Twenty-one of a planned 35 patients have been entered. Taxol has shown significant antitumor activity in minimally pretreated patients. How does Europe PMC derive its citations network? Protein Interactions. Protein Families. Nucleotide Sequences. Functional Genomics Experiments. Protein Structures. Gene Ontology GO Terms. Data Citations. When these less than optimal studies were excluded, postmastectomy radiation significantly improved overall survival, with an odds reduction for death of It should be noted that these data were predominantly powered by the Danish postmastectomy trials, which are discussed later in this paper.
It is also important to note that this degree of improvement in overall survival is of the same magnitude as that achieved by the early chemotherapy trials for lymph-node-positive disease [ 6 ]. A second meta-analysis focusing on more recent randomized trials also suggested that radiation use improved the overall survival of patients with intermediate-stage breast cancer [ 7 ]. This analysis compared the outcome of breast preservation therapy which included radiation treatment with modified radical mastectomy and found that breast preservation therapy provided a survival advantage over mastectomy in the trials that did not include postmastectomy radiation odds ratio favoring breast conservation therapy of 0.
However, in the trials that compared breast conservation therapy with mastectomy plus postoperative radiation, the two treatments achieved equivalent outcomes. These data again suggest that radiation should be a component of care for women with intermediate-risk breast cancer. It is generally accepted that reproduced large phase III randomized trials provide a higher level of scientific evidence than meta-analyses.
A recent study found that meta-analyses frequently fail to accurately predict the results of subsequent large phase III studies [ 8 ]. One can argue that such a discrepancy exists with respect to the question of whether postmastectomy radiation improves survival in breast cancer.
Subsequent to the initial meta-analyses, year data from three randomized trials investigating postmastectomy radiation provided new insights into the potential benefits of radiation. These studies differed from previous trials in the radiation treatment techniques used and in their use of systemic therapy. The use of chemotherapy is relevant to the relationship between radiation use and survival in that it reduces the competing risk of distant metastatic disease development, making the prevention of LRR more important.
Perhaps the most important of the recent randomized prospective trials is the Danish Breast Cancer Cooperative Group DBCCG 82b trial, which randomized 1, premenopausal women with stage II or III breast cancer to mastectomy followed by nine cycles of chemotherapy or mastectomy, radiation, and eight cycles of chemotherapy [ 9 ].
Radiation therapy consisted of 50 Gy in 25 fractions delivered to the chest wall and draining lymphatics utilizing electron beams in the regions over the heart to minimize dose to the cardiovascular structures. A much smaller trial, conducted in Vancouver, Canada, was of a similar design and reported remarkably similar results [ 10 ]. In that trial, premenopausal women with lymph-node-positive disease were randomized to receive mastectomy and chemotherapy plus or minus postmastectomy radiation.
Finally, coincident with the 82b study, the DBCCG conducted a companion trial, 82c, for postmenopausal women [ 11 ]. This trial randomized over 1, patients to mastectomy and tamoxifen or mastectomy, tamoxifen, and radiation. Taken together, these three studies demonstrated that by reducing postmastectomy LRR, radiation could improve overall survival.
One important contribution to the improvement in overall survival was the lack of increase in non-breast-cancer deaths. The Danish trials treated with techniques that minimized dose to the cardiac structures. This resulted in equivalent rates of heart-disease-related hospital admissions and cardiac deaths in the patients treated with radiation compared with those in the no radiation arm [ 12 ].
It is more difficult to determine from these studies which subcategories of patients have this degree of LRR risk. In part, these indications were justified by an investigation of failure patterns in patients treated with mastectomy and chemotherapy without radiation in Eastern Cooperative Oncology Group ECOG trials [ 13 ]. This study reported that these subgroups of patients had clinically relevant rates of LRR, whereas patients with less than four involved lymph nodes and T1 or T2 primaries had a low risk of LRR.
After publication of the Danish 82b trial and the Canadian trial, it became less clear whether postmastectomy radiation should be offered to women with stage II breast cancer with one to three positive lymph nodes. In part, this controversy arose because women with one to three positive lymph nodes made up a large percentage of both study populations. The potential consequences of having less than a standard axillary dissection are twofold. First, axillary sampling procedures lead to an underestimation of the true number of positive lymph nodes.
Controversies Regarding the Use of Radiation After Mastectomy in Breast Cancer
It is, therefore, likely that many of the patients reported to have one to three positive lymph nodes in the Danish trial may have had four or more positive lymph nodes if a more extensive surgical procedure had been performed. Secondly, the more limited dissection also increased LRR risk by failing to remove microscopic axillary disease. This percentage is significantly higher than the contributions of axillary recurrences to total LRR reported in other series that had standard axillary dissections [ 15 , 16 ].
To further investigate the risk of LRR for patients treated with mastectomy and chemotherapy, a number of groups recently have again explored failure patterns in women treated without radiation. The axillary surgical procedures in these series were different from the surgery performed in the Danish studies.
Anderson Cancer Center series were 15 and 17, respectively, over twice the median number recovered in the Danish trials [ 15 , 16 ]. In addition, the patients in many of these series were treated with doxorubicin-based chemotherapy, which has been suggested to have a greater efficacy than nonanthracycline-containing regimens [ 6 ]. Correspondingly, as the risk for LRR was significantly less, the expected benefit from postmastectomy radiation is unknown. However, it is unknown whether these assumptions are accurate. It is not clear that the proportional benefit of radiation on survival remains constant as the risk of LRR decreases.
One potential problem with extrapolating data from one risk group to another is that the potential toxicity of postmastectomy radiation would be expected to be roughly equivalent over all risk groups. Therefore, if radiation caused a small increase in non-breast-cancer deaths, it is likely that some threshold of LRR risk is needed for an increased overall survival. Ten-year local regional recurrence rates after mastectomy and systemic treatments. The M.
The one treatment-related factor that predicted high rates of LRR in patients with one to three positive lymph nodes was resection of less than 10 lymph nodes [ 16 ]. Recently, both the American Society for Therapeutic Radiology and Oncology and the American Society of Clinical Oncology have published consensus statements regarding postmastectomy radiation.
There is currently an ongoing national Inter-Group trial designed to determine the benefits of postmastectomy radiation for patients with small tumors and one to three positive lymph nodes. In that trial, patients with stage II breast cancer with one to three positive lymph nodes are randomized to receive postmastectomy radiation or observation after mastectomy and adjuvant chemotherapy. Patients must have 10 or more lymph nodes dissected and negative margins. Patients with gross extracapsular extension of disease or stage N2 or N3 disease are excluded.
This National Cancer Institute-designated high-priority study addresses a critically important clinical question that affects thousands of breast cancer patients in the U.
Schema of the current Inter-Group randomized prospective trial investigating the benefits of postmastectomy radiation for patients with stage II breast cancer with one to three positive lymph nodes. There are substantially less data to aid in determining which patients treated with neoadjuvant chemotherapy warrant postmastectomy radiation. In addition, determining the appropriate selection criteria is more complicated in this group of patients than in those initially treated with surgery.
This is because the majority of patients treated with neoadjuvant chemotherapy have a significant change in their disease resulting from the chemotherapy. Therefore, the pathological factors that historically have been used to identify subgroups of patients with clinically relevant risk of LRR after mastectomy are less certain. Investigators from M.
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Anderson Cancer Center Breast Cancer Group recently reported a study of LRR patterns in patients treated in neoadjuvant chemotherapy trials who did not receive postmastectomy radiation [ 23 ]. As expected, there was a significant change in disease extent with the chemotherapy treatment. After chemotherapy, the median pathological size of the primary tumor was 2 cm and the median number of positive lymph nodes was one. In a multivariate analysis, three factors were associated with higher rates of LRR. These were clinical stage IIIB disease or greater hazard ratio 4. There was no clear relationship between disease response to chemotherapy and LRR.
Those authors also compared rates of LRR in neoadjuvant chemotherapy patients with those previously reported after mastectomy and adjuvant chemotherapy [ 24 ]. Not surprisingly, for any given pathology, the risk of LRR was higher in those treated with neoadjuvant chemotherapy. These data indicate that both pretreatment clinical stage and posttreatment pathological findings should be considered when determining indications for radiation after neoadjuvant chemotherapy and mastectomy. Anderson Cancer Center.
Guidelines used at The University of Texas M. Anderson Cancer Center to determine which breast cancer patients are recommended to receive postmastectomy radiation. Many women who are treated with mastectomy for breast cancer elect to have an autologous tissue breast reconstruction or implant breast reconstruction. Our team is committed to providing you the most personalized treatment plan while helping you navigate your care.
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