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Background. Osteonecrosis of the Jaw (ONJ) frequency after antiresorptive treatment in prostate cancer patients largely varied in literature. Patients and Methods. Charts of all prostate cancer patients affected by bone metastases observed at the Oncology Unit of Alessandria Hospital in years 2005-2020 have been reviewed. ONJ frequency after antiresorptive treatment (bisphosphonates and/or denosumab) was investigated in prostate cancer patients with bone metastases undergoing preventive (before start of treatment) and/or screening (during treatment) evaluations, including oral inspection and panoramic dental radiography. Patients received antiresorptive agents according to international guidelines. Results. We examined charts of 120 patients receiving bisphosphonates (mostly zoledronic acid, or pamidronate or ibandronate) or denosumab or sequences of drugs, and evaluated for oral health, 112 being treated since 2006 after pre-treatment oral evaluation. Out of 120 total patients, 8 cases of Osteonecrosis of the Jaw (ONJ) were registered among prostate cancer patients treated at Alessandria Hospital: 2 ONJ cases were detected among 8 patients starting antiresorptive treatment before 2006 and without preventive visit, whereas 6 cases were found among 112 cases receiving dental visit before treatment start (6/112, 5.3%). Furthermore, other 8 ONJ cases in prostate cancer patients were referred by neighbour hospitals to the ONJ multidisciplinary group. Conclusions. Our preliminary data confirm that prostate cancer patients receiving bisphosphonates or denosumab are at not irrelevant risk of ONJ, even if in last decade less intensive schedules of antiresorptive drugs and measures of pre-treatment evaluation were adopted. Further evaluations have been planned to investigate if higher ONJ risk was associated to drug (denosumab versus zoledronic acid), prolonged treatment (> 2 years), pre-existing oral disease (periodontal disease, need for tooth extraction, ill-fitting dentures), and other potential predictive factors.

Objectives: To analyse the organisational changes adopted by the Oncology SC during the Covid-19 emergency in order to identify their future applicability as an ordinary model of oncology patient management. Methodology: Application of ministerial recommendations, of the Piedmont and Aosta Valley Oncology Network and of the main scientific societies on the management of oncological patients during the pandemic and in phase 2. Results: During the pandemic, organisational models and pathways were adopted that ensured continuity of care and patient safety and can also be applied in the post-Covid phase. Conclusions: The reorganisation model of Oncology during the Covid-19 emergency was effective and some of the pathways adopted may constitute an ordinary tool of activity.

Introduction: Patient-reported outcomes (PROs) can help clinicians better evaluate chemotherapy and immunotherapy toxicity based on patient perspectives. In this exploratory study, we tested a simplified PRO questionnaire (sPQ) in routine clinical practice and patient satisfaction with this tool. Methods: We included 16 items related to the main toxicities of chemotherapy and immunotherapy to be filled in by patients. A baseline sPQ was completed by patients before starting treatment and then in the interval between courses for a total of 4 sPQs. Patients communicated the results to a data manager, who alerted the referral oncologist in case of replies differing from the basal or previous sPQ. According to the severity of symptoms, the patient was then referred to the team nurse, the general practitioner, or another specialist. A satisfaction survey was also completed. Results: In a 3-month interval, 27 patients were enrolled. Fatigue and nausea were the most frequent symptoms reported as worsening during treatment. The oncologist was involved in the management of adverse events in 4 cases, home therapy variations were recommended by the dedicated nurse in 14 cases, additional visits were performed in 6 patients, and 1 patient was admitted to the oncology ward. None of the patients had unplanned visits to the emergency department or to the hospital. The sPQ was judged to be simple, useful, and satisfactory. Conclusions: Using sPQs in routine clinical practice was feasible and well-accepted by patients. PROs allowed us to recognize and promptly manage adverse events, reducing unplanned emergency department or hospital visits to zero.

Objectives Molecular diagnostics and care of non-small cell lung cancer (NSCLC) are continuously evolving. Few data document the current strategies to manage advanced NSCLC patients beyond progression in clinical practice. Patients and methods Be-TeaM is an Italian multi-center observational study conducted on consecutive EGFR-mutated stage IV NSCLC patients, progressed during/after a first-line EGFR-TKI. It consists of a retrospective phase, from first-line EGFR-TKI therapy start until study entry (i.e. beginning of the diagnostic process), and a prospective phase, until treatment choice or for 3 months if no therapy was prescribed. Primary objective was to describe the diagnostic and therapeutic approaches adopted after progression in a real-world setting. Results Of 308 patients enrolled in 63 centers from July 2017 to June 2018, 289 were included in the analysis. In first line, 53.3 % received gefitinib, 32.5 % afatinib and 14.2 % erlotinib. The testing rate (i.e. rate of all patients undergone any biopsy -liquid and/or tissue- for the T790 M detection) was 90.7 %, with liquid biopsy being the most frequently executed. Of 262 biopsied patients, 64.5 % underwent only 1 liquid biopsy, 10.7 % only 1 tissue biopsy and 18.3 % >1 biopsy, both liquid and solid in 85.4 %. The T790M positivity rate was 45.3 %; of 166 patients undergone only a liquid biopsy and tested for the mutation, 39.8 % were T790M+ and 60.2 % T790M-/undetermined. By the observation end, 87.9 % patients had a post-progression treatment chosen, osimertinib being the most frequent among the T790M+. Conclusion Be-TeaM provides the first snapshot of current practices for the management of NSCLC patients beyond progression in Italy; in clinical practice, assessing the T790M status is not always feasible.

Objectives: Critical analysis of Literature on Lung Cancer Screening, synthesis and balance between scientific evidence and real world applicability. Methodology: selection of the most relevant clinical trials on the topic. Results: the most representative and positive studies (NLST, NELSON and MILD) have been examined and discussed, pointing out their limits and unsolved issues. Conclusion: despite clear statistically positive and encouraging results, many concerns still remain about routine implementation in the real world, mainly on the costs, the need for expert and trained dedicated radiologists and technicians, the theorical advantage of shifting resources to smoking cessation programs, the possible next integration of new biological and genetic diagnostic tools.

Objectives Non-small-cell-lung-cancer (NSCLC) patients harbouring epidermal growth factor receptor (EGFR) mutations develop drug resistance after 9–12 months of EGFR tyrosine kinase inhibitors (TKIs) therapy pointing out the issue of the second-line treatment choice. Materials and methods From June 2009 until May 2013 patients affected by advanced NSCLC harbouring EGFR mutations receiving first-line TKI were collected mainly retrospectively in 24 Italian Centers. Primary objective was to describe the percentage of EGFR mutated patients receiving second-line therapy after progression to first-line EGFR-TKIs assessing the type, the activity in terms of objective response rate (ORR), efficacy in terms of progression free survival (PFS) and overall survival (OS), and safety of second-line treatment. Secondary objective was to describe the efficacy of first-line EGFR-TKIs. Results 312 patients were included. Most of them were females (203, 65.1%), never smokers (200, 64.1%), with adenocarcinoma histology (290, 92.9%). The most common mutations were EGFR exon 19 deletion and L858R, detected in 186 and 97 cases (59.6% and 31.1%), respectively. At data cut-off, 274 patients (95.1%) received any second-line treatment (including best supportive care or local treatments only). A total of 163 patients received second-line systemic therapy with an ORR of 20.9% (95% CI:14.62–27.10), a median PFS and OS of 4.7 (95% CI:3.81–5.26) and 24.5 (95% CI:21.65–27.37) months, respectively. Grade 3–4 hematological and non-hematological toxicities were reported in 9% and 6.3% of 144 patients treated with chemotherapy while non-hematological toxicity was reported in 4 cases of the 17 patients receiving second-line target agents. Conclusions BE-Positive is the first multicenter observational study reporting outcomes of therapies in a "real-life Caucasian EGFR-mutated population", highlighting the need of further researches about new treatment strategies in this setting.

Background Beyond progression after tyrosine kinase inhibitor in EGFR -positive non-small-cell lung cancer patients (BE-POSITIVE) was the first Italian multicenter observational study that reported the outcomes of first-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) in a “real-life” Caucasian EGFR -mutated non-small-cell lung cancer (NSCLC) population. The sharing of multi-institutional experiences represents a crucial strategy to enrich knowledge about uncommon EGFR mutations. Therefore, we performed a post hoc analysis of the BE-POSITIVE study. Patients and Methods Data of advanced NSCLC patients with uncommon EGFR mutations who received first-line first-generation EGFR-TKIs in 24 Italian Hospitals were collected. In this analysis we aimed to evaluate overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) of EGFR-TKIs in NSCLC patients harboring uncommon EGFR mutations. Results Thirty-five patients harboring uncommon EGFR mutations (any mutation other than deletion 19 or substitution of leucine by arginine at codon 858) were included of the original 312 EGFR -mutated cases. Most of them were female (n = 20, 57.1%), former smokers (n = 23, 65.7%), with adenocarcinoma (n = 31, 88.6%). The most frequent EGFR mutations were G719X (n = 6, 17.2%) and L861Q (n = 5, 14.2%). The population presented an ORR of 25.7%, a median PFS of 5.19 months, and a median OS of 14.49 months. When stratified according to type of EGFR mutation, median OS ranged from 3.65 months for unspecified mutations to 21.29 for double EGFR mutations. Median PFS ranged from 1.77 months for unspecified mutations to 20.83 months for concomitant EGFR-anaplastic lymphoma kinase alteration. ORR varied from 0% in exon 18, 20 and double gene alteration to 66.6% in exon 19. Conclusion Our study supports the existence of a strong outcome heterogeneity within patients harboring uncommon EGFR mutations, which needs to be clarified to achieve a real personalized treatment strategy.

Aim and background Neoadjuvant treatment for rectal adenocarcinoma improves local control and represents the standard for locally advanced disease. Laparoscopic and robotic total mesorectal excision has been increasingly adopted. It provides magnified visualization of the pelvic cavity, thereby facilitating the mesorectal dissection. Methods Consecutive patients with locally advanced/ultralow rectal adenocarcinoma received neoadjuvant treatment and mini-invasive total mesorectal excision at our center. We retrospectively reviewed the clinical records by using a prospectively collected data base and focusing on feasibility, tumor response and treatment outcomes. Results In a 13-year period, 117 rectal adenocarcinoma patients (80 males and 37 females) received neoadjuvant treatment and mini-invasive total mesorectal excision. Median age at diagnosis was 67 years; pre-treatment stage was I in 10 (9%); IIA in 58 (50%); IIC in 5 (4%); IIIA in 10 (9%); IIIB in 31 (26%) and IV in 3 (2%) patients. All patients received external beam radiation therapy, 79 (67%) combined with fluorouracil-based chemotherapy. One-hundred and three patients underwent laparoscopic surgery and 14 robotic surgery. Overall, 90 patients (77%) had anterior resection and 27 (23%) had abdominoperineal resection. Down-staging was obtained in 70 patients (66%). No major intraoperative nor delayed surgical complications were observed. At a median follow up of 52 months, 8 patients (7%) had a local relapse, 7 of them along with distant relapse, and 16 (14%) had distant relapse. The 5-year relapse-free survival was 76.5%. Conclusions Our data suggest that in a community hospital mini-invasive surgery after neoadjuvant treatment is feasible in real clinical practice and achieves consistent results in term of disease control rate.

In the present study both responsiveness and stimulatory capacity in autologous mixed lymphocyte reactions (AMLRs) of non-T/T and T/T type, as well as in allogeneic mixed lymphocyte reaction (MLR), were evaluated in 30 intravenous drug abusers (IDAs) infected by the human immunodeficiency virus (HIV) and in 10 HIV-negative IDAs. The production of interleukin 2 (IL2), and the expression of HLA Class II antigens and IL2 receptors by PHA-activated T lymphocytes were also evaluated. A severe impairment of both responsiveness and stimulatory capacity in MLR and AMLRs was found in the HIV-positive IDAs and not in the HIV-negative IDAs. The HIV-positive IDAs showed also a defective expression of HLA Class II antigens, whereas the IL2 production and the IL2 receptor expression were in the normal range. The present data are consistent with similar observations in male homosexuals with AIDS-related complex and confirm that the HIV infection induces a broad spectrum of immunological abnormalities leading to a progressive derangement of the immunocompetence.