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Objective: To describe the practice of prostate-specific antigen (PSA) testing over more than 20 years in Friuli Venezia Giulia (FVG), North-Eastern Italy., Methods: A population-based, ecological study was conducted using information derived from regional administrative health-related databases. Data on PSA and prostate biopsies performed on resident men aged ⩾45 years from 1998 to 2019 were retrieved. PSA and biopsy rates were calculated as the number of men who had at least one such procedure in each calendar year over the mean resident male population of the same year. Temporal trends were analyzed using joinpoint regression (annual percentage change -APC)., Results: A total of 2,502,670 PSA were made between 1998 to 2019 in men aged ⩾45 years. The number of PSA steadily increased from 51,055 in 1998-1999 to 134,504 in 2010-2011, then dropped to 122,080 in 2018-2019. Significant changes in the slopes of PSA rates emerged in 2002 and 2009: the largest increase occurred during 1998-2002 (APC 18.4), followed by a smaller increase in 2002-2009 (APC 3.4) and a subsequent reduction (APC -2.5). Similar patterns emerged for all ages, but the decrease since 2009 was smaller for men aged ⩾65 years. An upward trend emerged in biopsy rate from 1998 to 2001 (APC 13.0), followed by a smaller increase until 2007 (APC 5.7) and a subsequent decrease. Biopsies as percentage of PSA decreased from 3.2% to 2.2%, particularly in those aged ⩾75 years., Conclusions: Although overall declining PSA rates have been observed in FVG since 2009, rates remained higher in the ⩾65-year-old group than in the 45-64-year-old group.

Background: Incidence rates of thyroid cancer (TC) increased in the last decades worldwide. This study aimed to describe TC incidence in the Friuli Venezia Giulia (FVG) region, to estimate the quota of overdiagnosis, and to investigate the impact of surgery on long-term survival after TC diagnosis., Methods: TC cases reported to the FVG population-based cancer registry during 2002-2013, aged <85 years, were included. Age standardized rates (ASR) on the European population were computed, while proportion of TC overdiagnosis was estimated in comparison with expected age-specific incidence rates from published time series. Adjusted hazard ratios of death, with 95% confidence intervals, were also estimated., Results: During 2002-2013, 1701 TC cases were reported to the FVG cancer registry, with papillary TC (78.2%) as the most frequent histologic type. ASR increased from 12.4 to 16.5 in women and from 4.3 to 6.2 in men (+33.1% and +44.2%, respectively). Overdiagnosis was estimated as 79% of TC cases in women and 64% in men. Almost all TC cases (97.1%) underwent surgery, including 84.6% of women and 78.9% of men who underwent total thyroidectomy. Up to 10 years after TC diagnosis, the type of surgery did not appear to influence survival., Conclusions: This study documented an increase in TC incidence in FVG in the last decade, with overdiagnosis accounting for a large proportion of TC diagnoses and total thyroidectomy in more than 80% of cases. These findings suggest reconsidering thyroid screening practice and aggressive therapeutic strategies, as recommended by new TC guidelines.

Aims and Background: In cancer patients, fatigue interferes with the individual's functioning and quality of life (QoL). We investigated the association between fatigue and the main QoL dimensions and mood states as well as the main sociodemographic and clinical variables., Methods: A total of 105 inpatients undergoing chemotherapy were administered the Revised Piper Fatigue Scale and the EORTC QLQ-C30 and POMS questionnaires, along with a form for collecting personal and clinical data., Results: Compared with patients reporting lower fatigue levels, patients with higher levels showed worse functioning (P <0.001) in every QoL domain (i.e., physical, role, emotional, social, cognitive functioning, pain, and general health) as well as in the assessed mood states (depression-dejection, tension-anxiety, confusion-bewilderment). Moreover, both QoL and mood states in the subgroup reporting intermediate fatigue levels were worse than those of the subgroup with lower fatigue levels (P <0.02), except for emotional functioning, general health and QoL, and tension-anxiety. In addition, fatigue was significantly associated with gender, age, education, performance status, but not with marital status, survival rate of cancer type, and current chemotherapy cycle., Conclusions: The associations observed between fatigue, the main QoL domains, and negative mood states call for further active interventions to prevent and reduce fatigue.

Aims and Background: Since emotional distress is a relevant psycho-social component of an oncological disease experience, its study is useful in multidisciplinary patient cancer care. In the present research, emotional distress together with needs during hospitalization were recorded and their associations with several socio-demographic and clinical variables were verified., Methods and Study Design: Five hundred and forty-four consecutive oncological inpatients completed two self-assessment questionnaires concerning emotional distress and needs (i.e., Hospital Anxiety and Depression Scale, Needs Evaluation Questionnaire)., Results: 27.4% and 20.8% of the enrolled patients were probable cases, respectively, for anxiety and depression; when possible cases were included the percentages raised to 52.5% and 39.3%, respectively. Furthermore, 11.9% and 20.2% of participants were simultaneously probable and possible cases for both conditions. Few differences in anxiety and depression according to socio-demographic and clinical variables were demonstrated, whereas needs seemed to be more frequently associated to them. Finally, needs also seemed to be associated with both anxiety and depression, with possible and probable cases for anxiety and depression displaying more needs than non-cases., Conclusions: The implications for both the quality of care and disease adjustment by cancer patients are discussed together with study limitations.

Aims and Background: Association between pegylated liposomal doxorubicin-based regimens and palmar-plantar erythrodysesthesia have just been emphasized, whereas the relationship between previous treatment and palmar-plantar erythrodysesthesia is still a matter of discussion. We evaluate the relationship between previous chemotherapy treatments and the development of palmar-plantar erythrodysesthesia in patients receiving pegylated liposomal doxorubicin-based regimens., Methods: Between January 2005 and November 2006, 92 patients received regimens including pegylated liposomal doxorubicin. Patients were divided into three groups based on pegylated liposomal doxorubicin dosing interval length, different dose chosen, and previous chemotherapy., Results: Among pretreated patients receiving regimens including 30 mg/m2 of pegylated liposomal doxorubicin repeated every three weeks, the incidence of palmar-plantar erythrodysesthesia was not significantly higher than in unpretreated patients receiving the same weekly schedule (P = 0.4). There was no difference in the incidence of palmar-plantar erythrodysesthesia between pretreated patients with regimens including 30 mg/m2 of pegylated liposomal doxorubicin every three weeks and pretreated patients receiving 20 mg/m2 of pegylated liposomal doxorubicin every two weeks (P = 0.8). The prevalence of palmar-plantar erythrodysesthesia observed in the unpretreated group exposed to 30 mg/m2 every three weeks was comparable to that of the pretreated group receiving 20 mg/m2 biweekly (P = 0.3). However, excluding all the patients who developed grade 1 palmar-plantar erythrodysesthesia, the incidence of grade 2 and 3 palmar-plantar erythrodysesthesia observed in pretreated patients receiving regimens including 20 mg/m2 of pegylated liposomal doxorubicin biweekly was significantly higher than in unpretreated patients receiving 30 mg/m2 of pegylated liposomal doxorubicin every three weeks (P = 0.001)., Conclusions: Our findings indicate that the pretreatment is not involved in the increased incidence of any grade palmar-plantar erythrodysesthesia. On the contrary, the study could suggest that the type of previous treatment may be an important factor in the development of more severe forms of palmar-plantar erythrodysesthesia.

Aims and Background: Trastuzumab-based therapy has improved survival of women with human epidermal growth factor receptor 2 (HER2)-overexpressing metastatic breast cancer., Study Design: From September 2002 to July 2006, 45 women with metastatic breast cancer HER2 3+, or 2+ and positive for HER2 gene amplification, were enrolled in the study and received a combination therapy with vinorelbine, 25 mg/m2 weeks 1 and 2, plus trastuzumab, 4 mg/kg loading dose and then 2 mg/kg weekly, in a three weeks cycle. Eligibility criteria included measurable disease and a baseline ejection fraction > or = 50%. Forty-two percent of the patients were not pretreated, whereas 58% had received a previous chemotherapy regimen for metastatic disease, including anthracyclines and/or taxanes (47%), and trastuzumab plus taxol (11%)., Results: We observed 14 (31%) complete responses and 21 (47%) partial responses, with an overall response rate of 78%. Stable disease > 6 months was assessed for 5 (11%) patients with a clinical benefit of 89%. Five (11%) patients progressed. With a median follow-up of 11 months, median time to progression was 9 months and median duration of response was 7.6 months for complete remissions and 4 months for partial remissions. Median survival was 29 months., Conclusions: In spite of a smaller dose intensity of vinorelbine than previously reported, the regimen evaluated was notably effective in terms of response rate, time to progression and survival, with very mild toxicity.

Aims and Background: After the first adjuvant study on adult soft tissue sarcomas was concluded, the participating institutions continued to select and treat patients according to that protocol. The aim of this study was to test the protocol reproducibility when applied as a standard practice., Methods: A call for retrospective data was launched in June 1999 (self-referral of consecutive unregistered patients); thereafter, a prospective follow-up was performed. The treatment regimen consisted of epirubicin (60 mg/m2 days 1 and 2), ifosfamide (3 g/m2/die for 3 days) and equimolar doses of 6-mercapto-ethansulfonate (MESNA), with 300 microg G-CSF administered subcutaneously from day +8 until recovery, every 3 weeks for a total of 5 cycles., Results: From November 1996 to June 1999, 55 high-risk, adult patients were treated. The average median dose intensity was 89% of the planned program. Grade 3-4 toxicities were leukopenia (49%), thrombocytopenia (14%), transfusion requiring anemia in 7 patients (16%), and alopecia in all patients (100%). After a median follow-up of 70 months, 23 patients (41.8%) relapsed and 19 died. Median disease-free, local disease-free and overall survival rates have not yet been reached. The disease-free survival rates at 2 and 4 years were 73% and 57%, respectively; the corresponding overall survival rates were 91% and 70%, respectively., Conclusions: The feasibility and reproducibility of the original protocol were confirmed, since disease-specific overall survival and disease-free survival rates at the same period of observation and with the same prolonged follow-up did not differ.

Aims and Background: Until 1998 there was opportunistic screening in Friuli Venezia Giulia (FVG). Beginning in 1999, formal screening efforts were organized. The regional cancer registry was established in 1998, and data on incidence was collected for the period 1995-98. The scope of this study is to provide baseline data on the incidence of invasive cervical cancer in FVG for further examination of trends in incidence and of the effectiveness of screening efforts., Methods: Data from the regional cancer registry database was examined and linked with data from the regional pap smear screening database., Results: The incidence of cervical cancer in FVG was 8.6 per 100,000. Most women were diagnosed in stages I and II. Most cervical cancers (80%) were squamous cell. Opportunistic screening in FVG reached 39.8% of the total female population. Analysis by local health unit showed heterogeneous data., Conclusions: FVG has one of the highest incidence rates of cervical cancer in Italy. Approximately 1/3 of the diagnoses were in women over the age of 65. Pap smear screening prior to the formal program covered a low percentage of the female population. Screening efforts in the future should focus on screening coverage in the older female population.

Endometrial carcinoma (EC) is the second most common tumor in hereditary nonpolyposis colorectal cancer (HNPCC), with an incidence rate of 60% by the age of 70 in mutation carriers. The International Collaborative Group on HNPCC revised the Amsterdam criteria and proposed a new, wider definition including extracolonic cancers. The aim of our study was to evaluate the accuracy of a new definition called Amsterdam criteria II. We updated, reclassified and compared the pedigrees of 29 women, already reported as being affected by EC and having a colorectal cancer familial background, according to the two clinical diagnostic criteria for HNPCC (Amsterdam criteria I, ACI, and Amsterdam criteria II, ACII) after two periods of observation (1990-1995 and 1995-2000). According to ACII the frequency of HNPCC in the population under study increased from 0.9% to 3.7% in the period 1990-1995 and from 3.2% to 3.7% in the period 1995-2000. ACII allowed early detection of HNPCC families and thus made it possible to provide them with a suitable surveillance program and genetic testing.

Aims and Background: The aim of the study was to evaluate the impact of information level on quality of life in cancer patients previously studied for their information level., Patients and Methods: The information level was determined by means of a questionnaire that explored the degree of information on diagnosis and status of disease, the patient's interpretation of his/her disease status, and his/her satisfaction with the information received. Quality of life was evaluated, some months after evaluation of the information level, by means of the Functional Living Index for Cancer (FLIC) and the State-Trait Anxiety Inventory (STAI 1-2)., Results: A total of 175 patients were studied. Information was adequate in 53.7% of patients. An adequate level of information was present more frequently among patients aged < or = 65 years and in those patients followed at a cancer institute. There was no difference in the quality of life of adequately versus inadequately informed patients. Satisfaction with the information received influenced quality of life in both age groups. Objective clinical variables (active disease present and ongoing treatment) negatively affected quality of life in patients <65 years, whereas the subjective perception of the presence of disease was associated with a worse quality of life in older patients., Conclusions: In the study, although the level of information did not affect the quality of life, satisfaction with the information was associated with a better quality of life. The finding stresses the importance of a sensible disclosure of diagnosis and prognosis.

Aims and Background: The risk for several cancers is higher in urban than in rural areas. The gradient has seldom been studied in southern Europe., Patients and Methods: The geographical pattern of mortality for different cancers and all causes was studied in the Campania Region (about 5.6 million inhabitants), whose largest town is Naples. The key variables were residence in urban/rural and coastal/inland municipalities. Relative risks of death and corresponding 95% confidence intervals by residence were evaluated by means of Poisson log-linear regression models., Results: Significantly increased mortality rates in urban compared to rural municipalities were found for several cancer causes of death. In particular, in both sexes, excesses in the order of 30-50% were observed for tobacco-related neoplasms (i.e., larynx, lung, and bladder) and cancers of the intestine, liver, brain, multiple myeloma and non-Hodgkin's lymphoma, in addition to all-cancer, and all-cause mortality. In females, specific excesses were also noticed for cancer of the gallbladder, pancreas, breast and uterus (corpus and cervix). Conversely, significantly decreased mortality rates in urban with respect to rural municipalities were observed for cancer of the oral cavity and pharynx in males. Coastal location and degree of urbanization were strongly correlated, thus showing similar associations with most causes of death. However, a significant excess of cancer of the pleura in males was restricted to coastal municipalities., Conclusions: Anti-smoking campaigns, sanitation improvements, hepatitis B vaccination, and a decrease in obesity emerge as high priorities with respect to cancer control strategies in the Campania Region, particularly in overpopulated, underprivileged urban areas.

Aims and Background: Anthracyclines are among the most active agents for the treatment of patients with locally advanced breast cancer. The aim of our study was to evaluate the feasibility and activity of a relatively high-dose regimen with 4-epirubicin plus normal doses of cyclophosphamide over a short period of time without the use of hematologic growth factors as adjuvant in resected locally advanced breast cancer., Methods: Between January 1990 and June 1992, 43 consecutive patients, premenopausal or postmenopausal < 60 yrs, were surgically resected and then treated with epirubicin plus cyclophosphamide for at least 4 cycles (maximum 6). Electron beam (6-10 MeV energy) radiotherapy was delivered on the chest wall in patients with pathological skin infiltration (pT4b)., Results: Median age was 46 years (range, 27-59); 37 were premenopausal and 6 postmenopausal. The total number of administered cycles was 202 (6 in 15 patients and 4 in 28 patients); 195/202 (96.5%) were administered at full dose, and 7 (3.5%) were reduced to 75% of the planned dosage. The three-year disease-free survival was 67% for stage IIIa and 61% for stage IIIb patients. The three-year overall survival was 88% and 79%, respectively. Local relapse only was reported in one patient (2%), distant relapse in 11 patients (25%), and local and distant relapse in four patients (9%). Toxicity was acceptable and mainly hematologic., Conclusions: Our trial showed that the regimen is feasible without the use of hematologic growth factors. In this era of cost containment, the use of this short-term, high-dose induction course instead of repetitive courses of conventional dose regimens merits further evaluation, possibly in a large randomized trial.

Aims and Background: The present report combines descriptive statistics (partly never published) on four neighboring areas of north-eastern (NE) Italy [Friuli-Venezia Giulia (1970-89) and Veneto (1970-87) regions and the provinces of Trento (1970-89) and Bolzano (1971-90)], and all Italy (1970-89). The aim was to highlight potential differences in mortality trends and promote a more systematic sharing of data and methodologies., Methods: Death certificates stratified by cause, sex, age and residence were obtained from official publications of the Italian Central Institute of Statistics. Absolute numbers of deaths from different causes, age-standardized rates (on the basis of the European standard population) and percentage of change over the examined period for both sexes were computed for each geographic area., Results: Unfavorable trends were seen for neoplasms of the upper aerodigestive tract, lung, breast, colorectum, bladder, kidney and pancreas and cutaneous malignant melanoma. Increases in most of these neoplasms were more marked in the 4 NE areas than in Italy, especially with respect to cancers of the upper aerodigestive tract in both sexes and cancer of the lung and ovary in women. In Bolzano, rates of neoplasms associated with tobacco and alcohol consumption were lower and less steeply increasing than in the other NE areas, most notably Trento, therefore, contributing to produce the lowest overall cancer mortality rates of NE areas. Cancers of the stomach, uterus, and testis and Hodgkin's disease presented consistent downward trends in all examined areas., Conclusions: The analysis of mortality trends across areas is consistent with elevated and still increasing cancer rates in the 4 NE areas considered, especially for tobacco and alcohol-related neoplasms and skin melanoma. Preventive strategies, based on epidemiologic knowledge, especially against tobacco and heavy alcohol consumption, and intense intermittent sun exposure, seem to be priorities and may benefit from systematic sharing of information, expertise and intervention tools in NE Italy. At least part of the lack of cancer deaths in Bolzano must be attributable to the deaths of Bolzano residents abroad (especially in Austria) and/or to differences in coding practices. This should be elucidated in future studies.

Aims and Background: Substantial upward trends for skin cancer mortality have been observed in most European countries in the last two decades. The distinction, however, between cutaneous malignant melanoma (CMM) and non-melanomatous skin cancers on the basis of death certification is unreliable., Methods: In order to assess the trends of CMM, analysis of the specific code for CMM (International Classification of Disease VIII and IX:172) was coupled with analysis of total skin cancer mortality rates, standardized on the 1981 Italian Census population, at all ages and in selected age groups (15-44, 45-64 and 65-84 years). The analyses were carried out for the whole of Italy and for Friuli-Venezia Giulia (FVG), a region in North-East Italy with a high proportion of fair-complexioned individuals, elevated frequency of sunbathing, and especially good diagnostic standards., Results: In 1985-89 skin cancer mortality rates in men at all ages, as compared to 1970-74, were 33% higher in Italy and 46% higher in FVG. In women, there was a rise of 22% in Italy and 94% in FVG. More marked upward trends were observed in young and middle aged adults, especially among women in FVG (over 300% increase). In absolute terms, approximately 3000 more Italians died from skin cancers in 1985-89 as compared to 1970-74, about half of them prematurely (i.e., < 65 years). CMM was mentioned in death certifications for skin cancer increasingly often in all age groups, particularly in FVG., Conclusions: The analysis of mortality trends from skin cancer is consistent with a substantial rise of CMM-related deaths. The sensitivity of death certification with respect to CMM diagnosis is also increasing, especially in FVG. A public health strategy with the aim of reducing intermittent intense exposure to ultraviolet light, especially in children, is urgent in Italy as CMM represents one of the few causes of premature death with unfavorable trends.

Enhanced secretion of thyroid stimulating hormone (TSH) has been linked with increased risk of thyroid carcinoma. Diet can increase TSH secretion in various ways: 1) low iodine intake, 2) high goitrogen intake, especially in subjects living in iodine-deficiency areas and 3) direct stimulation of anterior pituitary gland. Excessive iodine intake, however, has also been shown to increase risk of goitre and, perhaps, also thyroid carcinoma. Epidemiological evidence on the role of diet in the etiology of thyroid carcinoma is reviewed here. Ad hoc studies in affluent countries are few and often conflicting. A case-control study conducted in the North of Italy suggests that perhaps dietary aspects other than iodine or goitrogens (i.e. fresh fruit and vegetables and animal fat) may be involved.

From May 1983 to September 1984, 48 consecutive patients with locally advanced, recurrent and/or metastatic head and neck squamous carcinoma were treated with cisplatin 60 mg/m2 i.v. on day 1, fluorouracil 10 mg/kg i.v. push from day 1 to day 4 and bleomycin 10 mg/m2 i.v. from day 1 to day 4, every 3 weeks. In the 44 evaluable patients complete remission was observed in 4, partial remission in 9, stable disease in 19, and progression in 12, for a 29.5% response rate. When the analysis was limited to the 21 patients with PS greater than 70 and no previous chemotherapy or radiotherapy, the response rate was 48%. Toxicity was acceptable, and no treatment related deaths occurred. Overall median survival (all eligible patients) was 7 months. Although further studies with this combination in poor risk patients (previously treated or with PS less than 70) do not appear to be indicated, a more accurate assessment in good risk patients might be warranted.