Conclusions: With a median duration of follow-up of 100 mo, the 7-year analysis from COLUMBUS part 1 confirms the long-term, sustained efficacy and known safety profile of enco + bini, with no new safety signals emerging, in pts with BRAF V600emutant metastatic melanoma.

Combined BRAF/MEK inhibitor therapy has demonstrated efficacy and tolerability in phase III clinical trials, and is standard of care for advanced / metastatic melanoma. However there is limited evidence in the real-world. BECARE is a retrospective, non-interventional study that investigates real-world effectiveness and tolerability of encorafenib plus binimetinib in unresectable advanced / metastatic BRAFV600-mut melanoma in 21 sites from Spain. The primary objective is to characterize the population of patients (pts) receiving EB and their outcomes. The study includes melanoma pts treated according to standard clinical practice with EB in the first line or after progression to a first line with immune checkpoint inhibitors (ICI) for advanced or metastatic stage. Previous BRAF- and/or MEK- inhibitor treatment (other than adjuvant ended ≥ 6 m before EB) or chemotherapy was not allowed. From September 2021, 56 pts were included. Median age was 58 years (range: 25-89), 58.9% were male, 67.9% had ECOG 0, 96.4% had metastasis being 51.8% IVM1C, and 73.2% had ≥3 organs involved (Brain: 17.9%). LDH was elevated in 37.5% of pts. EB was administered as the second line after IT in 10 (17.9%) pts. The ORR to EB was 80.4%. With a median follow up of 13 m (range: 1.1-26.7), median PFS was 11.4 m (95% CI: 9.9-21.6) and 6.6 m (95% CI: 4.4-NR) for pts in first-line and after ICI, respectively. The 12-m OS rate was 72.3% (95% CI: 60.1-87) and 30% (95% CI: 11.6-77.3) for pts in first-line and after ICI, respectively. There were no deaths related to study treatment and most common grade 3-4 toxicities were ALT increased (5.4%), fatigue (3.4%) and diarrhea (1.9%). EB showed similar efficacy in the real-world setting than in clinical trials, despite the population included pts with worse prognosis. Final OS results are awaited. The toxicity profile was consistent with previous experience.

Background Trastuzumab is a highly efficient drug in HER2-positive breast cancer that increases patient survival. Due to cardiotoxicity is the most important side effect of trastuzumab treatment, cardiac monitoring should be a priority, especially in the presence of comorbidities. Left ventricle ejection fraction (LVEF) determination remains the most used technique to diagnose cardiotoxicity in clinical practice. The purpose of this study is to analyse the usefulness of NT-ProBNP as a biomarker of cardiotoxicity in breast cancer patients treated with trastuzumab. Methods The study included 66 patients who received trastuzumab. We collected the LVEF and NT-proBNP values measured during the course of treatment, and cardiovascular risk factors including diabetes, hypertension, smoking, hypercholesterolemia and BMI. Cardiotoxicity was diagnosed during the follow-up program considering a decrease of the LVEF from baseline or clinical manifestation of congestive heart failure. According to the literature, NT-proBNP cut-off points were considered to stablish normal or abnormal values in terms of patent age. Results 174 paired LVEF/NT-proBNP values were found. 27.3% of patients suffered cardiotoxicity during trastuzumab treatment and most of cases were diagnosed based on cardiac symptomatology (66.7 %). Logistic regression analysis of NT-proBNP and the cardiovascular risk factors showed a significant association of diabetes mellitus (OR 5.9, 95% CI 1.2 - 28.5, p = 0.028) and NT-proBNP (OR 22.0, 95% CI 5.7 - 85.4, p = 0.000) with the development of cardiotoxicity during trastuzumab treatment, whereas the other variables were not statistically significant. Conclusions Diabetes and NT-proBNP values seem to be associated with an increased risk of cardiotoxicity in breast cancer patients during trastuzumab treatment. In diabetics, glycaemic control and a more intense cardiac monitoring could provide objective benefits during the treatment. Moreover, NT-proBNP determination could become an accessible way to evaluate cardiac risk in this context. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.

The treatment of localized stage lung cancer offers limited succes in terms of increase survival. This study aims to find out if there are differences in disease-free survival (DFS) between surgery and chemo-radiotherapy in lung cancer Stage III. A retrospective study was conducted on 96 patients with localized lung cancer treated in our center between from 2009 to and 2017, selecting only patients in Stage III. All the clinical medical histories were reviewed in order to analyze different parameters related to demography, histology and treatment. A statistical data analysis software (SPSS) was applied to search for relationships statistically significant among the variables. For the survival analysis, They used Kaplan-Meier curves and the Log-Rank test. 39 cases of patients in Stage III were collected. The surgery group (with neoadjuvant or adjuvant chemotherapy) covers 21 patients (54%). The group treated with Chemo-Radiotherapy includes 18 patients (46%). For the surgery group, the mean for the DFS is estimated at 51 months (39.5-62.3 months), the median has not yet been reached.The mean DFS in the Chemo-Radiotherapy group is 40.2 months (22.6-57.8 months); the median being 18.2 months (15.75-20.65 months). These differences are statistically significant. The group treated with surgery: median age of 66.5 years, 94% male smokers. The adenocarcinoma represented the 61% of the group compared to the epidermoids, which account for 39%. In 44% of the tumors, signs of inflammatory infiltration were found. The Standard Uptake Value (SUV) average was 11.19 (2.72-18 SUV). The group treated with Chemo-Radiotherapy: median age of 66 years, 95% male smokers, 57% epidermoid tumors versus 43% of adenocarcinomas. Only 14% had signs of histological inflammation. The average SUV was 15.94 (3-48 SUV). Patients candidates for surgery not only have optimal respiratory function tests. They seem to present less pulmonary pathology, a better immune response against tumors and a lower SUV value.

Lung cancer is the leading cause of cancer death. Most studies focus on metastatic disease, and the complementary treatment in localized disease has limited evidence. This study aims to highlight the factors that influence the survival of lung cancer in localized phase. A retrospective study was conducted on 96 patients (14% women and 86% men, median age of 66 years) with localized lung cancer treated in our center between 2009 and 2017. At the end of the data collection, 44 patients had died (46 %) but 52 (54%) remained alive until today. All the medical histories were reviewed in order to analyze different parameters related to histology, stage, tumor biology, imaging tests, surgery and treatment. A statistical data analysis software (SPSS) was applied to find statistically significant relationships between the variables. From the 49 patients with adenocarcinoma, 18 (37% of the total) died with a median overall survival (OS) of 35 months (27-43 months with CI <0.05%). From the 47 epidermoids, 26 died (55% of the total) although with a median OS of 59 months (40-78 months with CI <0.05%). By stages I and II: The median OS for the adenocarcinoma group was 12.33 months (3.6-21 months with CI <0.05%) versus the squamous cell group, with a median of 28.75 months (12.6-57, 8 months with CI <0.05%). Between stages III: The median OS in the adenocarcinoma group was 14 months (11.7-16.2 months with CI <0.05%) compared to the squamous group with 22.26 months (15.7-28.8 months with CI <0.05% ). The median OS among the patients with some inflammation data was 65.7 months (57-74 months with CI <0.05%). Adenocarcinomas seem to present a worse prognosis in localized stage, in contrast to metastatic stage. Inflammation seem to play an important role in the evolution of the tumor, regardless of the treatment.

The aims are to asses the different expression of ER, PR, HER2 and Ki-67 between primary tumor and the recurrence and theirs prognostic consequences. Observational retrospective unicentric study of 45 breast cancer patients. We have two different populations: patients who have a local and complete resected relapse (LR) and patients with a metastatic biopsied disease (MD).The changes in ER, PR, HER2 and Ki-67 between the pathologist report of primary tumor and the biopsy of the relapse have been analyzed. We studied ER, PR, HER2 and Ki-67 determined in the relapse as prognostic factor for relapse free survival (RFS) and overall survival (OS) in the LR group, and for progression-free survival (PFS) and OS in MD group. The conversion rate of 34,8% for Ki-67 (p = 0,046), 20% for ER (p = 0,001), 20% for PR (p < 0,001), and 15,6% for HER2 (p < 0,001). In LR group we have not found statistical differences in RFS according to ER, PR, HER2, either Ki-67; the mean for Ki-67≥ 14% 27,1 months (m) (IC95% 19,6-36,2) vs Ki-67 < 14% 69,5m (IC95% 0,0-145,0) (p = 0,262). In MD group we have not found statistical differences in PFS according to ER, PR, HER2, either Ki-67; the mean for Ki-67≥ 14% 18,2m (IC95% 10,3-26,0) vs Ki-67 < 14% 53,0m (IC95% 13,4-92,7) (p = 0,272). In the LR group, the OS mean for: ER+ 178,6m (IC95% 154,7-202,4) vs ER- 72m (IC95% 17,7-126,3) (p = 0,001); PR+ 173,4m (IC95% 143,8-203,0) vs PR- 102,4m (IC 95% 67,8-137,0) (p = 0,248); HER2- 162,3m (IC95% 127,0-197,6) vs HER2+ 146,5m (IC95% 76,5-216,5) (p = 0,633); in Ki-67 no statistical differences have been observed (p = 0,144). In the MD group, OS mean for: ER+ 137,7m (IC95% 105,9-169,5) vs ER- 43,1 m (IC95% 8,3-77,9) (p = 0,043); PR + 144,6m (IC95% 108,1-181,0) vs PR- 70m (IC 95% 27,3-112,8) (p = 0,027); HER2- 127,2m (IC95% 90,7-163,7) vs HER2+ 110m (IC95% 5,454-157,0) (p = 0,921); Ki-67 ≥ 14% 94m (IC95% 37,7-150,5) vs Ki-67 < 14% 147,3m (IC95% 85,6-209,0) (p = 0,411). We observed a significative conversion rate in Ki-67, ER, PR and HER2 between primary breast cancer and relapse. We saw that ER- in the local relapse or metastasis, as well as a PR- in the metastasis were associated with a worse prognosis.