To address the question of whether axillary dissection is necessary in older women, researchers in Milan, Italy recruited 238 women aged 65-80 years with cT1cN0 breast cancer and randomized them to receive conservative surgery with or without axillary node dissection. The randomized trial started in 1996, and 109 eligible patients who declined to participate in the trial received conservative breast surgery with or without axillary dissection depending on the patient’s preference and/or the surgeon’s opinion. Both the women in the trial and those followed as 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 axillary dissection.
After 15 years of follow-up, breast cancer mortality and overall survival did not differ between the two arms, in either the trial or out-trial groups. The 15-year cumulative incidence of axillary relapse was 6% in women randomized to not receive axillary dissection and none of the women in the out-trial group developed axillary relapse. The researchers concluded that older women with T1N0 breast cancer can be safely and effectively treated with conservative breast surgery, postoperative radiotherapy and tamoxifen for 5 years if ER-positive.
Martelli G, et al. Axillary dissection versus no axillary dissection in older T1N0 breast cancer patients: 15-year results of trial and out-trial patients. Eur J Surg Oncol 2014;40(7):805-812.