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QTc prolongation assessment in the development of anticancer medication: clinical and methodological aspects
G. Curigliano, g. Spitaleri, f. de Braud, Cardinal d., c. Onion, m. Craig, Colombo n., a. Colombo, m. Locatelli, r. Goldhirsch
Cardiac safety Assessments are commonly used in the development of investigational drugs of Clinical Oncology. In the development of anticancer medication were always more consideration to the potential of a compound of causing adverse elettrocardiografici changes, especially QT interval prolongation, that can be associated with risk for and torsades de he exhibited sudden death. Regardless of overt clinical toxicity, potentially QTc evaluation might influence the decision-making at many levels during clinical studies, including the eligibility for therapy protocol, delivery of dose or suspension and analysis of the optimal dose for subsequent development. Given the potential for serious and irreversible morbidity from adverse cardiac events, it is understandable that cardiac safety results may have broad impact on the management of conduct and patient study. The risk management methodologies of QTc prolongation for cardiac medications were developed from experience primarily of drugs used to treat diseases not fatal in a chronic setting or Antihistamines such as antibiotics. Extrapolation of these approaches to medicines to treat cancer for a period of acute may not be appropriate. Some specific guidelines is available for managing the risk of cardiac safety in the development and use of oncology drugs. In this manuscript, clinical and methodological aspects related QTc prolongation assessment will be reviewed. Discussions about the limitations being that design and development of oncology drugs will be highlighted.Efforts are needed to refine strategies for risk management, avoiding unintended consequences that negatively affect access patient and clinical development of promising new cancer treatments. a thoughtful risk management plan generated by organized collaboration between oncologists, cardiologists and regulatory agencies in support of an essential development program for oncology agents with heart problems.
Volume: 3 article number: 130 DOI: 10.3332/ecancer may.2009.130 received: 22/11/2008 published: 12/01/2009
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Post-genomic clinical trials-the perspective of ACGT
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No Graf, c. Desmedt, f. Buffa, d. Kafetzopoulos, n. Forgï ¿, r. Kollek, a. Hoppe, g., m. Tsiknakis Stamatakos
Advancing Genomic Clinical Trials (ACGT) is an EU co-funded project that develops open-source semantic and grid-based technologies in support of post genomic clinical trials in cancer research. It addresses clinicians bio-researchers as well as software developers providing an open platform where novel and powerful services can be offered and put to use by practitioners in the field.
This article discusses the ACGT’s approach to collecting and dealing with genomic data.It also looks at the ACGT’s ultimate objective providing a unified technological infrastructure which will facilitate the seamless and secure access and analysis of multi-level clinical and genomic data enriched with high-performing knowledge discovery operations and services.
By doing so it is expected that the influence of genetic variation in oncogenesis will be revealed the molecular classification of cancer and the development of individualised therapies will be promoted and finally the in-silico tumor growth and therapy response will be realistically and modelled reliably.
Volume: 2 Article Number: 66 DOI: 10.3332/eCMS. 2008.66 Received: 10/11/2007 Published: 21/01/2008
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Communication skills and awareness in clinical practice: an Italian experience
S. Liptrott, f. Sinners, r. Cocquio, g. Martinelli
The importance of communication as an essential component of health care is widely accepted throughout the literature. Its importance is especially relevant when it comes to patients with a diagnosis of cancer, which can tackle complex or difficult decisions about treatment options and end of life care issues.Notwithstanding the acceptance of its value, research has indicated dissatisfaction continues with communication skills. Although many counties have made recommendations towards integration of communication skills, training for health workers to care for cancer patients, this is not mandatory.
Using reflection on clinical practice, a pilot project was undertaken to watch the perceptions of personal communication skills, best practice methods and training opportunities within a unit of haemato-Oncology in a Cancer Hospital in Italy. A questionnaire distributed to members of the medical and nursing staff of the unit (n = 32) and focused on the practice of communication, difficult situations giving information and training. Replied the forty percent of personnel. The overall perception of the overall effectiveness of communication skills responders regarding communication of the diagnosis, prognosis and condition was high.Practicalities of giving information about the disease, prognosis and treatment for patients and relatives, have been highlighted in terms of importance of the environment-type and availability, having the necessary personnel for this type of communication and patient choice.Different methods and techniques of communication were reported, however this appeared independent doctors or nurses background and time in clinical practice. General, opinions of the team (stratified), showed no great difference between years of practice or occupation. projects of this has been instrumental in raising the issue of communication and encourage reflection on daily practice to give some direction for the development of the service, in an area where the need for communication skills training is not currently seen as mandatory but may be useful not only to patients but the personal well-being.
Areas for our future development practice include training, addressing environmental issues, team work and development of written information to support verbal information.
Volume: 3 article number: 135 DOI: 10.3332/ecancer may.2009.135 received: 02/01/2009 published: 11/02/2009
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LigaSure (TM) reduces fluid drainage in axillary dissection? A prospective randomized clinical study
Antonio m., t. Stone, L.G. Domenico, d., r. Ignatius, n. Anthony, Louis c.
Background-lymph node axillary dissection (ALND) is an integral part of the treatment of breast cancer. It is mandatory in approximately 60% of patients. Place a drain in the armpit after an operation is current surgical practice. Short stay surgical programs increase operational efficiency and reduce cost of medical care, without compromising the quality of care.LigaSureTM is a new device that uses energy Haemostatic bipolar for sealing vessels. the purpose of this study was to determine whether the axillary dissection with LigaSureTM reduces wound drainage, the duration of surgery and the volume of drainage after treatment.
patients and methods of this study is a prospective randomized controlled trial.100 women with breast cancer, who needed to axillary dissection were randomized into LigaSureTM or group of conventional axillary dissection. lymph node dissection level III was executed. A closed suction drain was always placed in the armpit and removed after 6-8 days or when was the amount of fluid
Results there are significant differences between the two groups when considering the duration of the surgical procedure: average duration was 70.7 24.66 minutes for patients of LigaSureTM, whereas in conventional dissection group the average was 70.6 22.47 minutes (p = 0,98). total amount of fluid drained was 624.49 cc in axillary dissection LigaSureTM and 792.96 ALND conventional group; this difference did not reach statistical significance (p = 0.09); the duration of drainage also was similar with no statistical difference (p = 0.15).
Conclusions of this study were not showing clear advantages in using for ALND LigaSureTM, although it is a good device Haemostatic, especially in abdominal Surgery.
Keyword breast cancer;breast cancer surgery; axillary dissection; Seroma; discharge; hemostasis; LigaSure.
Volume: 1 article number: 61 DOI: 10.3332/eCMS. 2007.61 received: 02/10/2007 published: 29/11/2007
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Poorly differentiated synovialosarcoma vagina: A case report and a review of the clinical literature
L. Minig, g. Farnetano Peiretti, m., g. Zanagnolo Roviglione, v., g. Pelosi, f. Landoni
Synovial Sarcoma (SS) account for 5-10% of all soft tissue sarcomas and typically occur in regions para-articulate of adolescents and young adults. However, the SS rarely can occur in other parts of the body. Here we present a first report of a patient’s clinical literature with a SS arising from wall vagina. A patient of 40 years, presenting a polypoid necrotic lesion measuring 50 mm and which extends from the urethral meatus outside the central part of Anterior vaginal wall. The biopsy showed that a poorly differentiated SS with abundant necrosis and a mutation SYT-SSX 1. CT scan stop was negative for distant metastases.The patient prior to surgery radical, received chemotherapy intravenous pyelogram (ifosfamide and epirubicin) for three She underwent cycles. post external operational and brachytherapy (50 Gy) due to tight margins (
Volume: 2 article number: 99 DOI: 10.3332/ecancer. 2008.99 received: 10/10/2008 published: 19/11/2008
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