A dose finding study of carboplatin and gemcitabine in advanced non-small cell lung cancer.

The excellent activity of the cisplatin-gemcitabine combination and favorable toxicological profile of carboplatin are the basis of carboplatin-gemcitabine combination therapy for non-small cell lung cancer. We carried out a dose-finding study with the aim of establishing the maximum tolerated dose (MTD) of carboplatin on day 1 in combination with gemcitabine at the dose of 1000 mg/m2 on days 1 and 8 in a 21-day cycle. The starting dose level for carboplatin was the area under the concentration time curve (AUC) 4 mg/ml/min. 18 patients were treated and a dose limiting toxicity was observed in 2 cases at the level of AUC 6 mg/ml/min. AUC 5 mg/ml/min was considered as the MTD for carboplatin in our regimen. Notably, 7 objective responses were observed.

[Resources and subsidies of scientific nature of the Instituti di Ricovero e Cura by geographic areas: inequalities between Center-North and South]. / Analisi delle risorse e delle prestazioni degli Istituti di Ricovero e Cura a Carattere Scientifico per aree geografiche: squilibrio fra Centro-Nord e Sud.

The Authors assess investments and resources appropriated for research and technological innovation and highlight the imbalance existing between the areas of Central-Northern and Southern Italy. In particular, data relative to Comprehensive Health Care Institutes (IRCCS) fully confirm the diversity between the Central-North and the South; indeed, in terms of economic resources and personnel, totals in this latter region amount to 13.8% and 10.5% of national figures respectively. The role that IRCCSes might assume within the framework of an effective program of the re-qualification and development of scientific research and health care in Italy, especially in Southern areas, is thus confirmed.

[Scientific institutions for treatment and care: purpose, characteristics and specific role in the oncologic sector]. / Istituti di ricovero e cura a carattere scientifico: finalità, caratteristiche e ruolo specifico nel settore oncologico.

The qualities of Comprehensive Health Care Institutes facilities established to foster, carry out and coordinate activities of scientific research and assistance in the field of biomedicine are described. At present there are 23 centers, their activity being based on two fundamental features: 1) topical research in specific themes characterizing the role these Institutes continuously play; 2) specialized research concerning subjects of particular interest and/or urgency suggested by the Ministry of Health.

[Ethics committees: international experience and of the National Institute for cancer research of Genoa]. / Comitati etici: esperienze internazionali e dell'Istituto Nazionale per la ricerca sul cancro di Genova.

The aim of the present study is to describe the constitutions and functions of Ethics Committees and Institutional Review Boards. In particular, the experience of the National Institute for Cancer Research of Genoa in which the Authors carry out their activity is presented.

Cisplatin and gemcitabine in malignant pleural mesothelioma: a phase II study.

Aims of this study were to evaluate the activity and toxicity of gemcitabine and cisplatin combination in malignant pleural mesothelioma (MPM). Patients with histologically proven MPM, < 75 years of age, Eastern Cooperative Oncology Group (ECOG) performance status (PS) < or = 2, and measurable MPM were eligible. Patients received gemcitabine 1250 mg/m intravenously on days 1 and 8 and cisplatin 75 mg/m on day 2, every 21 days, for a maximum of 6 cycles. From May 1999 to May 2001, 35 chemonaive patients (median age, 61 years) were enrolled. A total of 177 cycles were administered (median 5 cycles; range 1 to 6). One patient was not evaluable for response and toxicity. Nine (26%) patients had partial responses, 11 (32%) patients had progressive disease, and 14 (41%) stable disease. Median survival for all patients was 13 months. Median progression-free survival was 8 months. Grade 3 (World Health Organization) nausea and vomiting occurred in 35% of patients. Grade 3/4 anemia, grade 3/4 thrombocythemia, and grade 3/4 neutropenia were assessed in 24%, 52%, and 61% of patients, respectively. All other side effects were mild. In conclusion, gemcitabine-cisplatin combination seems to be moderately active in MPM. Furthermore, at this dose and schedule, the toxicity profile could be acceptable.

[Bioethics and drug experimentation in hospitalized patients]. / Bioetica e sperimentazione dei farmaci su pazienti ospedalizzati.

The authors discuss about clinical experimentation with drugs involving hospitalized subjects in consideration of four principles of Bioethics: Autonomy, Beneficence, Non Maleficence and Justice. This article explores also the problems linked to the application of good clinical practice according to the European and Italian recent rules. Human integrity, respect of patient's dignity, informed consent, correct methods, placebo, Ethics committees represent the essential basis for those researchers that intend conduct clinical trials really "with subject and not on the subject".