Management Of Early-stage Breast Cancer Research Articles

Long-term survival benefits of docetaxel plus cyclophosphamide compared to doxorubicin plus cyclophosphamide in the adjuvant treatment of operable breast cancer

563 Background: The U.S. Oncology Adjuvant Trial 9735 recently demonstrated disease-free survival and overall survival (OS) benefits over 7 years for docetaxel plus cyclophosphamide (TC) compared with doxorubicin plus cyclophosphamide (AC) as adjuvant treatment for women with operable stage I-III invasive breast cancer (BC). The life-time benefits of TC vs. AC, however, are unknown. This analysis aimed to project potential life-time survival benefits of TC vs. AC as adjuvant therapy for operable BC. Methods: The 7-year follow-up results of the 9735 study combined with US average life expectancy were used to project the life-time survival benefits of TC vs. AC. In the base case (scenario 1), it was assumed the survival advantage of TC did not persist beyond the 7-year clinical trial period. Rather, all patients alive and disease-free at 7 years (from the starting age of 51 to the age of 58), regardless of treatment, were assumed to be cured and received the average remaining life expectancy of a 58-year old woman in the US general population. As survival benefits from chemotherapy may persist beyond the clinical trial period, two sensitivity analyses were conducted: 1) greater life expectancy in the TC arm of 1.8 months equivalent to the mean difference in OS between TC and AC within the clinical trial period (scenario 2) and 2) greater life expectancy in the TC arm of 22 months equivalent to the difference in survival at the end of 7 years (scenario 3). The total life years gained (LYs) and quality-adjusted life years gained (QALYs) were then calculated. Results: Per patient LYs gained in scenarios 1, 2, and 3 were 0.850, 0.930, and 1.755, respectively; while QALYs gained were slightly lower at 0.674, 0.736 and 1.383, respectively. Applying this benefit to a cohort of 167,133 women in the US with newly diagnosed stage I-III invasive BC in 2008, the gains were 142,063 LYs and 112,648 QALYS in scenario 1. Conclusions: In addition to survival benefit observed within the clinical trial period, the use of TC is associated with long-term survival benefits compared to AC in patients with stage I-III invasive BC. The results provide additional support of the value of TC in the management of early stage BC. [Table: see text]

Current management of the axilla in patients with clinically node-negative breast cancer: a nationwide survey of United Kingdom breast surgeons

BackgroundPrecise knowledge of axillary lymph node status is essential in the treatment of operable carcinoma of the breast. For many years, axillary nodal clearance (ANC) has been an integral part of the conventional management of early-stage breast cancer. During the last few decades the trend of these surgical procedures has been one of decreasing invasiveness in order to try and achieve a much lower level of morbidity. To help reach this improved level of treatment the concept of the sentinel lymph node (SLN) was utilized. Recent studies have shown that SNB can provide an accurate assessment of the axillary nodal status in clinically node negative patients, negating the need to remove the majority of the axillary contents and thus reducing morbidity. A recent meta-analysis of all the literature to date appears to reveal that the dual technique (blue dye and technetium-labelled sulfur) is the gold-standard for successful identification of the SLN in the context of early-stage breast cancer. We aim to highlight the on-going wide range of differing methods employed, and compare this to the gold-standard recommended guidelines.MethodsA questionnaire was devised to provide a snapshot overview of the current management of the axilla in patients with clinically node-negative T1 invasive breast cancer amongst UK beast surgeons in August 2006.ResultsOf the 271 UK surgeons, 74 (27.3%) performed ANC as the initial management of the axilla in patients with clinically node negative T1 invasive breast cancer, 56 (20.7%) used axillary node sampling (not directed by sentinel node mapping) and a total of 141 (52.0%) used the technique of SNB, of which 50 (18.5%) used blue dye alone and 91 (33.6%) used a combination of blue dye and radioisotope.ConclusionDespite the obvious advantages, our survey has revealed that the procedure is only used by 52% of British breast surgeons in this subgroup of patients (clinically node negative, tumour equal of smaller than 2 cm) most of whom have no disease within the axilla. The reasons for this include limited hospital resources and lack of surgeons training and accreditation and ARSAC license (nuclear medicine license).

Sentinel lymph node identification in a primary ductal carcinoma arising in the vulva

Primary or metastatic breast-like carcinoma of the vulva is a rare event. Because of the similarity with breast ductal carcinoma, we think that the same principles used for treatment of orthotopic breast cancer can be applied, as well as the use of sentinel lymph node technique, which is widely accepted in the management of early-stage breast cancer. We report a 49-old-year postmenopausal woman who was referred to our institution after small biopsy of a 3.5- x 3-cm right vulvar tumor. Histopathologically, infiltration of the vulvar dermis by a ductal carcinoma of mammary gland type was reported. At operation, the sentinel node technique revealed two sentinel nodes in the right inguinal area. Although these nodes proved negative for malignancy, the patient underwent wide local excision of tumor and complete ipsilateral inguinofemoral lymphadenectomy. The remaining excised nodes were negative. Surgical specimen proved estrogen- and progesterone-positive receptors, the reason for which the patient received tamoxifen adjuvant therapy. This report represents the first case in the world literature of primary breast carcinoma arising in the vulva in which sentinel lymph node identification has been possible. Because of the rarity of this condition, the pathologic similarity of this tumor along with currently accepted guidelines for the management of breast cancer supports the possibility of local excision and sentinel lymph node identification as a possible alternative to inguinofemoral lymphadenectomy.

Sentinel node biopsy in non-palpable breast cancer and in patients with a previous diagnostic excision

Aim As a means of staging the axilla with minimal surgical trauma, sentinel lymph node biopsy (SNB) has dramatically altered the management of early-stage breast cancer. The aim of this prospective multicentre study was to assess the safety of the method in cases of non-palpable tumours and in cases with an open biopsy prior to SNB. Method In the period 1999–2001, 57 non-palpable breast cancers and 75 patients with diagnostic biopsy were collected prospectively to the first part of the study. In the second part, 745 patients with non-palpable breast cancers and 86 cases with prior open surgery diagnosed between 2000 and 2005 were followed up till the end of 2005. All patients in the first part of the study had an axillary clearance irrespective of sentinel node status, whereas in the second part axillary clearance was done only if the sentinel node was metastatic. Results The detection rate was 95% in the group of non-palpable breast cancers, with a false negative rate of 5.6% (1/18), and the corresponding figures for the group with prior intervention were 96% and 10% (2/20). Two axillary recurrences, after a negative SNB at primary surgery, were found in the non-palpable group after 16 and 17 months, respectively. No axillary recurrence has been observed in the group of cancers with a prior open biopsy. Four women in the non-palpable group and two women with a diagnostic operation experienced distant metastases. Conclusion We conclude that SNB is a safe procedure for women with non-palpable breast cancer, as well as after previous open diagnostic excision.

3–34 A Phase III Randomized Study on the Sequencing of Radiotherapy and Chemotherapy in the Conservative Management of Early-Stage Breast Cancer

3–34 A Phase III Randomized Study on the Sequencing of Radiotherapy and Chemotherapy in the Conservative Management of Early-Stage Breast Cancer

Ethnic Disparities in Breast Cancer Management Among Asian Americans and Pacific Islanders

Little is known about breast cancer management among Asian Americans and Pacific Islanders (AAPI). We performed a retrospective analysis of 2030 women (935 Japanese, 144 Chinese, 235 Filipino, 293 Hawaiian, and 423 white; mean age +/- SD, 59 +/- 13 years) with a diagnosis of early breast cancer (stages I, II, and IIIA) in Hawaii from 1995 to 2001. We linked data from the Surveillance, Epidemiology, and End Results program's Hawaii Tumor Registry to administrative health care claims. We evaluated (1) breast-conserving surgery (BCS); (2) radiotherapy after BCS; and (3) chemotherapy for node-positive disease. We used logistic regression to examine the association between AAPI ethnicity and treatment, adjusting for age, year, rural residence, tumor size, grade, nodal status, receptor status, prior cancer, comorbidity index, health plan type, and income. Overall, 60.3% of women had stage I disease, 36.8% had stage II, and 2.9% had stage IIIA. Only 55.6% received BCS, and 85.1% of these women also received radiation. Of those with nodal involvement (n = 521), 82.7% received chemotherapy. Japanese and Filipino women were significantly less likely than white women to undergo BCS (for Japanese: adjusted odds ratio, 0.62; 95% confidence interval, 0.48-0.80; for Filipinos: adjusted odds ratio, 0.47; 95% confidence interval, 0.33-0.66). Filipinos tended to be less likely than white women to receive radiation after BCS (adjusted odds ratio, 0.80; 95% confidence interval, 0.42-1.49). AAPI women were as likely as white women to receive adjuvant chemotherapy for nodal spread. We found disparities in the management of early-stage breast cancer among AAPI women, particularly among Japanese and Filipinos. Further study is needed to determine the reasons for the observed disparities and to understand their effect on health outcomes.

Prognosis and Management of Patients With Node-Negative Invasive Breast Carcinoma That Is 1 cm or Smaller in Size (stage 1; T1a,bN0M0): A Review of the Literature

Mammographic screening has led to an increase in the number of small, node-negative breast cancers being diagnosed. Node-negative breast cancers that are < or = 1 cm are stage T1a,bN0M0. Controversy surrounds the prognosis of these patients with locoregional therapy only and the need for adjuvant systemic therapy. We performed a comprehensive review of the literature describing outcome and prognostic factors in stage T1a,bN0M0 breast cancer. We also reviewed current guidelines for systemic therapy in these patients. Early studies reported 10-year relapse-free survival (RFS) rates higher than 90% without adjuvant systemic therapy, but some more recent data suggest inferior outcomes. High tumor grade is the most consistent factor associated with poor prognosis. Other adverse prognostic factors are younger age, lymphovascular invasion (LVI), high Ki-67, and larger tumors within the T1a,b subgroup. Patients with high-grade tumors and/or LVI may have 10-year RFS rates of less than 75% in the absence of systemic therapy. The prognostic significance of hormone receptor status is unclear. Current guidelines for the systemic management of early-stage breast cancer differ when applied to stage T1a,bN0M0, reflecting the controversial nature of the issue. Adjuvant systemic therapy is advisable for most patients with stage T1a,bN0M0 breast cancer who have grade 3 tumors and/or LVI. Other T1a,bN0M0 cases should be considered for systemic therapy based on clinicopathologic factors with known prognostic significance and assessment of the risk-benefit ratio. More reliable tools are needed to assess the prognosis of patients with stage T1a,bN0M0 breast cancer and their potential to benefit from specific therapeutic agents.

A phase III randomized study on the sequencing of radiotherapy and chemotherapy in the conservative management of early-stage breast cancer

To compare two different timings of radiation treatment in patients with breast cancer who underwent conservative surgery and were candidates to receive adjuvant cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy. A total of 206 patients who had quadrantectomy and axillary dissection for breast cancer and were planned to receive adjuvant CMF chemotherapy were randomized to concurrent or sequential radiotherapy. Radiotherapy was delivered only to the whole breast through tangential fields to a dose of 50 Gy in 20 fractions over 4 weeks, followed by an electron boost of 10-15 Gy in 4-6 fractions to the tumor bed. No differences in 5-year breast recurrence-free, metastasis-free, disease-free, and overall survival were observed in the two treatment groups. All patients completed the planned radiotherapy. No evidence of an increased risk of toxicity was observed between the two arms. No difference in radiotherapy and in the chemotherapy dose intensity was observed in the two groups. In patients with negative surgical margins receiving adjuvant chemotherapy, radiotherapy can be delayed to up to 7 months. Concurrent administration of CMF chemotherapy and radiotherapy is safe and might be reserved for patients at high risk of local recurrence, such as those with positive surgical margins or larger tumor diameters.

Understanding the mechanisms creating false positive lumpectomy margins

Objective All breast surgeons deal with the frustration of initial pathologic close or positive margins that have no residual cancer upon re-excision. To understand the mechanisms that create false positive margins, specimen handling was standardized in a single surgeon’s practice and margin issues were tracked. Methods Prospectively over a 3.5-year period, needle-localized lumpectomies for the management of early-stage breast cancer were standardized in all aspects of specimen handling, including surgeon inking and specimen compression for specimen radiography for quality assurance. The current study reviews 220 such cases where the original lumpectomy included a small piece of overlying skin from over the target lesion. All specimen radiography was performed with compression at the skin to deep level to bias the “pancaking” effect of pushing tumor to specimen surface to the deep margin. Results Of the 220 therapeutic lumpectomies performed for clinical stage 0–2 breast cancer in this fashion, 175 (79.5%) had negative margins by a distance of 10 mm or more. Margins less than 10 mm were classified as close and were present in 20 (9.1%) of cases. These were heavily biased toward margins closer than 2 mm. Positive initial margins accounted for 25 (11.4%) of cases. Of the 45 close or positive margin cases, 12 involved the deep margin only, and on re-excision none was found to have residual tumor. When other single margins were involved, re-excision found tumor in 5 of 14 cases (35.7%). When multiple margins were close or positive, 9 of 19 cases (47.3%) were found to have residual tumor at re-excision. Conclusions Specimen compression increases the incidence of false margin positivity. The best predictors of true margin positivity are multiple close or positive margins or margin positivity in a direction not associated with specimen ex vivo compression.

Limited-field radiation therapy in the management of early-stage breast cancer.

Several phase III trials have demonstrated equivalent long-term survival between breast conserving surgery plus radiation therapy and mastectomy in patients with early-stage breast cancer but have not provided information on the optimal volume of breast tissue requiring post-lumpectomy radiation therapy. Therefore, we examined the 5-year results of a single institution's experience with radiation therapy limited to the region of the tumor bed (i.e., limited-field radiation therapy) in selected patients treated with breast-conserving therapy and compared them with results of matched breast-conserving therapy patients who underwent whole-breast radiation therapy. A total of 199 patients with early-stage breast cancer were treated prospectively with breast-conserving therapy and limited-field radiation therapy using interstitial brachytherapy. To compare potential differences in local recurrence rates based on the volume of breast tissue irradiated, patients in the limited-field radiation therapy group were matched with 199 patients treated with whole-breast radiation therapy. Match criteria included tumor size, lymph-node status, patient age, margins of excision, estrogen receptor status, and use of adjuvant tamoxifen therapy. Local-regional control and disease-free and overall survival were analyzed using the Kaplan-Meier method, and the statistical significance of differences between treatment groups was calculated using the log-rank test. All statistical tests were two-sided. Median follow-up for surviving patients was 65 months (range = 12-115 months). Five ipsilateral breast failures (i.e., recurrences) were observed in patients treated with limited-field radiation therapy. The cumulative incidence of local recurrence was 1% (95% confidence interval [CI] = 0% to 2.8%). On matched-pair analysis, the rate of local recurrence was not statistically significantly different between the patient groups (1% [95% CI = 0% to 2.4%] for the whole-breast radiation therapy patients versus 1% [95% CI = 0% to 2.8%] for the limited-field radiation therapy patients; P =.65). Limited-field radiation therapy administered to the region of the tumor bed has comparable 5-year local control rates to whole-breast radiation therapy in selected patients.

Adjuvant therapy approaches to breast cancer: should taxanes be incorporated?

The triplet of docetaxel, doxorubicin, and cyclophosphamide (TAC) has emerged as an alternative chemotherapy regimen for adjuvant management of node-positive breast cancer. Based on recently reported 3-year data from the Breast Cancer International Research Group (BCIRG) 001, disease-free survival was significantly higher in patients who underwent adjuvant chemotherapy with TAC rather than the established regimen of 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC). TAC reduced the risk of disease recurrence in estrogen receptor-positive and -negative patients. Whereas overall survival was not significantly different between the two groups, TAC led to a significant reduction in mortality in the subset of patients with one to three involved axillary lymph nodes. Overall, these interim BCIRG 001 results, coupled with those from Cancer and Leukemia Group B-9344 and National Surgical Adjuvant Breast and Bowel Project (NSABP) B-28 (phase III trials of sequential adjuvant chemotherapy with doxorubicin and cyclophosphamide followed by paclitaxel), suggest that taxanes are a valuable component of adjuvant chemotherapy for patients with node-positive breast cancer, including those with estrogen receptor positivity and/or extensive lymph node involvement. Accumulating data in the neoadjuvant setting lend further support to the view that the taxanes confer clinically meaningful benefits in the management of early-stage breast cancer. Such ongoing studies as NSABP B-30 will be instrumental in establishing the relative merits of sequential versus concurrent taxane-anthracycline adjuvant regimens for patients with node-positive breast cancer.

Outcome of conservatively managed early-onset breast cancer by BRCA1/2 status

Management of early-stage breast cancer in young women with mutations in BRCA1 or BRCA2 remains controversial. This study assessed the long-term risks of ipsilateral and contralateral breast cancer in a cohort of young women who underwent breast-conserving surgery followed by radiotherapy. Between 1975 and 1998, 290 women with breast cancer diagnosed at age 42 years or younger underwent lumpectomy followed by radiotherapy at our hospital. We recruited 127 of these women for complete sequencing of BRCA1 and BRCA2. Demographic, clinical, pathological, and outcome data were recorded. The primary endpoints were rates of ipsilateral and contralateral breast cancer, in relation to germline BRCA1/2 status. 105 women were classified as having sporadic disease (94 with wild-type or known polymorphisms and 11 with variants of unclear significance) and 22 as having genetic predisposition (deleterious mutations in BRCA1 [15] or BRCA2 [seven]). At 12 years of follow-up, the genetic group had significantly higher rates of ipsilateral (49% vs 21%, p=0.007) and contralateral events (42% vs 9%, p=0.001) than the sporadic group. The majority of events were classified as second primary tumours. No patient in the genetic group had undergone oophorectomy or was taking prophylactic agents such as tamoxifen. Patients with germline mutations in BRCA1 or BRCA2 have a high risk of developing late ipsilateral and contralateral second primary tumours. With breast-conserving therapy, chemoprophylaxis or other interventions to reduce the rate of second cancers may be valuable. Alternatively, bilateral mastectomy may be considered, to minimise the risk of second tumours in the breasts.

Breast-conserving therapy in the management of early stage breast cancer: Our experience in 103 cases.

The aim of this study is to determine whether our results in breastconserving therapy of 103 patients with earlystage breast cancer are comparable to those of other facilities or not. From January 1990 to October 1999, 103 patients with earlystage breast cancer were treated by breastconserving surgery and whole breast irradiation. All patients were of Stages I or II, and the greatest dimensions of primary tumor were less than 3 cm. The median followup time was 47 months from the completion of postoperative radiotherapy. Local, regional and distant failure rates, and survival rate were presumed using the KaplanMeyer method. One patient suffered from local recurrence 30 months later. She was followed by simple mastectomy and kept from further recurrence. No regional relapse occurred. Distant metastases were seen in three patients:two patients in bones, and one patient in a bone and the liver after 19, 35, and 32 months, respectively. One patient died from disseminated cancer in 41 months. Only one patient died due to intercurrent disease. Both 5year and 10year diseasefree survival rates were 94.2%, and both 5year and 10year causespecific survival rates were 98.3%. Our results were comparable to previously reported data. In this stage although the followup time was too short to define the longterm outcome, it suggested that breast conserving therapy was acceptable and effective in the management of earlystage breast cancer.

Patient Preferences for Axillary Dissection in the Management of Early-Stage Breast Cancer

Recent data on the value of adjuvant therapy in lymph node-negative breast cancer and promising early data on less invasive strategies for managing the axilla have raised questions about the appropriate role of axillary lymph node dissection (ALND) in the management of early-stage breast cancer. We sought to evaluate how women weigh potential benefits of ALND-prognostic information, enhanced local control, and tailored therapy-against the risks of long-term morbidity that are associated with the procedure. We used hypothetical scenarios to survey 82 randomly selected women with invasive breast cancer who had been treated with ALND and 62 women at risk for invasive breast cancer by virtue of a history of ductal carcinoma in situ (DCIS) who had not undergone ALND. Women in both the invasive cancer and the DCIS groups required substantial improvements in local control of the cancer (5% and 15%, respectively) and overall survival (3% and 10%, respectively) before they would opt for this procedure. Women with invasive cancer would choose ALND if it had only a 1% chance of altering treatment recommendations, whereas DCIS subjects required a 25% chance. Sixty-eight percent and 29% of women in the invasive cancer and DCIS groups, respectively, would accepted a 40% risk of arm dysfunction to gain prognostic information that would not change treatment. For most subjects treated previously for invasive breast cancer and almost half those at risk of the disease, the potential benefits of ALND, particularly the value of prognostic information, were sufficient to outweigh the risks of morbidity. However, women varied considerably in their preferences, highlighting the need to tailor decisions regarding management of the axilla to individual patients' values.

Ovarian ablation for premenopausal early-stage breast cancer: an update.

Ovarian ablation is the oldest form of systemic treatment of breast cancer and consists of removal of the main source of estrogen biosynthesis in premenopausal women: Over the last century several different means of stopping ovarian function have been studied: surgical oophorectomy, ovarian irradiation, and more recently, chemical castration by gonadotropin-releasing hormone analog therapy. In unselected patients the response rate to ovarian ablation is of about 35% but the likelihood of response is considerably higher for patients with hormonal receptor-positive tumors, the therapy being most effective in women who are actively menstruating. In spite of this evidence, the role of ovarian ablation in the management of early-stage breast cancer still remains controversial. Here we review current evidence supporting the value of this ablative procedure as an adjuvant and update ongoing clinical research to refine our knowledge about its use.

Radiation therapy in the primary management of early-stage breast cancer.

The two most important indications for radiation therapy in the primary management of early stage breast cancer are: (1) postoperative treatment of the breast parenchyma following breast-conserving surgery in low-risk patients, and (2) treatment of the breast/chest wall (postmastectomy) and regional nodes in patients with high-risk disease. During the past 2–3 years several controlled clinical trials have contributed important information about the use of radiation therapy in these settings. This article will give a brief overview of some of these studies.

Breast Conservation Therapy for Invasive Breast Cancer: A Review of Prior Trials and the Mayo Clinic Experience

To assess the role of breast conservation therapy in the management of early-stage invasive breast cancer. We reviewed the results of previously published trials and summarized 165 cases of breast conservation surgical procedures and irradiation at the Mayo Clinic between January 1979 and September 1989. From the prior clinical trials, the criteria for selection of patients, the surgical and radiation techniques used, the complications of treatment, the cosmetic results, and the follow-up assessment and survival were analyzed. The 165 Mayo patients were also characterized, and their results were described. Breast conservation therapy consists of excision of the primary tumor followed by irradiation. A coordinated multidisciplinary approach should be used for selection of patients. Several large-scale clinical trials have demonstrated that breast conservation therapy is an appropriate option for most women with early-stage breast cancer and provides tumor control and survival rates equivalent to mastectomy. With a collaborative treatment program and judicious application of contemporary standards of practice, a good-to-excellent cosmetic outcome can be achieved in most patients, and the risk of treatment-related sequelae is minimal. The Mayo Clinic experience with breast conservation therapy is consistent with these observations and compares favorably with other institutional and clinical trial results. Patients should be fully educated about the options for primary management of early-stage breast cancer because the selection of therapy may profoundly influence psychologic adjustment and acceptance of the treatment program.

Medical management of early-stage breast cancer

With improved screening and education, a greater proportion of breast cancer is detected at an early stage. Although the prognosis for many of these patients is excellent following definitive local therapy alone, some subsets of node-negative patients have a 30% chance of eventually developing metastatic disease that will be incurable with current therapy. Thus, an increasing proportion of early-stage patients are being offered some form of adjuvant therapy, with the expectation of improved relapse-free survival, and possibly improved overall survival. Efforts have been made to base the selection of patients for adjuvant therapy on specific prognostic factors. Meanwhile, the scope and complexity of putative prognostic factors continues to widen, and now includes such items as the presence of occult microscopic metastases, DNA ploidy and proliferative fraction, cytogenetic abnormalities, oncogene expression, growth factor receptors, and expression of hormonally regulated proteins. In addition, there is now a considerable range of options with regard to the composition, dose intensity, and sequence of multimodality therapy. Data regarding the classification, significance, and interpretation of prognostic factors is reviewed together with the development, current status, and recommendations regarding adjuvant therapy for patients with early-stage breast cancer. For 1991, the National Cancer Institute (NCI) has estimated that 175,000 new cases of breast cancer will be diagnosed in American women. It is also estimated that 44,500 women will die of breast cancer. Unfortunately, the age-adjusted death rate from breast cancer has shown no overall change from 1930 through 1987. However, effective screening techniques continue to identify an increasing percentage of early-stage tumors, which should exceed 50% of all new tumors in 1991. Ultimately, our understanding of environmental and genetic risk factors may identify new ways to reduce the impact of this disease. In the interim, development and application of effective systemic adjuvant chemotherapy and hormonal therapy has become increasingly important. There is no question that a greater proportion of patients with less extensive disease are now being offered some form of adjuvant therapy. Meanwhile, selection of patients for adjuvant therapy, and choice specific adjuvant regimens, has remained controversial. Analysis of multiple prognostic factors is performed not only in the context of cooperative investigational trials, but more often in the offices of individual physicians caring for individual patients. Tumor biopsies can now be routinely sent to specialized laboratories for performance of complex assays with potential prognostic information, although interpretation of these results with reference to a specific patient is often uncertain. Conveying prognostic and therapeutic information to the patient is subject to bias and misperception. Ultimately, less than half of eligible patients offered the opportunity to participate in randomized clinical trials choose to do so, reflecting the complexity of doctor-patient communication and expectations. This review will analyze the significance of prognostic factors and explore the role of adjuvant chemotherapy and hormonal therapy for patients with early-stage breast cancer.