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.

Abstract

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.

• Authors: Kevin S Hughes, Lauren A Schnaper, Jennifer R Bellon, Constance T Cirrincione, Donald A Berry, Beryl McCormick, Hyman B Muss, Barbara L Smith, Clifford A Hudis, Eric P Winer, William C Wood
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 31 Issue 19 Pg. 2382-7 (Jul 01 2013) ISSN: 1527-7755 [Electronic] United States
• PMID: 23690420 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antineoplastic Agents, Hormonal
• Biomarkers, Tumor
• Receptors, Estrogen
• Tamoxifen

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Agents, Hormonal (therapeutic use)
• Biomarkers, Tumor (analysis)
• Breast Neoplasms (chemistry, drug therapy, mortality, pathology, surgery, therapy)
• Female
• Follow-Up Studies
• Humans
• Kaplan-Meier Estimate
• Mastectomy, Segmental
• Neoplasm Recurrence, Local (prevention & control)
• Neoplasm Staging
• Odds Ratio
• Radiotherapy, Adjuvant (statistics & numerical data)
• Receptors, Estrogen (analysis)
• Tamoxifen (therapeutic use)
• Time Factors
• Treatment Outcome