RESUMO
BACKGROUND: Our randomized trial found no survival advantage for axillary dissection (AD) compared observation only (no AD) in older patients with early breast cancer and a clinically negative axilla, indicating that AD is unnecessary. We compared characteristics and outcomes in out-trial patients with those in trial patients to provide indications as to whether AD can be safely omitted outside the trial setting. METHODS: The trial started in 1996, recruiting 238 patients age 65-80 years with cT1cN0 breast cancer, randomized to conservative surgery with or without AD. Over the recruitment period, 109 eligible patients who refused to participate in the trial, also received conservative breast surgery with or without AD depending on patient preference/surgeon opinion. Trial and out-trial patients received conventionally-fractioned whole breast radiation and tamoxifen for five years. Endpoints were breast cancer mortality, overall survival, and cumulative incidence of axillary disease in patients not receiving AD. RESULTS: After 15 years of follow-up, breast cancer mortality and overall survival did not differ between the AD and no AD arms, in either the trial or out-trial cohorts. The 15-year cumulative incidence of axillary relapse was 6% in the no AD arm of the trial group, and zero in the no AD arm of the out-trial group. CONCLUSIONS: Outside the trial setting, older patients with T1N0 breast cancer can be safely treated by conservative surgery, postoperative radiotherapy and tamoxifen for five years (if ER-positive). Axillary surgery is appropriate only for the small proportion of patients who develop overt axillary disease during follow-up.
Assuntos
Neoplasias da Mama/patologia , Neoplasias da Mama/terapia , Excisão de Linfonodo/métodos , Linfonodos/patologia , Mastectomia Segmentar/métodos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Axila/cirurgia , Biópsia por Agulha , Neoplasias da Mama/mortalidade , Quimioterapia Adjuvante , Estudos de Coortes , Intervalos de Confiança , Intervalo Livre de Doença , Fracionamento da Dose de Radiação , Feminino , Avaliação Geriátrica , Humanos , Imuno-Histoquímica , Linfonodos/cirurgia , Invasividade Neoplásica/patologia , Estadiamento de Neoplasias , Prognóstico , Modelos de Riscos Proporcionais , Radioterapia Adjuvante , Medição de Risco , Análise de Sobrevida , Tamoxifeno/administração & dosagem , Fatores de TempoRESUMO
Between 1982 and 1990, 321 elderly patients (range 70-92 years, median age 77) with operable breast cancer (T1 in 219, T2 in 77, T3 in one and T4b in 24 patients) and clinically uninvolved axillary nodes underwent surgery without axillary dissection and received adjuvant tamoxifen. All patients had surgery performed under local anaesthesia. Tamoxifen was given after surgery at the dose of 20 mg daily, indefinitely. With a median follow-up of 67 months (range 42-141), 17 patients developed local relapse, 14 ipsilateral axillary recurrence, five ipsilateral breast cancer, five contralateral breast cancer, 13 second primary and 23 developed distant metastases. The cumulative probability of developing a local, axillary and distant recurrence at 72 months was estimated to be 5.4%, 4.3% and 6.2%, respectively. Out of 244 patients who did not develop any relapse, 83 (25.8%) died from intercurrent disease. The 72 month relapse-free survival rate was 76%. This experience suggests that elderly patients with small tumours without clinical axillary involvement may be satisfactorily treated with conservative surgery and tamoxifen. The importance of axillary dissection is controversial owing to a high response rate to hormonal therapy and an increased death rate due to concomitant diseases.
