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Background: Targeted therapies and immunotherapies are increasingly prescribed, but classic chemotherapy agents are still highly used in cancer treatment. Both therapies, the old and the new, are associated with cutaneous adverse events (CAEs) that can cause treatment interruptions or reduce the quality of life of patients. Methods: An observational, cross-sectional, single-center study that included consecutive cancer patients presenting CAEs. The main objective was to describe CAEs derived from antineoplastic drugs. Secondary objectives were to determine the number and severity of CAEs and if there were differences regarding CAEs between conventional chemotherapeutics and targeted therapies. Results: A total of 114 patients were included with a total number of 177 CAEs. Of the 114 patients, 64 presented a single CAE, 37 patients had two CAEs, and 13 patients presented three CAEs. The most frequent CAEs were pruritus, xerosis, palmar-plantar erythrodysesthesia (PPE), and alopecia. The majority of CAEs were mild (63.2%), followed by moderate (29.9%) and severe (6.7%) CAEs. Of the 114 patients, 103 (90.3%) received topical agents and 11 (9.7%) required systemic treatment for the management of CAEs. Prophylactic treatment for CAE was delivered to only 4/114 (3.5%) patients. No significant differences were found in the number or severity of CAEs between conventional chemotherapy and targeted therapy. Conclusions: Close collaboration between oncologists and dermatologists is essential to start preventive measures on time, enhance patient education, and avoid unnecessary dose reductions or treatment interruptions. The multidisciplinary approach can offer better management of skin toxicities.

Background: Despite growing interest in cutaneous adverse events (CAEs) and their management in patients with cancer, they are often underreported and there are no extensive data on their impact on quality of life (QoL). Healthcare professionals should consider this issue in order to minimize its negative impact on QoL and improve patient outcomes. This study evaluates the impact of CAEs on QoL in outpatients receiving anticancer drugs and aims to determine the differences in QoL between conventional chemotherapy versus targeted therapies. Methods: A total of 114 cancer patients with CAEs were included in this observational, cross-sectional study. Patient-reported outcomes instruments (Functional Assessment of Cancer Therapy – General, Dermatology Life Quality Index, and Skindex-16) were used. Results: Mean scores in QoL indices were 65.3±13.4, 8.4±5, and 30.8±16.9 in Functional Assessment of Cancer Therapy – General, Dermatology Life Quality Index, and Skindex-16, respectively. The CAEs that had the greatest impact on dermatologic-related QoL were hand–foot skin reaction, rash, palmo-plantar erythrodysesthesia, and papulopustular eruption. No significant differences in QoL indices according to the type of treatment (conventional chemotherapy versus targeted therapy) were observed. Conclusions: CAEs, and particularly hand–foot toxicities, rashes, and papulopustular eruptions, can have an impact on QoL in outpatients receiving anticancer drugs as evaluated with three different patient-reported outcomes instruments. No differences in QoL related to CAEs were observed between conventional chemotherapy and targeted therapy.

Background The aim of the study was to assess health-related quality of life (HRQOL) in outpatients receiving anti-cancer treatment. Methods Observational, cross-sectional, single-center study that assessed HRQOL in cancer patients receiving antineoplastic treatment. Results A total of 184 patients were included in the study; the median total FACT-G score was 66 ± 12.9; the scores for the physical well-being, social/family well-being, emotional well-being and functional well-being domains were 17.8 + 4.8, 19.1 ± 4.4, 14.8 ± 3.8 and 14.3 ± 4.7 respectively. Patients with adverse events had poorer HRQOL compared to those without them (FACT-G score 62.2 vs. 67.3; p Conclusion In our study, the neoplastic disease and anti-cancer treatment toxicities had an impact on HRQOL. Patients had poorer scores in the functional well-being domain and higher ones in the social/family well-being domain. Variables associated with worse HRQOL were tumor stage, performance status (ECOG) and female sex.

Introduction: Opioid-Induced Constipation (OIC) is a common distressing symptom associated with cancer pain treatment. Consensus guidelines for management of OIC are limited and little is known about the decision making of Health Care Professionals (HCP) for the management of OIC. The aim of this study was to learn about the diagnostic and treatment criteria of OIC management in clinical practice in patients with cancer.

Purpose: The objective of the study was to analyses how Opioid-Induced Constipation (OIC) is managed in cancer patients in clinical practice for comparison against the current recommendations for the management of patients with OIC.

Purpose There is a lack of standards for the diagnosis, assessment and management of breakthrough cancer pain (BTcP). La Fundacion ECO (the Foundation for Excellence and Quality in Oncology) commissioned a study to establish a consensus and lay the foundations for the appropriate management of BTcP in oncology patients. Patients and methods A modified Delphi survey comprising two rounds was used to gather and analyze data, which was conducted over the Internet. Each statement that reached a consensus with the respondents was defined as a median consensus score (MED) of ≥7, and agreement among panelists as an interquartile range (IQR) of ≤3. Results In total, 69 medical oncologists responded, with a broad consensus that BTcP implied exacerbations of high-intensity pain, as opposed to moderate pain. Furthermore, they concurred that appropriate diagnostic equipment is needed, and that rapid-onset fentanyl formulations should be the preferred treatment for BTcP management. The panelists agreed that a lack of appropriate information and training to attend to patients, as well as limited patient visitation rights, were barriers to effective BTcP management. Regarding gaps in detected knowledge, the panelists were unsure of the measures necessary to assess the burden of the disease on the patient's quality of life and associated medication costs. Alongside this, there was a lack of awareness of the technical specifics of the different formulations of rapid-onset fentanyl. Conclusion These results represent the current status of BTcP management. They may inform recommendations and provide a framework for future research.

Background: Patient quality care is a discipline that has acquired enormous relevance in today’s healthcare. The Quality Oncology Practice Initiative (QOPI) is a referral worldwide in terms of quality for oncology practices. The ECO Foundation is a foundation of experts representing the major Spanish hospitals involved in the treatment of cancer patients. ECO reached an agreement with ASCO to involve Spanish hospitals in the QOPI program. Methods: 6 rounds of data collection have taken place (Fall 2015 to Round 1 2018). Practices had to register online and submit data into the QOPI platform, and the ECO Foundation offered all centers the necessary support. 17 Spanish hospitals have participated in the 6 rounds, and 7 of them have repeated participation. Core and lung cancer modules were completed. Results: During the 6 rounds, 1,877 charts were submitted by the Spanish practices. In most of the rounds, the highest scores were: pathology report confirming malignancy; number of chemotherapy cycles documented; patient consent for chemotherapy; and 5 measures of the lung cancer module. The lowest scores were: chemotherapy treatment summary provided to patient within 3 months of chemotherapy end; chemotherapy treatment summary provided or communicated to practitioner(s) within 3 months of chemotherapy end; smoking/tobacco use cessation counselling recommended to smokers/tobacco users in past year; and tobacco cessation counselling administered or patient referred in past year. The percentage of participating practices that presented results higher than 70% was successively 64%, 50%, 75%, and 100% in the last 3 rounds. For the 7 hospitals that repeated participation, 3 reported an improvement of their global scores. Regarding QOPI Certification, 3 Spanish hospitals received this accreditation in September 2017 and one in June 2018. Conclusions: These preliminary results are a good starting point for the continued implementation of the QOPI program in Spain, thus providing a well-structured approach to analyze cancer care. The ECO Foundation will continue pursuing excellence and quality with further activities like the QOPI Certification program and Quality Training Program, these being performed for the first time in Spain in 2017 and 2018, respectively.

espanolIntroduccion: El objetivo de este estudio fue evaluar la percepcion de los oncologos sobre la adherencia al tratamiento con opioides para el dolor irruptivo oncologico (DIO) en la practica clinica real. El estudio tambien incluyo una evaluacion de otros aspectos del manejo del DIO, como las razones de la no adherencia, la adecuacion del tratamiento, o las posibles intervenciones necesarias para mejorar la adherencia. Metodos: Este estudio observacional multicentrico se realizo en 84 hospitales de toda Espana. Los oncologos fueron encuestados por medio de un cuestionario online sobre su manejo del dolor oncologico basal y del DIO, y su percepcion de la adherencia a los tratamientos. Resultados: Los oncologos (n = 97) indicaron que su primera opcion para el DIO fue el fentanilo (varias formulaciones), con alta tolerancia (> 76 % de los pacientes). La mayoria de los oncologos (96,8 %) evaluaron la adherencia en sus pacientes, pero solo el 69,1 % siempre prescribio medicamentos para prevenir los efectos adversos de los opioides, y solo el 74,2 % siempre titulo la dosis minima. La mayoria de los oncologos (51 %) percibieron que el 25-50 % de los pacientes no mostraban buena adherencia al tratamiento para DIO. La adherencia a los tratamientos de dolor basal fue alta, aunque muchos oncologos consideraron que los pacientes generalmente dejaban de tomar el medicamento cuando se sentian mejor. Las principales razones para la no adherencia fueron la sensacion de que el tratamiento era innecesario, la ineficacia percibida del tratamiento, la preocupacion por los posibles efectos adversos y la falta de apoyo familiar. Conclusiones: Los oncologos percibieron que la adherencia al tratamiento para el DIO puede mejorarse y recomendaron el tratamiento de los efectos adversos de la medicacion, una mejor educacion sobre el manejo del dolor a los pacientes y familiares, instrucciones escritas de prescripcion y simplificacion de los regimenes de medicamentos. EnglishObjectives: The objective of this study was to evaluate the perception of oncologists on adherence to opioid treatment for breakthrough cancer pain (BTcP) in current clinical practice. Our study also included an assessment of other aspects of the management of BTcP, such as the reasons for non-adherence, the adequacy of the treatment, or the possible interventions required to improve adherence. Methods: This observational, multicentric study was carried out in 84 hospitals throughout Spain. Oncologists were surveyed by means of an online questionnaire on their management of background cancer pain and BTcP, and their perception of adherence to the treatments. Results: Oncologists (N = 97) reported that their first choice for BTcP was fentanyl (various formulations), with high perceived tolerance (> 76 % of patients). Most oncologists (96.8 %) evaluated adherence in their patients but only 69. 1% always prescribed medication to prevent adverse effects of opioids and only 74.2 % always titrated the minimum dose. Most oncologists (51.0 %) perceived that 25-50 % of the patients did not adhere to the treatment for BTcP. Adherence to background pain treatments was high, although many oncologists considered that patients usually stopped taking the medication when feeling better. The main reported reasons for non-adherence were the self-perceived feeling that treatment was unnecessary, perceived inefficacy of the treatment, concerns about potential adverse effects, and lack of family support. Conclusions: Oncologists perceived that adherenceto BTcP treatment can be improved and recommended treatment of adverse effects, better education about pain management to patients and relatives, written prescription instructions, and simplification of drug regimens.

e17562 Background: Rucaparib is a PARP inhibitor approved for the treatment of high-grade ovarian cancer (HGOC). Clinical trials have demonstrated its benefit both as maintenance therapy (MTN) for platinum (Pt)-sensitive recurrent HGOC, and as treatment (Tx) in BRCA-mutated relapsed or recurrent HGOC patients. Here we analyze real-world data from the rucaparib early access program (RAP) in Spain with focus in the long-term responder patients (LTR). Methods: A retrospective observational study was performed by GEICO at 22 hospitals in Spain that had treated patients within the RAP. Adult women with HGOC, fallopian tube, or primary peritoneal cancer were included and received rucaparib (600 mg BID) in the MTN, Tx Pt-sensitive or Tx Pt-resistant setting. Patients’ characteristics, medical history, safety, efficacy, and dosing data were collected. In this analysis, long-term response was defined as progression-free survival (PFS) ≥12 months for the MTN group and ≥6 months for the Tx group. LTR were stratified based on the rucaparib indication (MTN/Tx). Results: Between July 2020 and February 2021, 51 patients were recruited: 18 received rucaparib as MTN and 33 as Tx. In the MTN group, 6 patients (33.3%) were LTR, with a median age of 65 years (54-79). Of them, 2 patients (33.2%) harbored BRCA or RAD51C mutations. The median number of prior lines was 3 (2-6), being ≥5 in 33.2%, and 50.0% received prior bevacizumab. ECOG PS was ≤1 in all these patients, 66.6% had measurable disease and 50.0% achieved a partial response to prior Pt-based chemotherapy. In the Tx group, 10 patients (30.3%) were LTR, with a median age of 71 years (47-86). All of them harbored BRCA and/or RAD51C mutations. The median number of prior lines was 6 (2-9), with 60.0% receiving ≥5 prior lines, and 50.0% received prior bevacizumab. Regarding Pt-status, 40.0% of patients were Pt-sensitive and 60.0% were Pt-resistant. The ECOG PS was ≥1 in 30.0% of patients and 60.0% had measurable disease. The median PFS of LTR was not achieved in the MTN group and was 10.9 months (95% CI: 7.0-16.7) in the Tx group. Adverse events (AE) of any grade were reported in 66.6% of LTR within the MTN group and in 100.0% within the Tx group, while AE of grade ≥3 occurred in 16.6% and 50.0%, respectively. Rucaparib dose was reduced in 50.0% of LTR in the MTN group and 80.0% in the Tx group. Discontinuation rate due to rucaparib toxicity was 20.0% in the Tx group and there were no discontinuations due to toxicity in the MTN group. No new safety signals were detected. At present, 3 and 1 patients are still receiving rucaparib as MTN and Tx, respectively. Conclusions: A durable response was achieved in a notable proportion of patients, even despite their unfavorable conditions at treatment initiation (heavily pre-treated patients, partial response or resistance to Pt, or high volume of disease). The safety profile of rucaparib in this real-world setting is consistent with that reported in clinical trials.

Background: despite the growing interest in cutaneous adverse events (CAEs) and their management in oncology patients, they are often under-reported and there are no extensive data on their impact on quality of life. Health care professionals should pay attention to this issue in order to minimize its negative impact on quality of life (QoL) and improve patient outcome. The aim of this study was to evaluate the impact of CAEs on QoL in patients receiving anticancer drugs and to determine differences in QoL between conventional chemotherapy versus targeted therapies. Methods: 114 cancer patients with CAEs were included in this observational, cross-sectional study. Patient-reported outcomes instruments (FACT-G, DLQI and SKINDEX-16) were used. Results: Mean (SD) score in FACT-G was 65.3 (13.4), while in DLQI it was 8.4 (5) and in SKINDEX-16 it was 30.8 (16.9), showing a moderate impact on QoL. No significant differences in QOL indices according to the type of treatment (conventional chemotherapy vs targeted therapy) were observed Conclusions: CAEs had a moderate impact on QoL in cancer patients, evaluated with three different PRO instruments, but having more severe or two or more CAEs had a significant negative impact on QoL. No differences between conventional chemotherapy and targeted therapy were observed.

Resumen Introduccion La cirugia toracoscopica videoasistida se ha convertido en la tecnica de eleccion para las intervenciones de cancer de pulmon en estadio inicial en muchos centros, a pesar de que no se ha probado que la supervivencia a largo plazo sea la misma con todos los abordajes quirurgicos. Metodo Efectuamos una revision retrospectiva de 276 lobectomias practicadas en nuestro servicio mediante cirugia videoasistida, y analizamos la edad, sexo, comorbilidades, tabaquismo, FEV 1 y FCV, abordaje quirurgico, estadios TNM y patologico, tipo histologico, quimioterapia neoadyuvante o coadyuvante y tiempo hasta la recidiva o la deteccion de metastasis con el objetivo de evaluar la tasa de supervivencia y la duracion del periodo sin enfermedad en relacion con el abordaje quirurgico, dos/tres puertos o puerto unico, de los pacientes. Resultados Las tasas de supervivencia global al cabo de uno y cuatro anos fueron del 88,1 y 67,6%, respectivamente. En el analisis bivariante se observo que las variables que se asociaban con la supervivencia eran las comorbilidades, el tipo histologico, el estadio, el abordaje quirurgico y la necesidad de quimioterapia. Al analizar el abordaje quirurgico de forma independiente, se observo que la tasa de supervivencia era inferior en el grupo en el que se utilizo la tecnica monoportal frente al grupo en el que se utilizaron dos o tres puertos (VATS). Al estratificar a los pacientes segun el estadio tumoral (estadio I ) y el tamano del tumor (T2), la supervivencia fue significativamente inferior en los pacientes tratados con el abordaje monoportal, en comparacion con la VATS. En el analisis multivariante, el riesgo de muerte fue mayor con la tecnica monoportal (HR = 1,78). En el analisis del tiempo transcurrido sin enfermedad se observo una tendencia hacia una mayor supervivencia favorable a la VATS con dos/tres puertos, tanto para la recidiva local (p = 0,093) como para el desarrollo de metastasis (p = 0,091). Conclusiones Estos resultados cuestionan el uso de la tecnica uniportal en las neoplasias malignas de pulmon, lo que sugiere la necesidad de efectuar ensayos clinicos que permitan identificar el papel de esta tecnica en la cirugia del cancer de pulmon.

Purpose There is a lack of standards for the diagnosis, assessment and management of breakthrough cancer pain (BTcP). La Fundación ECO (the Foundation for Excellence and Quality in Oncology) commissioned a study to establish a consensus and lay the foundations for the appropriate management of BTcP in oncology patients. Patients and methods A modified Delphi survey comprising two rounds was used to gather and analyze data, which was conducted over the Internet. Each statement that reached a consensus with the respondents was defined as a median consensus score (MED) of ≥7, and agreement among panelists as an interquartile range (IQR) of ≤3. Results In total, 69 medical oncologists responded, with a broad consensus that BTcP implied exacerbations of high-intensity pain, as opposed to moderate pain. Furthermore, they concurred that appropriate diagnostic equipment is needed, and that rapid-onset fentanyl formulations should be the preferred treatment for BTcP management. The panelists agreed that a lack of appropriate information and training to attend to patients, as well as limited patient visitation rights, were barriers to effective BTcP management. Regarding gaps in detected knowledge, the panelists were unsure of the measures necessary to assess the burden of the disease on the patient’s quality of life and associated medication costs. Alongside this, there was a lack of awareness of the technical specifics of the different formulations of rapid-onset fentanyl. Conclusion These results represent the current status of BTcP management. They may inform recommendations and provide a framework for future research.

Goals of work: The aims of this study were to assess chemotherapy treatment characteristics, neutropenic event (NE) occurrence and related risk factors in breast cancer patients in Western Europe. Material and methods: Six retrospective audits of breast cancer chemotherapy were combined into a dataset of 2,860 individuals. NEs were defined as neutropenia-related hospitalisation, dose reduction >= 15% or dose delay >= 7 days. Summation dose intensity (SDI) was calculated to compare different types of chemotherapy regimens on a single scale. Risk factors of NE occurrence and of low relative dose intensity (RDI) >= 85% were identified by multiple logistic regression. Main results: Patient populations were comparable between audits. Until 1998, cyclophosphamide, methotrexate and fluorouracil regimens were most frequently used, but thereafter, anthracycline-based regimens were most common. NEs occurred in 20% of the patients and low RDI in 16%. NE occurrence predicted low RDI and was associated with higher age, bigger body surface area, lower body mass index, regimen type, more chemotherapy cycles planned, normal to high SDI, concomitant radiotherapy and year of treatment. First cycle NE occurrence predicted NEs from cycle 2 onwards. A risk score using age, SDI, number of planned chemotherapy cycles and concomitant radiotherapy differentiated patients with increasing NE risk (9-37%). An alternative score version not using concomitant radiotherapy performed moderately less well. Conclusions: NEs occurred frequently in this combined dataset and they affected treatment delivery. Identifying patients at high NE risk enables targeted prophylaxis and may avoid dose limitations.

Purpose The analysis of epidermal growth factor receptor (EGFR) mutations in many patients with advanced non-small-cell lung cancer (aNSCLC) has provided the opportunity for successful treatment with specific, targeted EGFR tyrosine kinase inhibitors. However, this therapeutic decision may be challenging when insufficient tumor tissue is available for EGFR mutation testing. Therefore, blood surrogate samples for EGFR mutation analysis have been suggested. Methods Data were collected from the Spanish cohort of patients in the large, non-interventional, diagnostic ASSESS study (NCT01785888) evaluating the utility of circulating free tumor-derived DNA from plasma for EGFR mutation testing. The incidence of EGFR mutation in Spain and the level of concordance between matched tissue/cytology and plasma samples were evaluated. Results In a cohort of 154 eligible patients, EGFR mutations were identified in 15.1 and 11.0% of tumor and plasma samples, respectively. The most commonly used EGFR mutation testing method for the tumor tissue samples was the QIAGEN Therascreen® EGFR RGQ PCR kit (52.1%). Fragment Length Analysis + PNA LNA Clamp was used for the plasma samples. The concordance rate for EGFR mutation status between the tissue/cytology and plasma samples was 88.8%; the sensitivity was 45.5%, and the specificity was 96.7%. Conclusions The high concordance between the different DNA sources for EGFR mutation testing supports the use of plasma samples when tumor tissue is unavailable. Electronic supplementary material The online version of this article (10.1007/s12094-018-1855-y) contains supplementary material, which is available to authorized users.

IF 6.029; International audience; BackgroundThe prognostic value of lymphocyte infiltration (LI) of colorectal carcinoma (CC) has been demonstrated by several groups. However, no validated test is currently available for clinical practice. We previously described an automated and reproducible method for testing LI and aimed to validate it for clinical use.Patients and methodsAccording to National Institutes of Health criteria, we designed a prospective validation of this biomarker in patients included in the PETACC8 phase III study. Primary objective was to compare percentage of patients alive and without recurrence at 2 years in patients with high versus low LI (#NCT02364024). Associations of LI with patient recurrence and survival were analysed, and multivariable models were adjusted for treatment and relevant factors. Automated testing of LI was performed on virtual slides without access to clinical data.ResultsAmong the 1220 CC patients enrolled, LI was high, low and not evaluable in 241 (19.8%), 790 (64.8%) and 189 (15.5%), respectively. Primary objective was met with a 2-year recurrence rate of 14.4% versus 21.1% in patients with high and low LI, respectively (p = 0.02). Patients with high LI also had better disease free survival (DFS) and overall survival (OS). Tumour stage, grade, RAS status and BRAF status were with LI the only prognostic markers in multivariable analysis for OS. Subgroup analyses revealed that high LI had better DFS and OS in mismatch repair (MMR) proficient patients, and in patients without RAS mutation, but not in MMR deficient and RAS mutated patients.ConclusionAlthough this is the first validation with high level of evidence (IIB) of the prognostic value of a LI test in colon cancers, it still needs to be confirmed in independent series of colon cancer patients.

e18296 Background: The ECO Foundation is a collaboration of experts representing the major Spanish hospitals in the pursuit of excellence in cancer treatment. Since 2015, ECO has been collaborating with ASCO (American Society of Clinical Oncology) in quality initiatives in cancer care, like the QOPI (Quality Oncology Practice Initiative) program and the QOPI Certification Program (QCP). The Quality Training Program (QTP) is a 6-month program with 3 in-person learning sessions that prepares oncology teams to design implement and lead successful quality improvement activities in their practices. In 2018, ECO reached a new agreement with ASCO to implement this program in Spain. Methods: The QTP was developed in Spain by the ECO Foundation in collaboration with ASCO, following the same methodology and contents of ASCO’s program. The first session was carried out on October 2018, with 12 Spanish teams participating with diverse quality improvement projects. The program counted with ASCO and ECO faculty, constituted by experts in the quality and oncology field. Results: The QTP Spanish teams counted with 2-3 representatives from their hospitals. Each team develop an improvement project, following the methodology of the course, including a problem statement, process map, cause and effect diagram, diagnostic data, aim statement, measures, baseline data, priority/pay-off matrix of possible changes/interventions, change data, next steps/plan for sustainability, among others. The projects were mainly focused on the waiting time reduction in the Emergency Area, the waiting time reduction for cancer patients from the visit to the oncologist until treatment administration, burnout reduction on oncology professionals, improvement of the identification and management of complications for cancer patients receiving immunotherapy, improvement of the uniformity in the medical records registry, among others. QTP participants will present the results of their projects on the third and last session of the program, on April 2019. Conclusions: The quality improvement approach followed in the QTP allows Spanish teams and the ECO Foundation to enhance the goal of a quality-oriented health care system. ECO will continue pursuing excellence and quality with further initiatives like the QOPI program, the QCP and the QTP.

e20636 Background: First or second line crizotinib has shown greater efficacy in clinical trials than chemotherapy in patients with NSCLC ALK positive and it was the first approved ALK inhibitor. However, there are limited data describing the use of crizotinib and its outcomes in real-world settings. Methods: This is a retrospective, observational study of patients crizotinib treated ALK positive metastatic NSCLC, who received treatment between 1 January 2013 and 30 november 2018. The primary objective was progression free survival (PFS); secondary objetives were overall survival (OS), response rates and toxicity. Results: Fifty-eight patients with NSCLC ALK+ were recollected, 33 women and 25 men. The median age was 61 years (25-88); 46.6% were never smokers, 31% were former smokers. The majority (96.6%) had confirmed adenocarcinoma histology and 25.9% had brain metastases at inicial treatment. Crizotinib was used as first line 55.2% and second line in 37.9%. Progression disease was the most frequent reason of discontinuation of crizotinib (74%) and in 5 patients was discontinued because of toxicity. The most frequent toxicities were edemas (37.9%), increased transaminases (27.5), diarrhea (24%) and nauseas (20%). Grade 3-4 toxicities were present in 4 cases with increase transaminases, 1 case of neumonitis and 2 patients with diarrhea. The response rate was 63.8%. The median PFS was 12.66 months (95% CI :7.95- 17.38) and median OS was 23.36 months (95%CI: 16.29-30.44).In patients with brain metastases (15) the response rate was 46.6% and median OS decrease to 15.36 months (95%CI: 0.1-30.8). Conclusions: Our findings indicate that the results of crizotinib in the real world are consistent or sightly improved with prior clinical trial in PFS and OS, despite our sample includes patients for first line and second/later line crizotinib and ¼ of patients had brain metastasic at crizotinib initiation.

e18295 Background: To develop an improvement project, the Lung Cancer Unit of Ramón y Cajal Hospital (Madrid) analyzed 45 patients treated with immunotherapy in 2017 and detected that 55% presented moderate-to-severe Adverse Events (AEs). Consequently, a specialized team from Ramon y Cajal Hospital and the ECO Foundation proposed to identify improvement areas that reduce grade 2 (G2) and 3 (G3) AEs. ECO is a collaboration of experts representing the major Spanish hospitals in the pursuit of excellence in cancer treatment. Methods: The team used as an instrument the American Society of Clinical Oncology (ASCO) Quality Training Program (QTP). A data collection process was conducted before attending the first out of three sessions of the QTP with the revision of medical records from lung cancer patients. The goal for the final QTP session in June 2018 was to reduce G2 and G3 AEs by 25%, by standardizing patient education sessions using ASCO guidelines for the management of immune-related AEs. Results: The data collected showed that G2 and G3 AEs had an impact on quality of care, specifically a treatment delay in 31% of patients, unscheduled visits in 19%, serious complications in 11% and patient dissatisfaction with the reporting system. The team created a cause and effect diagram, in which the most relevant causes were inadequate patient knowledge and a lack of communication with patients between visits. A run chart of the percentage of G2 and G3 AEs during 2017 displayed that G2 AEs were higher during January and August; and G3 AEs in February and December. The team, including patient advocates, prioritized the implementation of these short-term measures for patients: improvement of education, education follow-up, satisfaction questionnaire development and AE knowledge test. By June 2018, the resulting value of the “(mean + range)/standard deviation” formula for AEs perceived knowledge in patients increased from 5.4 to 11.1 points, the same value for patients’ AEs knowledge increased from 7.3 to 13.8 points, the percentage of G2 AEs reduced in 5% and the percentage of G3 AEs maintained in 0%. Conclusions: This improvement approach indicates the need to continue further quality projects in healthcare. Broader participation of Spanish hospitals in improvement initiatives will enhance the goal of a quality-oriented health care system.

e20579 Background: The current treatment of advanced non-small cell lung cancer (NSCLC) is conditioned by the presence of molecular and immunohistochemical biomarkers. In the absence of these, the therapeutic option is the use of chemotherapy with or without antiangiogenic agents. The efficacy of non-target systemic treatments is not proven, beyond a second-line and the experiences in their use are limited to retrospective analyzes. We present the experience of the Grupo Gallego de Cáncer de Pulmón in patients with advanced NSCLC treated exclusively with three or more lines of chemotherapy. Methods: Retrospective analysis of patients with advanced NSCLC, treated with three or more lines of chemotherapy in standard regimen, with or without antiangiogenic agents, in Galicia´s hospitals, Spain. Results: We included 168 patients (134 male and 34 female) treated with three or more chemotherapy lines, with a median age at the time of receiving the first-line, of 60.84 years (41-83). Of these, 51 (30,35%) received a fourth-line and 18 (10,74%) a fifth-line of treatment. None received antitarget therapy or immunotherapy. The median overall survival (OS) was 18.1 months. The median OS after the third line was 6.1 months, with 73% of patients alive at three months and 44% six months after the start of that therapeutic line. We did not appreciate differences in OS between those who received three lines and those who received the largest number of subsequent treatments. Our multivariate analysis (age, gender, histology, performance status at initiation of each teatment-line, response to previous treatments) identified that the individuals who benefited the most were those under the age of 60 years, PS-ECOG 0-1 at diagnosis and those with a more durable response to the first-line. Conclusions: The third-line of chemotherapy can benefit those patients with advanced NSCLC, under 60 years of age at the time of diagnosis, with good performance status and with long-lasting responses to the first line of treatment. We did not see benefit in adding fourth or fifth-line of chemotherapy. All data will be presented in the 2019 ASCO annual meeting.

Background: Bone is the most common lesion in metastatic breast cancer (MBC) patients. Pain due to bone disease is a very limiting and frequent symptom. We evaluated prospectively the BOMET-QoL questionnaire in the context of normal clinical practice, irrespectively of the treatment received, in order to assess the impact of bone metastasis on the Health-Related Quality of Life (HRQoL) of patients with MBC. Material and Methods: This is an observational, prospective, multicenter study conducted in Spain. Patients diagnosed of MBC with bone disease and a life expectancy ≥ 8 months were eligible. Patients completed the bone metastasis Quality of life questionnaire (BOMET-QoL), a Visual Analogue Scale (VAS) for pain and a self-perception of health status item at baseline and 4, 8, 12, 16, 20 and 24 months thereafter. Socio-demographic, clinical and therapeutic data were also collected. Assuming a level of significance of 0.05 and a 20% drop-out rate, 174 patients were to be included in the study in order to estimate the QoL with a precision of ±3.75. Results: From October-2007 to May-2010 172 evaluable patients were included in 15 Spanish institutions. Median age was 58 years (29.6-88.6). Bone disease was most frequently localized in the backbone (76.2% of patients), pelvis (53.5%) and ribs (45.3%). Seventy patients (40.5%) had visceral disease. Most patients (147, 88.5%) had ECOG 0-1. At study entry, 65 patients were receiving analgesic therapy (44 with NSAIDs and 21 with opioids) and 136 were receiving bisphosphonates. The values obtained on the BOMET-QoL and pain VAS scores at the different visits showed a moderate positive correlation (0.2-0.5; p Conclusions: The BOMET-QoL questionnaire is a consistent instrument to evaluate the HRQoL of patients with bone metastasis from breast cancer in regular clinical practice conditions, with regards to cross-sectional and longitudinal validity, feasibility and sensitivity to change. BOMET-QoL is easy to understand and can be completed in a short time by the majority of patients. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-10-02.

To evaluate the efficacy and safety profile of the combination of panitumumab and irinotecan every 3 weeks in a phase II trial as second-line treatment in patients with advanced wild-type (WT) K-RAS colorectal cancer (CRC). Fifty-three patients received 9 mg/kg of panitumumab followed by 350 mg/m2 of irinotecan every 21 days until disease progression, unacceptable toxicity or consent withdrawal. Median age of patients included was 67 years. All patients had previously received 5-fluorouracil, 84 % oxaliplatin and 8 % irinotecan as first-line treatment. Patients received a median of five infusions of panitumumab and irinotecan. On an intention-to-treat analysis, 12 patients (23 %) achieved partial responses and 22 patients (41 %) achieved disease stabilization. Median progression-free survival and overall survival were 4.5 and 15.1 months, respectively. The most frequent treatment-related severe toxicities per patient were diarrhoea (35.8 %), followed by skin rash (32.1 %), asthenia (18.9 %) and neutropenia (13.2 %). A significant association between clinical response and incidence and grade of skin toxicity was observed (p = 0.0032). This study shows that the administration of panitumumab plus irinotecan every 3 weeks is safe, active and feasible as second-line treatment in patients with advanced WT K-RAS CRC.

Introduction Video-assisted thoracoscopic surgery has become the technique of choice in the early stages of lung cancer in many centers although there is no evidence that all of the surgical approaches achieve the same long-term survival. Method We carried out a retrospective review of 276 VATS lobectomies performed in our department, analyzing age, sex, comorbidities, current smoker, FEV1 and FCV, surgical approach, TNM and pathological stage, histologic type, neoadjuvant or coadjuvant chemotherapy, relapse and metastasis time, with the main aim of evaluating the survival rate and disease-free time, especially with regard to the two/three versus single port approach. Result The one/four year global survival rate was 88.1% and 67.6% respectively. Bivariate analysis found that the variables associated with survival are comorbidity, histological type, stage, surgical approach and need for chemotherapy. When we independently analyzed the surgical approach, we found a lower survival rate in the single-port group vs the two/three-port group (VATS). Stratifying by tumoral stage (stage I) and by tumor size (T2) survival was significantly lower for patients with single-port group in comparison to VATS approach. In the multivariate analysis, single-port group is associated with a higher risk of death (HR=1.78). In analyzing disease-free survival, differences were found in both cases in favor of two/three port VATS: P =.093 for local relapses and P =.091 for the development of metastasis. Conclusions These results challenge the use of the single port technique in malignant lung pathologies, suggesting the need for clinical trials in order to identify the role this technique may have in lung cancer surgery.

310 Background: Patient care quality is a discipline with enormous relevance in today’s healthcare. Quality Oncology Practice Initiative (QOPI) is a referral worldwide in quality for oncology practices. ECO Foundation is a collaboration of experts representing the major Spanish hospitals involved in the treatment of cancer patients. ECO reached an agreement with QOPI to involve Spanish hospitals in the QOPI program. Methods: Six rounds of data collection have taken place (Fall 2015 to Round 1 2018). Practices had to register online and submit data into the QOPI platform, and ECO Foundation offered all centers the necessary support. 17 Spanish hospitals have participated in the six rounds, and 7 of them have repeated participation. Core and Lung Cancer modules were completed. Results: During the six rounds, 1877 charts were submitted by the Spanish practices. In most of the rounds, the highest scores were: Pathology report confirming malignancy, Number of chemotherapy cycles documented, Patient consent for chemotherapy and 5 measures of the Lung Cancer module. The lowest scores were: Chemotherapy treatment summary provided to patient within 3 months of chemotherapy end, Chemotherapy treatment summary provided or communicated to practitioner(s) within 3 months of chemotherapy end, Smoking/tobacco use cessation counselling recommended to smokers/tobacco users in past year and Tobacco cessation counselling administered or patient referred in past year. The percentage of participating practices that presented results higher than 70% was successively 64%, 50%, 75% and 100% in the last three rounds. For the 7 hospitals that repeated participation, 3 reported an improvement of their global scores. Regarding QOPI Certification, three Spanish hospitals received this accreditation in September 2017 and one in June 2018. Conclusions: These preliminary results are a good starting point for the continued implementation of the QOPI program in Spain, thus providing a well-structured approach to analyze cancer care. ECO Foundation will continue pursuing excellence and quality with further activities like the QOPI Certification program and Quality Training Program, these being performed for the first time in Spain in 2017 and 2018 respectively.

e16095Background: This study explores the prognostic value of a baseline and dynamic measure of neutrophil-lymphocyte ratio (NLR and dNLR) in metastatic gastric cancer (mGC), as well as chemotherap...

e18879Background: Precision medicine (PM) is an emerging field. Guidelines are needed to develop this approach in an efficient and sustainable way. Methods: Twenty-one Spanish top oncologists met t...

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.

Treatment of anaemia is a very important aspect in the management of cancer patients. In order to carry out a consensus process about the use of erythropoietic stimulating agents (ESAs) in cancer patients, the Spanish Society of Medical Oncology (SEOM) elaborated a working group which coordinated a panel of medical oncology specialists. This working group has reviewed the main issues about the use of ESAs. In addition a consensus meeting was held in Madrid on 25 April 2007. The following conclusions were made: Since ESA treatment increases the haemoglobin (Hb) level and decreases the red blood cell (RBC) transfusion requirements, ESAs should be used within the approved indications in patients undergoing chemotherapy treatment, beginning at a Hb level below 11 g/dl and maintaining it around 12 g/dl, with iron supplements if necessary. Neither increasing the ESA dose in non-responders nor the use of ESAs in the treatment of chronic cancer-related anaemia is recommended.

Neutropenia is a common complication of cancer chemotherapy. Colony-stimulating factors (CSF) may be used to avoid neutropenia-associated complications. The Spanish Society of Medical Oncology (SEOM) recently constituted a working group to review the main issues concerning the use of CSF and carried out a consensus process about the use of CSF in cancer patients, held in Madrid on 26 May 2006. The group concluded the following recommendations: prophylactic use of CSF is recommended when a rate of febrile neutropenia (FN) higher than 20% is expected without the use of CSF or when additional risk factors for neutropenia exist; therapeutic use of CSF is recommended in order to treat FN episodes but not to treat afebrile neutropenic episodes. In addition, the use of CSF is considered effective when used to mobilise stem cells before high-dose chemotherapy and when used for chemotherapy schedule optimisation in dose-dense and in dose-intense regimens.

Myelosuppression, particularly febrile neutropenia (FN), are serious dose-limiting toxicities that occur frequently during the first cycle of chemotherapy. Identifying patients most at risk of developing FN might help physicians to target prophylactic treatment with colony-stimulating factor (CSF), in order to decrease the incidence, or duration, of myelosuppression and facilitate delivery of chemotherapy as planned. We present a risk model for FN occurrence in the first cycle of chemotherapy, based on a subgroup of 240 patients with non-Hodgkin lymphoma (NHL) enroled in our European prospective observational study. Eligible patients had an International Prognostic Index of 0–3, and were scheduled to receive a new myelosuppressive chemotherapy regimen with at least four cycles. Clinically relevant factors significantly associated with cycle 1 FN were older age, increasing planned cyclophosphamide dose, a history of previous chemotherapy, a history of recent infection, and low baseline albumin (

El control de la emesis es uno de los retos que plantea el adecuado manejo de los pacientes sometidos a quimioterapia. Ademas, puede que existan diferencias entre los mecanismos causantes de la emesis aguda y la emesis tardia (posterior a las primeras 24 h). Objetivo: El presente estudio pretende establecer la efectividad de los regimenes basados en dos antagonistas de receptores 5HT3 (granisetron -GR- y ondansetron -OND-) frente a la emesis aguda y tardia, y realizar un analisis farmacoeconomico de los costes directos de la medicacion antiemetica. Material y Metodos: En un estudio prospectivo, observacional, multicentrico, se reclutaron 325 pacientes naive, sometidos al primer ciclo de quimioterapia moderada-altamente emetogena y a uno de los regimenes antiemeticos estudiados. Los pacientes completaron el cuestionario de calidad de vida EORTC QLQC-30 en la visita basal y un diario del paciente durante los 5 dias siguientes (que recogia la maxima intensidad de las nauseas y el numero de episodios de vomitos diarios, si habian necesitado acudir a urgencias y la medicacion antiemetica utilizada). Se estimo la proporcion de respuestas antiemeticas completas y parciales frente a la emesis aguda y tardia, se realizo un estudio de minimizacion de costes y se calculo el cociente de coste-efectividad incremental (ICER) para 1.000 y 10.000 muestras bootstrap. Resultados: No se constataron diferencias en la efectividad aguda del tratamiento (GR = 78,7%; OND = 79,0%). Los costes directos promedio fueron ligeramente superiores para GR ( $$ \bar x = 36,9 $$ €; DT = 35,3) frente a OND ( $$ \bar x = 34,1 $$ €; DT = 34,2). La efectividad frente a la emesis tardia fue superior en la rama GR (51,8%) frente a OND (42,7%), con un coste promedio menor para GR ( $$ \bar x = 19,54 $$ €; IC 90% = 16,57–22,6) frente a OND ( $$ \bar x = 55,26 $$ €; IC 90% = 46,4–64,2). El valor promedio del ICER fue de − 353,1 (P10 = − 1.120,8; P90 = − 85,7). Los diagramas de dispersion del espacio de coste-efectividad mostraron una clara segregacion de los tratamientos. Los resultados para el tratamiento global fueron similares a los obtenidos frente a la emesis tardia. Discusion: Este analisis de coste-efectividad demuestra que granisetron resulta ser mas coste-efectivo que ondansetron tanto en la respuesta tardia como en la global.

Purpose Therapy of patients with advanced gastric or gastroesophageal junction cancer should provide symptom relief and improve quality of life (QOL) because most patients are symptomatic at baseline. Using validated instruments, we prospectively assessed QOL (even after completion of protocol treatment) as one of the secondary end points of the V325 phase III trial. Patients and Methods Four hundred forty-five patients randomly received either docetaxel 75 mg/m2 and cisplatin 75 mg/m2 each on day 1 plus fluorouracil 750 mg/m2/d continuous infusion on days 1 to 5 every 3 weeks (DCF) or cisplatin 100 mg/m2 on day 1 plus fluorouracil 1,000 mg/m2/d continuous infusion on days 1 to 5 every 4 weeks (CF). The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and, where available, the EuroQOL EQ-5D questionnaire were administered every 8 weeks from baseline until progression and then every 3 months. Time to definitive deterioration of QOL parameters was analyzed. Results The proportions of patients having assessable EORTC QLQ-C30 and EQ-5D questionnaires at baseline were 86.0% and 78.7% with DCF, respectively, and 89.7% and 92.8% with CF, respectively. Time to 5% deterioration of global health status (primary end point) significantly favored DCF over CF (log-rank test, P = .01). QOL was preserved longer for patients on DCF than those on CF for all time to deterioration analyses, demonstrating the statistical superiority of DCF compared with CF. Conclusion V325 represents the largest trial with the longest prospectively controlled evaluations of QOL during protocol chemotherapy and follow-up in patients with advanced gastric or gastroesophageal junction cancer. In V325, advanced gastric or gastroesophageal junction cancer patients receiving DCF not only had statistically improved overall survival and time to tumor-progression, but they also had better preservation of QOL compared with patients receiving CF.

Numerous phase II and III clinical trials have demonstrated a higher activity of combined gemcitabine plus docetaxel schedules against non-small cell lung cancer (NSCLC) than that of both agents in monotherapy.This phase II study evaluated a 3-week based schedule of docetaxel 85 mg/m(2) (1-h i.v. infusion, d8) combined with gemcitabine 1,000 mg/m(2) (30-min i.v. infusion; d1,8) as first-line chemotherapy for patients with advanced NSCLC.Forty-one patients with non-resectable, stage IIIB/IV, and bidimensionally measurable disease were enrolled. A total of 182 chemotherapy cycles (median 6, range 1-6) was administered to 40 patients during the study; one patient did not receive chemotherapy due to a protocol deviation. Two patients were not evaluable for treatment efficacy. The overall response rate found was 44% (95% CI, 29-59%): three patients (7%) had a complete response and 15 patients (37%) had a partial response (median duration of response = 4.0 months). With a median follow-up of 8.7 months, the median time to disease progression was 4.4 months and the median overall survival was 7.3 months. The combined gemcitabine plus docetaxel chemotherapy was well tolerated except for pulmonary toxicity. The main grade 3-4 hematological toxicity was neutropenia (28% of patients, 9% of cycles). Two cases of febrile neutropenia were reported. The main grade 3-4 non-hematological toxicity was pulmonary toxicity (23% of patients, 6% of cycles).Gemcitabine 1,000 mg/m(2) on days 1 and 8 in combination with docetaxel 85 mg/m(2) on day 8 given in 3-week cycles is an active and well-tolerated first-line chemotherapeutic regimen for advanced NSCLC.

Purpose In the randomized, multinational phase II/III trial (V325) of untreated advanced gastric cancer patients, the phase II part selected docetaxel, cisplatin, and fluorouracil (DCF) over docetaxel and cisplatin for comparison against cisplatin and fluorouracil (CF; reference regimen) in the phase III part. Patients and Methods Advanced gastric cancer patients were randomly assigned to docetaxel 75 mg/m2 and cisplatin 75 mg/m2 (day 1) plus fluorouracil 750 mg/m2/d (days 1 to 5) every 3 weeks or cisplatin 100 mg/m2 (day 1) plus fluorouracil 1,000 mg/m2/d (days 1 to 5) every 4 weeks. The primary end point was time-to-progression (TTP). Results In 445 randomly assigned and treated patients (DCF = 221; CF = 224), TTP was longer with DCF versus CF (32% risk reduction; log-rank P < .001). Overall survival was longer with DCF versus CF (23% risk reduction; log-rank P = .02). Two-year survival rate was 18% with DCF and 9% with CF. Overall response rate was higher with DCF (χ2 P = .01). Grade 3 to 4 treatment-related adverse events occurred in 69% (DCF) v 59% (CF) of patients. Frequent grade 3 to 4 toxicities for DCF v CF were: neutropenia (82% v 57%), stomatitis (21% v 27%), diarrhea (19% v 8%), lethargy (19% v 14%). Complicated neutropenia was more frequent with DCF than CF (29% v 12%). Conclusion Adding docetaxel to CF significantly improved TTP, survival, and response rate in gastric cancer patients, but resulted in some increase in toxicity. Incorporation of docetaxel, as in DCF or with other active drug(s), is a new therapy option for patients with untreated advanced gastric cancer.

Background Mitoxantrone/prednisone ameliorates symptoms in hormone refractory prostate cancer (HRPC) but has no effect on survival. Docetaxel (Taxotere)/estramustine improves response but with significant toxicity. We reasoned that a sequential administration of the two regimens could be a viable alternative for delivering full doses of chemotherapy, avoiding overlapping toxicity and preserving dose intensity. Patients and methods Thirty HRPC patients were treated with mitoxantrone 10 mg/m2, day 1, every 3 weeks, plus prednisone 5 mg twice daily, for three cycles, followed by estramustine phosphate, 280 mg three times daily, days 1 to 5, plus docetaxel 75 mg/m2, day 2, every 3 weeks for a maximum of 10 cycles. Results All patients were assessable for response and toxicity. After mitoxantrone/prednisone treatment, the prostate-specific antigen (PSA) response rate was 23%, which increased to 63% after completion of sequential mitoxantrone/prednisone and docetaxel/estramustine treatment (12 partial and 7 complete responses). With a median follow-up of 18 months, median survival for all patients was 18 months, and median progression-free survival was 10 months. The mitoxantrone/prednisone regimen was well tolerated, and the only grade 3–4 toxicity was grade 3 neutropenia in four (13%) patients. Twenty-nine patients received a total of 173 cycles of docetaxel/estramustine (median, 6 cycles/patient). Six (20%) patients had grade 3–4 neutropenia and two (6%) patients had febrile neutropenia episodes. The most frequent non-hematological toxic effects were asthenia, nausea and vomiting, edemas and onycholysis. Two (6%) patients had deep venous thrombosis. Conclusions Mitoxantrone/prednisone followed by docetaxel/estramustine is a well-tolerated and active regimen in HRPC. Sequential therapy is feasible and can be used to integrate novel, more active regimens.

The addition of oral capecitabine to docetaxel improves response rate, time to progression (TTP) and overall survival in anthracycline-pretreated metastatic breast cancer (MBC). This phase II study evaluates the efficacy and safety of a 21-day cycle of oral capecitabine (1000 mg m(-2) twice daily, days 1-14) plus i.v. paclitaxel (175 mg m(-2), day 1) in anthracycline-pretreated advanced/MBC. In all, 73 patients were enrolled at 13 Swedish and Spanish centres. The objective response rate was 52% (95% confidence interval (CI): 40-63%) in the intent-to-treat population, including complete responses in 11%. Disease was stabilised in a further 29%. The median time to disease progression (TTP) was 8.1 months and the median overall survival was 16.5 months. The combination was generally well tolerated with a predictable safety profile. The most common treatment-related nonhaematological adverse events were hand-foot syndrome (42%), alopecia (30%) and diarrhoea (26%). The only treatment-related Grade 3/4 adverse events occurring in >5% of patients were alopecia (22%) and hand-foot syndrome (11%). Grade 3/4 neutropenia and lymphocytopenia were reported in 12 and 14% of patients, respectively. Capecitabine plus paclitaxel is highly active with a favourable safety profile in anthracycline-pretreated MBC.

Most patients with operable breast cancer now receive postoperative medical treatment in the form of adjuvant chemotherapy, hormone manipulation or both. These additional interventions have led to a significant improvement in disease-free survival and overall survival. Clinical trials suggest that total chemotherapy dose delivered and dose intensity both affect long-term clinical outcomes, yet clinical practice audits conducted in Europe and the USA show that dose reductions and delays are widely applied when haematological toxicities such as neutropenia occur. In order to reduce the risk of neutropenic complications and help deliver chemotherapy planned dose on time, targeted use of recombinant human granulocyte colony-stimulating factor (rHuG-CSF) in breast cancer patients is recommended. The availability of neutropenia risk prediction models and the first once-per-cycle, fixed-dose rHuG-CSF (pegfilgrastim), will allow more patients to benefit from receiving their planned chemotherapy dose on time, and enable the use of new dose-dense chemotherapy strategies in the adjuvant treatment of primary breast cancer. These hold the prospect of further improving chemotherapy treatment outcomes. (C) 2003 Elsevier Ltd. All rights reserved.

Purpose: To evaluate the efficacy and tolerability of paclitaxel, carboplatin and etoposide when administered in combination to previously-untreated small-cell lung cancer (SCLC) patients. Patients and methods: Patients (n=95) with limited-stage disease (LSD; n=45) or extensive-stage disease (ESD; n=50) from 14 Spanish hospitals were entered into the study. Etoposide was administered 80 mg/m2/day intravenous (i.v.) on days 1, 2 and 3, paclitaxel 175 mg/m2 i.v. on day 3 and carboplatin area-under-the-concentration-time-curve=6; i.v. on day 3, of a 3-week cycle, and repeated for up to 6 cycles. Results: The overall response (OR) rate was 74% (n=70; 32 complete, 38 partial). Although the OR in LSD and ESD patients was similar (73 vs 74%, respectively), the percentage complete response was significantly higher among the former (49 vs 20%). The main toxicities were grade 3–4 neutropenia and febrile neutropenia (62 and 18%, respectively) and there were 3 toxic deaths. Other toxicities were rare or easily manageable. Disease-free survival and overall survival rates at 1 year were 53 and 70% in LSD and 18 and 39% in ESD patients, respectively. Conclusion: The results indicate that the combination of paclitaxel, etoposide and carboplatin has an anti-tumour activity in SCLC that is comparable to other combination regimens, and is well tolerated.

BACKGROUND The response to epoetin-α treatment is hard to predict in cancer patients receiving chemotherapy. METHODS One hundred and seventeen patients were enrolled in this observational study. They had a hemoglobin (Hb) level less than or equal to 10.5 g/dL, were receiving platinum chemotherapy with three cycles pending, and they did not have an iron deficiency or hemolysis. Epoetin-α was administered subcutaneously three times a week at a dose of 150 IU/kg. Ninety patients were examined. RESULTS Response was defined as an increase in Hb of at least 2 g/dL during the treatment period. The response rate was 63.3%. The following data were compared between responders and nonresponders at the onset of treatment and after 2 and 4 weeks of epoetin therapy: Hb, reticulocytes, serum iron, ferritin, transferrin, transferrin saturation index, and endogenous erythropoietin levels. At baseline, these variables were similar for responders and nonresponders; after 2 weeks, responders showed higher Hb (P = 0.001) and transferrin levels (P = 0.042) and reticulocyte counts (P = 0.003); after 4 weeks, only the Hb level showed a significant difference (P < 0.0005). Changes from baseline in Hb level after 2 and 4 weeks correlated significantly (P < 0.01) with response. The change in Hb level at Week 4 was the best predictor. A change in Hb level of less than 0.5 g/dL was associated with a lack of response (predictive power, 71%); a change in Hb greater than or equal to 0.5 g/dL was associated with response (predictive power, 89%). CONCLUSIONS Response to epoetin-α treatment in cancer patients receiving platinum chemotherapy can be predicted from changes in Hb level after 4 weeks of therapy. Cancer 2002;95:2408–13. © 2002 American Cancer Society. DOI 10.1002/cncr.10980

35 Background: This study explores the prognosis impact of nutritional and immune status in metastatic gastric cancer (GC). Recently research has been focused on a proinflammatory status and the relevance of inmune system of the patient in GC. Neutrophil-lymphocyte ratio (NLR) and prognostic nutritional index (PNI) has showed prognostic value in local disease. Our study was assesed in metastatic disease. Methods: One hundred and twenty patients with metastatic gastric adenocarcinoma were retrospectively evaluated between 2011 and 2015. 67.2% were metastatic at diagnosis and 32.8% had a recurrence of disease. Clinical, laboratory and histopathological characteristics were selected as risk factors. The optimal cut-off levels were defined as NLR = 3, PNI (10 x albumin concentration +0.005 x total lymphocyte count) = 43.8, albumin = 3.5 g/dL, body mass index (BMI) = 25. Patients with high NLR and hypoalbuminemia were defined as 2, patients who presented only one abnormally were defined as 1 and those with neither abnormality were defined as 0. Lab data levels were related with survival by Kaplan-Meier and compared by long-rank test. Results: Among 120 patients, mean age was 69 years old, 35% female and 72.5% had no comorbidity. NLR > 3 (6.7 vs 12.5months, p = 0.001), low PNI (7.7 vs 13.1months, p = 0.01) and low albumin (6.2 vs 11.2 months, p = 0.002) were correlated with OS. Significantly, patients with an BMI < 25 had a worse prognosis compared with patients with BMI ≥ 25 (7.4 vs 12.4months, p = 0.02). Obesity in metastatic GC was related with good prognosis in our review. In the group of patients with hypoalbuminemia and h-NLR (27.6%) OS was much worse than patients with normal albumin and low-NLR, 33.6% (4.4months vs. 12.8 months, p < 0.001) Conclusions: High NLR ( > 3) and low PNI ( < 43.8), albumin ( < 3.5g/dL) were correlated with worse outcomes. Moreover, the association in a score of NLR plus albumin showed eight months OS diference. As a recent data in other cancer sites, obesity was related with good prognosis in mGC in our review.