ABSTRACT

The first of these two trials enrolled 720 women between 1948 and 1952. Eligible patients under age 70 with newly diagnosed breast cancer were treated with a Halsted radical mastectomy and then randomized to receive kilovoltage radiotherapy to the anterior chest wall and the apex of the axilla (‘quadrate technique’). Another 741 patients were randomized between 1953 and 1955 using a ‘peripheral technique’ that aimed at irradiating the internal mammary, axillary, and supraclavicular lymph nodes as well as the chest wall. Those randomized to the control or ‘watched group’ received radiotherapy if and when a local recurrence was found. The incidence of local recurrences were reduced by nearly two-thirds among those treated with radiotherapy immediately following mastectomy, but the percentage of patients with uncontrolled disease at the time of death was nearly the same in the two groups of patients. There was no significant difference in survival. In the second trial, 598 pre-and perimenopausal women were randomized after primary treatment to ovarian irradiation (450 r) or no ovarian ablation. The survival of the irradiated patients was superior to that of the control group at 10 and 15 years, but this did not reach conventional levels of statistical significance (p0.07 at 10 years). One hundred and forty-nine women with inoperable breast cancer were also randomized in the same fashion, and ovarian ablation did not result in a survival advantage for this group.