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CALGB 9343: Radiation did not improve survival in elderly women with breast cancer
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2010 ASCO Annual Meeting
The addition of radiation to chemotherapy with tamoxifen did not improve survival, distant DFS, breast cancer-specific survival or breast conservation in women aged 70 years or older with breast cancer.
An earlier analysis of CALGB 9343 published after a median follow-up of 7.9 years showed tamoxifen alone was an effective alternative to tamoxifen and radiation. These newly updated results, said Kevin Hughes, MD, co-director of the Avon Comprehensive Breast Evaluation Center at the Massachusetts General Hospital, suggest that physicians can safely eliminate radiation in the treatment of these patients.
Hughes discussed the results during a press conference in advance of the 2010 ASCO Annual Meeting in Chicago.
From July 1994 to February 1999, researchers recruited 636 women who had been treated with lumpectomy for stage I, ER-positive breast cancer. Patients were randomly assigned to tamoxifen (n=319) or tamoxifen plus radiation (n=317).
At a median follow-up of 10.5 years, 98% of the radiation group and 92% of the tamoxifen-only group were recurrence-free. The probability of being free from mastectomy was 96% for the tamoxifen-alone group and 98% for the radiation group. The probability of being free from distant metastases was 95% for the tamoxifen-alone group and 93% for the radiation group.
Hughes said 10-year breast-cancer-specific survival was 98% in the tamoxifen group vs. 96% in the radiation group. Ten-year OS was 63% for tamoxifen alone and 61% for tamoxifen plus radiation. He said most women in the study died from other causes.
Researchers observed a 6% reduction in ipsilateral breast tumor recurrence for the radiation group. However, Hughes said this meant researchers would have to irradiate more than 300 women to avoid 20 in-breast recurrences.
“But that has no impact on the ultimate ability to preserve the breast, ultimate ability to avoid mastectomy. No impact on distant metastases, no impact on death from breast cancer and no impact on overall survival,” he said. “The question becomes, for women aged 70 and older with these clinical stage I, ER-positive cancers, whether tamoxifen is enough treatment. Certainly, this needs to be discussed with patients, but avoiding radiation in this group is feasible.” – by Jason Harris
It is worth pointing out that this is a relatively common occurrence; older women often have small tumors that are ER-positive without evidence of spread to the lymph nodes. These results are certainly practice-affirming and potentially practice-changing. Many women, when they understand the small benefit, elect to defer radiation therapy, as has been in practice for roughly 20 years. These results give us some comfort as physicians in supporting the patient’s decision, and maybe it will change the recommendations we make to our patients.
– Douglas W. Blayney, MD
Medical Director,
The Comprehensive Cancer Center at the University of Michigan
For more information:
Hughes KS. #507. Lumpectomy plus tamoxifen with or without irradiation in women age 70 or older with early breast cancer. Presented at: the 2010 ASCO Annual Meeting; June 4-8, 2010; Chicago.
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