Lumpectomy Plus Tamoxifen With or Without Irradiation in Women Age 70 Years or Older With Early Breast Cancer: Long-Term Follow-Up of CALGB 9343
Menée sur 636 femmes âgées d'au moins 70 ans et atteintes d'un cancer du sein ER+ de stade T1N0M0 (durée médiane de suivi : 12,6 ans), cette étude évalue, du point de vue du taux de mastectomie, de la survie spécifique et de la survie globale, l'intérêt d'une radiothérapie adjuvante après une tumorectomie combinée à un traitement par tamoxifène
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.
Journal of Clinical Oncology , résumé, 2013