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Objective: Bladder cancer (BC) is considered one of the malignancies with moderate-high incidence, high rate of recurrence and costly management. Diagnosis and staging are thus important for therapeutic purposes. Considering the risk of residual tumour and understaging, in specific cases, international guidelines recommend performing a second transurethral resection of the bladder (reTURB). Our study aimed to evaluate the impact of hexaminolevulinate Photodynamic Diagnostics (PDD) at first TURB on the rate of residual tumour. Materials and Methods: We retrospectively analysed patients undergoing TURB in our centre between 2012 and 2020. Eightytwo patients had a re-TURB after a first complete TURB with a delay < 3 months. Patients who had an incomplete first resection were excluded. We compared patients who underwent standard white light cystoscopy/TURB and then hexaminolevulinate PDDguided reTURB (group A, n = 49) and patients with PDD-cystoscopy/ TURB at the first procedure then white light cystoscopy/reTURB (group B, n = 33). The residual tumour rate at reTURB as well as median recurrence-free survival (RFS) were compared between the two groups. Results: Residual tumour at reTURB was detected in 48.8% of cases in our cohort, with a significant difference between the two groups (71.4% in group A versus 12.5% in group B, p < 0.001). After a median follow-up of 22 months, the median RFS was 15 months in Group A and 32 months in Group B, but this difference was not significant (p = 0.7). Conclusions: Using PDD at the time of the initial TURB had a statistically significant impact on the rate of residual tumour at the reTURB. Nevertheless, the percentage of residual tumour even with the use of PDD does not allow for safely omitting second resection. Performing a reTURB with PDD for patients who did not have it initially, provides the same benefit in terms of recurrence-free survival.

For endocrine-positive Her2 negative breast cancer patients at an early stage, the benefit of adding chemotherapy to adjuvant endocrine therapy is not still confirmed. Several genomic tests are available on the market but are very expensive. Therefore, there is the urgent need to explore novel reliable and less expensive prognostic tools in this setting. In this paper, we shown a machine learning survival model to estimate Invasive Disease-Free Events trained on clinical and histological data commonly collected in clinical practice. We collected clinical and cytohistological outcomes of 145 patients referred to Istituto Tumori “Giovanni Paolo II”. Three machine learning survival models are compared with the Cox proportional hazards regression according to time-dependent performance metrics evaluated in cross-validation. The c-index at 10 years obtained by random survival forest, gradient boosting, and component-wise gradient boosting is stabled with or without feature selection at approximately 0.68 in average respect to 0.57 obtained to Cox model. Moreover, machine learning survival models have accurately discriminated low- and high-risk patients, and so a large group which can be spared additional chemotherapy to hormone therapy. The preliminary results obtained by including only clinical determinants are encouraging. The integrated use of data already collected in clinical practice for routine diagnostic investigations, if properly analyzed, can reduce time and costs of the genomic tests.

Background A timely diagnosis is essential for improving breast cancer patients’ survival and designing targeted therapeutic plans. For this purpose, the screening timing, as well as the related waiting lists, are decisive. Nonetheless, even in economically advanced countries, breast cancer radiology centres fail in providing effective screening programs. Actually, a careful hospital governance should encourage waiting lists reduction programs, not only for improving patients care, but also for minimizing costs associated with the treatment of advanced cancers. Thus, in this work, we proposed a model to evaluate several scenarios for an optimal distribution of the resources invested in a Department of Breast Radiodiagnosis. Materials and methods Particularly, we performed a cost-benefit analysis as a technology assessment method to estimate both costs and health effects of the screening program, to maximise both benefits related to the quality of care and resources employed by the Department of Breast Radiodiagnosis of Istituto Tumori “Giovanni Paolo II” of Bari in 2019. Specifically, we determined the Quality-Adjusted Life Year (QALY) for estimating health outcomes, in terms of usefulness of two hypothetical screening strategies with respect to the current one. While the first hypothetical strategy adds one team made up of a doctor, a technician and a nurse, along with an ultrasound and a mammograph, the second one adds two afternoon teams. Results This study showed that the most cost-effective incremental ratio could be achieved by reducing current waiting lists from 32 to 16 months. Finally, our analysis revealed that this strategy would also allow to include more people in the screening programs (60,000 patients in 3 years).

The article presents new information on the history of the Greek manuscript Vallicellanus B 93 and an essay of textual analysis of the Aristotelian and Galenic psychological texts it contains.

IntroductionRecently, accurate machine learning and deep learning approaches have been dedicated to the investigation of breast cancer invasive disease events (IDEs), such as recurrence, contralateral and second cancers. However, such approaches are poorly interpretable.MethodsThus, we designed an Explainable Artificial Intelligence (XAI) framework to investigate IDEs within a cohort of 486 breast cancer patients enrolled at IRCCS Istituto Tumori “Giovanni Paolo II” in Bari, Italy. Using Shapley values, we determined the IDE driving features according to two periods, often adopted in clinical practice, of 5 and 10 years from the first tumor diagnosis.ResultsAge, tumor diameter, surgery type, and multiplicity are predominant within the 5-year frame, while therapy-related features, including hormone, chemotherapy schemes and lymphovascular invasion, dominate the 10-year IDE prediction. Estrogen Receptor (ER), proliferation marker Ki67 and metastatic lymph nodes affect both frames.DiscussionThus, our framework aims at shortening the distance between AI and clinical practice

Data is lacking about long-term impact of JJ stents (JJst) on renal parenchyma. The aim of the study was to assess the evolution of renal parenchyma in patients with JJst indwelling for more than two years, and to find predictive factors for the development of renal atrophy.Consecutive patients with JJst indwelled for more than 24 months, with a history of cancer, were retrospectively included. Replacements of JJst were scheduled every six months, or earlier in case of premature obstruction. Patient characteristics at the time of insertion of JJst, history of indwelling JJst and most recent data (serum creatinine, cancer status, definite JJst removal, renal volume (RV) with3D software) were recorded.With a median follow-up of 4 years, 73 patients were included. The indication of JJst insertion was mostly external compression (65.8%). CT scans were available to assess RV evolution in 66 patients (90.4%). Median shrinkage of RV was higher when JJ stenting was unilateral versus bilateral: -40% (-63; -15) versus -16% (-36; -3), P0.001. The duration of indwelling JJst was the only statistically significative predictive factor of renal shrinkage in multivariate analysis (OR [CI 95%]: 1.35 [1.10-1.66] P=0.004). Median relative change from baseline in eGFR was -22% (-45%; -5%.). No statistically significant predictive factors of eGFR evolution were found in univariate and multivariate analysis.Unilateral JJst for more than 2 years was associated with a significant shrinkage of renal parenchyma, especially since the duration of the indwelling stent was long.

The treatment of HR+/HER2- metastatic breast cancer with cyclin-dependent kinases 4 and 6 inhibitors combined with endocrine therapy has recently emerged as the most relevant therapeutic strategy. However, in routine clinical practice, the best therapeutic approach in patients with comorbidities at early relapsing or ab initio metastatic disease, PI3KCA mutation, is still debated among oncologists. Given these areas of uncertainty, we conducted a Delphi survey to describe and confront the level of agreement or disagreement between clinicians working in referral vs local spoke oncological hospitals and summarize a consensus on these debated topics. In total, 56 items were drafted using the Nominal Group Technique and used for the Delphi Survey. A total of 46 clinicians participated in the survey. Overall, the consensus threshold among all participants was reached in 46/56 items (82%), and Delphi Survey results showed a high level of consensus. For the 10 items (18%) that did not reach the consensus threshold, possible explanations considering differences in clinical practice and recent findings from literature are provided in the Discussion. Outcomes from the present survey may help guide treatment in multiple comorbidities, early recurring and ab initio metastatic disease, and PI3KCA mutation, where evidence from randomized trials and level 1 evidence is currently missing.

Objective: To evaluate the impact on erectile and ejaculatory function following transrectal ultrasound-guided biopsies of the prostate (TRUS-Bx) in sexually active men. Methods: Monocentric prospective study from May 2021 to January 2022 of consecutive patients with suspected prostate cancer [elevated prostate specific antigen (PSA) level and/or abnormal digital rectal examination] undergoing TRUS-Bx. The 15-item version of the International Index of Erectile Function (IIEF-15), Premature Ejaculation Diagnostic Tool (PDET) and short form of Male Sexual Health Questionnaire (MSHQ-EjD Short Form) were assessed before, one and three months after TRUS-Bx. The primary endpoint was to evaluate the risk of temporary post-biopsy erectile and/or ejaculatory dysfunctions. The statistical significance was set as p value < 0.05. Results: A total of 276 consecutive patients were included in the study. The median age, PSA and biopsy cores were 65 years (IQR 59-69), 7 ng/ml (IQR 5-9.7) and 16 (IQR 12-16), respectively. We compared the IIEF subdomains before TRUS-Bx vs. one or three months: the erectile function (EF) decreased after one month (p

Venous thromboembolism is a feared frequent complication of cancer with a 2-way relationship. Low molecular weight heparin is the mainstay of treatment. The use of direct oral anticoagulants is supported by established evidence for the treatment of deep vein thrombosis also in active cancer and they are prioritized over low molecular weight heparin for cancer-associated thrombosis according to current guidelines. However, upper limb deep vein thrombosis is poorly studied with scant data on the use of direct oral anticoagulants in noncatheter-related deep vein thrombosis. We report the case of a patient with noncatheter-related deep vein thrombosis and a rare tumor site effectively and safely treated with a direct oral anticoagulant, edoxaban, after lack of efficacy with low molecular weight heparin.A 35-year-old man with primitive mediastinal seminoma presented at our Cardio-Oncology Unit for prechemotherapy assessment.Persistent brachiocephalic deep vein thrombosis, despite full-dose enoxaparin, was detected at ultrasonography.We decided to switch the anticoagulant treatment from enoxaparin to edoxaban.The 3-month ultrasonography showed almost total regression of the deep vein thrombosis without any adverse effects and a good patient compliance.We conducted a literature review on upper limb deep vein thrombosis, since its management is challenging due to inconsistency of evidence. This report highlights the benefits of direct oral anticoagulants compared to low molecular weight heparins in cancer-associated thrombosis therapy in terms of efficacy, safety and ease of use.

Dislocation or wrong placement of central venous catheters into the pleural cavity is rare, but if undiagnosed, may cause major, sometimes life-threatening, complications (pneumothorax, hemothorax, infection, and migration) and accidental pleural effusion due to intravenous injection of fluids containing drugs (i.e. chemotherapy, antibiotics, parenteral nutrition, other). We report a rare case of pleural effusion consisting of chemotherapy (chemothorax) directly injected into the pleural cavity due to the wrong placement of a central venous catheter (Porth-A-Cath) in a woman with breast cancer. A multidisciplinary management consisting of antidote administration, followed by removal of the venous device and washing of the pleural cavity through video-assisted thoracic surgery (VATS), avoided any major complication related to the adverse event.

Introduction: US National Cancer Institute’s (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) is a library of 78 symptom terms and 124 items enabling patient reporting of symptomatic adverse events in cancer trials. This multicenter study used mixed methods to develop an Italian language version of this widely accepted measure, and describe the content validity and reliability in a diverse sample of Italian-speaking patients. Methods: All PRO-CTCAE items were translated in accordance with international guidelines. Subsequently, the content validity of the PRO-CTCAE-Italian was explored and iteratively refined through cognitive debriefing interviews. Participants (n=96; 52% male; median age 64 years; 26% older adults; 18% lower educational attainment) completed a PRO-CTCAE survey and participated in a semi-structured interview to determine if the translation captured the concepts of the original English language PRO-CTCAE, and to evaluate comprehension, clarity and ease of judgement. Test-retest reliability of the finalized measure was explored in a second sample (n=135). Results: Four rounds of cognitive debriefing interviews were conducted. The majority of PRO-CTCAE symptom terms, attributes and associated response choices were well-understood, and respondents found the items easy to judge. To improve comprehension and clarity, the symptom terms for nausea and pain were rephrased and retested in subsequent interview rounds. Test-retest reliability was excellent for 41/49 items (84%); the median intraclass correlation coefficient was 0.83 (range 0.64-0.94). Discussion: Results support the semantic, conceptual and pragmatic equivalence of PRO-CTCAE-Italian to the original English version, and provide preliminary descriptive evidence of content validity and reliability.

Rectovesical fistula (RVF) is defined as an abnormal communication between the rectum and the urinary bladder, most commonly after an iatrogenic injury during pelvic surgery. Patients with RVF may have various clinical presentations, ranging from fecaluria, pneumaturia, to urine leakage through the anus. The quality of life for patients with this pathology is adversely affected owing to the associated psychological burden. Surgery is the preferred treatment given the low success rates reported for conservative or minimally invasive approaches. Herein, we present a case of a 65-year-old man with RVF after radical prostatectomy successfully treated by a transperineal approach using a modified Martius procedure.

Introduction: Large and consistent evidence supports the use of eribulin mesylate in clinical practice in third or later line treatment of metastatic triple negative breast cancer (mTNBC). Conversely, there is paucity of data on eribulin efficacy in second line treatment. Methods: We investigated outcomes of 44 mTNBC patients treated from 2013 through 2019 with second line eribulin mesylate in a multicentre retrospective study involving 14 Italian oncologic centres. Results: Median age was 51 years, with 11.4% of these patients being metastatic at diagnosis. Median overall survival (OS) and progression free survival (PFS) from eribulin starting were 11.9 (95%CI: 8.4-15.5) and 3.5 months (95%CI: 1.7-5.3), respectively. We observed 8 (18.2%) partial responses and 10 (22.7%) patients had stable disease as best response. A longer PFS on previous first line treatment predicted a better OS (HR=0.87, 95%CI: 0.77-0.99, p= 0.038) and a longer PFS on eribulin treatment (HR=0.92, 95%CI: 0.85-0.98, p=0.018). Progression free survival to eribulin was also favorably influenced by prior adjuvant chemotherapy (HR=0.44, 95%CI: 0.22-0.88, p=0.02). Eribulin was generally well tolerated, with grade 3-4 adverse events being recorded in 15.9% of patients. Conclusions: The outcomes described for our cohort are consistent with those reported in the pivotal Study301 and subsequent observational studies. Further data from adequately-sized, ad hoc trials on eribulin use in second line for mTNBC are warranted to confirm our findings.

Despite the recent advances in the biological understanding of breast cancer (BC), chemotherapy still represents a key component in the armamentarium for this disease. Different agents are available as mono-chemotherapy options in patients with locally advanced or metastatic BC (MBC) who progress after a first- and second-line treatment with anthracyclines and taxanes. However, no clear indication exists on what the best option is in some populations, such as heavily pretreated, elderly patients, triple-negative BC (TNBC), and those who do not respond to the first-line therapy. In this article, we summarize available literature evidence on different chemotherapy agents used beyond the first-line, in locally advanced or MBC patients, including rechallenge with anthracyclines and taxanes, antimetabolite and antimicrotubule agents, such as vinorelbine, capecitabine, eribulin, ixabepilone, and the newest developed agents, such as vinflunine, irinotecan, and etirinotecan.

Immune checkpoint inhibitors (ICIs) have made a breakthrough in the systemic treatment for metastatic triple-negative breast cancer (TNBC) patients. However, results of phase II and III clinical trials assessing ICIs plus chemotherapy as neoadjuvant treatment were controversial and conflicting. We performed a meta-analysis aimed at assessing the Odds Ratio (OR) of the pathological complete response (pCR) rate in trials assessing neoadjuvant chemoimmunotherapy in TNBC. According to our results, the use of neoadjuvant chemoimmunotherapy was associated with higher pCR (OR 1.95; 95% Confidence Intervals, 1.27–2.99). In addition, we highlighted that this benefit was observed regardless of PD-L1 status since the analysis reported a statistically significant and clinically meaningful benefit in both PD-L1 positive and PD-L1 negative patients. These findings further support the exploration of the role of ICIs plus chemotherapy in early-stage TNBC, given the potentially meaningful clinical impact of these agents. Further studies aimed at more deeply investigating this emerging topic in breast cancer immunotherapy are warranted.

We report the case of a 50-year-old female patient with breast cancer who, during preoperative workup, presented repeated wide QRS complex tachycardias, recorded by Holter ECG. She was immediately referred to a hub center for electrophysiological study where she was diagnosed with right ventricular outflow tract ventricular tachycardia and underwent catheter ablation. The chemotherapy with paclitaxel that the patient was receiving combined with psychological stress may have triggered the arrhythmias.

To date, some artificial intelligence (AI) methods have exploited Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) to identify finer tumor properties as potential earlier indicators of pathological Complete Response (pCR) in breast cancer patients undergoing neoadjuvant chemotherapy (NAC). However, they work either for sagittal or axial MRI protocols. More flexible AI tools, to be used easily in clinical practice across various institutions in accordance with its own imaging acquisition protocol, are required. Here, we addressed this topic by developing an AI method based on deep learning in giving an early prediction of pCR at various DCE-MRI protocols (axial and sagittal). Sagittal DCE-MRIs refer to 151 patients (42 pCR; 109 non-pCR) from the public I-SPY1 TRIAL database (DB); axial DCE-MRIs are related to 74 patients (22 pCR; 52 non-pCR) from a private DB provided by Istituto Tumori “Giovanni Paolo II” in Bari (Italy). By merging the features extracted from baseline MRIs with some pre-treatment clinical variables, accuracies of 84.4% and 77.3% and AUC values of 80.3% and 78.0% were achieved on the independent tests related to the public DB and the private DB, respectively. Overall, the presented method has shown to be robust regardless of the specific MRI protocol.

PURPOSE:Prostate cancer (PCa) imaging has been revolutionized by the introduction of multi-parametric Magnetic Resonance Imaging (mpMRI). Transrectal ultrasound (TRUS) has always been considered a low-performance modality. To overcome this, a computerized artificial neural network analysis (ANNA/C–TRUS) of the TRUS based on an artificial intelligence (AI) analysis has been proposed. Our aim was to evaluate the diagnostic performance of the ANNA/C-TRUS system and its ability to improve conventional TRUS in PCa diagnosis.METHODSWe retrospectively analyzed data from 64 patients with PCa and scheduled for radical prostatectomy who underwent TRUS followed by ANNA/C-TRUS analysis before the procedure. The results of ANNA/C-TRUS analysis with whole mount sections from final pathology.RESULTS On a per-sectors analysis, sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV) and accuracy were 62%, 81%, 80%, 64% and 78% respectively. The values for the detection of clinically significant prostate cancer were 69%, 77%, 88%, 50% and 75%. The diagnostic values for high grade tumours were 70%, 74%, 91%, 41% and 74%, respectively. Cancer volume (<0.5 or greater) did not influence the diagnostic performance of the ANNA/C-TRUS system.CONCLUSIONSANNA/C-TRUS represents a promising diagnostic tool and application of AI for PCa diagnosis. It improves the ability of conventional TRUS to diagnose prostate cancer, preserving its simplicity and availability. Since it is an AI system, it does not hold the inter-observer variability nor a learning curve. Multicenter biopsy-based studies with the inclusion of an adequate number of patients are needed to confirm these results.

Cancer-associated thrombosis (CAT) is the second main cause of cancer death with high related mortality and morbidity, leading to anticancer agent delays and interruptions. The recommended therapy, low-molecular-weight heparin (LMWH), however, is burdensome for patients and costly for society, as treatment should last until cancer is no longer active, even indefinitely. Tinzaparin is a manageable, efficient, safe, and cost-effective option. Compared to the other LMWHs, advantages are single-daily dose and safety in the elderly and those with renal impairment (RI). The purpose of this review is to critically discuss recent data on its efficacy and safety in CAT.

La moderna sfida dei cardiologi è affrontare le più efficaci terapie antitumorali senza causare complicanze cardio-logiche. Il tumore è la seconda causa di morte nel mondo occidentale ed è tuttoggi una malattia curabile grazie alle più recenti terapie come la targeted therapy, gli inibitori del ckeck point e le più tradizionali come chemioterapia, radioterapia ed ormonoterapia. Il paziente oncologico guarito di oggi non deve diventare il paziente cardiopatico di domani, infatti per tale ragione sono possibili diverse strategie. Questa presentazione è focalizzata sull’uso della doxorubicina non peghilata, un nuovo tipo di antraciclina efficace quanto la tradizionale ma dotata di maggiore sicurezza cardiologica, da somministrare da sola o in combinazione ad altre terapie antitumorali e, soprattutto, anche in pazienti ad alto rischio cardiologico perché già sottoposti in precedenza ad antracicline con indicazione a rechallenge.

BACKGROUND To test clinically significant prostate cancer (csPCa) rates during follow-up in biopsy naive patients that underwent two different diagnostic pathways: (1) SB GROUP (n = 354): systematic random biopsies (SB) vs. (2) TB GROUP (n = 264): multiparametric magnetic resonance imaging (mpMRI) and only targeted biopsies (TB) of PI-RADS ≥ 3 lesions. Patients with PI-RADS ≤ 2 score avoided prostate biopsies. METHODS Retrospective single centre study of 618 biopsy naive patients (2015-2018). Two different definitions of csPCa were used: (1) csPCa ISUP GG ≥ 2 (ISUP grade group [GG] ≥ 2) and (2) csPCa ISUP GG ≥ 3. Kaplan-Meier plots and univariable Cox regression models tested rates over time of csPCa ISUP GG ≥ 2 and caPCa ISUP GG ≥ 3 in SB GROUP vs. TB GROUP. RESULTS At initial biopsy, TB achieved higher rates of csPCa ISUP GG ≥ 2 (35.3 vs. 18.9%; p

Vesicouterine fistula (VUF) is a rare extra-anatomical communication developing between the uterus or cervix and the urinary bladder, most commonly after an iatrogenic injury during a cesarean section. Patients with VUF may have various clinical presentations, ranging from Youssef’s syndrome (vaginal urine leakage, amenorrhea, and menouria) to urinary tract infection and infertility. Quality of life for patients having this pathology is strongly affected owing to the psychological burden. Treatment is surgery based because low success rates have been reported for conservative or minimally invasive approaches. Herein, we present a case of a 35-year-old woman successfully treated by a minimally invasive endoscopic repair procedure with the injection of microfragmented autologous adipose tissue (Lipogems(®)).

Introduction Antineoplastic drugs may induce several side effects, including chemotherapy-induced nausea and vomiting (CINV). Two neurotransmitters play a central role in mediating the emetic response: serotonin acting on the 5HT3 receptor and the substance P targeting the NK1 receptor. Indeed, a combination of a 5HT3 receptor antagonist (5HT3-RA) and a NK1 receptor antagonist (NK1-RA) together with dexamethasone has been shown to be very effective. In fact, this combination is actually widely used and recommended for CINV prophylaxis for highly emetogenic cisplatin-based adriamycin/cyclophosphamide (AC) and carboplatin-based regimens. NEPA (netupitant/palonosetron) is the only fixed combination antiemetic available and it is composed by the long-lasting second-generation 5HT3-RA palonosetron and the highly selective NK1-RA netupitant. Aim The aims of this short review were to analyze the role of NEPA in CINV prophylaxis and management taking in account the risk factors related to the patient and to the antineoplastic treatment. Evidence review CINV development is not only correlated to the emetogenic potential of the antineoplastic drugs but is also very influenced by the patient characteristics and history, such as gender, age, alcohol intake, nausea during pregnancy and motion sickness. In pivotal and post-registration studies, NEPA has demonstrated to be effective and safe in both highly and moderately emetogenic chemotherapy. Conclusion A proper assessment of both chemotherapy- and patient-related risk factors is paramount to properly evaluate an appropriate prophylaxis of CINV and NEPA by simplifying the therapy, guarantees fully adherence to antiemetic guidelines, and consequently improves the control of CINV, especially in high risk patients.

Background. The combination of chemotherapy plus anti HER-2 agents is the mainstay of HER-2 positive advanced breast cancer (ABC) therapy. We conducted a phase II trial testing activity and safety of trastuzumab and metronomic capecitabine/cyclophosphamide (HEX) as first-line therapy in HER-2 positive ABC. Methods. Patients at first relapse or with synchronous metastasis were treated with trastuzumab (4 mg/kg, biweekly) plus oral capecitabine (1500 mg/daily) and cyclophosphamide (50 mg/daily). Primary endpoint was objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR + CR + SD for ≥ 24 weeks) and tolerability. Optimal two-stage design was applied. Results. Sixty patients with measurable ABC, tumors scored as +3 for HER-2 or FISH +, untreated for advanced disease were enrolled. Median age was 62.5 years, visceral metastases were present in most patients (57.9%). Median number of cycles was 16 (range 1–98). ORR was 56.7% (95% CI, 44.1–68.4%), with 5 CR (8.3%) and 29 PR (48.3%). Fifteen patients had SD (25%). The CBR was 78.2%. Nine progressions were observed (15%). Median PFS was 11 months. One year PFS was 47.7%. Median OS was 45.9 months. Worst toxicities were grade 3 hand-foot syndrome in 2 pts (3.3%), grade 3 anaemia in 2 pts (3.3%), grade 2 nausea in 2 pts (3.3%) and grade 3–4 diarrhea in 2 pts (3.3%). Cardiac toxicity grade 1 was reported in 1 pt. Conclusions. Combination of trastuzumab and metronomic oral chemotherapy has clinical activity. The tolerability was excellent and allowed the prolonged delivery of treatment., Highlights • Combination of chemotherapy plus anti HER-2 agents is the standard treatment of HER-2 positive breast cancer. • Combination of trastuzumab and metronomic chemotherapy is an alternative therapeutic approach. • Metronomic therapy allows long-term administration of drugs. • Mild toxicity in advanced breast cancer is desirable.

The current guidelines recommend the sentinel lymph node biopsy to evaluate the lymph node involvement for breast cancer patients with clinically negative lymph nodes on clinical or radiological examination. Machine learning (ML) models have significantly improved the prediction of lymph nodes status based on clinical features, thus avoiding expensive, time-consuming and invasive procedures. However, the classification of sentinel lymph node status represents a typical example of an unbalanced classification problem. In this work, we developed a ML framework to explore the effects of unbalanced populations on the performance and stability of feature ranking for sentinel lymph node status classification in breast cancer. Our results indicate state-of-the-art AUC (Area under the Receiver Operating Characteristic curve) values on a hold-out set (67%) while providing particularly stable features related to tumor size, histological subtype and estrogen receptor expression, which should therefore be considered as potential biomarkers.

Multiparametric MRI (mpMRI) has become the standard imaging technique for the diagnosis of prostate cancer. However, mpMRI pathways are depending on experience, expertise, and information transfer from radiology to urology. Micro-ultrasound (Micro-US) is a new system, using high frequency (up to 29 MHz) and high resolution (down to 75 µm) ultrasound images. We evaluated the diagnostic performance of Micro-US in the detection of the prostate cancer index lesion and compared its performance to mpMRI using pathological whole mount sections as the reference.We retrospectively reviewed the data of 32 patients with diagnosis of prostate cancer and scheduled for radical prostatectomy and who underwent Micro-US before surgery. Still images and cineloops of Micro-US were recorded. Sixteen patients had also mpMRI images with acceptable quality and complete sequences available. For validation purposes each prostate was partitioned into 12 sectors for a total of 192 sectors evaluated. Micro-US and mpMRI images were both scored according to a validated system (PRI-MUS and Pi-RADS) where a score ≥3 was suspicious for both scores. Preoperative and postoperative results regarding the identification of the index lesion, the biggest lesion visible, were then compared and sensitivity, specificity, negative and positive predictive values, and accuracy were calculated.Median age was 67 years, median PSA was 6.2ng/ml, and median cancer volume of the index lesion was 3.1cc. The sensitivity of Micro-US in the index lesion detection was 76.5%, specificity 76.6%, negative predictive value 85.6%, positive predictive value 64.1% and 76.6% of accuracy. The sensitivity of mpMRI was 65.1%, specificity 93.4%, negative predictive value 83.2%, positive predictive value 84.3%, and 81.8% of accuracy (all p.05).Micro-US showed good reliability in identifying prostate cancer index lesions. Its performance is comparable to that of mpMRI.

Background: To date, a consensus has not yet been reached about the therapy sequence after disease progression (PD) on CDK4/6 inhibitors in patients with HR+/HER2- metastatic breast cancer (MBC). Objectives: The present study assesses, in a real-world setting, the activity of different subsequent therapies in patients who experienced a PD on palbociclib (P) + endocrine therapy (ET), to evaluate the best therapy sequence. Methods: This is a multicenter retrospective observational study. Records of consecutive HR+/HER2- MBC patients from January 2017 to May 2019 were reviewed. The primary endpoint was the evaluation of progression-free survival (PFS) according to subsequent treatment lines after progression on P+ET. Toxicity data were also collected. Results: The outcomes were analyzed in 89 MBC patients that had progressed on previous P+ET: 17 patients were on hormone therapy (HT) and 31 patients on chemotherapy (CT) as second-line treatments; seven patients were on HT and 34 on CT as third-line therapies. PFS of patients treated with HT as second-line therapy is significantly improved when compared with patients treated with CT (p=0.01). Considering third-line settings, the difference in PFS was not statistically different between HT and CT. A better outcome in terms of toxicity is observed among HT patients for both second- and third-line therapies. Conclusions: patients who were progressive on P+ET could still benefit from a subsequent ET. In patients who experienced a good efficacy from prior ET, without visceral metastatic sites, HT seems the most suitable option, when compared to CT, also in terms of safety.

Aims TEV is a common cancer complication with 20% incidence. LMWH is the standard therapy for efficacy, safety and ease of use. However, some scenarios are deeply challenging for intercurrent prothrombotic anticancer drugs. Methods A 35-year-old man reported dysphagia, EGDS: oesophagus ulcers, thyroid echography: thoracic mass compressing proximal borders. Vascular ultrasound: thrombosis of left internal giugular, subclavian, axillary and brachial veins; he began enoxaparin 6000 IU ×2/die (65 kg). CT-scan: solid anterior–superior mediastinum vascularized mass (16 × 13 cm) incorporating great thoracic vessels with 20 cm cranio-caudal longitudinal extension with trachea dislocation. PET-CT: massive superior-anterior mediastinum pathological 18F-FDG accumulation suggestive for malignancy. Lung perfusion scan: absence of left lung perfusion. Angio-CT: showed compression of pulmonary artery trunk and of branches. He presented marked asthenia, sweating and presyncope. D-dimer: 6026 µg/L, NT-proBNP: 1417 pg/mL. Mediastinum biopsy exhibited seminoma (ki67+: 65%), he started BEP Protocol (etoposide, cisplatin, bleomycin). TTE: periaortic cuff from mediastinum mass which ab extrinseco compressed pulmonary artery trunk and branches with occlusion of left one, right chambers dilatation, sovra-epatic veins and inferior vena cava (21 mm) ectasia, decreased inspiratory collapse, pulmonary hypertension (SPAP: 52 mmHg), EF: 55%. After 2 months of enoxaparin, vein ultrasound: persistent DVT and positive CUS. So, we replaced enoxaparin with edoxaban 60 mg/die. After 2 months of edoxaban, overall regression of vein thrombosis with minimal residual thrombosis of left internal giugular vein; D-dimer: 1554 µg/L. Results After 2 months of BEP Protocol, CT-scan: decrease mediastinum mass (6 × 12 cm) dimensions. Conclusions Cancer associated thrombosis is a frequent complication, worsening mortality, morbidity and decision-making. Cancer stage and drugs favour development of severe thrombosis, not solvable with LMWH, the cornerstone of anticoagulant therapy in cancer-related thrombosis. DOACs appear as a new and successful therapeutical option, especially in the most challenging cases of highly thrombotic profile after ‘heparin failure’.

In breast cancer patients, an accurate detection of the axillary lymph node metastasis status is essential for reducing distant metastasis occurrence probabilities. In case of patients resulted negative at both clinical and instrumental examination, the nodal status is commonly evaluated performing the sentinel lymph-node biopsy, that is a time-consuming and expensive intraoperative procedure for the sentinel lymph-node (SLN) status assessment. The aim of this study was to predict the nodal status of 142 clinically negative breast cancer patients by means of both clinical and radiomic features extracted from primary breast tumor ultrasound images acquired at diagnosis. First, different regions of interest (ROIs) were segmented and a radiomic analysis was performed on each ROI. Then, clinical and radiomic features were evaluated separately developing two different machine learning models based on an SVM classifier. Finally, their predictive power was estimated jointly implementing a soft voting technique. The experimental results showed that the model obtained by combining clinical and radiomic features provided the best performances, achieving an AUC value of 88.6%, an accuracy of 82.1%, a sensitivity of 100% and a specificity of 78.2%. The proposed model represents a promising non-invasive procedure for the SLN status prediction in clinically negative patients.

Background: The evolution of therapeutic landscape of human epidermal growth factor receptor-2 (HER2)-positive breast cancer (BC) has led to an unprecedented outcome improvement, even if the optimal sequence strategy is still debated. To address this issue and to provide a picture of the advancement of anti-HER2 treatments, we performed a large, multicenter, retrospective study of HER2-positive BC patients. Methods: The observational PANHER study included 1,328 HER2-positive advanced BC patients treated with HER2 blocking agents since June 2000 throughout July 2020. Endpoints of efficacy were progression-free survival (PFS) and overall survival (OS). Results: Patients who received a first-line pertuzumab-based regimen showed better PFS ( p < 0.0001) and OS ( p = 0.004) than those receiving other treatments. Median PFS and mOS from second-line starting were 8 and 28 months, without significant differences among various regimens. Pertuzumab-pretreated patients showed a mPFS and a mOS from second-line starting not significantly affected by type of second line, that is, T-DM1 or lapatinib/capecitabine ( p = 0.80 and p = 0.45, respectively). Conversely, pertuzumab-naïve patients receiving second-line T-DM1 showed a significantly higher mPFS compared with that of patients treated with lapatinib/capecitabine ( p = 0.004). Median OS from metastatic disease diagnosis was higher in patients treated with trastuzumab-based first line followed by second-line T-DM1 in comparison to pertuzumab-based first-line and second-line T-DM1 ( p = 0.003), although these data might be partially influenced by more favorable prognostic characteristics of patients in the pre-pertuzumab era. No significant differences emerged when comparing patients treated with ‘old’ or ‘new’ drugs ( p = 0.43), even though differences in the length of the follow-up between the two cohorts should be taken into account. Conclusion: Our results confirmed a relevant impact of first-line pertuzumab-based treatment and showed lower efficacy of second-line T-DM1 in trastuzumab/pertuzumab pretreated, as compared with pertuzumab-naïve patients. Our findings may help delineate a more appropriate therapeutic strategy in HER2-positive metastatic BC. Prospective randomized trials addressing this topic are awaited.

Several retrospective analyses of large amounts of contemporary data have shown the superiority of breast conservative surgery (BCS) over mastectomy carried out in the early stage of breast cancer. The characteristics of the patients and cancers that are most likely to benefit from BCS remain unclear. In our work, we analyzed the disease-free survival (DFS) of a cohort of patients treated with BCS or mastectomy between 1995 and 2018 in our institute with pT1-2, pN0, or cM0 breast cancer. The DFS curves of patients treated with both mastectomy and quadrantectomy were compared in the different subsamples with respect to the clinical and histopathological characteristics. We identified 188 eligible patients treated with BCS and 64 patients treated with mastectomy. DFS was not found to be statistically higher in patients treated with BCS compared to those treated with mastectomy, who achieved a 5-year DFS of 89.9% vs. 81.3% and a 10-year DFS of 78.9% vs. 79.3%, respectively. No significant differences were detected for the DFS curves when patients were differentiated by the type of surgical treatment received, age, and the tumor histological characteristics. We verified a p-value just above the 10% significance threshold for patients with tumor dimensions between 20 mm and 50 mm and molecular sub-type Luminal B. In our experience, treatment with mastectomy is not associated with improved DFS compared to treatment with BCS in women with early-stage tumors.

Designing targeted treatments for breast cancer patients after primary tumor removal is necessary to prevent the occurrence of invasive disease events (IDEs), such as recurrence, metastasis, contralateral and second tumors, over time. However, due to the molecular heterogeneity of this disease, predicting the outcome and efficacy of the adjuvant therapy is challenging. A novel ensemble machine learning classification approach was developed to address the task of producing prognostic predictions of the occurrence of breast cancer IDEs at both 5- and 10-years. The method is based on the concept of voting among multiple models to give a final prediction for each individual patient. Promising results were achieved on a cohort of 529 patients, whose data, related to primary breast cancer, were provided by Istituto Tumori “Giovanni Paolo II” in Bari, Italy. Our proposal greatly improves the performances returned by the baseline original model, i.e., without voting, finally reaching a median AUC value of 77.1% and 76.3% for the IDE prediction at 5-and 10-years, respectively. Finally, the proposed approach allows to promote more intelligible decisions and then a greater acceptability in clinical practice since it returns an explanation of the IDE prediction for each individual patient through the voting procedure.

The psychological status of cancer outpatients receiving anti-neoplastic treatment during the lockdown in a Italian non-COVID Cancer Center, was been investigated with the following aims: to measure the levels of post-traumatic stress symptoms, depression and anxiety; to compare patients with different cancer sites; to compare the anxiety and depression levels measured in this emergency period between cancer and non-cancer patients and between cancer patients before and after the emergency.The following questionnaires were used: The Hospital Anxiety and Depression Scale (HADs) and the Impact of Event Scale-Revised (IES-R).Worries regarding the COVID-19 on patients' lives, socio-demographic and clinical details were collected using a brief structured questionnaire.One-hundred seventy-eight outpatients were enrolled. We found that 55% of patients were above the cut-off for HADS general scale and 23.7% had severe level of PTSD. The 68% of patients declared that their worries have increased during the pandemic especially for women. Patients with lung cancer have higher general distress compared with patients with breast cancer and lymphoma. The non cancer sample had values significantly higher both for the IES-R scales and for HADS Depression subscale. Finally, cancer patients who experienced the health emergency showed higher levels of anxiety than those measured 2 years ago.Cancer out-patients of the present sample have severe post-traumatic stress symptoms and psychological distress, those with lung cancer are at higher risk and may need special attention. Non-oncological subjects have higher depression levels than cancer patients.

Sentinel lymph node biopsy (SLNB) is an invasive surgical procedure and although it has fewer complications and is less severe than axillary lymph node dissection, it is not a risk-free procedure. Large prospective trials have documented SLNB that it is considered non-therapeutic in early stage breast cancer.Web-calculator CancerMath (CM) allows you to estimate the probability of having positive lymph nodes valued on the basis of tumour size, age, histologic type, grading, expression of estrogen receptor, progesterone receptor. We collected 595 patients referred to our Institute resulting clinically negative T1 breast cancer characterized by sentinel lymph node status, prognostic factors defined by CM and also HER2 and Ki-67. We have compared classification performances obtained by online CM application with those obtained after training its algorithm on our database.By training CM model on our dataset and using the same feature, adding HER2 or ki67 we reached a sensitivity median value of 71.4%, 73%, 70.4%, respectively, whereas the online one was equal to 61%, without losing specificity. The introduction of the prognostic factors Her2 and Ki67 could help improving performances on the classification of particularly type of patients.Although the training of the model on the sample of T1 patients has brought a significant improvement in performance, the general performance does not yet allow a clinical application of the algorithm. However, the experimental results encourage future developments aimed at introducing features of a different nature in the CM model.

The dynamic contrast-enhanced MR imaging plays a crucial role in evaluating the effectiveness of neoadjuvant chemotherapy (NAC) even since its early stage through the prediction of the final pathological complete response (pCR). In this study, we proposed a transfer learning approach to predict if a patient achieved pCR (pCR) or did not (non-pCR) by exploiting, separately or in combination, pre-treatment and early-treatment exams from I-SPY1 TRIAL public database. First, low-level features, i.e., related to local structure of the image, were automatically extracted by a pre-trained convolutional neural network (CNN) overcoming manual feature extraction. Next, an optimal set of most stable features was detected and then used to design an SVM classifier. A first subset of patients, called fine-tuning dataset (30 pCR; 78 non-pCR), was used to perform the optimal choice of features. A second subset not involved in the feature selection process was employed as an independent test (7 pCR; 19 non-pCR) to validate the model. By combining the optimal features extracted from both pre-treatment and early-treatment exams with some clinical features, i.e., ER, PgR, HER2 and molecular subtype, an accuracy of 91.4% and 92.3%, and an AUC value of 0.93 and 0.90, were returned on the fine-tuning dataset and the independent test, respectively. Overall, the low-level CNN features have an important role in the early evaluation of the NAC efficacy by predicting pCR. The proposed model represents a first effort towards the development of a clinical support tool for an early prediction of pCR to NAC.

BackgroundCancer-associated thrombosis is a worrisome complication for patients receiving chemotherapy. Management of anticoagulant therapy is complex in cancer patients because of comorbidities such as thrombocytopenia, renal impairment and a hypercoagulability due to the cancer itself. Therefore, tailoring anticoagulant treatment is challenging. Case presentationWe describe the case of a 35-year-old male patient with primitive mediastinal seminoma undergoing treatment with Bleomycin, Etoposide and Cisplatin (BEP protocol) who presented with marked upper-extremity vein thrombosis unresponsive to low molecular weight heparin. After unsuccessful therapy with heparin, therapy was switched to edoxaban, a direct oral anticoagulant, which was able to dissolve the huge thrombus, suggesting that direct oral anticoagulants (DOACs) may be a reliable option especially in long-term anticoagulant treatments like in this case.A short review of the literature on cancer-related thrombosis and the use of direct oral anticoagulants in malignancies is also presented. ConclusionsOur case suggests that in severe and extended cancer-associated thrombosis, instituting treatment with direct oral anticoagulants instead of low molecular weight heparin can be an effective, safe and practical option. This choice is preferred by most patients as shown by their proper adherence to treatment.

In recent years personalized medicine reached an increasing importance, especially in the design of oncological therapies. In particular, the development of patients’ profiling strategies suggests the possibility of promising rewards. In this work, we present an explainable artificial intelligence (XAI) framework based on an adaptive dimensional reduction which (i) outlines the most important clinical features for oncological patients’ profiling and (ii), based on these features, determines the profile, i.e., the cluster a patient belongs to. For these purposes, we collected a cohort of 267 breast cancer patients. The adopted dimensional reduction method determines the relevant subspace where distances among patients are used by a hierarchical clustering procedure to identify the corresponding optimal categories. Our results demonstrate how the molecular subtype is the most important feature for clustering. Then, we assessed the robustness of current therapies and guidelines, our findings show a striking correspondence between available patients’ profiles determined in an unsupervised way and either molecular subtypes or therapies chosen according to guidelines, which guarantees the interpretability characterizing explainable approaches to machine learning techniques. Accordingly, our work suggests the possibility to design data-driven therapies to emphasize the differences observed among the patients.

Simple Summary An early prediction of Breast Cancer Recurrence (BCR) for patients undergoing neoadjuvant chemotherapy (NACT) could better guide clinicians in the identification of the most suitable combination treatments for individual patient scenarios. We proposed a transfer learning approach to give an early prediction of three-year BCR for patients undergoing NACT, using DCE-MRI exams from I-SPY1 TRIAL and BREAST-MRI-NACT-Pilot public databases. Because no technical expertise is required in the extraction of meaningful features from images, the predictive model qualifies as a user-friendly tool for any medical expert in support of therapeutic choices. Only pre-treatment and early-treatment MRI examinations were analyzed to allow for potential therapy changes at a very early stage of treatment. We tested the strength of the model on an independent test. The best predictive performances (accuracy of 85.2%, sensitivity of 84.6%, and AUC of 0.83) were achieved by combining the extracted features with some clinical factors: age, ER, PgR, HER2+. Abstract Cancer treatment planning benefits from an accurate early prediction of the treatment efficacy. The goal of this study is to give an early prediction of three-year Breast Cancer Recurrence (BCR) for patients who underwent neoadjuvant chemotherapy. We addressed the task from a new perspective based on transfer learning applied to pre-treatment and early-treatment DCE-MRI scans. Firstly, low-level features were automatically extracted from MR images using a pre-trained Convolutional Neural Network (CNN) architecture without human intervention. Subsequently, the prediction model was built with an optimal subset of CNN features and evaluated on two sets of patients from I-SPY1 TRIAL and BREAST-MRI-NACT-Pilot public databases: a fine-tuning dataset (70 not recurrent and 26 recurrent cases), which was primarily used to find the optimal subset of CNN features, and an independent test (45 not recurrent and 17 recurrent cases), whose patients had not been involved in the feature selection process. The best results were achieved when the optimal CNN features were augmented by four clinical variables (age, ER, PgR, HER2+), reaching an accuracy of 91.7% and 85.2%, a sensitivity of 80.8% and 84.6%, a specificity of 95.7% and 85.4%, and an AUC value of 0.93 and 0.83 on the fine-tuning dataset and the independent test, respectively. Finally, the CNN features extracted from pre-treatment and early-treatment exams were revealed to be strong predictors of BCR.

The prognosis for patients with locally advanced or metastatic breast cancer (mBC) remains poor, with a median survival of 2-4 years. About 10% of newly diagnosed breast cancer patients present with metastatic disease, and 30%-50% of those diagnosed at earlier stages will subsequently progress to mBC. In terms of ongoing management for advanced/metastatic breast cancer after failure of hormonal therapy, there is a high medical need for new treatment options that prolong the interval to the start of intensive cytotoxic therapy, which is often associated with potentially serious side effects and reduced quality of life. Oral chemotherapeutic agents such as capecitabine and vinorelbine have demonstrated efficacy in patients with mBC, with prolonged disease control and good tolerability. Use of oral chemotherapy reduces the time and cost associated with treatment and is often more acceptable to patients than intravenous drug delivery. Metronomic administration of oral chemotherapy is therefore a promising treatment strategy for some patients with mBC and inhibits tumor progression via multiple mechanisms of action. Ongoing clinical trials are investigating metronomic chemotherapy regimens as a strategy to prolong disease control with favorable tolerability. This article provides an overview of metronomic chemotherapy treatment options in mBC, with perspectives on this therapy from a panel of experts.

4592 Background: In Bacillus Calmette-Guérin (BCG) refractory non-muscle-invasive bladder cancer (NMIBC), radical cystectomy is the standard of care. For patients unwilling or unable to undergo cystectomy, alternative intravesical therapies are currently being investigated to minimize the risk of recurrence and progression. Chemohyperthermia by HIVEC (Hyperthermic-Intra-Vesical Chemotherapy) is a therapeutic option in BCG-refractory patients. The objective of our study was to evaluate the 2-year oncological results of HIVEC in BCG-refractory patients. Methods: Between June 2016 and September 2021, patients treated with HIVEC (6 weekly instillations) for BCG-refractory NMIBC were prospectively included in our study. These patients had a theoretical indication for cystectomy but were ineligible for surgery or refused it. The primary endpoint was 1-year recurrence-free survival (RFS) rate. Secondary endpoints were 6-month complete response rate for Cis, 1-year overall and cancer-specific survival rates and bladder preservation rate. Results: Seventy patients, mean age 70 [42-89] years, were treated consecutively. After a mean follow-up of 20.9 months, 32 patients recurred (mean time of 10.6 months) and 7 patients finally had a cystectomy. The recurrence-free survival rate was 53.1% at 1 year and 20.5% at 2 years. Six patients progressed to a muscle-invasive disease, after a mean delay of 6.7 months. Four of them experienced metastatic progression and died from bladder cancer. Cancer-specific and overall survival rates were 95.1% and 92.9% at 1 year, and 87.5% and 77.8% at 2 years. The bladder preservation rate was 90%. For patients with Cis (34% of the entire series), the 6-month complete response rate was 75%. The presence of Cis was not a predictive factor of response to HIVEC. Tolerance was excellent with 38.2% grade 1-2 adverse events and no grade 3-4 adverse events. Conclusions: Chemohyperthermia using the HIVEC device achieved a RFS rate of 53.1% at 1 year and enabled a bladder preservation rate of 90%. While cystectomy remains the standard of care, HIVEC may be discussed cautiously for patients who are not eligible for surgery and well informed of the risk of progression to muscle-invasive disease.

This article aims at mapping the scholia on the first lines from Aristotle’s Posterior Analytics A 1. It offers the first edition of the scholia on 71a1–21 from Vaticanus Gr. 241 (13th century), Laurentianus 72,3 (second half of the 13th century) and Laurentianus 72,4 (second half of the 13th / beginning of the 14th century). Appendix II and III present the content of a brief writing of Psellus about the Aristotelian Organon and the Praefatio to the Latin translation of Themistius’ Paraphrasis to Posterior Analytics written by Hermolaus Barbarus in the 15th century.

Background Metastatic breast cancer (MBC) is highly prevalent in middle-aged or elderly patients. Eribulin is a nontaxane microtubule inhibitor, approved for the treatment of pretreated MBC. This multicentric study (sponsored by GIOGer, Italian Group for Geriatric Oncology) was designed to assess the efficacy and tolerability of eribulin, according to parameters usually used in geriatric oncology. Subjects, materials, and methods An observational study was conducted on 50 consecutive elderly patients with MBC. The primary endpoint was to evaluate the change in items score of comprehensive geriatric assessment (CGA) and health-related quality of life (HRQL). Italian versions of the CGA and HRQL questionnaires were administered at baseline, before the third and fifth cycles, and then every three cycles until treatment discontinuation. Secondary endpoints were efficacy and safety. Results Overall, both EQ-5D scores and EQ-5D-3 L visual analogic scale did not significantly change from baseline; the percentage of subjects without problems doing usual activities tended to decrease during treatment (p for linear trend .018), and the percentage of patients with minor problems performing usual activities tended to increase (p for linear trend.012). Among CGA items, Instrumental Activities of Daily Living tended to decrease during treatment and Geriatric Depression Scale tended to increase. After 12 months follow-up, 24 patients (out of 47) showed clinical benefits; median progression-free survival was 4.49 months (2.10-10.33) and median OS was 7.31 months (3.70-14.03). The treatment was associated with mild toxicity. Conclusion Eribulin treatment preserved quality of life and geriatric parameters included in the CGA, except for instrumental functioning and geriatric depression, in elderly patients with MBC. Implications for practice A collaboration between oncologist and geriatric specialists is essential in the management of patients with metastatic breast cancer, who are frequently elderly or frail. The assessment of geriatric parameters in the decision-making process can contribute to direct toward the most appropriate therapeutic plan and preserve the quality of life of patients. Eribulin does not seem to affect quality of life or worsen the overall geriatric status; therefore, it can be considered a suitable option for elderly patients with metastatic breast cancer.

Background: For assessing the predictability of oncology neoadjuvant therapy results, the background parenchymal enhancement (BPE) parameter in breast magnetic resonance imaging (MRI) has acquired increased interest. This work aims to qualitatively evaluate the BPE parameter as a potential predictive marker for neoadjuvant therapy. Method: Three radiologists examined, in triple-blind modality, the MRIs of 80 patients performed before the start of chemotherapy, after three months from the start of treatment, and after surgery. They identified the portion of fibroglandular tissue (FGT) and BPE of the contralateral breast to the tumor in the basal control pre-treatment (baseline). Results: We observed a reduction of BPE classes in serial MRI checks performed during neoadjuvant therapy, as compared to baseline pre-treatment conditions, in 61.3% of patients in the intermediate step, and in 86.7% of patients in the final step. BPE reduction was significantly associated with sequential anthracyclines/taxane administration in the first cycle of neoadjuvant therapy compared to anti-HER2 containing therapies. The therapy response was also significantly related to tumor size. There were no associations with menopausal status, fibroglandular tissue (FGT) amount, age, BPE baseline, BPE in intermediate, and in the final MRI step. Conclusions: The measured variability of this parameter during therapy could predict therapy effectiveness in early stages, improving decision-making in the perspective of personalized medicine. Our preliminary results suggest that BPE may represent a predictive factor in response to neoadjuvant therapy in breast cancer, warranting future investigations in conjunction with radiomics.

The prediction of lymph node involvement represents an important task which could reduce unnecessary surgery and improve the definition of oncological therapies. An artificial intelligence model able to predict it in pre-operative phase requires the interface among multiple data structures. The trade-off among time consuming, expensive and invasive methodologies is emerging in experimental setups exploited for the analysis of sentinel lymph nodes, where machine learning algorithms represent a key ingredient in recorded data elaboration. The accuracy required for clinical applications is obtainable matching different kind of data. Statistical associations of prognostic factors with symptoms and predictive models implemented also through on-line softwares represent useful diagnostic support tools which translate into patients quality of life improvement and costs reduction.