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The incidence of pancreatic cancer is increasing in developed countries. The incorporation of new therapies, to the first-line treatment of patients with good performance status led to better survival in clinical trials. However, there is a wide variability in their use and some concerns about the treatment of elderly patients who were not included in the clinical trials. This is a retrospective multicenter study. Data from consecutive patients diagnosed with metastatic pancreatic cancer (mPC) treated with FOLFIRINOX (FFX) or gemcitabine plus nab-paclitaxel (GnP) were analysed to evaluate efficacy (overall survival—OS) and toxicity. A total of 119 patients were included. 49.6% were treated with FFX and 50.4% with GNP in first-line. The median OS was 12 months with no statistically significant differences between both regimens (12.7 m for FFX vs 10.2 m for GnP). Elevated Ca 19.9 levels and neutrophil–lymphocyte ratio (NLR) increased the risk of death. Patients who received both regimens in first/second line had a median OS longer than 15 months whichever the sequence. 32 patients (27%) were older than 70-y. 54% patients received a second-line treatment, 56% in the FFX group and 44% in the GnP group. The median OS for patients older than 70 was 9.5 m versus 12.3 m for patients younger than 70. Progression of the disease was the cause of death in 67.6% of the patients. In our setting, the use of FFX and GnP for treating mPC is quite similar, but superiority could not be demonstrated for any of the schemes in the first line. OS was determined by basal levels of Ca 19.9 and NLR. Patients receiving both regimens in first/second line whichever the sequence, exhibited the best survival rates. In our series, elderly patients had poorer survival rates.

Background: Colitis is a frequent immune-related toxicity, without any biomarker that may predict its onset. It is endoscopically similar to intestinal inflammatory diseases, where fecal calprotectin (FC) is used as a biomarker to early-detect a relapse. We found contradictory evidence about FC and immunotherapy and no prospective study was already published. Methods: We present an analytical, observational and prospective study of one year’s duration. We analyzed FC basal, and then prior to each cycle until the sixth, ending with quarterly follow-up. For evaluating the predictive value of FC we estimated the area under the ROC curve for basal absolute values and for each cycle, and calculated its relative percentage change with respect to basal. We also planned to estimate sensitivity, specificity and predictive values indexes for different cut-off points. Because of lack of recruitment we did a preliminary analysis at the end of the initially estimated period before suggesting its prolongation. Results: 24 patients (19 male) were included in the study. This included n=15 diagnosed with lung cancer, head and neck, renal, bladder and colorectal cancer (n=2, each), and melanoma (n=1). They were treated with Anti PD-1/PDL-1 mono therapy (n=18), combo with chemo (n=2), or combo with anti-CTLA4 (n=2). Three patients had G1 colitis and two, >=G2, all treated with anti-PD1 and before 6th cycle, as described on literature. ROC curve presents AUC 0,559 (CI95%:0,32-0,798) and RR for colitis taking FC value is 1,001 for each 10 units (p=0,493). Conclusion: Even though we must take into account the limitations of the study we cannot conclude that FC could be used as a predictor for detecting immune-mediated colitis.

656 Background: Randomized clinical trials have established new chemotherapeutic standards of care for metastatic pancreatic cancer, namely FOLFIRINOX (FFX) and gemcitabine + nab-paclitaxel (GNP) after demonstrating a significant and relevant increase of overall survival. However, there are some important uncertainties regarding how many patients are candidate to each of the two new regimens in the real life and how is the pattern of use in the elderly population. Methods: This is a retrospective study. Departments of Pharmacy of 7 Spanish hospitals generated the listings of patients (pts) treated in first line with these new regimens (FFX or GNP). Non-metastatic patients were excluded. An exploratory analysis was performed in the elderly population. Results: From Jan 2012 to Dec 2017, a total of 119 pts (M/F 58/42 %) were treated. Med age 63 y (38-83 y), 99% adenocarcinoma. 40% located in the head of pancreas. ECOG 87% 0-1. 89% had liver mets. In the 1st line 49.6% were treated with FFX and 50.4% with GNP. 53% of the pts could receive a 2nd line (82% after FFX 75% after GNP). The median OS was 12 months with no statistically significant differences between both regimens (12,7m for FFX vs 10,2 m for GNP). Elevated Ca 19.9 levels and Neutrophil-Lymphocyte ratio (NLR) increased the risk of death. Patients who received both regimens in first/second line had a median OS longer than 15 months whichever the sequence. 32 patients (27%) were older than 70 yo. 13 (41%) were treated with FFX and 19 (59%) with GNP. The median OS for patients older than 70 was 9.5m versus 12.3m for patients younger than 70. Conclusions: In our setting the use of FFX and GNP for treating metastatic pancreatic cancer is quite similar. Superiority could not be demonstrated for any of the schemes in first-line. Overall survival was determined by basal Ca 19.9 and NLR. Patients receiving both regimens (FFX or GNP) in first/second line whichever the sequence, exhibited the best survival rates. In our series elderly patients had poor survival rates.

Mutational analysis of RAS is required for anti-epidermal growth factor receptor (EGFR) treatment for patients with metastatic colorectal cancer (mCRC). However, most patients with KRAS wild-type tumors still do not respond. Other molecules downstream of the EGFR may also play a role in resistance to EGFR therapies. Our objective was to investigate the clinical importance of biomarkers in relation to response, progression-free survival, and overall survival in patients with mCRC receiving first-line treatment with anti-EGFR therapy plus chemotherapy. We studied the EGFR pathway [EGFR, NRAS, BRAF, PIK3CA, phosphatase and tensin homolog (PTEN), amphiregulin (AREG), and epiregulin (EREG)] in 105 patients with mCRC KRAS codon 12 wild type. We analysed objective response, progression-free survival, and overall survival in molecularly defined subgroups of the patients receiving anti-EGFR therapy plus chemotherapy as first-line treatment. We found a significant association between RAS wild-type, BRAF wild-type, EREG, and AREG overexpression and response to anti-EGFR therapy (p = 0.003, p = 0.015, p = 0.05, and p = 0.009, respectively). Progression-free survival and overall survival were lower in patients with RAS (p = 0.36 and p ≤ 0.001, respectively) or BRAF (p = 0.003 and p = 0.002, respectively) mutant tumors. Patients with EREG and AREG messenger RNA (mRNA) expression had longer survival than those with low-expression tumors; progression-free survival and overall survival were significant for AREG (p = 0.001 and p = 0.05, respectively). Patients with EGFR amplification tumors responded better to treatment and had better survival rates, although this was not significant. PIK3CA and PTEN were not associated with either response or survival. The multivariate logistic regression model for response showed only BRAF as a significant predictor after adjustment for the other covariates (p = 0.04, odds ratio 8.3, 95 % confidence interval 0.81–86.0). RAS, BRAF, AREG, and EREG predict for efficacy of first-line anti-EGFR therapy in patients with mCRC.

Background Determining life expectancy in terminally ill cancer patients is a difficult task. We aimed to develop and validate a nomogram to predict the length of survival in patients with terminal disease. Methods From February 1, 2003, to December 31, 2005, 406 consecutive terminally ill patients were entered into the study. We analyzed 38 features prognostic of life expectancy among terminally ill patients by multivariable Cox regression and identified the most accurate and parsimonious model by backward variable elimination according to the Akaike information criterion. Five clinical and laboratory variables were built into a nomogram to estimate the probability of patient survival at 15, 30, and 60 days. We validated and calibrated the nomogram with an external validation cohort of 474 patients who were treated from June 1, 2006, through December 31, 2007. Results The median overall survival was 29.1 days for the training set and 18.3 days for the validation set. Eastern Cooperative Oncology Group performance status, lactate dehydrogenase levels, lymphocyte levels, albumin levels, and time from initial diagnosis to diagnosis of terminal disease were retained in the multivariable Cox proportional hazards model as independent prognostic factors of survival and formed the basis of the nomogram. The nomogram had high predictive performance, with a bootstrapped corrected concordance index of 0.70, and it showed good calibration. External independent validation revealed 68% predictive accuracy. Conclusions We developed a highly accurate tool that uses basic clinical and analytical information to predict the probability of survival at 15, 30, and 60 days in terminally ill cancer patients. This tool can help physicians making decisions on clinical care at the end of life.

Background: Irinotecan plus infusional 5-fluorouracil/leucovorin (FOLFIRI) is accepted as a reference treatment for the first-line treatment of patients with metastatic colorectal cancer (MCRC). The aim of this study was to demonstrate that a regimen without leucovorin (LV) (FUIRI) is not inferior to the standard FOLFIRI (response rate). Patients and methods: Chemotherapy-naive patients with MCRC were randomized to receive either irinotecan (180 mg/m(2) on day 1) + 5-fluorouracil (5-FU) (400 mg/m(2) bolus and 600 mg/m(2) 22-h infusion) + LV (200 mg/m(2) on days 1-2) (FOLFIRI) every 2 weeks or irinotecan (80 mg/m(2)) + 5-FU (2.250 mg/m(2) 48-h infusion) (FUIRI) weekly. Results: In all, 346 patients were included, 173 in each arm. In the intention-to-treat analysis, the response rates for FOLFIRI and FUIRI were 57% [95% confidence interval (CI) 49% to 64%] and 51% (95% CI 43% to 59%), respectively (P = 0.2809). No statistically significant differences were observed between FOLFIRI and FUIRI regarding median progression-free survival (8.3 versus 8.4 months; P = 0.4339) nor median overall survival (21.6 versus 19.2 months; log-rank test P = 0.2941). Grade 3/4 neutropenia was significantly more frequent on FOLFIRI arm (27% versus 9%), while the proportion of diarrhea was higher on FUIRI arm (21% versus 42%). Conclusion: FUIRI represents a valid alternative without LV to the FOLFIRI regimen as MCRC first-line treatment.

Background: This observational study evaluated the efficacy and safety of treatment with bevacizumab plus chemotherapy until disease progression (PD) in Spanish patients with metastatic colorectal cancer (mCRC). Methods: This multicentre, retrospective, observational analysis included patients receiving bevacizumab plus fluoropyrimidine-based chemotherapy as first-line treatment for mCRC who then developed PD. All patients received treatment in hospital oncology departments and none received bevacizumab as part of a clinical trial. Patients discontinuing treatment with bevacizumab for reasons other than PD were excluded. The primary endpoint was PFS; secondary endpoints were overall response rate (ORR) and safety. Results: Overall, 165 patients were evaluable for analysis: median age 63.0 years; male/female 62%/38%; ECOG performance status 0/1/2 55%/43%/2%. Median duration of bevacizumab treatment was 8.7 months. ORR was 48.5% (6 complete and 74 partial responses) and disease control rate was 74%. Median progression-free survival (PFS) was 8.4 months (95% CI 7.2-9.6). Patients receiving oxaliplatin- or irinotecan-based regimens had median PFS of 9.2 and 7.7 months, respectively; those receiving treatment not containing either oxaliplatin or irinotecan had a median PFS of 6.1 months. KRAS status did not have a statistically significant effect on PFS (9.5 vs. 7.8 months for KRAS wild-type vs. mutant tumours, respectively; p=0.647) or ORR (44.8% vs. 52.6%, respectively; p=0.391). The most common grade 3/4 adverse events were: diarrhoea (7%), paraesthesia (7%), neutropenia (3%), cutaneous toxicity (2%), and thrombocytopenia (2%). Conclusions: Treatment with bevacizumab plus standard chemotherapy is an effective and well-tolerated option for patients with mCRC who continue treatment until PD.

e14656 Background: The RECIST criteria may be limited in assessing response to biologic agents such as bevacizumab (BVZ). Retrospective studies of patients (pts) with colorectal liver metastases (C...

e14648 Background: Fluoropyrimidines (FP) based chemotherapy continue to be the cornerstone of advanced colorectal cancer (aCRC) treatment. However, FP cannot be appropriated for some patients (FP intolerance, DPD deficit, history of ischemic heart disease, etc). In these cases, Raltitrexed (R) in monotherapy or in combination with oxaliplatin (TOMOX) could be an effective alternative to FP. Methods: We assessed in an observational retrospective study the patient profile and the tolerability of R when it is used in monotherapy or in combination with oxaliplatin (TOMOX) as aCRC treatment in the normal clinical practice setting. Data from patients treated between 2010 and 2012 were collected from 15 Spanish hospitals. Reason for choosing R as aCRC treatment, patient and disease characteristics, previous treatment and toxicity were gathered. Results: The data from 144 patients treated with R (72) and TOMOX (72) were included in the analysis (64% male, median age 68 years, ECOG PS 0/1/2 in 18%/62%/19%). The main reasons to choose R were: similar efficacy and safety to other treatments (19%), convenience of the administration (18%), cardiovascular disease (17%), resistance to FP (14%), previous FP inacceptable toxicity (10%) and old age (11%). R was mainly used as third or successive treatment line (64%) while TOMOX was equally used in all treatment lines (37%, 28% and 35%). The mean number of cycles was 5 (1-15). The dose was reduced in 26% of the patients and the treatment administration was delayed in 53%. The creatinine clearance was only calculated in 20% of the cycles. The most common grade 3-4 toxicities were neutropenia (8%), anaemia (5%), nausea (2%), vomiting (1%), diarrhoea (7%) and hepatic toxicity (4%). There were 2 toxic deaths (1.4%). Conclusions: R and TOMOX represent a safe alternative for aCRC patients in which FP are not appropriated. Despite R good tolerance in normal clinical practice, it is a must to assess creatinine clearance before each cycle.

9595 Background: Determining an accurate prognosis for terminally ill cancer patients is one of the biggest challenges that confronts a physician. Correct predictions can be done in only 20–40% of all cases. Although the current prognostic scales are helpful, they have significant limitations. Our objective consists of determining the potential indicators that influence the survival of these patients and develop and validate a new predictive model. Methods: A prospective, multicentric and observational study was conducted in 880 terminally ill cancer patients. At first, 40 clinical, demographic and laboratory variables were recorded in 406 patients. A forward stepwise regression method was applied for the multivariate survival analysis. Hence, a predictive model was constructed. Subsequent validation was performed in 474 patients. Results: Median age was 66.4 years (range 18–95). The median overall survival was 21 days in the first 406 patients studied and 19 days in the validation group. A prognostic model with 9 variables was constructed (age, ECOG, the amount of time between initial diagnosis up to being considered terminal phase, nauseas, anorexia, cognitive impairment, lymphocytes, LDH and albumin). Afterwards, to simplify the model, 4 variables that were considered more objective and with greater Odds ratio were selected and assigned one point per each prognostically poor category. We obtained a survival model that discriminates 3 prognostic categories: Good prognoses (score 0) with a median survival of 95 days (44–146), intermediate prognoses (score 1–2) with a median survival of 33 days (26.8–39.2) and bad prognoses (score 3–4) with a median survival of 15 days (11.1–18.9). In the validation group, median survival times were 60 (47.1–72.8), 27 (22.8–31.1) and 11 days (9.2–12.7) respectively. Conclusions: We propose a predictive score model that is objective and easy to use to help in accurately predicting life expectancy in terminally ill cancer patients. Its effectiveness has been validated in a group of independent centers. No significant financial relationships to disclose.

15074 Background: XELOX [Oxaliplatin (Oxa) 130 mg/m2 plus Capecitabine (Cape) 1000 mg/m2 bid d1–14, every 3 weeks] with Bevacizumab (Bev) in patients (pts) with mCRC have been previously reported a...

5167 Background: One-third of epithelial ovarian cancer (EOC) patients (pts) present with localized disease and have a 50–70% ten-year survival. Prognostic factors and adjuvant strategies have been...