The PRIME (Post-Operative Radiotherapy in Minimum-Risk Elderly) Breast Cancer Trial of Adjuvant Radiotherapy after Breast Conserving Surgery: Impact on Quality of Life and Cost-Effectiveness at Three Years.
Authors: Kunkler I. , Williams L. , King C. , Prescott R. , Dixon M. , van der Pol M. 
Published: December 2010

Abstract
Background:Breast cancer in older women is a major and rising health care burden, due to demographic changes in the population. This places increasing pressure on the finite resources of radiotherapy treatment centres.If local recurrence rates in older ‘low risk’ patients were sufficiently low with the omission of radiotherapy (RT) following breast conserving surgery and adjuvant endocrine therapy, decisions on treatment might be influenced by considerations of Quality of Life (QoL) and cost-effectiveness.Methods: Patients over the age of 65 with a ‘low risk’ breast cancer (T0-2,N0,M0) were randomised to receive whole breast RT (40-50 Gy in 15-25 fractions) or no further treatment. All patients received endocrine therapy.Participants completed a questionnaire at baseline (before randomisation), two weeks after the end of RT (or equivalent time), and then at nine, 15 and 36 months after surgery. QoL was measured by the EORTC QLQ-C30 and -BR23 modules. The Hospital Anxiety and Depression Scale was included to measure mental health, and the EuroQol was used to calculate QALYs for the assessment of cost-effectiveness. Some open-ended questions were included to capture items of potential importance to the patients.Results: Although no differences in the overall QoL scores were detected, there were statistically significant differences between the irradiated and non-irradiated groups in insomnia (higher in the no RT group, p=0.01), breast symptoms (higher in the RT group, p&lt;0.0001), and systemic therapy side effects (higher in the irradiated patients, p=0.055). Social functioning in irradiated patients appeared to lag one time period behind those who did not receive RT, although by three years, this difference was minimal. There was no evidence to suggest a difference in terms of anxiety or depression between the two groups.Although the fatigue domain of the C30 scale showed no apparent difference between the treatment groups, the responses to open-ended questions would suggest otherwise, particularly at two weeks post-surgery, where 28% of the irradiated patients commented on their fatigue, compared with only 2% of those not receiving RT. QALYs in both groups were similar, with the additional cost of providing RT calculated to be £2128 ($2997) per patient. The costs of treating the 3 local recurrences in the non-irradiated group were not large enough for RT to become cost-effective. Conclusions:Radiotherapy was found to be well-tolerated in this group of patients, with no impairment in overall QoL. Some aspects were found to be significantly different between groups. Most of the effects were found to be short term, and had reduced in scale or disappeared by three years. At three years, the omission of RT is cost-effective. The local recurrence rate in the non-irradiated group would need to be at least 5.5% (absolute) higher than that in the irradiated group before radiotherapy would become the cost-effective option.
Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 958.