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Biomedical subjects

F Roila

Publications and source records attributed to F Roila.

At least 19 recordsLinked to original sources
PubMed2006

New antiemetic drugs.

BACKGROUND: Important progress in the prophylaxis of chemotherapy-induced acute and delayed emesis has been achieved but some fundamental needs still remain that requires new, efficacious antiemetic drugs. METHODS: A critical review of the results of published studies of aprepitant, a new NK1 receptor antagonist, and of palonosetron, a 5-HT3 receptor antagonist with a longer half-life. RESULTS: Aprepitant combined with dexamethasone and a 5-HT3 antagonist significantly increased the control of acute emesis with respect to dexamethasone and a 5-HT3 antagonist alone after cisplatin and moderately emetogenic chemotherapy. For cisplatin nausea, aprepitant combined with dexamethasone significantly increased the control of delayed emesis with respect to dexamethasone alone, while for moderately emetogenic chemotherapy aprepitant is superior to a 5-HT3 antagonist in the control of delayed emesis. Palonosetron showed superior or similar efficacy to ondansetron and dolasetron in patients submitted to moderately emetogenic chemotherapy and similar efficacy to ondansetron in patients submitted to cisplatin. CONCLUSIONS: More studies are necessary comparing aprepitant alone or combined with dexamethasone with respect to the recommended antiemetic drugs for the prevention of delayed emesis induced by cisplatin and moderately emetogenic chemotherapy as well as for palonosetron combined with dexamethasone with respect to other 5-HT3 antagonists combined with dexamethasone.

Antiemetics↗
PubMed2005

Prevention of chemotherapy- and radiotherapy-induced emesis: results of the 2004 Perugia International Antiemetic Consensus Conference.

BACKGROUND: In the late 1990s, several professional organizations convened antiemetic guideline groups and published the findings of these expert panels. Each of these documents was based on analyses of the available published trials and provided nearly similar recommendations. Nonetheless, small differences in emetic risk categories and treatment recommendations led to confusion in antiemetics selection. With the emergence of new findings and agents since the guidelines were initially published, many of the oncology professional societies have updated the antiemetic guidelines. MATERIALS AND METHODS: A literature review up to March 2004 was carried out using MEDLINE with evaluation of the evidence by an expert panel composed of 23 oncology professionals in clinical medicine, medical oncology, radiation oncology, oncology nursing, statistics, pharmacy, medical policy and decision making, and pharmacology. The experts represented nine oncology professional societies and came from 11 different countries on four continents. RESULTS: Recommendations on antiemetic regimens to prevent emesis induced by high, moderate, low and minimal risk chemotherapy were suggested as well as management of anticipatory emesis. Furthermore, recommendations for refractory emesis, emesis induced by high-dose chemotherapy and radiotherapy and for antiemetics in children receiving chemotherapy were elaborated. CONCLUSIONS: Recommendations about antiemetic prophylaxis in patients receiving treatment with chemo- and radiotherapy have been updated by representatives of nine oncological organizations.

Antiemetics↗
PubMed2003

Adjuvant systemic therapies in women with breast cancer: an audit of clinical practice in Italy.

BACKGROUND: Evidence-based guidelines, consensus conferences and experts' opinion are rarely promptly transferred to patient care. We audited prescriptions of adjuvant systemic therapies for Italian breast cancer patients and compared them with recommendations of an International Consensus Panel. PATIENTS AND METHODS: Disease characteristics and adjuvant therapies for 768 breast cancer patients referred to 87 Italian centers from 16 to 23 March 2000 were evaluated for adherence to the published recommendations. RESULTS: Endocrine therapy was not prescribed for 102 of 541 patients (19%) with endocrine-responsive disease and for 22 of 45 patients (49%) with unknown hormonal receptor status. Instead, endocrine therapy was prescribed for 22 of 182 patients (12%) with endocrine-unresponsive disease. Adjuvant chemotherapy was prescribed for 98% of the patients. The type of chemotherapy was the cyclophosphamide, methotrexate, 5-fluorouracil regimen for 453 of 754 (60%), while 253 of 754 (34%) received an anthracycline-based regimen. The proportion of patients with anthracyclines increased with the number of involved axillary nodes and grading, and decreased with age. Endocrine therapy was administered to 482 of 768 (63%) and was mainly represented by an antiestrogen. CONCLUSIONS: Lack of adherence to evidence-based guidelines for adjuvant treatment of Italian breast cancer patients was as high as 19%. It might be wise for national health authorities to promote education on life-saving procedures, like adjuvant systemic treatments, in cancer medicine.

Adult↗
PubMed2001

Quality of life as a primary end point in oncology.

BACKGROUND: In cancer clinical trials, the standard end points include response rates, progression free and overall survival, toxicity. These evaluation criteria do not measure how the cancer and its treatment affect the quality of life of cancer patients. DESIGN: The relevant literature was reviewed for the purposes of determining when, how and why quality of life should be measured in cancer clinical trials. The resulting clinical benefits were also reviewed. RESULTS: Along with survival, quality of life is the main end point of comparative clinical trials. Its evaluation can provide physicians and patients with important information and help to identify a better treatment. Cancer-specific questionnaires with forms for specific tumour types sites have been developed and have proven to be more sensitive to changes than generic questionnaires. Quality-of-life evaluation before the start of treatment may be an important prognostic factor, even independent from performance status. Clinical benefit assessment presents important shortcomings and the clinical relevance of this evaluation should be interpreted with caution. CONCLUSIONS: Quality of life is a fundamental task of oncological research. More studies are necessary to overcome the difficulties in assessing and interpreting this concept and the clinical benefits based on it.

Clinical Trials as Topic↗
PubMed2000

Cancer patients as 'experts' in defining quality of life domains. A multicentre survey by the Italian Group for the Evaluation of Outcomes in Oncology (IGEO).

Although the subjective nature of quality of life is generally accepted, less attention has been paid to the procedure of selecting domains to be explored with questionnaires. To explore what contributes to cancer patients' quality of life, a survey was conducted with the aim of identifying contents of quality of life using cancer patients as 'experts'. A questionnaire with open-ended items aimed at exploring the meaning of quality of life and at determining the contents of health and not health related quality of life, was submitted to a sample of cancer patients stratified by residence, cancer site and stage of disease. The 248 questionnaires received were transcribed and broken down into phrases to allow coding. A content analysis was performed, using as a conceptual framework, the domains identified by the Italian Society of Psycho-Oncology. Overall, 43 domains and a list of symptoms were identified. The two most frequently reported symptoms were pain (21.4% patients) and fatigue (14.1% patients). Social relationships and psychological domains were heavily represented. Twenty sub-domains related to the domain 'psychological well-being'. This study suggests that information on the content of quality of life questionnaires to be submitted to people affected by a specific disease, should be derived by studying people suffering the specific disease. These results reinforce the criticism that available quality of life instruments are more likely to reflect the perspective of health professionals than patients.

Female↗
PubMed1998

Optimal selection of antiemetics in children receiving cancer chemotherapy.

Only a few studies have been carried out specifically on the prevention of nausea and vomiting in children receiving chemotherapy. In these patients older antiemetic drugs such as metoclopramide and phenothiazines had moderate efficacy and induced significant side effects, especially marked sedation and extrapyramidal reactions. In comparative trials the 5-HT3 receptor antagonists have shown better efficacy and tolerability than chlorpromazine or metoclopramide combined with dexamethasone. The combination of a 5-HT3 receptor antagonist plus dexamethasone is superior to a 5-HT3 receptor antagonist alone and should be the standard antiemetic prophylaxis in all paediatric patients receiving highly or moderately emetogenic chemotherapy. The optimal dose and scheduling of these antiemetic drugs need to be studied, as well as the antiemetic efficacy, in the prevention of chemotherapy-induced delayed and anticipatory emesis in children.

Antiemetics↗
PubMed1998

Delayed emesis following anticancer chemotherapy.

Delayed emesis is a distinct syndrome where vomiting begins or persists 24 or more hours after chemotherapy. It is more likely to occur when the stimulus for emesis is strong and/or acute vomiting is poorly controlled. The pathophysiology appears different than that which causes acute emesis. The literature reporting clinical trials to prevent delayed nausea and vomiting are presented. The best ways of preventing delayed emesis following anticancer chemotherapy are discussed.

Antiemetics↗
PubMed1998

Consensus proposal for 5HT3 antagonists in the prevention of acute emesis related to highly emetogenic chemotherapy. Dose, schedule, and route of administration.

Selective antagonists to the Type 3 serotonin receptor (5HT3) in combination with corticosteroids are now considered the standard of care for the prevention of emesis from moderately to highly emetogenic chemotherapy. Here we address issues of optimal dose, schedule and route of administration of four currently available selectable 5HT3 antagonists. This paper utilizes an evidence based medicine approach to the literature regarding this class of drugs, emphasizing the results large, randomized, controlled trials to make formal recommendations concerning optimal use of this important new class of anti-emetic agents. We conclude that for each drug there is a plateau in therapeutic efficacy at a definable dose level above which further dose escalation does not improve outcome. Furthermore, a single dose is as effective as multiple doses or continuous infusion, and finally, emerging data demonstrate that the oral route is equally efficacious as the intravenous route of administration, even with highly emetogenic chemotherapy.

Antiemetics↗
PubMed1998

Consensus regarding multiple day and rescue antiemetic therapy.

Different forms of moderately and highly emetogenic cancer chemotherapy that are administered over several days per cycle are discussed with reference to the most efficacious antiemetic therapy. Both preventive and rescue antiemetic therapy are considered.

Antiemetics↗
PubMed1998

The efficacy and cost-effectiveness of various antiemetic regimens.

Recently, the availability of 5-hydroxytryptamine-3 antagonists has provided better protection from chemotherapy-induced emesis. These drugs, in combination with dexamethasone, are more expensive but more cost-effective than the alternative antiemetic regimens in the prevention of acute emesis induced by high single dose and low and repeated doses of cisplatin and, probably, of acute emesis induced by moderately emetogenic chemotherapy. In the prevention of emesis induced by oral cyclophosphamide-methotrexate-fluorouracil and in the prevention of delayed emesis induced by cisplatin and moderately emetogenic chemotherapy, the most cost-effective choices are represented, respectively, by a combination of intravenous dexamethasone on day 1 and 8 plus 14-day oral metoclopramide (a combination of oral dexamethasone plus metoclopramide and oral dexamethasone alone). In all cases, the 5-hydroxytryptamine-3 antagonists should be used only in patients in whom the most cost-effective antiemetic regimens either fail or are not tolerated.

Antiemetics↗
PubMed1997

Clinical and methodological issues in antiemetic therapy: a worldwide survey of experts' opinions. Multinational Association of Supportive Care in Cancer.

During the 1995 Multinational Association of Supportive Care in Cancer (MASCC) Congress, a consensus conference was planned by the Subcommittee for Antiemetics. To define the topics to be discussed, a questionnaire containing both clinical and methodological issues was sent to 118 experts in 31 countries. The questionnaire contained 33 items on clinical and 19 items on methodological issues, and each response was rated on a 4-level categorical scale. The clinical issues were evaluated for interest, that is clinical importance, and feasibility, that is availability of sufficient data to make them suitable topics for the consensus conference. About 60% of questionnaires were returned, with a small number of missing responses. The responses to the items of clinical interest showed that about two-thirds of the issues identified by the Subcommittee were found by the experts to be of at least high interest, but often the availability of data was found to be insufficient for their discussion. Prevention of acute emesis induced by cisplatin and by moderately emetogenic chemotherapy and the optimal intravenous dose and schedule of the 5-HT3 receptor antagonists were the items with the highest interest and feasibility. The issues in the methodological section were also mostly found to be of at least high interest. The distinction between acute and delayed emesis, the evaluation of the persistence of antiemetic efficacy in subsequent cycles of chemotherapy and the statistical analysis of delayed emesis were the methodological issues in which the highest interest was recorded. Data collected will be used to define the main topics to be discussed during the planned consensus conference.

Antiemetics↗