Breast Cancer (ABC) comprises both locally advanced breast cancer (LABC) and metastatic breast cancer (MBC) [1]. Although treatable, MBC remains virtually an incurable disease with a median overall survival (OS) of $3 years and a 5-year survival of only $25% [2, 3]. The MBC Decade Report [2] shows that progress has been slow in terms of improved outcomes, quality of life (QoL), awareness and information regarding ABC. More recently, some studies seem to indicate an improvement in OS, mostly due to advances in human epidermal growth factor receptor 2 (HER2)-positive ABC [4][5][6]. The better survival is seen in an environment with access to the best available care and particularly in de novo ABC, while recurrent ABC seems to become harder to manage [7,8].The last decade has seen an improvement in the levels of evidence (LoEs) used for many of the ABC recommendations, however, still far from the LoEs existing for the majority of early

Highlights This ESO-ESMO ABC 5 Clinical Practice Guideline provides key recommendations for managing advanced breast cancer patients. It provides updates on managing patients with all breast cancer subtypes, LABC, follow-up, palliative and supportive care. Updated diagnostic and treatment algorithms are also provided. All recommendations were compiled by a multidisciplinary group of international experts. Recommendations are based on available clinical evidence and the collective expert opinion of the authors.

Background: PDL1 expression in the tumor is used as a biomarker predictive of benefit from ICIs in NSCLC. We prospectively evaluated clinical, imaging and laboratory parameters to identify additional factors that could be used for patient (pt) selection. Methods: Pt and disease characteristics, sites (brain, liver, bones) and extent (1 vs ! 2) of metastases, concomitant use of steroids, antibiotics, or chronic use of proton pump inhibitors, neutrophil to lymphocyte ratio and LDH were prospectively collected from pts with NSCLC treated with ICIs in the 2 nd or 3 rd line. Response rate ( RR ), Progression free survival ( PFS ) and overall survival ( OS ) data were prospectively recorded. Results: Forty-four pts, median age 69 years, 50% squamous, 50% non-squamous, were included in the analysis. Performance status was 0-1 in 75% and 2 in 25% of pts, 92.7% were active/former smokers and PDL1 was !1% in 62% of pts with available PDL1 status. Partial response was recorded in 20% of pts, 30% had stable and 50% progressive disease. Median PFS and OS were 2.7 and 7.6 months, respectively. Prolonged (!14d, either within 30d pre-or during treatment) use of antibiotics (p ¼ 0,007) and concurrent steroids (p ¼ 0,047) were inversely correlated with response. In multivariate analysis, liver metastases [HR ¼ 4 (CI: 1,6 -9,9; p ¼ 0.003)], prolonged antibiotic use [HR ¼ 2,76 (CI: 1,8 -6,4; p ¼ 0,02)] and concurrent steroids [HR ¼ 3,3 (CI: 1,4 -8,1; p ¼ 0,009)] were independent predictors of shorter PFS, whereas, only antibiotics had a negative impact on OS [HR 4,6 ( CI: 1,[7][8][9][10][11][12] p ¼ 0,003 )]. Conclusions: To our knowledge this is the first prospective evaluation of routine clinical parameters potentially associated with outcome from ICIs in NSCLC. Our data are in accordance with previous retrospective reports regarding the adverse effect of antibiotics and steroids in the outcome of pts. Moreover, we show that in these pts liver metastases are predictive for inferior outcomes.

was present in field 1 or 2 on the claim. Descriptive analyses used per-patient-permonth (PPPM) measures and the Kaplan-Meier method.Results: Among pts treated with ICI monotherapy with irAEs (N¼955; 71 y, 54% male, 69% with treatment before ICI), the top HCRU for irAEs was ambulatory visits (0.23 PPPM), followed by inpatient stays (0.09 PPPM; Table ). Mean irAE-related medical costs were $2,359 PPPM, driven by the cost of inpatient stays. 34% of all pts who experienced an irAE had an irAE-related inpatient stay within 12 mo after ICI initiation.Conclusions: Inpatient stays were the driver for irAE-related costs; approximately onethird of pts with an irAE ultimately required an inpatient stay within a year of initiating ICIs. These study findings help elucidate the economic burden associated with the management of ICI irAEs.

the vaccination. Here, we evaluated attitude towards and effects of COVID-19 vaccination in patients with breast or gynecological cancer. The aim was to improve counseling of our patients in clinical routine.Methods: Since March 15 th 2021, patients who received one of the approved COVID-19 vaccines were routinely interviewed about immediate (0-2 days) and late side effects (within two weeks after vaccination). Clinical parameters such as current therapy, time interval between therapy administration and vaccination, and changes in the therapy schedule due to the vaccination were documented. Furthermore, the willingness of non-vaccinated patients to be vaccinated was assessed. The collected data were anonymously analyzed as a part of routine quality assurance.Results: By May 10 th 2021, 111 out of 217 (51.1%) interviewed patients had received at least one shot of COVID-19 vaccine and 21 patients both shots. More than half of the vaccinated patients were >55y (60.2%; mean: 60.7y, range 30-92y); 69% with UICC/ FIGO stage III/IV cancer. 74.6% received Conmirnaty (BioNTech/ Pfizer), 18.9% Vaxzevria (AstraZeneca) and 6.5% Covid-19 Vaccine Moderna. After the first shot, 33.3% of the patients described no side effects, 49.1% reported a local reaction (swelling or pain), 23.4% flu-like symptoms, 10.8% headache and 3.6% nausea. 11 patients had symptoms that lasted longer than two days. In 11 cases, COVID-19 vaccination had an impact on delivery of the systemic therapy (n¼10 postponements of therapy and n¼1 dose reduction). 61.3% of the non-vaccinated patients (in total n¼118) were already registered to get vaccinated; 32.8% chose to postpone vaccination for personal reasons; 5% refused vaccination.Conclusions: Breast and gynecological cancer patients appear to tolerate COVID-19 vaccination well under systemic therapy and only in few cases the vaccination interfered with the treatment schedule. Updated results will be presented at the ESMO Congress.