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Biomedical subjects

S Viviani

Publications and source records attributed to S Viviani.

At least 19 recordsLinked to original sources
PubMed2003

Immunogenicity and safety in infants of a DTwPHib full liquid vaccine.

AIM: Combining paediatric vaccines is a rational solution to reduce the number of injections during a single clinical visit, to maintain parents' compliance and to extend vaccine coverage. Different diphtheria, tetanus and whole cell pertussis (DTwP)-containing combination vaccines are licensed and used world-wide. This study assessed the immunogenicity and safety in infants of a combined diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b-CRM197 conjugate full liquid vaccine. METHODS: The safety and efficacy of a combined ready-to-use liquid vaccine containing diphtheria and tetanus toxoids, cell suspension of Bordetella pertussis and H. influenzae type b-CRM197 conjugate vaccine (DTwPHib) were assessed in infants eligible for the local Expanded Programme on Immunization (EPI) in Valencia, Spain. The comparative group received separate injections of reference vaccines DTwP + Hib. RESULTS: Local and systemic reactions and adverse events were generally mild and similar in the two groups. DTwPHib elicited anti-PRP antibody titres > or = 0.15 microg ml(-1) in 97% and DTwP + Hib in 94% of infants. Furthermore, 89% of DTwPHib and 78% of DTwP + Hib recipients attained anti-PRP antibody titres > or = 1.0 microg ml(-1), signifying long-term protection. The anti-PRP geometric mean titre was significantly higher in the combined DTwPHib vaccine group (6.65 vs 3.57 microg ml(-1)). In both groups, 99% of infants achieved protective (> or = 0.01 IU ml(-1)) anti-diphtheria antibody levels and all children achieved protective (> or = 0.1 IU ml(-1)) anti-tetanus antibody levels. DTwPHib caused a > or = 2-fold increase in anti-pertactin antibody titres in 91% and a > or = 4-fold increase in 82% of recipients. The corresponding proportions in the DTwP + Hib group were 95% and 90%. DTwPHib induced a > or = 2-fold increase in anti-Aggl2 and 3 antibody levels in 79% and a > or = 4-fold increase in 73% of recipients. The corresponding proportions among DTwP + Hib infants were 85 and 82%. CONCLUSION: Overall, the combined liquid vaccine DTwPHib is a safe and effective immunogenic vaccine for EPI use in infants.

Antibodies↗
PubMed2003

Effect of an intensive chemotherapy followed by mediastinal irradiation on pulmonary and cardiac function in advanced Hodgkin's disease.

Mediastinal irradiation combined with chemotherapy in patients with Hodgkin's disease have been associated with cardiopulmonary toxic effects that can last over the years. In this study we monitored pulmonary and cardiac function in 39 patients affected by advanced Hodgkin's disease (stage II B-III and IV) with mediastinal involvement and submitted to an intensive chemotherapy regimen (epirubicin, vincristine, ciclophosphamide, and etoposide) followed by involved field irradiation. Pulmonary function was verified with chest x-ray, spirometric parameters, arterial blood gas analysis, single breath CO transfer factor (DLCO), and its components Dm and Vc. Cardiac function was verified with electrocardiogram (EKG) and left ventricular ejection fraction (LVEF) by means of radionuclide angiocardiography. The median follow-up was 40 months. Spirometric parameters did no show modifications at the end of treatment, on the contrary they improved during the follow-up. Chest x-ray showed radiographic parenchimal damage in 51% of patients. DLCO remained constantly decreased. sEKG did not show significant modification, whereas LVEF significantly decreased at the end of treatment and remained persistently decreased during follow-up. None of the patients with reduction of DLCO or LVEF showed clinical symptoms of heart and pulmonary dysfunctions. One patient, 49 years old, suffered from myocardial infarction 25 months after the completion of radio-chemotherapy. These data indicate that this combined regimen can induce persistent pulmonary and cardiac damages at subclinical level.

Adolescent↗
PubMed2001

High-dose ifosfamide and vinorelbine as salvage therapy for relapsed or refractory Hodgkin's disease.

In an effort to improve results in patients with relapsed or refractory Hodgkin's disease (HD), an intensive regimen combining vinorelbine (25 mg/m2 i.v. days 1 and 5) and high-doses of ifosfamide (3000 mg/m2/d, days 1-4 by continuous infusion) with mesna uroprotection and G-CSF support was designed. Forty-seven patients were treated; 14 had failure to initial induction therapy and 33 had disease relapsed from an initial response. The response rate was 83%, with 21 complete (45%, CR) and 18 partial remissions (38%, PR). Partial response was achieved after a median of two cycles (range 1-3) and CR after a median of six cycles (range 2-10). At the end of ifosfamide and vinorelbine, 10 patients in CR, one in PR, and one with stable disease also received radiotherapy to nodal sites of relapse. Eleven patients who had undergone peripheral blood stem cell (PBSC) harvesting following ifosfamide-vinorelbine proceeded to receive high-dose chemotherapy (HDCT) and PBSC transplantation. The main toxic effect was grade III-IV neutropenia, documented in 65% of cycles with a median duration of 4 days, and non-haematological toxicity was mild. The combination of high-doses of ifosfamide and vinorelbine was well tolerated and an active regimen in treatment of patients with relapsed and refractory HD. It was not only useful as salvage therapy with or without consolidative radiotherapy but it also was a valuable induction regimen before high-dose intensification therapy followed by PBSC reinfusion in patients eligible for this approach.

Adult↗
PubMed2000

Elevated pretreatment serum levels of Il-10 are associated with a poor prognosis in Hodgkin's disease, the milan cancer institute experience.

Alterated cytokine secretion may play a role in determining Hodgkin's disease-related immunosuppression. The aim of this study was to analyze the clinical significance of interleukin-10 (IL-10) serum levels in 73 chemotherapy-naive patients with Hodgkin's disease. We evaluated the relationship between pretreatment circulating values of IL-10 and both the clinical characteristics of the disease as well as the prognosis in terms of freedom from progression and overall survival. Abnormally high pre-treatment serum levels (mean+/-standard error: 26.79+/-13.24 pg/ml) were detected in 33/73 (45%) patients. The percentage of patients with enhanced IL-10 secretion was significantly higher in the presence of advanced disease (56% vs 32%, P<0.03), systemic symptoms (57% vs 34%, P<0.04) and more than 3 involved sites (61% vs 36%, P<0.03). The high basal levels of IL-10 negatively influenced long-term results: at 8-years freedom from progression (FFP) and overall survival (OS) for patients with IL-10>6 pg/ml vs</=6 pg/ml were 69% and 76% vs 97. 5% and 95%, respectively. The multivariate analysis confirmed the prognostic value of IL-10 basal serum levels (FFP, P=0.0001; OS, P=0. 06). Our study suggests that high pre-treatment circulating levels of IL-10 are associated with a poor prognosis, irrespective of other common prognostic variables.

Adolescent↗
PubMed2000

Late pulmonary effects in favorable stage I and IIA Hodgkin's disease treated with radiotherapy alone.

Radiotherapy (RT) in patients with favorable-stage Hodgkin's disease can induce clinical and subclinical evidence of pulmonary damage lasting over the years. In this study, we monitored 36 patients with stage IA-IIA Hodgkin's disease treated with subtotal nodal RT. The planned dose of RT was 40 Gy to 44 Gy to the involved areas and 36 Gy to the adjacent uninvolved areas. Pulmonary function was evaluated by chest radiograph, spirometric parameters, arterial blood gas analysis, and single-breath CO transfer factor (DLCO). The tests were performed before and at the end of irradiation, and during the follow-up 1 and 3 to 5 years after the treatment. At the end of RT, we found a significant decrease of total lung capacity, vital capacity, forced expiratory volume in 1 second, residual volume, and DLCO. Spirometric parameters improved during the follow-up period, whereas the decline of DLCO (-6.4%) was persistent. No correlation was found between mantle RT dose and DLCO changes. Four patients showed a decline of DLCO of >20% from pretreatment values but only one was symptomatic. Our study confirms that RT induces a pulmonary-restrictive disease at a subclinical level that seems to be reversible in the majority of patients.

Adolescent↗
PubMed2000

Gemcitabine in the treatment of refractory Hodgkin's disease: results of a multicenter phase II study.

PURPOSE: To explore the use of gemcitabine for the treatment of patients with relapsing or refractory Hodgkin's disease. PATIENTS AND METHODS: Eligible patients had measurable disease and more than one previous chemotherapy regimen. Patients previously treated with high-dose chemotherapy with autologous bone marrow or peripheral stem-cell support were not included. Gemcitabine, 1,250 mg/m(2), was administered as a 30-minute intravenous infusion on days 1, 8, and 15 of each 28-day cycle of therapy. The dosing schedule remained fixed, and any dose of gemcitabine that could not be given on time was omitted. Patients who had not experienced any hematologic or nonhematologic toxicity after one complete cycle of therapy were permitted to have subsequent doses increased by 20%: that is, from 1, 250 mg/m(2) to 1,500 mg/m(2). RESULTS: Of the 23 enrolled patients, 22 were assessable for response; all 23 patients were included in the efficacy analysis. Disease status for two patients (9%) reached a state of complete remission, and seven patients (30%) achieved a partial response, for an overall response rate of 39% (95% confidence interval, 19.7% to 61.5%). The likelihood of achieving a response was not influenced by a patients' main pretreatment characteristics or by their response to their last prior chemotherapy. The median duration of response was 6.7 months (range, 2 to 33+ months), and the median overall survival time was 10.7 months (range, 4 to 34.7+ months). In general, toxicities were mild; no treatment-related deaths occurred, and only one life-threatening adverse event was reported for this study. CONCLUSION: Gemcitabine was shown to be active in heavily pretreated patients with Hodgkin's disease, producing a response rate of 39%. Additionally, drug-related toxicities were mild, which thus suggests the possible inclusion of gemcitabine in an earlier phase of treatment.

Adult↗
PubMed1999

Hepatitis B vaccination in infancy in The Gambia: protection against carriage at 9 years of age.

To estimate the efficacy in The Gambia (West Africa) of infant hepatitis B vaccination against infection and carriage with the virus at the age of 9 years. The HBV status of 9-year old children vaccinated in infancy was compared to that of unvaccinated children of the same age. Eight percent of the vaccinated children had been infected by HBV compared to 50% of the unvaccinated control group; HBV carrier status was 0.6 and 10% respectively, resulting in a vaccine efficacy of 83% against infection and of 95% against chronic carriage. The results show that infant vaccination provides a high level of protection at the age of nine years against both HBV infection and chronic carrier status and no booster dose of vaccine is required in the first decade. These findings support the WHO recommendation for the introduction of HBV vaccination into the Expanded Programme on Immunization in Africa.

Carrier State↗
PubMed1998

Serum level of the soluble form of the CD30 molecule identifies patients with Hodgkin's disease at high risk of unfavorable outcome.

Preliminary reports suggested a prognostic significance for serum levels of soluble CD30 (sCD30) in patients with Hodgkin's disease (HD). In this study, we investigated the prognostic impact of sCD30 concentration at diagnosis in relation to the other recognized prognostic parameters in 303 patients with HD observed in three different institutions between 1984 and 1996. sCD30 levels were correlated with stage, presence of B symptoms, and tumor burden. High sCD30 levels entailed a higher risk of poor outcome, and the event-free survival (EFS) probability at 5 years for patients with sCD30 levels >/=100 and less than 100 U/mL was 59.9% (95% confidence interval [CI], 40.6% to 65.9%) and 87.5% (95% CI, 81.5% to 91.6%), respectively (P < .001). On the basis of the results of univariate analysis of 14 pretreatment characteristics, we included five prognostic factors (high sCD30 serum level, stage III-IV, B symptoms, low hemoglobin level, and age >/=50 years) into a multivariate model. High sCD30 and advanced stage were independently associated with an unfavorable prognosis. Their combined evaluation identified patients at high risk (stages III and IV and sCD30 >/=100 U/mL: EFS, 46.9%) and low risk (stages I and II with sCD30 <100 U/mL: EFS, 88. 7%) of treatment failure (P < .001). We conclude that the combined evaluation of sCD30 serum level and stage at presentation identifies patients with HD at high risk of an unfavorable outcome.

Adolescent↗
PubMed1998

Soluble interleukin-2 receptors (sIL-2R) in Hodgkin's disease: outcome and clinical implications.

The aim of this study was to assess the prognostic role of soluble interleukin-2 receptors (sIL-2R) in Hodgkin's disease (HD) both in the achievement of complete remission (CR) and in predicting disease relapse. Between August 1988 and June 1993 sIL-2R serum levels were measured in 174 untreated patients; in 137 of them evaluation was repeated at the end of treatment and in 132 also during the follow-up. Baseline sIL-2R levels (mean+/-standard error) were significantly higher in patients than in 65 healthy control subjects (1842+/-129 U ml(-1) vs 420+/-10 U ml(-10, P< 0.0001). At the end of treatment 135 out of 137 evaluated patients achieved complete response (CR) and their mean sIL-2R serum levels were significantly lower than those at diagnosis (635+/-19 U ml(-1) vs 1795+/-122 U ml(-1), P=0.0001). After a median follow-up of 5 years, sIL-2R remained low in 114 patients in continuous CR, while they increased in 9 out of 12 patients (75%) who relapsed. However, a temporary increase was also observed in six patients (5%) still in CR. Treatment outcome in terms of freedom from progression was linearly related to sIL-2R levels. Our study confirms that patients with untreated HD have increased baseline levels of sIL-2R compared with healthy subjects and that their pretreatment values may be an indication of disease outcome similar to other conventional prognostic factors, such as number of involved sites, presence of B symptoms and extranodal extent.

Adolescent↗
PubMed1998

Ifosfamide and vinorelbine: an active regimen for patients with relapsed or refractory Hodgkin's disease.

Twenty-six patients with relapsed or refractory Hodgkin's disease (HD) were treated with an intensive salvage regimen combining ifosfamide (3000 mg/m2/d, days 1-4 through continuous intravenous infusion) and vinorelbine (25 mg/m2, i.v. days 1 and 5) with mesna uroprotection and G-CSF support. Courses were given at 3-week intervals. Ten patients achieved a complete and 10 patients a partial response, yielding an overall response rate of 77%. The main toxic effect was neutropenia and the combination was well tolerated.

Adult↗
PubMed1997

Outcome of patients with Hodgkin's disease failing after primary MOPP-ABVD.

PURPOSE: This study analyzed long-term results in patients with Hodgkin's disease who were resistant to or relapsed after first-line treatment with MOPP and ABVD. Response to salvage treatments and prognostic factors were also evaluated. PATIENTS AND METHODS: The study population included 115 refractory or relapsed patients among a total of 415 patients treated with alternating or hybrid MOPP-ABVD followed by radiotherapy (25 to 30 Gy) to initial bulky sites. The median follow-up duration of the present series was 91 months. Thirty-nine of 115 patients (34%) showed disease progression while on primary treatment (induction failures); 48 relapsed after complete remissions that lasted < or = 12 months and 28 after complete remission that lasted more than 12 months from the end of all treatments. RESULTS: At 8 years, the overall survival rate was 27%, being 54% and 28% in patients whose initial complete remission was longer or shorter than 12 months, respectively, and 8% in induction failures (P < .001). Response to first-line chemotherapy and disease extent at first progression significantly influenced long-term results, as well as the incidence and duration of complete remission. CONCLUSION: The present data confirm previous observations that showed the main prognostic factors to influence outcome after salvage treatment are response duration to first-line therapy and disease extent at relapse. The results indicate that patients who relapse after the alternating MOPP/ABVD regimen have a prognosis similar to that of patients who relapse after a four-drug regimen (MOPP or ABVD alone). Re-treatment with initial chemotherapy seems the treatment of choice for patients who relapse after an initial complete remission that lasts greater than 12 months, while the real impact of high-dose chemotherapy or new regimens should be assessed in resistant patients.

Adult↗
PubMed1997

Comparison of gallium scan, computed tomography, and magnetic resonance in patients with mediastinal Hodgkin's disease.

BACKGROUND: In patients with Hodgkin's disease, the use of gallium-67 scintigraphy (Ga-67) compared to conventional staging and restaging techniques is still controversial. In particular, in a combined modality treatment with chemotherapy and radiotherapy given in sequence, its role in detecting active disease after chemotherapy may be useful in planning the subsequent radiotherapeutic strategy. PATIENTS AND METHODS: From March 1990 to September 1994, 125 patients with previously untreated histologically proven Hodgkin's disease were enrolled in two different prospective trials according to clinical stage. Staging procedures included Ga-67, chest-abdominal computed tomography (CT), and/or magnetic resonance (MR). All three tests were performed in 53 patients at staging and in 47 at restaging. Results of Ga-67 at staging were compared to conventional procedures or pathological findings. Results of Ga-67, CT scan, and MR at restaging were compared to disease outcome during the follow-up. Finally a cost/benefit ratio for each test was determined. RESULTS: At staging, Ga-67 showed lower sensitivity than CT and MR (90 vs. 96 and 100%, respectively) because of the number of false-negative images. Nevertheless, by using both CT and Ga-67 scan, the sensitivity is equal to that observed with MR (100%). At restaging, Ga-67 is superior to CT scan and equivalent to MR in detecting true negative patients (specificity: 98% vs. 45% vs. 92%). CONCLUSIONS: As a single technique, Ga-67 scan cannot substitute for CT scan or MR in staging patients with Hodgkin's disease. Nevertheless, Ga-67 scan has an important role in defining complete remission after treatment and therefore in planning subsequent treatment. Considering the lower costs of CT scan plus Ga-67 ($320) versus MR alone ($810), the two tests may be considered procedures of choice in staging as well as in restaging patients with Hodgkin's disease.

Adult↗
PubMed1996

Alternating versus hybrid MOPP and ABVD combinations in advanced Hodgkin's disease: ten-year results.

PURPOSE: To compare, in a prospective randomized trial, the efficacy of two different sequences of mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) and doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) chemotherapy in untreated advanced Hodgkin's disease. PATIENTS AND METHODS: From June 1982 to September 1990, 427 consecutive previously untreated patients with pathologic stage IB, IIA bulky, IIB, III (A and B), and IV (A and B) disease were prospectively randomized to receive two different sequences of MOPP and ABVD for a minimum of six cycles followed by radiotherapy (median dose, 30 Gy) to the nodal site(s) of pretreatment bulky disease. Of 415 assessable patients, 211 received one cycle of MOPP monthly, alternated with one cycle of ABVD (alternating regimen), and 204 patients received one-half cycle of MOPP alternated with one-half cycle of ABVD within a 1-month period (hybrid regimen). RESULTS: The complete remission (CR) rate was 91% with the alternating regimen and 89% with the hybrid regimen. At 10 years, the freedom-from-progression (FFP) rate was 67% versus 69% and the overall survival (OS) rate was 74% versus 72%, respectively. After attainment of CR, 85 patients relapsed in nodal (n = 60) versus extranodal with or without nodal (n = 25) sites. In patients given consolidative radiation because of bulky lymphoma, the true recurrence rate was 13%. A total of 23 second malignancies (6%) were documented, including 11 cases of acute nonlymphocytic leukemia. No cases of congestive heart failure attributable to doxorubicin or pulmonary toxicity related to bleomycin were documented. CONCLUSION: By delivering MOPP and ABVD, it is possible to cure approximately 70% of patients with advanced Hodgkin's disease. The two different drug sequences yielded superimposable results.

Adolescent↗
PubMed1996

Vinorelbine: a new promising drug in Hodgkin's disease.

Vinorelbine is a new semisynthetic vinca alkaloid that differs chemically from vinblastine by a substitution of the catharanthine moiety. The powerful cytostatic activity of vinorelbine against murine tumors, human malignant cell lines and human tumor xenografts in nude mice has been demonstrated. Phase I-II studies of intravenous vinorelbine, administered weekly as single agent or in combination chemotherapy have been conducted since 1986. Results suggest that vinorelbine has high activity in non-small cell lung cancer, breast cancer and cisplatin-resistant ovarian cancer with mild toxicity, being neutropenia the major treatment related complication. In this paper we critically review the activity of vinorelbine in pretreated Hodgkin's patients. Available results strongly suggest the inclusion of this drug in first or second line chemotherapy regimens in Hodgkin's disease.

Animals↗
PubMed1994

Extended-field radiotherapy in favorable stage IA-IIA Hodgkin's disease (prognostic role of stage).

PURPOSE: The study was undertaken to evaluate the long-term results in a favorable subset of patients with pathological Stage IA-IIA treated with irradiation alone. METHODS AND MATERIALS: One hundred and forty-seven adults with laparotomy- Staged IA-IIA "favorable" Hodgkin's disease were treated with primary subtotal nodal irradiation. Patients with infradiaphragmatic presentation were irradiated through paraortic and inguino-iliac node chains (inverted Y field) followed by prophylactic mediastinal and supraclavicular fields. RESULTS: Actuarial overall survival (OS) at 7 years (median follow-up 77 months) was: 93% for the whole series, 94% for Stage I, and 92% for Stage II. The freedom from first progression (FFP) (80% for the whole series) showed a statistically significant difference (p = 0.008) between Stage I (88%) and Stage II (71%). By univariate analysis, stage alone had an independent prognostic significance for OS and FFP. Of the 29 relapsed patients, 8 were previously classified as Stage I and 21 as Stage II; 16 of 29 (55%) of the relapses occurred in the pelvis and 9 in extranodal sites. After salvage treatment with chemotherapy all patients achieved a second complete remission. Seven second malignancies (two acute nonlymphocytic leukemias, one preleukemic syndrome, and four solid tumors) have been detected so far. Hypothyroidism was observed in 16% of patients and a reversible pulmonary restrictive syndrome in 14% of cases, respectively. CONCLUSIONS: Within 7 years from radiation therapy, about one-quarter of the patients with Stage II disease will experience a relapse and need intensive salvage chemotherapy. This is not invariably successful and safe, for it may be complicated by either acute or potentially fatal long-term adverse effects, such as second malignancies and cardiac or pulmonary sequelae, in about 5% of patients. The high frequency of relapse in Stage IIA patients suggests a combined modality approach with relatively short-term chemotherapy not including alkylating agents.

Adolescent↗