Activity of weekly paclitaxel-cetuximab chemotherapy in unselected patients with recurrent/metastatic head and neck squamous cell carcinoma: prognostic factors.

BACKGROUND: Standard treatment for recurrent/metastatic head and neck squamous cell carcinoma (RM-SCCHN) is based in on platinum and cetuximab combination therapy. Unfortunately, not all patients are candidates to receive platinum-based treatment, because of different conditions as comorbidity and poor performance status. Weekly paclitaxel and cetuximab (WPC) is an active therapeutic alternative, based on a phase II study, with less toxicity. Our main objective is to confirm its activity in unselected patients, mostly unfit for aggressive therapies, analysing also some clinically relevant prognostic factors (PFs). METHODS: Retrospective data was collected for RM-SCCHN patients, treated at our institution between January 2008 and July 2014 with weekly paclitaxel (80 mg/m2) and cetuximab (400/250 mg/m2). RESULTS: 148 patients were treated. The objective response rate (OR) was as follows: 13 patients (8.78%) complete response (CR); 57 patients (38.51%) partial response (PR) and 30 patients (20.3%) stable disease (SD). Median overall survival (OS) was 10 months (95% CI 8.31-11.69) and median progression free survival (PFS) was 7 months (95% CI 5.88-8.12). Response to treatment showed independent prognosis relevance as PF in multivariate analysis for PFS and OS. Furthermore, decline in serum magnesium during the treatment was also an independent PF for OS. CONCLUSIONS: WPC activity was confirmed as a useful therapy on real-life unselected RM-SCCHN patients, with similar benefit to that obtained in the phase II study, and comparable to platinum and cetuximab based treatment, confirming its value in unfit patients. In addition to treatment response, a change in serum magnesium values during treatment was proved as independent PF on OS.

Mejora de la calidad de la especificación de la inclusión en ensayo clínico sobre prescripciones en quimioterapia / Improving the specification quality of inclusion criteria of patients in chemotherapy clinical trials

Objetivos: Evaluar la mejora de la calidad de las prescripciones de quimioterapia para pacientes en ensayo clínico (EC) y analizar si en la orden médica se especifica la participación en el ensayo tras determinar los principales factores de riesgo y mediante la aplicación de medidas correctoras. Método: Estudio retrospectivo de omisiones recogidas durante 2006 y 2007. Con los datos del 2006 se analizaron los factores de riesgo y se implantaron medidas de mejora (información a prescriptores e inicio de prescripción electrónica). Posteriormente, se evaluaron los datos del 2007. Variables analizadas: EC, número de prescripciones, investigador principal, prescriptor, servicio, antineoplásicos y enfermedad. Resultados: Los servicios de Oncología y Hematología realizaron el 57,1% de los ensayos del hospital. En 2006 se recibieron 1.625 prescripciones y se detectaron 151 incorrectas (9,3%), y en 2007 se recibieron 1.858 prescripciones y se detectaron 65 incorrectas (3,5%). En 2006 se observó mayor frecuencia de prescripciones incorrectas en Hematología (34,1%) que en Oncología (8,6%). En 2007 Hematología apenas tuvo omisiones (1,8%) y en Oncología disminuyeron al 3,6%. Respecto a la enfermedad, la tasa de error desapareció prácticamente en mieloma múltiple (del 34,1 al 2,2%) y disminuyó en mama (del 10,8 al 4,4%). El incumplimiento siempre fue mayor cuando el prescriptor difería del investigador principal. Conclusiones: La frecuencia de las prescripciones con error se redujo (pasó del 9,3 al 3,5%). Destaca la reducción extraordinaria en Hematología relacionada con ensayos en mieloma múltiple. Las medidas correctoras han resultado útiles en la mejora de la calidad (AU)

Objectives: To assess the quality improvement of chemotherapy prescriptions for patients included in clinical trials (CT) analyzing whether the prescription is specified for patient participation, after having identified the major risks factors and the appropriate corrective measures are applied. Methods: Retrospective study of omissions collected during 2006 and 2007. After collecting all the information, we analyzed the risks factors and introduced improvement measures (information to prescribers and the beginning of electronic prescription). The 2007 data were then evaluated. Variables analyzed: CT, number of prescriptions, principal investigator, prescriber, department, anti-neoplastic involved and pathology. Results: Oncology and Haematology make up 57.1% of hospital trials. In 2006, 1625 chemotherapy prescriptions were received and there were 151 incorrect prescriptions (9.3%), and in 2007, 1858 prescriptions with 65 (3.5%) incorrect. In 2006, there was a higher frequency of incorrect prescriptions in Haematology (34.1%) and (Oncology (8.6%)). In 2007 Hematology had just 1.8% of omissions and in Oncology it decreased to 3.6%. As regards the pathology, the error rate has virtually disappeared in multiple myeloma prescriptions (34.1 to 2.2%) and decreased in breast cancer (10.8 to 4.4%). The non-fulfilment rate is higher when the prescriber is not the principal investigator. Conclusions: The overall frequency of prescriptions with errors decreased significantly from 9.3% to 3.5%, with an extraordinary reduction in Haematology (34.1% to 1.8%) related to the multiple myeloma trials. The corrective measures implemented have proved to be useful in CT (AU)

Cardiotoxicity associated with trastuzumab in normal clinical practice.

OBJECTIVE: To evaluate the incidence of cardiotoxicity associated with treatment with trastuzumab in clinical practice by describing its characteristics, progress and associated risk factors. METHODS: Retrospective observational study of patients with HER2-positive breast cancer treated with trastuzumab in the fi rst quarter of 2007 in a tertiary hospital. Follow-up was performed from start of treatment until the end of March 2008. The data sources used were the oncological computer program Oncowin® from the pharmacy department and the patient clinical history. We gathered variables related to patient baseline characteristics, treatment and safety. RESULTS: The study included 61 patients. 19 women (32.8%) presented cardiotoxicity, which was the second most common adverse affect of those frequently attributed to the treatment. The average time for toxicity to appear was 7 months, with an average FEVI decrease of 15.6 +/- 9.1 points. In 63.2% of the patients it was symptomatic, and its most frequent manifestation was stress-induced dyspnoea, with a single case of congestive heart failure. Cardiotoxicity led to suspension of treatment in 22.9% of the total patients, which was definitive for 7 out of the 14 patients who interrupted the treatment. No statistically significant differences were found for the possible risk factors. CONCLUSIONS: The incidence of cardiotoxicity in clinical practice is much higher than expected. The important clinical implication of this information and the increasing use of trastuzumab mean that there is a new challenge for the optimal treatment of HER2-positive breast cancer.

Cardiotoxicidad asociada a trastuzumab en la práctica clínica asistencial / Cardiotoxicity associated with trastuzumab in normal clinical practice

Objetivo: Evaluar la incidencia de cardiotoxicidad asociada al tratamiento con trastuzumab en la práctica clínica asistencial, describiendo sus características, su manejo y los factores de riesgo asociados.Método: Estudio observacional retrospectivo que incluyó a pacientes con cáncer de mama HER-2 positivo en tratamiento con trastuzumab durante el primer trimestre de 2007 en un hospital de tercer nivel. Se realizó un seguimiento desde el inicio del tratamiento hasta fi nales de marzo de 2008. Las fuentes de datos utilizadas fueron el programa informático de oncología del servicio de farmacia, Oncowin®, y la historia clínica del paciente. Se recogieron variables relacionadas con las características basales del paciente, con el tratamiento y con la seguridad.Resultados: Se incluyó a 61 pacientes en el estudio; 19 (32,8 %) mujeres presentaron cardiotoxicidad, que supuso el segundo efecto adverso atribuido el tratamiento en frecuencia. La mediana de tiempo de aparición de la toxicidad fue de 7 meses, con un descenso medio de fracción de eyección del ventrículo izquierdo (FEVI) de 15,6 ± 9,1 puntos. En el 63,2 % fue sintomática, la manifestación más frecuente fue la disnea de esfuerzo y hubo un único caso de fallo cardíaco congestivo. La cardiotoxicidad supuso la suspensión del tratamiento en el 22,9 % del total de pacientes, y fue de forma defi nitiva en 7 de las 14 pacientes que interrumpieron el tratamiento. No se hallaron diferencias estadísticamente signifi cativas en cuanto a los posibles factores de riesgo.Conclusiones: La incidencia de cardiotoxicidad en la práctica clínica asistencial se muestra mucho más elevada que la esperada. Su importante implicación clínica y el uso creciente de trastuzumab hacen que suponga un nuevo reto para el tratamiento óptimo del cáncer de mama HER-2 positivo (AU)

Objective: To evaluate the incidence of cardiotoxicity associated with treatment with trastuzumab in clinical practice by describing its characteristics, progress and associated risk factors.Methods: Retrospective observational study of patients with HER2-positive breast cancer treated with trastuzumab in the fi rst quarter of 2007 in a tertiary hospital. Follow-up was performed from start of treatment until the end of March 2008. The data sources used were the oncological computer program Oncowin® from the pharmacy department and the patient clinical history. We gathered variables related to patient baseline characteristics, treatment and safety.Results: The study included 61 patients. 19 women (32.8 %) presented cardiotoxicity, which was the second most common adverse affect of those frequently attributed to the treatment. The average time for toxicity to appear was 7 months, with an average FEVI decrease of 15.6 ± 9.1 points. In 63.2 % of the patients it was symptomatic, and its most frequent manifestation was stress-induced dyspnoea, with a single case of congestive heart failure. Cardiotoxicity led to suspension of treatment in 22.9 % of the total patients, which was defi nitive for 7 out of the 14 patients who interrupted the treatment. No statistically signifi cant differences were found for the possible risk factors.Conclusions: The incidence of cardiotoxicity in clinical practice is much higher than expected. The important clinical implication of this information and the increasing use of trastuzumab mean that there is a new challenge for the optimal treatment of HER2-positive breast cance (AU)