RESUMEN
INTRODUCTION: The standard treatment of ovarian cancer is the combination of debulking surgery and chemotherapy. There is an ongoing discussion on which treatment is best: primary debulking surgery (PDS) or neoadjuvant chemotherapy with interval debulking (NACT-IDS). Even a large randomized trial has not settled this issue. We examined whether comparing a specified treatment protocol would not be a more logical approach to answer this type of discussions. METHODS: A retrospective study of 142 consecutively treated patients according to a fixed protocol between 2000 and 2012 was conducted. Disease-free survival and overall survival were calculated by univariate and multivariate analyses for the whole group and for advanced stages separately. Specific differences between PDS and NACT-IDS were studied. Comparison of results from large databases was made. RESULTS: Disease-free survival and overall 5-year survival for the whole group were 35% and 50%. For the advanced stages, disease-free survival and overall 5-year survival were 14% and 36%, with a median disease-free and overall survival of 16 and 44 months. Of the 98 women with advanced ovarian carcinoma, 54% of operable patients underwent PDS and 44% underwent NACT-IDS. More patients in the PDS group were optimally (<1 cm) debulked: 80% vs 71%. There was no significant difference in survival between PDS or NACT-IDS. Optimally debulked patients had a significant better overall survival in multivariate analysis with a hazard ratio of 2.1. DISCUSSION: Outcome of treatment according to a fixed protocol with a mixture of PDS and NACT-IDS was similar to results from large databases. We hypothesize that comparison of a specific strategy may yield more useful results than awaiting the perfect randomized trial.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Procedimientos Quirúrgicos de Citorreducción/mortalidad , Terapia Neoadyuvante/mortalidad , Neoplasias Ováricas/mortalidad , Tiempo de Tratamiento/normas , Adenocarcinoma de Células Claras/tratamiento farmacológico , Adenocarcinoma de Células Claras/mortalidad , Adenocarcinoma de Células Claras/patología , Adenocarcinoma de Células Claras/cirugía , Adenocarcinoma Mucinoso/tratamiento farmacológico , Adenocarcinoma Mucinoso/mortalidad , Adenocarcinoma Mucinoso/patología , Adenocarcinoma Mucinoso/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Quimioterapia Adyuvante , Terapia Combinada , Cistadenocarcinoma Seroso/tratamiento farmacológico , Cistadenocarcinoma Seroso/mortalidad , Cistadenocarcinoma Seroso/patología , Cistadenocarcinoma Seroso/cirugía , Neoplasias Endometriales/tratamiento farmacológico , Neoplasias Endometriales/mortalidad , Neoplasias Endometriales/patología , Neoplasias Endometriales/cirugía , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/patología , Neoplasias Ováricas/cirugía , Pronóstico , Estudios Retrospectivos , Tasa de Supervivencia , Factores de TiempoRESUMEN
OBJECTIVE: Before the knowledge that 5 years of adjuvant tamoxifen is less efficacious than 2 to 3 years of tamoxifen followed by 2 to 3 years of anastrozole/exemestane, we designed a multicenter double-blind randomized controlled trial in women taking tamoxifen with a thickened endometrium to compare uterine and quality-of-life parameters between those switching to anastrozole and those continuing tamoxifen. METHODS: Asymptomatic postmenopausal women who took adjuvant tamoxifen for 2 to 3 years for operable breast cancer with a double endometrial thickness greater than 7 mm were randomized to 20 mg tamoxifen or 1 mg anastrozole for the remaining duration, totaling 5 years. Tablets were unrecognizable for drug assignment. The primary endpoints were the differences in double endometrial thickness and uterine volume after 1 year. Uterine and quality-of-life data were analyzed using regression methods, and missing values were handled using multiple imputation. RESULTS: Seventy-two women (median age, 60 y) were randomized in five hospitals. Relative to women continuing tamoxifen, women switching to anastrozole experienced a decrease of 53% (95% CI, 41%-63%) in double endometrial thickness and a decrease of 51% (95% CI, 39%-60%) in uterine volume. Vaginal dryness (b = 0.064; 95% CI, 0.016-0.112) and sexual problems (b = 0.054; 95% CI, 0.007-0.102) increased in women taking anastrozole compared with women taking tamoxifen. Treatment arms did not differ regarding withdrawal rate and the experience of (serious) adverse events. CONCLUSIONS: Despite premature trial closure, our data provided valuable insights. Switching to anastrozole strongly decreased the endometrial thickness and uterine volume but increased sexual disturbances. Safe and effective interventions are needed to alleviate sexual dysfunction.