We evaluated the efficacy and safety of trifluridine/tipiracil (TAS-102) plus bevacizumab in treating refractory metastatic colorectal cancer (mCRC) in a retrospective, observational study. Patients refractory or intolerant to standard therapies received TAS-102 (30–35 mg/m2 twice daily on days 1–5 and days 8–12 every 28 days) plus bevacizumab 5 mg/kg on days 1 and 15. Clinical and pathological characteristics, overall response rate (ORR), disease control rate (DCR), overall survival (OS) and progression-free survival (PFS) data were collected and analysed. Thirty-five patients were treated from July 2019 to October 2021 (median age 64 years). The majority of patients (68.6%) were receiving TAS-102 plus bevacizumab as third-line treatment. Patients received a median of 4 (range 2–15) cycles of treatment. Among 31 patients evaluable for response (88.6%), ORR and DCR were 3.2% and 51.6%, respectively. After a median 11.6 months’ follow-up, median PFS was 4.3 (95% confidence interval [CI] 3.4–5.1) months and median OS was 9.3 (95% CI 6.6–12.1) months. The most common grade 3–4 toxicities were neutropenia, asthenia and nausea/vomiting, and there were no treatment-related deaths. This real-world study confirms the efficacy and safety of TAS-102 plus bevacizumab in patients with refractory mCRC.

99 Background: TASBEV, compared with TAS-102, was associated with an improvement in progression-free survival (PFS) with tolerable toxicity in a randomized, open-label phase 2 trial. However, the subgroups of patients who may benefit from long-term TASBEV treatment are unknown. Methods: We conducted a retrospective, observational study of patients (pts) with mCRC refractory or intolerant to standard therapies treated with TAS-102 30-35 mg/m2 twice daily on days 1–5 and 8–12 every 28 days plus BEV 5 mg/kg on days 1 and 15 at University Hospital a Coruña (Spain). Results: We recorded 47 pts treated between July 2019 to June 2022. Median age was 65 years (range 41 – 82 years), 78.7% ECOG PS0-1, 51.1% RASmt, 78.7% of pts had liver and 23.4%, peritoneal metastases; 29.8% time since diagnosis of 1st metastases <18 months and 57.4% poor prognostic Tabernero Subgroup. Previous treatment included 94.3% previous antiVEGF treatment and 74.5% received TAS-102 BEV as 3rd line of treatment. Median of cycles received was 4 (range 1-15 cycles). ORR and DCR were 2.4% and 48.8%, respectively. With a median follow up of 15.7 months, median PFS was 4.3 months (95% CI, 3.4-5.1 months) and median OS was 9.8 months (95% CI, 7.3-12.3 months). Univariate analysis of prognostic factors for progression-free and overall survival are listed in the table. Conclusions: In our series identified that Tabernero's prognostic subgroups or the development of grade 3-4 neutropenia during treatment, among others; identify patients who may benefit from long-term TASBEV treatment. [Table: see text]

No abstract

Since Coronavirus Disease 2019 (COVID-19) was declared pandemic in March 2020, there have been 545.226.550 cases up to 4 July 2022 (1). Several studies concluded that patients (pts) with cancer are at increased risk of COVID-19 infection, morbidity and mortality. Those undergoing neoadyuvant treatment are at particularly risk of disease progression if chemotherapy or surgery are delayed. Also, is known that a higher NLR (neutrophil to limphocyte ratio) is related to worse outcomes (3). Our hospital is located at the Northwest of Spain and in the last months we noticed a never seen number of infections in cancer population. The aim of this study is to evaluate the severity of COVID-19 and its impact on chemotherapy and surgery delay in pts undergoing neoadjuvant chemotherapy breast cancer. METHODS: We conducted a ambispective, unicenter, observational study of breast cancer pts, treated with neoadjuvant chemotherapy, between March 2020 and May 2022 at University Hospital A Coruña (Spain). We analyzed type of infection, need of hospitalization, chemotherapy and surgical delay, and its association with tumor type; BRCA germline mutation; clinical stage; treatment; vaccination status; and neutrophils, lymphocytes, and NLR before COVID-19 disease. RESULTS: During the study period, from 1 March 2020 to 31 May 2022, 183 pts underwent neoadjuvant chemotherapy. A total of 23 (12.5%) pts experienced COVID-19 infection, of which 21 were diagnosed between January and May 2022. The median age was 47,91 years [range 33 – 69 years]. Luminal B HER 2 negative comprised the most common molecular subtype (40.9%), followed by Triple Negative (36.4%), Luminal B HER 2 positive (13.6%), and HER 2 enriched (9.1%). Germline mutations in BRCA account for 13.6% pts. At diagnosis, 4.5%, 72.7%, and 22.7% had stages I, II, and III respectively. Chemotherapy treatments included: paclitaxel followed by Adryamicine-Cyclophosphamide (AC) (45.4%); carboplatin – paclitaxel – trastuzumab - pertuzumab (18,2%); carboplatin – paclitaxel followed by AC (18,2%); KEYNOTE-756: pembrolizumab/placebo - paclitaxel followed by AC (13.7%); and paclitaxel – trastuzumab – pertuzumab followed by myocet – cyclophosphamide – trastuzumab - pertuzumab (4.5%). The association of G-CSF ocurred in 9 pts (40.9%). 22 pts were fully vaccinated, 8 pts (36.4%) with two doses and 13 pts (59.1%) with three doses. 77.3% pts experienced mild respiratory symptoms with 9.1% hospitalizations. The median duration of delays was 15 days for chemotherapy and 29,58 days for surgery. NLR percentil 25 was associated with COVID-19 type of infection. For those pts with a lower rate, infection was asymptomatic and for those with a higher rate symptoms were moderate (Χ2= 5,119, p = 0,024). CONCLUSIONS: COVID-19 disease become a high prevalent infection in pts undergoing neoadjuvant breast cancer chemotherapy. Most pts are fully vaccinated and experienced an indolent infection. NLR is an easily measurable and cost-effective parameter that could be useful as a prognostic marker of severity in COVID-19. We will continue to follow-up these pts to see the impact of chemotherapy or surgery delay in pathological complete response and disease-free survival until the congress in December 2022. BIBLIOGRAPHY: 1. WHO Coronavirus (COVID-19) Dashboard [Internet]. world health organization. 2022 [3rd July 2022]. Disponible en: https://covid19.who.int. 2. YekedÜz E, Utkan G, ÜrÜn Y. A systematic review and meta-analysis: the effect of active cancer treatment on severity of COVID-19 [Internet]. European Journal of Cancer. 2020. [24th June 2022]. Disponible en: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7538140/pdf/main.pdf 3. Jimeno S, Ventura PS, Castellano JM, García-Adasme SI, Miranda M, Touza P, et al. Prognostic implications of neutrophil-lymphocyte ratio in COVID-19 [Internet]. Eur J Clin Invest. 2021. [22th June 2022]. Disponible en: https://onlinelibrary.wiley.com/doi/10.1111/eci.13404. Table 1: Clinical characteristics of patients Table 2: Blood cell count in percentils Citation Format: Beatriz Alonso de Castro, Igor Gomez-Randulfe Rodriguez, Sofia Silva Diaz, Cristina Reboredo, Silvia Antolin Novoa, Eva Perez Lopez, Patricia Cordeiro, Rocio Lesta, Iria Parajo Vazquez, Lourdes Calvo. NEOADYUVANT TREATMENT IN THE COVID ERA [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-07-39.

306 Background: Non-standardized data collection in medical records has a negative impact on the quality of care: it increases the possibility of medical errors, hinders the performance of clinical studies, precludes the development of improvement plans and impedes accreditation in quality-of-care programs. The ASCO QOPI (Quality Oncology Practice Initiative) certification program accredits the quality of care of oncology departments through a self-assessment process. An overall quality score (OQS) above 75% on 26 measures that focus on quality of care and patient safety is required for application. In order to begin the certification process, we analysed the quality of the data collected in our initial medical history to implement improvement actions. Methods: Based on the 26 QOPI measures, plus 17 additional measures that were chosen by consensus as relevant, we performed a retrospective baseline analysis of the data collected in the initial medical history of patients assessed in June 2021. Patients with breast cancer, colorectal cancer and non-small cell lung carcinomas who initiated systemic treatment were included. Those who participated in clinical trials were excluded. The OQS of the 26 patients analyzed was 59%. Given this negative result, and once the problem was identified, the objective was established (OQS > 75%), changes were prioritized and an improvement plan was developed based on rounds of training, feedback and reinforcement to the entire medical team, and through the design of a template with the essential data to be collected. Results: With the baseline result of June 2021 (n = 26; OQS = 59%), improvement rounds were performed in November 2021 (n = 29; OQS = 82%), December 2021 (n = 26; OQS = 74%), January 2002 (n = 35; OQS = 75%), February 2022 (n = 32; OQS = 78%) and March 2022 (n = 31; OQS = 79%). Conclusions: Correct data collection in medical records is essential for quality of care. Simple short-term measures based on training, feedback and reinforcement, and the creation of a data template, have increased OQS from 59% to exceed the 75% threshold required by QOPI to apply for the certification program. However, a long-term sustainable plan needs to be established through the introduction of computerized checklists in the free-text electronic medical history.