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The aim of this study was to describe clinical and survival characteristics of transplant-eligible multiple myeloma (MM) patients in Latin America (LA), with a special focus on differences between public and private healthcare facilities. We included 1293 patients diagnosed between 2010 and 2018. A great disparity in outcomes and survival between both groups was observed. Late diagnosis and low access to adequate frontline therapy and ASCT in public institutions probably explain these differences. Patients treated with novel drug induction protocols, followed by autologous stem cell transplantation (ASCT) and maintenance, have similar overall survival compared to that published internationally.

Background: In recent years, abundant scientific evidence has been generated based on clinical trials (CT) in the field of oncology. In spite of this, there are still major disagreements among the group when it comes to establishing a treatment and therapies for these kinds of patients. The general objective of this paper is to find out the extent to which decision-making is based on knowledge of the most recent CT. Its specific objectives are to pinpoint difficulties with decision-making based on the CT performed and find out the motivations patients and clinicians have when taking part in a CT.Methodology: Combined, prospective study, based on the Delphi method.Results: A lack of correspondence between the people who take part in CT and patients who come for consultation has been identified. Healthcare professionals' motivations for taking part in a CT include finding better treatment for the patient and boosting their research career. A need for training in analysing and interpreting CT has also been identified and a lack of trust in the results of CT financed by the pharmaceutical industry itself has been perceived. Conclusion: There is a difficulty in selecting oncological treatment due to the lack of correspondence between the patients included in the CT and patients seen in consultation. In this process, real world data studies may be highly useful, as may be providing this group with greater training in interpreting CT and their results. Aiding the professional progression of their research career is an incentive for clinicians to participate in a CT.

Aims: To obtain real-world data on ramucirumab use and effectiveness for the treatment of advanced gastric cancer (AGC) or gastroesophageal junction adenocarcinoma (GEJ). Methods: Observational, retrospective study carried out in 20 Spanish hospitals, in patients who started ramucirumab treatment between December 2015 and December 2018. Descriptive analysis was conducted for patient characteristics, treatment patterns and effectiveness outcomes. Results: Three hundred seventeen patients were included (93.7% treated with ramucirumab-paclitaxel and 6.3% with ramucirumab); age 62.5 (11.3) years; 66.9% male. Median progression-free survival and overall survival were 3.9 months (95% CI: 3.4–4.3) and 7.4 (95% CI: 6.4–8.9) in combination regimen and 2.0 (1.1–2.8) and 4.3 (95% CI: 1.9–7.3) in monotherapy, respectively. Conclusion: The study findings were consistent with available real-world studies and randomized clinical trials.

Objective and Outcomes Measures: Our aim was to characterize the population of patients diagnosed with AML who were attended in 7 health institutions in Colombia, from 2009 to 2020, included based on RENEHOC (online platform) and PETHEMA (Spanish Program for Hematology Treatments). Kaplan-Meier analysis was used to assess overall survival at 1 year (1-OS) and 5 years (5-OS) of follow-up and relapse-free survival (1-RFS, 5-RFS). Results: A total of 289 patients were included; almost half (50.2%) were female, and the median age at diagnosis was 62 years old (14–95). Most patients were ECOG 1 (39.3%) and ECOG 2 (38.8%). The patients (12.5%) presented with secondary AML, and 0.3% had hereditary predisposition syndromes to AML (Down syndrome). Complete remission was achieved in 45.0% of patients, 17.8% absolute resistance, and 13.6% patients died in induction, the majority after day 15 (66.7%). Most of the patients received intensive chemotherapy 7+3 induction regimen (55.8%). Hematopoietic stem cell transplantation (HSCT) was a treatment option for 21.2% of patients, and 77.4% met criteria for HSCT. Allogeneic HSCT (alloTPH) was performed in 19% and autologous HSCT (autoTPH) in 2.2%. The survival at 1-OS and 5-OS was 56.1% (95%CI 48.0–63.4) and 26.7% (95%CI 18.1–36.1), respectively. The RFS was 56.6% (95%CI 48.4–64.0) at 1-year and 22.2% (95%CI 14.0–31.6) at 5-years. For patients younger than 65 years ( Conclusion: Our results also show AML in an older population and that age is associated with shorter survival. We identified a low proportion of AlloHSCT, despite the survival benefit compared to non-transplant patients.

Context The most frequently used induction treatments for newly diagnosed multiple myeloma in Colombia are VTD and CyBorD for transplant-eligible patients. Objective At present, there are no clinical studies in our region that compare the effectiveness of these two regimens. Design To reduce the bias between the groups, we performed a 1:1 propensity score matching (PSM) technique for analysis. Setting The Registro Epidemiologico de Neoplasias Hematologicas en Colombia (RENEHOC) collected data electronically on Colombian patients with multiple myeloma between 2010 and 2018. Patients or Other Participants After pairing using PSM by nearest neighbor, a total of 448 patients, 224 in each group, were identified. Patients in the two groups were matched for age, sex, myeloma type, international staging system stage at diagnosis, kidney injury, dialysis, extramedullary involvement, and transplantation. Interventions None. Main Outcomes Measures Overall response rate and overall survival. Results In the unpaired model, statistically significant differences were shown in age, which was corrected after running the PSM. In all the variables used for the model, no differences were shown between the two groups. The VTD regimen tends to be favored 73.47% vs 63.68% p = 0.061 in the unpaired model; however, when the analysis is made after the PSM, the differences dissipate and become non-significant 68.75% vs 73.66% p = 0.565. There were no statistically significant differences for complete response or very good partial response. We did an overall survival analysis for each regimen whether or not they had undergone transplantation. The median overall survival in the transplanted VTD group was 34 months IQR (20–54) and in VTD not taken to transplantation, it was 8 months IQR (5–17) p Conclusions VTD or CyBorD were equally effective in terms of response and survivability in real world practice. Overall survival was adversely affected when patients did not undergo autologous bone marrow transplantation, regardless of the regimen used in induction.

[Purpose] To evaluate the health-related quality of life (HRQoL), global health status (GHS), and deterioration-free survival of an elderly population (> 70 years) with unresectable locally advanced (LAPC) or metastatic pancreatic cancer (mPC) treated with nab-paclitaxel in combination with gemcitabine., [Methods] In this open-label, single-arm, multicenter, phase II trial, patients received 4-week cycles of intravenous (i.v.) nab-paclitaxel at a dose of 125 mg/m2, followed by i.v. injections of gemcitabine at a dose of 1000 mg/m2 on days 1, 8 and 15 until disease progression or unacceptable toxicity was observed. The primary outcome was the HRQoL (deterioration-free rate at 3 months as evaluated with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30., [Results] Eighty patients (median age: 74.6 years) were enrolled (56 with mPC, 24 with LAPC). The percentage of patients who had not experienced deterioration at 3 months was 54.3% (95% CI 41.6–67.0%). The median (interquartile range) time until definite deterioration was 1.6 (1.1–3.7) months. The objective response rate and clinical benefit rate were achieved by 11 (13.8%, 95% CI 6.2–21.3%) and 54 patients (67.5%, 95% CI 57.2–77.8%), respectively. The median overall survival was 9.2 months (95% CI 6.9–11.5), and the median progression-free survival was 7.2 months (95% CI 5.8–8.5). Only fatigue and neutropenia demonstrated a grade 3–4 toxicity incidence > 20%., [Conclusions] Our study confirms the clinical benefit of the combination of nab-paclitaxel and gemcitabine in an elderly population with pancreatic cancer in terms of improved survival and clinical response. However, we were unable to confirm a benefit in terms of quality-of-life., The BIBABRAX study was funded by Celgene. Medical writing assistance in the preparation of this paper was provided by Apices with financial support from Celgene.

This is a post hoc analysis of biomarkers from a large cohort of patients with chemo-naive metastatic colorectal cancer. Both high baseline circulating tumor cell count and RAS mutated were associated with clinical or pathologic features classically associated with poor prognosis. Selection of high- and low-risk populations may help to individualize approaches in the future. Background: Clinicopathologic characteristics and prognostic and predictive factors offer valuable guidance when selecting optimal first-line treatment in patients with metastatic colorectal cancer (CRC). The association between baseline circulating tumor cell (bCTC) count, molecular tumor profile, and clinicopathologic features was analyzed in a chemo-naive metastatic CRC population. Patients and Methods: A total of 1202 patients from the Spanish VISNU-1 (FOLFIRINOX/bevacizumab vs. FOLFOX/bevacizumab) and VISNU-2 (FOLFIRI/bevacizumab vs. FOLFIRI/cetuximab; RAS-wildtype) studies were analyzed for mutational status and bCTC count. The association between clinicopathologic characteristics and bCTC count, mutational status, and microsatellite instability (MSI) was analyzed in 589 eligible patients. Results: Interestingly, 41% of the population studied presented >= 3 bCTC count. bCTC count >= 3 was associated with worse performance status (according Eastern Cooperative Oncology Group scale), stage IV at diagnosis, at least 3 metastatic sites, and elevated carcinoembryonic antigen (CEA) levels; but not with RAS or BRAF mutations or high MSI. BRAFmut (BRAF mutated) tumors were associated with right-sided primary tumors, peritoneum, distant lymph node metastasis, and less frequent liver involvement. RASmut (RAS mutated) was associated with worse performance status; stage IV at diagnosis; right-sided primary tumors; liver, lung, and bone metastases; at least 3 metastatic sites; and elevated CEA, whereas PIK3CAmut (PIK3CA mutated) tumors were associated with right-sided primary tumors, high CEA serum levels, and older age. High MSI was associated with right-sided primary tumors, distant lymph nodes metastasis, and lower CEA levels. Conclusions: In our study, elevated bCTCs and RASmut were associated with clinicopathologic features known to be associated with poor prognosis; whereas the poor prognosis of BRAFmut tumors in chemo-naive metastatic CRC is not explained by associations with poor clinicopathologic prognostic factors, except right-sided primary tumors. (C) 2020 Elsevier Inc. All rights reserved.

The land node (also called wireless or cableless) seismic acquisition revolution hit North America in 2008-2009 and very quickly proved to be a technical and economic success. The rationale for the choice to use wireless rather than cable systems has been presented in numerous publications and venues (e.g., Caldwell, 2010; Mougenot et al., 2014; Munoz et al., 2015; Uribe et al., 2016; Yates et al., 2016; Dean et al., 2018), so suffice it to say that increased productivity, reduced costs, comparable or better data quality, and reduced health, safety, and environmental (HSE) risks have catalyzed its acceptance by the industry, particularly in North America, but also in Europe. Furthermore, the wireless systems are evolving to address what some have perceived as the inherent weaknesses of these systems: the inability to provide sufficient information in real-time about the status of the live spread of receiver stations, and to deliver in real-time substantial amounts of seismic data. It has taken longer for wireless systems to make significant inroads in other places in the world outside of North America, but that has been in the process of changing over the last few years. One place in particular where that has been changing is South America. In a geographic area where seismic activity has not been that strong over the last 5-6 years, at least 23 seismic surveys (9 2D and 14 3D) have been acquired since the beginning of 2011 using wireless acquisition systems. This paper describes how quality checking (QC) during acquisition operations was accomplished for a node system (Geospace GSX) used to acquire two 3D surveys by SAExploration for Hocol in Colombia in 2016 and 2017.

Background Proteasome inhibitors (PIs) are approved for treating newly diagnosed and relapsed multiple myeloma (MM) in Colombia. This propensity score matching (PSM) analysis using data from the real-world, was designed to establish the role PIs (bortezomib or carfilzomib) at first relapsed or refractory MM. The primary endpoint was overall response rate (ORR) and secondary endpoint included was overall survival (OS). Moreover, an analysis of OS was done regarding response attained. On Behalf of RENEHOC-GRIMMCO (Colombian Registry for Hemato-Oncological Diseases and Colombian Mieloma Múltiple study group). Methods PSM by nearest neighbor analysis to evaluate the role of PIs used at first relapse in multiple myeloma of patients belonging to RENEHOC registry, between 2010 and 2020. Results 390 patients were identified in the first relapse of the Colombian registry, 269 patients with PI and 121 patients without PI. One hundred and ten patients were included in each group after PSM. Patients were matched for age, ISS, extramedullary disease, and use of lenalidomide to define the influence of this immunomodulatory drug in the PI group. A difference was found in the use of lenalidomide because only 1 patient was treated with PI and lenalidomide concomitantly (0.91%) compared to 31 patients in the group without PI (28.18%), (p Regarding ORR, no differences were found between the 2 groups 38.18% in PIs vs 37.27% in non-PIs group (p = 0.801). A trend towards better OS was found in the PIs group with a median of 58 months versus 39 months (p = 0.179). Overall survival in patients who achieved at least PR was better compared to those who did not reach 79 months versus 32 months in non-responders (p = 0.0001). Conclusion In this study, we found that the use of PI has a tendency to improve overall survival in real-world in MM patients when used in the first relapse and that this effect could possibly be enhanced with the combination with lenalidomide. Regardless of the treatment used, better responses are associated with better survival. Figure 1 Figure 1. Disclosures Abello: Janssen: Honoraria; Amgen: Honoraria; Dr Reddy's: Research Funding. Sossa: Amgen: Research Funding.

Context: Tyrosine kinase inhibitors (TKIs) dramatically changed outcomes in CML; achieving and maintaining treatment milestones is highly dependent on adherence. Colombia subscribes a principle of universal health coverage; however, there is significant difference in access to high-cost drugs between different insurance types (Subsidized [SS] vs Contributory [SC]). Objective: To describe the current patient management and outcomes of CML in Colombia and possible factors associated with outcomes. Design: ACHO’s hematological disease registry (RENEHOC) is a multicenter study that has collected information on CML patients since 2019. Setting: RENEHOC is a real-world registry that captures information from 16 academic and general community centers in 5 cities in Colombia. Patients or Other Participants: Adult CML patients. Interventions: Due to its observational nature, all treatment decisions depend on treating investigator preferences. Main Outcomes Measures: RENEHOC is an online database. This report summarizes data on CML patients as of May 2020, focused on general descriptive statistics. The Kaplan-Meier method was used to assess progression free survival (PFS) rates, defined as progression to AP/BP or death. Hazard ratios (HR) using Cox proportional hazards regression modeling were estimated. Results: A total of 442 patients have been registered with a median follow-up of 60 months (IQR 26.5–106.5). At diagnosis, mean age was 54 years (SD 15.23), 58.6% (259) were males, most patients were in chronic phase (92.3%) and most had intermediate or high risk Sokal (35.6% and 36%, respectively). Median time from symptoms to diagnosis was 4 weeks (IQR 1–11), with no difference between SS and CS (p=0.54) and from diagnosis to treatment 4 in SS vs 0 in CS (p=0.041). Imatinib was the first-line treatment in 62.9%, dasatinib in 20%, and nilotinib 15%. Median OS and EFS were 60 (IQR 26.5–106.5) and 51 months (IQR 21–91), respectively. Only 7 (2.5%) patients died; all deaths were CML-related. Type of insurance (median EFS 51 CS vs 38.5 months SS; p=0.04), phase at diagnosis (p=0.039), and achieving MMR with first-line were the only factors related with EFS. Conclusions: OS for CML is excellent (97.5%) in Colombian patients. Unequal treatment between insurance types appears to have an impact on outcomes, which has to be addressed.

Aim: RENEHOC (Registro Epidemiológico de Neoplasias Hematológicas en Colombia) is a multicenter clinical quality database established in January 2018. The primary aim of the database is to provide local information on diagnosis and treatment of Multiple Myeloma (MM) and other hematologic neoplasms; this is key to show authorities the improvements that must be made to achieve better outcomes for Colombian patients and pose research questions relevant to our population. The aim of this report is to analyze variables related to event free survival (EFS) and overall survival (OS) in MM Colombian patients. Study population: An ambispective registry of adult MM patients, treated in approved centers over the last 10 years in Colombia. As of July 2020, 890 patients have been registered. Descriptive statistics were used for patient's demographic and clinical characteristics. The Kaplan-Meier method was used to assess DFS and OS. Hazard Ratios (HR) using Cox proportional hazards regression modeling was estimated. Results: Data from 890 MM patients were reviewed. Median age at diagnosis was 66.8 (SD 11.17) years (TE 57 yrs., SD 6.71; TI 74.8 yrs., SD 6.87); 398 (57%) were TE; 52.9% were male. At diagnosis median hemoglobin was 10.1 (SD 2.5), 242 (27.2%) had renal failure, and 379 (42.6%) pathological fractures. IgG was the most common M component (n=328, 36.8%). Most patients were in an advanced stage by Durie Salmon at diagnosis (DS IIIA or IIIB: n=523, 77.4%), and had high risk ISS (ISS 1: n=128, 20.6%; ISS 2: n=180, 29.0%; ISS 3: n=312, 50.3%; NA n=270). Only 17,9% (n=160) had cytogenetic prognostic characterization. There were not significant differences in clinical characteristics at diagnosis between TE and TI patients. The most common induction regimen for TE were Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) (n=190, 49%) and Bortezomib-Thalidomide-Dexamethasone (VTD) (n=103, 27%). For TI patients, most common regimens in first line were CyBorD (n=111, 245), VTD (n=90, 19%) and Bortezomib-Dexamethasone (Vd) (n=84, 18%). 69% TE and 59% TI patients had partial response or better after first line. 41% of TE patients actually received an Autologous Stem Cell Transplantation (ASCT) after 1 line. 19% of TI patients received an ASCT. Of note, in 78% of patients considered to have indication not taken to transplant, administrative barriers of access are reported. Mean follow-up for the entire group was 28.35 months (SD 29.27, CI 26.41-30.29). The median DFS was 62 months being significantly longer in TE patients (74 vs 53 months for TI, p=0.0002), estimated 5 years DFS 52% (TE 56% vs 46% for TI). Median OS was 88 months (Not reached for TE vs 75 moths for TI, p=0.0001), estimated 5 years OS 62% (TE 70% vs 56% for TI). Univariate analysis showed ISS at diagnosis, age and ASCT were significantly related to OS. On multivariate analysis ISS 3 (HR 1.89; p=0.004; CI 1.22-2.93) at diagnosis and ASCT (HR 0.26, p=0.0001, CI (0.18-0.39) were the only factors significantly associated with OS. 5 yrs. OS for patients that received ASCT was 80% in comparison to 48% if not done. Conclusion: At this timepoint data from RENEHOC is still limited, however, the potential of this growing registry is evident; until now little information about hematologic neoplasms in Colombia was available, this effort allows us to know the reality of our patients and plan relevant trials in our settings. We report here characteristic of a large cohort of MM patients in Colombia. OS and DFS are comparable with what have been published for similar patients in other latitudes. Consolidation with ASCT was the most important factor affecting prognosis in this cohort; the low transplant rate has to be addressed to improve outcomes for myeloma patients in Colombia. Figure Disclosures Abello: Abbvie: Consultancy, Research Funding; Dr. Reddy's: Consultancy, Research Funding; Takeda: Honoraria, Research Funding; Amgen: Consultancy, Research Funding; Novartis: Consultancy, Honoraria. Sossa:Takeda: Honoraria; Novo: Honoraria; Astellas: Honoraria; Roche: Honoraria. Idrobo:Takeda: Honoraria, Speakers Bureau; Abbvie: Honoraria, Speakers Bureau; Janssen: Honoraria, Speakers Bureau; Tecnofarma: Honoraria, Speakers Bureau; Amgen: Honoraria, Speakers Bureau. Henao-Uribe:Alexion: Consultancy, Speakers Bureau; Pfizer: Speakers Bureau; Takeda: Consultancy, Speakers Bureau.

Context Adherence is a key factor for good outcomes in CML. There are two types of insurance in Colombia: Contributory (CS) and Subsidized Systems (SS), which provide highly unequal access to Tyrosine Kinase Inhibitors (TKI) for CML. Objective The aim of this report is to compare outcomes in patients with different access to TKI and analyze other factors that affect progression-free survival (PFS). Design The Colombian Association of Hematology and Oncology (ACHO)'s hematological disease registry (RENEHOC) is a multicenter study; it has collected information on CML patients since 2019, in 14 centers with institutional Ethics Committee approval. Setting RENEHOC is a real-world registry and captures information from academic and general community centers. Patients or other participants 357 CML adult patients treated in the last 20 years. Interventions Treatment was according to investigators' preferences. Imatinib was first-line treatment for 223 patients (62.4%), dasatinib for 69 (19.4%) and nilotinib 53 (14.8%); 47.9% required a second line of treatment. Main outcome measures Primary end points were Optimal Response (OR) according to LeukemiaNet 2020 definition and progression-free survival (PFS) rates. The Kaplan-Meier method was used to assess PFS, and hazard ratios (HR) using Cox proportional regression modeling were estimated. Results Mean age was 54 years (19–92), 60.1% were males, most patient were diagnosed in chronic phase (92%) and 36% were high Sokal. At a median follow for the entire cohort of 69 months (1–228), 60% of patients were in OR, including 11 patients in treatment-free remission (TFR). There were no significant differences between contributory and subsidized cohorts in terms of patient or disease characteristics. 76% of patients were in OP at the last visit in the CS in comparison to 48% for the SS cohort. Ten patients died, all CML-related. The only significant prognosis factors associated with PFS were Sokal score (mean PFS: 57 months low/int vs 39 high; p=0.012) and type of insurance (mean PFS 70 months for CS vs 57.7 for SS; p=0003). Conclusions This report suggests that differences in access to TKI in CML according to insurance regimes results in significantly different PFS. This is the first time in the country that the impact of these attention inequalities in CML patient care have been demonstrated. Funding ACHO has received grants for RENEHOC project from Takeda, Abbvie, Amgen, Dr. Reddy's.

Acute leukemia is a heterogeneous set of diseases affecting children and adults. Current prognostic factors are not accurate predictors of the clinical outcome of adult patients and the stratification of risk groups remains insufficient. For that reason, this study proposes a multifactorial analysis which integrates clinical parameters, ex vivo tumor characterization and behavioral in vivo analysis in zebrafish. This model represents a new approach to understand leukemic primary cells behavior and features associated with aggressiveness and metastatic potential. Xenotransplantation of primary samples from patients newly diagnosed with acute leukemia in zebrafish embryos at 48 hpf was used to asses survival rate, dissemination pattern, and metastatic potential. Seven samples from young adults classified in adverse, favorable or intermediate risk group were characterized. Tumor heterogeneity defined by Leukemic stem cell (LSC) proportion, was performed by metabolic and cell membrane biomarkers characterization. Thus, our work combines all these parameters with a robust quantification strategy that provides important information about leukemia biology, their relationship with specific niches and the existent inter and intra-tumor heterogeneity in acute leukemia. In regard to prognostic factors, leukemic stem cell proportion and Patient-derived xenografts (PDX) migration into zebrafish were the variables with highest weights for the prediction analysis. Higher ALDH activity, less differentiated cells and a broader and random migration pattern are related with worse clinical outcome after induction chemotherapy. This model also recapitulates multiple aspects of human acute leukemia and therefore is a promising tool to be employed not only for preclinical studies but also supposes a new tool with a higher resolution compared to traditional methods for an accurate stratification of patients into worse or favorable clinical outcome.

Introducción: El síndrome metabólico (SM) es un problema de salud asociado a diabetes y enfermedades cardiovasculares. Se desconoce la prevalencia de SM en adolescentes del estado de Morelos. Ciertas conductas alimentarias de riesgo podrían estar asociadas a ese fenotipo.Objetivo: Determinar la prevalencia de SM en adolescentes y su asociación con las conductas alimentarias de riesgo.Métodos: Estudio transversal en escuelas secundarias y preparatorias de Morelos. Se investigaron datos antropométricos, clínicos, percepción de la imagen corporal y de conductas alimentarias de riesgo (CAR). El síndrome metabólico se diagnosticó con criterios internacionales para adolescentes y se analizó su asociación con las CAR. Mediante análisis de regresión logística se estimaron razones de momios ajustadas e intervalos de confianza al 95%.Resultados: Fueron estudiados 869 adolescentes de 14.6 ±1.6 años. Reportaron 2.6±1.8 CAR, el puntaje global fue 5.9 ± 0.33. El 16.6% presentaban riesgo CAR moderado o alto. La prevalencia de SM (6.4%) estuvo asociada al puntaje de CAR, OR 1.2 (1.1 - 1.3), valor que permaneció después de ajustar por edad, sexo, omisión del desayuno, región de residencia, percepción de la imagen corporal y de antecedentes familiares de obesidad, diabetes, hipertensión o infarto (ODHI), ORaj 1.2 (1.1- 1.3), pseudo R2= 0.14, Chi2 47.2, p

Background: Treatment with nab-paclitaxel plus gemcitabine increases survival in patients with metastatic pancreatic cancer. However, the assessment of treatment efficacy and safety in non-selected patients in a real-life setting may provide useful information to support decision-making processes in routine practice. Methods: Retrospective, multicenter study including patients with metastatic pancreatic cancer, who started first-line treatment with nab-paclitaxel plus gemcitabine between December 2013 and June 2015 according to routine clinical practice. In addition to describing the treatment pattern, overall survival (OS) and progression-free survival (PFS) were assessed for the total sample and the exploratory subgroups based on the treatment and patients' clinical characteristics. Results: All 210 eligible patients had a median age of 65.0 years (range 37-81). Metastatic pancreatic adenocarcinoma was recurrent in 46 (21.9%) patients and de novo in 164 (78.1%); 38 (18%) patients had a biliary stent. At baseline, 33 (18.1%) patients had an ECOG performance status =2. Patients received a median of four cycles of treatment (range 1-21), with a median duration of 3.5 months; 137 (65.2%) patients had a dose reduction of nab-paclitaxel and/or gemcitabine during treatment, and 33 (17.2%) discontinued treatment due to toxicity. Relative dose intensity (RDI) for nab-paclitaxel, gemcitabine, and the combined treatment was 66.7%. Median OS was 7.2 months (95% CI 6.0-8.5), and median PFS was 5.0 months (95% CI 4.3-5.9); 50 patients achieved either a partial or complete response (ORR 24.6%). OS was influenced by baseline ECOG PS, NLR and CA 19.9, but not by age = 70 years and/or the presence of hepatobiliary stent or RDI < 85%. All included variables, computed as dichotomous, showed a significant contribution to the Cox regression model to build a nomogram for predicting survival in these patients: baseline ECOG 0-1 vs. 2-3 (p = 0.030), baseline NLR > 3 vs. = 3 (p = 0.043), and baseline CA 19.9 > 37 U/mL vs. =37 U/mL (p = 0.004). Conclusions: Nab-Paclitaxel plus gemcitabine remain effective in a real-life setting, despite the high burden of dose reductions and poorer performance of these patients. A nomogram to predict survival using baseline ECOG performance status, NLR and CA 19.9 is proposed.

Background Multiple myeloma (MM) is a heterogeneous disease that is most frequently diagnosed in the elderly. Therefore, data on clinical characteristics and outcomes in the young population are scarce and it is recognized that it remains incurable even in this group of patients. We present here the outcomes of patients under 40 years old cohort in Latin-American countries. On behalf of GELAMM (Grupo de Estudio Latino-Americano de Mieloma Múltiple). Methods Retrospective international multicenter cohort study. We analyzed MM patients under 40 years old who received treatment in 6 Latin-American countries, between 2010 and 2018. Demographics and disease features were analyzed using descriptive statics. We examined treatment characteristics and response rates. The overall survival (OS) of the entire cohort was analyzed using Kaplan-Meier curves. Results Eighty-six patients of 6 countries were analyzed (Table1). The mean age was 35.4 years old, and 60% were male. The most frequent monoclonal component type was IgG followed by light chain MM. Risk determined by ISS was distributed in almost equal percentages. The most frequent cytogenetic alteration was the t (4;14) that was found in four patients out of 25 evaluated. The missing data were greater than 70%. Skeleton-related events were the most frequent clinical feature, followed by anemia and renal failure. Plasmacytomas and fractures were present in more than 20 percent of cases. With regard to treatment, VCD / CyBorD was the most used regimen, followed by VTD. The overall response rate (ORR) was 63%. Fifty-three patients received high dose therapy and autologous stem cell transplantation (62%). Only 8% received post-transplant consolidation, and 45% received maintenance therapy. The median OS of the entire cohort was 45 months, and a plateau in the survival curve was not observed, suggesting that patients continue relapsing over the time. Conclusion In this Latin American multicenter study, we found that the young population with MM has similar presentation characteristics to those of elderly patients. A significant amount of information is lost regarding the risk characterization, especially in regard with cytogenetics. With respect to treatment, less than half of the patients achieve very good partial response or better. It is striking that more than a third of this young patients did not access to high doses of chemotherapy and bone marrow transplantation. Maintenance therapy is offered to less than half patients. The median OS is lower than in other series of patients younger than 40 years, even than in the elderly cohorts. Prospective multicentric studies are required to elucidate the behavior of the disease in this group of patients. Disclosures Peña: Pfizer: Membership on an entity's Board of Directors or advisory committees; Janssen: Other: Congress inscription and flights; Biotoscana: Other: Congress inscription and flights; Novartis: Other: Congress inscription and flights; Tecnofarma: Other: Congress inscription and flights; Roche: Other: Congress inscription and flights. Rojas:Novartis: Membership on an entity's Board of Directors or advisory committees; Pfeizer: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees. Abello:Takeda: Other: Participation in advisory board meeting. Gomez-Almaguer:Takeda: Consultancy, Speakers Bureau; Celgene: Consultancy, Speakers Bureau; Amgen: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau; Teva: Consultancy, Speakers Bureau.

Background Multiple myeloma (MM) is a frequent hematologic malignancy. The current gold standard frontline strategy includes a proteasome inhibitor (PI)-based induction, followed by autologous stem cell transplant (ASCT). Access to novel drugs in Latin America (LA) is limited. ASCT is available in most countries, but real access to it is highly heterogeneous. Data regarding patients´ outcomes in candidates to ASCT in the region is scarce. The aim of this study was to describe clinical characteristics and outcomes of MM transplant eligible patients in LA countries. Material and Methods Retrospective international multicenter cohort study. Consecutive MM transplant- eligible patients diagnosed between 2010 and 2018 from participating centers in Chile, Argentina, Ecuador, Mexico, Colombia, and Uruguay were included. Data were collected from clinical records in a standardized report form. We analyzed clinical characteristics at diagnosis and frontline therapy outcomes, including ASCT. Transplant-eligible patients were defined as fit patients younger than 66 years old. Active MM and response to treatment were defined according to current IMWG criteria. Inclusion criteria: 1.- Patients with newly diagnosed active MM between 2010 and 2018. 2.- Older than 18 years, and younger than 66 years. 3- Candidates for ASCT according to the evaluation of the attending physician Exclusion criteria: 1- Lack of minimum data in the clinical history 2- Plasma cell leukemia, AL amyloidosis or solitary plasmacytoma. 3- HIV infection 4-No consent and/or Ethics Committee approvals. Statistical analysis A descriptive statistic has been done. Comparisons of characteristics between groups was made usingT-student, Chi2 or ANOVA, as appropriate. Survival analysis was performed using Kaplan-Meier curves. Comparisons of survival between groups were made by the logarithmic recording method and the calculations of the risk relationships by Cox regression. Statistical analysis was performed by using STATA 13. Results We included 1293 patients in the study, 363 from Chile, 395 from Argentina, 209 from Colombia, 45 from Ecuador, 151 from Mexico, and 130 from Uruguay. The main characteristics at diagnosis and therapeutic strategies are shown in Table 1. Optimal response (sCR, CR and VGPR) was achieved in 38% of the patients in the cyclophosphamide, bortezomib, and dexamethasone (CyBorD) group, in 46% in the bortezomib, thalidomide, and dexamethasone (VTD) group, and in 36% in the cyclophosphamide, thalidomide, and dexamethasone (CTD) group, the 3 main induction regimens used. Only 53% of patients finally received ASCT. Significant differences were found between both groups, private and public institutions, regarding burden of symptoms, ISS staging, access to PI based induction, ASCT completion and adequate maintenance, with patients from the latter being more symptomatic, and receiving suboptimal therapy. FISH analysis was performed in less than 50% of patients, both in the public and private setting. With a median follow up of 34 months (range 1-113), median overall survival (OS) was 86 months. The 5-year progression free survival (PFS) was 38% and 5- year overall survival (OS) was 64%. When comparing public vs private settings, 5 year OS was 45% vs 80%, with a median OS of 56 months vs not reached, respectively (P In the multivariable analysis renal failure (p=0.03), achieving less than VGPR response (p Conclusion This is the largest report on transplant eligible patients with MM in LA. Great inequities are shown between public and private health systems. Survival in transplant-eligible patients is lower than that described in other regions. Only one third of patients had FISH performed. This means that very few patients are treated with a risk-based induction in LA. Patients in the public setting are diagnosed with a more symptomatic disease, probably due to a late diagnosis. OS is significantly worse in the public setting. This might be explained by the significant differences in access to PI-based induction, ASCT and maintenance between private and public institutions, with patients from the latter receiving suboptimal frontline therapy and maintenance. Reasons for 47% of potential candidates not being transplanted merit further analysis. Table 1 Disclosures Peña: Novartis: Other: Congress inscription and flights; Tecnofarma: Other: Congress inscription and flights; Roche: Other: Congress inscription and flights; Biotoscana: Other: Congress inscription and flights; Janssen: Other: Congress inscription and flights; Pfizer: Membership on an entity's Board of Directors or advisory committees. Rojas:Roche: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; Pfeizer: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees. Abello:Takeda: Other: Participation in advisory board meeting. Gomez-Almaguer:Amgen: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau; Teva: Consultancy, Speakers Bureau; Takeda: Consultancy, Speakers Bureau; Celgene: Consultancy, Speakers Bureau.

Introducción: La esplenectomía representa una herramienta diagnóstica y terapéutica para múltiples patologías hematológicas benignas y malignas. Se presenta el análisis de una cohorte de pacientes esplenectomizados por enfermedad hematológica en la Fundación Santa Fe de Bogotá. Materiales y métodos: entre 2004 y 2011, se identificaron 30 pacientes esplenectomizados por indicación hematológica benigna (n = 23) y maligna (n = 7). Se evaluaron las historias clínicas respecto de diversos parámetros y desenlaces a largo plazo. Resultados: La edad promedio de los sujetos fue de 54 años; la mayoría fueron mujeres (64%) y la patología más frecuente fue la trombocitopenia inmunológica (60%). Previo al procedimiento, el 23% requirió algún tipo de soporte transfusional y en el 60% la esplenectomía se utilizó como primera o segunda línea terapéutica. En cuatro casos, el procedimiento se hizo como método diagnóstico y en otros tres, no hubo información de seguimiento. El análisis de desenlaces se realizó sobre 23 pacientes. Durante los primeros 30 días posoperatorios, se presentaron complicaciones infecciosas (17.4%) y hemorrágicas (13%) sin ninguna muerte atribuible al procedimiento. El 78% tuvo respuesta hematológica global y la mediana de supervivencia global fue de 133 meses (r, 108 a 157), período que fue menor entre quienes tuvieron dependencia transfusional preoperatoria (p = 0.04) y para quienes lograron la respuesta hematológica (p = 0.026). La tasa de complicaciones a largo plazo fue inferior al 10%. Conclusiones: La esplenectomía obtiene frecuencias importantes de respuesta para patologías benignas y malignas de la sangre y se corresponde con una elevada supervivencia global relacionada a una baja tasa de complicaciones a largo plazo. La supervivencia se modifica principalmente por la dependencia transfusional preoperatoria, por lo que se sugiere explorar esta variable como determinante en otros estudios.

Introducción: La trombosis venosa profunda iliofemoral extensa (TVPIF) tiene un importante impacto a largo plazo en términos de insuficiencia venosa crónica e incapacidad secundaria. La trombolisis dirigida por catéter (TDC) puede reducir la morbilidad asociada a este evento. Materiales y métodos: Se diseñó y proyectó un registro monográfico de seguimiento, que incluyó una serie de pacientes tratados con TDC en la Fundación Santa Fe de Bogotá (FSFB) entre el 2008 y 2011. Se describieron las características clínicas de los pacientes, el procedimiento y los desenlaces a corto y a largo plazo. Resultados: La TDC se realizó en cuatro pacientes con TVPIF izquierda, tres mujeres y un hombre; la mediana de edad fue 58 años (rango 35 a 70). En tres casos, se documentó un síndrome de May-Thurner asociado (SMT). Las trombosis agudas y subagudas, caracterizadas por ultrasonografía, se encontraron cada una en dos pacientes. La TDC se llevó a cabo utilizando alteplase y tenecteplase en uno y tres pacientes, respectivamente. Al finalizar la TDC, todos los casos catalogados con SMT fueron manejados con angioplastia por balón más stent (ABS). El éxito trombolítico fue completo en los dos casos de TVPIF aguda, y parcial en los dos casos de TVPIF subaguda. Solo hubo un evento hemorrágico mayor y la permeabilidad del vaso a largo plazo se mantuvo en los cuatro pacientes, sin eventos trombóticos reincidentes o reestenosis. No se diagnosticó síndrome postrombótico en ninguno después de seis meses de seguimiento. Conclusiones: La TDC para la TVPIF es un procedimiento factible de efectuar en nuestra institución, ofreciendo una frecuencia aceptable de complicaciones con importantes beneficios clínicos a largo plazo. En los casos de TVPIF y SMT, el uso concomitante de ABS pudo mantener la permeabilidad venosa durante el tiempo de seguimiento.

Bioavailability and acceptability of heme-iron obtained from swine hemoglobin (Hb) included in the chocolate-flavored filling of biscuits was assessed in adolescent girls. The supplemented groups received biscuits fortified with 9.5 mg of iron per day for 13 weeks (65 days) of either iron sulfate (IS, n = 64) or heme-iron concentrate (HIC, n = 59). The control (C) group consisted of 70 teenagers with the highest baseline Hb concentrations. The iron-supplemented biscuits were well accepted by the adolescents. Blood chemistry analyses were performed at baseline and the 7th and 13th weeks. The Hb levels in the HIC group increased (p

Background In plasma cell neoplasms, the percentage of plasma cells in bone marrow (PPCBM) is important for diagnosis and assessment of the treatment. This quantification is performed using bone marrow multiparameter flow cytometry (FC), aspirate smears (BMA) and biopsy. Differences among the percentage of infiltration detected by these techniques have been reported, which can be related to a heterogeneous pattern of infiltration of multiple myeloma (MM) or sample quality. However, a simultaneous evaluation of these three techniques has not been reported nor their ability to detect bone marrow involvement with high or low infiltration, associated with different stages of this disease. Purpose The aim of this study was to compare the results of PPCBM obtained by FC, BMA, and biopsy with CD138 immunohistochemistry (BMB) in different stages of the disease with high and low infiltration, and the ability of these techniques to correctly classify the disease. Methods Pathological studies of patients referred to Hospital Fundación Santa Fe, Colombia were reviewed between January 2015 and June 2018. The selection of patients was based on both, a diagnosis of plasma cell neoplasms, classified according to the International Myeloma Working Group criteria and the simultaneous use of FC by FACSCanto II flow cytometer (Infinicyt 2.0 software program), wright-stained aspirate smears and biopsy with CD138 immunohistochemistry in the detection. Descriptive analysis was performed and PPCBM was expressed as the mean± standard error of the mean (SEM). The Kruskal-Wallis test was used to compare the mean of PPCBM among the three methods. Lineal regression and Spearman´s coefficient were used to correlate the variables. Statistical association was considered significant for p values Results A total of 130 patients with plasma cells neoplasms were included in this study, 57 with newly diagnosed MM (N), 58 following therapy MM (F) and 15 MGUS patients. In the N patients, the mean of infiltration was 12.3% ±1.8, 30.3% ±3.4 and 52.2% ±3.74 detected by FC, BMA and BMB, respectively. The PPCBM detected by this three analysis were significantly different (p In the comparative analysis of the three methods in all patients, the highest infiltration was always detected by BMB, followed by BMA and finally by FC (p 0.8). Finally, given that there are important PPCBM such as ≥10 that allows establishing the diagnosis of MM or ≥60%, considered an MM definitive event, we found that 21% and 52% of cases assessed by BMA and FC had PPCBM Conclusion In the comparison of the PCBM was observed a high linear correlation between MFC, BMA, and BMB, although we found a differential behavior of these methods, depending on the level of tumor infiltration. High percentages of infiltration, such as newly diagnosed MM patients, the BMB detected significantly more PPCBM than the others two methods (1.7 to 4-fold compared to BMA and FC). This supports the systematic incorporation of BMB into the analysis of patients with suspected MM for allowing a proper classification of disease. With low percentages of infiltration, such as MGUS and following therapy patients, the difference of PPCBM between BMA and BMB was not significant. Although, FC detected the lowest percentage of infiltration, it known its high specificity to discriminate tumor and normal plasma cells, being in one of the most important analysis to monitor minimal residual. Disclosures No relevant conflicts of interest to declare.

Background: Combination of bevacizumab and FOLFIRI has currently become one of the standard therapeutic regimens. However, published information is still limited. The objective of the present retrospective observational study is to analyse the response and toxicity of first-line treatment with FOLFIRI+bevacizumab in patients with metastatic colorectal cancer (mCRC). Methods: Data were collected from patients from nine Spanish sites diagnosed with mCRC, ECOG⩽2, whose first treatment for advanced disease was at least three cycles of FOLFIRI+bevacizumab. Results: A total of 95 patients were enrolled into the study: 64.2% males, median age of 59 years (53.2–67.1 years), ECOG=0–1 in 96.9% of patients. The main site of primary tumour was the colon (69.7%), and most metastases occurred in the liver (71.6%). Clinical benefit was detected in 67.4% (57.0–76.6; 95% confidence interval (CI)), with 8.4% of CR and 42.1% of PR. Median TTP was 10.6 months (10.0–11.3; 95% CI), PFS was 10.6 months (9.8–11.3; 95% CI), and OS was 20.7 months (17.1–24.2; 95% CI). Main grade I–II toxicities included haematological toxicity (35.8%), diarrhea (27.3%), mucositis (25.3%), asthenia (19.0%), haemorrhages (11.6%), and emesis (10.6%). Toxicities reaching grades III–IV were haematological toxicity (9.5%), diarrhea (8.5%), mucositis (5.3%), hepatic toxicity (2.1%), asthenia (2.1%), proteinuria (1.1%), emesis (1.1%), pain (1.1%), and colics (1.1%). Conclusion: Results of this study support the beneficial effect of adding bevacizumab to FOLFIRI regimen in terms of efficacy and show a favourable tolerability profile.

Background: We gathered data from multiple institutions on the cetuximab regimen of patients with metastatic colorectal cancer. Methods: 126 patients from 19 centers were included from July 2006 to July 2007 in this prospective non-controlled study. Irinotecan-refractory metastatic colorectal cancer patients with Karnofsky ≧70 received cetuximab 500 mg/m2 every 2 weeks (q2w) in combination with irinotecan 180 mg/m2 q2w until disease progression or unacceptable toxicity. The primary endpoint was the progression-free rate at 12 weeks. Results: Median age was 65 years; 65.9% male; colon/rectum 64.3/34.1%; Karnofsky status ≤80/≧90% in 45.3/54.7% of the patients. The progression-free rate was 42.7 (95% CI 32.8–52.6) and 22.4% (95% CI 14.2–30.7) at 12 and 24 weeks, respectively. The main grade 3 or 4 toxicities were: diarrhea 13.5% and acne-like rash 10.3%. No grade 3 or 4 infusional or allergic reactions were reported. Conclusions: The progression-free rates confirm that cetuximab q2w in combination with irinotecan is an option, and is as active and safe as the standard weekly regimen.

Resumen es: El objetivo de este estudio fue probar la utilidad de la dosis semanal de hierro en el tratamiento y prevencion de la anemia ferropenica en mujeres adole...

Previous studies have shown that docetaxel and cisplatin, as single agents, are effective and relatively well tolerated in patients with advanced gastric cancer. The aim of this study was to assess efficacy and toxicity of a biweekly regimen of docetaxel plus cisplatin in patients with advanced gastric cancer.Fifty-five patients with histologically proven advanced gastric cancer with at least 1 measurable lesion and ECOG PS ≤ 2 were enrolled. Patients received docetaxel 50 mg/m(2) and cisplatin 50 mg/m(2) every 2 weeks until progression disease, unbearable toxicity or a maximum of 12 cycles.In total, 426 cycles were administered (median 8.5 cycles) to 52 evaluable patients. One patient (1.9 %) showed a complete response, while 21 (40.4 %) had partial responses. The objective response rate was 42.3 % (95 % CI 28.9-55.7), the median time to progression was 5.5 months (95 % CI 4.0-7.0), and the median overall survival was 8.9 months (95 % CI 6.0-11.9). The most common grade 3-4 toxicities per cycle were haematological [neutropenia (5.9 %)].Biweekly administration of docetaxel and cisplatin in advanced gastric cancer has a manageable toxicity profile and shows a promising antitumour activity as a first-line therapy.

Background : A phase II multicentric trial of paclitaxel and cisplatin was conducted in previously untreated patients, with locally advanced transitional-cell carcinoma (TCC) of the bladder, to assess its toxicity and efficiency in preserving the bladder. Methods: Forty-four patients with locally advanced TCC of the bladder (seven with T3a, 27 with T3b, and eight with T4a) were treated with paclitaxel 175 mg/m2 over 3 h, and cisplatin 75 mg/m2 over 30 min, on the first day of each 21-day treatment cycle. Therapy was continued for three cycles. Patients were re-evaluated and scheduled for radiotheraphy or radical surgery depending on tumoral response. Tumoral response was measured by citology, computed tomographical scans, and deep randomized biopsies of the bladder. Results: Thirty-two out of 42 patients (76%; 95% confidence interval 45–93%) showed a major response (22 complete, and 10 partial). Response times ranged from 18 to 54 months. Three patients with T4 bladder primary tumors experienced a pathological CR. At a median follow-up of three years, 20 patients remain free of disease (47.6%), six patients are alive with disease (14.3%), 12 patients died of disease (28.5%), and four others died of unrelated causes (9.5%). Hematological toxicity included anemia, thrombocytopenia, and neutropenia. No grade four febrile neutropenia was observed. Non-hematological toxicity included alopecia (93.2%), diarrhea (11.4%), vomiting (18.5%) mucosytis (4.6%), and neuropathy (4.6%). Drug omissions or dose delay for adverse events were only necessary in one patient (2.2%), and three patients (6.8%), respectively. Conclusions: Paclitaxel and cisplatin is an active and well-tolerated neo-adjuvant regimen for previously untreated patients with pure TCC of the bladder, achieving a vesical preservation rate of 52%.

Background: This phase II study aims to evaluate the efficacy and safety of biweekly cetuximab in combination with oxaliplatin, leucovorin, and fluorouracil (FOLFOX-4) as first-line treatment of metastatic wild-type KRAS colorectal cancer. Methods: Previously untreated patients with wild-type KRAS tumours received biweekly cetuximab (500 mg/m2 on day 1) plus FOLFOX-4 (oxaliplatin 85 mg/m2 on day 1, leucovorin 200 mg/m2 on days 1 and 2, and fluorouracil as a 400 mg/m2 bolus followed by a 22-hour 600 mg/m2 infusion on day 1 and 2). Treatment was continued until disease progression, onset of unacceptable toxicities, metastases surgery, or discontinuation request. The primary endpoint was ORR. Results: The intention-to-treat population included 99 patients with a median age of 64.1 years (range, 34-82). The ORR was 60.6% (95% CI, 50.3% to 70.3%). The median follow-up was 17.8 months; the median OS and PFS were 20.8 and 10.1 months, respectively. Metastases from colorectal cancer were surgically resected in 26 (26.3%) patients, with complete resection achieved in 18 (69.2%) patients. Median PFS and OS in patients undergoing metastatic resection were 12.6 and 29.5 months, respectively. The most common grade 3-4 toxicities were neutropenia (32.3%), acne-like rash (15.2%) and diarrhoea (11.1%). Conclusions: The efficacy of the biweekly combination of cetuximab with FOLFOX-4 in patients with wild-type KRAS tumours supports the administration of cetuximab in a dosing regimen more convenient for patients and healthcare providers. The activity of the biweekly administration is similar to what has been reported for the weekly regimen. Reported toxicity was also consistent with the known toxicity profile of weekly cetuximab. Trial registration: EudraCT Number 200800690916

Objective The combination of oxaliplatin and oral capecitabine (XELOX) has shown to be an active regimen in metastatic colorectal cancer (MCRC). However, the experience with XELOX in elderly patients is limited. This study aimed to evaluate the efficacy and safety of XELOX as first-line treatment in elderly patients with MCRC. Patients and Methods Patients aged ≥70years with previously untreated MCRC received oxaliplatin 85mg/m 2 on day 1, every 2weeks plus capecitabine 1000mg/m 2 (or capecitabine 750mg/m 2 if creatinine clearance was 30–50mL/min) twice daily on days 1–7, every 2weeks. Treatment was continued until progression, intolerable toxicity, or for a maximum of 12cycles. Results Thirty-five patients were enrolled. Median age was 78years (range, 70–83). Patients received a median of 11cycles of treatment. The objective response rate (ORR) was 49% and the tumor control rate was 86%. Median time to progression and overall survival were 8.6 (95% CI: 5.5–11.7) and 15.5 (95% CI: 9.6–21.3) months, respectively. Toxicities were generally mild to moderate. Major grade 1–2 toxicities were asthenia (40%), nausea (43%), and diarrhea (40%). No grade 4 toxicity was detected and grade 3 toxicities were reported in 17% of patients. There was no treatment-related death. Conclusion Our findings show that the biweekly XELOX regimen represents an effective and tolerable first-line treatment option for elderly patients with MCRC.

483 Background: Placement of a biliary stent is a standard measure for patients (pts) with pancreatic cancer. We evaluated prognostic/predictive factors that could predict the benefit of gemcitabine/nabpaclitaxel in pts with locally advanced unresectable and metastatic pancreatic adenocarcinoma and whether the presence of a biliary stent reduced the treatment efficacy Methods: We retrospectively analyzed 39 pts with locally advanced and metastatic pancreatic cancer treated with gemcitabine/nabpaclitaxel. Data included lactate dehydrogenase (LDH) level, alkaline phosphatase, neutrophil/lymphocyte ratio (NLR), performance status (PS), weight loss, presence of stent, analgesics use and CA 19.9 level. The correlation with response rate, progression-free survival (PFS) and overall survival (OS) was analyzed. Objective toxicities were assessed. Results: 30 pts (77%) had metastatic disease and 9 (23%) locally advanced pancreatic cancer. 46% had liver metastases and 41% lung metastases. Mean age of pts: 62 years (62% male). 20% had PS:0, 67% PS:1 and 13% PS:2. Stents were placed in 30% of pts, 69% had weight loss and 64% used analgesics at diagnosis. At the time of analysis 14 pts had died (25 alive). 56% had progressed, 3% were lost to follow-up and 41% had not progressed. A total of 54% disease stabilizations, 21% partial responses and 18% progressions were achieved (deaths: 7%). 43% required dose reduction. The main toxicity was hematologic (grade 1 anemia). Median PFS: 6 months (95%CI 4.4-7.6). Median OS: 15 months (95%CI 10.4-19.6). There was a statistically significant relationship between LDH level, NLR and PS and OS: LDH level higher than 363 increased the risk of death, NLR above 3.1 increased 1.8 times the risk of death and mean OS of pts with ECOG:0,1 was greater than that of pts with ECOG:2. No relationship between the presence of stent and PFS or OS was found, as well as with any of the other variables. Conclusions: The presence of stent did not reduce the efficacy of gemcitabine/nabpaclitaxel. Univariate analysis showed PS as a prognostic factor while multivariate showed LDH and NLR.

Background Sorafenib (SOR) is a potent inhibitor of c-Raf, b-Raf VEGFR-1/2/3 and PDGFR-β. In NSCLC, proliferative signaling through the Ras/Raf/MEK/ERK pathway is often activated from K-ras mutations. Their efficacy as monotherapy for treating advanced NSCLC has been demonstrated in several trials. In them, SOR improved the rate of disease stabilization in patients who had previously been treated with chemotherapy. Our objective is to confirm the clinical and safety results in daily clinical activity. Methods Between October 2008 and December 2011, 16 Caucasian patients with metastatic NSCLC and measurable disease were treated after having received two or more prior lines of therapy for metastatic disease.SOR was administered at a starting dose of 400 mg bid continuously in 28-day cycles.The primary end-point was Progression Free Survival (PFS). The secondary end-points were Overall Survival (OS) and Response Rate (RR). Results Median age was 59 years (40-86). 100% patients were PS (ECOG) 0/1 (5/11, 31/69%). Most were males (n = 10, 62%). The predominant histologic type was adenocarcinoma (n = 10, 62%). Thirteen (81%) patients were in stage IV at diagnosis. The predominant metastatic sites were lung (n = 9, 56%), lymph nodes, (n = 6, 38%), pleura (n =3, 19%) and bone (n = 3, 19%) Patients received a median of 3 (range: 2 to 4) treatment lines prior to the SOR regimen; Eleven (68.8%) patients received at least 3 treatment lines before SOR. The median duration of the SOR regimen was 114 days (9-247).Median PFS and median OS were 2.8 and 3.3 months, respectively. After administration of SOR, 2 patients (13%) had a partial response and 5 (33%) had stable disease. The toxicity profile was mild. Adverse events CTC G3/4 were dyspnea (n = 4, 25%), skin toxicity (n = 1, 6%) and vomiting (n = 1, 6%). In 1 case, treatment was interrupted by non-hematological toxicity. Conclusions Patients with advanced NSCLC receiving SOR after two or more lines of therapy got a 2.8 and 3.3 months median PFS and OS, respectively, with a 46% Disease Control Rate and with an acceptable safety profile. While still waiting for the results of ongoing trials, SOR is active and safe in this widely treated patient population. Disclosure All authors have declared no conflicts of interest.

e18070 Background: Sorafenib is a potent inhibitor of c-Raf, b-Raf VEGFR-1/2/3 and PDGFR-β. In NSCLC, proliferative signaling through the Ras/Raf/MEK/ERK pathway is often activated from K-ras mutations. Their efficacy as monotherapy to treat advanced NSCLC has been demonstrated in several trials. In them, SOR improved the rate of disease stabilization in patients who had previously been treated with chemotherapy. Our objective is to confirm the clinical and safety results in the daily clinical activity. Methods: Between October 2008 and December 2011, patients with metastatic NSCLC and measurable disease, ECOG 0-1 were treated after having received two or more prior chemotherapy regimens for metastatic disease. SOR was administered at a starting dose of 400 mg bid continuously in 28-day cycles.The primary end points were Overall Survival (OS) and Progression Free Survival (PFS). Survival medians were estimated by the Kaplan-Meier method and comparisons between subgroups were assessed by the log-rank test. Results: Fifteen Caucasian patients were enrolled, with a mean age at diagnosis of 61 (SD = 13.5) years and most of them were males (n = 10, 67%). The predominant histologic type was adenocarcinoma (n = 9, 60%). Twelve (80%) patients were in stage IV at diagnosis. The predominant metastatic sites were lung (n = 8, 53%), lymph nodes, (n = 5, 33%), pleura (n =3, 20%) and bone (n=3, 20%).Patients received a median of 3 (range: 2 to 4) treatment lines prior to the SOR regimen, with a median duration of 80.5 (range: 9 to 247) days.Median OS and median PFS were 98 and 84 days, respectively. No significant differences in survival were found according to gender, smoking, histologic type, stage, metastatic site, ECOG nor presence of biomarkers.The toxicity profile was mild. Adverse events CTC G3/4 were dyspnea (n = 4, 27%), skin toxicity (n = 1, 7%) and vomiting (n = 1, 7%). Conclusions: In this study, patients with metastatic NSCLC receiving SOR had a median PFS of 3 months. The safety profile is acceptable, reversible and manageable without unexpected adverse events to this therapy. While still waiting for the results of ongoing trials, we can say thatSOR is safe, so far, in patients who have been widely treated.

649 Background: In ASCO2004, Y. Fernandez et al. showed their experience in gemcitabine/capecitabine use in patients with metastatic advanced colorectal cancer (ACRC), with previous progression or contraindicated standar treatment, with encouraging results. This study was design to evaluate the efficacy and safety of this combination in these patients, in our area. Methods: This is an observational, multicentric and retrospective study performed in metastatic colorectal cancer patients refractory to treatment. The study treatment was to evaluate the gemcitabine/capecitabine (gemcitabine 1000 mg/m2, day 1+ capecitabine 1250 mg/m2/12hours, days 1-7, every 15 days) until progression or unacceptable toxicity. The principal endpoint was the best overall response rate achieved during the study period. Secondary endpoints were Progresión Free Survival (PFS), Overall Survival (OS) and safety profile. Results: Of 45 patients recruited a total of 39 patients were evaluated. Median age was 66(37-78) and 69.2 were male. 86.8% of the patients were ECOG PS 1. Mean time from diagnostic was 2.7±2.4 years. Primary tumor was: colon 73.7%, rectum 23.7% and both 2.6%. Adjuvant therapy was received in 34.3% of the patients. Metastatic locations were: liver 82.1%, lung 64.1% and lymph nodes 25.6%. Previous treatment lines received: two 48.7%, three 23.1%, four 17.9%, five 7.7% and six 2.6%. The mean of cycles were 6.4±6 and mean time of treatment was 3.3±2.8 months. Best response during treatment period was partial response 2.9%, stable disease 17.6% and progression 79.4%. OS was 7.32 months and median PFS was 3.02 months. Most frequent toxicities grade 3 experienced: Palmar plantar erythrodysesthesia 5.1%, neutropenia 5.1%, asthenia 2.6%, dyspnea 2.6% and hiperbilirrubinemia 2.6%. No grade 4 toxicities were reported. Conclusions: Despite of the adequate safety profile of the gemcitabine/capecitabine combination, our study does not confirm the efficacy figures reported by others authors. New agents or combinations should be investigated in the treatment of this patient subgroup.

277 Background: Patients with metastatic pancreatic cancer (mPC) have poor prognosis. Given the activity of both capecitabine and erlotinib in pancreatic cancer, we hypothesized that combination use of two drugs in first-line therapy would improve clinical outcomes in these patients. Methods: A prospective, single arm, open-label, phase II study. Patients received capecitabine 1,000mg/m2 twice daily on days 1-14 in 3-week cycles combined with erlotinib 150 mg po daily for 18 weeks, until disease progression, unacceptable toxicity or withdrawal, with a follow-up visit performed at 30-days post-treatment. The primary endpoint was objective response rate measured with RECIST criteria. Results: A total of 32 patients were evaluated. Baseline characteristics: median age was 64 years (56-70), male: 50%, Karnofsky PS ≥ 80%: 94%, tumor histology: 93.5% adenocarcinoma, 49% moderately differentiated. 11 (34%) patients had surgery, 2 (6%) had prior radiotherapy and 3 (9%) prior chemotherapy. Median treatment duration was 61 days (6-156). 3 (9%) patients required dose reduction of capecitabine and 8 (25%) of erlotinib. Of the 32 patients, 6 completed the treatment period, 22 discontinued the study prematurely due to disease progression and 4 due to AEs. Disease control rate (confirmed complete response [CR], partial response [PR] and stable disease [SD] according to RECIST criteria) was 28.2%. 2 (6.3%) patients achieved PR and 7 (21.9%) had SD. After a mean follow-up of 6.3 months, the median progression-free (PFS) and overall survival (OS) was 2.10 and 4.3 months, respectively, with a 6-months survival rate of 43.8%. Safety analysis revealed that the main grade 1/2 toxicities were rash (34%), asthenia (31%), diarrhea (31%), stomatitis (22%) and emesis (22%). Three cases of grade 3 hand-foot syndrome and 1 case of infection due to biliary stent were detected. No toxicity grade 4 occurred. Conclusions: Capecitabine administered in combination with erlotinib is an active regimen in patients with metastatic pancreatic cancer with a favourable safety profile. These results suggest that this regimen could represent a first-line treatment option for these patients. No significant financial relationships to disclose.

e15053 Background: Analysis of efficacy and toxicity of biweekly XELOX as first line monotherapy in elderly patients (pts) with metastatic colorectal cancer (MCRC), based in results of W. Scheithauer (J Clin Oncol 2003; 21: 1307). Methods: From March/06 to November/08, 28 chemonaïve elderly pts (>75 years old) with MCRC, PS: 0–2, and adequate renal, hepatic and bone marrow functions, were included in a phase II study of: oxaliplatin 85 mg/ m2/ day 1 plus capecitabine 2000/ m2/ in 2 divided doses/ days 1–7 every 2 weeks. Treatment was continued until 12 cycles, tumour progression or innaceptable toxicity. Response evaluation every 6 cycles and toxicity every cycle was performed. At present 28 pts for toxicity and 24 pts for response are evaluable. Results: Median age: 78.2 years (range: 73.5–79.5). Male/Female: 14/14. Rectal/Colon: 9/19. Metastatic sites 1/2/>2: 15/6/6. Liver 78.6%, Lung 32.1%, Local tumour 7.1%, Retroperitoneum 14.2%, Peritoneum 10.7%. and Bones 7.1 %. Previous adjuvant with 5-FU regimens to 4 pts. Comorbidity grade by Charlson index 0–1/2/>2: 60.8%/ 28.6% / 10.7%, respectively. Median number of cycles for oxaliplatin and capecitabine were 8 (5.25–12) and 8 (5.25–11.75). Response rate: 2 pts complete response (8.3%), 8 pts partial response (33.3%),10 pts stable disease (41.7 %) and 4 pts progression (16.7%). The main CTC toxicity was Asthenia G2+3 in 6 (21.5%), Nausea and emesis G2 in 7 (25%), Diarrhea G2+3 in 7 (25%) and Hand-foot syndrome G1+2 in 5 pts (17.8%). No G4 toxicity or toxic deaths were observed. Median time to progression was 8.6 months.Median overall survival will be given updated at the congress. Conclusions: Preliminary results suggest that bi-weekly XELOX is an effective first line treatment for MCRC in elderly pts with an acceptable toxicity profile (especial surveillance of diarrhea is necessary) and protocol cumpliment. Combination with bevacizumab should be considered. No significant financial relationships to disclose.

15601 Background: Docetaxel and cisplatin, as single agents, have demonstrated activity in patients with advanced gastric cancer. Docetaxel and cisplatin have shown a different toxicity profile; consequently the combination of these drugs could be a safe and effective treatment. Therefore, we conducted a phase II study to assess efficacy and toxicity of a biweekly regimen of docetaxel plus cisplatin in patients with advanced gastric cancer who have never been treated with palliative chemotherapy. Methods: Fifty-two patients with advanced gastric cancer were enrolled, histologically confirmed of gastric adenocarcinoma, at least one measurable lesion, ECOG PS ≤2, no prior palliative chemotherapy and adequate bone marrow, renal and hepatic function. Docetaxel 50 mg/m2 and cisplatin 50 mg/m2 were administered every two weeks until progression disease, unbearable toxicity or a maximum of 12 cycles. The objective response was evaluated according to RECIST criteria and toxicity was assessed according to the NCI-...

13551 Background: Pts with chemotherapy-resistant MCRC have a really poor prognosis with few therapeutic options. Cetuximab (Erbitux®) is an IgG1 monoclonal antibody targeting the EGFR, shown to be effective in pts with EGFR-expressing MCRC refractory to prior irinotecan-based chemotherapy (Cunningham NEJM 2004). Methods: The goal of this multicenter phase II study is to investigate the safety and efficacy of cetuximab in combination with irinotecan as third line treatment in 40 pts with heavily pre-treated MCRC. From Jan to Dec 2005, 40 pts with EGFR-expressing MCRC, refractory to irinotecan, pre-treated with both irinotecan and oxaliplatin with fluorouracil or capecitabine combinations, and PS 0–2, were included to receive cetuximab (400 mg/m2 week 1 and 250 mg/m2 weekly thereafter) plus irinotecan (180 mg/m2 every 2 weeks) until tumour progression or unacceptable toxicity. Pts were analysed weekly for toxicity and every 12 weeks for response. Recruitment is completed. Currently, 38 pts are evaluable for toxicity (2 pts recently recruited) and 23 pts for response (16 pts on treatment for 2 16/19/3 (Liver 43%, lung 23%, nodes 17%, pelvic 5%, others 12%). A total of 418 weekly infusions were administered (mean: 11; range: 3–37). Preliminary efficacy data is as follows: 3 PR, 3 SD, 17 PD with an overall response rate of 13% (95% CI: 3–34%) and disease control rate of 26% (95% CI: 10–48%). Major toxicities (G 1–2/G 3–4) were: Acne-like skin rash 58/11%, Anemia 32/3%, Neutropenia 16/13%, Nausea-vomiting 32/0%, Diarrhoea 32/11%. Median time to progression was 3.5 months (Range: 1–10+) and median overall survival was 7.3 months (Range: 1.5–12+). Conclusions: These preliminary results suggest that cetuximab and irinotecan combination, is a reasonably effective treatment for pts with highly pre-treated MCRC with an acceptable toxicity profile No significant financial relationships to disclose.

7241 Background: Combined thoracic radiation and chemotherapy has become the treatment of choice for unresectable stage III NSCLC, but the optimal strategy remain undefined. Methods: 94 patients (p...