e12629 Background: Adyuvant therapy with Concurrent docetaxel-adriamycin-cyclophosphamide (TAC) increases overall survival in positive node breast cancer. However it is associated with an increased risk of infection and cardiotoxicity. Switching to epirubicin (TEC) and adding Filgrastim prophylaxis (GCSF) could be an useful and safe option in the neoadjuvant setting. Methods: We reviewed the efficacy and safety of neoadjuvant regimen TEC x 6 cycles(c) and GCSF in HNBC. Kaplan–Meier, Cox regression and binary logistic regression were performed to analyze survival prognostic factors, pathological complete response rate (pCR) and serious adverse events. Results: From 2015 to 2021, 204 patients (pt) and 1125 cycles were registered. Median follow-up of 39.4 months. Median age 48 years (SD 8.3), stage II to IIIC (35% IIB), 64% were positive node and 25% Triple Negative(TN) tumors. A median dose of 90% (87.9-93.4) was administered, 93% with a cumulative dose higher than 66% (equivalent to 4 c). Radiologic response in 75% pt. 16.3% pt achieved pCR (3.2% in LumA, 15% in LumB and 35% in TN tumors). OR 4.98 (2.18-11.35) for TN and OR 0.94 (0.89-0.99) for older p<0.05. No relapses were detected in TN patients with PCR. PCR was non-inferior in pt who received 66% of planned dose (OR 1.3, p=0.76) and was higher in LumB than LumA, OR 5.2 (1.13- 24.61), p <0.05. Lymphadenectomy was avoided in 29.2% of patients with affected node at baseline. 3 years (y) relapse free (F) survival (S) of 86.1% (91-80%), better prognosis in stage II HR 0.29 (0.14-0.58) and older HR 0.93 (0.89-0.98), p< 0.005. 3y overall FS of 89% (93-84%), worse prognosis in TN with HR 3.48 (1.37-8.84). Lower risk in stage II with HR 0.31 (0.13-0.75) and in Pegfilgastrim with HR 0.14 (0.03-0.67), p<0.05. Hospital admissions in 24% for any cause. Older age (OR 1.05, p=0.01). 21% neutropenia G3/4. Infections in 17.2% of pt. Febril neutropenia in 18.1%, no related to age (p=0.5) or pegfilgrastim Vs filgrastim (p=0.99). Asthenia 17%, colitis 6% and thrombosis in 2%. No cardiacs events were reported. Conclusions: TEC is effective in the neoadjuvant setting of HNBC. It has similar pCR and survivall to those reported in meta-analysis. GCSF facilitates treatment compliance but the risk of neutropenia and admissions are still present. A lower cumulative dose could be enough to achieve the same results. Stage III and TN have shown a worse prognosis.

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e12612 Background: Double anti-Her2 blockade combined with chemotherapy (CT) is a standard regimen in Her2 positive locally advanced breast cancer (LABC) with a high risk of relapse. TCHP provides more anti-Her2 treatment, better pathological complete response (pCR) rates and less cardiotoxicity. However, it is not a very widespread option due to the risk of toxicity. Our group shows a manageable toxicity profile by adding G-CSF as primary prohylaxis. Methods: We describe our experience with neoadjuvant TCHP and pegfilgrastim combination between years 2017-2023. Efficacy and safety were analyzed and compared with other schemes accepted by clinical guidelines. Results: 62 patients, median age 48 years; 61.3% were premenopausal; 54.8% were stage II at diagnosis and 45.2% were stage III; 67.7% had N+; 62.9% had RH-. A total of six cycles were completed in 85.5%; 8 patients discontinued treatment due to toxicity. The most frequent adverse events were hematological (grade 3-4 in 8.1%) and digestive (grade 3-4 in 19.4%). No cardiac event was reported. 6.5% were hospitalized due to toxicity (3.2% febrile neutropenia). Dose reduction was needed in 43.5%. Clinical response occurred in 98.4% and radiological response in 87.1% (complete in 38.7%). pCR (ypT0/isN0) was obtained in 67.7% (66.7% in N+; 77.4% in RH-). Up to now, 4 patients have relapsed (3 of them had pRC) and 3 have died. After median 24.5 months of follow-up, the median relapse-free and overall survival by Kapplan-Meier have not been reached. Cox regression shows that getting rPC does not impact survival. The Odds Ratio shows a higher proportion of obtaining pRC in the RH- and N+ subgroups, but without statistically significant differences. Conclusions: Our data based on combination of TCHP and pegfilgrastim shows considerable efficacy with an acceptable toxicity profile. The main advantage is the intensification of double lock dose, without anti Her2 window period, avoiding the addition of anthracyclines and, therefore, cardiac toxicity. pRC and toxicity profile results were better than other regimen proposed in other studies. Our data shows that pRC has no impact on survival. We assume a favorable association between pRC and N+ and HR-, although not statistically significant, probably due to the small amount of patients. Based on these favorable results, we believe that the priority use of TCHP-GCSF should be considered in the neoadjuvant treatment of Her2+ LABC. [Table: see text]

e21150 Background: The frequency of transmission on EGFR is more frequent in women and non-smokers. It is characteristic of the Asian population (10% in the Caucasian race). EGFR tyrosine kinase domain inhibitors (EGFR-TKIs) are the standard first-line therapy in non-small cell lung cancer (NSCLC) with EGFR mutations. The efficacy and safety of osimertinib (third generation TKI-EGFR) were evaluated in the FLAURA phase III clinical trial, comparing it against first and second generation TKI-EGFR (erlotinib and gefitinib) in patients with advanced NSCLC. The objective is to evaluate the efficacy and safety of osimertinib in routine clinical practice at the Juan Ramon Jimenez Hospital. Methods: Descriptive observational, and retrospective study of patients with advanced NSCLC and EGFR + treated TKI-EGFR in the period 2015-2022. We analyzed (IBM SPSS Statistics 22) sociodemographic and clinical variables, toxicity profile, objective response rate (ORR), treatment response and progression-free survival (PFS) with Kappan-Meier curves. Results: We included 41 patients (p). 24 women (58.5%). The median age 66 years. 61% had a smoking habit (39% active smokers and 22% ex-smokers). 1p South American race, rest Caucasians. Present histologies: adenocarcinoma (87.8%), squamous cell (4.9%) and signet ring cells (2.4%). EGFR mutations: 53.7% exon 19 deletion and 36.6% exon 20 mutation and 9.8% were not specified. In 10 p the T790 mutation was analyzed, positive in 14.6%. Stage at diagnosis: IV (87.8%); III (12.2%). Symptoms at diagnosis: persistent cough (22%), pain (22%), dyspnea (19.5%) and constitutional syndrome (12.2%). Status Performance: 0-1 (85.4%). Pulmonary (48.8%), bone (36.6%), lymph node (29.3%), liver (22%), brain (22%), and adrenal (14.6%) metastases. 58.5% received osimertinib in the first line, 17.1% in the second. ORR: 77.4% partial response, 9.7% complete response and 12.9% disease progression. Toxicity (T) 90.9%. Digestive T: Diarrhea: grade G1 36.7%, G2 13.3%, G3 6.7%; nausea: G1 3.3%; hyporexia: G1 25.8%; hypertransaminasaemia: G1 3.2%. Dermal T: skin dryness: G1 20.7%, G2 10.3%, G3 3.4%; onycholysis: G1 19.4%. Asthenia: G1 25.8%, G2 12.9%, G3 12.9%. Pneumonitis: G1 3.2%, G2 3.2%, G3 6.5%. Hematological T: anemia: G1 6.5%, G2 16.1%, G3 3.2%. Dose reduction to 40 mg (37.5%). 12.5% discontinued osimertinib. mPFS in 1st line (L): 14 m (m). mPFS in 2nd L: 8 m. 95% CI (0-31.5). 95% CI (9.8- 18.1. mOS: 21 m (95% CI: 17.73-24.26). Conclusions: Osimertinib presents an adequate safety profile for patients with G1, G2 toxicities, generally easy to manage in clinical practice. A very low percentage of patients had to discontinue treatment. No fatal adverse event was reported. Our results in OS and PFS, although favorable, are somewhat lower than those of the FLAURA clinical trial, possibly due to dealing with real-life patients and/or the size of the sample, which is not entirely sufficiently representative.