Lumpectomy Without Radiation
Is it possible to perform a lumpectomy and skip the radiation? As the studies below demonstrate, in younger women radiation is still quite useful, in older women if the tumor is sensitive to hormone therapy (i.e. positive estrogen receptors) it may be acceptable to skip the radiation and just do lumpectomy plus Tamoxifen. (see summary table here and here). The NCCN states that" radiation may be omitted in those women 70 y or overwith T1 cancers, which are clinically node negative with ERP + cancers if they are treated with adjuvant hormonal therapy."  A typical study of low risk breast cancer patients treated with lumpectomy and Arimidex then with or without radiation is shown here. Another long term study in elderly women is here.

In the original NSABP-B06 trial 1/3 of the women had a lumpectomy without radiation and 1/3 had a lumpectomy plus radiation (the other 1/3 had mastectomies.) The local relapse rates were much higher in those women who did not receive radiation as noted below. Those patients who were node positive also received chemotherapy which did not eliminate the need for radiation (in fact those treated with lumpectomy plus chemotherapy but no radiation had the highest risk of local relapse as noted in the tables below, but those women who received both chemotherapy and radiation had the lowest risk of a local relapse.)

Risk of a Relapse for Node negative or node positive patients treated with lumpectomy alone (in red) or lumpectomy followed by radiation (in blue)

nsabp_b06.gif (5023 bytes)

Local Relapse at 12y from NSABP B-06 (N Engl J Med 1995;333:1456-61)
  All No Chemo Chemo
Lumpectomy 35% 32% 41%
Lump + Radiation 10% 12% 5%
 

After the NSABP B-06 trial it was clear that lumpectomy alone was inadequate for most patients, but the question arose as to whether patients with very small tumors (1cm or less) with lumpectomy and clear margins, could skip the radiation and instead receive Tamoxifen. This led to the NSABP B-21 trial. They noted that those receiving Tamoxifen had a lower risk of developing breast cancer in the opposite breast (0.6% versus 3.3%) but it did not eliminate the need for radiation.

Tamoxifen, Radiation Therapy, or Both for Prevention of Ipsilateral Breast Tumor Recurrence After Lumpectomy in Women With Invasive Breast Cancers of One Centimeter or Less (Journal of Clinical Oncology, Vol 20, Issue 20 (October), 2002: 4141-4149)

This trial was prompted by uncertainty about the need for breast irradiation after lumpectomy in node-negative women with invasive breast cancers of <= 1 cm, by speculation that tamoxifen (TAM) might be as or more effective than radiation therapy (XRT) in reducing the rate of ipsilateral breast tumor recurrence (IBTR) in such women, and by the thesis that both modalities might be more effective than either alone. After lumpectomy, 1,009 women were randomly assigned to TAM (n = 336), XRT and placebo (n = 336), or XRT and TAM (n = 337).

RESULTS: XRT and placebo resulted in a 49% lower hazard rate of IBTR than did TAM alone; XRT and TAM resulted in a 63% lower rate than did XRT and placebo. When compared with TAM alone, XRT plus TAM resulted in an 81% reduction in hazard rate of IBTR. Cumulative incidence of IBTR through 8 years was 16.5% with TAM, 9.3% with XRT and placebo, and 2.8% with XRT and TAM. XRT reduced IBTR below the level achieved with TAM alone, regardless of estrogen receptor (ER) status. Distant treatment failures were infrequent and not significantly different among the groups. When TAM-treated women were compared with those who received XRT and placebo, there was a significant reduction in CBC (hazard ratio, 0.45; 95% confidence interval, 0.21 to 0.95; P = .039). Survival in the three groups was 93%, 94%, and 93%, respectively.


breast_nsabp_b21.gif (14146 bytes)

 

Lumpectomy plus Tamoxifen Plus or Minus Radiation for T1/T2N0 in Women over 50y
NEJM 2004; 351:963 see study below
Tamoxifen Tam plus Radiation
Local Relapse Rates T1/T2 7.7% / 5y 0.6% / 5y
T1 5.9% / 5y 0.4% / 5y
T1 15.2% / 8y 3.6% / 8y
< 1cm 2.6% / 5y 0%
Disease Free Survival T1/T2 84%/5y 91%/5y

Lumpectomy plus Tamoxifen Plus or Minus Radiation for T1N0 in Women over 70y
NEJM 2004; 351:971 see study below
  Tamoxifen Tamoxifen plus Radiation
Local /Regional Relapse at 5 Years 4% 1%
Survival at 5 Years 96% 99%
 
As noted in the study below, the benefits of using radiation for ealy stage cancers in much higher in younger women than older women

Radiation Therapy Plus Tamoxifen Versus Tamoxifen Alone After Breast-Conserving Surgery in Postmenopausal Women With Stage I Breast Cancer: A Decision Analysis

Rinaa S. Punglia, Karen M. Kuntz, Jason H. Lee, Abram Recht  Journal of Clinical Oncology, Vol 21, Issue 12 (June), 2003: 2260-2267
From the Joint Center for Radiation Therapy, Harvard Medical School;

To compare outcomes for hypothetical cohorts of postmenopausal patients with estrogen receptor–positive tumors that are < 2 cm in size, with pathologically uninvolved axillary nodes, treated with radiation therapy plus tamoxifen versus tamoxifen alone after breast-conserving surgery.

The modeled recurrence-free survival benefit of giving radiation therapy was 3.35 years for women who were 50 years of age at diagnosis, versus 0.61 years for women who were 80 years of age. In the 50-year-old cohort, radiation therapy resulted in additional 0.60 years survival, compared with 0.04 years among 80-year-olds. A 50-year-old woman who received radiation therapy plus tamoxifen was less likely to die from breast cancer than if she received tamoxifen alone (2.43% v 5.29%; relative-risk reduction, 54%). An 80-year-old woman had a 1.17% chance of dying from breast cancer if she received radiation therapy plus tamoxifen, versus 2.02% with tamoxifen alone (relative-risk reduction, 42%). Sensitivity analyses showed that the magnitude of benefit was strongly influenced by including unequal rates of developing distant disease after breast recurrence between the treatment arms and varying rates of local recurrence.

Conclusion: The absolute and relative benefits of radiation therapy and individual patient preferences for different health states should be considered when selecting treatment
 
Tamoxifen with or without Breast Irradiation in Women 50 Years of Age or Older with Early Breast Cancer
A. W. Fyles NEJM 2004; 351:963.

Background We determined the effect of breast irradiation plus tamoxifen on disease-free survival and local relapse in women 50 years of age or older who had T1 or T2 node-negative breast cancer.

Methods Between December 1992 and June 2000, 769 women with early breast cancer (tumor diameter, 5 cm or less) were randomly assigned to receive breast irradiation plus tamoxifen (386 women) or tamoxifen alone (383 women). The median follow-up was 5.6 years.

Results The rate of local relapse at five years was 7.7 percent in the tamoxifen group and 0.6 percent in the group given tamoxifen plus irradiation (hazard ratio, 8.3; 95 percent confidence interval, 3.3 to 21.2; P<0.001), with corresponding five-year disease-free survival rates of 84 percent and 91 percent (P=0.004). A planned subgroup analysis of 611 women with T1, receptor-positive tumors indicated a benefit from radiotherapy (five-year rates of local relapse, 0.4 percent with tamoxifen plus radiotherapy and 5.9 percent with tamoxifen alone; P<0.001). Overall, there was a significant difference in the rate of axillary relapse at five years (2.5 percent in the tamoxifen group and 0.5 percent in the group given tamoxifen plus irradiation, P=0.049), but no significant difference in the rates of distant relapse or overall survival.

Conclusions As compared with tamoxifen alone, radiotherapy plus tamoxifen significantly reduces the risk of breast and axillary recurrence after lumpectomy in women with small, node-negative, hormone-receptor–positive breast cancers.

Lumpectomy plus Tamoxifen with or without Irradiation in Women 70 Years of Age or Older with Early Breast Cancer
K. S. Hughes NEJM 2004; 351:971  for the Cancer and Leukemia Group B, Radiation Therapy Oncology Group, and Eastern Cooperative Oncology Group

Background In women 70 years of age or older who have early breast cancer, it is unclear whether lumpectomy plus tamoxifen is as effective as lumpectomy followed by tamoxifen plus radiation therapy.

Methods Between July 1994 and February 1999, we randomly assigned 636 women who were 70 years of age or older and who had clinical stage I (T1N0M0 according to the tumor–node–metastasis classification), estrogen-receptor–positive breast carcinoma treated by lumpectomy to receive tamoxifen plus radiation therapy (317 women) or tamoxifen alone (319 women). Primary end points were the time to local or regional recurrence, the frequency of mastectomy for recurrence, breast-cancer–specific survival, the time to distant metastasis, and overall survival.

Results The only significant difference between the two groups was in the rate of local or regional recurrence at five years (1 percent in the group given tamoxifen plus irradiation and 4 percent in the group given tamoxifen alone, P<0.001). There were no significant differences between the two groups with regard to the rates of mastectomy for local recurrence, distant metastases, or five-year rates of overall survival (87 percent in the group given tamoxifen plus irradiation and 86 percent in the tamoxifen group, P=0.94). Assessment by physicians and patients of cosmetic results and adverse events uniformly rated tamoxifen plus irradiation inferior to tamoxifen alone.

Conclusions Lumpectomy plus adjuvant therapy with tamoxifen alone is a realistic choice for the treatment of women 70 years of age or older who have early, estrogen-receptor–positive breast cancer.