Internet-based interdisciplinary therapeutic group (Grupo Interdisciplinar Online, GIO) for perinatal anxiety and depression-a randomized pilot study during COVID-19.

Early interventions may promote reductions in mothers' anxiety-depression (AD) symptoms and improvements in their offspring. This longitudinal randomized research was conducted to assess the effects of interdisciplinary online therapeutic groups (GIO) in at-risk mothers and babies during the COVID-19 pandemic in a disadvantaged neighborhood in Barcelona (Spain). A total of 135 babies were born from March 2020 to June 2021 in a primary healthcare center of Barcelona (Spain). Pregnant woman and new mothers were screened for AD symptomatology through EPDS and STAI questionnaires. Seventy-two of them met high-risk criteria for AD and were included in the study. They were randomly assigned into the two groups of the study: 40 participants were assigned to GIO, the therapeutic group (TG), while 32 of them were assigned to the control group (CG) and received treatment as usual. The course of the mothers' symptomatology was assessed, as well as the baby's development at 6 months old in a blind pediatric follow-up. No differences were found in AD between both groups before the intervention. However, we obtained a significant decrease in AD symptomatology (EPDS p < .001; STAI state p = .015 and STAI trait p < .001at 6 months of life) after the intervention in the TG compared to the CG. Pediatric follow-up at 6 months demonstrated significant differences between groups in babies' development assessment (manipulation p = .003; language p < .001; sociability p < .001). The GIO helped to ensure healthy development of the baby and reduction of the mothers' depressive-anxiety symptomatology.

First-line treatment of exudative vocal fold-lesions by in-office local corticosteroid injection: A literature review.

OBJECTIVES: There are emerging reports of the effectiveness of in-office awake vocal-fold corticosteroid injection in the treatment of exudative vocal-fold lesions. The aim of this study was to review this therapy and specify indications, practical modalities and outcomes. STUDY DESIGN: Systematic review of the literature without meta-analysis. METHODS: A systematic review by PubMed search for the period January 2000 to December 2018 was carried out. RESULTS: Nine articles were included, for a total of 502 lesions: nodules (46.4%), polyps (31.7%), and Reinke's edema (21.9%). Submucosal injection of low-dose triamcinolone acetonide (0.1 to 0.3mL) was transoral, transcutaneous or transnasal via flexible endoscope with operating channel. Lesion volume was significantly reduced in more than 90% of cases, with significant vocal improvement in all studies. Relapse rates ranged between 4% and 31%, with time to relapse of 1 to 40 months. CONCLUSIONS: First-line treatment of exudative glottic lesions by submucosal corticosteroid injection provides at least transient significant reduction in lesion volume and vocal improvement. It is consensually reserved to moderate-sized mainly exudative lesions without fibrosis. In-office injection provides an immediate therapeutic response in case of vocal impairment, enabling surgery under general anesthesia to be postponed.

Fístula cutánea secundaria a litiasis residual poscolecistectomía / Cutaneous fistula caused by postcholecystectomy residual litiasis

No disponible

A randomized phase II/III study of cabazitaxel versus vinflunine in metastatic or locally advanced transitional cell carcinoma of the urothelium (SECAVIN).

BACKGROUND: Despite the advent of immunotherapy in urothelial cancer, there is still a need to find effective cytotoxic agents beyond first and second lines. Vinflunine is the only treatment approved in this setting by the European Medicines Agency and taxanes are also widely used in second line. Cabazitaxel is a taxane with activity in docetaxel-refractory cancers. A randomized study was conducted to compare its efficacy versus vinflunine. PATIENTS AND METHODS: This is a multicenter, randomized, open-label, phase II/III study, following a Simon's optimal method with stopping rules based on an interim futility analysis and a formal efficacy analysis at the end of the phase II. ECOG Performance Status, anaemia and liver metastases were stratification factors. Primary objectives were overall response rate for the phase II and overall survival for the phase III. RESULTS: Seventy patients were included in the phase II across 19 institutions in Europe. Baseline characteristics were well balanced between the two arms. Three patients (13%) obtained a partial response on cabazitaxel (95% CI 2.7-32.4) and six patients (30%) in the vinflunine arm (95% CI 11.9-54.3). Median progression-free survival for cabazitaxel was 1.9 versus 2.9 months for vinflunine (P = 0.039). The study did not proceed to phase III since the futility analysis showed a lack of efficacy of cabazitaxel. A trend for overall survival benefit was found favouring vinflunine (median 7.6 versus 5.5 months). Grade 3- to 4-related adverse events were seen in 41% patients with no difference between the two arms. CONCLUSION: This phase II/III second line bladder study comparing cabazitaxel with vinflunine was closed when the phase II showed a lack of efficacy of the cabazitaxel arm. Vinflunine results were consistent with those known previously. TRIAL NUMBER: NCT01830231.

Efectos de la imitación en la interacción social recíproca en un niño con Trastorno del Espectro Autista Grave / Effects of imitation on mutual social interaction in children with severe autism spectrum disorder / Efectes de la imitació en la interacción social recíproca en un nen amb trastorns de l'espectre autista greu

Los niños con trastorno del espectro autista (TEA) presentan dificultades de empatía y relación social. Estudios previos sugieren un déficit primario en el sistema de neuronas espejo. En este estudio de caso único se ha aplicado la metodología observacional para investigar el uso de la imitación en un proceso de una psicoterapia de orientación psicoanalítica en un niño con TEA grave. Los resultados sugieren que el uso de la imitación en este tipo de psicoterapia es una opción recomendable, ya que favorece los procesos de diferenciación y mejora las capacidades de interacción

Children with autism spectrum disorders (ASD) show difficulties in empathy and social interaction. Previous studies suggest primary deficits in the mirror system brain network. In this single case study observational methodology has been used to investigate the process of a psychoanalytic psychotherapy with imitation in a child with severe ASD. Results suggest that the use of imitation within this psychotherapy approach promote the differentiation processes and stimulates social interaction

Efectes de la imitació en la interacció social recíproca en un nen amb trastorn de l’espectre autista greu. Els nens amb trastorn de l’espectre autista (TEA) presenten dificultats d’empatia i relació social. Estudis previs suggereixen un dèficit primari en el sistema de neurones mirall. En aquest estudi de cas únic s’ha aplicat la metodologia observacional per investigar l’ús de la imitació en un procés d’una psicoteràpia d’orientació psicoanalítica en un nen amb TEA greu. Els resultats suggereixen que l’ús de la imitació en aquest tipus de psicoteràpia és una opció recomanable, ja que afavoreix els processos de diferenciació i millora les capacitats d'interacció

Hypoxia imaging with [18F]-FMISO-PET for guided dose escalation with intensity-modulated radiotherapy in head-and-neck cancers.

BACKGROUND AND PURPOSE: Positron emission tomography (PET) with [(18)F]-fluoromisonidazole ([(18)F]-FMISO) provides a non-invasive assessment of hypoxia. The aim of this study is to assess the feasibility of a dose escalation with volumetric modulated arc therapy (VMAT) guided by [(18)F]-FMISO-PET for head-and-neck cancers (HNC). PATIENTS AND METHODS: Ten patients with inoperable stages III-IV HNC underwent [(18)F]-FMISO-PET before radiotherapy. Hypoxic target volumes (HTV) were segmented automatically by using the fuzzy locally adaptive Bayesian method. Retrospectively, two VMAT plans were generated delivering 70 Gy to the gross tumour volume (GTV) defined on computed tomography simulation or 79.8 Gy to the HTV. A dosimetric comparison was performed, based on calculations of tumour control probability (TCP), normal tissue complication probability (NTCP) for the parotid glands and uncomplicated tumour control probability (UTCP). RESULTS: The mean hypoxic fraction, defined as the ratio between the HTV and the GTV, was 0.18. The mean average dose for both parotids was 22.7 Gy and 25.5 Gy without and with dose escalation respectively. FMISO-guided dose escalation led to a mean increase of TCP, NTCP for both parotids and UTCP by 18.1, 4.6 and 8% respectively. CONCLUSION: A dose escalation up to 79.8 Gy guided by [(18)F]-FMISO-PET with VMAT seems feasible with improvement of TCP and without excessive increase of NTCP for parotids.

A cross-sectional study comparing strength profile of dorsal and palmar flexor muscles of the wrist in epicondylitis and healthy men.

BACKGROUND: Strength training has been proposed by several authors to treat Lateral Epicondylitis. However, there is still a lack of information concerning muscle weakness and its relationship to imbalances and fatigability of forearm muscles during dynamic conditions in subjects after epicondylitis recovery. AIM: To analyze the relationship between lateral humeral epicondylitis, and forearm muscle strength and fatigue. SETTING: Rehabilitation specialized center POPULATION: Cross-sectional study in eight former epicondylitis men free of symptoms and actively working at the moment of the evaluation and eight healthy men volunteers. METHODS: Isokinetic tests were performed at different velocities in order to assess strength in concentric and eccentric contractions. Additionally, a long-term concentric test was carried out in order to analyze strength during endurance. The following variables were analyzed: Average torque of dorsal and palmar flexors of the wrist and ratio of agonist/antagonist for non-endurance contractions; length of initial and final plateaus and the slope of average torque decay during the endurance test. RESULTS: In both groups, average torque produced by palmar flexor muscles was higher than that produced by dorsal flexor muscles. Patients showed higher strength in palmar flexor muscles, whereas dorsal flexor strength was similar for both populations. Palmar flexor vs. dorsal flexor ratio was significantly higher in patients for eccentric contractions. Regarding fatigue, results showed that torque decreased earlier in patients. CONCLUSIONS AND CLINICAL REHABILITATION IMPACT: Both palmar flexor force and palmar/dorsal ratio in eccentric exercise were significantly higher in patients. This finding indicates a muscular imbalance in patients underlying the epicondylitis condition. Additionally, former patients fatigued earlier. Findings indicate that muscle imbalances and fatigability might be related to lateral epicondylitis. This information may be useful in the design and monitoring of programs intended for lateral epicondylitis rehabilitation. More studies are necessary to conclude if these differences are cause or consequence of the epicondylitis.

[Chondrocalcinosis of the temporomandibular joint revealed by a hearing loss: a case report]. / Une chondrocalcinose de l'articulation temporo-mandibulaire révélée par une hypoacousie: à propos d'un cas.

INTRODUCTION: Chondrocalcinosis is a microcrystalline arthropathy that principally affects the knee. It is a rare disorder, usually asymptomatic, that occurs mainly in the elderly people. PURPOSE: To report a case of a temporomandibular joint chondrocalcinosis with ossicular contact revealed by a conductive hearing loss. CASE REPORT: We describe the case of a 57-year-old man with a right conductive sudden hearing loss of 15 dB. The CT scan revealed a lytic lesion in the right attic extended to the middle cerebral fossa in contact with the ossicles with a suspicion of lysis of the head of the malleus. MRI showed a lesion enhancing after gadolinium injection on T1 weighted images. A biopsy revealed a chondrocalcinosis of the temporomandibular joint. Due to the complexity of surgical excision and the benin character of the lesion, a medical treatment and a radiologic follow-up every six months were proposed. CONCLUSION: Chondrocalcinosis of the temporo-mandibular joint is rare especially when it is revealed by a hearing loss. We present here a review of the literature.

Use of the Ambu(®) aScope™ in 10 patients with predicted difficult intubation.

Fibreoptic intubation is the gold standard for patients with predicted difficult intubation. The Ambu(®) aScope™ is a single-use device for fibreoptic tracheal intubation. We assessed its performance in 10 patients with predicted difficult tracheal intubation. The procedure was easy and successful in nine patients. However, the limited time of use did not permit intubation in one patient who required three attempts with different size tracheal tubes. The limited image resolution that can be expected of a single-use fibreoptic system and the absence of a suction channel are other potential limitations. On the other hand, being single-use this device has the advantage of avoiding the risk of infectious disease transmission and is always ready to use.

[Ultrasound-guided single dose injection of 0.5% levobupivacaine or 0.5% ropivacaine for a popliteal fossa nerve block in unilateral hallux valgus surgery]. / Levobupivacaína 0.5% frente a ropivacaína 0.5% en el bloqueo poplíteo con dosis única de anestésico local por abordaje posterior dirigido por ecografía para cirugía de hallux valgus unilateral.

OBJECTIVE: To compare the perioperative analgesic efficacy of 0.5% levobupivacaine and 0.5% ropivacaine injected in a single dose to block the tibial and peroneal nerves for surgery using a posterior (popliteal fossa) approach. MATERIAL AND METHODS: Prospective randomized trial in patients undergoing hallux valgus surgery; anesthesia was provided by blocking nerves in the popliteal fossa with either 0.5% levobupivacaine or 0.5% ropivacaine. Variables studied were times until anesthetic block onset and reversal, need for additional sedation or peripheral block anesthetic, course of postoperative pain at 12, 24 and 48 hours and at 7 days, nighttime rest, need for additional analgesia, and patient satisfaction. RESULTS: Forty-six patients were enrolled. Times until onset of the sensory and motor blocks were similar in the 2 groups. For 57.1% of the patients, the sensory and motor block lasted 24 hours after surgery, with no between-group differences. The levobupivacaine group had less pain at rest 24 hours after surgery (mean [SD] visual analog scale score of 0.16 [0375] vs. 1.17 [1.88] in the ropivacaine group; P < .05). No patient reported severe pain or required additional analgesics. None were readmitted. More than 80% rested well at night. No between-group differences were observed. CONCLUSIONS: The use of a single dose of either levobupivacaine or ropivacaine to provide anesthesia for a popliteal approach to hallux valgus surgery is effective for controlling postoperative pain.

Levobupivacaína 0.5 % frente a ropivacaína 0.5 % en el bloqueo poplíteo con dosis única de anestésico local por abordaje posterior dirigido por ecografía para cirugía de hallux valgus unilateral / Ultrasound-guided single dose injection of 0.5% levobupivacaine or 0.5% ropivacaine for a popliteal fossa nerve block in unilateral hallux valgus surgery

OBJETIVOS: Comparar la eficacia analgésica perioperatoriade levobupivacaína 0,5% frente a ropivacaína0,5% en el bloqueo con punción única de los nerviostibial y peroneo por abordaje poplíteo.MATERIAL Y MÉTODOS: Estudio prospectivo, randomizadoen pacientes sometidos a cirugía de hallux valgus. Bloqueoen el hueco poplíteo con levobupivacaína 0,5% o ropivacaína0,5%. Se estudiaron tiempo de inicio y reversióndel bloqueo anestésico, necesidad de sedación adicional orefuerzo anestésico periférico, evolución del dolor postoperatoriotras la cirugía y a las 12 h, 24 h, 48 h y 7º día postoperatorio,valoración del descanso nocturno, necesidadde analgesia adicional y satisfacción del paciente.RESULTADOS: Se incluyeron 46 pacientes. El tiempo deinstauración de bloqueo sensitivo y motor fue similar enambos grupos. En el 57,1% de los pacientes la recuperacióndel bloqueo motor y sensitivo se produjo durantelas 24 primeras horas de postoperatorio, sin diferenciasentre los grupos. Se constató menor grado de dolor postoperatorioen reposo a las 24 horas de la intervención enel grupo de levobupivacaína (EVA medio 0,16 ± 0,375)frente al grupo de ropivacaína (EVA medio 1,17 ± 1,88),p<0,05. Ningún paciente acusó dolor severo ni precisóanalgesia suplementaria, no se produjo ningún reingreso,más del 80% de los pacientes presentaron buen descansonocturno, sin diferencias entre ambos grupos.CONCLUSIONES: La utilización de levobupivacaína oropivacaína en dosis única por abordaje poplíteo es altamenteeficaz para el control del dolor postoperatorio dela cirugía por hallux valgus(AU)

OBJETIVE: To compare the perioperative analgesicefficacy of 0.5% levobupivacaine and 0.5% ropivacaineinjected in a single dose to block the tibial and peronealnerves for surgery using a posterior (popliteal fossa)approach.MATERIAL AND METHODS: Prospective randomizedtrial in patients undergoing hallux valgus surgery;anesthesia was provided by blocking nerves in thepopliteal fossa with either 0.5% levobupivacaine or0.5% ropivacaine. Variables studied were times untilanesthetic block onset and reversal, need for additionalsedation or peripheral block anesthetic, course ofpostoperative pain at 12, 24 and 48 hours and at 7 days,nighttime rest, need for additional analgesia, and patientsatisfaction.RESULTS: Forty-six patients were enrolled. Times untilonset of the sensory and motor blocks were similar in the2 groups. For 57.1% of the patients, the sensory andmotor block lasted 24 hours after surgery, with nobetween-group differences. The levobupivacaine grouphad less pain at rest 24 hours after surgery (mean [SD]visual analog scale score of 0.16 [0.375] vs 1.17 [1.88] inthe ropivacaine group; P<.05). No patient reportedsevere pain or required additional analgesics. None werereadmitted. More than 80% rested well at night. Nobetween-group differences were observed.CONCLUSIONS: The use of a single dose of eitherlevobupivacaine or ropivacaine to provide anesthesia fora popliteal approach to hallux valgus surgery is effectivefor controlling postoperative pain(AU)

Knee isokinetic test-retest: a multicentre knee isokinetic test-retest study of a fatigue protocol.

AIM: The aim of this study was to establish the test-retest reliability of a knee extensor and flexor muscle fatigue protocol using a biodex system 3 isokinetic dynamometer. METHODS: Three-outpatient Rehabilitation Departments undertook the study. Fatigue was evaluated in the dominant knee of 90 healthy female volunteers, non-sportswomen, aged between 20 and 40. They performed 40 consecutive concentric knee flexions and extensions, at 120 degrees /s, on a Biodex 3 isokinetic dynamometer. Two evaluations were done over a period of seven days. Analysed variables were: maximal repetition of total work, maximal work repetition number, work to body weight ratio, total work, work during first and last third of the protocol, fatigue ratio, work fatigue. Statistical analysis determined mean values, medians and box-plots. Intraclass Correlation Coefficients (ICC) (confidence interval 95 %), t-test and one-way analysis of variance (ANOVA) evaluated reliability. Difference of means (di), standard error of measurement (SEM) and 95% of interval confidence (IC di) were also calculated (P<0.05). RESULTS: All participants completed the study. Reliability data were excellent (ICC>0.75) for total work (0.85), work during first third (0.80) and last third (0.80) in extension, and for total work in flexion. Reliability data were fair to good (ICC 0.4-0.75) for the rest of the variables. Median varied less than 20% in all cases during test-retest. CONCLUSION: This knee fatigue protocol is reliable for flexion and extension, above all when using the total work as a variable. The desirability of multicentre studies in rehabilitation and standardisation of protocols is emphasised.

[The Strategic Plan for the development of Internal Medicine in Andalusia]. / El Plan Estratégico para el desarrollo de la Medicina Interna en Andalucía.

The Strategic Plan for the Development of Internal Medicine in Andalusia arose from the need that the internal medicine doctors had to redefine the purpose and values of their specialty to cope with the numerous changes occurring in the health care area. The project was developed in three phases. First, the tendency of the health care system and current position of the specialty were analyzed. After, the internal and external opinions on the present-future of Internal Medicine were checked out. Finally, five strategic lines with their action plans were established. Specific objectives were defined within each line: results to be achieved, methodology according to action plan. After several years of collegial work in this initiative, very positive results have been achieved. We conclude that the Strategic Plan has been useful to better define the position of our specialty and to state which tools such as those mentioned are effective to cope with the new challenges that may occur in other groups.

[Stroke in the hands of the internist. Cardiovascular risk factors]. / El ictus en manos del internista. Factores de riesgo cardiovascular.

INTRODUCTION: This study has aimed to describe cardiovascular risk factors (CVRF) associated to stroke and their detection and monitoring during the acute episode and the recommendations on hospital discharge. The hypothesis was to check if the integral care of the internist improved the care to these patients. MATERIAL AND METHODS: The clinical histories of patients who had suffered a stock between January 2002 and December 2003 were reviewed, obtaining different biological and clinical variables. RESULTS: We obtained a total of 727 patients suffering cerebral vascular disease (CVD). Of these, 194 (26.7%) patients were discharged from the Emergency Department and 533 required hospitalization. The most frequent etiology was atherothrombotic ischemia, except in patients under 45 years in which it was the undetermined. The most prevalent CVRF was arterial hypertension. CONCLUSIONS: Action on the CVRFs during admission and at the time of discharge was deficient. Secondary prevention programs of CVRF in stroke are required to improve care, quality of life and decrease relapse risk.

El ictus en manos del internista. Factores de riesgo cardiovascular / Stroke in the hands of the internist. Cardiovascular risk factors

Introducción. El objetivo del estudio era describir los factores de riesgo cardiovascular (FRCV) asociados al ictus, y su detección y control durante el episodio agudo, así como las recomendaciones al alta hospitalaria. La hipótesis era comprobar si la atención integral del internista mejoraba el cuidado de estos pacientes. Material y método. Se revisaron historias clínicas de pacientes que habían padecido un ictus entre enero de 2002 y diciembre de 2003, recogiendo diferentes variables biológicas y clínicas. Resultados. Obtuvimos un total de 727 pacientes con enfermedad vascular cerebral (EVC).De éstos, 194 (26,7%) pacientes fueron dados de alta desde el Servicio de Urgencias, y 533 necesitaron hospitalización. La etiología más frecuente fue la isquémica aterotrombótica, excepto en los pacientes menores de 45 años, que fue la indeterminada. El FRCV más prevalente fue la hipertensión arterial. Conclusiones. La actuación sobre los FRCV durante el ingreso y en el momento del alta fue deficiente. Son necesarios programas de prevención secundaria de los FRCV en el ictus para mejorar la asistencia y la calidad de vida, y disminuir el riesgo de recidiva (AU)

Introduction. This study has aimed to describe cardiovascular risk factors (CVRF) associated to stroke and their detection and monitoring during the acute episode and the recommendations on hospital discharge. The hypothesis was to check if the integral care of the internist improved the care to these patients. Material and methods. The clinical histories of patients who had suffered a stock between January 2002 and December 2003 were reviewed, obtaining different biological and clinical variables. Results. We obtained a total of 727 patients suffering cerebral vascular disease (CVD). Of these, 194 (26.7%) patients were discharged from the Emergency Department and 533 required hospitalization. The most frequent etiology was atherothrombotic ischemia, except in patients under 45 years in which it was the undetermined. The most prevalent CVRF was arterial hypertension. Conclusions. Action on the CVRFs during admission and at the time of discharge was deficient. Secondary prevention programs of CVRF in stroke are required to improve care, quality of life and decrease relapse risk (AU)

El Plan Estratégico para el desarrollo de la Medicina Interna en Andalucía / The strategic plan for the development of internal medicine in Andalusia

El Plan Estratégico para el Desarrollo de la MedicinaInterna en Andalucía surgió de la necesidad sentidapor los internistas de redefinir la misión y valores denuestra especialidad, para afrontar los numerososcambios que estaban ocurriendo en la arenasanitaria. El proyecto se desarrolló en tres fases:primero se analizaron las tendencias del sistemasanitario y la situación actual de la especialidad;posteriormente se pulsó la opinión interna y externasobre el presente-futuro de la Medicina Interna; yfinalmente se establecieron 5 líneas estratégicas consus planes de acción. Dentro de cada línea sedelimitaron objetivos específicos, resultados alograr, y metodología acorde al plan de acción. Trasvarios años de trabajo colegiado en esta iniciativa sehan logrado resultados muy positivos. Concluimosque el Plan Estratégico ha resultado útil para situarmejor nuestra especialidad, y que herramientascomo la detallada son efectivas para afrontar nuevosretos que puedan acaecer a otros colectivos

The Strategic Plan for the Development of InternalMedicine in Andalusia arose from the need thatthe internal medicine doctors had to redefine thepurpose and values of their specialty to cope withthe numerous changes occurring in the health carearea. The project was developed in three phases.First, the tendency of the health care system andcurrent position of the specialty were analyzed.After, the internal and external opinions on thepresent-future of Internal Medicine were checkedout. Finally, five strategic lines with their actionplans were established. Specific objectives weredefined within each line: results to be achieved,methodology according to action plan. After severalyears of collegial work in this initiative, very positiveresults have been achieved. We conclude that theStrategic Plan has been useful to better definethe position of our specialty and to state which toolssuch as those mentioned are effective to cope withthe new challenges that may occur in other groups (AU)

Weekly irinotecan plus UFT and leucovorin as first-line chemotherapy of patients with advanced colorectal cancer.

We evaluated the antitumoral efficacy and safety of CPT-11 125 mg/m2 (weekly 90 min i.v. infusion; days 1, 8 and 15) combined with UFT (oral combination of tegafur and uracil) 200 mg/m2/day plus leucovorin (LV) 45 mg/m2/day (both divided into three separate oral doses every 8 h, days 1-21) every 4 weeks as first-line chemotherapy of metastatic colorectal cancer (CRC). Fifty-three patients > or =18 years old with histologically confirmed diagnosis of advanced CRC and bidimensionally measurable disease were enrolled. Three patients (6%) showed CR and 8 patients (15%) showed PR (ORR = 21% (95% CI, 10-32). Stable disease was reported in 19 patients (36%) [tumor control rate = 57% (95% CI, 43-70)]. The median time to progression and overall survival were 7.9 and 18.2 months, respectively (1-year rate = 74%; 2-years rate = 26%). CPT-11/UFT/LV treatment was well tolerated: the most reported grade 3/4 toxicities were neutropenia (11% of patients) and delayed diarrhea (28% of patients). No significant differences in response rate, survival or toxicity were found between younger (< or =65 years) and older patients (> 65 years). Weekly CPT-11 plus UFT/LV was found effective and safe as first-line chemotherapy for metastatic CRC. The addition of CPT-11 to UFT/LV doubled the response rate compared to the results previously reported with UFT/LV, while myelosuppression remained low.