The daily practice of oncology in Italy is increasingly strained, with bureaucratic rigidity making routine clinical work progressively more difficult. A panel of clinical oncologists, reunited in the DonnaRosa Group, an emerging model of community-based collaboration, where clinicians share real-world challenges and develop actionable strategies, debate the points with the aim of producing some tips to close the gap in clinical practice.

Background:Postmastectomy radiation therapy (PMRT) improves locoregional control and survival in patients with early breast cancer, but it is unclear whether these benefits extend to human epidermal growth factor receptor 2 (HER2)-positive patients in the anti-HER2 era. Methods:This was a retrospective cohort analysis of prospectively collected data from the phase III ALTTO trial and includes all ALTTO participants who underwent mastectomy regardless of randomisation arm. The phase III ALTTO trial enrolled patients between 2007 and 2011 from 946 centers from 44 countries in four different continents. Eligible patients had histologically confirmed HER2-positive breast cancer with either node-positive disease or node-negative disease with pathologic tumour size ≥1 cm. PMRT was non-randomised and delivered at the investigator's discretion. Primary efficacy analyses were conducted in the intention-to-treat population; safety analyses included all patients who received at least 1 dose of anti-HER2 therapy. Endpoints were locoregional recurrence (LRR), distant recurrence (TTDR), disease-free (DFS), and overall survival (OS). DFS and OS were analysed using Cox models; LRR and TTDR competing risk models. All models included the interaction between number of metastatic nodes, 0 (pN0), 1-3 (pN1) or ≥4 (pN2) and PMRT. Multivariable models accounted for patient and tumour characteristics. Hazard ratios (HR) and their 95% confidence interval (CI) are reported. Findings:Overall, 4154 patients treated with mastectomy were analysed: 1987 (47.8%) with and 2167 (52.2%) without PMRT. Baseline characteristics were worse in the PMRT group, whereas adjuvant endocrine and chemotherapy use/type was similar between groups. At a median follow-up of 9.2 years (IQR, 6.4-10), 129 LRR events occurred: 43 (2.2%) in the PMRT group and 86 (4.0%) in the no-PMRT group. In patients with pN2, PMRT was associated with improved LRR control (HR 0.31; 95% CI 0.16-0.59), TTDR (HR 0.59; 95% CI 0.44-0.79), DFS (HR 0.58; 95% CI 0.45-0.75), and OS (HR 0.61; 95% CI 0.44-0.86). In patients with pN1, PMRT showed marginal benefit in DFS (HR 0.82; 95% CI 0.64-1.05) but not in LRR (HR not calculated), TTDR (HR 0.89; 95% CI 0.65-1.23), nor OS (HR 0.88; 95% CI 0.62-1.24). Only 229 (15%) patients with pN0 received PMRT, with no evidence of benefit in any endpoints. Interpretation:In this large HER2-positive, predominantly node-positive, adjuvant cohort, PMRT improved locoregional control and conferred a clinically meaningful survival benefit in pN2. In the landscape of personalized treatment and growing interest in axillary de-escalation, future prospective studies are warranted to better define which HER2-positive patients with low nodal burden (particularly pN1 disease) derive meaningful benefit from PMRT in the context of modern systemic therapy. Funding:The publication of this analysis was funded by the Italian Ministry of Health through Ricerca Corrente funds.

PURPOSE:We aimed to investigate the prognostic and predictive value of tumor infiltrating lymphocytes (TILs) for adjuvant immunotherapy in high-risk early TNBC. PATIENTS AND METHODS:The phase III A-BRAVE trial randomized 466 patients with high-risk early TNBC to adjuvant avelumab or observation after standard therapy. Inclusion criteria allowed two strata: Stratum A (primary surgery followed by adjuvant chemotherapy, defined at high risk based on pathological stage) and Stratum B (neoadjuvant chemotherapy followed by surgery without pathological complete response). TILs were centrally assessed on treatment-naive tumor samples (BSL-TILs) and on residual disease after neoadjuvant chemotherapy (RD-TILs, Stratum B). Residual cancer burden (RCB) was assessed in Stratum B. Survival endpoints were: disease-free survival (DFS), distant disease-free survival (DDFS), and overall survival (OS). RESULTS:BSL-TILs were available for 387 patients, RD-TILs for 330 patients (290 with both BSL-TILs and RD-TILs). Higher BSL-TILs were independently associated with improved outcomes across all endpoints. In Stratum B, higher RD-TILs showed a significant independent association with improved outcomes, outperforming BSL-TILs. RCB was also independently prognostic. Avelumab improved outcomes only for patients with BSL-TILs ≥30%, particularly in Stratum B (3-yr DDFS rates 92.0% vs 58.7%, HR 0.20 in high BSL-TILs and 70.4% vs 70.1%, HR 0.92 in low BSL-TILs, interaction p=0.019). Similar results for DFS and OS. RCB was not predictive for avelumab benefit. CONCLUSIONS:TILs may predict benefit from adjuvant immunotherapy in early TNBC. These findings warrant validation and support TILs-guided immunotherapy strategies in future trials. TRIAL REGISTRATION:NCT02926196.

Neoadjuvant chemotherapy (NAC) enables tumor downstaging and assessment of response in early breast cancer (EBC). Pathological complete response (pCR) predicts favorable outcomes, but patients with residual disease are heterogeneous, and the prognostic value of residual tumor biology remains incompletely defined. We retrospectively analyzed 586 patients with EBC treated with NAC between 2000 and 2021. Baseline clinical, pathological, and treatment-related variables—including residual disease characteristics—were collected. The primary endpoints were pCR and long-term outcomes. Event-free survival (EFS), relapse-free survival (RFS), and overall survival (OS) were estimated using Kaplan–Meier curves and compared with log-rank tests. Multivariable logistic and Cox regression identified independent predictors of pCR and survival. Overall, 36.3

The follow up in early breast cancer represented a major challenging in oncology practice. Current guidelines are supported by evidence demonstrating no benefit of intensive surveillance.Despite evidence, many oncologists still practice a more intensive follow-up, prompting studies to evaluate and improve real-world effectiveness: the effectiveness of routine screening is further questioned by the varied relapse patterns across breast cancer subtypes. Rethinking surveillance as a calibrated clinical choice, rather than an automatic procedure, is a scientific and civic duty in the era of personalized and sustainable healthcare.

1010 Background: Circadian rhythms regulate immune functions, and morning (AM) administration of immunotherapy (IO) is associated with survival in several solid tumors. However, whether time-of-day (ToDa) of IO delivery influences outcomes in early-stage triple-negative breast cancer (TNBC), and whether this effect depends on immune biomarkers, remains unknown. Methods: A-BRAVE randomized patients with high-risk early-stage TNBC to 1 year of adjuvant avelumab or observation. Infusion time of avelumab was retrieved from eCRF. AM-rate was calculated for each patient as the proportion of the first 4 infusions occurring before 12:30 PM (cohort median ToDa) and patients categorized as AM-dominant (AM-rate ≥50%) or PM-dominant. Tumor-infiltrating lymphocytes (TILs) and PD-L1 (Dako 73-10) were centrally assessed on treatment-naive tumor samples. We analyzed distant disease-free survival (DDFS) and overall survival (OS) by adjusted Cox models. Results: ToDa data were available for 221 avelumab-treated patients (94.0%); TILs and PD-L1 were evaluable in 188 (85%) and 195 (88%) of these, respectively. AM-rate was not associated with outcomes. However, ToDa effects were strongly immune-dependent. Increasing AM-rate was associated with improved DDFS and OS in immune-hot tumors (TILs [≥20%] or PD-L1 [≥21] high), but with worse outcomes in immune-cold tumors (TILs or PD-L1 low) (AM-rate*TILs interaction: DDFS p=0.008, OS p=0.001; AM-rate*PD-L1 interaction: DDFS p=0.030, OS p=0.039). These findings were concordant using AM-dominant vs. PM-dominant categorization (Table). Patients receiving immune-aligned treatment (immune-hot/AM-dominant OR immune-cold/PM-dominant) had superior survival compared with immune-misaligned (immune-hot/PM-dominant OR immune-cold/AM-dominant) and the observational arm (TILs-based: 3-year OS 95.7% vs 75.2% vs 78.0%; p<0.001; PD-L1-based: 3-year OS 93.4% vs 79.4% vs 76.1; p=0.035). Conclusions: In early-stage TNBC, time of IO administration may be a driver of efficacy, with opposing effects according to baseline immune milieu. Immune-informed circadian alignment may represent a previously unrecognized determinant of IO efficacy in TNBC. Clinical trial information: NCT02926196 . Outcome AM-dominant3-yr Rate % (95% CI) PM-dominant3-yr Rate % (95% CI) Log-rank p AM vs PM dominant HR (95% CI) TILs High DDFS 90.1 (81.3–99.8) 72.0 (56.4–91.9) 0.064 0.39 (0.13–1.21) OS 97.5 (92.8–100) 76.0 (61.0–94.7) 0.019 0.35 (0.10–1.20) TILs Low DDFS 63.1 (52.6–75.7) 84.7 (75.5–95.1) 0.003 2.61 (1.23–5.55) OS 74.9 (65.2–86.0) 94.3 (88.3–100) 0.003 3.84 (1.30–11.29) PD-L1 high DDFS 100 (100–100) 61.5 (40.0–94.6) 0.015 0.11 (0.01–0.94) OS 100 (100–100) 76.9 (57.1–100) 0.008 0.11 (0.01–1.03) PD-L1 low DDFS 66.4 (57.3–77.0) 83.0 (74.7–92.2) 0.026 1.82 (1.00–3.31) OS 79.8 (71.9–88.6) 91.5 (85.3–98.2) 0.025 2.05 (0.95–4.43)

Background: Healthcare communication often relies on complex digital infrastructures, yet clinicians increasingly adopt general-purpose Instant Messaging Apps (IMAs) such as WhatsApp® to meet unmet needs. DonnaRosa, an Italian community of breast cancer specialists founded in 2017, is a Community of Practice (CoP), where experts exchange second opinions, guidelines, and trial opportunities. This paper examines its origins, practices, and implications. Methods: A mixed-methods design was applied: (1) qualitative analysis of chat logs to identify interaction patterns and rules; (2) a 2024 online survey of 54 members (92.5% response rate) exploring demographics, usage, and perceived value; (3) ongoing semi-structured interviews with founders and participants to reconstruct history, recruitment, and professional impact. Results: The group has grown through personal invitations, creating a friendly network of oncologists. Communication is concise, colloquial, and collegial. Activities focus on case discussions, reassurance, interpretation of guidelines, and exchange of research opportunities. This article presents data from an online survey conducted in 2024, showing that the group is widely used for second opinions, often consulted even on weekends and holidays, and perceived as a source of professional support and learning. Members report that participation frequently changes or refines their clinical judgement, especially when guidelines are incomplete or ambiguous. The community also promotes resilience, reduces professional isolation, supports informal collaboration in research projects, and encourages interaction on organisational and healthcare management issues. Conclusions:DonnaRosa illustrates how informal IMAs can evolve into robust infrastructures of care and professional solidarity, complementing formal systems. In the era of artificial intelligence, CoPs like DonnaRosa may become even more relevant: AI tools, especially large language models, can accelerate literature retrieval and data synthesis, while the CoP provides the critical, experience-based interpretation needed for safe and meaningful application. Such a dual infrastructure-technological and human-offers a promising path for oncology, where complexity requires both computational breadth and the depth of expert clinical judgement. Taken together, these findings and the evolving role of AI in clinical communication underscore the need for oncology societies to develop governance frameworks that ensure the safe, accountable, and clinically appropriate use of instant-messaging tools in professional practice.

The prognosis for Hormonal Receptor positive-HER2-negative (HR+ HER2-negative) metastatic breast cancer (mBC) has significantly improved by advances in hormone therapies, targeted drugs, and antibody–drug conjugates (ADCs). Nevertheless, maintaining quality of life (QoL), managing symptoms, and reducing treatment-related toxicity remain essential. Background: eHealth solutions offer new opportunities to enhance patient engagement and well-being through digital tools. This paper aims to delineate the fundamental functionalities and objectives of TreC_Metha, a technologically advanced instrument to provide effective support during all care process of patients diagnosed with HR+HER2-negative mBC able to proactively change its configuration depending on the treatment line or on the intra-line treatment phase the patient undergoes, as set by the healthcare team. Methods: The TreC_Metha platform was developed through a structured, evidence-based four-phase process aimed at scalability, usability, and clinical relevance. The development began with a formal analysis of the metastatic breast cancer (mBC) care pathway using BPMN modeling to map phases, activities, and stakeholders, highlighting differences from early-stage breast cancer. This analysis informed the identification of key points where digital support could enhance care. Patient needs were assessed through a web-based questionnaire (N = 20) and two focus groups (N = 11), enabling a participatory design approach. Based on these insights, the platform’s functional and non-functional requirements were defined, leading to the design and implementation of a patient-facing mobile app and a clinical dashboard tailored to mBC-specific needs. Results: Preliminary findings from the web survey focus groups revealed significant gaps in communication and information delivery during the mBC care journey, contributing to patient anxiety and reduced confidence. Participants expressed a preference for digital and printed resources to improve understanding and facilitate interactions with healthcare providers. These insights informed the development of the TreC_Metha platform. The clinical dashboard enables real-time monitoring and decision-making, while the mobile app supports bidirectional communication, therapy adherence, and patient-reported data collection. A system prototype is currently under refinement and will undergo usability testing with a small cohort of users. Following this phase, the pilot study will evaluate the platform’s impact on QoL, aiming for a ≥10% improvement in outcome measures and contributing to a more patient-centered care model in the mBC setting. Conclusions: TreC_Metha represents an innovative tool that may enable involvement and active participation in the mBC care process for both a multidisciplinary care team of professionals and the patient, and that can be easily adapted to other cancer types and chronic diseases.

Background: The A-BRAVE trial showed an improvement in long-term outcome with the anti-PD-L1 avelumab administered as adjuvant therapy for high-risk early TNBC patients. Here, we report the efficacy of avelumab according to PD-L1, tumor infiltrating lymphocytes (TILs), and residual cancer burden (RCB). Methods: The phase III A-BRAVE trial randomized 466 patients with high risk early TNBC to 1-year avelumab vs observation after completion of standard surgery and neoadjuvant/adjuvant chemotherapy. High risk was defined as high disease burden in case of primary surgery (n=83 Stratum A) or invasive residual disease (breast and/or nodes) after neoadjuvant chemotherapy (n=383 Stratum B). Avelumab vs observation improved outcomes (Conte P ASCO 2024): +5.1% in 3-yr DFS in ITT and Stratum B (non-significant, co-primary endpoints); +8.5% in 3-yr OS in ITT (p=0.035) and Stratum B (p=0.070); +7.5% in 3-yr DDFS in ITT (p=0.028). Here, we report DFS (secondary endpoint), DDFS and OS by PD-L1 status in ITT, as well as DFS, DDFS and OS by post-neoadjuvant chemotherapy TILs and RCB in Stratum B. PD-L1 was evaluated on surgical tumor samples (Stratum A) and diagnostic core-biopsies (Stratum B) with the IHC 73-10 RUO assay (Agilent Technologies); the % of positive stromal cells/total stromal cells was calculated with digital pathology. PD-L1 high was defined according to a previously published >21% cut-off (Dieci MV, Eur J Cancer 2020). In Stratum B, surgical samples were evaluated for TILs (centrally) and RCB (locally) according to guidelines. Only p values <0.05 are shown. Results: PD-L1 expression was prognostic: every 1% increment was associated with improved DFS (HR 0.99, 95%CI 0.97-1.00, p=0.014), DDFS (HR 0.98, 95%CI 0.97-0.99, p=0.005) and OS (HR 0.99, 95%CI 0.97-1.00, p=0.049). PD-L1 high vs PD-L1 low patients showed better outcome: 3-yr DFS 80.6% vs 64.3%, p=0.004; 3-yr DDFS 85.1% vs 69.8%, p=0.002; 3-yr OS 89.6% vs 79.5%, p=0.032. No significant interaction between PD-L1 and treatment arm was observed for any efficacy endpoint. However, the benefit of avelumab vs control was more evident for PD-L1 low: 3-yr DFS 67.3% vs 61.1%, 3-yr DDFS 73.6% vs 65.9%, 3-yr OS 84.6% vs 74.1% in PD-L1 low; 3-yr DFS 77.1% vs 84.4%, 3-yr DDFS 85.7% vs 84.4%, 3-yr OS 91.4% vs 87.5% in PD-L1 high. In Stratum B, RCB was prognostic. Outcomes by RCB I, II and III were: 3-yr DFS 76.7%, 67.5%, 32.4%; 3-yr DDFS 76.5%, 73.6%, 39.7%; 3-yr OS 83.1%, 81.7%, 46.6%, p<0.001 for all endpoints. No significant interaction for any efficacy endpoint was observed between RCB and treatment arm. The benefit of avelumab vs control by RCB category was: RCB I (n=30, 3-yr DFS 84.6% vs 70.6%; 3-yr DDFS 84.6% vs 70.6%; 3-yr OS 84.6% vs 82.4%), RCB II (n=224, 3-yr DFS 67.3% vs 67.6%; 3-yr DDFS 75.8% vs 71.3%; 3-yr OS 87.4% vs 75.7%), RCB III (n=55, 3-yr DFS 44.6% vs 19.2%, p=0.028; 3-yr DDFS 55.0% vs 23.1%, p=0.003; 3-yr OS 57.5% vs 33.6%, p=0.026). TILs on residual disease were significantly prognostic in Stratum B: every 1% increase was associated with: HR 0.98 95%CI 0.97-0.99, p=0.002 for DFS; HR 0.98 95%CI 0.97-0.99, p=0.004 for DDFS; HR 0.98, 95%CI 0.96-1.00, p=0.010 for OS. Results were similar after correction for RCB. There was no significant interaction for any efficacy endpoint between TILs and treatment arm. The benefit of avelumab vs control was more evident in TILs<10% (3-yr DFS 57.7% vs 50.0%; 3-yr DDFS 64.7% vs 53.6%; 3-yr OS 74.6% vs 61.8%) than TILs>10% (3-yr DFS 72.5% vs 75.4%; 3-yr DDFS 81.5% vs 79.2%; 3-yr OS 89.6% vs 85.6%). Conclusions: Efficacy of avelumab for high-risk TNBC did not significantly differ by PD-L1 in the ITT, or by TILs and RCB in Stratum B. However, these biomarkers help identifying subgroups of patients at poorer prognosis deriving the greatest magnitude of benefit from this treatment. Citation Format: Maria Vittoria Dieci, Giancarlo Bisagni, Lorenzo Nicolé, Peter Schmid, Vittoria Fotia, Federico Piacentini, Adolfo Favaretto, Giulia Bianchi, Saverio Cinieri, Lucia Del Mastro, Domenico Corsi, Michelino de Laurentiis, Grazia Arpino, Marta Mion, Antonino Musolino, Antonella Ferro, Donata Sartori, Fable Zustovich, Simon Spazzapan, Alessandra Gennari, Claudio Zamagni, Stefano Tamberi, Tommaso Giarratano, Elisa Gasparini, Giovanna Magni, Gian Luca De Salvo, Pierfranco Conte, Valentina Guarneri. Efficacy of adjuvant avelumab by PD-L1, tumor infiltrating lymphocytes and residual cancer burden in high-risk triple negative breast cancer: secondary and exploratory endpoints of the phase III A-BRAVE trial [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr RF3-02.

Importance For patients with early ERBB2 (formerly HER2 )–positive breast cancer, there is a need to identify biomarkers to guide treatment de-escalation. Objective To evaluate the association of tumor-infiltrating lymphocytes (TILs) with distant disease-free (DDFS) and overall survival (OS) for patients with ERBB2 -positive early breast cancer. Design, Setting, and Participants The ShortHER randomized clinical trial was a multicentric trial in Italy that enrolled patients with ERBB2 -positive breast cancer from December 2007 to October 2013. Patients received 9 weeks or 1 year of adjuvant trastuzumab combined with chemotherapy. Tumor samples were evaluated for TILs. Herein, patients were evaluated at a median follow-up of 9 years, and data were analyzed from February 2023 to August 2024. Intervention Four cycles of anthracycline-based chemotherapy followed by 4 courses of taxanes combined with trastuzumab for 1 year (long arm) or 3 courses of taxanes combined with trastuzumab for 9 weeks followed by reduced-dose anthracycline-based chemotherapy for 3 courses (short arm). Main Outcomes and Measures The association of TILs with DDFS and OS was assessed with Cox models. Results Of 1253 patients enrolled in the ShortHER trial, 866 women (median [IQR] age, 56 [48-64] years) had evaluable TILs. In Cox models with relevant factors, each 5% TIL increment was associated with improved DDFS (hazard ratio [HR], 0.87; 95% CI, 0.80-0.95; P = .001) and OS (HR, 0.89; 95% CI, 0.81-0.98; P = .01). The 10-year OS rate was 91.3% for patients with TILs 20% or higher, 93.3% for patients with TILs 30% or higher, and 98.1% for patients with TILs 50% or higher, resulting higher vs lower TIL counterparts. Patients with TILs lower than 20% showed a better outcome with the long vs short treatment (10-year DDFS, 88.7% vs 81.0%), whereas patients with TILs 20% or higher showed the opposite (10-year DDFS, 87.1% vs 92.2%; P for interaction = .01). Similarly, patients with TILs 20% or higher had a 10-year OS rate of 89.3% in the long arm vs 93.1% in the short arm (HR, 0.36; 95% CI, 0.10-1.36); patients with TILs lower than 20% had a 10-year OS rate of 91.3% in the long arm vs 86.9% in the short arm (HR, 1.36; 95% CI, 0.82-2.23; P for interaction = .06). Conclusions and Relevance This follow-up analysis of the ShortHER randomized clinical trial is, to our knowledge, the first demonstration of an independent effect of TILs in terms of OS for patients with ERBB2 -positive early breast cancer treated with adjuvant chemotherapy and anti- ERBB2 therapy. Patients with TILs 20% or higher who de-escalated trastuzumab duration and chemotherapy dose were not exposed to an excess risk of distant relapse or death. Trial Registration EudraCT: 2007-004326-25

BACKGROUND:Non-small cell lung cancer (NSCLC) patients undergoing neoadjuvant chemotherapy (NACT) followed by surgery represent an ideal clinical setting to identify prognostic factors. To date, major pathological response (MPR) and complete pathological response (pCR) have been used as surrogates of NACT response and clinical outcome. The aim of the study was to investigate the role of additional clinico-pathological features, taking advantage of morphometry and artificial intelligence (AI). METHODS:Seventy stage III NSCLC patients undergoing surgery after NACT were studied. A granular evaluation of histological parameters with morphometrical quantification of the stromal components (fibrosis/inflammation) in addition to the tumour bed analysis (2020 IASLC statement) was carried out in all cases. An AI algorithm of the different immunophenotypes was also applied on immunohistochemistry-stained whole-slide images. A ClinPATH combined score including MPR, baseline blood lymphocytes, perineural invasion, vascular invasion, proliferative index, fibrosis extension percentage and AI-quantified CD4+ cell % was tested. RESULTS:MPR and pCR were related to disease-free survival (DFS) and overall survival (OS) but also vascular/perineural/pleural invasion and Ki-67 were useful in stratifying the study population. Concerning the tumour bed stromal components, only morphometrical quantification highlighted the prognostic role of fibrosis and inflammation, particularly when distinguishing CD4+ and FOXP3+ cells, mainly in adenocarcinomas. Interestingly, the combination of the most impactful clinico-pathological parameters in a ClinPATH combined score correlated better with DFS and OS than any individual parameter, including MPR or pCR. CONCLUSION:AI-based method can be used to accurately decipher the complexity of tumour bed stromal components, providing extra information for outcome prediction. The combination of different clinico-pathological features could be highly valuable in guiding therapeutic decisions and ultimately improve patient outcomes.

BACKGROUND AND PURPOSE:CDK 4/6 inhibitors with ET are the recommended choice as 1st-line therapy in HR+/HER2- MBC patients, however ET alone could remain an option for some of them. HERMIONE-7 is a multicenter, single-arm, Phase II study, aimed to evaluate Abemaciclib 150 mg BID + AIs, in patients who progressed on 1st line Fulvestrant. MATERIALS AND METHODS:Primary aim was the efficacy of Abemaciclib + AIs in terms of Clinical Benefit Rate (CBR), secondary aims were Time to Progression (TTP), Overall Response Rate (ORR), duration of response (DOR), and safety. RESULTS:From April 2020 to January 2022, we enrolled 31 patients. Median age was 72 years (range 47-86), 55% had < 2 comorbidities, mainly hypertension (12, 38.7%). Clinical Benefit Rate was 69% (95% CI, 49-85) and ORR was 21% (95%CI, 8-40). 1-year TTP and OS rates were 53.8% (95% CI, 38.6-74.9%) and 69.5% (95% CI, 54.8%-88.5%), respectively. Main adverse events remain diarrhea (80.6%), fatigue (54.8%) and nausea (35.5%), 3 patients (10.7%) had non drug-related fatal events. CONCLUSIONS:HERMIONE-7 study showed that 2nd-line treatment with Abemaciclib + AIs is a feasible option in MBC patients who progressed on Fulvestrant in 1st-line setting and could be an alternative especially in terms of optimizing the cost-benefit ratio in some Countries.

BackgroundEmerging digital tools play an innovative and key role in supporting women’s psychological well-being throughout the different stages and challenges of cancer. The development and adoption of digital interventions, including chatbots and virtual coaches within smartphone apps, are increasingly recognized as valuable resources for enhancing women’s mental health. ObjectiveThe aim of this paper is to present the research protocol for a pilot study designed as a proof-of-concept investigation. The study evaluates the feasibility, acceptability, and perceived utility of a mobile app delivering an acceptance and commitment therapy–based stress management intervention. The intervention is delivered through ALBA (A Well-Being Assistant), a virtual coach embedded within the TreC (an acronym for cartella clinica del cittadino, meaning “citizen’s electronic health record”) research platform—a mobile health ecosystem designed to support research and digital health interventions. ALBA guides users through 5 coaching sessions tailored for women undergoing breast cancer (BC) treatment. The chatbot-delivered app is an adaptation of Self-Help Plus, a World Health Organization (WHO)–validated stress management intervention, and is provided in text, audio, and video formats. The intervention’s potential impact on participants’ psychological well-being is also explored. MethodsA convenience sample size of 50 participants will be identified to meet the study’s objectives. Participants will be recruited using a convenience sampling approach from women receiving care at the Breast Unit of the Azienda Provinciale per Servizi Sanitari di Trento. ALBA will interact with the participants for 6 weeks. Specifically, there will be 1 coaching session per week, followed by weekly assigned acceptance and commitment therapy exercises to be performed between sessions. ResultsThe app is expected to demonstrate high usability and engagement, aligning with the WHO Self-Help Plus protocol. Improvements in psychological well-being and quality of life are anticipated. Data from this pilot will be analyzed using both quantitative and qualitative methods, with a focus on assessing feasibility, acceptability, and perceived utility and usability in supporting women during BC treatment. ConclusionsExisting literature indicates a promising role for new technologies in delivering validated mental health interventions, highlighting the potential of digital interventions to address barriers related to social stigma and seeking assistance. This pilot is expected to provide valuable insights on the potential acceptability and usefulness of providing consistent mobile health psychoeducational support to women throughout the course of BC. International Registered Report Identifier (IRRID)PRR1-10.2196/65837

Importance For patients with early ERBB2 (formerly HER2)-positive breast cancer, there is a need to identify biomarkers to guide treatment de-escalation. Objective To evaluate the association of tumor-infiltrating lymphocytes (TILs) with distant disease-free (DDFS) and overall survival (OS) for patients with ERBB2-positive early breast cancer. Design, Setting, and Participants The ShortHER randomized clinical trial was a multicentric trial in Italy that enrolled patients with ERBB2-positive breast cancer from December 2007 to October 2013. Patients received 9 weeks or 1 year of adjuvant trastuzumab combined with chemotherapy. Tumor samples were evaluated for TILs. Herein, patients were evaluated at a median follow-up of 9 years, and data were analyzed from February 2023 to August 2024. Intervention Four cycles of anthracycline-based chemotherapy followed by 4 courses of taxanes combined with trastuzumab for 1 year (long arm) or 3 courses of taxanes combined with trastuzumab for 9 weeks followed by reduced-dose anthracycline-based chemotherapy for 3 courses (short arm). Main Outcomes and Measures The association of TILs with DDFS and OS was assessed with Cox models. Results Of 1253 patients enrolled in the ShortHER trial, 866 women (median [IQR] age, 56 [48-64] years) had evaluable TILs. In Cox models with relevant factors, each 5% TIL increment was associated with improved DDFS (hazard ratio [HR], 0.87; 95% CI, 0.80-0.95; P = .001) and OS (HR, 0.89; 95% CI, 0.81-0.98; P = .01). The 10-year OS rate was 91.3% for patients with TILs 20% or higher, 93.3% for patients with TILs 30% or higher, and 98.1% for patients with TILs 50% or higher, resulting higher vs lower TIL counterparts. Patients with TILs lower than 20% showed a better outcome with the long vs short treatment (10-year DDFS, 88.7% vs 81.0%), whereas patients with TILs 20% or higher showed the opposite (10-year DDFS, 87.1% vs 92.2%; P for interaction = .01). Similarly, patients with TILs 20% or higher had a 10-year OS rate of 89.3% in the long arm vs 93.1% in the short arm (HR, 0.36; 95% CI, 0.10-1.36); patients with TILs lower than 20% had a 10-year OS rate of 91.3% in the long arm vs 86.9% in the short arm (HR, 1.36; 95% CI, 0.82-2.23; P for interaction = .06). Conclusions and Relevance This follow-up analysis of the ShortHER randomized clinical trial is, to our knowledge, the first demonstration of an independent effect of TILs in terms of OS for patients with ERBB2-positive early breast cancer treated with adjuvant chemotherapy and anti-ERBB2 therapy. Patients with TILs 20% or higher who de-escalated trastuzumab duration and chemotherapy dose were not exposed to an excess risk of distant relapse or death. Trial Registration EudraCT: 2007-004326-25

In oncologia e in particolare nella cura del tumore mammario, il ricorso alla telemedicina si è dimostrato essere una via sicura ed efficace per migliorare la qualità della vita e dell'assistenza per i pazienti. L'emergenza Covid-19 e l'esigenza di ridurre gli accessi ai presidi ospedalieri hanno rappresentato un momento di accelerazione nel disegno e nell'utilizzo di strumenti di telemedicina.L'uso della telemedicina può trovare ampia applicazione nell'assistenza alle pazienti affette da tumore mammario che, grazie alla cronicizzazione della malattia, hanno un bisogno continuo di assistenza e di disponibilità di informazioni chiare e accessibili.L'efficacia degli interventi di telemedicina può essere migliorata attraverso i processi partecipativi di co-design che coinvolgano gli utenti finali e gli stakeholder in tutti gli aspetti dello sviluppo dell'intervento. Questo contributo riporta un'esperienza di co-design partecipato finalizzato allo sviluppo di un'applicazione mobile per le pazienti affette da tumore mammario all'interno della Rete Senologica dell'APSS di Trento.

In Italy, breast cancer is the most frequently diagnosed cancer in women, with 55,900 new cases in 2023 (over 90% in the early stages). Due to the screening, early diagnosis and adjuvant treatment, these patients have a 5-years survival rate of 87% after the diagnosis. There are 834,154 women in Italy with a previous diagnosis of breast cancer: most of these women require a follow-up. The AIOM, ESMO and ASCO Guidelines recommend for early breast cancer (EBC) a clinical follow-up with only physical examination (and eliciting of symptoms) and an annual X-ray mammography, on the basis of the results of two randomized trials published in 1994 that showed no benefit in overall survival with intensive follow-up. However, an Italian survey reported the application by 80% of oncologists of an intensive follow-up based on the individual patient’s risk of recurrence. In fact, the oncologists believe that an early diagnosis of locoregional or distant recurrence may allow an early start of very effective therapies. In this lack of up-to-date scientific data, many questions about follow-up remain unanswered and the few ongoing studies will provide results in several years. Non-compliance with guideline recommendations leads to increased costs for the healthcare system. Furthermore, management varies widely from centre to centre with regard to guideline recommendations, resulting in inequalities between patients. For these reasons, the follow-up of breast cancer should be reconsidered. In the absence of recent scientific evidence, a multidisciplinary group of breast cancer experts has initiated a Consensus on the follow-up of EBC according to the mini-Delphi methodology. The project will be completed by the end of 2024.