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S Trippoli

Publications and source records attributed to S Trippoli.

31 records · Page 2Linked to original sources
PubMed1998

Treatments for newly diagnosed advanced ovarian cancer: analysis of survival data and cost-effectiveness evaluation.

The main therapeutic options currently available for patients with newly diagnosed advanced ovarian cancer include: (i) cisplatin-based chemotherapy at conventional doses without paclitaxel, (ii) paclitaxel+cisplatin at conventional doses and (iii) high-dose chemotherapy with autologous hematopoietic rescue. After conducting a literature search to identify large-scale clinical trials based on these three therapeutic modalities, we carried out an analysis of the survival data and evaluated the cost-effectiveness ratio where appropriate. Cost data were obtained from published information. Effectiveness was estimated by determining the values of mean lifetime survival (MLS). Our analysis included a total of 15 clinical trials. The values of MLS were 3.05 years per patient for cisplatin-based chemotherapy at conventional doses without paclitaxel (1931 patients), 2.95 years per patient for chemotherapy with paclitaxel+cisplatin at conventional doses (184 patients) and 5.76 years per patient for high-dose chemotherapy with autologous hematopoietic rescue (53 patients). As compared with cisplatin-based chemotherapy without paclitaxel, high-dose treatments with hematopoietic rescue yielded a significantly better survival. Using cisplatin-based chemotherapy as a reference term, the incremental cost-effectiveness ratio for high-dose treatments was $25641 per life year gained (discounted dollars per discounted life year gained). Sensitivity testing suggested that the ratio remained below $50000 under most circumstances. We conclude that in the treatment of patients with advanced ovarian cancer, high-dose chemotherapy with hematopoietic rescue seems to be more effective and more cost-effective than standard treatments with cisplatin-based regimens at conventional doses.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1997

Adjuvant cyclophosphamide, methotrexate and fluorouracil for node-positive breast cancer: a lifetime cost-utility analysis based on a modified Q-TWIST method.

The Q-TWIST (time spent without symptoms and toxicity) method [1-4] and the Gompertz extrapolation method [5-11] are two techniques that have been proposed for evaluating survival in cancer patients. The mathematical basis of the Q-TWIST method relies on estimating the area under the survival curve and partitioning its value into three components with different levels of quality of life (presence of toxicity, presence of symptoms, absence of symptoms and toxicity). The Gompertz approach utilises a curve-fitting procedure to extrapolate the survival curves to infinity. A recent report [12] has described a combined application of the Q-TWIST method and the Gompertz approach ("extrapolated Q-TWIST" method), which allows one to conduct a cost-utility analysis with the calculation of the cost per QALY (quality-adjusted life year) gained. In this paper, we describe a reappraisal of an earlier cost-effectiveness study [7] by application of this extrapolated Q-TWIST method [12]. Our cost-effectiveness study [7] evaluated the pharmacoeconomic profile of adjuvant cyclophosphamide, methotrexate and fluorouracil (CMF) in patients with node-positive breast cancer [13] and utilised a Gompertz analysis to estimate lifetime overall survival (OS), which was 862 and 756 discounted years per 100 patients in the CMF and the control groups, respectively. In applying the extrapolated Q-TWIST method to this data set, a second Gompertz analysis is carried out on the disease-free survival (DFS) curve of the two patient groups. Lifetime DFS of Bonadonna's patients can thus be estimated as 741 years in the CMF group and 572 years in the controls (discounted values normalised to 100 patients). Figure 1 shows the two curves of OS and DFS for the CMF group and the partition of the area under the OS curve into its three components. To introduce an assessment of quality of life into these data, the Q-TWIST method partitions the value of OS into the three components called TWIST (absence of symptoms and toxicity), TOX (time spent with toxicity) and REL (survival after relapse). Hence, OS = TWIST + REL + TOX, where REL = OS - DFS. In the control group, TOX = O and TWIST = DFS because no treatment-related toxicity is present.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1997

A retrospective cost-effectiveness analysis of interferon as adjuvant therapy in high-risk resected cutaneous melanoma.

To assess the cost per life year gained of alpha interferon (IFN) as adjuvant therapy for patients with high-risk resected melanoma, we conducted a retrospective, incremental cost-effectiveness analysis on clinical data from a previously published ECOG trial [9]. The Gompertz model was used to estimate the total lifetime values of patient-years of subjects receiving IFN in comparison with subjects given no adjuvant treatment. The ECOG trial involved 143 patients treated with high-dose IFN and 137 given no adjuvant treatment. Estimated drug expenditures were based on the assumption of a cost of $109.25 per 10 MU of IFN. Our analysis of the ECOG results showed that the adjuvant treatment of 100 subjects with high-dose IFN improved survival expectancy by 133.6 discounted life years or 308 undiscounted life years. The use of IFN (compared with no adjuvant treatment) implied an incremental cost of $16,467 per discounted life year saved (95% CI of $4752-50,000) or $7143 per undiscounted life year saved (95% CI of $3226-33,846). Sensitivity testing, in which variations were introduced in the main factors influencing cost and effectiveness, showed that this value always remained below $50,000. Our pharmacoeconomic analysis indicates that adjuvant treatment with high-dose IFN in patients with high-risk resected melanoma implies a favourable cost-effectiveness ratio. Because two other studies showed no significant survival benefit in patients receiving adjuvant IFN at lower values of total dose per patient, the controversy remains and confirmation data are needed for the ECOG trial's results. If these clinical results are confirmed, our analysis shows that the dosage of IFN given in this trial has a favourable pharmacoeconomic profile.

Antineoplastic Agents↗
PubMed1997

Advanced HIV infection treated with zidovudine monotherapy: lifetime values of absolute cost-effectiveness as a pharmacoeconomic reference for future studies evaluating antiretroviral combination treatments. The Osservatorio SIFO sui Farmaci.

OBJECTIVE: This study was undertaken to evaluate the cost and the effectiveness of zidovudine monotherapy in patients with advanced HIV infection and to derive preliminary data on the cost-effectiveness of the triple treatment with saquinavir plus zalcitabine plus zidovudine compared with zidovudine alone. DESIGN: We used a combined method of survival analysis utilizing both the quality-adjusted time without symptoms or toxicity (Q-TWIST) method and the Gompertz approach. This combined method was applied to assess the absolute cost-effectiveness and cost-utility ratios of zidovudine monotherapy and to perform a preliminary incremental cost-effectiveness comparison of saquinavir plus zalcitabine plus zidovudine versus zidovudine alone. The clinical material used in our study was derived from two reports on the treatment of advanced HIV infection. Data of lifetime costs of HIV infection were obtained from published information. RESULTS: In patients with advanced HIV infection treated with zidovudine monotherapy, lifetime survival was 252.1 discounted person-years per 100 patients. Using an average lifetime cost of $93,000 (discounted) per individual, the absolute ratio of cost-effectiveness for zidovudine monotherapy was $36,980 per life-year, while the absolute cost-utility ratio was $47,112 per quality-adjusted life-year. In the comparative analysis of saquinavir plus zalcitabine plus zidovudine versus zidovudine alone, our calculations showed that the administration of the triple treatment can have an "average" cost-effectiveness, provided that mean lifetime survival per patient (discounted) is improved to at least 3.68 years (with an average survival gain of at least 14 mo per patient). CONCLUSIONS: The values of absolute cost-effectiveness and cost-utility ratios for zidovudine monotherapy are a useful reference point for further pharmacoeconomic studies in the area of antiretroviral drugs.

Anti-HIV Agents↗
PubMed1996

Pharmacoeconomic profile of paclitaxel as a first-line treatment for patients with advanced ovarian carcinoma. A lifetime cost-effectiveness analysis.

BACKGROUND: Analysis of published survival curves has recently been proposed as a method for conducting incremental cost-effectiveness analysis in which two treatments are compared with each other in terms of cost per year of life gained. In patients with advanced ovarian carcinoma, the combination of paclitaxel and cisplatin has been reported to improve survival more significantly than standard therapy with cyclophosphamide and cisplatin. However, the high cost of paclitaxel indicates a need for an evaluation of the pharmacoeconomic profile of these treatments. METHODS: The authors conducted an incremental cost-effectiveness analysis to assess the paclitaxel-based regimen in terms of cost per year of life gained. The analysis utilized data from a published controlled long term trial involving 184 patients treated with paclitaxel and cisplatin and 202 patients treated with cyclophosphamide and cisplatin. Gompertz' law was employed to obtain the lifetime estimate of the years gained by patients given the first treatment in comparison with patients given the second. RESULTS: The paclitaxel-based treatment was found to improve life expectancy by 46 years for every 100 patients. Costs of chemotherapy were higher in the paclitaxel group than in the standard-therapy group (the cost difference was $901,723 for every 100 patients; costs for treating febrile neutropenia induced by chemotherapy were taken into account). On the basis of these data of cost and effectiveness, the administration of paclitaxel and cisplatin was found to imply a cost per year of life gained of $19,603 more than standard chemotherapy. CONCLUSIONS: The pharmacoeconomic profile of paclitaxel compares favorably with economic data previously calculated for other types of pharmacologic treatment.

Antineoplastic Agents↗
PubMed1996

Cost-effectiveness of adjuvant chemotherapy with cyclophosphamide+methotrexate+fluorouracil in patients with node-positive breast cancer.

BACKGROUND: The analysis of published survival curves can be used as the basis for incremental cost-effectiveness analyses in which two treatments are compared with each other in terms of cost per life year saved. In patients with node-positive breast cancer adjuvant chemotherapy with cyclophosphamide+ methotrexate+fluorouracil has been reported to improve survival in comparison with patients who are not given this treatment. METHODS: To assess the pharmacoeconomic profile of this adjuvant chemotherapeutic regimen in terms of cost per life-year gained, we conducted an incremental cost-effectiveness analysis in which the Gompertz model was used to calculate the lifetime estimate of the patient-years gained by treated subjects compared to controls. RESULTS: Using data from a published, controlled long-term trial involving 207 patients treated with cyclophosphamide+methotrexate+fluorouracil and 179 controls, we estimated that this adjuvant chemotherapy improved life expectancy by 357 patient-years per 100 subjects. Direct costs, which were almost exclusively related to the administration of chemotherapy, were estimated to be US $159,516 per 100 patients. On the basis of these data, adjuvant chemotherapy was found to imply an incremental cost of US $447 per life-year saved. CONCLUSIONS: The cost-effectiveness ratio of adjuvant chemotherapy with cyclophosphamide+methotrexate+fluorouracil in patients with node-positive breast cancer seems to be particularly favourable in comparison with estimates of cost per life-year saved previously calculated for other types of pharmacological intervention.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1996

G-CSF for the prophylaxis of neutropenic fever in patients with small cell lung cancer receiving myelosuppressive antineoplastic chemotherapy: meta-analysis and pharmacoeconomic evaluation.

Standard meta-analytical and pharmacoeconomic techniques were used to study the clinical effectiveness and the cost-effectiveness ratio of the prophylactic (or pre-emptive) administration of G-CSF to patients with small cell lung cancer treated with conventional myelosuppressive cytotoxic chemotherapy. In the first part of our study, we conducted a meta-analysis of the randomized clinical trials evaluating G-CSF for this clinical indication. Three trials were identified by our literature search and were included in the meta-analysis (overall number of patients = 606). The end-points for evaluating G-CSF included mortality from infection and the cumulative incidence of neutropenic fever over six cycles of chemotherapy. The results of our meta-analysis demonstrate that prophylactic G-CSF did not affect mortality but significantly reduced the incidence of neutropenic fever from 68.3% to 38.7% (pooled odds ratio = 0.29, 95% CI: 0.21-0.40; P < 0.001). In the second part of our study, we carried out a pharmacoeconomic analysis to estimate the cost-effectiveness ratio of pre-emptive G-CSF (i.e. the 'average' cost associated with the prevention of an episode of neutropenic fever). This cost-effectiveness ratio was US$ 14,372 using the Italian price of the drug converted into dollars, or US$ 41 088 using the US price. Finally, we estimated the revenue-neutral price of G-CSF based on American data of the cost-of-illness. The price ranged from US$ 395 to US$ 569 per cycle, a figure higher than the value (US$ 150) previously reported in the literature.

Antineoplastic Agents↗
PubMedDate not supplied

Treatments for newly diagnosed multiple myeloma: analysis of survival data and cost-effectiveness evaluation.

The main therapeutic options currently available to induce remission in newly diagnosed cases of multiple myeloma include: i) melphalan at conventional doses without concurrent administration of interferon; ii) melphalan at conventional dose combined with interferon; iii) autologous bone marrow transplantation (ABMT). We conducted an analysis of the survival data reported in five large-scale published clinical trials and we evaluated the cost-effectiveness ratio. We determined the mean lifetime survival (MLS) for each treatment group using the Gompertz model. The cost data of patients given ABMT or standard chemotherapy were estimated from published information. The values of MLS were 3.47 years per patient for melphalan at conventional doses without interferon, 3.74 years for melphalan at conventional doses combined with interferon, and 7.28 years for ABMT. As compared with conventional melphalan treatment, ABMT yielded a significantly better survival. Survival after melphalan combined with interferon was not significantly different from that following melphalan alone. Using melphalan at conventional doses without interferon as reference term, the marginal cost-effectiveness ratio of ABMT was of about $26,000 per life year gained. For the induction treatment in patients with newly diagnosed myeloma, ABMT seems to be more effective and more cost-effective than the standard treatment with melphalan at conventional doses.

Antineoplastic Agents↗
PubMedDate not supplied

A new method for expressing survival and life expectancy in lifetime cost-effectiveness studies that evaluate cancer patients (review).

The methodology of cost-effectiveness studies that use a lifetime perspective is based on the extrapolation to infinity of the survival curves. However, the research in this methodological area is at an initial phase. Hence, adequate techniques for survival curve extrapolation still need to be devised for handling the different clinical settings that can be analysed by cost-effectiveness survival studies. After a brief overview of the two most commonly used extrapolation methods (Markov decision-tree model and Gompertz technique), we describe a new method for expressing lifetime survival in cost-effectiveness studies that evaluate cancer patients. Our method extrapolates to infinity a traditional survival curve by assigning a normal life expectancy to patients (or long-term survivors). In this way, the value of mean lifetime survival (MLS) for the patient cohort under study can be determined using a lifetime perspective. This value can be employed in lifetime cost-effectiveness analyses that compare different forms of intervention for that disease condition. A separate section of our method compares the overall survival pattern of cured and not cured patients with that of a reference healthy population to assess the impact of the disease on life expectancy. As an example of the application of our method, we reanalysed a survival data set reported by Spinolo et al in 1992, that refers to patients with acute leukaemia who relapsed after their first allogeneic bone marrow transplantation and who received a second transplant (n=17, mean age at relapse = 26 years). The use of our extrapolation method provided the following results: MLS for leukaemia patients = 105.9 months per patient or 8.8 years per patient; MLS for the reference cohort of healthy subjects = 583.8 months per patient or 48.6 years per patient. We conclude that the extrapolation technique described herein can be useful to handle lifetime survival data in cost-effectiveness analysis.

Cost-Benefit Analysis↗
PubMedDate not supplied

Treatment of large cell lymphoma with the Fi2 regimen (doxorubicin, vincristine, cyclophosphamide, bleomycin and prednisone): 25-year experience.

The CHOP protocol is the reference treatment for large cell lymphomas, but several other schemes of different intensity have recently been studied with controversial clinical findings. We report here the results obtained at our institution with a CHOP-like regimen called Firenze 2 (Fi2), which is characterised by an original scheduling of chemotherapy administration. A total of 225 patients, who were diagnosed from 1974 to 1996, were included in this retrospective study. All patients received the Fi2 regimen as a first-line intervention. One-hundred and sixty-two (72%) achieved complete remission; the overall survival at 120 months was 51% with a disease-free survival of 67% (median follow-up = 78 months). The survival curve showed a stable plateau of 42% after 16 years, which remained stable for further 4 years. In a multivariate survival analysis, achievement of complete remission (p<0.001) and IPI index of 0 or 1 (p=0.05) were significantly associated with a better survival. Overall, the outcome of our patients was similar to that reported by others, but the distinguishing feature of our study is the very long follow-up of the patients. Our study confirms that first generation regimens are effective and can cure a substantial proportion of patients. The long-term results of our study are helpful to retrospectively identify high-risk patients whose prognosis is poor and who can be candidates for more aggressive schemes of chemotherapy.

Aged↗