RESUMEN
204 eligible patients were entered into a multicentre randomised trial of neo-adjuvant chemotherapy prior to radical radiotherapy. The aim of this study was to assess whether there was any survival advantage in patients undergoing chemotherapy and radiotherapy compared with those given radiotherapy alone. Patients were aged up to 70 years, performance status 0-1/2, with bulky stage IIb, stage III or stage IVa squamous or adenosquamous carcinoma. Three cycles of methotrexate 100 mg/m2 and cisplatin 50 mg/m2 were given at 2-weekly intervals before radical radiotherapy. 104 eligible patients received the combination treatment and 100 radiotherapy only. The two arms of the study were well balanced for tumour and patient characteristics. The response rate to chemotherapy was 49%, 33% of patients in the radiotherapy (XRT) alone arm and 45% of the combination arm were clinically free of tumour at the end of treatment. The median follow-up for surviving patients is 5.4 years (range: 11 months-8 years) and 84% have been followed-up for more than 4 years. 134 patients have died (68 XRT only, 66 combined arm). The median survival RT alone was 111 weeks (95% confidence interval (CI) 72-151 weeks), combination arm 125 weeks (95% CI 79-170 weeks). The estimated death ratio is 0.79 (P = 0.19, 95% CI 0.56-1.12). The estimated 3-year survival is 40% (95% CI 30-50%) RT only compared with 47% (95% CI 37-57%) in the combination arm. Acute and late toxicity of radiotherapy was not increased by the addition of chemotherapy.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma Adenoescamoso/tratamiento farmacológico , Carcinoma de Células Escamosas/tratamiento farmacológico , Neoplasias del Cuello Uterino/tratamiento farmacológico , Adulto , Anciano , Carcinoma Adenoescamoso/radioterapia , Carcinoma de Células Escamosas/radioterapia , Quimioterapia Adyuvante , Cisplatino/administración & dosificación , Inglaterra , Femenino , Humanos , Metotrexato/administración & dosificación , Persona de Mediana Edad , Estadificación de Neoplasias , Escocia , Resultado del Tratamiento , Neoplasias del Cuello Uterino/radioterapiaRESUMEN
OBJECTIVE: To assess the needs of patients with cancer for information about their condition. DESIGN: Cross sectional survey of patients' views by means of semistructured interview with questionnaire. SETTING: A regional cancer centre and two university hospitals in west Scotland. SUBJECTS: 250 (93%) of 269 cancer patients invited to participate in study who were selected by age, sex, socioeconomic status, and tumour site to be representative of cancer patients in west Scotland. MAIN OUTCOME MEASURES: Patients' need to know whether they had cancer, the medical name of their illness, progress through treatment, how treatment works, side effects, chances of cure, and treatment options. RESULTS: 79% (95% confidence interval 73% to 84%) of patients wanted as much information as possible, and 96% (93% to 98%) had a need or an absolute need to know if they had cancer. Most patients also wanted to know the chance of cure (91% (87% to 94%)) and about side effects of treatment (94% (90% to 97%)). When the replies were cross tabulated with patients' age, sex, deprivation score, and type of treatment there was a linear trend for patients from more affluent areas to want more information and those from deprived areas to want less. There was a strong preference for diagnosis of cancer to be given by a hospital doctor (60% (53% to 66%). CONCLUSION: Almost all patients wanted to know their diagnosis, and most wanted to know about prognosis, treatment options, and side effects.
Asunto(s)
Actitud Frente a la Salud , Neoplasias/psicología , Revelación de la Verdad , Adolescente , Adulto , Anciano , Comunicación , Estudios Transversales , Femenino , Encuestas Epidemiológicas , Humanos , Servicios de Información , Masculino , Persona de Mediana Edad , Medición de Riesgo , EscociaRESUMEN
The aim of this study was to see if antibiotic pastilles could reduce radiation mucositis, pain, dysphagia and weight loss in patients undergoing radical radiotherapy for head and neck cancer. A total of 275 patients with T1-T4 tumours entered the study; 136 were allocated to suck four times daily a pastille containing amphotericin, polymyxin and tobramycin. The remaining 139 patients received an identical placebo. In all, 54 patients were unevaluable (24 active, 30 placebo). Bacteriological monitoring was carried out before and twice weekly during treatment. Both arms of the study were well balanced for T and N stage, age, sex and radiation dose (60 Gy). There was a slight imbalance in the site of disease which had no substantive effect on the results. The primary study end point was the percentage of patients who developed intermediate or thick pseudomembranes. No statistically significant difference was found in this end point, with 36% of patients in the active arm developing this type of membrane compared with 48% in the placebo arm (P = 0.118). The estimated odds ratio (placebo/active) of developing an intermediate or thick pseudomembrane was 1.59 (95% CI 0.89-2.82). However a more sensitive test comparing the worst recorded mucositis grade between the two arms was statistically significant (P = 0.009). This indicated that the active pastilles had a beneficial effect, but the magnitude was probably smaller than the trial was designed to detect. There was a reduction in mucositis distribution (P = 0.002), mucositis area (P = 0.028), dysphagia (P = 0.006) and weight loss (P = 0.009) in the active arm. There was a clear tendency for patients with positive cultures for aerobic Gram-negative bacteria (AGNB) (P = 0.003) and yeasts (P = 0.026) during treatment to have more severe mucositis. The active pastilles reduced the percentage of patients with yeast cultures (P = 0.003) but had less effect on AGNB. The benefit derived from the pastilles should materially increase patient tolerance to radical radiotherapy for head and neck cancer.