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e24093 Background: Malnutrition is a condition with great impact in oncology patients. Poor nutritional status is often associated with increased morbidity and mortality, increased toxicity and reduced tolerance to chemotherapy, among other complications. The recent GLIM criteria for malnutrition aim to homogenize its diagnosis, considering the baseline disease status. Due to the few studies that assess the predictive capacity of these new criteria, we aimed to evaluate their performance for the prediction of complications and mortality in patients with cancer. Methods: Prospective, single-centre study. All outpatients under active treatment for head and neck, upper gastrointestinal and colorectal tumors between February and October 2020 were recruited. These patients were followed up for 6 months, assessing the occurrence of complications and survival, based on GLIM diagnosis of malnutrition. Results: We enrolled 165 outpatients 46.66% malnutrition. During 6-month follow-up, patients with malnutrition (46.7%, according to GLIM criteria) had an ̃3-fold increased risk of hospital admission (p < 0.001) and the occurrence of severe infections (considered as such those requiring hospitalization, intravenous antibiotics and/or drainage by interventional procedure) during follow-up (p = 0.002). Similarly, malnourished patients had a 3.5-fold increased risk of poor pain control and a 4.4-fold increased need for a higher dose of opioids (both p < 0.001). They also had a 2.6-fold increased risk of toxicity (p = 0.044) and a 2.5-fold increased likelihood of needing a dose decrease or discontinuation of cancer treatment (p = 0.011). 6-month survival of malnourished patients was significantly lower (p = 0.023) than non-malnourished patients. Conclusions: Diagnosis of malnutrition according to GLIM criteria in oncology patients on active treatment predicts increased complications and worse survival at 6-month follow-up, making them a useful tool to assess the nutritional status of oncology patients.[Table: see text]

TPS6086 Background: Nivolumab is the standard of care for patients (pts) with R/M HNSCC in the platinum-refractory setting. Up to 20% of R/M HNSCC pts are ineligible for cisplatin-based CT due to poor performance status and/or comorbidities. ERBITAX (weekly cetuximab + paclitaxel) is a recommended regimen for this patient population according to the Spanish Society of Medical Oncology guidelines. Preclinical data suggests a role for paclitaxel as immuno-modulator, mainly by increasing tumor infiltrating CD8+ (Galluzzi L., et al 2015). NIVOTAX trial aims to evaluate efficacy and safety of nivolumab + paclitaxel vs ERBITAX as first-line treatment for R/M HNSCC pts with platinum-refractory disease or ineligible for platinum-based chemotherapy. Methods: NIVOTAX (NCT04282109) is a randomized, open-label, multicenter, phase II trial sponsored by the Spanish Group of Head and Neck Cancer Treatment (TTCC) including R/M HNSCC pts not amenable for curative-intent therapy, previously untreated for R/M disease and not candidates for cisplatin-based chemotherapy. Population is distributed in 3 Groups: 1= Platinum-refractory; 2=Platinum-sensitive but unable to receive cisplatin due to: Karnofsky performance status (KPS) 70% and/or major comorbidities (renal/heart failure, grade ≥2 hearing loss) and/or previous allergic reactions to platinum compounds; 3= Platinum-sensitive but cumulative cisplatin dose received ≥225 mg/m² for locally-advanced disease. Pt are stratified according to: KPS (70% vs 80-100%); PD-L1 by Combined Positive Score (CPS ≥1 vs < 1); and HPV positivity (HPV+ oropharynx vs HPV-/non-oropharyngeal). 141 Pt are being randomized 2:1 to NIVOTAX (nivolumab 240 mg q2 weeks + weekly paclitaxel at 80 mg/m2 up to 12 weeks followed by maintenance nivolumab 480 mg/ q4 weeks) or ERBITAX ( weekly 250 mg/m2 plus paclitaxel 80 mg/m2 up to 12 weeks followed by maintenance cetuximab 250 mg/m2 weekly). Both arms will be continued up to a maximum of 24 months. Primary end-point is to evaluate treatment efficacy in terms of 2-year overall survival (2-y OS). It is assumed that 2-y OS in the NIVOTAX arm will be at least 26% (10% gain when compared to the expected 16% 2-y OS rate in this pt population). Secondary objectives include progression free survival (PFS), overall response rate, disease control rate, duration of response, 6m PFS, 5y-OS and safety profile. Response endpoints will be assessed using RECIST 1.1 criteria. As of February 12, 2021, 64 pts have been randomized. Planned safety data review for the first 10 pts treated with NIVOTAX regimen did not show any unexpected AE. Clinical trial information: NCT04282109.

e24065 Background: Malnutrition is one of the most prevalent problems among oncological patients. It reduces the response to treatments and negatively impacts survival. In 2019, a consensus criteria for diagnosing malnutrition (GLIM criteria) were proposed by most scientific nutrition societies. The objective of our work is 1) to assess the diagnostic capacity of the GLIM criteria in ambulatory patients with cancer and 2) to compare the GLIM with the ESPEN criteria to evaluate the contributions of these new criteria with respect to the existing ones. Methods: Observational, cross-sectional, and single-center study carried out at the Medical Oncology Department in the Lozano Blesa Clinical Hospital in Zaragoza (Spain). One hundred and sixty-five outpatients with tumors in the upper gastrointestinal tract, head and neck, and colorectal locations were recruited. All of them received the MST, MUST, and Nutriscore screening tools along with the ESPEN and GLIM diagnostic criteria. Results: The prevalence of malnutrition was 46.7% according to the GLIM criteria and 21.2% using the ESPEN tool. Patients diagnosed by GLIM had a higher body mass index (BMI, 24.3 kg/m2) and muscle mass (MM, 16.1 kg/m2) than those diagnosed by ESPEN (21.2 kg/m² and 14.3 kg/m2 respectively, both p = 0.001). The MST, MUST, and Nutriscore tools had a higher degree of concordance with GLIM compared to ESPEN (MST 0.53 vs 0.26; MUST 0.36 vs 0.66; Nutriscore 0.28 vs 0.54). Conclusions: The found prevalence of malnutrition in cancer patients is higher using the GLIM instead of ESPEN criteria. This disparity can be explained at least in part by the difficulty of the ESPEN criteria for malnutrition to diagnose patients with high baseline BMI or MM. The use of criteria with greater sensitivity, such as the new GLIM criteria, could help early diagnosis and thus early intervention in cancer patients. [Table: see text]

e21052 Background: Immunotherapy is proposed as a therapeutic novelty in metastatic non-small cell lung cancer (NSCLC), in many cases already in front line. It presents different adverse effects than traditional schemes, due to the stimulation of the immune system. There is a possible relationship between toxicity and response. Neutrophil-to-lymphocyte ratio (NLR) as a possible predictive factor of response. Objectives: Evaluating the response according to the toxicity degree in NSCLC patients in real clinical practice. Analyze whether pretreatment NLR high patients have a worse prognosis. Methods: Observational, retrospective, analytical, single-center study. HCULB stage IV NSCLC patients with inmunotherapy treatment during 2016-2018. Descriptive and multivariate analysis. Toxicity grade: CTCAE version 4.0. Response assessment: RECIST 2.0 and immunorelated criteria. Toxicity degree and response (global and individualized results according to treatment and histology). Neutrophil-to-lymphocyte ratio and response. Results: N = 43 patients (35 men, 8 women). Average age 64 years. Response: 3 complete response (CR) (toxicity ≥2), 13 partial response (PR) (toxicity ≥1), 13 stable disease (SD), 12 progression (P) (only 4 toxicity and ≤2), 2 not evaluated. Hypothyroidism as the most common irAE. Relationship between toxicity and response: the absence of irAEs conditions worse prognosis p < 0.05. Histology: 25 adenocarcinoma [18 with irAES (1 CR, 7 PR, 8 SD,) and 7 without (1 SD, 5 P, 1 no ev.)]; 17 squamous [13 with irAES (1 CR, 6 PR, 4 SD) and 4 without (3 P, 1 no ev.)]; 1 adenosquamous with irAES and CR. Drug: Atezolizumab N = 8 [6 with irAES (2 PR, 3 SD, 1 P) and 2 without (both P)], Nivolumab N = 16 [9 with irAES (1 CR, 3 PR, 3 SD, 2 P) and 7 without (1 SD, 4 P, 2 no ev.)], Pembrolizumab N = 19 [17 with irAEs (2 CR, 8 PR, 6 SD, 1 P) and 2 without (both P)]. Significant positive correlation between toxicity and response (p < 0.001) R = 0.067, (CI 99% 0.378-0.837), regardless of histology and drug. It is observed a better response in those patients who presented a NRL close to 3 or less at the beginning of treatment. On the contrary, it is observed that subjects with NRL greater than 4 obtained worse results when they were treated with immunotherapy. Conclusions: The appearance of irAES like a response indicator of immune system, seem to conditione better evolution. In contrast, the absence of toxicity predicts a worse prognosis. Further studies with a larger sample are needed to confirm our findings about the predictive value of NLR and optimize therapeutic regimens if necessary.

e16080Background: Normal and pathological angiogenesis is under the control of various developmental genetic programs, including Notch and Hedgehog pathways. More recently, miRNAs have emerged as k...

e15597 Background: The IMRCC prognostic model for mRCC treated with VEGF-targeted agents (Heng, JCO '09) has been externally validated (Heng, Lancet Oncol '13), however, pt treated with Pz were not...

6037 Background: IC with docetaxel/cisplatin/fluorouracil (TPF) is superior to PF in organ preservation. Bioradiotherapy (BRT) is superior to RT alone in the loco-regional control of locally-advanc...

4578 Background: Deregulation of stem cell signaling pathways, such as Notch and Sonic Hedgehog (SHH) seems necessary for tumor initiation, maintenance and progression. Preclinical evidence support...