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Background: The digital world has undergone an essential metamorphosis in recent years, making the easy sharing of information possible, including those related to pharmacovigilance and the safety aspects of pharmaceutical and other healthcare products. These new interactive ways pose both opportunities and challenges to healthcare/pharmaceutical companies. The Pharmacovigilance Working Group “Ernesto Montagna” of the Italian Society of Pharmaceutical Medicine (SIMeF) decided to carry out a survey to gain a better understanding of the role of pharmacovigilance in digital activities. Methods: The Pharmacovigilance Working Group “Ernesto Montagna” sent a questionnaire via Computer-Assisted Web Interview (CAWI) technology to the members of the Pharmacovigilance Working Group (N = 257). The questionnaire was composed of 11 questions in four clusters exploring: (i) digital channels and projects implemented by the healthcare/pharmaceutical companies; (ii) governance tools in place for digital channels and projects; (iii) management of adverse events collected from digital channels and projects; (iv) impact of artificial intelligence on pharmacovigilance activities. Results: Ninety-three members of the Group “Ernesto Montagna” completed the questionnaire. The results show that, in the panorama of Italian healthcare/pharmaceutical companies, digital activities are ongoing, but there are still areas of uncertainty: on when a pharmacovigilance team should be involved, on the governance tools and on the guidance to be used to ensure effective governance of digital projects. Conclusion: In a scenario which is evolving very quickly, a critical factor is the availability of specific and updated regulations. Scientific societies, such as SIMeF and Farmindustria, the Italian national Pharma-Companies Association, could give a valuable contribution to the development of appropriate guidance together with the competent authorities. Plain Language Summary Results of an Italian survey on pharmacovigilance and digital world Background: The digital world allows and makes the sharing of information easy, including information related to the health status of patients and side effects of drugs. Healthcare/pharmaceutical companies are faced with both opportunities and challenges provided by such new ways of interaction among patients and healthcare professionals. The Pharmacovigilance Working Group “Ernesto Montagna” of the Italian Society of Pharmaceutical Medicine (SIMeF) carried out a survey to gain a better understanding of the role of pharmacovigilance in digital activities. Methods: The Pharmacovigilance Working Group “Ernesto Montagna” distributed a questionnaire to the 257 members of the Pharmacovigilance Working Group. The questionnaire was composed of 11 questions exploring: (i) digital channels and projects implemented by the companies; (ii) governance tools in place for digital channels and projects; (iii) management of adverse events collected from digital channels and projects; (iv) impact of artificial intelligence on pharmacovigilance activities. Results: Ninety-three members completed the questionnaire. The results show that digital activities are ongoing in the Italian healthcare/pharmaceutical companies. Despite this, there are still areas of uncertainty, in particular: on when pharmacovigilance team should be involved and on the tools and guidance to be used to ensure effective governance of digital projects. Conclusion: In a scenario that is evolving very quickly, an important factor is represented by the availability of straightforward and updated pharma-regulations and guidelines. Scientific societies like SIMeF and Farmindustria, the Italian national Pharma-Companies Association, could give a valuable contribution to the development of appropriate guidance together with the qualified authorities, in order to coordinate and standardize the approach among pharmaceutical companies.

Mucoepidermoid carcinoma (MEC) can have a variety of clinical outcomes, but prognosis seems to be related to the tumor grade. The system proposed by Auclair and Goode is useful, and our data lend further support to its application and validity in clinical practice. We have clinicopathologically reviewed 108 cases of MEC originating in major (MASG) and minor (MISG) salivary glands that were treated at the National Cancer Institute of Milan between 1975 and 1995. Following the methods of Auclair and Goode, a quantitative grading system was used. The relationships between clinical and pathologic characteristics and survival rate were investigated. Twenty-six (44%) cases located in MASG and 19 (39%) cases in MISG were categorized as high-grade tumors. In patients with MASG tumors, the 5-year disease-free survival rate was 22.5% when the tumor was high grade and 97.0% if the tumor was low grade (P <.0001). For patients with a tumor of the MISG, the percentages were 35.3% for high-grade and 80.0% for low-grade tumors (P =.0066). Our study confirms that in MEC, tumor grade, subdividing cases into low and high grade by using the criteria delineated by Auclair and Goode, correlates well with prognosis.

At present, abdominoperineal resection remains the most diffuse method of treatment of very low rectal cancer. Today, we can avoid this method in some patients by using a sphincter-saving procedure. From March 1990 to January 1999, 273 consecutive total rectal resections and coloendoanal anastomoses were performed at our Institute; this study concerns 141 consecutive patients treated for a primary adenocarcinoma of the distal rectum, from 3.5 to 8 cm from the anal verge. Patient stratification, based on definitive pathological report, was 31 Dukes' stage A (T2N0), 44 stage B (T3N0), and 66 stage C (T2N+-T3N+). Overall recurrence rate was 9.2%; postoperative morbidity attributable to the procedure was low. A perfect continence was documented in 61% of cases. The only pathological factor related to local recurrence rate is peritumoral lymphocytic reaction inside and around the tumor (P = .0005 and .031) independently from the number of metastatic lymph nodes, depth of fatty tissue infiltration, and lymphatic and venous neoplastic emboli. The minimum follow-up time is 12 months. Our data, in accordance with other authors, seem to highlight the relevant role that a well-practiced surgery, together with accurate information on the spreading of this disease, has in achieving an optimal local control of cancer.

Recent reports suggest that a distal clearance (DC) of 10 mm at the lower surgical margin may be considered adequate in the surgical treatment of rectal cancer, but there are no data on the possible adequacy of a < 10-mm DC in N0 patients in whom a good prognosis can otherwise be expected, that is, those with negative surgical margins and negative lymph nodes. Between November 1991 and December 1998, 154 consecutive patients with adenocarcinoma of the lower third of the rectum had a total rectal resection with total mesorectal excision and coloendoanal anastomosis. Among 76 N0 patients, there were 35 with <10-mm DC and 41 with > or =10-mm DC. Each group was divided into two subgroups depending on whether the surgical margins were involved or not, and the rate of local recurrence in the various categories was compared. All B2 Astler-Coller stage patients in the series received postsurgical chemoradiotherapy. The local recurrence rate in the 35 patients with DC < 10 mm was 11.4% and that of the 41 patients with DC > or =10 mm was 7.3%. When only patients with negative surgical margins were considered, the local recurrence rate was 3.4% for those with < 10-mm DC and 5.1% for those with > or =10-mm DC. Our results suggest that a radical surgery with <10-mm DC followed by chemoradiotherapy may be adequate in N0 patients, provided that a careful pathologic examination of the surgical specimen excludes the presence of lymph node metastases and that the distal rectal and mesorectal resection margins fall in healthy tissue.

The number of examined lymph nodes and metastases in lymph nodes smaller than 5 mm (small lymph nodes) are a determining factor in the stage of rectal cancer although the clinical significance of occult micrometastases is controversial. We are reporting our preliminary results on the identification and prognostic utility of metastases in small lymph nodes and occult micrometastases. We searched small metastatic lymph nodes in 101 cases of adenocarcinoma of the lower third of the rectum. We used the manual technique to dissect mesorectal fat and occult micrometastases in the lymph nodes of 52 Dukes' A and B patients, using a pool of anticytokeratin antibodies. Forty-five percent of the metastatic lymph nodes were smaller than 5 mm in diameter and determined the Dukes' stage in 15 (30.6%) of 49 Dukes' C patients. Occult micrometastases were found in 21 (40.4%) patients: five recurred but vascular invasion, positive distal margin of the rectum, and positive circumferential margin of the mesorectum were present. Small metastatic lymph nodes, vascular invasion, positive distal margin of the rectum, and positive circumferential margin of the mesorectum were found to be more important than occult micrometastases in predicting early recurrence of rectal cancer.