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Routine testing for cancer patients not presenting COVID-19-related symptoms and fully vaccinated for SARS-CoV-2 prior to cancer treatment is controversial.In this retrospective study we evaluated whether antigen-rapid-diagnostic-test (Ag-RDT) monitoring for SARS-CoV-2 in a large cohort of consecutive asymptomatic (absence of SARS-CoV-2-related symptoms such as fever, cough, sore throat or nasal congestion) and fully vaccinated cancer patients enrolled in a short period during cancer treatment has an impact on the therapeutic path of cancer patients.From December 27, 2021, to February 11, 2022, 2439 cancer patients were screened through Ag-RDT for SARS-CoV-2 before entering the hospital for systemic treatment. Fifty-three patients (2.17%) tested positive, of whom 7 (13.2%) subsequently developed COVID-related symptoms, generally mild. Cancer treatment was discontinued, as a precaution, in 49 patients (92.5%) due to the test positivity.SARS-CoV-2 screening in asymptomatic and fully vaccinated cancer patients during systemic treatment appeared to be not cost-effective: the low rate of SARS-CoV-2 positive patients and the low percentage of overt associated infection do not seem proportional to the direct costs (nursing work for swabs, costs of materials and patient monitoring) and indirect costs (dedicated rooms, extension of waiting times for patients and oncologists in delivering therapy as well as its discontinuation in the positive ones). It can, on the other hand, be detrimental when systemic cancer treatment is suspended as a precaution. Given the small number of patients testing positive and the rapid and favorable trend of the infection, it is recommended to always consider continuing systemic oncological treatment, especially when this impacts patient survival as in the adjuvant or neoadjuvant setting.

The impact of the COVID19 pandemic on treatment practices for patients diagnosed with early breast cancer: a cross-sectional study from a large comprehensive cancer centre in Italy. Introduction: The Coronavirus Disease 2019 (COVID19) has disrupted health services worldwide. The evidence on the impact of the pandemic on cancer care provision, however, is conflicting. Some reports found that management for patients diagnosed with early breast cancer (EBC) during the pandemic did not differ from pre-pandemic practices; other reports suggested that delays in breast cancer surgery may have occurred. We aimed to audit the management of patients diagnosed with EBC during the pandemic in a large, tertiary-level cancer centre in Italy. Methods: We conducted a cross-sectional study to track the route to first treatment for patients diagnosed with EBC during 2019, 2020, and 2021. We abstracted data for all consecutive patients referred to the Veneto Institute of Oncology (Padua, Italy). We defined as point of contact (POC) the date of the first consultation with a breast cancer specialist of the breast unit. We considered patients with a first POC in the 6 months preceding the multidisciplinary (MDT) meeting and initiating a treatment within 6 months from the POC. We chose the 3-month period April-June because in 2020 it was when health services were first acutely disrupted. We analysed the same period for 2019 and 2021. First treatment was defined as either upfront surgery or neoadjuvant chemotherapy (NACT). The time to first treatment was defined as the interval between the first POC and the first treatment. We used the median time to first treatment in 2019 to define the threshold for treatment delay. Results: We reviewed medical records for 878 patients for whom an MDT report during 2019-2021 (April through June) was available. Of these, 431 (49%) were eligible: 144 in 2019, 127 in 2020 and 150 in 2021. Median age at first POC was 61 years. The proportion of screen-detected tumours was larger in 2019 and 2021 than in 2020 (59%). Conversely, the proportion of screen-detected tumours was offset by the proportion of palpable tumours in 2020 (44% versus 56%). These differences were statistically significant (chi-square test 11.12, p=0.004). Distribution of tumour and nodal stage was unchanged over time, but in-situ tumours were slightly fewer in 2020 than in 2019 or 2021. The odds ratio for treatment delay (45 days or more) was 0.87 for 2020 versus 2019 (95% CI, 0.5-1.53) and 0.9 for 2021 versus 2019 (95% CI, 0.52-1.55), after adjusting for type of POC, presentation with symptoms, treatment type, tumour stage, nodal stage, and EBC subtype (i.e., luminal, HER2-positive, triple-negative). Conclusions: There was no evidence for major changes in the management of EBC patients during 2019-2021 and no treatment delays were observed. However, our results show a slight decrease in the absolute number of patients being treated in 2020, offset by an increase in 2021 to levels comparable to 2019. Our findings suggest that disruption of breast cancer screening programmes may have impacted on the characteristics of the patient population, with a larger proportion of women presenting with palpable nodules. Validation on a larger, population-based cohort of patients is warranted to robustly assess the impact of the COVID19 pandemic on treatment practices and outcome for EBC patients. Characteristics of the population Citation Format: Fabio Girardi, Sabrina Marini, Francesca Porra, Ilaria Mietto, Sonia Carpentieri, Alberto Marchet, Tania Saibene, Marcello Lo Mele, Tommaso Giarratano, Carlo Alberto Giorgi, Eleonora Mioranza, Cristina Falci, Giovanni Faggioni, Francesca Caumo, Gaia Griguolo, Maria Vittoria Dieci, Valentina Guarneri. The impact of the COVID19 pandemic on treatment practices for patients diagnosed with early breast cancer: a cross-sectional study from a large comprehensive cancer centre in Italy. [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P3-03-01.

We analyzed a cohort of patients with cancer and Sars-Cov-2 infection from the Veneto Oncology Network registry across two pandemic time periods.761 patients with cancer and SARS-CoV-2 infection were included.198 patients were diagnosed during the first pandemic time period (TP1; February 2020 September 2020), 494 during TP2 before the vaccination campaign (TP2/pre-vaccination; September 2020-21 February 2021) and 69 in TP2/post-vaccination (22 February 2021-15 May 2021). TP2 vs TP1 patients were younger (p = 0.004), showed more frequently a good performance status (p0.001) and2 comorbidities (p = 0.002), were more likely to be on active anticancer therapy (p = 0.006). Significantly fewer patients in TP2 (3-4%) vs TP1 (22%) had an in-hospital potential source of infection (p0.001). TP2 patients were more frequently asymptomatic (p = 0.003). Significantly fewer patients from TP2 were hospitalized (p0.001) or admitted to intensive care unit (p = 0.006). All-cause mortality decreased from 30.3% in TP1, to 8.9% and 8.7% in the two TP2 periods (p0.001), reflected by a significant reduction in Sars-Cov-2-related mortality (15.2%, 7.5% and 5.8% in the three consecutive time periods, p = 0.004).Differences in clinical characteristics and features of Sars-Cov-2 infection between TP1 and TP2 reflect the effects of protective measures and increased testing capacity. The lower mortality in TP2 is in line with a less frail population. However, the vast majority of death events in TP2 were related to COVID-19, reinforcing the priority to protect cancer patients.

Background: Trastuzumab + pertuzumab + taxane and ado-trastuzumab emtansine (T-DM1) are standard first and second-line therapies for HER2+ metastatic breast cancer. Lapatinib is approved in combination with capecitabine in trastuzumab-resistant patients and in combination with letrozole in hormone receptor positive HER2+ pts for whom endocrine treatment is indicated. In Italy, L is also approved in combination with trastuzumab for hormone receptor-negative HER2+ pts. There are only few data on the activity of lapatinib in pts who received prior pertuzumab and /or T-DM1. Methods: We retrospectively analysed HER2+ metastatic breast cancer pts who received lapatinib after prior pertuzumab and/or T-DM1 from July 2013 to June 2018. Objective response rate (ORR) was assessed according to RECIST 1.1. Progression-free survival (PFS) was calculated from lapatinib-based therapy starting to disease progression (PD) or last follow-up. Overall Survival (OS) was calculated from lapatinib-based therapy starting to death or last follow up. Results: Data from 32 HER2+ mBC treated with lapatinib-based therapy were recorded: 30 pts (94%) received lapatinib combined with capecitabine, 1 pt received lapatinib combined with letrozole and 1 pt received lapatinib combined with trastuzumab. All patients had been treated with prior T-DM1 and 9 (28%) with prior pertuzumab for metastatic breast cancer. Setting of treatment with lapatinib-based therapy was: 2° line (n=2, 6%), 3° line (n=17, 53%) and >4° line (n=13, 41%). Patients characteristics were as follows: median age 55 years (range 35-71), hormone receptor positive 66% (n=21), stage IV at diagnosis 34% (n=11), visceral involvement at lapatinib-based therapy starting 91% (n=29). As of June 2018, lapatinib-based therapy was ongoing for 4 pts and 28 pts discontinued treatment due to disease progression (median number of courses for these pts was 8.5, range 2-27). ORR in evaluable pts was: complete response (n=1, 3%), partial response (n=13, 41%), stable disease (n=9, 28%), disease progression (n=9, 28%). Median PFS was 6.4 months (95% CI 3.0-9.8). As of June 2018, 14 pts (44%) were alive, median OS was 11.8 months (95% CI 9.9-13.6). Conclusion: These results confirm that lapatinib-based therapy retains clinical efficacy in HER2+ metastatic breast cancer pts treated with prior pertuzumab and/or T-DM1 and represents a valid therapeutic option in this setting. Citation Format: Frezzini S, Giarratano T, Dieci MV, Giorgi CA, Griguolo G, Vernaci G, Menichetti A, Mantiero M, Tasca G, Faggioni G, Falci C, Miglietta F, Mioranza E, Angelini S, Ghiotto C, Conte P, Guarneri V. Lapatinib-based therapies after pertuzumab and/or T-DM1 for HER2+ metastatic breast cancer patients [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-18-24.

Background: Brain metastases (BM) are a serious relatively common complication of breast cancer (BC). We evaluated prognostic factors for survival after diagnosis of BM from BC in a contemporary cohort of pts. Methods:Pts diagnosed with BM from BC between 1999 and march 2016 and treated at the Istituto Oncologico Veneto of Padua were evaluated. Overall survival (OS) was defined as time from BM diagnosis to death or last follow-up. Pts were classified in 4 categories according to the breast cancer-specific Graded Prognostic Assessment (GPA) index according to validated criteria (Sperduto et al, 2012), based on age, Karnofsky Performance Status (KPS) and BC phenotype. Cox proportional models were used to calculate HR and 95% CI. Results: 199 pts were identified. Median age at BM diagnosis was 56 yrs (range 28-84). Tumor phenotype distribution was as follows: triple negative (TN, 20.1%), hormone receptor (HR)-HER2+ (16.8%), HR+HER2+ (24.0%) and HR+HER2- (39.1%). Median time to BM diagnosis was 48.9 months (range 0-327), with significant differences according to tumor phenotype (median 27.3, 31.8, 46.1 and 55.2 months in TN, HR-HER2+, HR+HER2+, HR+HER2-, respectively, p=0.009). With respect to OS, no significant difference was observed across tumor phenotypes, with TN patients experiencing the worse outcome (median: 4.7, 7.7, 11.0 and 6.2 months in TN, HR-HER2+, HR+HER2+, HR+HER2-, p=0.187). The breast-specific GPA index, which combines tumor phenotype with patient-related features, was significantly associated with OS (Table). The number of local treatment received (radiotherapy, either whole brain or stereotactic, or neurosurgery) and the administration of systemic treatment after BM diagnosis were significantly associated with better OS (Table). Patients in the less favorable GPA category (GPA index Prognostic factorsMedian OS, months (95%CI)HR (95%CI), univariatep, univariateHR (95%CI), corrected for GPAGPA category 3.5-418.8 (15.2-22.5)ref -2.5-38.8 (3.8-13.8)1.40 (0.80-2.43) -1.5-25.5 (3.5-7.5)1.76 (1.00-3.10) -0-1.02.7 (1.2-4.3)2.67 (1.35-5.28)0.019-Number of local tretaments received 03.0 (1.8-7.5)ref ref18.0 (5.8-10.3)0.53 (0.38-0.74) 0.54 (0.38-0.78)221.3 (15.2-27.3)0.36 (0.20-0.65) 0.49 (0.26-0.93)335.5 (33.5-37.6)0.12 (0.04-0.38) Conclusions: Patient-related features, tumor phenotype and multimodal treatments all independently contribute to modulate the prognosis of pts with BM from BC. Citation Format: Griguolo G, Dieci MV, Giarratano T, Giorgi CA, Orvieto E, Ghiotto C, Falci C, Mioranza E, Tasca G, Milite N, Miglietta F, Conte P, Guarneri V. Factors related to the prognosis of breast cancer patients after the development of brain metastases [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P1-12-06.

Background: Tumor infiltrating lymphocytes (TILs) have emerged as a prognostic and potential predictive factor in early triple negative (TN) and HER2+ breast cancer (BC). The prognostic role of TILs in advanced disease is largely unknown. Methods: 109 HER2+ and TNBC patients with available tumor tissue from regional/distant BC recurrence (collected between 2001 and 2015) were identified from a prospectively maintained database at the Istituto Oncologico Veneto of Padova (Italy). Ipsilateral in-breast relapse/second primaries and contralateral BC were excluded from the definition of recurrence. StrTILs were assessed according to consensus guidelines (Salgado, 2014) on hematoxylin and eosin stained slides from BC recurrence samples and, when available, matched primaries. Post-progression survival was calculated as the time from first BC recurrence to last follow up or death. Results: StrTILs were evaluable on recurrent BC for 72 cases (HER2+ n=43, TN n=29), after exclusion of lymphnode metastases. Median time to recurrence from initial BC diagnosis was longer for HER2+ than TN cases: 37 months (95%CI 23-51) and 18 months (95%CI 13-23), respectively. Accordingly, median time to biopsy of recurrence from initial BC diagnosis was 43 months (95%CI 35-51) for HER2+ patients and 20 months (95%CI 9-31) for TN patients. Site of biopsy was visceral metastasis in 54% and soft tissue metastasis in 46% of cases (similar for HER2+ and TN). Median StrTILs level on recurrence was 5% (Q1 2,5%, Q3 10%), without differences according to TN or HER2+ phenotype (Student's t-test p=0.5). In the whole cohort, post-progression survival did not differ for patients with high (>10%) vs low ( In the TN subgroup, high StrTILs on recurrence were associated to a better post-progression survival (median not reached vs 12.7 months for StrTILs >10% and StrTILs were assessed on matched primary tumors for 43 patients. Overall, no significant StrTILs variation between primary tumor and recurrence was observed (mean change -4.5%, Wilcoxon p=0.5). Mean change was -2.5% and -7% in HER2+ and TN cases (Wilcoxon p=0.63 and p=0.15, respectively). For TN patients with StrTILs Conclusions: Levels of StrTILs on recurrent BC seem to have an opposite effect on prognosis of metastatic BC patients according to tumor phenotype. Immunohistochemical characterization of TILs is ongoing, data will be available for the meeting. Citation Format: Dieci MV, Giaratano T, Miglietta F, Griguolo G, Orvieto E, Falci C, Giorgi CA, Mioranza E, Tasca G, Cappellesso R, Ghiotto C, Conte P, Guarneri V. Tumor infiltrating lymphocytes in recurrent HER2+ and triple negative breast cancer: Prognostic value according to tumor phenotype [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P2-05-20.

Background: The integration of Residual Cancer Burden (RCB) and post-treatment Ki67 (Residual Proliferative Cancer Burden [RPCB] index) has been proposed as a stronger predictor of long-term outcome in unselected breast cancer (BC) patients undergoing neoadjuvant chemotherapy (NACT), as compared to RCB. However, no specific analysis in the subgroup of patients with hormone-receptor (HR)-positive/HER2-negative BC is available so far. We investigated the prognostic value of RPCB in an independent cohort of hormone-receptor (HR) positive/HER2 negative BC patients treated with NACT at our Institution. Methods: A cohort of 130 stage II-III, HR+/HER2 negative BC patients who underwent NACT between 2000 and 2014 was included. Archival surgical specimens were evaluated for RCB (Symmans et al. J Clin Oncol 2007). RPCB was calculated by combining RCB and Ki67 as previously described (Sheri et al, Ann Oncol 2015). Patients were categorized in 4 RCB categories (pathological complete response -pCR- and RCB tertiles) and 4 RPCB categories (pCR and RPCB tertiles). Disease-free Survival (DFS) and overall Survival (OS) estimates were determined by Kaplan-Meier analysis and compared using the log-rank test. The c-index was used to compare the performance of the prognostic models. Results: Patients characteristics were: ductal histology 70%, Grade 3 41%, Stage III 54%, PgR negative (≤10%) 35%, median Ki67 at diagnosis 25%. Neoadjuvant chemotherapy included both anthracycline and taxane in 92% of cases. The rate of pCR was 8%. The vast majority of patients received adjuvant endocrine therapy (96%), whereas 30% received further adjuvant chemotherapy. Median follow up was 8.5 years (95% CI 8.0-9.0). RCB was calculated for 105 patients and RPCB was calculated for 85 patients. RPCB was better than RCB in predicting both DFS and OS (5-year DFS and 8-year OS according to RPCB and RCB are reported in the Table). The c-index for DFS prediction was numerically higher for RPCB vs RCB (0.4042316 vs 0.3396437, p=0.08). Similar results were observed for OS prediction: c-index 0.3099490 (RPCB) vs 0.2372449 (RCB), p=0.08. Conclusions: This is the first study evaluating RPCB specifically in HR+/HER2- BC patients treated with NACT. In this independent cohort, after a median follow up of 8.5 years, RPCB was a strong predictor of DFS and OS. The better performance of RPCB vs RCB was in part due to the ability of RPCB to discriminate a subgroup of patients with a particularly worse prognosis after NACT, who may be candidate for clinical trials evaluating novel adjuvant treatments. Five-year DFS and eight-year OS according to RPCB and RCB5-year DFSp-value8-year OSp-valueRPCBpCR100%0.041100% Citation Format: Federica Miglietta, Vassilena Tsvetkova, Maria Vittoria Dieci, Gaia Griguolo, Grazia Vernaci, Alice Menichetti, Cristina Falci, Giovanni Faggioni, Tommaso Giarratano, Simona Frezzini, Eleonora Mioranza, Marcello Lo Mele, PierFranco Conte, Valentina Guarneri. Validation of residual proliferative cancer burden (RPCB) as a predictor of long-term outcome following neoadjuvant chemotherapy in hormone-receptor positive/HER2 negative breast cancer patients [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P5-06-12.

Chemotherapy-induced alopecia (CIA) affects the majority of patients receiving chemotherapy (CT) for early breast cancer. It is a highly distressing side effect of CT, with psychological and social impact. Primary aim of the present analysis was to assess the efficacy of scalp cooling with DigniCap® in preventing CIA. Success rate was defined as patients' self-reported hair loss

Background: Neoplastic pericardial effusion (NPE) is a life-threatening condition that can worsen clinical outcome in cancer patients. The optimal management of NPE has yet to be defined because randomized studies are lacking. Objective: We report a retrospective monoinstitutional experience describing characteristics, management and prognostic factors in NPE patients. Design: We reviewed clinical, pathological, and echocardiographic features, therapeutic strategies, and outcome in NPE patients referred to our institute from August 2011 to December 2017. Measurements: Twenty-nine patients with NPE from solid tumors have been identified: 21 lung, 5 breast, and 3 other cancer patients. Results: Median age was 62 years. Most of the patients had Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥2 (69%) and a symptomatic NPE (69%). In 52% of patients NPE was detected at first diagnosis of metastatic disease, and in 20% of patients pericardium was the only site of metastases. Most of the patients (62%) received systemic therapy, 28% received combined locoregional and systemic therapy, and 10% received locoregional therapy alone. Median overall survival (OS) from NPE diagnosis was 3.9 months. Patients with PS ≥2 had worse OS than patients with better PS

Background The value of adding carboplatin (Cb) to neoadjuvant chemotherapy for TNBC is debated. Current evidence supports the association between Cb use and increased pathological complete response (pCR) rate. However, treatment schedules and doses adopted in randomized trials were not always consistent with those used in clinical practice. Methods Clinicopathological data of TNBC (ER & PgR Results 166 patients were included: 61% treated with AT, 39% with AT+Cb (all patients in this group received Cb AUC2 weekly administered concomitantly to the taxane segment). Main characteristics: median age 50 yrs, ductal histology 93%, grade 3 90%, cT > 2cm 86%, cN + 57%, median TILs 10%, median Ki67 60%, BRCA mutated 10%. After propensity score matching, pCR rate was significantly higher for AT+Cb vs AT: 52% vs 31% (OR 2.39 95%CI 1.04-5.50, p = 0.040). In multivariable analysis, treatment with AT+Cb maintained an independent association with pCR: OR 2.51 95%CI 1.03-6.11, P = 0.043. The achievement of pCR was significantly associated with improved disease-free survival (HR 0.16, 95%CI 0.06-0.45). No difference in DFS was observed comparing AT+Cb vs AT: HR 0.99, 95%CI 0.44-2.25. Conclusions We confirmed in a clinical practice setting the association of Cb-containing neoadjuvant chemotherapy with higher pCR rates. Additional data are needed to clarify the impact on long-term survival. These data support the conditional positive recommendation for Cb inclusion in neoadjuvant chemotherapy for TNBC provided by the Italian Association of Medical Oncology Guidelines on Breast Cancer. Funding Has not received any funding. Disclosure M.V. Dieci: Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Celgene; Advisory / Consultancy: Genomic Health. V. Guarneri: Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Novartis; Advisory / Consultancy: Roche; Speaker Bureau / Expert testimony: Eli Lilly; Speaker Bureau / Expert testimony: Novartis; Research grant / Funding (institution): Roche. All other authors have declared no conflicts of interest.

Brain metastases are a serious relatively common complication of breast cancer. We evaluated prognostic factors for survival after diagnosis of brain metastases from breast cancer in a contemporary cohort of patients. Patients diagnosed with breast cancer brain metastases at our institution between 1999 and March 2016 were evaluated. Overall survival was defined as time from brain metastasis diagnosis to death or last follow-up. Patients were classified according to the Breast cancer-specific Graded Prognostic Assessment (BS-GPA), based on age, Karnofsky performance score and breast cancer phenotype. 181 patients were identified. Tumor phenotype distribution was as follows: triple negative (TN, 18.8%), hormone receptor (HR)−HER2+ (16.6%), HR+HER2+ (23.2%) and HR+HER2− (30.9%), not available (10.5%). Median overall survival from brain metastasis diagnosis was 7.7 mos (95% CI 5.4–10.0 mos). Although TN patients experienced the worse outcome, no significant difference was observed across tumor phenotypes (median 5.1, 7.7, 11.0 and 8.6 months in TN, HR−HER2+, HR+HER2+, HR+HER2−, p = 0.081). The BS-GPA index was significantly associated with overall survival (median 18.8, 8.8, 6.2 and 3.6 months, respectively, for BS-GPA categories 3.5–4, 2.5–3, 1.5–2 and 0–1, p = 0.014). Increased number of local treatments for brain metastasis (radiotherapy or neurosurgery) or the administration of systemic therapy after brain metastasis diagnosis were also significant predictors of better overall survival (p