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Background: Recent data suggest that HER2-low breast cancer (BC) may represent a distinct entity. Approximately 55-60% of BC are considered as Her2-low, of which 80% are Luminal-like tumors. Recent studies support potential clinic-pathological and molecular features differences between Estrogen Receptor (ER) positive HER2-low and ER positive Her2-0 disease. Among patients (pts) with high genomic risk (Oncotype DX RS) HER2-low expression was associated with a significant improvement in overall survival compared to Her2-0. The objective of our study is to compare disease characteristics and outcomes between HER2-low and Her2-0 in estrogen receptor (ER) positive, early (e) BC. (Murtai R et al. The Breast. 60(2021)62-69. Methods: A single center retrospective study of all pts. with ER positive, Her2 negative eBC, for whom Oncotype DX test was performed between 1/Nov/2012 and 14/Febr/2019. The pts were separated into HER2-low (immunohistochemistry (IHC) +1 or + 2 and in situ hybridization not amplified) or HER2-0. Clinic-pathological features included were: demographics, tumour size, nodal status, histologic grade, Her2 expression, ER and progesterone receptor (PR), Ki-67, presence of lymph-vascular (LV1) tumor cell invasion and Oncotype recurrence score (RS) result. Results: A total of 344 pts were screened, of whom 297 pts were included (Exclusion for: Her2 “negative” expression (45 pts); HER2 positive disease by IHC (1 pts); metastatic disease (1 pts)). The distribution of HER2-0 and HER2-low subgroups was 121 pts (41%) and 176 pts (59%). The pathological characteristics according to Her2 expression status are summarized in Table 1. Median age was 57 year (38-79), similar between both groups: Her2-0 58 yr (41-78) and 56 yr (38-79) in Her2 low. The postmenopausal status was 76 pts (62,8%) Her2-0 Vs 113 pts (64,2%) in Her2 low. 1 pts was male. Proliferation Index: Ki67% < 20 was: 65 pts (53,7%) Her2-0 Vs 86 pts (48,5%) in Her2 low; 65 pts (13,5%) had Lympho-vascular invasion in Her2 low; 115 pts (95%) were ER positive in Her2-0 Vs 157 pts (89,2%) in Her2 low; PR positive > 20 was 106 pts (87,6%) in Her2-0 Vs 137 (78,7%) in Her2 Low. The median follow-up was 72 month (SD+- 22,52). 5 pts had a recurrence: 4 pts were Her2 low (1 local and 3 distant metastasis) and 1 Her2-0 with distant metastasis. Most of the pts received adjuvant hormone therapy. There were no statistically significant differences between both groups owing to neither the clinic-pathologic features nor the recurrence score. It was not reached the mínimum number of events for a survival analysis. Conclusions: Our results show that HER2-low eBC pts have similar characteristics and survival rates compared to HER2-0 BC pts without significant differences. Table 1. Baseline pathological characteristics. Citation Format: Elena Galve, Fernando Pikabea-Diaz, Borja Lopez-de-San-Vicente-Hernandez, Covadonga Figaredo-Berjano, Jairo Legaspi-Folgueira, Maria Angeles Sala-Gonzalez, Juan Fernando Arango-Arteaga, Sara Fernandez-Ferrer, Pablo Leonardo Loaiza-Jaramillo, Pablo Casado-Cuesta, Marina Temino-Frances, Anne Bilbao-Penas, Purificacion Martinez-del-Prado. Clinical and pathologic characteristics in early breast cancer Her2-low and high risk Oncotype DX RS [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 P1-07-09.

Introduction: Oncotype DX (ODX) Recurrence Score (RS) is a gene-expression assay that provides prognostic and predictive information in hormonal-receptor positive (HR +), human epidermal growth factor receptor 2 negative (HER2-), axilary lymph node negative (LN-) disease. It estimates the 10 year-risk of distant recurrence and it is recommended to asses this issue and the potential benefit of adjuvant systemic therapy in early stage breast cancer (ESBC). (JCO 2016, NCCN 2019). Objective: To evaluate the impact of RS on our adjuvant treatment decision making and follow-up (FU). Materials and methods: Observational, prospective single institution study. Eligible patients (pts) were diagnosed between September 2012 and December 2018 with HR+, HER2 -, N0 and N+ (N1mic) ESBC for who underwent ODX assay. Criteria for ordered ODX assay were established by the group of experts from the Basque Country Health System. Treatment recommendations were documented before and after the conventional RS results. We reviewed clinical and pathology reports for FU and events. Descriptive statistics were used to summarize patient and tumor characteristics and changes in oncologists’ treatment recommendations. Mc Nemar’s test was used to identify how these tests impact in decisión. Results: N=337 pts. Median age was 57 years (SD 9,11); women 328 pts (97%); premenopausical 114 (34%); conservative surgery 271 pts (80%); sentinel node 318 pts (94 %); pN0: 248 pts (74%), pN1mic: 89 (26%); tumor size: pT1a-b: 41 pts (12 %), pT1c: 234 pts (69%) and pT2: 62 pts (18%); histologic type: ductal 280 pts (83%); histological grade: G1 49 pts (16%), G2 250 pts (74 %), G3 34 pts (10%); Ki 67 index >=13: 221 pts (66 %); progesterone receptors: positives: 304 pts (90%); presence of lymphovascular invasión:36 pts (11%). Treatment decision before assay was hormonal therapy (HT) in 242 pts (72 %) and chemotherapy (CT) in 95 pts (28 %). Conventional RS were: low risk RS30 (HR): 22 pts (7%). TAILORx RS cutpoints were: LR RS 25: 52 pts (15%). Post-assay treatment: 278 pts (82.5%) received HT and 59 pts (17.5 %) CT. Treatment recomendation pre and post ODX assay changed in 17,5% of pts: in 10,5% from CT to HT and 7% from HT to CT. The McNemar's test was significant value (0.000). With a median FU of 35 months (range 1-77) there were 5 events: (1.5%): 1 local (0.3%) and 4 distant (1.2%). Conclusions: In our cohort, the 82.5% of pts received HT. The treatment decisión changed 17.5% of pts. The ODX avoided CT in 10.5% of 38 pts (28% pre and 17.5% post). At this time, insufficient median FU and number of events are available to examine long-term prognosis and CT benefit. Citation Format: Maria Purificacion Martínez del Prado, Borja López de San Vicente, Juan Fernando Arango Arteaga, Jairo Legaspi Folgueira, Ane Zumárraga Cuesta, Fernando Pikabea Diaz, Patricia Novas Vidal, María López Santillán, Laura Sande Sardina, Maitane Nuño Escolástico, María Teresa Abad Villar, Maria Ángeles Sala Gonzalez, Covadonga Figaredo Berjano, María Teresa Pérez Hoyos, Elena Galve Calvo. Oncotype DX assay’s real world data in early stage breast cancer patients. Outcomes of a cohort treated in the Basurto University Hospital, Spain [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 P3-14-05.

The combination of Pegylated Liposomal Doxorubicin (PLD) plus Gemcitabine (GEM) has been previously investigated in the treatment of metastatic breast cancer (MBC). PLD is a doxorubicin formulation with prolonged circulation time and better tissue distribution. GEM is a nucleoside analog with nonoverlapping toxicity compared to PLD. The aim of our study was to assess efficacy, toxicity, and long-term outcome of this combination. Patients with heavily treated MBC were retrospectively analyzed. Chemotherapy consisted of PLD 25 mg/m2 and GEM 800 mg/m2 day 1, on a three-week schedule. Cardiac function was evaluated baseline and during treatment. Radiological response was graded according to RECIST criteria v1.1. Toxicity was scored according to CTCAE v4.0. Progression-free survival (PFS) and overall survival (OS) were evaluated. From 2001 to 2014, 122 pts were included. Median age was 55 (range: 28-84). Median previous treatment schedules in the metastatic scenario were 3 (range: 1-15). Most patients received prior anthracyclines (85%). Median number of metastatic sites was 2 (range: 1-7). Median number of cycles delivered was 5 (range: 1-36). Overall response rate was 31% (5% complete responses; 26% partial responses). Stable and progressive diseases were observed in 32% and 26% of patients. Grade ≥3 neutropenia was observed in 29 patients (24%). Grade ≥3 hand-foot syndrome was detected in 17 patients (14%), mostly since cycle 3 (88%). Median cumulative PLD dose was 125 mg/m2 . At a median follow-up of 101 months, median PFS and OS were 7 and 22 months, respectively. PLD-GEM combination achieves remarkable long-term outcomes with an acceptable toxicity profile in patients with MBC.

Background: The degree of histopathological response after neoadjuvant therapy in locally advanced gastric cancer (GC) is a key determinant of patients' long-term outcome. We aimed to assess the pattern of histopathological regression after two neoadjuvant approaches and its impact on survival times. Methods: Regression grade of the primary tumour (Becker criteria) and the degree of nodal response by a 4-point scale (grades A–D) were assessed. Grade A—true negative lymph nodes (LNs); grade B and C—infiltrated LNs with any or little evidence of nodal response; and grade D—complete pathological response in a previously infiltrated LN. A favourable pathological response was defined as Becker Ia–b and grade D. Results: From 2004 to 2014, 80 patients with GC (cT3–4/N+ by CT-scan/EUS) were treated with either preoperative chemotherapy (ChT, n=34) or chemoradiation (CRT, n=46). Patients in the CRT group had a higher likelihood of achieving a Becker Ia–b response (58 vs 32%, P=0.001), a grade D nodal regression (30 vs 6%, P=0.009) and a favourable pathological response (23 vs 3% P=0.019). Patients with a grade D nodal response had a longer 5-year PFS and OS compared with those with a grade B or C response. Patients with a baseline negative LN status had similar outcomes irrespective of the preoperative therapy received (5-year OS; ChT vs CRT, 58 vs 51%, P=0.92). Conclusions: Preoperative chemoradiation increases the likelihood of achieving favourable histopathological features that correlate with a 5-year OS>70% in GC patients.

ObjectivesThe aim of this study was to determine the long-term results of a 7-week schedule of external beam radiation therapy, high dose rate brachytherapy, and weekly cisplatin and paclitaxel in patients with locally advanced carcinoma of the cervix.MethodsThirty-seven patients with International Federation of Gynecology and Obstetrics stages IB2 to IVa cervical cancer were treated with 40 mg/m2 per week of intravenous cisplatin and 50 mg/m2 per week of intravenous paclitaxel combined with 45 Gy of pelvic external beam radiation therapy and 28 to 30 Gy of high dose rate brachytherapy.ResultsSixteen patients (43.2%) were able to complete the 6 scheduled cycles of chemotherapy. The median number of weekly chemotherapy cycles administered was 5. Thirty-six (16.2%) of 222 cycles of chemotherapy were not given because of toxicity. The mean dose intensity of cisplatin was 29.6 mg/m2 per week (95% confidence interval, 27.0–32.1); that of paclitaxel was 40.0 mg/m2 per week (95% confidence interval, 36.9–43.1). Thirty-four patients (91.8%) completed the planned radiation course in less than 7 weeks. Median radiation treatment length was 43 days. After a median follow-up of 6 years, 7 patients (18.9%) experienced severe (RTOG grade 3 or higher) late toxicity. No fatal events were observed. Ten patients have failed, 1 locally and 9 at distant sites. The 14-year locoregional control rate was 96.7%, and the 14-year freedom from systemic failure rate was 64.6%. Fourteen-year actuarial disease-free survival and overall survival rates were 44.8% and 50%, respectively.ConclusionsThis study demonstrates excellent very long-term results and tolerable toxicity although the target weekly dosage of cisplatin and paclitaxel needs to be adjusted in the majority of the patients.

e18073 Background: Electronic Medical Records (EMR) were born as a result of medicine digitalization. Healthcare information systems (HIS) hold great value to the workflow management and patient care. New technologies not only allow us work with a faster and more reliable medical history, but also understand how health professionals think and work. Time consumption is one of the biggest issues that geriatric assessment (GA) has to deal with. Hurria et al. developed a brief tool which requires minimal resources and time spent (≈30 mins) by healthcare providers. On the other hand, patients´ medical history review, writing reports or tumor board discussions are often underestimated on daily time schedule. The aim of this study is to analyse the effective working time (EWT) invested in geriatric assessment in our centre by Big Data analytics. Methods: From 1 March 2018 to 31 december 2018, > 70 years-old patients were prospectively recruited from the outpatient oncology practices at Basurto University Hospital. Nurse-guided geriatric assessment was scheduled 45 mins before oncologist’s first visit, and functional status, comorbidity, cognitive function, psychological state, social support, polypharmacy, nutritional status, and nurse interventions were measured. Patterns of nurse and medical behaviors from EMRs were tracked. The model to figure out active behaviour in HIS was defined as > 23 events/hour. EWT was established as time spent between first and last access to HIS. Isolated events and interventions by users other than oncologists and nurses were excluded. Results: 280 patients were enrolled, 54.3% men. Geriatric assessment detected: cognitive impairment 17 pts (6.9%), mental health alteration 78 pts (27.8%), Poor social support 10 pts (3,7%), polypharmacy 239 pts (89,28%), and severe malnutrition 34 pts (13.2%). Nurse specific intervention was made in 90 pts (32,6%). The median EWT by nurses for a GA was 39 minutes (SD 0:21), and 46 mins (SD 0:17) by oncologists´global evaluation. Nurses started in average 3 mins (SD 0:27) before scheduled visit, and oncologists 9 mins (SD 0:28) after. Conclusions: Big data analytics show an assumable effective working time for a geriatric assessment in our patients. HIS users behavior analysis could help in the management of our healthcare systems.

e13029Background: De novo metastatic breast cancer (dnMBC) represents approximately 6–10% of breast cancer. In luminal-like dnMBC recommendation for endocrine therapy (ET) as first-line treatment i...

Lung cancer is the most frequent neoplasm in humans. Surgery is considered the best therapeutic approach for stage I non-small lung cell cancer (NSCLC). However, a remarkable amount of patients are considered as inoperable. Stereotactic body radiotherapy (SBRT) has risen as an option for those patients, rendering excellent results in quality of life and survival. We analyzed clinical studies published between 2002 and 2015 which included SBRT as a treatment modality. Our own clinical series was analyzed as well. The patterns of failure following SBRT were investigated, together with the outcomes and the toxicity observed. SBRT has proven to maintain an excellent local control. The analysis showed the tumor size and the histology as determinant factors for the response to treatment. According to the published evidence as well as our own experience, SBRT is a safe and feasible approach for early NSCLC. Its results may be comparable with surgery treatment.

Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitors (TKIs) have changed the paradigm of treatment in non-small cell lung cancer (NSCLC). The molecular biology study of EGFR has led to clinical trials that select patients more accurately, regarding the presence of EGFR activating mutations. Nonetheless, a lack of response or a temporary condition of the response has been detected in patients on EGFR TKIs. This has urged to study potential resistance mechanisms underneath. The most important ones are the presence of secondary mutations in EGFR, such as T790M, or the overexpression of mesenchymal-epithelial transition factor (MET) that may explain why patients who initially respond to EGFR TKIs, may ultimately become refractory. Several approaches have been taken and new drugs both targeting EGFR resistance-mutation or MET are currently being developed. Here we review and update the EGFR biological pathway as well as the clinical data leading to approval of the EGFR TKIs currently in the market. New compounds under investigation targeting resistance mutations or dually targeting EGFR and other relevant receptors are also reviewed and discussed.

1081Background: Levels of tumor infiltrating lymphocytes (TILs) at diagnosis have shown to improve survival in TNBC and HER2 overexpressing breast cancer (BC) patients. Indeed, high levels of TILs ...

e12621 Background: The National Lung Cancer Screening Trial found, after 6.5 years, a 20% reduction in LC mortality in high-risk patients (pts) screened with low-dose computed tomography compared t...

Aim: We previously reported the prognostic impact of Id1 in all NSCLC stages and of the combined Id1/Id3 expression in stage III-N2 patients undergoing radical chemo-radiotherapy. Further, we found that Id1 expression in the tumor microenvironment is crucial for the development of liver metastasis from lung cancer in an in-vivo model. In other neoplasms, Id genes are considered to be regulators of EMT-facilitated metastasis. Here we study Id1 and Id3 combined expression in a large NSCLC cohort and its correlation with EMTrp and overall survival (OS). Methods: Three tissue microarrays of 538 NSCLCs including 284 squamous-cell carcinomas (SCC) and 254 adenocarcinomas (AC) were stained by immunohistochemistry using the following antibodies: Sox10, Beta-catenin, E-cadherin, Vimentin, Slug, Podoplanin, S6, ERCC1, Id1 and Id3. Immunoreactivity was H-scored for intensity (range 0 to 3) multiplied by percentage of positive cells and computed by Spearman's Rho correlation test. Results: Among SCC histology a significant positive correlation was observed between the combined expression of Id1 and Id3 and the expression of Sox10, Beta-catenin, E-Cadherin, Slug, Podoplanin and ERCC1. In the AC subset, significant positive correlations were found between Id1/Id3 and Beta-catenin, E-Cadherin, Vimentin, pS6, and ERCC1. As expected, Id1/Id3 expression showed a negative correlation with OS (r= -0.157; p=0.013). Protein SCC AC (n.s; not significant) r p value r p value Sox10 0.146 0.018 n.s. n.s. Beta-Catenin 0.218 0.001 0.161 0.01 E-cadherin 0.128 0.038 0.150 0.017 Vimentin n.s. n.s. 0.147 0.019 Slug 0.187 0.002 n.s. n.s. Podoplanin 0.127 0.039 n.s. n.s. S6 n.s. n.s. 0.150 0.014 ERCC1 0.265 0.001 0.185 0.003 Conclusions: In NSCLC, the combined expression of Id1 and Id3 negatively correlated with OS and positively with several key EMTrp, suggesting a possible key regulation of the EMT process favoring vessel infiltration and distant organ metastasis, respectively. Disclosure: All authors have declared no conflicts of interest.

Aim: Multimodal therapy is the standard of care in locally advanced esophagogastric adenocarcinoma. However, most trials include both, gastric (GC) and gastroesophageal junction (GEJ) cancers. We aimed to rule out whether patients (pts) with either locally advanced GEJ (group A) or GC (group B) have different outcomes when treated with a neoadjuvant approach based on induction chemotherapy (ICT), chemoradiotherapy (CRT) and surgery. Methods: EUS-T2-4 and/or N+ M0 GEJ or GC adenocarcinoma patients were scheduled to receive preoperative therapy (3-4 cycles of chemotherapy followed by concurrent CRT). Surgery was scheduled 4 to 6 weeks after the end of CRT. Pathological response was graded according to the Becker criteria. Patterns of recurrence, progression-free survival (PFS) and overall survival (OS) were also evaluated. Results: From november 2004 to July 2013, 87 pts (27 in group A, 60 in group B) met the specified criteria. Pts characteristics were; Group A; M/F; 23/4; EUS-T3 52%, T4 40,7%, N+ 95%, median age 56 (31-81); Diffuse/Intestinal 55%/44%. Group B; M/F; 42/18; EUS-T3 40%, T4 56%, N+ 95%; median age 60.5 (36-76); Diffuse/Intestinal 57%/42%. Seventy-four pts underwent surgery (group A/ B; 92.6%/82%). Pathological response (Group A/B); Grade Ia-Ib according to Becker criteria (72%/51%), pN0 (60.3%/53%). R0 resection (Group A/B); (96%/94%). Among resected pts we analysed the impact of tumor location (GC vs GEJ) on known prognostic factors such as Lauren classification and degree of pathological response regarding PFS and OS. In group A, median OS and PFS did not difer according to Lauren neither classification nor pN status. In contrast, median PFS varied according to Becker response (Ia-b: Not Reached; II-III: 13m; p = 0.02). In group B, we found differences in PFS and OS according to; a)- Lauren Classification; Intestinal GC vs Diffuse GC pts [median PFS; NR vs 13.6m; p = 0.028, median OS: NR vs 15.3m; p = 0.026]. b)pN status (-/+) [median PFS; NR vs 18m; p Conclusions: When treated with ICT followed by CRT, GEJ and GC pts have different outcomes in terms of pathological response degree, patterns of recurrence and survival times. Disclosure: All authors have declared no conflicts of interest.