RESUMEN
We have reported the results of a previous Phase II trial of two courses of neoadjuvant mitomycin (6 mg/m2), ifosfamide (3 g/m2) and cisplatin (50 mg/m2) (MIC) in squamous or anaplastic carcinoma of the oesophagus. In this current study, we have investigated whether there was any clinical benefit in extending the preoperative treatment to four courses for patients who responded after two courses. Response was assessed by barium swallow, which was compared with previous barium swallows performed prior to any treatment and after the second course of MIC. Of an initial 43 patients, 27 (63%) were assessed as responders after two courses of MIC. Twenty of these 27 patients were entered into the study with a view to receiving two further courses of MIC prior to surgery. Seventeen completed four courses. Five patients were complete responders after two courses and remained complete responders after four courses. Twelve patients were partial responders after two courses; six of these became complete responders after four courses, five remained partial responders, and one showed progression. Haematological toxicity and alopecia were increased after extending the number of courses beyond two. On pathological assessment, three patients with a complete response after four courses, and one with a complete response after three courses, had microscopic clearance of tumour. Extension beyond two courses of neoadjuvant MIC gives an improvement in response, as judged by barium assessment, but increases toxicity, cost of treatment and delay before surgery. Although the numbers are small, the results suggest that a worthwhile improvement in the radiological response of squamous or anaplastic oesophageal tumours may be gained by proceeding beyond two courses of MIC. A randomized trial, with larger numbers of patients, is needed to show whether there is any improvement in radiological and pathological response rates and in survival to be gained by the extension of treatment beyond two courses.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma de Células Escamosas/cirugía , Carcinoma/cirugía , Neoplasias Esofágicas/cirugía , Adulto , Anciano , Alopecia/inducido químicamente , Antibióticos Antineoplásicos/administración & dosificación , Antibióticos Antineoplásicos/efectos adversos , Antibióticos Antineoplásicos/economía , Antineoplásicos/administración & dosificación , Antineoplásicos/efectos adversos , Antineoplásicos/economía , Antineoplásicos Alquilantes/administración & dosificación , Antineoplásicos Alquilantes/efectos adversos , Antineoplásicos Alquilantes/economía , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Sulfato de Bario , Carcinoma/diagnóstico por imagen , Carcinoma/tratamiento farmacológico , Carcinoma de Células Escamosas/diagnóstico por imagen , Carcinoma de Células Escamosas/tratamiento farmacológico , Quimioterapia Adyuvante , Cisplatino/administración & dosificación , Cisplatino/efectos adversos , Cisplatino/economía , Medios de Contraste , Esquema de Medicación , Neoplasias Esofágicas/diagnóstico por imagen , Neoplasias Esofágicas/tratamiento farmacológico , Femenino , Costos de la Atención en Salud , Enfermedades Hematológicas/inducido químicamente , Humanos , Ifosfamida/administración & dosificación , Ifosfamida/efectos adversos , Ifosfamida/economía , Masculino , Persona de Mediana Edad , Mitomicinas/administración & dosificación , Mitomicinas/efectos adversos , Mitomicinas/economía , Radiografía , Ensayos Clínicos Controlados Aleatorios como Asunto , Inducción de RemisiónRESUMEN
Recent studies have shown that the analysis of published survival curves allows cost-effectiveness evaluations in which two treatments are compared with each other in terms of cost per life-year saved. In patients with colorectal cancer, the administration of adjuvant intraportal chemotherapy (with mitomycin and fluorouracil) has been reported to improve long-term survival in comparison with patients who are not given this treatment. To assess the pharmacoceconomic profile of this adjuvant chemotherapy, we carried out an incremental cost-effectiveness analysis in which we used the Gompertz model to estimate lifetime patient years gained by patients given this chemotherapy in comparison with controls. Using the data of a published controlled long-term trial involving 252 patients treated with intraportal chemotherapy and 253 controls who were given no such therapy, we estimated that the adjuvant treatment improved life expectancy by 89 discounted patient years (or 218 undiscounted patient years) every 100 patients. Cost of chemotherapy was calculated as $107,720 for every 100 patients. On the basis of these data, the administration of adjuvant intraportal chemotherapy was found to imply an incremental cost of $1,210 per discounted life-year saved or $494 per undiscounted life-year saved. The cost-effectiveness ratio of adjuvant intraportal chemotherapy in patients with colorectal cancer seems to be particularly favorable in comparison with estimates of cost per life-year saved previously obtained in many other areas of pharmacological intervention. Even though systemic fluorouracil + levamisole is the form of adjuvant chemotherapy most widely used in these patients, intraportal chemotherapy has the best cost-effectiveness profile.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias Colorrectales/tratamiento farmacológico , Economía Farmacéutica , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Quimioterapia Adyuvante/economía , Neoplasias Colorrectales/mortalidad , Análisis Costo-Beneficio , Esquema de Medicación , Fluorouracilo/administración & dosificación , Fluorouracilo/economía , Heparina/administración & dosificación , Heparina/economía , Humanos , Levamisol/administración & dosificación , Levamisol/economía , Mitomicinas/administración & dosificación , Mitomicinas/economía , Sistema Porta , Tasa de SupervivenciaRESUMEN
STUDY OBJECTIVES: compare the costs of two regimens of chemotherapy. Apply weighted costs to an economic model in a hospital perspective. DESIGN: prospective randomized study of two groups of patients receiving: branch B, mitomycin-navelbine-cisplatin (MNP); branch A, mitomycin-vindesine-cisplatin (MVP). SETTING: pneumologic units of University and non-University hospitals. METHODS: clinical evaluation during chemotherapy incorporated events enabling construction of an event tree. Direct hospital costs included those of: cytostatic agents, materials used and nursing time; costs of side-effects (medical and paramedical time, diagnostic and therapeutic examinations). Effectiveness was measured in terms of response rates. PATIENTS: 209 patients were included, 100 in arm B, 109 in arm A. RESULTS: the response rates were 25% in branch B, 17% in branch A. In the hypothesis of equivalence of the two strategies, we compared only overall mean cost per patient. Despite the fact arm B needed more hospital injections, the difference was low (+4.6%). For a difference in effectiveness, the opposite was observed for the average cost-effectiveness ratio: arm B was less costly (-12 339.40 FF for a responder). CONCLUSION: incorporation of economic parameters was found to have a bearing on the choice of chemotherapeutic regimen for the treatment of non-small cell lung cancer. Economic analyses of this kind can provide useful extra information for rational therapeutic decisions.