Women with early-stage breast cancer may be treated with mastectomy (removal of the entire breast) or breast-conserving therapy (BCT) (which involves "lumpectomy", or removal of the cancer and a portion of surrounding tissue, plus treatment with radiation). Mastectomy and BCT have been shown to produce similar long-term survival outcomes in women with early-stage breast cancer.
Some but not all research however suggests that breast BCT may actually offer a greater chance of survival than mastectomy. Researchers performed a retrospective study evaluating over 16,000 women with early stage breast cancer and discovered that women electing BCT had the highest survival rate. Women electing BCT had a 5-year overall survival of 96% compared to 90% of those who underwent a mastectomy. Doctors believe that the key factor is the use of radiation as part of the overall BCT approach.14,15
Because these treatment approaches produce similar outcomes, many professionals have endorsed BCT as the preferred treatment strategy; however, many women with early-stage breast cancer continue to undergo mastectomy.1 More women, particularly young women, are electing to have a mastectomy” says Dr. Laura Dominci M.D. a surgeon at Dana-Farber/Brigham and Women’s Cancer Center. “They frequently offer peace of mind as the reason for their decision – even though research shows that unless a woman has a genetic predisposition to breast cancer, she has a very low risk of developing cancer in the healthy breast.
Patients’ attitudes and perceptions play a powerful role in their treatment decisions. Patients with early-stage breast cancer who take an active role in decision-making tend to opt for mastectomy over lumpectomy. Researchers found that more women who reported a “patient-based decision” underwent mastectomy compared with those who reported a “shared or surgeon-based decision.” Women who reported that they were concerned about recurrence, or the effects of radiation were more likely to choose mastectomy than those who did not share those concerns. In contrast, women who reported concerns about body image or their spouse’s opinion were more likely to opt for breast-conserving therapy than women who were less concerned about body image or who were less influenced by their spouses’ opinion.3
The decision of whether to have a mastectomy or breast-conserving surgery should be a shared decision between patients and their doctors. Particularly when talking to young women, who are likely to have a long period of survivorship, it’s important that clinicians discuss the potential impacts of mastectomy on their quality of life.
How much cancer should be removed?
When removing a breast tumor, a surgeon’s goal is to eliminate the cancer completely. To accomplish this both the tumor and a narrow rim of healthy cells around it—an area called the surgical margin is removed. But how much healthy tissue must be removed to effectively limit the likelihood that the tumor will return? The Society of Surgical Oncology (SSO) and American Society for Radiation Oncology (ASTRO) issued a joint statement describing surgical margins should be to have the best chances of reducing recurrence in patients with early-stage breast cancers. The statement detailed the conclusions of a multidisciplinary panel that reviewed the results of 33 different studies involving more than 28,000 patients who received both breast-conserving surgery and whole-breast radiation to treat Stage I or Stage II breast cancer.4
The majority of women with early-stage breast cancer opt for BCT and as many as 40% have been found to have positive margins and may have required additional surgery, which can be emotionally and physically challenging, worsen cosmetic outcome, delay other planned therapies, and increase healthcare costs.The study shows that none of the different margins—1, 2, or even 10 mm—reduced risk or changed the type of radiation therapy needed. Wider margins also do not matter for cancers with different biological characteristics. Rather than zeroing in on how wide the margin is, now the patient and her caregivers can focus on the other treatments for breast cancer to reduce recurrence. They can move forward with their systemic and local therapies without delay from additional operations.
Is Radiation Necessary with Lumpectomy?
Several studies have reported giving radiation therapy after lumpectomy results in a lower risk of breast cancer recurrence than lumpectomy alone. To further evaluate the benefits of post-lumpectomy radiation therapy, researchers conducted a combined analysis of 17 previous studies. These studies included more than 10,000 women with early-stage breast cancer.5
- Post-lumpectomy radiation therapy reduced the 10-year risk of breast cancer recurrence from 35% to 19%.
- The 15-year risk of death from breast cancer was 25% among women who did not receive post-lumpectomy radiation therapy and 21% among women who did receive radiation therapy.
- For every four breast cancer recurrences that were prevented by radiation therapy by year 10, one breast cancer death was prevented by year 15.
- Benefits of radiation therapy were seen in women with node-negative breast cancer as well as women with node-positive breast cancer.
These results provide strong evidence that giving radiation therapy after a lumpectomy substantially reduces the risk of cancer recurrence and also reduces the risk of death from breast cancer.
Women over age 65 who undergo BCT and hormone therapy for hormone receptor-positive, node-negative breast cancer may be able to skip radiation therapy, according to the results of a study presented at the San Antonio Breast Cancer Symposium.
To evaluate this theory, researchers conducted the PRIME 2 study, designed to determine whether whole-breast radiation therapy could be omitted in subgroups of older patients receiving appropriate therapy. The study included 1,326 patients randomly assigned to receive or forego radiation therapy. All of the women in the study were over age 65 and had early stage hormone-positive, node-negative breast cancer.
At five years, there was no significant difference between patients who received radiation and those who did not in terms of overall survival (97% vs. 96.4%), regional recurrence, or breast cancer in the opposite breast. IBTR at five years was 2.7 percent without radiation therapy and 0.6 percent with it. The difference in breast cancer-free survival between women receiving radiation (98.5%) and those not receiving radiation (96.4%) was statistically significant, however.10
The researchers concluded that although radiation reduces recurrence the absolute reduction is very small. Put simply, for every 100 women treated with radiation, four will have a recurrence prevented, one will have a recurrence, and 95 will have undergone unnecessary treatment. What’s more, once a patient has radiation, they cannot have it again on the same breast—so for some women, it might be better to “save” the option of radiation therapy in case there is a recurrence.
The researchers concluded that some women older than age 65 with hormone-positive, node-negative early breast cancer can forego radiation therapy and instead have breast-conserving therapy and hormone therapy.
What About Older Women?
There is no benefit in adding radiation therapy after lumpectomy and tamoxifen in women aged 70 years or older with early stage breast cancer, according to the results of a study published in the Journal of Clinical Oncology. To examine the best course of action in this population, researchers analyzed data from a long-term study known as Cancer and Leukemia Group B (CALGB) 9343. The data included 636 women age 70 or older with stage I estrogen receptor (ER)-positive breast cancer. All women underwent lumpectomy and then were randomly assigned to receive tamoxifen plus radiation therapy or tamoxifen alone.6
The median follow-up for patients in this study was 12.6 years. At 10 years, 98 percent of patients receiving tamoxifen plus radiation were free from local and regional recurrences, compared with 90 percent of those who received tamoxifen alone. There were no significant differences between the two groups in regards to overall survival, time to mastectomy, time to distant metastasis, or breast cancer-specific survival. The 10-year overall survival rate was 67 percent in the tamoxifen plus radiation group and 66 percent in the tamoxifen alone group.
The researchers concluded that after long-term follow-up, there appears to be little or no benefit with the addition of radiation after lumpectomy in older women with early stage breast cancer. The small improvement in locoregional recurrence does not appear to translate to an advantage in overall survival, distant disease-free survival, or breast preservation. They concluded that lumpectomy and tamoxifen is a reasonable option for women over age 70 with ER-positive early stage breast cancer.
Researchers from Canada conducted a similar clinical trial to further evaluate the addition of radiation to lumpectomy and hormone therapy in women with early, hormone-positive breast cancer. This trial included 636 women who were aged 50 years or older. All were treated with a lumpectomy plus the hormone therapy agent tamoxifen (Nolvadex®). Approximately half of the patients were also treated with radiation therapy to the breast, while the other half did not receive radiation therapy. Overall, at 5 years, cancer-free survival was 91% for women treated with radiation, compared with 86% for those not treated with radiation. Cancer recurrences within the breast at 8 years were only 3.5% for those treated with radiation, compared with 17.6% for those not treated with radiation. However, upon subgroup analysis, the greatest risk of a cancer relapse within the breast was among women who were aged 50-59 years. Overall, women who were 60 years or older had a significantly decreased risk of a cancer relapse within the breast compared to their younger counterparts. Women who were 60 years or older with a cancer that was 1 centimeter or smaller in size had nearly identical rates of breast cancer relapses whether or not they were treated with radiation therapy. There was no subgroup analysis that evaluated the group of women who were 70 years or older.7
The researchers concluded that the addition of radiation to lumpectomy and tamoxifen reduces the risk of a cancer relapse in women 50 years or older with hormone-positive, early breast cancers. However, the additive benefit of radiation therapy was significantly reduced in women ages 60 years or older, particularly in those with smaller cancers. These results add to a growing number of trial results that should prompt patients, particularly elderly patients to ask their physician about their individual risks and benefits of treatment with radiation therapy with lumpectomy and hormone therapy.
Breast Conserving Surgery with Breast Implants
Research suggests that women with breast implants who are diagnosed with early breast cancer may be effectively treated with breast-conserving therapy plus radiation therapy with favorable cosmetic results. Historically, women with breast implants who were diagnosed with early breast cancer and underwent a lumpectomy followed by radiation therapy suffered from poor cosmetic results. However, these studies involved older radiation techniques. Researchers from the Mayo Clinic recently conducted a study to evaluate cosmetic results and effectiveness of a lumpectomy followed by radiation therapy in women diagnosed with early breast cancer. This study included the use of newer radiation techniques than those used in previous studies. The researchers concluded that a lumpectomy followed by radiation therapy produces favorable cosmetic results in women with early breast cancer who have breast implants. Furthermore, rates of cancer recurrence do not seem to be increased in women with implants.8
Lumpectomy vs Mastectomy Impact on Quality of Life
More young women with breast cancer opt to have mastectomies and many experience a persistent decline in their sexual and psychosocial well-being following the procedure, as detailed in research by Dana-Farber/Brigham and Women’s Cancer Center. The findings underscore the importance of counseling patients about the potential long-term physical and emotional consequences of the procedure.xxx
In this study, a patient reported outcomes survey known as BREAST-Q was completed by 561 women age 40 and younger with breast cancer. Patients who had a mastectomy scored markedly lower in three quality of life measures – satisfaction with the appearance of their breasts, psychosocial well-being, and sexual well-being – than patients who underwent breast-conserving surgery. The results were consistent regardless of whether the patients had one or both breasts removed, and despite the fact that most had breast reconstruction surgery.
The study’s primary limitation is that it was not randomized, and it evaluated quality of life only at a single time point. She added that researchers did not have information about women’s quality of life prior to the study, which could have affected their decision making and their post-surgery quality of life. The findings however do illustrate that surgical choices may have a long-term impact on the quality of life.
Following mastectomy, women undergoing reconstruction with implants may choose between implants that are filled with saline (salt water) or silicone gel. Both types of implants are approved by the U.S. Food and Drug Administration. While safety and effectiveness have been and continue to be important concerns about implants, patient satisfaction and quality of life following reconstruction are also significant considerations. Research suggests that women who have undergone mastectomy and breast reconstruction report somewhat higher satisfaction with silicone implants than with saline implants.
To compare patient satisfaction among women who received silicone implants with those who received saline implants, researchers evaluated questionnaires completed by 472 women. One hundred seventy-six of these women had received silicone implants, and 306 had received saline implants. Women who had received silicone implants tended to report greater satisfaction with their reconstructed breasts than those who had received saline implants. Women in both groups who had received radiation therapy following their mastectomy were less satisfied with their reconstruction.
As well, all women reported reduced satisfaction with their reconstruction over time. The researchers concluded that women who received silicone implants tended to be more satisfied than those who received saline implants. They add, however, that patient satisfaction with reconstruction following mastectomy is generally high and that variables in addition to implant type affect satisfaction. Patients may therefore be confident that good outcomes are possible with either type of implant.
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Brachytherapy Provides Good Cosmetic Outcomes Among Women with Breast Implants
For women with early-stage breast cancer a lumpectomy followed by brachytherapy (placement of radioactive “seeds” in the breast) appears to be effective and to provide better cosmetic outcomes than lumpectomy followed by whole-breast radiation therapy.
For women with breast implants, whole-breast radiation therapy can result in the formation of scar tissue around the breast implant (a condition known as capsular contracture). This can be painful and can also distort the appearance of the breast. As a result, women with breast implants and breast cancer often undergo mastectomy with implant exchange rather than breast-conserving therapy. Because brachytherapy provides radiation to a more targeted area of the breast, it may reduce the risk of capsular contraction and allow more women with breast implants to undergo breast-conserving therapy.
To evaluate the effects of lumpectomy followed by brachytherapy, researchers conducted a study among 65 women with small, early-stage breast cancers and breast implants. After lumpectomy, the women were treated with brachytherapy in two doses per day over a five-day period.
All of the study participants had good or excellent cosmetic outcomes and none of the study participants experienced capsular contracture.
These results suggest that lumpectomy followed by brachytherapy is effective and associated with good cosmetic outcomes in women with breast implants. Women with breast implants and early-stage breast cancer may wish to talk with their doctor about the range of cancer treatment options that are available.9
Can Radiation Be Delayed?
Women who delay radiation treatment after surgery for early-stage breast cancer have worse outcomes than women who undergo radiation sooner, according to two recent studies, one published in the Journal of Clinical Oncology and the other in Cancer.11,12 The delivery of prescribed cancer treatment at a specific time and schedule is critical for producing the best outcomes from treatment. Research is ongoing to determine the effects of delaying radiation therapy after surgery.
According to an article recently published in the International Journal of Radiation Oncology, Biology and Physics, a delay of radiation following a lumpectomy of more than three
Radiation therapy may sometimes be delayed due to several factors, including patient inconvenience with travel and clinic time, side effects from surgery and healing from the procedure, additional medical conditions, and various other factors. However, the effect on outcomes of long delays before beginning radiation therapy after a lumpectomy is still being evaluated. Researchers recently evaluated data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database to try to identify outcome associations with time intervals between a lumpectomy and initiation of radiation therapy. The data included women aged 65 years or older who were diagnosed between 1991 and 1999 with Stages I–II breast cancer. The patients included in the analysis had not received chemotherapy.
- 97% of patients received radiation within three months of a lumpectomy.
- Patients who received radiation after three months following a lumpectomy had a nearly four-fold higher increased risk of death from their disease, and nearly a two-fold higher risk of overall death than patients who received radiation within three months of a lumpectomy.
- Older age, more advanced stage of cancer, unmarried status, additional medical conditions, and Black race were associated with a greater rate of not receiving radiation therapy within three months of a lumpectomy.
The researchers concluded that although further study is necessary to confirm these findings, it appears that women with early breast cancer should aim undergo radiation therapy within three months following a lumpectomy. Patients with early breast cancer should speak with their physician regarding their individual risks and benefits of scheduling of radiation therapy.13
Follow Up Care
Many women who are diagnosed with early stage breast cancer choose a breast conserving surgical treatment with lumpectomy. A lumpectomy preserves the majority of the breast by only removing the cancer and surrounding tissue, versus a mastectomy which is the complete removal of the affected breast. However, a recent study published in The Lancet reports that up to one fifth of women receiving breast conserving surgery may not be receiving the necessary follow up treatment needed to achieve an optimal chance for a cure.
Breast conserving surgery is an attractive treatment option for women with early stage breast cancer, producing comparable results to a mastectomy while sparing women from the complete removal of a breast. However, it is imperative for most women who decide on breast conserving therapy to receive follow up treatment in order to decrease their chance of a cancer recurrence by 50%. Follow up treatment consists of a lymph node biopsy to determine if the cancer has spread and radiation to kill any remaining cancer cells after surgery.
In a recent study, data was evaluated involving the treatment of almost 145,000 women who were diagnosed with early stage breast cancer between 1983 and 1995. The proportion of women not receiving adequate follow-up treatment (the omission of radiation, lymph node biopsy or both) following breast-conserving surgery has increased since 1989. By 1995, almost 20% of women in this study receiving breast-conserving surgery had not received appropriate follow-up treatment. It is important to note, however, that legitimate reasons which were not considered in the study, may contribute to the percentage of women who do not receive appropriate follow-up treatment. One reason may be that older patients do not have the necessary life span to consider a cancer recurrence a health risk, so further treatment would provide no benefit for them. Additionally, patients with other medical illnesses simply may not be able to tolerate the side effects of additional treatment. However, younger and otherwise healthy women deciding to receive breast-conserving therapy need to question their physician if appropriate follow-up treatment is not offered.
Since the risk of a cancer recurrence is doubled if follow up treatment is not administered after breast-conserving surgery, it is imperative that all women who choose breast-conserving therapy thoroughly discuss treatment strategies, potential side-effects of treatment and follow up schedules with their physician. In addition, women choosing breast-conserving surgery should educate themselves as much as possible about breast cancer, obtain second opinions from other physicians as well as seek opinions from specialists in chemotherapy and radiation. The addition of appropriate follow up treatment consisting of radiation and lymph node biopsies makes breast-conserving therapy an effective treatment option for women with early stage breast cancer, eliminating the need for a mastectomy.
1. Veronesi U, Cascinelli N, Mariani L, et al. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. The New England Journal of Medicine. 2002;347;1227-1232.
2. Fisher B, Anderson S, Bryant J, et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. The New England Journal of Medicine. 2002;347:1233-1241.
3. Hawley ST, Griggs JJ, Hamilton AS, et al. Decision involvement and receipt of mastectomy among racially and ethnically diverse breast cancer patients. Journal of the National Cancer Institute. 2009; 101: 1-11.
4. Moran MS, Schnitt SJ, Giuliano AE, et al. Society of Surgical Oncology-American Society for Radiation Oncology consensus guideline on margins for breast-conserving surgery with whole-breast irradiation in Stages I and II invasive breast cancer. International Journal of Radiation Oncology, Biology, Physics. 2014;88(3):553-64. doi: 10.1016/j.ijrobp.2013.11.012.
5. Early Breast Cancer Trialists’ Collaborative Group. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. Early online publication October 20, 2011.
6. Hughes KS, Schnaper LA, Bellon JR, et al. 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. Journal of Clinical Oncology. Published early online May 20, 2013. doi: 10.1200/JCO.2012.45.2615
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8. Morrell R, et al. Results of Primary Radiation Therapy for Breast Cancer in Cosmetically Augmented Patients. Proceedings from the 47th annual meeting of the American Society of Therapeutic Radiation Oncology. Presented October 16, 2005. Denver, Colorado.
9. McCarthy CM, Klassen AF, Stefan J. Cano SJ, et al. Patient satisfaction with post mastectomy breast reconstruction: a comparison of saline and silicone implants. Cancer [early online publication]. November 8, 2010.
10.Kunkler IH, Williams LW, Jack W, et al. The PRIME 2 trial: Wide local excision and adjuvant hormonal therapy ± postoperative whole breast irradiation in women older than 65 years with breast cancer managed by breast conservation. San Antonio Breast Cancer Symposium December 10-14, 2013. Abstract S2-01.
11.Olivotto IA, Lesperance ML, Truong PT, et al. Intervals longer than 20 weeks from breast-conserving surgery to radiation therapy are associated with inferior outcome for women with early-stage breast cancer who are not receiving chemotherapy. Journal of Clinical Oncology. 2008;early release on November 17.
12.Gold HT, Do HT, Dick AW. Correlates and effect of suboptimal radiotherapy in women with ductal carcinoma in situ or early invasive breast cancer. Cancer. 2008;113:3108-3115.
13.Hershan D, Wang X, McBride R, et al. Delay in Initiating Adjuvant Radiotherapy Following Breast Conservation Surgery and Its Impact on Survival. International Journal of Radiation Oncology Biology and Physics. 2006; 65: 1353-1360.
14.Parker C, Lin HY, Shen Y, et al. Effect of hormone receptor status and local treatment on overall survival for early-stage breast cancer.J Clin Oncol 32, 2014 (suppl 26; abstr 60)
15.EBCTCG (Early Breast Cancer Trialists’ Collaborative Group). Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials. The Lancet. Published early online March 19, 2014. doi:10.1016/S0140-6736(14)60488-8