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Biomedical subjects

M Balducci

Publications and source records attributed to M Balducci.

At least 19 recordsLinked to original sources
PubMed2003

Locoregional pain treatment. Troubles and prospectives: antalgic radiotherapy.

Pain control in patients with cancer represents a significant aspect of radiation therapy practice. Radiation therapy is one of the most effective, and often the only, therapeutic option to relieve pain caused by nerve compression or infiltration by malignant tumor, pain from liver and bony metastases and it provides also successful palliation of dysphagia caused by oesophageal carcinoma and of pain due to pancreatic cancer. Various instruments are avaliable for pain evaluation but a valid methodology to assess the pain status in the patient with cronic cancer pain is still an important clinical problem. In this complex and wide scene this contribution wants to confirm the role of radiotherapy in cancer pain control, in paricular in bone metastases, and to involve the patient himself in the survey of radiation treatement response by a subjective evaluation of bone pain, elaborating a reliable and valid unidimensional method by which recording the self-rating of the patient's sensation. Materials and Methods For the subjective evaluation of pain caused by bone metastases we used an application form with which drawing information in the course of time in terms of: response to the treatment, duration of symptom relief and quality of life. Results Considering as cut-off a dose of 30 Gy, which is commonly considered the conventional treatment for bone metastases, the partial and complete response were, respectively, of 54% and 30% in the patients treated with dose higher than or equal to 30 Gy, and 60% and 20% in the ones treated with doses lower than 30 Gy. In the whole, in 84 patients, the global response was of 82%, in accordance with literature. Conclusion In this retrospective study, the analysis of patient's subjective experience confirmed the effectiveness of radiotherapy in reducing pain caused by bone metastases and in improving quality of life of the patient himself. Given the conflicting opinions on low-dose short-course radiotherapy versus prolonged or higher dose schedules on initial pain relief, we are going to define categories of homogenous patients on whom starting treatment schedules with the aim or of palliation of the symptom or of the functional restitutio, on the base of the expectation and the quality of life.

Bone Neoplasms↗
PubMed2002

Intraoperative radiotherapy: current thinking.

Intraoperative radiotherapy (IORT) refers to the delivery of irradiation at surgery. A large single dose of irradiation is delivered to a surgically defined area, while uninvolved and dose-limiting tissues are displaced, the final goal of IORT being enhanced locoregional tumour control. IORT is used in most modern protocol studies as a boost radiation component of multidisciplinary treatment approaches. More recently, high activity radiation sources or mobile operating room treatment machines are used to facilitate the IORT procedure. Clinical experiences have shown that IORT may improve local control and disease-free survival, especially when used in adjuvant setting, combined with external beam irradiation in some neoplasms such as cancer of the stomach, pancreas, colorectum, and soft tissue sarcoma.

Colorectal Neoplasms↗
PubMed2001

Lamivudine treatment failure in preventing fatal outcome of de novo severe acute hepatitis B in patients with haematological diseases.

BACKGROUND: Patients with malignant haematological diseases administered or no longer receiving immunosuppressive therapy are at high risk of reactivation or de novo hepatitis B infection and fulminant hepatitis. Despite promising results in the treatment of chronic hepatitis and its use in selected patients with acute hepatitis B, there is no consensus on lamivudine treatment in severe acute hepatitis portending a fatal clinical outcome. CASE REPORTS: Of the ten patients with malignant haematological disorders who became infected with the same strain of hepatitis B virus during hospitalisation in a haematology ward, five received lamivudine (and in some cases, ganciclovir and famciclovir). The other patients received only supportive therapy, since deteriorating clinical conditions hampered specific treatment efforts. Eight patients died from acute liver failure and one from a fatal course of the haematological disease; one had a favourable outcome from the therapy. There was no significant difference in terms of survival between the treated and untreated patients. CONCLUSIONS: Although lamivudine has proved promising in the therapy of chronic hepatitis B and of recurrent hepatitis after liver transplantation, its use in de novo severe acute hepatitis should be investigated further, particularly in immunocompromised patients.

Acute Disease↗
PubMed2000

Reduction in mortality with availability of antiretroviral therapy for children with perinatal HIV-1 infection. Italian Register for HIV Infection in Children and the Italian National AIDS Registry.

CONTEXT: Since the introduction of combined antiretroviral therapy, mortality rates in adults with human immunodeficiency virus type 1 (HIV-1) infection have decreased. However, little information is available outside the setting of controlled trials on survival of perinatally HIV-infected children treated with antiretroviral therapy. OBJECTIVE: To assess effect of availability of antiretroviral therapy on decreasing mortality in perinatally HIV-infected children. DESIGN: Population-based, multicenter longitudinal study involving data collected by the Italian Register for HIV Infection in Children. SETTING: A network of 106 pediatric clinical centers. SUBJECTS: A total of 1142 children born between November 1980 and December 1997 with perinatally acquired HIV infection with a median follow-up of 5.9 years. MAIN OUTCOME MEASURE: Time to HIV-related death calculated for birth cohort and calendar period and grouped by distribution of predominant type of antiretroviral therapy administered over time. RESULTS: Survival was longer in the 1996-1997 birth cohort (crude relative hazard [RH] of death, 0.39; 95% confidence interval [CI], 0.15-0.96) and 1996-1998 calendar period (crude RH of death, 0.65; 95% CI, 0.45-0.95) than in birth cohort and calendar period 1980-1995, but not when adjusted for maternal antiretroviral treatment during pregnancy and clinical condition at time of delivery, gestational age, and birth weight (adjusted RH of death, 0.55; 95% CI, 0.20-1.50, for birth cohort; and adjusted RH of death, 0.71, 95% CI, 0.43-1.16, for calendar period). In a multivariate model with 1980-1995 as comparison, the 1996-1997 birth cohort had an RH of 0.57 (95% CI, 0.22-1.47; P=.27) but RH for calendar period 1996-1998 was 0.63 (95% CI, 0.47-0.85; P<. 01). When the effects of birth cohort, calendar period, and type of antiretroviral therapy were evaluated simultaneously in the same model, the RH of death was not significantly different from 1.0 for the 1996-1997 birth cohort (P=.19) and calendar period 1996-1998 (P=. 83) suggesting a causal relationship between decreased risk of death and use of combination therapy. The RH of death in children receiving monotherapy or double or triple combination therapy was 0. 77 (95% CI, 0.55-1.08), 0.70 (95% CI, 0.42-1.17), and 0.29 (95% CI, 0.13-0.67), respectively, vs no antiretroviral therapy. CONCLUSION: Survival of perinatally HIV-infected children improved in 1996-1998 as a result of the introduction of combined antiretroviral therapies. JAMA. 2000;284:190-197

Adolescent↗
PubMed2000

Radiotherapy versus follow-up in the treatment of pathological stage Ia and Ib non-small cell lung cancer. Early stopped analysis of a randomized controlled study.

OBJECTIVE: This is an analysis of a randomized controlled clinical trial planned to evaluate the effects of adjuvant radiotherapy (AR) on the local recurrence rate in patients with non-small cell lung cancer (NSCLC) with pathological stage (pStage) Ia (pT1N0) and Ib (pT2N0). The effects of AR on the long-term survival have also been marginally evaluated. MATERIALS AND METHODS: This clinical trial was planned with the hypothesis that AR on pStage Ia and Ib, R0 NSCLCs was effective on local recurrence rate. From July 1989 through March 1997, 104 patients with NSCLC who presented with pStage Ia and Ib have been observed and treated and entered the study. Male/female ratio was 91:13; the mean age was 62 years (range 41-75 years). All patients underwent major pulmonary resection and homolateral standard hilar and mediastinal lymph node dissection. pStage was T1N0 in 29 and T2N0 in 75 cases. Patients have been randomized 'by chance' into two groups (G1 and G2). G1 received radiotherapy, G2 did not receive any adjuvant treatment. Fifty-two patients entered G1 and 52 entered G2. RESULTS: Post-operative mortality was nil. Seven patients have been excluded from the study (four in G1 and three in G2), due to incomplete follow-up data. We do not report any radiotherapy-related complication or deterioration of lung function. The treatment effect on the local recurrence rate demonstrated a clearly significant protective effect of the AR. No statistically significant difference was found from the comparison of the 5-year survival rate of the treated (83%) versus untreated (70%) patients. No detrimental effect of the radiotherapy has been assessed. CONCLUSIONS: AR in the treatment of pStage Ia and Ib NSCLC has been well tolerated and had a significant relative effect on the local recurrence rate but did not significantly modify overall survival even if a positive trend in the group of treated patients is reported.

Adult↗
PubMed1999

Temporal changes in the rate of progression to death among Italians with known date of HIV seroconversion: estimates of the population effect of treatment. Italian HIV Seroconversion Study (ISS).

OBJECTIVE: To evaluate changes in survival among HIV-positive individuals with known date of seroconversion (SC). DESIGN: Prospective cohort study. METHODS: Follow-up lasted from SC to death or to the end of 1997. A multivariate Cox model was applied to estimate relative hazards (RH) of death. The year of SC (as a categoric fixed variable) and calendar year (as a time-dependent variable) were considered to evaluate, respectively, cohort and prevalent changes in the rate of death. A separate Cox model was used to assess the association between survival and new combination therapies, using an "intention to treat" approach. RESULTS: The study included 1535 individuals (53.9% injecting drug users, 25.3% homosexuals, 19.5% heterosexuals); 75.8% seroconverted between 1980 and 1991, and 24.2% seroconverted between 1992 and 1997. When adjusting for year of SC, the RH of death (and that of AIDS) was significantly lower in 1997, compared with before 1991 (RH = 0.54; 95% confidence interval, 0.30-0.98). Adjusted RHs of death were significantly lower for combination antiretroviral therapy, compared with no therapy. When combining the two Cox models, the 1997 reduction in risk of death was largely due to antiretroviral therapies; similar results were obtained when the endpoint was AIDS. CONCLUSIONS: A reduction in the risk of death, probably due to combination antiretroviral therapy, was observed in 1997 after having adjusted for age at SC and year of SC.

Adolescent↗
PubMed1999

HIV incidence among repeat HIV testers with sexually transmitted diseases in Italy. STD Surveillance Working Group.

OBJECTIVES: To provide data on the incidence of HIV infection among repeat testers with sexually transmitted diseases (STD) in Italy. DESIGN: Retrospective longitudinal study. METHODS: Study participants, enrolled by 47 STD centres throughout Italy, included individuals with a newly diagnosed STD who were tested for HIV at the time of the STD diagnosis and who had a previous documented HIV-negative test. 'Seroconverters' were defined as those individuals who tested HIV-positive at the time of the STD diagnosis. The cumulative and the annual incidence of HIV in this population were estimated. RESULTS: Of 1950 patients, 47 were seroconverters, with an incidence rate of 1.7 per 100 person-years (PY) (95% confidence interval, 1.2-2.2). HIV incidence was higher among males than among females (2.5 versus 0.6 per 100 PY). The highest incidence rate was found among homosexual injecting drug users (IDU) (13.8 per 100 PY), whereas the lowest rate was observed among heterosexual non-IDU (0.4 per 100 PY). The annual incidence decreased from 1.8 per 100 PY in 1989 to 0.9 per 100 PY in 1996. CONCLUSIONS: Our results show that new HIV infections have occurred among STD patients in Italy since 1988, although a clear decrease in incidence has occurred since 1989. However, the rate of seroconversion appears to be alarmingly high in some high-risk groups. These findings suggest that there is a need for continued monitoring of new HIV infections among STD patients, and these individuals may represent a useful sentinel population for a better understanding of the HIV epidemic.

Cohort Studies↗
PubMed1997

Phase I-II trial of concomitant continuous carboplatin (CBDCA) infusion and radiotherapy in advanced nonsmall cell lung cancer with evaluation for surgery: final report.

PURPOSE: The goal of this trial was to determine the maximum tolerable dose when carboplatin (CBDCA) was administered in continuous infusion concurrently with radiotherapy in patients with nonsmall cell lung cancer. METHODS AND MATERIALS: From October 1989 to July 1993, 54 patients were studied (male/female ratio: 44 to 10), median age was 62 years. Two patients had Stage II cancer, 22 had Stage IIIA, 24 had Stage IIIB, and 6 had Stage IV. Carboplatin was given for 96 h, starting at a dose of 30 mg/m2/day: 13 patients received 30 mg/m2/day (group A), 12 patients received 50 mg/m2/day (group B), 12 patients received 70 mg/m2/day (group C), 10 patients received 90 mg/m2/day (group D), and 7 patients 110 mg/m2/day (group E). The radiation dose was 50.40 Gy delivered to the target volume in 5.3 weeks. RESULTS: Fifty-three of 54 patients were evaluable for toxicity and 52 out of 54 for response. Toxicity (Miller score): Myelotoxicity: in groups A and B it was almost absent; in groups C and D it was moderate (leukopenia G1-2: 45.4% patients; trombocytopenia G1-2: 22.7%, G3: 9%; anemia G1-2: 9%); only in group E was it severe (leukopenia G1 and G3 16.6% respectively; trombocytopenia G3: 33.3%, G4: 16.6%; anemia G1-2: 50%). Nephrotoxicity was present only in one patient of group E and was Grade 3. Nausea and vomiting were related to CBDCA dose. One patient in Group E died of intractable toxicity 3 days after the end of infusion; then the study was closed. The limiting toxicity dose was shown to be 110 mg/m2/day given for 96 h. Clinical response rate: Twenty-six of 52 patients had major response, 24 had minor response, and only 2 patients had progression of disease. SURGERY: Twenty-one of 52 tumors were judged resectable: 18 patients had complete tumor resection, 1 had exploratory thoracotomy, and 2 patients refused surgery. Pathological response rate: Five patients had pathologic state T0 or Tis. CONCLUSIONS: These results indicate that the maximum tolerable dose of CBDCA infusion for 96 h is 90 mg/m2/day, and this schedule seems to produce an appreciable response rate. Therefore, we have started a Phase II trial, which will permit us to define the true efficacy of this schedule.

Adult↗
PubMed1997

Epidemiologic features of intestinal parasitic infections in Italian mental institutions.

To determine the prevalence of intestinal parasitic infections in the residents of four Italian psychiatric institutions, we examined the stool specimens collected in triplicate from 238 residents, enrolled between May 1995 and May 1996. Besides, physician and staff nurses provided data about each resident by standardized questionnaires. Parasites were detected in the fecal samples from 128 patients (53.8%). However, in the stool specimens from 106 residents only non-pathogenic protozoa were found (82.8%). Trichuris trichiura ova, Giardia lamblia cysts and trophozoites, Cryptosporidium parvum oocysts, and Balantidium coli cysts were found in the fecal samples from 22 residents (9.2%). B. hominis was the most prevalent parasite. It was detected in the fecal specimens from 97 residents (40.8%). The so-called nonpathogenic amebae were detected in the fecal specimens from 65 residents, though, at the same time, there was no evidence of Entamoeba histolytica infection. Twelve residents (5.0%) showed intestinal colonization by nonpathogenic flagellates. All the subjects with T. trichiura infection were housed in the facility of Ancona. Parasites were found in fecal samples from all the 11 residents with behavioural aberrations, but only three of those suffering from intestinal pathogen infection associated to diarrhea. Statistical analyses revealed that the presence of pathogenic parasites in fecal specimens was significantly associated with diarrhea, nausea, vomiting, abdominal pain, fever, behavioural aberrations and nonpathogenic protozoa (p < 0.01), but did not demonstrate any other significant associations between these parasites and the other variables, such as pruritus, mucus or blood in the stools and presence of fecal leukocytes. On the other hand, the presence of nonpathogenic protozoa was significantly related to aberrations such as pica, geophagia, phytophagy, coprophagy, coprophilia and pathogenic parasites (p < 0.01). Data analyses revealed that both pathogenic and nonpathogenic parasites were significantly more common in institutionalized patients than in controls. The rare presence of clinical signs and symptoms in colonized patients represents an important public health problem, since the presence of asymptomatic carriers among residents with low hygienic conditions, raises concern of transmission of parasitic infections to professional staff and other residents. Since the eradication of parasitic colonization in residential facilities is hard to reach, an effective prevention is the only measure to deal with this public health problem.

Adult↗
PubMed1997

Prevalence and antifungal susceptibility of vaginal yeasts in outpatients attending a gynecological center in Ancona, Italy.

Between February 1993 and May 1994 we studied the prevalence of fungal vulvovaginitis among women attending the Obstetric and Gynecology Clinic of the University of Ancona. Out of the 222 patients, 18 (8.2%) women had symptomatic vaginitis and 24 (10.8%) were carriers. Candida albicans was the species most frequently isolated (44.2%), followed by Torulopsis glabrata (28%) and Saccharomyces cerevisiae (16.2%), from symptomatic and carrier patients. The activity of acid proteinase was determined for C. albicans isolated from both symptomatic and carrier patients. All 13 carriers showed low activity for aspartyl proteinase (score 1+), while 5 of 6 symptomatic patients showed higher activity (score 2+), with a significant difference (p = 0.026). In general, isolates of T. glabrata and S. cerevisiae were less susceptible in vitro to fluconazole than isolates of C. albicans. We did not find any differences in fluconazole MIC results among the C. albicans strains isolated from symptomatic and carrier patients. On the other hand, the fluconazole MICs of T. glabrata and S. cerevisiae isolates showed statistically significant differences between symptomatic and carrier patients (p = 0.009 and p = 0.000, respectively). The differences in proteinase secretion between the isolates from symptomatic and carrier patients suggest a correlation between proteinase production and vaginal candidiasis caused by C. albicans. Torulopsis glabrata, however, was found to be the most common causative agent of vaginitis (7 out 19 episodes), followed by C. albicans (6 out of 19 episodes). Due to the varying patterns of antifungal susceptibility, mainly to fluconazole for the yeast isolates considered in this study, an in vitro susceptibility testing program might be useful for monitoring the outcome of this infection.

Adult↗
PubMed1997

[Neoadjuvant combined hormonal therapy and radiotherapy with external beam irradiation in prostatic carcinoma].

From January, 1991, to December, 1995, forty-two patients with prostatic cancer (T2-T4: 40 patients) were treated with a luteinizing hormone-releasing hormone (LHRH) analog (2 administrations before and 3 during irradiation), Flutamide (1 month) and external beam radiation therapy (45 Gy to the whole pelvis and a 20 Gy boost). All patients completed the protocol and the LHRH analog was continued for 1-6 months in 5 patients with partial response at the end of radiotherapy. The incidence of acute toxicity was low according to the Radiation Therapy Oncology Group and European Organization for Research and Treatment in Cancer score (grades 1-2; 19% hematologic, 36% intestinal and 38% urological toxicity). At a median follow-up of 21 months (range: 1-60 months), one patient had local disease progression and lung metastases and two had bone metastases; the three relapsing patients were given the LHRH analog and exhibited partial response to rectal examination (1 case) and to bone scan (2 cases). Pain disappeared completely in both the patients with bone metastases. Overall 3-year survival and disease-free survival rates were 97% and 79%, respectively. Disease-free survival was significantly related to cT (at 3 years: cT2: 100%; cT3: 81.2%; log rank test: 0.0081). Late toxicity was observed in two patients: rectal bleeding in one case and chronic diarrhea in the other. The combined protocol used in this study was feasible and well tolerated. Our results seem to confirm the promising preliminary results of Radiation Therapy Oncology Group 8610 study.

Adenocarcinoma↗
PubMed1993

[Diagnostic and therapeutic integration in non-small cell lung tumors: preliminary notes].

An interdisciplinary study relative to non-small cell lung cancers was activated in 1990 at the Policlinico A. Gemelli, Rome, Italy. A working group including radiologists, radiotherapists, oncologists, surgeons, respiratory physiopathologists and pathologists defined the goals to reach and the protocols to follow for staging, treatment, and follow-up. A hundred and ninety patients with non-small cell lung cancer were examined: 134 of them, who were in the initial or locally advanced phases, were considered, together with 6 patients with postoperative recurrences. Ninety-three cases were considered to be resectable and therefore operated: the extant 41, considered unresectable/slightly resectable, and the 6 with postoperative recurrences were started on combined chemo- and radiotherapy. Primary tumor (T) and lymph nodes (N) were staged by means of CT. In the evaluation of T in resectable patients, CT exhibited 78.5% agreement with pathology, with a tendency to understaging. In the evaluation of N, CT exhibited 62.4% agreement with pathology, once again with a tendency to understaging. Surgery was exploratory in 4.3% of cases only. Combined chemo- and radiotherapy in unresectable patients and in postoperative recurrences yielded > 50% response in 18/47 patients, that is 40.4% especially relative to the cases treated with carboplatinum in continual infusion. Eight of 18 responsive patients were considered to be resectable and therefore submitted to surgery: in 2 of them histology showed no neoplastic cells. This study, which is still in progress, is aimed at verifying its hypotheses and attaining its prefixed goals.

Adult↗