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8007 Background: The multinational, randomized, phase III FLEX study compared cisplatin/vinorelbine (CT) plus the EGFR- antibody, cetuximab (Erbitux), with CT alone in the 1st-line treatment of patients (pts) with advanced EGFR-expressing NSCLC and demonstrated a statistically significant OS benefit for the cetuximab combination. We hypothesized that KRAS mutation status is predictive for cetuximab efficacy and enables optimal use of cetuximab. The relationship between early-onset acne-like rash (ie rash that developed ≤21 days of treatment initiation) and OS time of pts treated with CT and cetuximab was also evaluated. Methods: Archived tumor samples from 554/1125 pts were available. Genomic DNA derived from formalin-fixed paraffin embedded tumor tissue was analyzed for KRAS using an LNA-mediated qPCR clamping assay capable of detecting oncogenic mutations at codons 12 and 13. The Kaplan-Meier method was used to estimate OS time and PFS time in pts with KRAS wild-type (wt) and mutant (mt) tumors for each treatment arm. All pts treated with cisplatin/vinorelbine plus cetuximab who were alive at 21 days were included in a landmark analysis evaluating the relationship between early-onset acne-like rash and OS time. Results: KRAS results were obtained from 379 pts. A KRAS mutation was detected in 72 (19%) pts. The comparison of the cetuximab treatment effects in pts with KRAS wt tumors and pts with KRAS mt tumors showed no marked differences with regard to OS or PFS. A total of 518 pts were included in the landmark analysis. Pts treated with cetuximab who developed early acne-like rash of any grade (grade 1–3; 56%, n=290) had a longer median OS than those without acne-like rash (n=228) (median [95% CI]: 15.0 months [12.8–16.4] vs 8.8 months [7.6–11.1]; HR [95% CI]: 0.63 [0.52–0.77]; p<0.001). Analysis of EGFR FISH is ongoing and results will be presented. Conclusions: Clinical data from the FLEX study do not support the hypothesis that KRAS mutation status is predictive for cetuximab efficacy when combined with 1st- line chemotherapy in advanced NSCLC, whereas early acne-like rash of any grade appears to be associated with better outcome in pts treated with platinum-based chemotherapy plus cetuximab in this setting. [Table: see text]

Background Testosterone suppression is the standard treatment for advanced prostate cancer, and it is associated with side-effects that impair patients’ quality of life, like sexual dysfunction, osteoporosis, weight gain, and increased cardiovascular risk. We hypothesized that abiraterone acetate with prednisone (AAP) and apalutamide, alone or in combination, can be an effective hormonal therapy also possibly decreasing castration-associated side effects. Methods Phase II, open-label, randomized, efficacy trial of abiraterone acetate plus prednisone (AAP) and Androgen Deprivation Therapy (ADT) versus apalutamide versus the combination of AAP (without ADT) and apalutamide. Key eligibility criteria are confirmed prostate adenocarcinoma; biochemical relapse after definitive treatment (PSA ≥ 4 ng/ml and doubling time less than 10 months, or PSA ≥ 20 ng/ml); newly diagnosed locally advanced or metastatic prostate cancer; asymptomatic to moderately symptomatic regarding bone symptoms. Patients with other histology besides adenocarcinoma or previous use of hormonal therapy or chemotherapy were excluded. Discussion There is an urgent need to study and validate regimens such as new hormonal agents that may add benefit to castration with an acceptable safety profile. We aim to evaluate if apalutamide in monotherapy or in combination with AAP is an effective and safety hormonal treatment that can spare patients of androgen deprivation therapy. Trial registration This trial was registered in ClinicalTrials.gov on October 16, 2017, under Identifier: NCT02867020.

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INTRODUCTION: The evaluation of an individual with risk of hereditary breast cancer is based on the patient's family history and the characteristics of the neoplasia. BRCA1 and BRCA 2 are the most common genes associated with hereditary predisposition for breast or ovarian cancer. The evaluation of an individual with risk of hereditary breast cancer is key to identify patients with indication to BRCA test. Recent studies in US suggests that 31 to 34% of patients with breast cancer should be referred for genetic evaluation. In Brazil, the proportion of BC patients with indication to genetic evaluation is unknown. OBJECTIVE: To describe the prevalence of breast cancer patients enrolled in the AMAZONA III study with indication for genetic evaluation considering the criteria for hereditary breast and ovarian cancer syndrome (HBOC). METHOD: We evaluated the database of the AMAZONA III observational, prospective cohort study which included 2950 patients newly diagnosed with BC in the period of 2016-18 within 23 Brazilian sites. The criteria used to select patients who should be referred for genetic testing were extracted from the National Comprehensive Cancer Network (NCCN) guideline 2018. The characteristics of interest were summarized through descriptive statistics. RESULTS: A total of 1094 (37%) BC patients had at least one criteria for HBOC syndrome test. The most common criteria for testing was age equal or inferior 45 years (27%), BC diagnosis under 50 years and family history of breast cancer (13.5%). From the 2950 enrolled patients, 651 (22%) had the information about whether an evaluation of BRCA test was performed. Of them only 45 (6.9%) performed BRCA test, one patient from public health system and the others from private health system and from those tested 18 (40%) had an identified pathogenic mutation. CONCLUSION: A high proportion of patients diagnosed with BC in Brazil have a criteria for HBOC syndrome testing. Nonetheless a few patients have access to genetic counseling and BRCA test, especially in the public health system. Therefore its critical to implement health policies to facilitate the access to specialized care in hereditary cancer. Frequency of each criteria regarding all 2950 patientsTotal - n (%)Missing - n (%)&lt;=45 years806 (27.32)62 (2.10)&lt;= 60 years and molecular subtype triple negative234 (7.93)681 (23.08)Family history of ovarian cancer101 (3.42)214 (7.25)&lt;= 50 years and family history of breast cancer388 (13.15)214 (7.25)&lt;= 50 years and personal history of breast cancer26 (0.88)142 (4.81)Personal history of ovarian cancer4 (0.14)142 (4.81) Citation Format: Alessandra BorbaAnton de Souza, Daniela Rosa, Antonio LuiZ Frasson, Felipe Pereira Zerwes, Nathalia Cunha Rossato, Patricia Asthon-Prolla, Sergio Simon, Jose Bines, Carlos Barrios, Alessandra Morelle, Carlos AlbertoSampaio Filho, Max Mano, Rafaela Gomes, Gustavo Werutsky. Prevalence of patients with indication of genetic evaluation for hereditary breast and ovarian syndrome in the Brazilian cohort study - AMAZONA III [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 P2-09-11.