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1.
Arzneimittelforschung ; 62(12): 590-4, 2012 Dec.
Article in English | MEDLINE | ID: mdl-23086581

ABSTRACT

Chalcones constitute one of the major classes of natural products belonging to the flavonoid family, and they have been reported as having a range of important therapeutic activities, including some chalcones are effective as antimicrobial agents. Currently, the search for new structures with antimicrobial activity has been intensified due to the emergence of many strains resistant to antibiotics currently used to treat infectious diseases.3 chalcone series (amino, acetamido and nitrochalcones) were prepared (23 compounds) and evaluated for their antimicrobial and cytotoxic potential. The effects of substituents on their respective activities also was evaluated.The results showed that 4 aminochalcones (2, 4, 8, 9), 3 acetoamidochalcones (10, 14, 18) and 3 nitrochalcones (20, 22, 23), exhibited antifungal effects. The aminochalcones were more toxic than the acetamidochalcones, while the nitrochalcones did not present any toxic effect. It was verified that there seems to be structure-activity correlation in some electron-donating and withdrawing substituents groups in rings A and B of the synthetized chalcone analogues and its antifungal and cytotoxic activity.


Subject(s)
Anti-Infective Agents/chemical synthesis , Anti-Infective Agents/pharmacology , Antineoplastic Agents/chemical synthesis , Antineoplastic Agents/pharmacology , Chalcones/chemical synthesis , Chalcones/pharmacology , Animals , Anti-Bacterial Agents/chemical synthesis , Anti-Bacterial Agents/pharmacology , Antifungal Agents/chemical synthesis , Antifungal Agents/pharmacology , Artemia , Culture Media , Lethal Dose 50 , Magnetic Resonance Spectroscopy , Microbial Sensitivity Tests , Quantitative Structure-Activity Relationship
2.
Methods Find Exp Clin Pharmacol ; 32(10): 707-11, 2010 Dec.
Article in English | MEDLINE | ID: mdl-21225005

ABSTRACT

The present study evaluated the antinociceptive properties of an alkaloid extract and 2-phenylquinoline obtained from the bark of Galipea longiflora Krause (Rutaceae) against different models of pain in mice. The results demonstrate that the alkaloid extract caused a pronounced antinociceptive effect with the main alkaloid detected, 2-phenylquinoline, exhibiting moderate activity. The alkaloid extract had a calculated ID50 value of 20.3 mg/kg i.p. and less than 50 mg/kg p.o. against the writhing test which proved to be more effective than the reference drugs when administered by both routes. The ID50 of 2-phenylquinoline was 52.8 mg/kg i.p. with an inhibition of 24.5% when administered orally at 100 mg/kg. In the formalin test the alkaloid extract, but not 2-phenylquinoline, significantly inhibited both phases of pain (neurogenic and inflammatory) at 10 mg/kg i.p. with inhibitions of 37.4% and 58.3%, respectively. The alkaloid extract and 2-phenylquinoline caused only a modest effect in the capsaicin and glutamate tests. In the hot plate test, the alkaloid extract increased the latency time by 25.6% at 10 mg/kg i.p. compared to 2-phenylquinoline which was less effective. It appears that the antinociceptive effects of this plant may be attributed, at least in part, to the presence of some antinociceptive alkaloids in minor concentrations.


Subject(s)
Analgesics/pharmacology , Pain/drug therapy , Plant Extracts/pharmacology , Rutaceae/chemistry , Administration, Oral , Alkaloids/administration & dosage , Alkaloids/isolation & purification , Alkaloids/pharmacology , Analgesics/administration & dosage , Analgesics/isolation & purification , Animals , Disease Models, Animal , Dose-Response Relationship, Drug , Male , Mice , Plant Extracts/administration & dosage , Quinolines/administration & dosage , Quinolines/isolation & purification , Quinolines/pharmacology
3.
G Ital Med Lav Ergon ; 30(3): 228-35, 2008.
Article in Italian | MEDLINE | ID: mdl-19069220

ABSTRACT

The board of the Thematic Section on Preventive Medicine for Health Care Workers of the Italian Society of Occupational Medicine and Industrial Hygiene (SIMLII) programmed a national conference on occupational risks of health care workers to be held in late 2009. Main topics will be: a) biohazards; b) biomechanical risk; c) psychosocial factors. Three different working groups were established to tackle critical aspects and suggest practical recommendations to occupational health professionals. Preliminary issues are presented while final results will be presented at the conference on September 2009.


Subject(s)
Health Personnel , Occupational Diseases/prevention & control , Occupational Health , Disease Transmission, Infectious/prevention & control , Humans , Italy , Musculoskeletal Diseases/prevention & control , Risk Factors , Stress, Psychological/prevention & control
4.
Ann Oncol ; 18(2): 324-30, 2007 Feb.
Article in English | MEDLINE | ID: mdl-17071935

ABSTRACT

BACKGROUND: Triplet regimens were occasionally reported to produce a higher response rate (RR) than doublets in locally advanced or metastatic non-small-cell lung cancer (NSCLC). This trial was conducted to assess (i) whether the addition of cisplatin (CDDP) to either gemcitabine (GEM) and vinorelbine (VNR) or GEM and paclitaxel (PTX) significantly prolongs overall survival (OS) and (ii) to compare the toxicity of PTX-containing and VNR-containing combinations. PATIENTS AND METHODS: Stage III or IV NSCLC patients were randomly assigned to (i) GEM 1000 mg/m(2) and VNR 25 mg/m(2) on days 1 and 8 (GV arm); (ii) GEM 1000 mg/m(2) and PTX 125 mg/m(2) on days 1 and 8 (GT arm); (iii) GV plus CDDP 50 mg/m(2) on days 1 and 8 (PGV arm); and (iv) GT plus CDDP 50 mg/m(2) on days 1 and 8 (PGT arm). Treatments were repeated every 3 weeks for a maximum of six cycles. RESULTS: A total of 433 (stage III, 160; stage IV, 273) patients were randomly allocated to the study. RR was 48% [95% confidence interval (CI), 42% to 54%] for triplets and 35% (95% CI, 32% to 38%) for doublets (P = 0.004). Median progression-free survival (6.1 versus 5.5 months, P = 0.706) and median OS (10.7 versus 10.5 months, P = 0.379) were similar. CDDP significantly increased the occurrence of severe neutropenia (35% versus 13%), thrombocytopenia (14% versus 4%), anaemia (9% versus 3%), vomiting (6% versus 0.5%), and diarrhoea (6% versus 2%). Conversely, frequency of severe neutropenia (30% versus 17%) and thrombocytopenia (11% versus 6%) was significantly higher with VNR-containing regimens. CONCLUSIONS: Adding CDDP to GV or GT significantly increased RR, but did not prolong the OS of patients. Among doublets, the GT regimen should be preferred in view of its better safety profile.


Subject(s)
Adenocarcinoma/drug therapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Large Cell/drug therapy , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Squamous Cell/drug therapy , Lung Neoplasms/drug therapy , Adenocarcinoma/secondary , Adult , Aged , Carcinoma, Large Cell/secondary , Carcinoma, Non-Small-Cell Lung/pathology , Carcinoma, Squamous Cell/secondary , Deoxycytidine/administration & dosage , Deoxycytidine/analogs & derivatives , Female , Humans , Italy , Lung Neoplasms/pathology , Male , Middle Aged , Paclitaxel/administration & dosage , Prognosis , Survival Rate , Vinblastine/administration & dosage , Vinblastine/analogs & derivatives , Vinorelbine , Gemcitabine
5.
Ann Oncol ; 17 Suppl 7: vii10-4, 2006 Jun.
Article in English | MEDLINE | ID: mdl-16760270

ABSTRACT

BACKGROUND: Tamoxifen, for many years the 'gold standard' in the adjuvant setting for the management of endocrine sensitive early breast cancer, is associated with an increased risk of endometrial cancer and other life-threatening events. Moreover, many women relapse during or after tamoxifen therapy due to the development of resistance. This provided the rationale for a switching trial with anastrozole, the updated results of which are reported here. PATIENTS AND METHODS: This trial investigated the efficacy of switching to anastrozole for women already receiving tamoxifen. After 2-3 years of tamoxifen treatment, postmenopausal, node-positive, ER-positive patients were randomized to receive either anastrozole 1 mg/day or to continue tamoxifen, 20 mg/day, giving a total duration of 5-years treatment. The primary end point was disease-free survival and secondary endpoints were event-free survival, overall survival and safety. RESULTS: A total of 448 patients were enrolled. At a median follow-up time of 64 months (range 12-93), 63 events had been reported in the tamoxifen group compared with 39 in the anastrozole group [HR 0.57 (95% CI 0.38-0.85) P = 0.005]. Relapse-free and overall survival were also longer in the anastrozole group [HR 0.56 (95% CI 0.35-0.89) P = 0.01 and 0.56 (95% CI 0.28-1.15) P = 0.1]. However, the latter difference was not statistically significant. Overall more patients in the anastrozole group experienced at least one adverse event (209 versus 151: P = 0.000). However, numbers of patients experiencing serious adverse events were comparable (37 versus 40, respectively: P = 0.7). CONCLUSIONS: Switching to anastrozole after the first 2-3 years of treatment was confirmed to improve event-free and relapse-free survival of postmenopausal, node-positive, ER-positive early breast cancer patients already receiving adjuvant tamoxifen.


Subject(s)
Aromatase Inhibitors/therapeutic use , Breast Neoplasms/drug therapy , Nitriles/therapeutic use , Selective Estrogen Receptor Modulators/therapeutic use , Tamoxifen/therapeutic use , Triazoles/therapeutic use , Anastrozole , Antineoplastic Agents, Hormonal/adverse effects , Antineoplastic Agents, Hormonal/therapeutic use , Aromatase Inhibitors/adverse effects , Breast Neoplasms/metabolism , Chemotherapy, Adjuvant , Disease-Free Survival , Female , Follow-Up Studies , Humans , Nitriles/adverse effects , Postmenopause , Receptors, Estrogen/biosynthesis , Selective Estrogen Receptor Modulators/adverse effects , Tamoxifen/adverse effects , Triazoles/adverse effects
6.
Farmaco ; 60(4): 321-6, 2005 Apr.
Article in English | MEDLINE | ID: mdl-15848207

ABSTRACT

Marrubiin, a furane labdane diterpene, is the main analgesic compound present in Marrubium vulgare, a medicinal plant used in Brazil and other countries to treat several ailments. Considering its important pharmacological action, as well as its high yield, some structural modifications were performed in order to obtain more active compounds. Success was obtained in reducing the lactonic function, in the formation of marrubiinic acid and two esterified derivatives, which exhibited significant analgesic effect against the writhing test in mice. Marrubiinic acid showed better activity and excellent yield, and its analgesic effect was confirmed in other experimental models of pain in mice, suggesting its possible use as a model to obtain new and potent analgesic agents.


Subject(s)
Analgesics/chemical synthesis , Diterpenes/chemical synthesis , Marrubium/chemistry , Analgesics/isolation & purification , Analgesics/therapeutic use , Animals , Disease Models, Animal , Diterpenes/isolation & purification , Diterpenes/therapeutic use , Male , Mice , Molecular Structure , Pain/drug therapy , Plant Leaves/chemistry , Structure-Activity Relationship
7.
Ann Oncol ; 16(6): 878-86, 2005 Jun.
Article in English | MEDLINE | ID: mdl-15837702

ABSTRACT

PURPOSE: The primary end point of this phase III trial was to compare the response rate (RR) of oxaliplatin (OXA) plus levo-folinic acid (l-FA) and 5-fluorouracil (5-FU) bolus with that of irinotecan (IRI) plus l-FA and 5-FU bolus in advanced colorectal carcinoma. PATIENTS AND METHODS: Patients with measurable metastatic colorectal carcinoma were randomly allocated to receive: IRI 200 mg/m(2) on day 1, l-FA 250 mg/m(2) intravenously plus 5-FU 850 mg/m(2) on day 2 (IRIFAFU); or OXA 100 mg/m(2) on day 1, l-FA 250 mg/m(2) plus 5-FU 1050 mg/m(2) on day 2 [OXAFAFU high dose (hd)]. Cycles were given every 2 weeks. After a planned interim analysis, OXA was reduced to 85 mg/m(2) and 5-FU to 850 mg/m(2) [OXAFAFU low dose (ld)]. RESULTS: Two hundred and seventy-four patients (IRIFAFU, 135; OXAFAFUhd, 71; OXAFAFUld, 68) were treated. Forty-two confirmed responses were achieved with IRIFAFU, 29 with OXAFAFUhd and 32 with OXAFAFUld. The response rate with OXAFAFU [44%; 95% confidence interval (CI) 35% to 52%] was significantly higher (P=0.029) than that of IRIFAFU (31%; 95% CI 23% to 40%). Occurrence of grade > or =3 neutropenia with OXAFAFUld was similar to that for IRIFAFU (29% versus 31%), while severe diarrhoea was significantly lower (12% versus 24%). Median failure-free survival (7 versus 5.8 months; P=0.046) and overall survival of patients (18.9 versus 15.6 months; P=0.032) were significantly prolonged with OXAFAFU. CONCLUSIONS: OXAFAFU was more active and less toxic than IRIFAFU, and it should be preferred in the first-line treatment of advanced colorectal cancer patients.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Colorectal Neoplasms/drug therapy , Adult , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Colorectal Neoplasms/mortality , Female , Fluorouracil/administration & dosage , Humans , Leucovorin/administration & dosage , Male , Middle Aged , Organoplatinum Compounds/administration & dosage , Oxaliplatin
8.
Pharmazie ; 59(11): 879-81, 2004 Nov.
Article in English | MEDLINE | ID: mdl-15587592

ABSTRACT

Continuing our search for antinociceptive agents from natural sources, this study analyzed the antinociceptive effects of some fractions obtained from different parts (roots, flowers and fruits) of Calophyllum brasiliense, a Brazilian medicinal plant used to treat several diseases, including inflammation and pain. For this purpose, the writhing and formalin induced-pain models in mice were used. We also analyzed the chemical composition of these different parts and tested two pure compounds isolated from chloroform fraction (roots) identified as friedelin (1) and 1,5-dihydroxyxanthone (3), by direct comparison with authentic samples. The results showed that some fractions and both compounds exhibited considerable antinociception properties, particularly against the writhing test, and that these are more potent than acetyl salicylic acid and acetaminophen, two reference drugs used here for comparison.


Subject(s)
Analgesics, Non-Narcotic/pharmacology , Calophyllum/chemistry , Acetaminophen/pharmacology , Acetic Acid , Analgesics, Non-Narcotic/chemistry , Animals , Anti-Inflammatory Agents, Non-Steroidal/chemistry , Anti-Inflammatory Agents, Non-Steroidal/pharmacology , Aspirin/pharmacology , Chloroform , Chromatography, Thin Layer , Flowers/chemistry , Formaldehyde , Fruit/chemistry , Indomethacin/pharmacology , Methanol , Mice , Pain Measurement/drug effects , Plant Extracts/pharmacology , Plant Roots/chemistry , Solvents
9.
Br J Cancer ; 91(3): 489-97, 2004 Aug 02.
Article in English | MEDLINE | ID: mdl-15266334

ABSTRACT

The aim of this study was to assess whether a combination of gemcitabine (GEM) with either paclitaxel (PTX) or vinorelbine (VNR) could be more effective than GEM or PTX alone in elderly or unfit advanced non-small-cell lung cancer (NSCLC) patients. A total of 264 NSCLC patients aged >70 years with ECOG performance status (PS)< or =2, or younger with PS=2, were randomly treated with: GEM 1200 mg m(-2) on days 1, 8 and 15 every 28 days; PTX 100 mg m(-2) on days 1, 8 and 15 every 28 days; GEM 1000 mg m(-2) plus PTX 80 mg m(-2) (GT) on days 1 and 8 every 21 days; GEM 1000 mg m(-2) plus VNR 25 mg m(-2) (GV) on days 1 and 8 every 21 days. In all arms, an intra-patients dose escalation was applied over the first three courses, provided that no toxicity of WHO grade > or =2 had previously occurred. At present time, 217 (82%) patients had died. The median (months) and 1-year survival probability were 5.1 and 29% for GEM, 6.4 and 25% for PTX, 9.2 and 44% for GT, and 9.7 and 32% for GV. Multivariate analysis showed that PS< or =1 (hazard ratio (HR)=0.67; 95% CI 0.51-0.90), and doublet treatments (HR=0.76; 95% CI 0.59-0.99) were significantly associated with longer survival. Doublets produced no more toxicity than single agents. GT should be considered a reference regimen for elderly NSCLC patients with PS< or =1.


Subject(s)
Antimetabolites, Antineoplastic/therapeutic use , Antineoplastic Agents, Phytogenic/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Non-Small-Cell Lung/drug therapy , Deoxycytidine/analogs & derivatives , Deoxycytidine/therapeutic use , Lung Neoplasms/drug therapy , Paclitaxel/therapeutic use , Vinblastine/analogs & derivatives , Adult , Aged , Aged, 80 and over , Carcinoma, Non-Small-Cell Lung/pathology , Deoxycytidine/administration & dosage , Female , Health Status , Humans , Infusions, Intravenous , Lung Neoplasms/pathology , Male , Middle Aged , Paclitaxel/administration & dosage , Survival Analysis , Vinblastine/administration & dosage , Vinorelbine , Gemcitabine
10.
Ann Oncol ; 15(3): 433-9, 2004 Mar.
Article in English | MEDLINE | ID: mdl-14998845

ABSTRACT

BACKGROUND: This randomized phase II study was conducted to evaluate the efficacy of doxorubicin and docetaxel (DOC) administered either as a combination, an alternating or a sequential regimen in women with metastatic breast cancer. Secondary objectives included overall response, time to progression, survival and safety. PATIENTS AND METHODS: Patients with breast cancer (n=123) were randomized to receive doxorubicin and DOC either in combination (60 mg/m2 of each drug), or by alternated or sequential schedule (100 mg/m2 DOC and 75 mg/m2 doxorubicin) every 3 weeks for a maximum of eight cycles as first chemotherapy for stage IV disease. A second randomization allocated patients from each arm to receive prophylactic oral ciprofloxacin or no therapy to prevent febrile neutropenia. RESULTS: Patients received a median of eight cycles. In an intention-to-treat analysis, the overall response was 63%, 52% and 61% in the combination, alternating and sequential schedules, respectively. Corresponding rates of complete response were 15%, 14% and 11%. Grade 4 neutropenia was common in all arms (81%) and, together with febrile neutropenia, was significantly more frequent with the combination. Prophylaxis with ciprofloxacin did not reduce the incidence of febrile neutropenia or infection. Other frequent non-hematological adverse events included alopecia, nausea, vomiting, stomatitis and asthenia. Congestive heart failure only occurred in the combination arm (10%). CONCLUSION: All three schedules are feasible and endowed of good therapeutic activity. In view of the more pronounced toxicity and the risk of cardiac events because of the higher exposure to doxorubicin, the combination should be least favored when treating women with metastatic breast cancer. Prophylaxis with ciprofloxacin was ineffective and is not recommended.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Adolescent , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/mortality , Breast Neoplasms/secondary , Disease Progression , Docetaxel , Doxorubicin/administration & dosage , Female , Humans , Middle Aged , Survival Rate , Taxoids/administration & dosage , Time Factors
11.
Br J Cancer ; 89(6): 992-6, 2003 Sep 15.
Article in English | MEDLINE | ID: mdl-12966414

ABSTRACT

The aim of this study was to assess the safety and efficacy of biweekly irinotecan plus leucovorin-modulated 5-fluorouracil i.v. bolus in metastatic colorectal carcinoma according to the age of patients. For this purpose, we have analysed 108 patients randomly allocated to receive irinotecan 200 mg m(-2) i.v. (1-h infusion) on day 1, and L-leucovorin 250 mg m(-2) i.v. (1-h infusion) plus 5-fluorouracil 850 mg m(-2) i.v. bolus on day 2 every 2 weeks (IRIFAFU) in our previous SICOG 9801 trial. According to age, patients were retrospectively divided into three groups: younger (/=70 years, n=17). Apart from gender, pretreatment characteristics were well balanced across the three groups. WHO grade >/=3 neutropenia and diarrhoea affected on the whole 46 and 16 patients, respectively, without any significant difference according to age-grouping. Patients aged

Subject(s)
Adenocarcinoma/drug therapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Camptothecin/analogs & derivatives , Colorectal Neoplasms/drug therapy , Adenocarcinoma/secondary , Adult , Aged , Camptothecin/administration & dosage , Colorectal Neoplasms/pathology , Disease-Free Survival , Drug Administration Schedule , Female , Fluorouracil/administration & dosage , Humans , Infusions, Intravenous , Irinotecan , Leucovorin/administration & dosage , Male , Middle Aged , Retrospective Studies , Survival Rate , Treatment Outcome
13.
Ann Ig ; 15(5): 559-66, 2003.
Article in Italian | MEDLINE | ID: mdl-14969310

ABSTRACT

The Italian juridical and legislative aspects of vaccination based on a compulsory system are presented considering the medico-legal questions. The prospective of a voluntary system, as anticipated by many normatives and other official documents, is examined. The experience of some local health authorities on cases of in observance of the vaccinal obligation are detailed Finally professional risks for vaccinal operators are examined and the need of specific guidelines for parents' consent to compulsory vaccination during infancy is prospected.


Subject(s)
Immunization/legislation & jurisprudence , Italy , Voluntary Programs
15.
Ann Oncol ; 13(6): 866-73, 2002 Jun.
Article in English | MEDLINE | ID: mdl-12123331

ABSTRACT

PURPOSE: The purpose of this study was to compare the activity and toxicity of the combination of irinotecan (IRI) plus folinic acid (FA)-modulated 5-fluorouracil (5-FU) i.v. bolus with a regimen of double modulation of 5-FU with methotrexate (MTX) and FA in patients with advanced colorectal carcinoma. PATIENTS AND METHODS: Two-hundred and thirty-four patients were enrolled: 118 patients received IRI 200 mg/m2 (90-min i.v. infusion) on day 1, followed by levo-FA 250 mg/m2 (2-h i.v. infusion) and 5-FU 850 mg/m2 (i.v. bolus) on day 2 (IRIFAFU), and 116 patients received MTX 750 mg/m2 (2-h i.v. infusion) on day 1, followed by levo-FA 250 mg/m2 (2-h i.v. infusion) and FU 800 mg/m2 (i.v. bolus) on day 2 (MTXFAFU). Both cycles were repeated every 2 weeks until progression or to a maximum of 16 cycles. Response rate (RR) was the main end point of the study; responses were assessed every four cycles and confirmed after 2 additional months of treatment. RESULTS: RR was significantly greater with IRIFAFU (36%) than with MTXFAFU (20%) (P <0.001). Multivariate analysis showed that IRIFAFU was significantly associated with a greater activity (P = 0.028). Median progression-free survival was longer with IRIFAFU than with MTXFAFU (7.2 months compared with 4.8 months; P = 0.048). Median survival time (MST) did not differ between the two arms (14.7 months compared with 14.8 months, respectively). Patients not receiving second-line chemotherapy, however, lived longer when treated in the first-line with IRIFAFU (MST 11.9 months compared with 6.4 months; P = 0.038). IRIFAFU caused a significantly greater occurrence of grade 3 or 4 neutropenia (40% compared with 9%; P = 0.001) and diarrhoea (13% compared with 4%; P = 0.024), but a significantly lower incidence of stomatitis (3% compared with 12%; P = 0.007), than the comparative regimen. CONCLUSIONS: IRIFAFU appeared comparable in terms of activity and toxicity with other weekly or biweekly bolus or infusional combination regimens. IRIFAFU, however, seems easier to administer, because it does not require infusional catheter or pump devices, and it is less expensive. It may represent a new option for treating advanced colorectal carcinoma.


Subject(s)
Adenocarcinoma/drug therapy , Adenocarcinoma/pathology , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Camptothecin/analogs & derivatives , Colorectal Neoplasms/drug therapy , Colorectal Neoplasms/pathology , Adenocarcinoma/mortality , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Biopsy, Needle , Camptothecin/administration & dosage , Camptothecin/adverse effects , Colorectal Neoplasms/mortality , Disease-Free Survival , Dose-Response Relationship, Drug , Drug Administration Schedule , Female , Fluorouracil/administration & dosage , Fluorouracil/adverse effects , Humans , Irinotecan , Italy , Leucovorin/administration & dosage , Leucovorin/adverse effects , Male , Methotrexate/administration & dosage , Methotrexate/adverse effects , Middle Aged , Neoplasm Staging , Prognosis , Remission Induction , Survival Analysis , Treatment Outcome
16.
J Nephrol ; 14(2): 93-7, 2001.
Article in English | MEDLINE | ID: mdl-11411020

ABSTRACT

In 1998, the Italian Ministry of Health urged the Italian Society of Nephrology (SIN) to draft recommendations for uniform decision-making procedures in the field of dialysis. In accordance with the Ministry's specifications, at the time the Society approved diagnostic protocols regarding clinical questions, but without fully recognizing the multiple issues arising in complex medical situations where dialysis is likely to go on for a long time. The authors propose some guidelines for ethical conduct and their application, with special regard to medico-legal dilemmas, together with the principles of clinical guidelines that would further improve the "perceived quality" of chronic dialytic treatment.


Subject(s)
Bioethics , Kidney Failure, Chronic/therapy , Nephrology/standards , Renal Dialysis/standards , Decision Making , Humans , Italy
17.
J Clin Oncol ; 17(8): 2341-54, 1999 Aug.
Article in English | MEDLINE | ID: mdl-10561296

ABSTRACT

PURPOSE: This phase III study compared docetaxel and doxorubicin in patients with metastatic breast cancer who had received previous alkylating agent-containing chemotherapy. PATIENTS AND METHODS: Patients were randomized to receive an intravenous infusion of docetaxel 100 mg/m(2) or doxorubicin 75 mg/m(2) every 3 weeks for a maximum of seven treatment cycles. RESULTS: A total of 326 patients were randomized, 165 to receive doxorubicin and 161 to receive docetaxel. Overall, docetaxel produced a significantly higher rate of objective response than did doxorubicin (47.8% v 33.3%; P =.008). Docetaxel was also significantly more active than doxorubicin in patients with negative prognostic factors, such as visceral metastases (objective response, 46% v 29%) and resistance to prior chemotherapy (47% v 25%). Median time to progression was longer in the docetaxel group (26 weeks v 21 weeks; difference not significant). Median overall survival was similar in the two groups (docetaxel, 15 months; doxorubicin, 14 months). There was one death due to infection in each group, and an additional four deaths due to cardiotoxicity in the doxorubicin group. Although neutropenia was similar in both groups, febrile neutropenia and severe infection occurred more frequently in the doxorubicin group. For severe nonhematologic toxicity, the incidences of cardiac toxicity, nausea, vomiting, and stomatitis were higher among patients receiving doxorubicin, whereas diarrhea, neuropathy, fluid retention, and skin and nail changes were higher among patients receiving docetaxel. CONCLUSION: The observed differences in activity and toxicity profiles provide a basis for therapy choice and confirms the rationale for combination studies in early breast cancer.


Subject(s)
Antineoplastic Agents, Phytogenic/therapeutic use , Antineoplastic Agents/therapeutic use , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Doxorubicin/therapeutic use , Paclitaxel/analogs & derivatives , Taxoids , Adult , Aged , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/adverse effects , Antineoplastic Agents, Phytogenic/administration & dosage , Antineoplastic Agents, Phytogenic/adverse effects , Chemotherapy, Adjuvant , Disease-Free Survival , Docetaxel , Dose-Response Relationship, Drug , Doxorubicin/administration & dosage , Doxorubicin/adverse effects , Drug Administration Schedule , Female , Humans , Infusions, Intravenous , Middle Aged , Neoplasm Metastasis , Paclitaxel/administration & dosage , Paclitaxel/adverse effects , Paclitaxel/therapeutic use
18.
Vopr Onkol ; 45(4): 361-8, 1999.
Article in Russian | MEDLINE | ID: mdl-10532092

ABSTRACT

The study compares letrozole (Femara and aminoglutethimide (AG), a standard therapy for postmenopausal women with advanced breast cancer, previously treated with anti-estrogens. 555 women were randomly assigned letrozole 2.5 mg once daily (n = 185), letrozole 0.5 mg once daily (n = 192) or aminoglutethimide 250 mg twice daily with corticosteroid support (n = 178) in an open-label, multicenter trial. The primary end-point was objective response rate (ORR), with time events as secondary. ORR was analysed nine months after enrollment of the last patient, while survival was analysed 15 months after the last patients was enrolled. We report the results of these analyses plus an extended period of observation (covering a total duration of approximately 45 months) to determine the duration of response and clinical benefit. Overall objective response rates (complete + partial) of 19.5%, 16.7% and 12.4% were seen for letrozole 2.5 mg, 0.5 mg and AG respectively. Median duration of response and stable disease was longest for letrozole 2.5 mg (21 months) compared with letrozole 0.5 mg (18 months) and AG (14 months). Letrozole 2.5 mg was superior to AG in time to progression, time to treatment failure and overall survival. Treatment-related adverse events occurred in fewer patients on letrozole (33%) than on AG (46%). Letrozole 2.5 mg offers longer disease control than aminoglutethimide and letrozole 0.5 mg in the treatment of postmenopausal women with advanced breast cancer, previously treated with anti-estrogens.


Subject(s)
Antineoplastic Agents/therapeutic use , Aromatase Inhibitors , Breast Neoplasms/drug therapy , Enzyme Inhibitors/therapeutic use , Nitriles/therapeutic use , Triazoles/therapeutic use , Aged , Aminoglutethimide/therapeutic use , Antineoplastic Agents, Hormonal/therapeutic use , Breast Neoplasms/pathology , Disease-Free Survival , Female , Humans , Letrozole , Middle Aged , Survival Analysis , Treatment Failure , Treatment Outcome
20.
Intensive Care Med ; 25(4): 371-6, 1999 Apr.
Article in English | MEDLINE | ID: mdl-10342510

ABSTRACT

OBJECTIVE: (1) To describe the pattern of intracranial pressure (ICP) and cerebral perfusion pressure (CPP) in a group of severe head-injured patients, (2) to quantify complications of ICP monitoring, and (3) to describe a management protocol and its results. DESIGN: Prospective observational study. SETTING: General intensive care unit in a teaching hospital. PATIENTS: 138 comatose patients, selected according to the following criteria: age > 16 years, coma [Glasgow Coma Scale (GCS) < or = 8] with at least one pupil reactive after resuscitation, digital recording of intracranial and arterial pressure, and jugular saturation measurements. MEASUREMENTS AND RESULTS: Median GCS was 5, and 62 patients had significant extracranial injuries; 71 had intracranial hematomas, which were urgently evacuated. Mean ICP was 20.5 mmHg (SD 8.34), mean CPP was 71.86 mmHg (SD 11.22); cerebral extraction of oxygen averaged 29 %. Medical therapy was used to control ICP in 130 cases; 93 patients required hyperventilation. Vasopressors were infused in 16 cases; in 14 cases a barbiturate infusion was started. In 6 patients all pharmacological treatments failed and surgical decompression was done. The only complication of ICP monitoring was meningitis in 3 patients. Outcome at 6 months was a good recovery and moderate disability for 82 patients (59.4%), severe disability and vegetative status for 37 (26.8%), and 19 patients died (13.7%). The severity of intracranial hypertension was related to poorer results at 6 months. CONCLUSIONS: Intracranial hypertension is very frequent in severe head injury but can be reasonably well controlled by combined surgical and medical therapy.


Subject(s)
Craniocerebral Trauma/physiopathology , Craniocerebral Trauma/therapy , Intracranial Hypertension/therapy , Intracranial Pressure , Adolescent , Adult , Aged , Female , Glasgow Coma Scale , Humans , Intensive Care Units , Intracranial Hypertension/diagnostic imaging , Italy , Lactates/blood , Length of Stay , Male , Middle Aged , Monitoring, Physiologic , Oxygen/blood , Prospective Studies , Tomography, X-Ray Computed , Treatment Outcome
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