Breast-Conserving Surgery with or without Irradiation in Early Breast Cancer

Abstract

BackgroundLimited level 1 evidence evaluates the omission of postoperative radiotherapy after breast-conserving surgery in older women with hormone receptor positive early breast cancer receiving adjuvant endocrine therapy. MethodsA phase 3, randomized trial of omitting irradiation was performed in 1326 women aged ≥65 years with pT1-T2 (≤3cm), pN0, hormone receptor positive breast cancer treated by breast-conserving surgery with clear margins and adjuvant endocrine therapy. Patients were randomly assigned to whole breast irradiation or no irradiation. The primary endpoint was ipsilateral breast tumor recurrence.Results 658 women were randomized to whole breast irradiation and 668 to no irradiation and the median follow up was 9.1 years. Cumulative incidences of ipsilateral breast cancer recurrence to 10 years were 0.9% (95% CI 0.1-1.7%) for irradiation and 9.5% (95% 6.8-12.3%) for no irradiation [HR 10.4 (95% CI 4.1-26.1.) p<0.0001]. Although the local recurrence was higher in the no irradiation group, distant recurrences at 10 years were not increased in this group and were 3.0% (95%CI 1.4%, 4.5%) with irradiation and 1.6% (95%CI 0.4, 2.8%), without irradiation. Overall survival at 10 years was almost identical, at 80.8% (95% CI 77.2-84.3%) with irradiation vs 80.7% (95% CI 76.9, 84.3%) with no irradiation. Regional recurrence and breast cancer specific survival also did not differ between the two groups. Conclusion 3Omission of radiotherapy increases local recurrence but has no detrimental effect on distant recurrence and overall survival for women ≥65 years with low risk, hormone receptor positive early breast cancer.

Experience with Intraoperative Radiation Therapy in an Urban Cancer Center

“…Women ≥ 70 years of age comprise 30% of our cohort. While the CALGB 9343 and PRIME II trial (13,14,15) offer the option of no RT for those patients despite the increased -albeit still low risk of local failure, our study shows that IORT could be an alternative option for this group of patients who want the bene t of adjuvant RT without the added inconvenience of daily visits. This is currently being explored in the phase II prospective TARGIT-E trial (16).…”

Real World and Public Health Perspectives of Intraoperative Radiotherapy in Early-Stage Breast Cancer: A Multidisciplinary Analysis Beyond the Statistical Facts

“…In total, 1,326 patients were studied and managed with WBRT or observation. Overall survivals were equal; however, there were very high local recurrence rates in the observation arm, as shown in Figure 2 (9.5% versus 0.9% between observation vs. RT arms, respectively) [58]. This again speaks more in favor of IORT in low-risk patients considering their QOL (e.g., the fear of recurrence as well as the inconvenience of requiring surveillance periodically) and the added costs of surveillance.…”

“…One of the recent options can be even completely omitting RT in EBC in very selected populations [ 58 ]. In a recent study, Kunkler et al reported the results of a phase III randomized study in women 65 years or older with eligibility criteria similar to that of IORT eligibility for EBC.…”

“…In total, 1,326 patients were studied and managed with WBRT or observation. Overall survivals were equal; however, there were very high local recurrence rates in the observation arm, as shown in Figure 2 (9.5% versus 0.9% between observation vs. RT arms, respectively) [ 58 ].…”

“… This image is reproduced from Kunkler et al [ 58 ], and permission was obtained from the licensed content publisher Massachusetts Medical Society. …”