Factors correlating with lymph node metastases in patients with T1 breast cancer.

BACKGROUND: Identification of reliable predictors of axillary metastases (ALNM) may be useful in selecting appropriate management for patients with T1-size breast cancer. This study was undertaken to determine the degree of correlation between ALNM and several variables, including age, race, menopausal status, palpability, tumor size, positive margin on initial excision, histology, grade, lymphatic invasion (LI), estrogen receptor status (ER), progesterone receptor status, S-phase, and ploidy. METHODS: Data from 1416 patients with T1 breast cancers treated at Columbia-Presbyterian Medical Center between 1989 and 1998 was reviewed. Patients with multifocal tumors were excluded. RESULTS: Mean patient age was 57.5 years (SD = 12.0); 65% of the patients were postmenopausal. One hundred thirty-one patients with Tla (< or =0.5 cm), 435 with T1b (0.6-1.0 cm), and 850 patients with T1c (1.1-2.0 cm) lesions were studied. The overall rate of ALNM was 23%. AM was identified in 11% of T1a, 15% of T1b, and 29% of T1c patients. Statistically significant factors from univariate analysis were age, palpability, skin changes, tumor size, LI, histology, grade, ER status, and positive margin on initial excision. CONCLUSIONS: Axillary staging by either sentinel lymph node biopsy or level I/II axillary dissection is indicated for most T1 breast cancer patients. Omission of axillary staging can be considered for highly selected patients with T1a cancers.

Randomized trial of black cohosh for the treatment of hot flashes among women with a history of breast cancer.

PURPOSE: Most breast cancer survivors experience hot flashes; many use complementary or alternative remedies for these symptoms. We undertook a randomized clinical trial of black cohosh, a widely used herbal remedy for menopausal symptoms, among breast cancer patients. PATIENTS AND METHODS: Patients diagnosed with breast cancer who had completed their primary treatment were randomly assigned to black cohosh or placebo, stratified on tamoxifen use. At enrollment, patients completed a questionnaire about demographic factors and menopausal symptoms. Before starting to take the pills and at 30 and 60 days, they completed a 4-day hot flash diary. At the final visit, they completed another menopausal symptom questionnaire. Follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels were measured in a subset of patients at the first and final visits. RESULTS: Of 85 patients (59 on tamoxifen, 26 not on tamoxifen) enrolled in the study, 42 were assigned to treatment and 43 were assigned to placebo; 69 completed all three hot flash diaries. Both treatment and placebo groups reported declines in number and intensity of hot flashes; the differences between the groups were not statistically significant. Both groups also reported improvements in menopausal symptoms that were, for the most part, not significantly different. Changes in blood levels of FSH and LH also did not differ in the two groups. CONCLUSION: Black cohosh was not significantly more efficacious than placebo against most menopausal symptoms, including number and intensity of hot flashes. Our study illustrates the feasibility and value of standard clinical trial methodology in assessing the efficacy and safety of herbal agents.

Current treatment for lobular carcinoma in situ.

BACKGROUND: We thought that observation for patients with lobular carcinoma in situ (LCIS) had been generally accepted by the mid-1980s. A questionnaire mailed to oncologic surgeons in 1988 revealed that 33% of the respondents still advised unilateral mastectomy, although a slim majority (54%) advised observation. New studies have been published in the intervening 8 years, and we decided it would be worth recirculating the 1988 questionnaire. METHODS: The identical questionnaire was mailed to members of the same oncologic societies (Society of Surgical Oncology [SSO] and Society for the Study of Breast Disease), but changes in membership necessitated new mailing lists. RESULTS: Observation has yet to be universally accepted by the oncologic community, but at this time 85% of the respondents suggest it as the preferred option for their patients. CONCLUSIONS: Recent studies have questioned some of the tenets laid down by Haagensen in 1978, but it appears clear that his formulation of LCIS as a marker of increased risk continues to gain ground over the original concept of inevitable progression to invasive disease.

Axillary clearance in operable breast cancer: still a necessity?

Complete axillary dissection, as part of radical mastectomy, was the standard of care for the first three-quarters of this century. Long-term follow-up of these patients showed substantial cure rates for positive-node patients before systemic therapy was available, indicating a therapeutic value to nodal dissection. There was also good control of the axilla; axillary recurrence after removal of positive nodes was quite low. Even today, in patients with positive nodes, complete axillary clearance as part of a modified radical mastectomy or a breast conservation approach with lumpectomy leads to control of the axilla and complete axillary staging, allowing medical oncologists to tailor their systemic treatment to the total number of nodes involved. Today, due to a combination of factors including patient awareness and the ability of mammography to detect smaller lesions, many women present with small cancers that carry a much lower risk of axillary involvement. Whereas a complete dissection is indicated for patients with clinically involved nodes, a level I-II dissection is the standard in most centers for patients with clinically negative nodes. In those patients with very small (T1a, T1b) cancers, the role of sentinel lymphadenectomy is being explored; it may spare these patients the morbidity of complete axillary dissection.

Axillary lymphadenectomy: a diagnostic and therapeutic procedure.

Axillary dissection for primary operable cancer follows the basic tenants of surgical oncology and achieves the stated goals. Local control is excellent with failure rates in the 0-2% range. Long-term and disease-free survival is improved with axillary dissection. It is often stated that axillary dissection is not required for the smallest of lesions, but the 15% risk of axillary disease with the T1A lesion would suggest otherwise. Axillary sampling would not achieve the stated goals because of the high probability of retained, potentially resectable disease in the node positive group. Axillary recurrence is associated with an unacceptably high morbidity and mortality. Although the survival is similar in the three treatment groups of NSABP B-04, the inordinately high systemic failure rate with axillary recurrence would suggest that more aggressive local control could prevent many of these failures. After all, long-term survival free of disease is reported in many series even in patients with multiple involved nodes. Axillary dissection also generates the most accurate prognostic variable upon which further therapeutic interventions are predicated. At present there is no other diagnostic or therapeutic approach that achieves all of these goals. In summary the value of the axillary dissection is to provide accurate prognostic information as well as excellent local control and to improve the survival rate in the node positive group. It is hoped that in the future a diagnostic test such as PET scanning or sentinel node mapping may predict those patients with a clear axilla and therefore not require an axillary dissection. Finally, there has yet to be a primary operable carcinoma that benefits from preservation of potentially fully resectable disease.

Systemic adjuvant therapy of breast cancer.

Systematic adjuvant therapy has improved the outcome for women with operable breast cancer. As a result, a substantial proportion of patients with this disease are candidates for adjuvant treatment. In providing a woman with recommendations for therapy, her risk of developing recurrent breast cancer needs to be assessed in relationship to the degree of benefit she will obtain from treatment. With the range of presently available treatments, an individualized approach is necessary to provide the patient with options appropriate for her own situation. For women with a high risk of recurrence despite current standard adjuvant therapies, innovative approaches with high dose chemotherapy followed by infusion of autologous hematopoietic stem cells and growth factors are being evaluated. Ongoing clinical trials will demonstrate whether or not these newer therapies result in a better outcome.

Breast-conserving treatment: controversies and consensus.

Although breast-conserving therapy (BCT) is an accepted alternative for the treatment of breast cancer, numerous controversies surround the selection criteria and the treatment details. A review of the literature revealed that patient selection is of critical importance. However, there is disagreement over the relative importance of some of the criteria for patient selection. A wide excision is preferable to a less complete excision (tumorectomy) or a more radical excision (quadrantectomy). Accurate assessment of surgical margins is important. The risk of local recurrence may be diminished if a re-excision is performed to obtain tumor-free margins. However, the suitability and practicality of the techniques used to assess the resection margins have been questioned. Radiotherapy is an integral part of BCT. Surgery alone remains an investigational approach. Axillary dissection remains a reliable method of assessing nodal status and treating regional disease.

Breast sarcoma.

Primary sarcoma of the breast is a rare problem and accounts for less than 5% of all soft-tissue sarcomas and less than 1% of all breast malignancies. As experience with breast sarcoma has increased, the perceived differences with other soft-tissue sarcomas has decreased. Outcome is predicated upon histologic type, degree of differentiation, and tumor size. Recurrences are primarily local as an early event and distant to the lung somewhat later in the course of the disease.

Is axillary lymph node dissection necessary in the routine management of breast cancer? Yes.

Axillary dissection for primary operable cancer follows the basic tenets of surgical oncology and achieves the stated goals. Local control is excellent, with failure rates of 0% to 2%. Long-term, disease-free survival is improved with axillary dissection. It is often stated that axillary dissection is not required for the smallest lesions, but the 15% risk of axillary disease with the T1A lesion suggests otherwise. Axillary sampling would not achieve the stated goals because of the high probability of retained, potentially resectable disease in the node-positive group. Axillary recurrence is associated with unacceptably high morbidity and mortality rates. Although the survival is similar in the three treatment groups of NSABP B-04, the inordinately high systemic failure rate with axillary recurrence would suggest that more aggressive local control could prevent many of these failures. After all, long-term survival free of disease is reported in many series, even in patients with multiple involved nodes. Axillary dissection also generates the most accurate prognostic variable on which further therapeutic interventions are predicated. At present, no other diagnostic or therapeutic approach achieves all these goals. The value of the axillary dissection is to provide accurate prognostic information, provide excellent local control, and improve the survival rate in the node-positive group. Perhaps in the future, a diagnostic test such as PET scanning or sentinel node mapping will identify patients with a clear axilla, who therefore do not require an axillary dissection. There has yet to be a primary operable carcinoma that benefits from preservation of potentially fully resectable disease.

The surgical management of primary invasive breast cancer.

The treatment of operable primary breast cancer has evolved dramatically in the past few decades. The standard operative procedure has changed from the radical mastectomy to the modified radical mastectomy, and the use of breast-conserving treatment is increasing. This article reviews trends in treatment of early-stage breast cancer, factors associated with increased risk for local recurrence after breast-conserving treatment, and the use of axillary lymph node dissection.

Breast reconstruction after mastectomy: who seeks it, who refuses?

Recent Food and Drug Administration hearings on silicone gel implants have drawn attention to the paucity of information about women who seek reconstruction after mastectomy compared with those who do not. New analyses of data gathered in the early 1980s address this issue. Three groups of mastectomy patients were compared: 117 women who sought and obtained delayed reconstruction, 26 who sought but decided against delayed reconstruction, and a comparison group of 53 who were not seeking reconstruction. Results indicated that although younger and more knowledgeable about reconstruction, patients in the reconstruction group were similar to those in the comparison group. However, the women who sought but chose not to proceed with reconstruction appear to have been at greater risk for physical and emotional disappointment with the results of reconstruction, which suggests that poor candidates for reconstruction may select themselves out at the time of consultation.

Hypnotic efficacy and safety of triazolam administered during the postoperative period.

This study examined the hypnotic efficacy and safety of short-term use of triazolam following elective surgery. One hundred women (ages 26-69) who had received 0.125 mg of traizalam the evening before breast cancer surgery were enrolled in a randomized, double-blind study comparing triazolam to placebo. Study medication was begun on the first or second evening following surgery, depending on the patient's level of postoperative alterness, and was administered in the hospital for three consecutive evenings. The starting dose of triazolam was 0.125 mg, with the option of increasing the dose to 0.25 mg on subsequent nights if sleep response was inadequate. Relative to patients in the placebo group, patients in the triazolam group reported significantly (p < 0.05) less difficulty falling asleep, fewer nightime awakenings, better overall sleep quality, and a greater sense of restfulness. No clinically significant adverse reactions were encountered and no adverse reactions occurred more frequently in the triazolam group than in the placebo group. Results indicate that administration of traizalam is a safe and effective method of improving sleep in patients recovering from surgery.

Method of tumor detection influences disease-free survival of women with breast carcinoma.

BACKGROUND: Screening mammography provides the primary means of reducing breast cancer mortality. Clinical breast examination (CBE) and breast self-examination (BSE) may be complementary screening modalities enabling palpation of interval cancers and detection of tumors not visualized by mammography; however, their combined contribution to improving prognosis has not been evaluated adequately. METHODS: Disease-free survival was assessed in relation to method of tumor detection among 729 consecutive patients treated by mastectomy and axillary dissection for primary breast carcinoma between 1976 and 1978. RESULTS: Disease-free survival at 10 years was significantly higher after detection by mammography (77% of 30 patients) or CBE (78% of 101 patients) compared to self-detection (64%). The hazard ratio of recurrence associated with clinical examination or mammography in contrast to self-detection was significantly reduced to 0.55 (95% CI, 0.37-0.81; P = 0.001). In addition, annual CBE, compared to less frequent clinical palpation, reduced the risk of recurrence controlling for detection modality (P = .03). In multivariate analyses, the method of detection and frequency of clinical breast examination remained statistically significant prognostic factors after controlling for number of screening mammograms, history of prior breast surgery, family history of breast cancer, and age at diagnosis. Differences in self-examination frequency were not associated with prognosis. CONCLUSIONS: Among patients diagnosed before widespread mammography screening, tumor detection by CBE was associated with a significant reduction in recurrence compared with detection by self-palpation. Improvement in the frequency and quality of CBE and BSE may enhance the contribution of these modalities to early detection, complementing the role of screening mammography in reducing breast cancer mortality rates.

Patient selection criteria for conservation surgery versus mastectomy: Memorial Hospital breast service experience.

Breast cancer remains the most common noncutaneous malignancy of women. Although the incidence of the disease continues to rise, most women now present with early (stage I or II) disease. Breast conservation has been demonstrated to be equal in efficacy to mastectomy in such patients in six modern-day randomized trials. The utilization of breast conservation has been slow throughout the United States. At Memorial Hospital the utilization of breast conservation almost equals that of modified mastectomy in the treatment of 950+ annual primary operable cancers. Excellent local-regional control can be obtained with a defined surgical approach to the primary tumor and axillary nodes, radiotherapy to the breast with a boost to the primary site, and finally patient selection.

Menstrual timing of treatment for breast cancer.

Although the hormone dependency of breast cancer has been recognized for nearly a century, the influence on disease progression of cyclical hormonal levels among premenopausal women has not been extensively researched. The findings of recent studies, assessing the effect on prognosis of the hormonal milieu at the time of surgery, have been conflicting. However, several reports have noted improved survival among patients with positive, axillary lymph nodes surgically treated in the later phase of the menstrual cycle when progesterone levels are elevated. Biologic support for the influence of menstrual timing is provided by cyclical patterns of cell division and cell death observed in normal breast tissue as well as potential tumor cell dissemination during surgery among patients with positive axillary nodes. Immune parameters, which also respond to cycling endogenous hormones, may influence the metastatic potential of circulating tumor cells. Comparisons among studies of menstrual timing of surgery have been complicated by differences in cycle divisions, extent of primary surgery, frequency of adjuvant therapy, duration of follow-up, and analytic procedures. Although several clinicians are now scheduling breast surgery of premenopausal women in relation to day of the menstrual cycle, a majority of surgeons have deferred consideration of menstrual timing until additional research is available. While waiting 5-10 years for the results of prospective studies, additional retrospective analyses, using carefully collected data, may provide clinical guidance. With increasing concern for issues related to women's health, multidisciplinary studies will be required to adequately characterize the influence of the menstrual cycle and other aspects of women's reproductive physiology on breast cancer and other medical conditions.

Conservation surgery for breast cancer: selection criteria and technical considerations.

Patients with stage I or II breast cancer are candidates for either modified radical mastectomy or breast preservation therapy involving limited resection of the primary tumor, axillary dissection, and breast irradiation. The overall survival rates of both these approaches are comparable according to retrospective reviews and ongoing clinical trials, and long-term follow-up confirms the earlier findings. Thus, patients should be given the choice between these two options by surgeons, radiation therapists, and other physicians involved in their care. However, not all breast cancer patients will choose breast preservation surgery, and because of tumor-related and other factors not all patients are candidates. The patient selection criteria are discussed herein and the optimal surgical techniques are reviewed.