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1.
Tumori ; 96(1): 122-30, 2010.
Artículo en Inglés | MEDLINE | ID: mdl-20437869

RESUMEN

AIMS AND BACKGROUND: In Italy, euthanasia and assisted suicide remain illegal but have been the subject of constant debate. Such discussions, however, seem to take relatively little account of physicians' views and attitudes. METHODS AND STUDY DESIGN: We used an anonymous questionnaire to survey the attitudes and practices concerning euthanasia and the care of terminally ill patients of 5000 Italian physicians from among the approximately 20,000 members of seven of the most important Italian scientific societies. They were asked to complete an anonymous questionnaire consisting of 15 items, which also collected demographic and professional information. RESULTS: The response rate was 23.5%, and 855 questionnaires were returned. The respondents (75% males) had a median age of 51 years and 47% practiced medicine in a hospital or university setting. The survey showed that the attitude of Italian physicians towards caring for terminal patients is generally against the practice of euthanasia insofar as 84% and 87%, respectively, would, on a theoretical basis, be unwilling to prescribe or administer lethal drugs. Only 1.2-2% of the physicians declared that they had resorted at least once to active euthanasia practices consisting of the prescription and/or direct administration of lethal drugs during their professional lives, and 0.5-0.9% during the previous year. The main factor significantly influencing the opinions and behaviors of the physicians was religion. CONCLUSIONS: To our knowledge, this is the first Italian survey investigating the opinions and practices on euthanasia of a large sample of physicians from all over the country, belonging to various medical specialties. Our findings confirm the considerable influence of religion on physician's opinions and practice concerning end-of-life care.


Asunto(s)
Actitud del Personal de Salud , Conducta de Elección , Cuidados Paliativos al Final de la Vida , Cuidados Paliativos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Cuidado Terminal/estadística & datos numéricos , Enfermo Terminal , Adulto , Anciano , Estudios Transversales , Femenino , Cuidados Paliativos al Final de la Vida/estadística & datos numéricos , Humanos , Italia/epidemiología , Masculino , Persona de Mediana Edad , Análisis Multivariante , Cuidados Paliativos/estadística & datos numéricos , Rol del Médico , Relaciones Médico-Paciente , Suicidio Asistido/estadística & datos numéricos , Encuestas y Cuestionarios , Cuidado Terminal/normas , Cuidado Terminal/tendencias , Privación de Tratamiento/estadística & datos numéricos
2.
Acta Biomed ; 78(3): 204-9, 2007 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-18330080

RESUMEN

AIMS AND BACKGROUND: To demonstrate the efficacy of 13-cis-retinoic acid (RA) or Interferon alpha-2a (IFN alpha-2a) with Tamoxifen (TAM) in the treatment of advanced breast cancer. METHODS: Ninety-nine postmenopausal patients with advanced breast cancer, and a positive or unknown estrogen (ER) or progesterone (PgR) receptor status, were randomised to receive TAM 20 mg/m2/day orally (arm A), or TAM plus RA 1 mg/kg/day orally (arm B), or TAM plus IFN alpha-2a 3 MU thrice a week intramuscular (arm C). The three treatment groups were well balanced in terms of the main prognostic factors. RESULTS: Response was evaluable in 32 of the patients in arm A, 32 in arm B, and 30 in arm C. Intention-to-treat analysis showed no significant difference of response rate in the three arms (44% vs 38% vs 42%). After an eight years median follow-up, there was no significant between-group difference in median overall survival: 47.4 vs 38.2 vs 45.1 months. Side effects were negligible in arm A, but cutaneous (39%) and mucosal (62%) toxicities were frequent in arm B, and flu-like syndrome and/or myalgia (46%) in arm C. CONCLUSIONS: The administration of RA or IFN alpha-2a does not add anything to the therapeutic effects of TAM.


Asunto(s)
Antineoplásicos Hormonales/administración & dosificación , Antineoplásicos/administración & dosificación , Neoplasias de la Mama/tratamiento farmacológico , Interferón-alfa/administración & dosificación , Isotretinoína/administración & dosificación , Tamoxifeno/administración & dosificación , Administración Oral , Anciano , Antineoplásicos/efectos adversos , Antineoplásicos Hormonales/efectos adversos , Neoplasias de la Mama/mortalidad , Interpretación Estadística de Datos , Femenino , Estudios de Seguimiento , Humanos , Interferón alfa-2 , Interferón-alfa/efectos adversos , Isotretinoína/efectos adversos , Estimación de Kaplan-Meier , Persona de Mediana Edad , Posmenopausia , Pronóstico , Estudios Prospectivos , Proteínas Recombinantes , Tamoxifeno/efectos adversos , Factores de Tiempo , Resultado del Tratamiento
3.
Am J Clin Oncol ; 29(2): 171-7, 2006 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-16601438

RESUMEN

OBJECTIVES: The value of HER-2/neu status as a predictor of response to anthracycline-based chemotherapy is still a matter of debate. We evaluated the contribution of HER-2/neu gene amplification and other biologic markers in predicting response to different doses of neoadjuvant anthracycline-based chemotherapy. METHODS: Clinical and pathologic records of 115 primary breast cancer patients were reviewed. Forty-eight and 67 patients received high (doxorubicin > or =20 mg/m2/wk; epirubicin > or =30 mg/m2/wk) and moderate-low anthracycline dose intensity regimens, respectively. Pathologic diagnosis, hormonal receptor status (HR), Ki67, and HER-2/neu status were assessed on tumor samples before neoadjuvant chemotherapy. HER-2/neu was determined by fluorescence in situ hybridization (FISH). RESULTS: HER-2/neu amplification was observed in 29/115 (25%) tumors, 18 from moderate-low-dose and 11 from high-dose group. In the univariate analysis, a high Ki67 index (> or =20%) and positive clinical axillary nodes were predictive of an objective tumor response (P = 0.033 and 0.001, respectively). In the multivariate analysis, Ki67 was the only factor predictive of response (OR = 3.08, 95% CI = 1.1-8.5, P = 0.03). HER-2/neu status was not a factor in predicting objective response to different anthracycline dose intensities. The same finding was observed with regards to HR and Ki67. CONCLUSIONS: In our series, no significant dose-response relationship was found according to HER-2/neu status.


Asunto(s)
Antraciclinas/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Biomarcadores de Tumor/análisis , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/genética , Amplificación de Genes , Genes erbB-2 , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/cirugía , Relación Dosis-Respuesta a Droga , Femenino , Humanos , Antígeno Ki-67 , Persona de Mediana Edad , Análisis Multivariante , Terapia Neoadyuvante , Valor Predictivo de las Pruebas , Pronóstico , Estudios Retrospectivos , Resultado del Tratamiento
4.
Eur J Intern Med ; 17(1): 32-7, 2006 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-16378883

RESUMEN

BACKGROUND: Given the great public demand for unconventional medicines (UM) in most Western countries, the aim of this study was to assess the attitudes to, and supply of, UM by physicians in Italy. METHODS: A cross-sectional survey of all of the physicians belonging to the Ordine dei Medici of the province of Parma was carried out by means of an anonymous questionnaire mailed to 2631 physicians and returned by 1734 (66%). The outcome measurements were the prevalence of opinions concerning UM, the prevalence of its practice, and the extent to which demographic and practice characteristics influenced it. RESULTS: The majority of the physicians (53%) attributed some efficacy to UM. This belief was significantly more frequent amongst female physicians (p<0.01). A small proportion of physicians (8%) claimed to practice some form of UM. The following types of physicians were also more likely to practice UM: rural physicians (p=0.01), those working as National Health Service (NHS) general practitioners or in private practice (p<0.0001) and those specialized in areas relating to the musculoskeletal apparatus or anesthesia/intensive care (p<0.01). CONCLUSIONS: This Italian survey found a smaller proportion of physicians practicing UM on their patients than those indicated by other published surveys.

5.
Tumori ; 91(2): 121-5, 2005.
Artículo en Inglés | MEDLINE | ID: mdl-15948537

RESUMEN

AIMS AND BACKGROUND: Taxanes are largely metabolized and almost exclusively excreted in the feces by the liver through the biliary pathway, thus providing a rationale for investigating the activity of their hepatic artery delivery in case of liver metastases. STUDY DESIGN: The aim of this study was to assess the feasibility of administering docetaxel via the hepatic artery in advanced breast cancer patients in whom the liver was the only or the predominant site of metastatic involvement. The dose was increased cycle by cycle in a prospective manner. RESULTS: Ten eligible patients were enrolled. The median administered dose in the last cycle was 65 mg/m2 (range, 40-100 mg/m2). The treatment was generally well tolerated, and only one patient stopped after two cycles because of toxicity. Four of the 9 eligible patients with assessable liver tumors achieved an objective response. After a median follow-up of 41 months, 4 of the 10 eligible (and 11 treated) patients were alive with a median overall survival of 46 months. CONCLUSIONS: The administration of docetaxel via the hepatic artery is feasible. The highly interesting response and survival results observed in this limited series of patients warrant further studies.


Asunto(s)
Neoplasias de la Mama/patología , Neoplasias Hepáticas/tratamiento farmacológico , Neoplasias Hepáticas/secundario , Hígado/irrigación sanguínea , Hígado/patología , Taxoides/administración & dosificación , Taxoides/uso terapéutico , Adulto , Anciano , Neoplasias de la Mama/tratamiento farmacológico , Docetaxel , Estudios de Factibilidad , Femenino , Humanos , Inyecciones Intraarteriales , Neoplasias Hepáticas/irrigación sanguínea , Persona de Mediana Edad , Taxoides/efectos adversos , Tomógrafos Computarizados por Rayos X
6.
Cancer ; 103(10): 2109-17, 2005 May 15.
Artículo en Inglés | MEDLINE | ID: mdl-15803492

RESUMEN

BACKGROUND: The current study was designed to assess the activity and safety of a novel combination therapy for patients with recurrent or refractory aggressive non-Hodgkin lymphoma (NHL). METHODS: Forty-three consecutive patients with recurrent or refractory aggressive NHL were treated with lomustine (chloroethylnitrosourea [CCNU]; 60 mg/m2 on Day 1), ifosfamide (1.5 g/m(2 on Days 1, 2 and 21, 22), bleomycin (5 mg/m2 on Days 1, 5 and 21, 25), vincristine (1.4 mg/m2 on Days 1, 8 and 21, 28), and cisplatin (25 mg/m2 on Days 3, 4, 5 and 23, 24, 25), every 42 days (CIBO-P regimen). RESULTS: Thirty-nine patients (91%) were evaluable for response. The median patient age was 63 years. Thirty-five percent of the patients had received > or = 2 lines of previous chemotherapy and 40% had elevated lactate dehydrogenase levels at the time of treatment initiation. The overall objective response rate was 77% (95% confidence interval [95% CI], 63-90%), including 19 (49%) complete (CR) and 11 (28%) partial responses. CIBO-P induced responses in primary refractory disease and in patients treated for second or subsequent disease recurrences. A CR with previous therapy was the most important factor associated with a significantly higher CR rate. The median duration of response was 6 months (95% CI, 4.4-7.7 months) and the median survival duration was 10.7 months (95% CI, 5.9-18.1 months). Five patients (11.6%) remained disease free for > or = 24 months. By multivariate analysis, a CR with previous therapy and average dose intensity of CIBO-P drugs were independent prognostic factors for time-to-treatment failure, whereas a CR with previous therapy and serum lactate dehydrogenase were independent predictors for survival. Myelosuppression was the most frequent serious complication of this regimen. However, none of the patients had hemorrhage with thrombocytopenia, and only 2 patients (5%) had febrile neutropenia. CONCLUSIONS: In the current study, CIBO-P was a novel, highly active, and safe combination therapy for patients with refractory disease with a poor prognosis or for patients with multiply recurrent aggressive NHL.


Asunto(s)
Antibióticos Antineoplásicos/administración & dosificación , Antineoplásicos Alquilantes/administración & dosificación , Antineoplásicos Fitogénicos/administración & dosificación , Antineoplásicos/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Bleomicina/administración & dosificación , Cisplatino/administración & dosificación , Ifosfamida/administración & dosificación , Lomustina/administración & dosificación , Linfoma no Hodgkin/tratamiento farmacológico , Vincristina/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Médula Ósea/efectos de los fármacos , Estudios de Cohortes , Supervivencia sin Enfermedad , Femenino , Estudios de Seguimiento , Humanos , L-Lactato Deshidrogenasa/sangre , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/tratamiento farmacológico , Inducción de Remisión , Tasa de Supervivencia
7.
Tumori ; 90(3): 276-9, 2004.
Artículo en Inglés | MEDLINE | ID: mdl-15315304

RESUMEN

AIMS AND BACKGROUND: Periodic follow-up after primary treatment for breast cancer is a common procedure for the early detection of recurrent disease in the asymptomatic state. Anyway, there is no clinical evidence that treatment of metastases may improve the prognosis if applied in the asymptomatic state. The aim of the present study was to investigate the modality of detection of the first relapse in the asymptomatic vs the symptomatic state. METHODS: We retrospectively analyzed 717 breast cancer patients who had been consecutively referred to the Parma Oncology Division during the period 1986 to December 1988. Recurrences were detected in the course of periodic follow-up. RESULTS: A total of 211 of the 408 patients evaluated had a first relapse with a median follow-up of 94.7 months. Local and distant recurrences were 49% and 47%, respectively. Bone recurrences represented 24% of the total first recurrences, then chest wall recurrences in 23%, local regional nodes in 13%, lung in 7%, liver in 4%, and brain in 2%. The distribution of the studied patients according to recurrence site and asymptomatic or symptomatic state was different: 69% of asymptomatic patients (110) had a local recurrence vs 31% of symptomatic patients (101). A difference in survival was recorded in favor of cases detected in the asymptomatic state (P <0.001). CONCLUSIONS: The present study suggests that an early detection of local recurrence might have a favorable impact on the prognosis of patients followed after primary treatment for breast cancer. It should be considered that any difference in survival could also be explained by several "biases" and that breast cancer follow-up is still an area of investigation open to discussion in which many questions remain to be clarified.


Asunto(s)
Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/prevención & control , Vigilancia de la Población , Adulto , Anciano , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/patología , Diagnóstico Precoz , Femenino , Humanos , Persona de Mediana Edad , Recurrencia Local de Neoplasia/diagnóstico , Recurrencia Local de Neoplasia/prevención & control , Vigilancia de la Población/métodos , Pronóstico , Medición de Riesgo , Análisis de Supervivencia
8.
Tumori ; 90(3): 280-4, 2004.
Artículo en Inglés | MEDLINE | ID: mdl-15315305

RESUMEN

AIMS AND BACKGROUND: We previously designed and tested combinations made up of the CMF agents, two at a time by rotation, and of doxorubicin or epirubicin. The present study was aimed to similarly test new combinations made up of the CMF agents, two at a time by rotation, and paclitaxel or docetaxel. METHODS: The doses of each taxane were escalated with the objective of reaching at least a single dose level of 90 mg/m2 of paclitaxel and 45 mg/m2 of docetaxel on days 1 and 8 of each four-week cycle. Thirty-two patients with advanced breast carcinoma were randomized to receive increasing doses of paclitaxel (45, 65, 80, 90 and 100 mg/m2) or docetaxel (30, 35, 40, 45 and 50 mg/m2) together with the CMF agents at the same dose as that used in the conventional regimen. Each dose level was administered to a triplet of patients. No direct comparison of the two taxanes was made. RESULTS: The fourth dose level was reached for paclitaxel and docetaxel. The most important toxicities were grade 4 neutropenia and grade 1-2 nausea/vomiting and stomatitis. The objective response rate, assessed only after the third cycle at any dose level, was 31% (95% CI, 15-47%). CONCLUSIONS: The combinations of the CMF agents (two at a time in rotation) with paclitaxel (90 mg/m2) or docetaxel (45 mg/m2) on days 1 and 8 of each four-week cycle are feasible and lead to definite signs of therapeutic activity, and the side effects are generally mild. Further studies are therefore warranted.


Asunto(s)
Antineoplásicos Fitogénicos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Paclitaxel/uso terapéutico , Taxoides/uso terapéutico , Adulto , Anciano , Antineoplásicos Fitogénicos/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias de la Mama/patología , Cisplatino/administración & dosificación , Docetaxel , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Estudios de Factibilidad , Femenino , Fluorouracilo/administración & dosificación , Humanos , Metotrexato/administración & dosificación , Persona de Mediana Edad , Estadificación de Neoplasias , Paclitaxel/administración & dosificación , Análisis de Supervivencia , Taxoides/administración & dosificación , Resultado del Tratamiento
9.
N Engl J Med ; 350(11): 1081-92, 2004 Mar 11.
Artículo en Inglés | MEDLINE | ID: mdl-15014181

RESUMEN

BACKGROUND: Tamoxifen, taken for five years, is the standard adjuvant treatment for postmenopausal women with primary, estrogen-receptor-positive breast cancer. Despite this treatment, however, some patients have a relapse. METHODS: We conducted a double-blind, randomized trial to test whether, after two to three years of tamoxifen therapy, switching to exemestane was more effective than continuing tamoxifen therapy for the remainder of the five years of treatment. The primary end point was disease-free survival. RESULTS: Of the 4742 patients enrolled, 2362 were randomly assigned to switch to exemestane, and 2380 to continue to receive tamoxifen. After a median follow-up of 30.6 months, 449 first events (local or metastatic recurrence, contralateral breast cancer, or death) were reported--183 in the exemestane group and 266 in the tamoxifen group. The unadjusted hazard ratio in the exemestane group as compared with the tamoxifen group was 0.68 (95 percent confidence interval, 0.56 to 0.82; P<0.001 by the log-rank test), representing a 32 percent reduction in risk and corresponding to an absolute benefit in terms of disease-free survival of 4.7 percent (95 percent confidence interval, 2.6 to 6.8) at three years after randomization. Overall survival was not significantly different in the two groups, with 93 deaths occurring in the exemestane group and 106 in the tamoxifen group. Severe toxic effects of exemestane were rare. Contralateral breast cancer occurred in 20 patients in the tamoxifen group and 9 in the exemestane group (P=0.04). CONCLUSIONS: Exemestane therapy after two to three years of tamoxifen therapy significantly improved disease-free survival as compared with the standard five years of tamoxifen treatment.


Asunto(s)
Androstadienos/uso terapéutico , Antineoplásicos Hormonales/uso terapéutico , Inhibidores de la Aromatasa , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias Hormono-Dependientes/tratamiento farmacológico , Tamoxifeno/uso terapéutico , Administración Oral , Anciano , Androstadienos/efectos adversos , Antineoplásicos Hormonales/efectos adversos , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/cirugía , Quimioterapia Adyuvante , Supervivencia sin Enfermedad , Método Doble Ciego , Antagonistas de Estrógenos/efectos adversos , Antagonistas de Estrógenos/uso terapéutico , Femenino , Humanos , Persona de Mediana Edad , Posmenopausia , Receptores de Estrógenos/análisis , Tamoxifeno/efectos adversos
10.
Am J Clin Oncol ; 26(6): 535-42, 2003 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-14663368

RESUMEN

We designed the P-CHOP regimen, which involves the addition of cisplatin (P) to the standard CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) regimen, and investigated its activity and its toxicities in a single institution phase II study. Twenty-two consecutive patients with untreated, aggressive, stage I-IV non-Hodgkin lymphoma were enrolled in the study. Cisplatin was administered at a dose of 40 mg/m2 on days 1 and 2, every 3 weeks; the dose and schedule of the other agents were identical to those used in the standard CHOP regimen. The complete remission (CR) rate was 86% in eligible and 80% in all the treated patients, which compares favorably with the CR rates of two recent randomized studies of CHOP versus other regimens. P-CHOP is an innovative regimen for the front-line treatment of aggressive non-Hodgkin lymphoma. It is feasible and warrants further research, which would ideally take the form of a randomized comparison of P-CHOP and CHOP, possibly with the addition of rituximab in both arms.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Cisplatino/administración & dosificación , Ciclofosfamida/administración & dosificación , Doxorrubicina/administración & dosificación , Linfoma no Hodgkin/tratamiento farmacológico , Prednisona/administración & dosificación , Vincristina/administración & dosificación , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Inducción de Remisión , Análisis de Supervivencia
11.
Breast Cancer Res Treat ; 80(3): 313-20, 2003 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-14503803

RESUMEN

We hypothesized that the advantage of adjuvant anthracycline-containing regimens over the conventional CMF combination found by the Early Breast Cancer Trialists' Collaborative Group overview may depend on the 'additive' or 'substitutive' nature of the administration of anthracycline in the experimental arm. The aim of this study was to explore this hypothesis. By means of computerized and hand searches, we identified 21 published randomized trials comparing early breast cancer adjuvant chemotherapies with and without anthracycline, and divided them into those in which the use of anthracycline was substantially 'additive' or substantially 'substitutive'. The trial results were then judged 'positive' or 'negative' depending on whether they showed statistically significant differences in disease-free or overall survival in favor of the anthracycline-containing regimen. Anthracycline was substantially 'additive' in 14 trials, eight of which were 'positive', and substantially 'substitutive' in seven, all of which were 'negative': this difference is statistically significant (P = 0.018). In conclusion this trial classification, an attempt to test a very simple unifying concept with the aim of explaining the different results of trials involving the administration of anthracyclines in the adjuvant setting of early breast cancer, significantly correlated with patient outcome. It therefore seems that anthracycline-containing chemotherapeutic regimens can be considered optimal or suboptimal depending on whether or not they reflect the potential benefit offered by anthracycline administration.


Asunto(s)
Antraciclinas/farmacología , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Estadificación de Neoplasias , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Neoplasias de la Mama/patología , Neoplasias de la Mama/cirugía , Quimioterapia Adyuvante , Ciclofosfamida/administración & dosificación , Femenino , Fluorouracilo/administración & dosificación , Humanos , Metotrexato/administración & dosificación , Ensayos Clínicos Controlados Aleatorios como Asunto , Reproducibilidad de los Resultados , Análisis de Supervivencia , Resultado del Tratamiento
12.
Cancer ; 95(2): 228-35, 2002 Jul 15.
Artículo en Inglés | MEDLINE | ID: mdl-12124820

RESUMEN

BACKGROUND: According to the overview of Early Breast Cancer Trialists' Collaborative Group, anthracycline containing regimens are superior to cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) as adjuvant chemotherapy for breast carcinoma, but no comparative information is available in terms of primary chemotherapy. In the current randomized controlled trial, the authors compared CMF with a chemotherapy regimen including CMF, epirubicin, and vincristine (CMFEV). METHODS: Two hundred eleven patients with Stages I and II palpable breast carcinoma and tumor diameter > 2.5 cm or < or = 2.5 cm with cytologically proven axillary lymph node involvement were randomized to receive CMF (arm A) or CMFEV regimen (arm B) for four cycles before surgery. After surgery, patients in both arms received adjuvant CMF for three cycles; the postmenopausal patients also received tamoxifen for two years. RESULTS: There were no significant differences in the complete response (CR) and in the CR plus partial response (PR) rates between the two arms. In the subset analysis, among premenopausal patients, significantly higher rates of CR (26% vs 4%, P = 0.004) and of CR + PR rates (80% vs 54%, P = 0.007) were observed in the CMFEV, as compared to the CMF arm. Multivariate analysis confirmed the presence of a significant interaction between menopausal status and type of treatment on the probability of achieving CR (P = 0.02) or CR + PR (P = 0.01). There were no major differences in the side effects of the two treatments, with the exception of more frequent alopecia in the experimental arm. CONCLUSIONS: The results of the current study are in line with those of previous published randomized clinical trials comparing regimens without and with anthracycline as adjuvant treatment, indicating an agreement between the short term response to primary chemotherapy and the long term results observed in the adjuvant setting.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias de la Mama/cirugía , Quimioterapia Adyuvante , Ciclofosfamida/administración & dosificación , Ciclofosfamida/efectos adversos , Epirrubicina/administración & dosificación , Epirrubicina/efectos adversos , Femenino , Fluorouracilo/administración & dosificación , Fluorouracilo/efectos adversos , Humanos , Modelos Logísticos , Metástasis Linfática , Menopausia , Metotrexato/administración & dosificación , Metotrexato/efectos adversos , Persona de Mediana Edad , Análisis Multivariante , Estudios Prospectivos , Vincristina/administración & dosificación , Vincristina/efectos adversos
13.
Tumori ; 88(2): 85-8, 2002.
Artículo en Inglés | MEDLINE | ID: mdl-12088263

RESUMEN

The so-called norms of good clinical practice have been incorporated into the Italian regulatory legislation governing clinical trials sponsored by pharmaceutical companies, but there are no legislative provisions governing independent clinical trials: ie those not sponsored by the industry. The pharmaceutical industry has recently increased considerably its commitment to sponsored trials by establishing a series of economic relationships with individual researchers and hospital or university institutions. It has also set up and strengthened a series of bodies and service companies with the aim of making the clinical trials "machine" more efficient. Such developments have aroused alarm in the medical literature because of the risk that they may have negative effects on the freedom of research and research results. At the same time, there is also the risk that independent clinical trials will be greatly penalized by having to compete with sponsored trials in terms of patient enrollment, and because they are currently having to face a series of difficulties connected with the lack or scarcity of economic resources provided by the State or non-profit organizations, with problems relating to patient insurance and to the availability of the necessary drugs. However, the objective of independent trials is to improve the medical art by answering specific diagnostic and therapeutic questions, whereas that of industry-sponsored trials is to generate money, directly or indirectly, by means of the registration of new drugs. It is therefore now necessary to ensure better surveillance of the influence of pharmaceutical companies over the trials they sponsor (as a minimum by ensuring the transparency of a series of potential conflicts of interest between them and clinical researchers) and, simultaneously, protect independent trials from coming to an inglorious end by means of specific support initiatives such as those proposed in this article.


Asunto(s)
Ensayos Clínicos como Asunto , Conflicto de Intereses , Industria Farmacéutica , Ética Profesional , Humanos , Cobertura del Seguro , Sector Público
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