Purpose: To determine whether there is a benefit to adjuvant radiation therapy after breast-conserving surgery and tamoxifen in women age ≥ 70 years with early-stage breast cancer. Patients and Methods: Between July 1994 and February 1999, 636 women (age ≥ 70 years) who had clinical stage I (T1N0M0 according to TNM classification) estrogen receptor (ER) –positive breast carcinoma treated by lumpectomy were randomly assigned to receive tamoxifen plus radiation therapy (TamRT; 317 women) or tamoxifen alone (Tam; 319 women). Primary end points were time to local or regional recurrence, frequency of mastectomy, breast cancer–specific survival, time to distant metastasis, and overall survival (OS). Results: Median follow-up for treated patients is now 12.6 years. At 10 years, 98% of patients receiving TamRT (95% CI, 96% to 99%) compared with 90% of those receiving Tam (95% CI, 85% to 93%) were free from local and regional recurrences. There were no significant differences in time to mastectomy, time to distant metastasis, breast cancer–specific survival, or OS between the two groups. Ten-year OS was 67% (95% CI, 62% to 72%) and 66% (95% CI, 61% to 71%) in the TamRT and Tam groups, respectively. Conclusion: With long-term follow-up, the previously observed small improvement in locoregional recurrence with the addition of radiation therapy remains. However, this does not translate into an advantage in OS, distant disease-free survival, or breast preservation. Depending on the value placed on local recurrence, Tam remains a reasonable option for women age ≥ 70 years with ER-positive early-stage breast cancer.

These NCCN Guidelines Insights highlight the important updates/changes to the surgical axillary staging, radiation therapy, and systemic therapy recommendations for hormone receptor–positive disease in the 1.2017 version of the NCCN Guidelines for Breast Cancer. This report summarizes these updates and discusses the rationale behind them. Updates on new drug approvals, not available at press time, can be found in the most recent version of these guidelines at NCCN.org. These NCCN Guidelines Insights highlight the important updates/changes to the surgical axillary staging, radiation therapy, and systemic therapy recommendations for hormone receptor–positive disease in the 1.2017 version of the NCCN Guidelines for Breast Cancer. This report summarizes these updates and discusses the rationale behind them. Updates on new drug approvals, not available at press time, can be found in the most recent version of these guidelines at NCCN.org.

Purpose: The Radiation Therapy Oncology Group 9804 study identified good-risk patients with ductal carcinoma in situ (DCIS), a breast cancer diagnosis found frequently in mammographically detected cancers, to test the benefit of radiotherapy (RT) after breast-conserving surgery compared with observation.Patients and Methods: This prospective randomized trial (1998 to 2006) in women with mammographically detected low- or intermediate-grade DCIS, measuring less than 2.5 cm with margins ≥ 3 mm, compared RT with observation after surgery. The study was designed for 1,790 patients but was closed early because of lower than projected accrual. Six hundred thirty-six patients from the United States and Canada were entered; tamoxifen use (62%) was optional. Ipsilateral local failure (LF) was the primary end point; LF and contralateral failure were estimated using cumulative incidence, and overall and disease-free survival were estimated using the Kaplan-Meier method.Results: Median follow-up time was 7.17 years (range, 0.01 to 11.33 years). Two LFs occurred in the RT arm, and 19 occurred in the observation arm. At 7 years, the LF rate was 0.9% (95% CI, 0.0% to 2.2%) in the RT arm versus 6.7% (95% CI, 3.2% to 9.6%) in the observation arm (hazard ratio, 0.11; 95% CI, 0.03 to 0.47; P < .001). Grade 1 to 2 acute toxicities occurred in 30% and 76% of patients in the observation and RT arms, respectively; grade 3 or 4 toxicities occurred in 4.0% and 4.2% of patients, respectively. Late RT toxicity was grade 1 in 30%, grade 2 in 4.6%, and grade 3 in 0.7% of patients.Conclusion: In this good-risk subset of patients with DCIS, with a median follow-up of 7 years, the LF rate was low with observation but was decreased significantly with the addition of RT. Longer follow-up is planned because the timeline for LF in this setting seems protracted.

Chest wall irradiation is becoming increasingly common for mastectomy patients who have opted for immediate breast reconstruction with tissue expanders and implants. The optimal approach for such patients has not yet been defined. This study assesses the outcomes of a reconstruction protocol for patients who require irradiation after tissue expander/implant reconstruction. The charts of all patients who underwent immediate tissue expander/implant reconstruction at Memorial Sloan-Kettering Cancer Center between January of 1995 and June of 2001 and who had not previously undergone irradiation were retrospectively reviewed. A subgroup of patients who required chest wall irradiation after mastectomy and reconstruction was identified. Those patients were treated according to the following treatment algorithm: (1) reconstruction with tissue expander placement at the time of mastectomy, (2) tissue expansion during postoperative chemotherapy, (3) exchange of the tissue expander for a permanent implant approximately 4 weeks after the completion of chemotherapy, and (4) chest wall irradiation beginning 4 weeks after the exchange. All irradiated patients with at least 1 year of follow-up monitoring after the completion of radiotherapy were evaluated with respect to aesthetic outcomes, capsular contracture, and patient satisfaction. A control group of nonirradiated patients was randomly selected from the cohort of patients treated during the study period. During the 5-year study period, a total of 687 patients underwent immediate reconstruction with tissue expanders. Eighty-one patients underwent postoperative irradiation after placement of the final implant. A total of 68 patients who received postoperative chest wall irradiation underwent at least 1 year of follow-up monitoring after the completion of radiotherapy, with a mean follow-up period of 34 months. Seventy-five nonirradiated patients were evaluated as a control group. Overall, 68 percent of the irradiated patients developed capsular contracture, compared with 40 percent in the nonirradiated group (p = 0.025). Eighty percent of the irradiated patients demonstrated acceptable (good to excellent) aesthetic results, compared with 88 percent in the nonirradiated group (p = not significant). Sixty-seven percent of the irradiated patients were satisfied with their reconstructions, compared with 88 percent of the nonirradiated patients (p = 0.004). Seventy-two percent of the irradiated patients stated that they would choose the same form of reconstruction again, compared with 85 percent of the nonirradiated patients. The results of this study suggest that tissue expander/implant reconstruction is an acceptable surgical option even when followed by postoperative radiotherapy and should be considered in the reconstruction algorithm for all patients, particularly those who may not be candidates for autogenous reconstruction.