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Mdi965 36.38

Annals of Oncology 16 (Supplement 8) viii36–viii38, 2005 3rd International Ovarian Cancer Consensus Conference:outstanding issues for future consideration G. Stuart1, E. Avall-Lundqvist2, A. du Bois3, M. Bookman4, D. Bowtell5, M. Brady4, A. Casado6,A. Cervantes7, E. Eisenhauer1, M. Friedlaender5, K. Fujiwara8, S. Grenman2, J. P. Guastalla9,P. Harper10, T. Hogberg2, S. Kaye11, H. Kitchener10, G. Kristensen2, R. Mannel4, W. Meier3,B. Miller12, A. Oza1, R. Ozols4, M. Parmar10, J. Pfisterer3, A. Poveda7, D. Provencher1,E. Pujade-Lauraine9, M. Quinn5, M. Randall4, J. Rochon3, G. Rustin10, S. Sagae8, F. Stehman4,E. Trimble13, T. Thigpen4, P. Vasey11, I. Vergote6, R. Verheijen6, J. Vermorken6 & U. Wagner3 1NCIC-CTG (Canada); 2NSGO (Scandinavia); 3AGO-OVAR (Germany); 4GOG (USA); 5ANZGOG (Australia–New Zealand); 6EORTC (Europe); 7GEICO (Spain);8JGOG (Japan); 9GINECO (France); 10MRC/NCRI (UK); 11SGCTG (Scotland, UK); 12RTOG (USA); 13NCI-US The process of consensus reflects an agreement upon one or cooperative group and a timeframe for action. It is expected that more statements about a topic at a particular point in time. Sub- these items would be completed before a subsequent Conference.
sequent to that time, the level of consensus and the nature of The second component of this manuscript will seek to collate consensus may change. In this context, it is noted that this those new questions that emanated from this Conference and requires a dynamic process to remain current. The first Consen- may be considered for future consensus statements. This is best sus Workshop on Ovarian Cancer was held in 1993 and the considered in the context of a cancer control model.
second in 1998. There has been a period of some 6 years sincethe last event. It is anticipated that as knowledge about ovarian cancer evolves, so will the need to realign consensus statementsabout the management of the disease process.
This topic was recognized as an area of intense interest during It is also acknowledged that any such process is unlikely to this Conference. This included the concept of identification of satisfactorily address all aspects of knowledge about the man- risk through molecular markers as well as the need for techno- agement of ovarian cancer. The 3rd International Ovarian Can- logical and genetic imaging techniques for early detection. The cer Consensus Conference (OCCC) successfully focused on ability to conduct rapid proteomics screening for the purposes aspects of treatment relevant to the conduct of clinical trials.
of early diagnosis is viewed as a critical issue for subsequent Although this was intended and appropriate, it was noted that this precluded appropriate consideration of the research andclinical elements of etiology, prevention, screening, early de-tection, diagnosis, supportive care and palliative care for those persons affected by ovarian cancer. Therefore, the framework There is a need to conduct randomized prospective trials to for any subsequent conferences will have to consider these areas validate biologic markers of disease and the impact on out- and define the scope of the process.
comes. This includes both known subpopulations at significant Thus, this manuscript will first summarize those specific hereditary risk as well as less well-known groups. Molecular questions that were generated through this OCCC which require profiling through increased utilization of cooperative tumor further action before the next Conference. Secondly, there will banks has generated a considerable body of knowledge, but it be an identification of those new questions that emanated from is still not clear whether this is able to correlate with improved this OCCC and may be considered for future consensus state- outcomes. Although much is known about the conventional his- ments. Thirdly, there is a proposed agenda for a subsequent topathology of ovarian cancer, the specific entity of micropapil- Conference subject to the ongoing changes in knowledge and lary ovarian tumors will require further study.
practice. Finally, there is a brief discussion as to how this andearlier consensus workshops have affected current practice.
First, during the course of the OCCC it was recognized that there were a number of critical issues in the management ofwomen with ovarian carcinoma that could and should be Undoubtedly, the definition of end points in clinical trials that addressed prior to any subsequent consensus process. These pro- produce conclusions in a definitive but timely manner will re- posed steps reflect discussion in the plenary sessions about spe- main of great interest. This is particularly relevant if one con- cific questions. These steps are summarized in tabular format siders prevention, diagnostic and maintenance trials where (Table 1). These items are identified with a specific responsible traditional end points may not suffice. Even in therapeutic trials, Ó 2005 European Society for Medical Oncology Table 1. Summary of proposed action steps To undertake a systematic review of ovarian cancer treatment trials to assess shifts in progression-free relative to overall survival To confirm definition of terminology in ovarian cancer treatment trials To conduct a literature review of patient perception of preferencesfor outcomes To review the characteristics of long-term survivors (i.e. >5 years) of prior ovarian cancer trials in advanced ovarian cancer To conduct a meta-analysis of actual carboplatin dose using appropriate trials To establish a ‘bank’ of questions for consideration at next Ovarian Cancer To establish a GCIG Working Group on the levels of evidence required to change the standard arm of clinical trials To provide a ddefinition and a validation tool of symptom control as a trial To conduct a meta-analysis of outcomes in the subset of clear cell and To identify the ‘new’ standard radiation therapy regimen for the treatment of women with advanced epithelial ovarian cancer To define the role of PET scanning in future ovarian cancer clinical trials stabilization of disease and control of symptoms could be con- directly, but also for more effective accrual into phase II and sidered as desirable primary outcomes for specific interventions It is very positive that outcomes in the population of women The present OCCC did not intend to evaluate the role of surgery with ovarian cancer have improved in the past few decades.
in the management of women with ovarian cancer. Yet, signif- However, this has created a number of new issues that require icant questions remain about the timing and extent of primary consideration. It is possible that much is to be learned from cytoreductive surgery and the specific role of secondary cytor- profiling those women who have long-term survivals following eductive surgery. It is still not clear how best to apply detailed a diagnosis of ovarian cancer to better understand the disease.
molecular pathology data including drug resistance/prognostic Furthermore, there are numerous issues to be considered factors/molecular genetics to intelligently inform molecular tar- amongst this population including quality of life, risk of second geted therapy amongst women with a diagnosis of ovarian can- malignancies and next generation risk analysis.
cer. There is increasing clinical adoption of neo-adjuvanttherapy regimens without the supporting high quality evidence.
This requires evaluation in a randomized trial setting. It is also apparent that there remains an asymmetry between availabledata, inferred knowledge and subsequent practice in the appli- In addition to the clinical issues there are a number of related cation of both dose-dense therapies and alternative administra- issues that must be given future consideration in the manage- ment of women with a diagnosis of ovarian cancer and theconduct of clinical trials. This includes regulatory issues withinthe Food and Drug Administration USA, pharmacoeconomic issues and the broader economic analysis. The need to harmo-nize regulatory issues around tumor banks is evident.
The scheduling and nature of regular follow-up after completionof primary therapy for ovarian cancer has not been objectivelydetermined. The duration of surveillance has been affected by therapies unable to allow long-term survivals. Furthermore,there is significant consideration about the establishment of With the rapid accumulation of new knowledge, the answers to standard second-line therapy regimens for those women who many of these questions may quickly become apparent. Other develop recurrent disease. This would impact front-line trials areas may remain unresolved until after a subsequent workshop.
The third area for consideration is to identify those questions cooperative clinical trials group. In aggregate form, these trials and issues that are anticipated to be of high priority at subse- and others have confirmed the role of a platinum compound with quent workshops and thus, provide a framework for an agenda.
a taxane as standard therapy for women with ovarian cancer, This futuristic consideration must allow for significant shifts recognized the option of single-agent carboplatin as a standard in the knowledge about ovarian cancer. However, it expected therapy and demonstrated the lack of benefit of an anthracycline that subsequent workshops will still wish to consider four spe- to the above-mentioned regimens [2–6]. This may be viewed as a marker of positive impact on the global consensus process.
However, it is important that future consensus workshops have 1. Early diagnosis. The benefit of early diagnosis has been included a process of evaluation in order to effectively measure identified but the specific mechanism to do so remains sub- the impact of this process on the burden of ovarian cancer.
ject to investigation. This will include consideration of the Additionally, in considering the consensus process, it is ap- role of proteomics as well as molecular markers. There parent that the generation of new data so frequently presented in should also be an assessment of the role of diagnostic imag- the setting of publications and/or meetings does not necessarily ing including PET scanning in women with ovarian cancer.
lead to better information. Furthermore, it is even less often that 2. First-line therapies. This will likely remain as a focus of better information promotes new knowledge or practices. As interest over the next decade and require ongoing review.
new data become available, they must be considered in the This should include a consideration of the role of optimal context of how this might be effectively adopted into practice.
radiation therapy both in first-line and salvage therapy.
Future international consensus workshops on the treatment of 3. Maintenance/consolidation. The question will likely remain women with ovarian cancer should consider the impact of pre- as to whether one should consider novel therapies in this vious workshops on the outcome of women affected by ovarian regard and what should the valid end points be in this setting.
cancer. The relevant questions must be derived from a direct 4. Post-recurrence/progression therapy. This area will undoubt- correlation of the issues with the desired outcomes and an edly remain as a major issue. The question should consider opportunity created for discussion and consensus.
treatment selection (as relates to prediction of responseand resistance), appropriate surgery, measures of symptomcontrol/quality of life, survivorship, end points. The issue of whether there should be a standard protocol for women with 1. Heintz APM, Odicino F, Maisonneuve P et al. Carcinoma of the Ovary.
progressive disease after first-line therapy merits consideration.
Volume 25 of the FIGO Annual Report on the Results of Treatment in The final area to be addressed is the impact that this and earlier Gynecologic Cancer. Int J Gynecol Obstet 2003; 83 (Suppl 1): 135–156.
consensus workshops have had on current practice. Although 2. Piccart MJ, Bertelsen K, James K et al. Randomized intergroup trial of this issue is important to understand, it is one that is very diffi- cisplatin–paclitaxel versus cisplatincyclophosphamide in women with advanced epithelial ovarian cancer: three year results. J Natl Cancer Inst cult to quantify. If the intent is to influence the standard of practice, then one could consider that the shifts in 5-year sur- 3. McGuire WP, Hoskins WJ, Brady MF et al. Cyclophosphamide and vival rates as documented by FIGO are markers of this impact.
cisplatin compared with paclitaxel and cisplatin in patients with stage During the period from 1988–2003, the 5-year survival rate for III and stage IV ovarian cancer. N Engl J Med 1996; 334: 1–6.
women diagnosed with stage III ovarian cancer has increased 4. International Collaborative Ovarian Neoplasm Group. Paclitaxel plus from 22.9% to a high of 49.2% (range 28.9% to 49.2%) [1].
carboplatin versus standard chemotherapy with either single-agent Although numerically modest, this is a significant gain at carboplatin or cyclophosphamide, doxorubicin and cisplatin in women a global level. However, there are multiple confounding factors with ovarian cancer: the ICON3 randomized trial. Lancet 2002; 360: in this correlation that may consider the relationship only as coincidental. If the intent of the consensus process is to provide 5. du Bois A, Combe M, Rochon J et al. Epirubicin/paclitaxel/carboplatin support to the effective conduct of clinical trials, then the impact (TEC) vs paclitaxel/carboplatin (TC) in first-line treatment of ovarian cancer (OC) FIGO stages IIB–IV. An AGO-GINECO Intergroup phase may be evaluated by a record of successful completion of in- III trial. J Clin Oncol 2004; 22 (Suppl 14): (Abstr 5007).
ternational phase III trials in the population of women with 6. Kristensen GB, Vergote I, Eisenhaeur E et al. First line treatment of a diagnosis of ovarian cancer. This is more readily quantified ovarian/tubal/peritoneal cancer FIGO stage IIB–IV with paclitaxel/ as since the previous consensus conference, there have been at carboplatin with or wihout epirubicin (TEC vs TC). A Gynecologic least four randomized clinical trials completed assessing the Cancer Intergroup study of NSGO, EORTC GCG and NCIC CTG.
first-line treatment of women with a diagnosis of advanced ovar- Results on progression free survival. J Clin Oncol 2004; 22 (Suppl 14): ian cancer that include accrual from more than one national


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