RESUMEN
Three thousand eight hundred and twelve patients participated in the TemporELLES survey; these patients were treated for breast cancer with intravenous chemotherapy in 105 different outpatient clinics in France. The survey shows that patients spend on average 3hours in the outpatient clinic per chemotherapy session, which includes on average 50minutes of waiting time. Forty percent of patients would like to reduce this waiting time. Availability of new dosage forms and ready to use medications will address the need for reduced waiting time while freeing up time for providing support to the patients.
Asunto(s)
Instituciones de Atención Ambulatoria , Atención Ambulatoria/psicología , Antineoplásicos/administración & dosificación , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/psicología , Personal de Enfermería/psicología , Satisfacción del Paciente , Adulto , Anciano , Anciano de 80 o más Años , Actitud del Personal de Salud , Femenino , Francia , Humanos , Infusiones Intravenosas/métodos , Persona de Mediana Edad , Personal de Enfermería/estadística & datos numéricos , Encuestas y Cuestionarios , Factores de TiempoRESUMEN
BACKGROUND: The Hermine study observed the use of trastuzumab for metastatic breast cancer (MBC) in routine practice, including patients who received trastuzumab treatment beyond progression (TBP). PATIENTS AND METHODS: The study observed 623 patients for > or = 2 years. Treatment was given according to oncologists' normal clinical practices. Endpoints included duration of treatment, efficacy, and cardiac safety. The TBP subanalysis compared overall survival (OS) in 177 patients who received first-line trastuzumab and either continued trastuzumab for > or = 30 days following progression or stopped at or before progression. RESULTS: The median treatment duration was 13.3 months. In the first-, second-, and third-line or beyond treatment groups, the median time to progression (TTP) were 10.3 months, 9.0 months, and 6.3 months, and the median OS times were 30.3 months, 27.1 months, and 23.2 months, respectively. Heart failure was observed in 2.6% of patients, although no cardiac-associated deaths occurred. In the TBP subanalysis, the median OS duration from treatment initiation and time of disease progression were longer in patients who continued receiving trastuzumab TBP (>27.8 months and 21.3 months, respectively) than in those who stopped (16.8 months and 4.6 months, respectively). However, the groups were not completely comparable, because patients who continued trastuzumab TBP had better prognoses at treatment initiation. The median TTP was longer in patients who continued trastuzumab TBP (10.2 months) than in those who stopped (7.1 months). CONCLUSION: The Hermine findings confirm that the pivotal trials of first-line trastuzumab treatment in MBC patients are applicable in clinical practice. The subanalysis suggests that trastuzumab TBP offers a survival benefit to MBC patients treated with first-line trastuzumab.
Asunto(s)
Anticuerpos Monoclonales/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales/administración & dosificación , Anticuerpos Monoclonales/efectos adversos , Anticuerpos Monoclonales Humanizados , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias de la Mama/enzimología , Neoplasias de la Mama/patología , Estudios de Cohortes , Progresión de la Enfermedad , Femenino , Humanos , Persona de Mediana Edad , Metástasis de la Neoplasia , Observación , Farmacoepidemiología , Pronóstico , Estudios Prospectivos , Receptor ErbB-2/antagonistas & inhibidores , Estudios Retrospectivos , Trastuzumab , Resultado del TratamientoRESUMEN
The prevention of delayed emesis following chemotherapy remains an important challenge. This randomized, double-blind, double-dummy, multicenter study was designed to compare the efficacy and tolerance of metopimazine and ondansetron at preventing nausea and emesis in patients receiving chemotherapy. Two hundred patients were evaluated for efficacy: 103 patients received metopimazine (7.5 mg x 2 t.i.d.) and 97 received ondansetron (8 mg b.i.d.) for 5 days. Patients were asked to report episodes of nausea and emesis in a diary, and quality of life (QoL) was evaluated using the Functional Living Index--Emesis questionnaire. The incidence of complete response (defined as no nausea and emesis for 5 days) did not differ between the two treatment arms (53.4% for metopimazine versus 49.5% for ondansetron; P=0.58). No significant difference was found for the incidence of emesis (23.3% for metopimazine versus 30.9% for ondansetron) or QoL. Tolerance was as expected for both drugs and comparable, except for the incidence of gastrointestinal disorders, which was significantly lower in the metopimazine group (19.4 versus 32.7%; P=0.03). We conclude that metopimazine is an alternative to ondansetron that is better tolerated for the prevention of delayed emesis in patients receiving chemotherapy.
Asunto(s)
Antieméticos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Ácidos Isonipecóticos/uso terapéutico , Náusea/tratamiento farmacológico , Ondansetrón/uso terapéutico , Vómitos/tratamiento farmacológico , Administración Sublingual , Método Doble Ciego , Quimioterapia Combinada , Femenino , Humanos , Masculino , Dosis Máxima Tolerada , Persona de Mediana Edad , Náusea/inducido químicamente , Neoplasias/tratamiento farmacológico , Calidad de Vida , Encuestas y Cuestionarios , Vómitos/inducido químicamenteRESUMEN
BACKGROUND: To evaluate longitudinal variations of serum HER-2/neu extracellular domain (sHER-2) in metastatic breast cancer patients receiving combined trastuzumab treatment. PATIENTS AND METHODS: Thirty-three patients were monitored by serial sHER-2 ELISA (Oncogene Science). Results were compared to time to progression (TTP) and survival from treatment initiation. Non parametric statistical tests were used. RESULTS: Median sHER-2 before first injection was 41.37 ng/ml (range 7.54-1597.00 ng/ml, n=32). Mean sHER-2 levels differed significantly between responders (n=20) and non responders (n=13) (p<0.0001). Median TTP (266 days, range 35-1000 days) was unrelated to clinico-biological variables at diagnosis or number and site of metastases before treatment. Patients with pre-treatment sHER-2 levels < or = 30 ng/ml (n=14) had a significantly longer TTP than the group with sHER-2 > 30 ng/ml (n=18) (p=0.0346) and sHER-2 levels were of prognostic value for overall survival from first injection (p=0.0150). CONCLUSION: Our results show that monitoring serum HER-2/neu levels during metastatic breast cancer can provide a real time assessment of a woman's HER-2/neu status and can provide important information for therapeutic decisions.