Erlotinib and chemoradiation in patients with surgically resected locally advanced squamous cell carcinoma of the head and neck: a GICOR phase I trial.

BACKGROUND: Standard treatment of advanced squamous cell carcinoma of the head and neck (SCCHN) is concurrent chemoradiation. Erlotinib is an oral tyrosine kinase inhibitor of epidermal growth factor receptor, which has shown activity in SCCHN. Phase I study aims to determine the maximum tolerated dose and dose-limiting toxicity (DLT) of adding erlotinib to chemoradiation therapy in patients with surgically resected locally advanced SCCHN. PATIENTS AND METHODS: Inclusion criteria--SCCHN patients with T3 or T4 primary lesion (except T3N0 with negative resection margins); pathologic N2-N3 disease; poor prognostic findings; age 18-70 years; Eastern Cooperative Oncology Group performance status of zero to one; no evidence of metastasis; adequate organic function and written informed consent. Study design--dose-escalating phase I study with three cohorts of three to six patients each that received increasing doses of erlotinib (100-150 mg/day p.o.) and cisplatin (30-40 mg/m(2) i.v., day 1) for 7 weeks. Radiotherapy--standard regimen of 1.8 Gy daily (5 fractions/week) to a maximum total dose of 63 Gy in 7 weeks. RESULTS: Thirteen male (median age: 57 years) were enrolled. Overall, the regimen was well tolerated. Two of three patients treated at dose level III (erlotinib: 150 mg/day; cisplatin: 40 mg/m(2)) developed DLT consisting of grade 3 infection and grade 3 mucositis. Other toxic effects included diarrhea, asthenia, and rash. Recommended dose for additional studies: erlotinib 150 mg/day p.o.; cisplatin 30 mg/m(2)/week i.v. CONCLUSION: Erlotinib can be safely combined with chemoradiation without requiring dose reduction of chemo- or radiotherapy in this postsurgical population.

The EORTC information questionnaire, EORTC QLQ-INFO25. Validation study for Spanish patients

INTRODUCTION: The EORTC QLQ-INFO25 evaluates the information received by cancer patients. This study assesses the psychometric properties of the QLQ-INFO25 when applied to a sample of Spanish patients. MATERIALS AND METHODS: A total of 169 patients with different cancers and stages of disease completed the EORTC QLQINFO25, the EORTC QLQ-C30 and the information scales of the inpatient satisfaction module EORTC IN-PATSAT32 on two occasions during the patients' treatment and follow- up period. Psychometric evaluation of the structure, reliability, validity and responsiveness to changes was conducted. Patient acceptability was assessed with a debriefing questionnaire. RESULTS: Multi-trait scaling confirmed the 4 multi-item scales (information about disease, medical tests, treatment and other services) and eight single items. All items met the standards for convergent validity and all except one met the standards of item discriminant validity. Internal consistency for all scales (α>0.70) and the whole questionnaire (α>0.90) was adequate in the three measurements, except information about the disease (0.67) and other services (0.68) in the first measurement, as was test-retest reliability (intraclass correlations >0.70). Correlations with related areas of IN-PATSAT32 (r>0.40) supported convergent validity. Divergent validity was confirmed through low correlations with EORTC QLQ-C30 scales (r<0.30). The EORTC QLQ-INFO-25 discriminated among groups based on gender, age, education, levels of anxiety and depression, treatment line, wish for information and satisfaction. One scale and an item showed changes over time. CONCLUSIONS: The EORTC QLQ-INFO 25 is a reliable and valid instrument when applied to a sample of Spanish cancer patients. These results are in line with those of the EORTC validation study (AU)

[Health-related quality of life in the oncology departments of the hospital of Navarra. The EORTC Quality of Life Group]. / Calidad de vida relacionada con la salud en los servicios de Oncología del Hospital de Navarra. Grupo de Calidad de Vida de la.

Quality of life assessment is one of the key elements of the care that is offered to cancer patients. The aim of this work is to present the research line on quality of life that has been carried out since 1992 in the Oncology Departments of the Hospital de Navarra. These departments actively collaborate with the European Organisation of Research and Treatment of Cancer - EORTC - Quality of Life Group in creating questionnaires and also in other projects of this group. Our institution has coordinated the development process of the EORTC information module. Different EORTC questionnaires have been validated for use in our country. Quality of life studies have been carried out in the main tumour sites and in other areas, such as patients' satisfaction with care. This research line has a direct benefit on the attention that patients receive.

Calidad de vida relacionada con la salud en los servicios de Oncología del Hospital de Navarra. Grupo de Calidad de Vida de la EORTC / Health-related Quality of Life in the Oncology departments of the Hospital of Navarra. The EORTC Quality of Life Group

La evaluación de la calidad de vida es uno de los elementos clave de la atención que se ofrece al paciente oncológico. Este trabajo presenta la línea de investigación que sobre la calidad de vida se ha realizado desde 1992 en los servicios de oncología del Hospital de Navarra. Se trabaja dentro del Grupo de Calidad de Vida de la Organización Europea para la Investigación y Tratamiento del Cáncer –EORTC– en el desarrollo de cuestionarios y en otros proyectos. Se ha coordinado la creación de la escala de la EORTC de información. Se han validado instrumentos de medida de dicho organismo para nuestro país. Se han llevado a cabo estudios de calidad de vida en tumores y en satisfacción delos pacientes con los cuidados recibidos. Esta línea de investigación tiene un beneficio directo en la atención que reciben los pacientes(AU)

Quality of life assessment is one of the key elements of the care that is offered to cancer patients. The aim of this work is to present the research line on quality of life that has been carried out since 1992 in the Oncology Departments of the Hospital de Navarra. These departments actively collaborate with the European Organisation of Research and Treatment of Cancer –EORTC– Quality of Life Group in creating questionnaires and also in other projects of this group. Our institution has coordinated the development process of the EORTC information module. Different EORTC questionnaires have been validated for use in our country. Quality of life studies have been carried out in the main tumour sites and in other areas, such as patients’ satisfaction with care. This research line has a direct benefit on the attention that patients receive(AU)

The EORTC Quality of Life questionnaire for patients with colorectal cancer: EORTC QLQ-CR29 validation study for Spanish patients

INTRODUCTION: The EORTC Quality of Life (QL) Group has developed a questionnaire -the EORTC QLQ-CR29- for evaluating QL in colorectal cancer. The aim of this study is to assess the psychometric properties of the EORTC QLQCR29 when applied to a sample of Spanish patients. MATERIALS AND METHODS: Eighty-four locally advanced rectal cancer patients in the treatment follow-up period after receiving surgery and neoadjuvant chemoradiotherapy were included in the study. Seventy subjects also had adjuvant chemotherapy. Patients completed both the EORTC QLQC30 and the QLQ-CR29 once. The psychometric evaluation of the questionnaire's structure, reliability, and convergent, divergent and known-groups validity was performed. RESULTS: Multitrait scaling analysis showed that three of the multi-item scales met the standards of convergent and discriminant validity. These same scales reached the 0.7 Cronbach's coefficient criterion or were close to it. In both analyses exceptions were observed in the blood and mucus in stool scale. Correlations between the scales of the QLQC30 and the module were low (r<0.02) in most cases. A few areas with more related content had higher correlations (r<0.05). Group comparison analyses showed differences in QL between groups of patients based on age, comorbidity, performance status, receipt of adjuvant chemotherapy and surgery modality. CONCLUSIONS: The EORTC QLQ-CR29 is a reliable and valid instrument when applied to a sample of Spanish rectal cancer patients. These results are in line with those of the EORTC validation study (AU)

Hemorragia digestiva en paciente con cáncer de orofaringe. A propósito de un caso / Digestive haemorrhage in a patient with oropharyngeal cancer. A case study

Las metástasis gástricas de tumores sólidos sonmuy infrecuentes y en la mayoría de los casos aparecensimultáneamente con otras metástasis. Los tumoresprimarios que más frecuentemente metastatizan a estenivel son los de pulmón y mama. Los síntomas y datosclínicos que presentan son inespecíficos y pueden abarcardesde la dispepsia hasta una hemorragia gastrointestinalmasiva. Para el diagnóstico la gastroscopia es laherramienta fundamental. En esta nota clínica presentamosun caso inusual de hemorragia digestiva masiva enun paciente con un carcinoma de orofaringe(AU)

Gastric metastases from solid tumours are veryinfrequent and in most cases appear simultaneouslywith other metastases. The most frequent primary tumorsare lung and breast. Clinical data and symptomsare non-specific, and can range from abdominal discomfortto massive gastrointestinal bleeding. The diagnosesmust be established by gastroscopy and biopsy.We present an unusual case of digestive haemorrhagesecondary to gastric metastases from oropharyngealcarcinoma(AU)

[Current state of PET in head and neck tumours: impact on the planning of radiotherapy treatment]. / Estado actual del PET en los tumores de cabeza y cuello: impacto en la planificación del tratamiento radioterápico.

The use of positron emission tomography (PET) in head and neck tumours is increasingly widespread. To its clinical indications--especially in the staging of patients but also in evaluating response to treatment and in detecting or confirming relapses--is now added its possible therapeutic impact through its contribution to the planning of radiotherapy treatment. The integration of PET images in the radiotherapy process seems promising, although important doubts remain about it, which means that it is still under research. This article reviews the current state of PET in the area of head and neck tumours, as well as its impact on radiotherapy treatment planning.

Estado actual del PET en los tumores de cabeza y cuello: impacto en la planificación del tratamiento radioterápico / Current state of PET in head and neck tumours: impact on the planning of radiotherapy treatment

El uso de la tomografía de emisión de positrones(PET) en los tumores de cabeza y cuello está cada vezmás extendido. A sus indicaciones clínicas –especialmenteen el estadiaje de los pacientes pero tambiénen la valoración de la respuesta al tratamiento y en ladetección o confirmación de recidivas–, se une ahorael posible impacto terapéutico a través de su aportaciónen la planificación del tratamiento radioterápico.La integración de las imágenes del PET en el procesoradioterápico parece prometedora, aunque persistenimportantes dudas acerca del mismo que hacen que demomento se reserve al campo de la investigación. Eneste trabajo se revisa el estado actual del PET en el áreade los tumores de cabeza y cuello, así como su impactoen la planificación del tratamiento radioterápico(AU)

The use of positron emission tomography (PET)in head and neck tumours is increasingly widespread.To its clinical indications –especially in the staging ofpatients but also in evaluating response to treatmentand in detecting or confirming relapses– is now addedits possible therapeutic impact through its contributionto the planning of radiotherapy treatment. The integrationof PET images in the radiotherapy process seemspromising, although important doubts remain about it,which means that it is still under research. This articlereviews the current state of PET in the area of head andneck tumours, as well as its impact on radiotherapytreatment planning(AU)

The EORTC Quality of Life Questionnaire for patients with prostate cancer: EORTC QLQ-PR25. Validation study for Spanish patients.

OBJECTIVES: The EORTC Quality of Life (QL) Group has developed a questionnaire, the EORTC QLQ-PR25, for evaluating QL in prostate cancer. The aim of this study is to assess the psychometric properties of the EORTC QLQPR25 when applied to a sample of Spanish patients. MATERIALS AND METHODS: One hundred and thirty-seven prostate cancer patients with localised disease who started radiotherapy with radical intention combined with or without hormonotherapy prospectively completed the EORTC QLQ-C30 and EORTC QLQ-PR25 questionnaires three times: on the first and last day of radiotherapy and in the follow-up period. Psychometric evaluation of the questionnaires' structure, reliability and validity was conducted. RESULTS: Multitrait scaling analysis showed that many of the item-scale correlation coefficients met the standards of convergent and discriminant validity. Exceptions appeared mainly in the scales for bowel symptoms and for hormonal- treatment-related symptoms. Cronbach's coefficients of the scales were good (0.72-0.86) for the urinary symptoms and sexual function scales but they were lower (<0.70) for the bowel and hormonal treatment scales. Most scales of the EORTC QLQ-PR25 had low to moderate intercorrelations. Correlations between the scales of the QLQ-C30 and the module were generally low. Group comparison analyses showed better QL in patients with higher Performance Status. Changes in QL appeared throughout the measurements. These were in line with the treatment process. CONCLUSIONS: The EORTC QLQ-PR25 was a reliable and valid instrument when applied to a sample of Spanish prostate cancer patients. These results are in line with those of the EORTC validation study.

The EORTC Quality of Life Questionnaire for patients with prostate cancer: EORTC QLQ-PR25. Validation study for Spanish patients

OBJECTIVES: The EORTC Quality of Life (QL) Group has developed a questionnaire, the EORTC QLQ-PR25, for evaluating QL in prostate cancer. The aim of this study is to assess the psychometric properties of the EORTC QLQPR25 when applied to a sample of Spanish patients. MATERIALS AND METHODS: One hundred and thirty-seven prostate cancer patients with localised disease who started radiotherapy with radical intention combined with or without hormonotherapy prospectively completed the EORTC QLQ-C30 and EORTC QLQ-PR25 questionnaires three times: on the first and last day of radiotherapy and in the follow-up period. Psychometric evaluation of the questionnaires' structure, reliability and validity was conducted. RESULTS: Multitrait scaling analysis showed that many of the item-scale correlation coefficients met the standards of convergent and discriminant validity. Exceptions appeared mainly in the scales for bowel symptoms and for hormonal- treatment-related symptoms. Cronbach's coefficients of the scales were good (0.72-0.86) for the urinary symptoms and sexual function scales but they were lower (<0.70) for the bowel and hormonal treatment scales. Most scales of the EORTC QLQ-PR25 had low to moderate intercorrelations. Correlations between the scales of the QLQ-C30 and the module were generally low. Group comparison analyses showed better QL in patients with higher Performance Status. Changes in QL appeared throughout the measurements. These were in line with the treatment process. CONCLUSIONS: The EORTC QLQ-PR25 was a reliable and valid instrument when applied to a sample of Spanish prostate cancer patients. These results are in line with those of the EORTC validation study (AU)

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[Digestive haemorrhage in a patient with oropharyngeal cancer. A case study]. / Hemorragia digestiva en paciente con cáncer de orofaringe. A propósito de un caso.

Gastric metastases from solid tumours are very infrequent and in most cases appear simultaneously with other metastases. The most frequent primary tumors are lung and breast. Clinical data and symptoms are non-specific, and can range from abdominal discomfort to massive gastrointestinal bleeding. The diagnoses must be established by gastroscopy and biopsy. We present an unusual case of digestive haemorrhage secondary to gastric metastases from oropharyngeal carcinoma.

Quality of Life assessment through the EORTC questionnaires of colorectal cancer patients in advanced disease stages

PURPOSE: The purpose of the present work is to evaluate Quality of Life in a group of colorectal cancer patients in advanced stages of their disease, along a standard chemotherapy treatment protocol, through the EORTC core questionnaire QLQ-C30 and the colorectal cancer module QLQ-CR38. These two questionnaires had previously been validated in our country. The present study has the novelty of its use during the chemotherapy treatment. MATERIALS AND METHODS: A consecutive sample of 44 colon o rectal cancer patients in stage IV, from an initial group of 46 patients who were addressed, have filled in the questionnaires, in three moments during their treatment process. Clinical and demographic data have also been recorded. Quality of Life scores and changes in them among the three assessments have been calculated. RESULTS: The quality of life scores of patients who have followed the treatment have been >70 points (100) in most dimensions, and has shown similar to the clinical data. Changes of >20 points in the quality of life scores during the treatment process appear in areas related to toxicity, fatigue and insomnia. Quality of life has been stable or has had small changes (between 10 and 20 points) in most dimensions. CONCLUSIONS:Quality of Life in the present sample has been good in general. The treatment has been administered to patients who could tolerate it adequately (AU)

Chemotherapy and concurrent hyperfractionated radiotherapy for patients with limited small-cell lung cancer: long term results from a single institution and a review of the literature

- Objetivos: Nuestro principal objetivo fue estimar la supervivencia libre de enfermedad (SLE) y la supervivencia global (SG) a largo plazo, en pacientes con enfermedad limitada de cáncer de pulmón de células pequeñas (EL-CPCP), tratados con quimioterapia y radioterapia torácica (RTT) hiperfraccionada concurrente. También se evaluó la toxicidad y la respuesta al tratamiento.- Material y métodos: 23 pacientes EL-CPCP, confirmados histológica o citológicamente, fueron tratados con quimioterapia y RTT hiperfraccionada concurrente. La quimioterapia consistió en 4 ciclos de 20 mg/m2/d de cisplatino (P) y 80 mg/m2/d de etopósido (E). Los ciclos se repitieron cada 21 días. La dosis total de RTT fue de 45 Gy. Los pacientes que obtuvieron una respuesta clínica completa (RC) o una respuesta parcial (RP) recibieron irradiación craneal profiláctica (ICP). El protocolo fue completado en 21 pacientes (91 por ciento). La SLE y la SG fueron calculadas por el método de KaplanMeier.- Resultados: Con una mediana de seguimiento para el grupo entero de pacientes, la SG a los 2, 4 y 6 años fue de 52.2 por ciento, 29.4 por ciento y 23.5 por ciento, respectivamente. La SLE a los 2, 4 y 6 años fue de 52.2 por ciento, 33.8 por ciento y 21.1 por ciento, respectivamente. Respuestas objetivas se observaron en 21 pacientes (91 por ciento): 17 pacientes (74 por ciento) alcanzaron RC y 4 pacientes (17 por ciento) alcanzaron RP. La principal toxicidad fue hematológica.- Conclusiones: Los resultados de este estudio, apoyan la eficacia de la RTT administrada dos veces al día concurrente con EP, en pacientes con EL-CPCP aunque muchos de estos pacientes probablemente sean enfermedad diseminada al inicio del diagnóstico o tratamiento. La toxicidad resultó ser aceptable y menor sobre otros regímenes (AU)

Situación actual de la quimio-radioterapia en el cáncer de cabeza y cuello / Present date of radio-chemotherapy of head and neck cancer

A pesar de que el pronóstico de los pacientes con carcinomas de cabeza y cuello (CCC) en estadíos precoces es relativamente bueno con el tratamiento estándar -cirugía o radioterapia-, el pronóstico de los CCC localmente avanzados es mucho peor, con tasas de curación inferior al 30 por ciento. Dado que son tumores sensibles a la radioterapia y también a la quimioterapia, numerosas investigaciones han sido realizadas usando ambas modalidades terapéuticas con el fin de aumentar la actividad antineoplásica y, finalmente, prolongar la supervivencia de estos pacientes. Hasta el momento, salvo en los tumores de la nasofaringe, no existe evidencia de que la quimioterapia administrada antes o después del tratamiento local (cirugía o radioterapia) mejore el control local o la supervivencia. Sin embargo, cuando se utiliza la quimioterapia de forma simultánea o concomitante con la irradiación, produce un efecto radiopotenciador que clínicamente se traduce en un aumento de la tasa de respuestas y en la supervivencia de los pacientes. El tratamiento radioquimioterápico concomitante produce una mayor toxicidad que el tratamiento radioterápico exclusivo. El grado de toxicidad depende de factores del paciente y, sobre todo, del esquema terapéutico utilizado. En este artículo se comentan los trabajos más significativos relacionados con la radio-quimioterapia en los CCC y se hace una breve revisión del estado actual del tratamiento radioquimioterápico (AU)

[Priapism as the first manifestation of chronic granulocytic leukemia]. / Priapismo como primera manifestación de una leucemia granulocítica crónica.

We report a case of priapism in a patient with philadelphia positive chronic granulocytic leukemia. Combined medical and surgical therapy, including chemotherapy with hydroxyurea and multiple punctures of the corpora cavernosa respectively, effected a rapid detumescence and resolution of the priapism and control of the primary disease, although subsequent ability of erection was not fully restored.