Clinical trials in malignant disease

The study reported was designed to assess the value of post-operative radiotherapy following radical mastectomy for breast cancer on a true clinical trial basis. Separate findings are given for each of two distinct post-operative techniques, one mainly covering the flap and axilla, the other mainly the axilla, supraclavicular area, and parasternal region.

No statistically significant overall differences could be established in crude mortality at five years between groups of cases treated prophylactically on orthodox lines and cases ‘watched’ and treated only on need. An apparent minor advantage to the ‘watched’ policy seems to be demonstrated for the surgical Stage-I cases and for younger women.

Investigation of the incidence of local recurrences showed the prophylactic irradiation to have been effective in the treated areas, but that subsequent purposive treatment eventually evened out the situation to a large extent.

Analyses of distant (blood-borne) metastases showed in general remarkable similarity of incidence, but a possible increased incidence in liver metastases in the irradiated cases is commented on.