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Biomedical subjects

Paolo Bruzzi

Publications and source records attributed to Paolo Bruzzi.

At least 37 records · Page 2Linked to original sources
PubMed2004

Concomitant versus sequential administration of epirubicin and paclitaxel as first-line therapy in metastatic breast carcinoma: results for the Gruppo Oncologico Nord Ovest randomized trial.

BACKGROUND: The authors performed a randomized trial comprising patients with metastatic breast carcinoma (MBC). They used a noninferiority design to evaluate whether the results of sequential administration of epirubicin and paclitaxel were not markedly worse than the concomitant administration in terms of objective response rates (ORRs). Toxicity profile, quality of life (QOL), and pharmacoeconomic evaluations were evaluated as well. METHODS: In the current study, 202 patients with MBC were randomized to receive either the combination of epirubicin at a dose of 90 mg/m2 plus paclitaxel at a dose of 200 mg/m2 for 8 cycles (concomitant arm, n = 108) or epirubicin at a dose of 120 mg/m2 for 4 cycles followed by paclitaxel at a dose of 250 mg/m2 over 3 hours for 4 cycles every 21 days (sequential arm, n = 94). RESULTS: The authors rejected the null hypothesis that the sequential treatment is less active than the standard concomitant regimen (ORRs: concomitant = 58.5%, sequential = 57.6%). The median progression-free and overall survival periods were 11.0 months (95% confidence interval [95% CI], 9.7-12.3) and 20.0 months (95% CI, 17.2-22.6), respectively, in the concomitant arm and 10.8 months (95% CI, 7.9-13.6) and 26 months (95% CI, 18.1-33.8), respectively, in the sequential arm (P = not significant). Patients who received the sequential regimen experienced a higher incidence of Grade 3/4 (according to the World Health Organization grading system) neutropenia (62.2% of courses vs. 50.62%; P = 0.003) and Grade > or = 2 neuropathy (45.5% vs. 30.4% of patients; P = 0.03), whereas 6 patients who received the concomitant regimen developed Grade II cardiotoxicity according to New York Heart Association criteria. QOL analyses failed to provide clear differences. CONCLUSIONS: The sequential administration of epirubicin and paclitaxel at full doses was found to be as active as their association. Therefore, both the sequential and the combined administration were acceptable options.

Adult↗
PubMed2004

Prevalence of the Y165C, G382D and 1395delGGA germline mutations of the MYH gene in Italian patients with adenomatous polyposis coli and colorectal adenomas.

Biallelic germline mutations in the base excision repair gene MYH have been reported in patients with multiple colorectal adenomas and cancer and in sporadic FAP patients not showing a detectable APC germline mutation. In this study, the prevalence of the common Y165C and G382D germline variants of the MYH gene was examined in 70 FAP/AAPC patients with no detectable APC mutation and a family history compatible with recessive inheritance. In addition, 141 normal-population adenoma patients (mean number of adenomas, 2.8; range, 1-9) and 52 clean colon controls were studied. The entire coding region of the MYH gene was analyzed in Y165C or G382D heterozygous patients. Since the same second mutational event (a 3 bp deletion in exon 14, 1395delGGA) was detected in 3 patients, the prevalence of this variant was also examined in all groups. In all, 14 of 70 patients in the FAP/AAPC group (20%; 95% CI = 11.7-31.6%) had biallelic germline MYH variants and 3 were heterozygotes (4.3%). None of the 141 normal-population adenoma patients carried biallelic germline MYH variants (95% CI = 0.06-4.1%) and 3 were heterozygotes (2.1%). In the control group, no MYH variants were detected. These results indicated that MYH-associated polyposis (MAP) is present in about 20% of Italian FAP/AAPC patients, in whom no germline APC mutation is detectable and showing a family history compatible with recessive inheritance, and in a small fraction of patients with colorectal adenomas in the general population. In addition, our data suggest that mutation 1395delGGA is a subpolymorphic MYH mutational event in some Caucasian populations.

Adenine↗
PubMed2004

An extended assessment of bowel habits in a general population.

AIM: Bowel habits are difficult to study, and most data on defecatory behaviour in the general population have been obtained on the basis of recalled interview. The objective assessment of this physiological function and its pathological aspects continues to pose a difficult challenge. The aim of this prospective study was to objectively assess the bowel habits and related aspects in a large sample drawn from the general population. METHODS: Over a two-month period 488 subjects were prospectively recruited from the general population and asked to compile a daily diary on their bowel habits and associated signs and symptoms (the latter according to Rome II criteria). A total of 298 (61%) participants returned a correctly compiled record, so that data for more than 8 000 patient-days were available for statistical analysis. RESULTS: The average defecatory frequency was once per day (range of 0.25-3.25) and was similar between males and females. However, higher frequencies of straining at stool (P=0.001), a feeling of incomplete emptying and/or difficult evacuation (P=0.0001), and manual manoeuvres to facilitate defecation (P=0.046) were reported by females as compared to males. CONCLUSION: This study represents one of the first attempts to objectively and prospectively assess bowel habits in a sample of the general population over a relatively long period of time. The variables we analyzed are coherent with the criteria commonly used for the clinical assessment of functional constipation, and can provide a useful adjunct for a better evaluation of constipated patients.

Adult↗
PubMed2004

False-positive galactomannan platelia Aspergillus test results for patients receiving piperacillin-tazobactam.

At the bone marrow transplantation center of the San Martino Hospital (Genoa), we observed an increase in the rate of patients with positive Platelia Aspergillus (PA; Bio-Rad) test results, from 10% (38 of 386 patients) in the period from January 1999 through January 2003 to 36% (21 of 59 patients) in the period from February 2003 through May 2003. Positivity was significantly (P<.001) associated with the administration of piperacillin-tazobactam (PT) (17 [74%] of 23 patients who received PT had positive results vs. 4 [11%] of 36 who did not receive PT). Multivariate analysis found administration of PT ( chi 2=34.7; P<.001) and underlying disease ( chi 2=21.14; P<.001) to be associated with PA positivity. Of 15 PT batches tested, 12 had positive PA test results.

Anti-Bacterial Agents↗
PubMed2004

Twelve-year experience with left atrial resection in the treatment of non-small cell lung cancer.

BACKGROUND: We retrospectively reviewed our 12-year experience in the surgical treatment of non-small cell lung cancer invading the left atrium. End points of the study were overall survival and factors potentially affecting survival. METHODS: Nineteen consecutive patients with lung cancer invading the left atrium underwent surgery. Three patients with N2 disease underwent induction chemotherapy. Patients with either incomplete resections or pN2 disease received postoperative chemoradiotherapy. RESULTS: Five-year survival was 14%, and the median survival time was 25 months. These figures refer to a very homogeneous group of patients with respect to the extent of atrial infiltration. Patients with N2 disease tended to have a worse outcome than patients with N0 or N1 disease (p = 0.06). The 3 patients with N2 disease who underwent induction chemotherapy were alive and disease-free at 30, 15, and 11 months from surgery. Survival was not affected by histology, type of surgery, or completeness of resection. Three patients with residual cancer in the atrial resection margin underwent postoperative chemoradiotherapy and are alive at 25, 17, and 15 months after surgery. CONCLUSIONS: In spite of the poor survival rates we report, the present experience suggests that more-favorable results could be expected by the routine preoperative use of positron emission tomographic scan staging, a more-extensive assessment of atrial invasion, the application of induction chemotherapy in patients with N2 disease, and postoperative chemoradiotherapy in patients with tumors abutting the atrial resection margin.

Aged↗
PubMed2003

Disseminated neuroblastoma in children older than one year at diagnosis: comparable results with three consecutive high-dose protocols adopted by the Italian Co-Operative Group for Neuroblastoma.

PURPOSE: To compare the outcomes associated with modifications in three consecutive protocols employed by the Italian Co-Operative Group for Neuroblastoma (ICGNB) in disseminated neuroblastoma. PATIENTS AND METHODS: Between January 1985 and November 1997, a total of 359 children aged 1 to 15 years with newly diagnosed stage 4 neuroblastoma were enrolled in three consecutive protocols. Compared with ICGNB-85, the ICGNB-89 protocol contained two more chemotherapy cycles, and some drugs were given at greater doses, whereas in the ICGNB-92 protocol, the induction phase included a chelating agent, and individual cycles contained four drugs instead of two. RESULTS: A total of 330 of 359 evaluable children were included in this analysis; 106 children were treated with ICGNB-85, 65 children were treated with ICGNB-89, and 159 children were treated with ICGNB-92 protocols. Radical resection of primary tumor was carried out in 59.4%, 50.8%, and 57.9% of the patients, respectively. Major tumor response after induction therapy was achieved in 66.7%, 69.2%, and 68.6% of the patients, respectively. A total of 218 of 232 patients received consolidation therapy consisting of conventional chemotherapy in 65 patients and of high-dose chemotherapy in 153 patients. Disease recurrence or progression occurred in 82.1%, 69.2%, and 74.8% of the patients, respectively. Therapy-related deaths occurred in 1.9%, 12.3%, and 6.9% of the patients, respectively. Five-year overall survival (OS) for the three studies was 26%, 23%, and 28%, and event-free survival (EFS) was 19%, 17%, and 17%, respectively. CONCLUSION: The therapeutic modifications adopted in the ICGNB-89 and ICGNB-92 protocols were not associated with a significant improvement in response rate or in the 5-year OS and EFS as compared with the ICGNB-85 protocol. Attempts at intensifying chemotherapy were associated with greater toxicity.

Adolescent↗
PubMed2003

Interobserver agreement in the histologic diagnosis of colorectal polyps. the experience of the multicenter adenoma colorectal study (SMAC).

Current clinical practice guidelines for patients with colorectal polyps are mainly based on the histologic characteristics of their lesions. However, interobserver variability in the assessment of specific polyp characteristics was evaluated in very few studies. The purpose of this study was to evaluate the interobserver agreement of four pathologists in the diagnosis of histologic type of colorectal polyps and in the degree of dysplasia and of infiltrating carcinoma in adenomas. A stratified random sample of 100 polyps was obtained from the 4,889 polyps resected within the Multicentre Adenoma Colorectal Study (SMAC), and the slides were blindly reviewed by the four pathologists. Agreement was analyzed using kappa statistics. A median kappa of 0.89 (range 0.79-1.0) was estimated for the interobserver agreement for the diagnosis of hyperplastic polyp vs. adenoma. The agreement in the diagnosis of tubular, tubulovillous, and villous type, was given by median kappa values of 0.50, 0.15, and 0.36, respectively. The median kappa for the diagnosis of infiltrating carcinoma was 0.78 (range 0.73-0.84). Agreement on diagnosis of adenoma histologic subtypes, degrees of dysplasia, or infiltrating carcinoma in adenoma was moderate. A simpler classifications might help to better identify patients at different risk of colorectal cancer.

Adenocarcinoma↗
PubMed2003

Cancer of the nasopharynx.

Nasopharyngeal cancer (NPC) is quite rare throughout Europe, accounting for an annual incidence rate below 1 per 100.000, whereas the highest risk area is South East Asia. A predominant occurrence in males is to be noted. NPC is an etiologically multifactorial disease, most probably involving viral, genetic and environmental factors. Carcinomas of the nasopharynx can be divided into two major histotypes: keratinizing squamous cell carcinomas (WHO-type 1) and non-keratinizing carcinomas (WHO-type 2). The histological type is a prognostic factor and it has a clear impact on the outcome of treatment. Standard therapeutic option for early stages of NPC is radiation, while an integration of radiation therapy and chemotherapy is indicated in more advanced stages.

Humans↗
PubMed2003

Major and minor salivary glands tumours.

Malignant salivary gland tumours are rare. The most common tumour site is the parotid. Aetiologic factors are not clear. Nutrition may be a risk factor, as well as irradiation or an histologically benign tumour occurred at a young age. Painless swelling of a salivary gland should always be considered as suspicious, especially if no sign of inflammation is present. Signs and symptoms related to major salivary gland tumours differ from those concerning minor salivary gland tumours, as they depend on the different location of the salivary gland. Surgical excision represents the standard option in the treatment of resectable tumours of both major and minor salivary glands. Neutron radiation may be a treatment option for inoperable locoregional disease. Surgery, irradiation or re-irradiation are treatment options for local relapse, whereas radical neck dissection is indicated for regional relapses. Metastastic disease may be either treated with radiotherapy or palliative chemotherapy, depending on the site of metastases.

Humans↗
PubMed2003

Malignant melanoma.

In the European Community cutaneous melanoma accounts for 1 and 1.8% of cancers occurring in men and women, respectively. The incidence rate is increasing faster than that of any other tumour. Sun exposure, patient's phenotype, family history, and history of a previous melanoma are the major risk factors. The change over a period of months is the main sign of a skin lesion turned into a melanoma. The ABCDE scheme for early detection of melanoma is commonly accepted. A new staging classification will be published in the next AJCC/UICC Cancer Staging System Manual in 2002. The clinical course of melanoma is determined by its dissemination and depends on thickness, ulceration, localisation, gender and histology of the primary tumour. Tumour stage at diagnosis remains the major prognostic factor. Surgery is the standard treatment option for operable local-regional disease. Sentinel node biopsy represents a promising experimental approach in the clinical detection and early treatment of occult lymph node involvement. For metastatic inoperable patients systemic chemotherapy can be attempted, while radiation therapy has to be considered as palliative treatment. No studies concerning frequency of follow-up are currently available, but common procedures may be performed.

Female↗
PubMed2003

A multicenter, randomized, double blind placebo-controlled trial of amoxicillin/clavulanate for the prophylaxis of fever and infection in neutropenic children with cancer.

AIM OF THE STUDY: To evaluate the effectiveness of oral amoxicillin/clavulanate (25 mg/kg every 12 h) for prevention of fever and/or infection in neutropenic children with cancer. METHODS: Multicenter, prospective, randomized, double blind placebo-controlled trial. RESULTS: In the intention-to-treat analysis, amoxicillin/clavulanate had a 12% benefit increase in terms of reduction in the incidence of febrile or infectious episodes, compared with placebo [44 of 83 (53%) vs.55 of 84 (65%); 95% confidence interval, -28% to +3%; P = 0.101]. This benefit was also associated with a 30% increase in the probability of failure-free survival at Day 15 (P = 0.138). A logistic regression analysis showed the effect of prophylaxis to be relevant, especially in patients with leukemia or lymphoma and in those not receiving hematopoietic growth factors, with 17 and 15% absolute benefit increases (logistic P = 0.014 and 0.034, respectively). Compliance with oral drugs was good, with very few and nonsevere drug-related adverse events. CONCLUSIONS: In this study amoxicillin/clavulanate was associated with a detectable clinical effect in the reduction of fever and infection in neutropenic children with cancer, especially those with acute leukemia and not receiving growth factors; the study was not powered to demonstrate a statistically significant effect in the overall patient population.

Adolescent↗
PubMed2003

Effect of a palliative home care team on hospital admissions among patients with advanced cancer.

This was a quasi-experimental study designed to determine whether, in patients with advanced cancer, a palliative home care team (PHCT) modified hospital utilization in the last six months before death. Of 2503 cancer deaths in the municipality of Genoa, Italy, in 1991, 189 (7.5%) received care from a PHCT. Three hundred and seventy-eight controls matched for primary tumour were selected. The groups were similar in terms of age, gender and most other demographic variables, except that educational level was lower, and times to death, from first diagnosis and from diagnosis of advanced or metastatic cancer, were longer among PHCT patients compared with the controls. Before referral to a PHCT, or a matched time in controls, both groups spent about 15% of days in hospital. After admission to a PHCT, the percentages of days in hospital increased in both groups as death approached, but it was much higher in the control group (30.3%; 95% confidence interval (CI): 26-34) than in the PHCT group (19.0%; 95% CI: 15-23). The difference between groups was most marked in the last month of life, and disappeared among those patients who were in care for more than 120 days (throughout the course of their illness). We conclude that a PHCT appears to reduce days in hospital and allows patients to spend more time at home. Differences in time in care between groups requires further investigations.

Adult↗
PubMed2002

Risk associated with pregnancy in hypertrophic cardiomyopathy.

OBJECTIVES: We sought to assess mortality and morbidity in pregnant women with hypertrophic cardiomyopathy (HCM). BACKGROUND: The risk associated with pregnancy in women with HCM is an important and increasingly frequent clinical issue for which systematic data are not available and a large measure of uncertainty persists. METHODS: Maternal mortality in 91 consecutively evaluated families with HCM was compared with that reported in the general population. The study cohort included 100 women with HCM with one or more live births, for a total of 199 live births. Morbidity related to HCM during pregnancy was investigated in 40 women evaluated within five years of their pregnancy. RESULTS: Two pregnancy-related deaths occurred, both in patients at a particularly high risk. The maternal mortality rate was 10 per 1,000 live births (95% confidence interval [CI] 1.1 to 36.2/1,000) and was in excess of the expected mortality in the general Italian population (relative risk 17.1, 95% CI 2.0 to 61.8). In the 40 patients evaluated within close proximity of their pregnancy, 1 (4%) of the 28 who were previously asymptomatic and 5 (42%) of the 12 with symptoms progressed to functional class III or IV during pregnancy (p < 0.01). One patient had atrial fibrillation and one had syncope, both of whom had already experienced similar and recurrent events before their pregnancy. CONCLUSIONS: Maternal mortality is increased in patients with HCM compared with the general population. However, absolute maternal mortality is low and appears to be principally confined to women at a particularly high risk. In the presence of a favorable clinical profile, the progression of symptoms, atrial fibrillation, and syncope are also uncommon during pregnancy.

Adolescent↗
PubMed2002

Time to progression in metastatic breast cancer patients treated with epirubicin is not improved by the addition of either cisplatin or lonidamine: final results of a phase III study with a factorial design.

PURPOSE: To investigate the value of the addition of either cisplatin (CDDP) or lonidamine (LND) to epirubicin (EPI) in the first-line treatment of advanced breast cancer. PATIENTS AND METHODS: Three hundred seventy-one metastatic breast cancer patients with no prior systemic chemotherapy for advanced disease were randomized to receive either EPI alone (60 mg/m(2) on days 1 and 2 every 21 days), EPI and CDDP (30 mg/m(2) on days 1 and 2 every 21 days), EPI and LND (450 mg orally daily, given continuously), or EPI, CDDP, and LND. Time to progression, response rates, side effects, and survival were compared according to the 2 x 2 factorial design of this study. RESULTS: The groups were well balanced with respect to prognostic factors. Time to progression did not differ in the comparison between CDDP arms and non-CDDP arms (median, 10.9 months v 9.4 months, respectively; P =.10) or between that of LND arms and non-LND arms (median, 10.8 months v 9.9 months, respectively; P =.47), nor did overall survival. The response rate did not significantly differ in the comparison between LND arms and non-LND arms (62.9% v 54.0%, P =.08). No difference in treatment activity was observed between CDDP arms and non-CDDP arms. Toxicity was significantly higher in the CDDP arms, leading to CDDP dose adjustment in 40% of cases. The most frequent side effects were of a hematologic and gastrointestinal nature. The addition of LND produced more myalgias and fatigue. CONCLUSION: Neither CDDP nor LND was able to significantly improve the time to progression obtained by EPI. CDDP, however, significantly worsened the drug's tolerability.

Adult↗
PubMed2002

Randomized trial comparing cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) with rotational CMF, epirubicin and vincristine as primary chemotherapy in operable breast carcinoma.

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.

Adult↗
PubMed2002

MRI metrics as surrogate markers for clinical relapse rate in relapsing-remitting MS patients.

OBJECTIVE: To formally validate metrics derived from conventional MRI as surrogate endpoints for relapse rate in MS. BACKGROUND: Although metrics derived from MRI are used widely in clinical trials of MS, a formal statistical validation of MRI metrics as surrogate endpoints for clinical outcome in MS is lacking. METHODS: A validation procedure was applied to clinical and MRI data collected in the context of a randomized, double-blind, placebo-controlled trial of glatiramer acetate in patients with relapsing-remitting MS. The four Prentice operational criteria were applied to assess surrogacy for the number of new enhancing lesions, the percentage change of T2 lesion volume, and a composite MRI score based on these two metrics. RESULTS: The results of this analysis show that all three MRI measures considered by the authors had a behavior compatible with the Prentice criteria for valid surrogates. The composite MRI score correlated with relapses and accounted for much of the treatment effect on relapse rate. CONCLUSIONS: This preliminary study suggests that conventional MRI metrics might serve as valid surrogate endpoints in MS trials with glatiramer acetate or treatments thought to have a similar mode of action.

Follow-Up Studies↗