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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 RS<18 (LR): 180 pts (53%), intermediate risk RS 18-30 (IR): 135 pts (40%) and high risk RS >30 (HR): 22 pts (7%). TAILORx RS cutpoints were: LR RS <11: 78 pts (23%), IR RS 11-25: 207 pts (61%), HR 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.

ObjectivesTo compare the efficacy and tolerance at 3 and 6 months of two methotrexate (MTX) initiation strategies in rheumatoid arthritis (RA).MethodsRetrospective, monocentric, cross-sectional study including patients with RA who initiated MTX as first-line therapy during the last 2 years according to one of the following 2 strategies: a “classic” strategy defined by an initiation of oral MTX a dose of 10-15 mg/week or an “aggressive” strategy, defined by an initiation of subcutaneous (SC) MTX at a dose of 15 mg/week SC or >15 mg/week either orally or SC. Each strategy allowed the possibility to increase the doses and/or switch to the SC route at 3 months. Efficacy was assessed at 3 and 6 months using the DAS28-CRP. The tolerance of each strategy was also assessed at month 3 and 6.ResultsWe included 101 patients (85 women) with a mean age of 55±12 years and disease duration of 5±6 months. The frequency of rheumatoid factors, anti-CCP antibodies and erosions was 83%, 81% and 38% respectively. 61 patients initiated MTX according to the “classic” strategy, with an increase of dose and/or a switch to the SC route at 3 months for 31 patients, and 40 patients started treatment according to the “aggressive” strategy, with an increase of dose and/or switch to the SC route at 3 months for 14 patients. There was no difference between these 2 groups in terms of age, gender, disease duration, antibody status, frequency of bone erosions, body mass index, comorbidities and disease activity at baseline.Efficacy at 3 months was significantly higher with the “aggressive” strategy (reduction of the DAS28-CRP from 4.34±0.91 to 2.39±0.75, mean difference of 1.95±1.21, p<0.001) compared to the “classic” strategy (reduction of the DAS28-CRP from 4.09±0.62 to 2.88±0.73, mean difference of 1.21±0.90, p=0.12) (Figure 1). The improvement of tender/swollen joint counts, patient global assessment and CRP levels was also significantly more important at 3 months with the “aggressive” strategy (Table 1). At 6 months, although the DAS28-CRP was similar in the 2 groups (Figure 1), less patients from the “aggressive” strategy subgroup required an escalation to a targeted biologic/synthetic therapy compared to the “classic” strategy (12/40, 30% vs. 29/61, 48%, p=0.073).The frequency of digestive side effects at 3 months was significantly lower in the “aggressive” strategy (3/40, 7,5% vs. 16/61, 26%, p=0.021). The frequency of hepatic cytolysis at 3 month was higher in the aggressive strategy (4/40, 10% vs. 1/61, 1,6%, p=0.057). The frequency of asthenia at 3 months was similar in both groups (7/4, 18% vs. 6/61, 10%, p=0.25). Only one infection was observed in the “classic” strategy and no hematological side effect was recorded. At 6 months, the cumulative incidence of side effects was 23% with the “aggressive” strategy compared to 46% with the “classic” strategy (p=0.015). Only one treatment discontinuation was noted in the “aggressive” subgroup vs. 9 in the “classic” subgroup (p=0.042).ConclusionThis study suggests that it is possible to use a more aggressive initiation strategy of MTX in RA in routine clinical practice. This strategy allows to obtain an earlier clinical response and it is associated with a better tolerance than the classic strategy. These results need to be confirmed in prospective studies.Table 1.Evaluation of efficacy parameter at 3 months according to the methotrexate initiation strategy“Classic” strategy(n=61)“Aggressive” strategy(n=40)p-valueVariation of tender joint count-2.6±3.4-4.4±4.90.032Variation of swollen joint count-2.0±5-4.7±4.00.005Variation of PGA-VAS-24±25-40±350.009Variation of CRP (mg/L)-1.8±13-15±20<0.001PGA-VAS: patient Global Assessment - Visual Analogic ScaleFigure 1.Evolution at 3 and 6 months of DAS28-CRP index according to the methotrexate initiation strategyREFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone Declared.