF decline was reported in a patient after 50 overall cycles of trastuzumab, with LVEF declining from 80%, at baseline, to 66 and vistaril.
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Correctional systems of all sizes need to consider their current state of preparedness for pandemic influenza and other similar catastrophes. It is difficult to fully prepare for the worst and few, if any, correctional facilities can adequately plan to meet the challenges of a pandemic of influenza without substantial coordination with local health authorities. However, by outlining some of the problems correctional facilities will likely face during an outbreak we hope to help administrators of jails and prisons to begin to consider how they would function during such a catastrophe. The specter of pandemic influenza is one that is almost too horrific to imagine; however, now, on the cusp of winter, is the perfect time for correctional facility health and custody leaders to assess how well-prepared the facility is to deal with such an outbreak - remembering, it is not a question of if, but when.
This phase ii trial evaluated biweekly gemcitabine and vinorelbine in nsclc patients who have had one prior chemotherapeutic regimen and have had disease progression and vivelle.
The council of the association, at a meeting duly convened on may 2, 2003 approved the following administrative drug schedule amendments recommended by the national drug scheduling advisory committee.
Outlook Aponetics has set unprecedented industry standards for rapid and accurate cancer drug selection. In less than 2 years, five proprietary chemical classes have been successfully pushed from screening to preclinical testing which has already yielded a number of compounds with striking activity anti-cancer in mouse models. Aponetics' vision is to continue producing a constant flow of 3-5 cancer leads per annum. Aponetics is focussing on cancer, knowing that its technology has a much wider application e.g. in auto-immune, neuro-degenerative and cardio-vascular diseases. Aponetics is already and will increasingly be an attractive partner for codevelopment of drugs in the cancer area as well as for collaborations in other target areas where apoptosis plays an important role and voriconazole.
Of squalamine and cisplatin reduced the number of vessels approximately 25% Figs. 6 and 7 ; . This reduction was observed as early as 2 h after squalamine-plus-cisplatin treatment, lasted for 24 h, and had dissipated by 48 h Fig. 6 ; . By contrast, no difference in the number of CD31 staining vessels was observed with squalamine and vinorelbine at any time after chemotherapy treatment data not shown ; . At 4 h, tumors treated with vinorelbine had 111% of control CD31-staining vessels, whereas vinorelbine plus squalamine had 108.
Further large well-conducted RCTs are required to investigate the use of vinorelbine in the settings for which it is currently indicated as first- or secondline or later treatment in ABC following failure of an anthracycline-containing regimen ; . Such trials should pay particular attention to the research question whether they are trying to demonstrate a difference or equivalence ; and include sufficient numbers of participants to answer the research question. Randomisation procedures including allocation concealment ; should be adequate and clearly reported, as should the duration of the treatment. Outcome assessments should be blind where possible. Baseline characteristics of participants should be reported including data on distribution ; , and any discrepancies should be controlled for in the analysis. All outcomes should be clearly presented not just as percentages ; and measures of variance given where appropriate. All withdrawals from the trial should be clearly reported and handling of missing data should be explicit. In trials trying to demonstrate a difference, an ITT analysis should always be undertaken ideally. Outcomes assessed should include alleviation of symptoms and pain. The number of people in the control group who received the treatment under investigation due to disease progression should also be clearly reported. When reporting survival data, HRs should be presented. The most relevant comparators for RCTs of vinorelbine used as second- or third-line therapy would be CMF if not given before ; , oxaliplatin, mitomycin C, antimetabolites or gemcitabine. Possible comparators for vinorelbine used as firstline therapy for MBC would include capecitabine or taxotere and vortex.
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Or radiosurgery have been developed more recently but the precise indications for their optimal use remain to be defined by prospective randomised trials [5-7] Chemotherapy constitutes the principal approach to the treatment of disseminated NSCLC [8-10] and the combination of cisplatin and vinorelbine is one of the most active schedules [11, 12]. The difficulty experienced in penetrating the blood-brain barrier with cytotoxic drugs has meant that this approach has generally been viewed as ineffective for the treatment of brain metastases, however, several studies have demonstrated that chemotherapy can produce regression of intracranial secondaries [13-16] and this has been repeatedly noted in patients with NSCLC [17-19] The explanation for this unexpected activity is thought to relate to physical disruption of the blood-brain barrier during growth of metastatic lesions on the surface of the brain. Additional evidence of efficacy and increase in the local response rate has been obtained from studies of concomitant radiotherapy and chemotherapy with positive results obtained using cisplatin-mitomycin-vindesine [20], carboplatinteniposide [21] or carboplatin alone [22]. The increase in response rate has resulted in improved survival. We wished to compare two treatment schedules both combining chemotherapy and radiotherapy for the management of NSCLC with cerebral metastases. The standard treatment in our study consisted of chemotherapy alone as initial treatment given for a minimum of two cycles unless progression occurred ; followed by cranial irradiation. The choice of radiotherapy schedule 30 gray Gy ; in 10 fractions over 12 days ; was made on the basis of the results of randomised trials in particular that of RTOG [23, 24] which reported equivalent efficacy for 40 Gy in four weeks, 30 Gy in two weeks and 20 Gy in one week both in respect of relief of neurological symptoms and survival. The sequential approach in which chemotherapy was followed by cranial irradiation was designed to permit control of the systemic manifestations of the tumour while allowing use of cranial irradiation in case of failure to control cerebral lesions The experimental arm of the study involved the use of identical chemotherapy with a combination of cisplatin and vinorelbine but with cranial irradiation starting as soon as the chemotherapy was initiated. This approach was justified by the hypothesis that cerebral metastases might progress swiftly and require the control provided by early use of radiotherapy. We here report the results of this multicenter prospective randomised trial which sought to establish the optimal timing of cranial irradiation. The object of this trial was to compare early with late cranial irradiation in patients presenting with NSCLC with one or more inoperable brain metastases also treated with chemotherapy; the analysis was undertaken in the context of known prognostic factors [25, 26]. Patients and methods and vinorelbine.
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Non-small cell lung cancer NSCLC ; frequently occurs in more than 50% of patients aged over 65 years, and in 30% of patients aged 70 or more 1 ; . For patients with advanced NSCLC, cisplatin based chemotherapy can improve survival and quality of life when compared with best supportive care, but it has been demonstrated only in cisplatin-containing regimens 2 ; . However, the inclusion criteria of these studies only selected patients aged under 70 with a good performance status. Most of the elderly patients had comorbidities and reduction in functional reserve that might be unsuitable for cisplatin-based chemotherapy 3 ; . Based on these clinical findings in elderly patients, single agent chemotherapy was the first investigative approach 4 ; . Vinorelbine is a semisynthetic compound of the vinca alkaloid group that inhibits mitosis by targeting microtubules and thus blocks the spindle and vytorin.
Background Iressa ZD-1839 ; is an oral epidermal growth factor receptor-tyrosine kinase inhibitor in phase III clinical trials for non-small cell lung cancer in combination with currently available chemotherapy agents. The Technology Iressa ZD-1839 ; AstraZeneca, is an oral epidermal growth factor EGF ; receptor-tyrosine kinase inhibitor in phase III clinical trials. It is intended for use in good performance status patients with nonsmall cell lung cancer nsclc ; in combination with chemotherapy. AstraZeneca anticipate submitting for a licence for Iressa during Q2 2002, with launch early 2003. They also anticipate extending the licence to other solid tumours. It is likely to be administered as an oral tablet 250-500mg once daily. Patient group The incidence of lung cancer for 1997 in England and Wales was 65 per 100, 000 population, a total of 33, 300 cases. Lung cancer has a 1-year survival rate of 20% and a 5-year survival rate of 5%. It is estimated that nsclc accounts for 80% of all lung cancers 26, 600 patients ; , of these, 85% 22, 600 ; will have advanced disease not suitable for curative surgery1. It is estimated that between 5% and 20% of all patients with nsclc receive chemotherapy 1, 300 4, patients ; . Current treatment and alternatives Treatment options for nsclc include a combination of chemotherapy, radiotherapy and surgery. Common drugs used in chemotherapy for nsclc include cisplatin, carboplatin, docetaxol, paclitaxel, gemcitabine and vinorelbine. A recent HTA report and related NICE guidance looked at the clinical and cost-effectiveness of the use of docetaxol, paclitaxel, gemcitabine and vinorelbine in nsclc2. NICE recommended chemotherapy gemcitabine, paclitaxel and vinorelbine in combination ; as the first-line therapy for those patients who are unsuitable for, or unlikely to respond to, curative treatment. Docetaxol is recommended as the second-line treatment for patients who have relapsed after prior therapy. Cost The cost of Iressa is not known at this time, although it is likely to be an expensive addition to current therapy. The recent NICE report1 estimated the additional cost of patients switching to a combination of platinum based drugs with one or more new chemotherapy agents at approximately 2900 per patient1. As Iressa would be used in adjunct to these chemotherapy agents and may need to be continued for the patients remaining life the cost per patient would be additional.
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One of Northern Europe's major collections of Neolithic fishing gear, including a large number and variety of organic and stone artefacts relating to fishing nets, comes from the wetland site of Srnate, on the west coast of the Kurzeme Peninsula, Latvia. This collection at the Latvian History Museum, recovered in the course of excavations directed by Eduards Sturms 1938-40 ; and Lcija Vankina 1949, 1953-9 ; and concisely treated in a monograph by Vankina 1970 ; , has now been studied comprehensively, in order to obtain a clearer picture of net fishing technology. The artefacts are classified into functional groups. However, the Srnate material is not culturally homogeneous, deriving from a large number of separate dwellings with Comb Ware, Early and Late Srnate Ware, representing successive phases of occupation Brzis 2003 ; and thus also revealing the development of fishing practices and abraxane.
The opinions expressed in this editorial are not necessarily those of the editors or of the American Heart Association. From the Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, Calif. Dr Teirstein is a consultant for and receives research grants from several manufacturers of products designed to reduce restenosis; he also receives royalties from the sale of radiation delivery catheters. Correspondence to Paul S. Teirstein, MD, Division of Cardiovascular Diseases, Scripps Clinic, 10666 North Torrey Pines Road, La Jolla, CA 92037. E-mail Radman scrippsclinic Circulation 2001; 104: 1996-1998. ; 2001 American Heart Association, Inc. Circulation is available at : circulationaha and viracept.
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