A total of 115 patients who used everolimus were evaluated. The mean age was 57 (±13.3) years old, and 87 patients were women (75.6%). mTOR inhibitor-associated stomatitis (mIAS) was observed in 36 patients (31.3%). The lesions ranged from 0.5 cm to 1.5 cm, and the tongue was the main site affected. In addition, 21 patients (58.3%) required a dose reduction of everolimus due to mIAS. Patients who had breast cancer presented 2.29-fold higher risk for developing mIAS when compared to patients with kidney or neuroendocrine tumors. This study emphasizes the high prevalence of mIAS in patients using everolimus, in particular, in patients with breast cancer.
Background: Recent studies suggest that the percentage of TILs is a predictive factor for response to NAC and a prognostic factor associated with long-term disease control in hormone receptor-negative breast cancer. The TILs working group's current recommendation is to evaluate stromal TILs as the principal parameter in future studies. The term lymphocyte-predominant breast cancer (LPBC) can be used as a descriptive term for tumors that contain more lymphocytes than carcinoma cells. Typically, the threshold of stromal lymphocytes for LPBC is around 50% of the stromal surface area. It is unclear if this cutoff will be used in the future as such an intense TIL infiltration in tumors has been reported to be infrequent (∼10%). Studies with TNBC have demonstrated increasingly better overall survival (OS) and disease-free survival (DFS) associated with continuous scores of TIL in patients treated with adjuvant chemotherapy. In patients treated with NAC, TILs predicted pathological complete response (pCR). Our goal was to evaluate the impact of TIL on OS in TNBC patients treated with NAC. Methods: Data from patients with histologically confirmed TNBC treated with NAC from a single institution (A. C. Camargo Cancer Center - ACCCC), between July 2002 and November 2013, were retrospectively collected using electronic medical records. Patients with metastatic disease or in situ carcinoma at diagnosis were excluded. The density of TILs was evaluated in full-face hematoxylin and eosin-stained (HE) slides. Three blinded pathologists made the assessment of each slide, and a consensus on the TIL percentage was achieved. A cut-off of 10% for TIL percentage was employed for OS and DFS calculations, based on technical statistical maximizing log-rank test. We use this cut-off to test the association with pathological pCR rate as well. For pCR rate, we also used a cut-off of 50% (LPBC). We used Chi-square test to evaluate the association with pCR. A p-value<0,05 was considered statistically significant for all tests. Results: We identified 78 patients that fulfilled all inclusion and exclusion criteria. The median age was 42 years (range 17-70), and the clinical stage distribution was IIA (14%), IIB (22%), IIIA (19%), IIIB (33%) and IIIC (11%). 58 patients had archival FFPE blocks available and suitable for pathological analysis. Median follow-up was 4,1 years. Overall survival in 5 years in this subgroup was 62% (median not reached). 23 (39.7%) tumors had TIL> 10%, however only 10 had TIL > 50%. TIL >10% was associated with improved OS (HR 0.33, 95% CI, 1.0 to 0.11; p = 0.04). The same cut-off was associated with better DFS, although not statistically significant (HR 0.46, 95% CI, 1.1 to 0.18; p = 0.1). The overall pCR rate was 39.6% (48% for patients with TIL > 10% and 34% for patients with TIL <or = 10%; p = 0.3). LPBC had similar pCR rate (40% for LPBC vs. 39% for non-LPBC), probably due to the small number of samples analyzed. pCR was associated with a decreased risk of death (HR 0.06, 95% CI, 0.008 to 0.47; p<0.01). Conclusion: We observed improved OS associated with TIL>10% in TNBC patients treated with NAC. pCR was also associated with better OS. Citation Format: Sampaio CdDAT, de Lima VCC, de Andrade VP, Neotti T, Tavares MC, Sessa VA, Calsavara VF, Zenun GR, Giongo AA, da Costa AABA. Tumor-infiltrating lymphocytes (TILs) is associated with improved overall survival in triple-negative breast cancer (TNBC) patients treated with neoadjuvant chemotherapy (NAC) [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P6-09-44.
T-cells, and 3) tumors without CD276, CTLA4, MMP-2, and TP53 mutations. Conclusion: We detected cell phenotypes and gene mutations associated with tumor metastases in NSCLC.
Background: Lung cancer remains as the leading cause of cancer-related deaths worldwide, with non-small cell carcinoma (NSCLC) being the most frequent histology (85%). Therapies that target activating EGFR mutations are NSCLC first-line treatments that improve patient life expectancy and quality of life. However, despite the current availability of novel TKI drugs in Chile and other Latin-Americans countries, little is known about the molecular epidemiology of EGFR mutations in the region. In particular, Latin American patients are still largely under-represented in genomics databases or clinical trials for this disease. We are presenting the results of a large NGS-based screening of the NSCLC EGFR mutations in Chilean patients. The study is aimed at describing the prevalence of specific somatic actionable mutations, within this population and correlated data with relevant clinical and tumor aspects such as gender, age, specific histology, smoking habits, progression stage and co-occurrencewith KRAS mutations and other mutations. Method: Non-small cell lung cancer FFPE samples from 821 subjects, part of the non-interventional clinical study NIRVANA (NCT03220230), were sequenced using Oncomine Focus Assay (Thermo Fisher Scientific), which covers the most frequent and actionable EGFR mutations through nine amplicons of w100bp, spanning eight exons, to call variant at an expected mean coverage of 1000x. Variants called by the Ion Reporter Server were manually filtered by allele frequency >¼ 0.05 and at least 10 supporting reads, discarding synonymous substitutions and homozygous reference genotypes. Variants were annotated against COSMIC, dbSNP and ExAC databases to classify them in known or novel variants. Functional impact algorithms SIFT and PolyPhen were used. Clinical information was gathered on a GCP-compliant setup and monitored 100% on-site. Prevalence is reported within 95% CI, and associations with clinical characteristics are evaluated by Chi-Squared test or ANOVA, as appropriate (p<0.05). Results: We found that 214 out of 821 subjects, or 26.06% (95% CI: 23.15% to 29.14%) of the studied population, harbor an EGFR mutation. Among known variants, exon 19 E746_A750 deletion (COSM13243) and exon 18 A698T (COSM41905) were the most abundant variations. Non-smokers and under 45 years old subjects were more likely to have a relevant EGFR mutation (p<0.01), in agreement with the literature. Gender did not correlate significantly as a predictor of EGFR mutations (p>0.15) in the cohort analyzed. Conclusion: We expect these results shed light into the Chilean molecular epidemiology and supports initiatives to establish new diagnosis methods and treatment opportunities for Chilean cancer patients.
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