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Biomedical subjects

Fausto Roila

Publications and source records attributed to Fausto Roila.

At least 19 recordsLinked to original sources
PubMed2006

The impact of chemotherapy-induced nausea and vomiting on health-related quality of life.

GOAL OF WORK: The objectives of this prospective observational study were to estimate the frequency of patients who reported an impact of chemotherapy-induced nausea and vomiting (CINV) on their daily life and to evaluate the determinants of such an impact. MATERIALS AND METHODS: Adult cancer patients at seven Italian oncology centers who were receiving cisplatin-containing regimens reported incidence and intensity of CINV for eight consecutive days in a diary and completed a Functional Living Index for Emesis (FLIE) questionnaire. MAIN RESULTS: Overall, 34% of patients reported vomiting and 62% reported nausea after chemotherapy. On days 1 to 5 after receiving chemotherapy, 67% of patients who had at least one emetic episode and 77% of those who suffered from at least mild nausea experienced an impact on their daily activities as measured on the FLIE questionnaire. More than 90% of all patients with both acute and delayed nausea or vomiting reported an impact on their daily life. Both acute and delayed vomiting contributed in similar measure to impact daily life; however, the importance of delayed nausea was greater than that of acute nausea. CONCLUSIONS: Despite antiemetic prophylaxis, CINV is still prevalent and often impacts the daily life of patients in Italy, especially in the delayed phase. The duration more than the severity seems to be responsible for the impact of CINV on the patients' daily lives.

Aged↗
PubMed2006

The cost of chemotherapy-induced nausea and vomiting in Italy.

GOALS OF WORK: The aim of this paper is to analyze the costs of chemotherapy-induced nausea and vomiting (CINV) in Italy. MATERIALS AND METHODS: In this prospective observational study at seven public oncology centers, incidence and intensity of CINV daily for 8 days after chemotherapy in consecutive patients receiving cisplatin-containing chemotherapy were recorded. All costs related to CINV (direct medical, direct nonmedical, and indirect) were recorded (in 2003 euros). MAIN RESULTS: A total of 172 patients were enrolled; cost data were available for 168 patients. Thirty-seven percent of patients experienced acute CINV, and 57% experienced delayed CINV; 39% achieved total control, defined as no nausea, vomiting, or rescue therapy. Mean per-patient costs of acute and delayed CINV were 30.03 euro from the hospital perspective, 4.9 euro from the patient perspective, and 26.85 euro from the National Health Service (NHS) perspective. Costs of CINV were highly variable among oncology centers, largely because of differences in procedures for preventing delayed CINV. These costs were four times higher when antiemetic drugs were prescribed and paid for by the NHS than when antiemetic prophylaxis was provided directly from hospital pharmacies. Moreover, in the delayed phase, the NHS incurred a 94% increase in costs for patients without total control. Overall costs for patients who did not experience total control of CINV were 35.57 euro higher than for those who did (85% increase). CONCLUSIONS: Costs of CINV for the Italian NHS could be reduced if hospitals furnished antiemetic prophylaxis directly to patients. Better control of both acute and delayed CINV would improve patient well-being as well as reduce the budgetary impact of CINV in Italy.

Adult↗
PubMed2005

Germ cell tumours of the testis.

Cancer of the testis is a relatively rare disease, accounting for about 1% of all cancers in men. Cryptorchidism is the only confirmed risk factor for testicular germ cell tumour. The majority of GCT are clinically detectable at initial presentation. Any nodular, hard, or fixed area discovered in the testis, must be considered neoplastic until proved otherwise. The appropriate surgical procedure to make the diagnosis is a radical orchidectomy through an inguinal incision. Many GCT produce tumoural markers (AFP, HCG, LDH), who are useful in the diagnosis and staging of disease; to monitor the therapeutic response and to detect tumour recurrence. In 1997 a prognostic factor-based classification for the metastatic germ cell tumours was developed by the IGCCCG: good, intermediate and poor prognosis, with 5-year survival of 91, 79 and 48%, respectively. GCT of the testis is a highly table, often curable, cancer. Germ cell testicular cancers are divided into seminoma and non-seminoma types for treatment planning because seminomatous testicular cancers are more sensitive to radiotherapy. Seminoma (all stages combined) has a cure rate of greater than 90%. For patients with low-stage disease, the cure approaches 100%. For patients with non-seminoma tumours, the cure rate is >95% in stages I and II; it is approximately 70% with standard chemotherapy and resection of residual disease, if necessary, in stages III and IV. Minimum guidelines for clinical, biochemical, and radiological follow-up have been reported by ESMO in 2001.

Germinoma↗
PubMed2005

Cancer of the penis.

Cancer of the penis is rare in Europe, accounting for less than 0.5% of all cancers. Phimosis and poor hygiene are strong risk factors whereas neonatal circumcision is a contributing factor in the prevention of this disease. More than 95% of penile carcinomas are squamous cell carcinomas. Early disease (stage I-II) is curable in most patients, who can be treated by conventional penile amputation or, in selected cases, by organ preserving techniques, including Moh's micrographic surgery, laser ablation or radiation therapy (external-beam, brachytherapy). For more advanced primary tumours, penile amputation is required. Survival of patients with penile cancer is strongly related to the presence and extent of nodal metastases. Bilateral inguinal lymphadenectomy is recommended for palpable lymph nodes that persist 3 or more weeks after removal of the primary tumour and a course of antibiotic therapy. In patients with proven inguinal lymph node metastases, bilateral ileoinguinal dissection should be performed. When the nodes are clinically negative, "prophylactic" inguinal lymphadenectomy may be a reasonable approach in patients with invasive tumours (T2 or greater), high grade tumours, or tumours exhibiting vascular invasion. The role of chemotherapy, as adjuvant and neoadjuvant or primary treatment in metastatic disease, needs to be further explored in prospective clinical trials.

Carcinoma, Squamous Cell↗
PubMed2005

The oral NK(1) antagonist aprepitant for the prevention of acute and delayed chemotherapy-induced nausea and vomiting: Pooled data from 2 randomised, double-blind, placebo controlled trials.

In this work, data from two phase III studies were pooled to further evaluate the NK(1) antagonist aprepitant for prevention of cisplatin induced nausea and vomiting. One thousand and forty three patients receiving cisplatin (> or = 70 mg/m2) were randomised to receive either a control regimen (32 mg intravenous ondansetron [O] and 20 mg oral dexamethasone [D] on day 1; 8 mg D twice daily on days 2-4) or an aprepitant (A) regimen (125 mg A plus 32 mg O and 12 mg D on day 1, 80 mg A and 8 mg D once daily on days 2-3, and 8 mg D on day 4). The primary endpoint was no emesis and no rescue therapy. Potential correlations between acute and delayed emesis were assessed, as were frequency of emetic episodes by time interval and effects on nausea and quality of life as measured by the functional living index emesis (FLIE) questionnaire. In the aprepitant group, there was statistically significantly less nausea over the study period as well as higher functioning on the FLIE questionnaire in both the nausea and vomiting domains. Patients without acute emesis were more likely to have no emesis in the delayed phase. Compared with control, the aprepitant regimen improved prevention of delayed emesis by 16% points in patients without acute emesis, and by 17% points in patients with acute emesis. Among patients who did not have complete response, the frequency of emesis at various intervals over 5 days was consistently lower in patients receiving aprepitant. Analyses of this combined Phase III population further characterized the clinical profile of the aprepitant regimen, showing that delayed emesis is correlated with, but not entirely dependent on, the presence of acute emesis, and that aprepitant has a favorable effect against nausea throughout 5 days postchemotherapy. In addition, even among patients who had emesis or needed rescue therapy, aprepitant was associated with a lower frequency of these events compared with the control regimen.

Acute Disease↗
PubMed2005

Evidence-based recommendations for the use of antiemetics in radiotherapy.

BACKGROUND AND PURPOSE: To report recommendations given in the Multinational Association of Supportive Care in Cancer (MASCC) International Consensus Conference regarding the use of antiemetics in radiotherapy. PATIENTS AND METHODS: A steering committee under MASCC auspice chose panel participants for the guidelines development process on prevention of chemotherapy- and radiotherapy-induced emesis (RIE). Pertinent information from published literature as of March 2004 was reviewed for the guideline process. Both the MASCC level of scientific confidence and level of consensus, and the American Society of Clinical Oncology (ASCO) type of evidence and grade for recommendation were adopted. RESULTS: Total body irradiation is classified at high risk, upper abdomen at moderate, lower thorax, pelvis, cranium (radiosurgery) and craniospinal at low, head and neck, extremities, cranium and breast at minimal risk. The recommendations for the use of antiemetics in radiotherapy are as follows: prophylaxis with a 5-HT3 antagonist in patients at high and moderate risk levels of RIE (+/-dexamethasone in the former group), prophylaxis or rescue with a 5-HT3 antagonist in the low risk group, and rescue with dopamine or a 5-HT3 receptor antagonist in minimal risk level. CONCLUSIONS: These recommendations represent a valid tool for prophylaxis and treatment of RIE in clinical practice.

Antiemetics↗
PubMed2004

Radiotherapy-induced nausea and vomiting (RINV): antiemetic guidelines.

As many as 40-80% of patients undergoing radiotherapy (RT) will experience nausea and/or vomiting, depending on the site of irradiation. Fractionated RT may involve up to 40 fractions over a 6-8 weeks period, and prolonged symptoms of nausea and vomiting could affect quality of life. Furthermore, uncontrolled nausea and vomiting may result in patients delaying or refusing further radiotherapy. Nausea and vomiting are often underestimated by radiation oncologists. Incidence and severity of nausea and vomiting depend on RT-related factors (single and total dose, fractionation, irradiated volume, radiotherapy techniques) and patient-related factors (gender, general health of the patient, age, concurrent or recent chemotherapy, psychological state, tumor stage). Current antiemetic guidelines prescribe the emetogenicity of radiotherapy regimens and recommend the use of 5-HT(3) antagonists with or without a steroid for prophylaxis in moderately and highly emetogenic treatment (MASCC, ASCO, ASHP, NCCN). The new proposed guidelines summarise the updated data from the literature and take into consideration the existing guidelines. According to the irradiated area (the most frequently studied risk factor), the proposed guidelines are divided into four levels of emetogenic risk: high, moderate, low and minimal. They offer guidance to prescribing physicians for effective antiemetic therapies in RINV.

Antiemetics↗
PubMed2004

Acute emesis: moderately emetogenic chemotherapy.

This paper is a review of the recommendations for the prophylaxis of acute emesis induced by moderately emetogenic chemotherapy as concluded at the Perugia Consensus Conference, which took place at the end of March 2004. The review focuses on new studies appearing since the last consensus conference in 1997. The following issues are addressed: dose and schedule of antiemetics, different groups of antiemetics such as corticosteroids, serotonin (5-HT(3))-receptor antagonists, dopamine D(2) receptor antagonists, and neurokinin (NK(1)) receptor antagonists. Antiemetic prophylaxis in patients receiving multiple cycles of moderately emetogenic chemotherapy is also reviewed. Consensus statements are given, including optimal dose and schedule of 5-HT(3)-receptor antagonists and of dexamethasone. The new 5-HT(3)-receptor antagonist, palonosetron, is a reasonable alternative to the well-established agents of this class--ondansetron, granisetron, tropisetron and dolasetron. It is concluded that the best prophylaxis in patients receiving moderately emetogenic chemotherapy is still the combination of one of the 5-HT(3)-receptor antagonists and dexamethasone. The results of studies adding a NK(1)-receptor antagonist to this combination are awaited and might change future recommendations.

Acute Disease↗
PubMed2004

Delayed emesis: moderately emetogenic chemotherapy.

Data on the incidence and efficacy of antiemetic prophylaxis against delayed emesis induced by moderately emetogenic chemotherapy are scanty. An overview of the literature has been done that showed the efficacy of dexamethasone in two of three randomized trials. Its optimal dose and duration of administration has not been defined. Only one of four randomized studies showed a statistically significant efficacy of 5-HT(3) antagonists. Finally, only weak evidence has been published on the efficacy of dopamine receptor antagonists.

Antiemetics↗
PubMed2004

Antiemetics in children receiving chemotherapy.

Only a few studies have been carried out in children on the prevention of chemotherapy-induced acute emesis. 5-HT3 antagonists have been shown to be more efficacious and less toxic than metoclopramide, phenothiazines and cannabinoids. The optimal dose and scheduling of the 5-HT3 antagonists has not been identified. Combinations of a 5-HT3 antagonist and dexamethasone show increased efficacy with respect to 5-HT3 antagonists alone. All pediatric patients receiving chemotherapy of high or moderate emetogenic potential should receive a combination of a 5-HT3 antagonist and dexamethasone to prevent acute emesis. No studies have specifically evaluated antiemetic drugs in the prevention of chemotherapy-induced delayed and anticipatory emesis in children.

Antiemetics↗
PubMed2004

Transferring scientific evidence to oncological practice: a trial on the impact of three different implementation strategies on antiemetic prescriptions.

GOALS: In 1996, a gap between the literature evidence for the prevention of chemotherapy-induced emesis and the prescription pattern in clinical practice was demonstrated in a drug utilization study. This study, carried out in 103 Italian oncological centers (77 new; 26 old that participated in the previous study) evaluates three different intervention strategies to implement these guidelines. PATIENTS AND METHODS: In cancer patients submitted to chemotherapy, prescriptions of antiemetics were prospectively monitored for 2 consecutive weeks in 1999. Simple diffusion of guidelines was evaluated in an observational study in the 77 new centers, while the double combination of simple diffusion and "audit and feedback" strategy was randomly compared in the old centers with the triple combination of the same two strategies plus an "educational outreach visit." MAIN RESULTS: Simple diffusion of guidelines improved the prescription but only for acute and delayed emesis induced by high-moderate emetogenic chemotherapy. No significant difference was detected in the prescriptions against cisplatin-induced emesis. The inappropriate use of 5-HT(3) antagonists for prophylaxis of low emetogenic chemotherapy was found most frequently. Similar poor results were achieved by the audit and feedback strategy, while the educational outreach visit significantly increased the prescription of the optimal prophylaxis for cisplatin-induced acute and delayed emesis. CONCLUSIONS: A combination of interventions, including an educational outreach visit, seems to be a good strategy for transferring the results of antiemetic research to oncological practice.

Adult↗
PubMed2003

The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin--the Aprepitant Protocol 052 Study Group.

PURPOSE: In early clinical trials with patients receiving highly emetogenic chemotherapy, the neurokinin antagonist aprepitant significantly enhanced the efficacy of a standard antiemetic regimen consisting of a type-three 5-hydroxytryptamine antagonist and a corticosteroid. This multicenter, randomized, double-blind, placebo-controlled phase III study was performed to establish definitively the superiority of the aprepitant regimen versus standard therapy in the prevention of chemotherapy-induced nausea and vomiting (CINV). PATIENTS AND METHODS: Patients receiving cisplatin > or = 70 mg/m2 for the first time were given either standard therapy (ondansetron and dexamethasone on day 1; dexamethasone on days 2 to 4) or an aprepitant regimen (aprepitant plus ondansetron and dexamethasone on day 1; aprepitant and dexamethasone on days 2 to 3; dexamethasone on day 4). Patients recorded nausea and vomiting episodes in a diary. The primary end point was complete response (no emesis and no rescue therapy) on days 1 to 5 postcisplatin, analyzed by a modified intent-to-treat approach. Treatment comparisons were made using logistic regression models. Tolerability was assessed by reported adverse events and physical and laboratory assessments. RESULTS: The percentage of patients with complete response on days 1 to 5 was significantly higher in the aprepitant group (72.7% [n = 260] v 52.3% in the standard therapy group [n = 260]), as were the percentages on day 1, and especially on days 2 to 5 (P <.001 for all three comparisons). CONCLUSION: Compared with standard dual therapy, addition of aprepitant was generally well tolerated and provided consistently superior protection against CINV in patients receiving highly emetogenic cisplatin-based chemotherapy.

Administration, Oral↗
PubMed2003

Impact of nausea and vomiting on quality of life in cancer patients during chemotherapy.

It is commonly claimed that the nausea and vomiting accompanying cytotoxic chemotherapy have a negative impact on health-related quality of life. While this may seem self-evident, until a few years ago there was little empirical data demonstrating that the failure to control postchemotherapy emesis affects aspects of quality of life. In spite of their limitations, several observational studies showed that nausea and vomiting associated with chemotherapy induced a decrease in health-related quality of life with respect to patients without nausea and vomiting. This has also been demonstrated after the adjustment for health-related quality of life before chemotherapy that is an important prognostic factor of chemotherapy-induced nausea and vomiting. Furthermore, one study suggests that the optimal time of assessment of quality of life to evaluate the impact of chemotherapy-induced nausea and vomiting is day 4 if a 3-day recall period is used or day 8 when the recall period is 7 days. In double-blind studies the efficacy, tolerability and impact on quality of life of the 5-HT3 receptor antagonists was superior with respect to metoclopramide, alizapride and prochlorperazine. Similar results have been achieved with the combination of ondansetron with dexamethasone, the standard treatment for the prevention of acute emesis induced by moderately emetogenic chemotherapy, with respect to the metoclopramide plus dexamethasone combination. Instead, in another double-blind study, in patients submitted to moderately emetogenic chemotherapy, a 5-HT3 antagonist did not seem to significantly increase complete protection from delayed emesis and the patients' quality of life with respect to dexamethasone alone. In conclusion, the evaluation of quality of life in randomized trials comparing different antiemetic drugs for the prevention of chemotherapy-induced nausea and vomiting can add important information useful for the choice of the optimal antiemetic treatment.

Antiemetics↗
PubMed2002

Antiemetic therapy.

The emetogenic potential of cancer chemotherapeutic agents varies according to the agent employed. Among the highly emetogenic agents, cisplatin has been the most studied. As for emesis induced by cisplatin, an optimal antiemetic schedule is effective in 70-90% of cases of acute emesis, in 60% of cases of delayed emesis, whereas acute emesis induced by moderately emetogenic agents can be prevented in over 90% of cases. The major risk factor in delayed emesis is the vomiting experienced during the previous chemotherapy cycles. Special situations are represented by high-dose chemotherapy and radiation therapy. Drugs and scheduling for emesis prevention in children are empirically derived from the regimens employed for adults, although some differences in the pharmacokinetics and in toxicity profiles have been reported.

Adult↗
PubMed2001

Delayed emesis: incidence, pattern, prognostic factors and optimal treatment.

Delayed emesis has been arbitrarily defined as vomiting and/or nausea beginning, or persisting for, more than 24 h after chemotherapy administration. Acute emesis is the most important prognostic factor for delayed emesis. Owing to the relatively high incidence and severity all patients treated with cisplatin > or = 50 mg/m(2) should receive antiemetic prophylaxis. In these patients a combination of dexamethasone plus metoclopramide or a 5-HT3 antagonist is the most efficacious regimen. All patients submitted to moderately emetogenic chemotherapy, such as cyclophosphamide, carboplatin, doxorubicin and epirubicin, should also receive antiemetic prophylaxis with oral dexamethasone to prevent delayed emesis.

Antineoplastic Agents↗