Brachytherapy in the treatment of breast cancer.

Whole-breast external-beam radiation therapy (EBRT) involves a 6-week course of fractionated treatments. In contrast, brachytherapy can be completed in a 4- to 5-day treatment course. Because of this shortened time frame, there has been interest in breast brachytherapy as a sole modality after lumpectomy. The American Brachytherapy Society (ABS) has issued guidelines specifically for the use of brachytherapy in breast carcinoma. In these guidelines, the ABS addresses important areas of controversy related to the indications, execution, and evaluation of breast implants when utilized in the following settings: as the sole treatment modality following lumpectomy, as an alternative to a 6-week course of EBRT following lumpectomy, as a boost following whole-breast irradiation, and for the treatment of local recurrences following breast-conservation treatment. The ABS recommends a precise definition and meticulous delineation of the clinical target volume. In addition, the Society recommends the routine use of dose-volume histograms and a dose-homogeneity index as tools to ensure reproducible brachytherapy and to allow interinstitutional comparisons. Brachytherapy as a sole modality is currently considered investigational and should be performed in the context of a controlled clinical trial. Practitioners and cooperative groups are encouraged to use these guidelines to formulate treatment and dose-reporting policies, but responsibility for medical decisions ultimately rests with the treating radiation oncologist.

Postmastectomy radiotherapy: clinical practice guidelines of the American Society of Clinical Oncology.

OBJECTIVE: To determine indications for the use of postmastectomy radiotherapy (PMRT) for patients with invasive breast cancer with involved axillary lymph nodes or locally advanced disease who receive systemic therapy. These guidelines are intended for use in the care of patients outside of clinical trials. POTENTIAL INTERVENTION: The benefits and risks of PMRT in such patients, as well as subgroups of these patients, were considered. The details of the PMRT technique were also evaluated. OUTCOMES: The outcomes considered included freedom from local-regional recurrence, survival (disease-free and overall), and long-term toxicity. EVIDENCE: An expert multidisciplinary panel reviewed pertinent information from the published literature through July 2000; certain investigators were contacted for more recent and, in some cases, unpublished information. A computerized search was performed of MEDLINE data; directed searches based on the bibliographies of primary articles were also performed. VALUES: Levels of evidence and guideline grades were assigned by the Panel using standard criteria. A "recommendation" was made when level I or II evidence was available and there was consensus as to its meaning. A "suggestion" was made based on level III, IV, or V evidence and there was consensus as to its meaning. Areas of clinical importance were pointed out where guidelines could not be formulated due to insufficient evidence or lack of consensus. RECOMMENDATIONS: The recommendations, suggestions, and expert opinions of the Panel are described in this article. VALIDATION: Seven outside reviewers, the American Society of Clinical Oncology (ASCO) Health Services Research Committee members, and the ASCO Board of Directors reviewed this document.

Long-term results of wide-field brachytherapy as the sole method of radiation therapy after segmental mastectomy for T(is,1,2) breast cancer.

BACKGROUND: We hypothesized that wide-field brachytherapy (BRT) after margin negative excision would result in complication rates, local recurrence rates, and cosmesis scores equivalent to external beam radiotherapy (ERT). METHODS: Patients with T(is,1,2) tumors less than or equal to 4 cm, 0 to 3 positive axillary nodes, and negative inked surgical margins were entered prospectively into BRT phase I/II trial. Patients who met the eligibility criteria for BRT but were treated with ERT during the same time period were retrospectively identified as controls. A blinded panel of healthcare professionals graded cosmetic outcome. RESULTS: Fifty patients with 51 breast cancers received BRT from January 1992 to October 1993. We identified 94 patients eligible for BRT but concurrently treated with ERT. At a median follow-up of 75 months, the two groups were similar for grade III treatment toxicities, local/regional recurrence rates, and cosmesis scores. CONCLUSIONS: For selected breast cancer patients undergoing breast-conserving therapy, BRT is an attractive alternative to ERT.

The influence of young age and positive family history of breast cancer on the prognosis of ductal carcinoma in situ treated by excision with or without radiation therapy or by mastectomy.

BACKGROUND: Several recent studies have investigated the influence of family history on the progression of DCIS patients treated by tylectomy and radiation therapy. Since three treatment strategies have been used for DCIS at our institution, we evaluated the influence of family history and young age on outcome by treatment method. METHODS: Between 1/1/82 and 12/31/92, 128 patients were treated for DCIS by mastectomy (n = 50, 39%), tylectomy alone (n = 43, 34%), and tylectomy with radiation therapy (n = 35, 27%). Median follow-up is 8.7 years. Thirty-nine patients had a positive family history of breast cancer; 26 in a mother, sister, or daughter (first-degree relative); and 26 in a grandmother, aunt, or cousin (second-degree relative). Thirteen patients had a positive family history in both first- and second-degree relatives. RESULTS: Six women developed a recurrence in the treated breast; all of these were initially treated with tylectomy alone. There were no recurrences in the mastectomy group or the tylectomy patients treated with postoperative radiation therapy. Patients with a positive family history had a 10.3% local recurrence rate (LRR), vs. a 2.3% LRR in patients with a negative family history (p = 0.05). Four of 44 patients (9.1%) 50 years of age or younger recurred, compared to two of 84 patients (2.4%) over the age of 50 (p = 0.10). Fifteen patients had both a positive family history and were 50 years of age or younger. Among these women, the recurrence rate was 20%. Women in this group treated by lesionectomy alone had a LRR of 38% (3 of 8). CONCLUSION: The most important determinant of outcome was the selection of treatment modality, with all of the recurrences occurring in the tylectomy alone group. In addition to treatment method, a positive family history significantly influenced LRR in patients treated by tylectomy, especially in women 50 years of age or younger. These results suggest that DCIS patients, particularly premenopausal women with a positive family history, benefit from treatment of the entire breast, and raise concerns about treating patients with a possible genetic susceptibility to breast cancer with tylectomy alone.

The role of postmastectomy radiation in the treatment of early stage breast cancer: back to the future.

Oncologists once downplayed the adjuvant role of radiotherapy after mastectomy. A decade ago, lacking a survival benefit, studies demonstrating late fatal myocardial infarctions nearly put a stop to any referrals of postoperative high-risk women to radiation oncology. The potential survival benefits of adjuvant radiotherapy may be overshadowed by inadequate technique leading to late cardiac deaths. Is it possible to cover the chest wall, internal mammary lymph chain, supraclavicular, and, where indicated, the axillary nodes and keep the dose to the coronary arteries and the lung to well within tolerance? A modern five-field comprehensive technique can deliver less cardiac and lung irradiation than the standard three-field technique, i.e. supraclavicular field matched to broad tangential fields. Linear accelerators with 4 megavolt (MV) to 6 MV photons, a full spectrum (6 MV to 20 MV) of electron energies, and meticulous computerized treatment planning based on multiple computed tomography planes allow an experienced physics/dosimetry team to treat all target sites while wrapping the dose around critical normal tissues.Whether to offer postmastectomy radiation to women with one to three positive nodes after adjuvant chemotherapy treatment has been the subject of intense discussion since the publication of two major randomized prospective trials. Although before these studies radiotherapy after mastectomy was an established treatment for women with four or more positive axillary nodes, existing data did not justify its use in patients with less extensive nodal involvement. Now, with results from these studies showing improved survival after radiotherapy in all node-positive premenopausal and perimenopausal women, with perhaps its greatest benefit in women with 1-3 positive nodes, practice patterns are again shifting toward strong consideration of treatment in women with less tumor nodal involvement.

Breast brachytherapy.

The benefits and problems of applying brachytherapy to breast cancer management are examined in this article. A history of breast brachytherapy is provided before the uses of brachytherapy in breast cancer are discussed, using several trials as examples. Techniques and tips for implementing brachytherapy are provided and dosimetry is discussed.

Adjuvant irradiation after mastectomy in women with one to three positive axillary nodes: then no; now yes.

The decision whether to offer women with one to three positive nodes postmastectomy radiation after adjuvant chemotherapy has been the subject of intense discussion since the publication of two major randomized prospective trials. Although radiotherapy after mastectomy was an established treatment for women with four or more positive axillary nodes, before these studies, existing data did not justify its use in patients with less extensive nodal involvement. Now with results from these studies showing improved survival after radiotherapy in all node-positive premenopausal and perimenopausal women, with perhaps its greatest benefit in women with one to three positive nodes, practice patterns are again shifting toward strong consideration of treatment in women with less tumor involvement. The arguments supporting this new treatment philosophy are presented.

Image-guided core-needle breast biopsy is an accurate technique to evaluate patients with nonpalpable imaging abnormalities.

OBJECTIVE: The goal was to evaluate one institution's experience with image-guided core-needle breast biopsy (IGCNBB) and compare the pathologic results with wire-localized excisional breast biopsy (WLEBB) for patients with positive cores and the mammographic surveillance results for patients with negative cores. SUMMARY BACKGROUND DATA: IGCNBB is becoming a popular, minimally invasive alternative to WLEBB in the evaluation of patients with nonpalpable abnormalities. METHODS: This study includes all patients with nonpalpable breast imaging abnormalities evaluated by IGCNBB from July 1993 to February 1997. Patients with positive cores (atypical hyperplasia, carcinoma in situ, or invasive carcinoma) were evaluated by WLEBB. Patients with negative cores (benign histology) were followed with a standard mammographic protocol. IGCNBB results were compared with WLEBB results to determine the sensitivity and specificity for each IGCNBB pathologic diagnosis. RESULTS: Of 1440 IGCNBBs performed during the study period, 1106 were classified as benign, and during surveillance follow-up only a single patient was demonstrated to have a carcinoma in the index part of the breast evaluated by IGCNBB (97.3% sensitivity, 99.7% specificity). IGCNBB demonstrated atypical hyperplasia in 72 patients, 5 of whom refused WLEBB. The remaining 67 patients were evaluated by WLEBB: nonmalignant findings were found in 31, carcinoma in situ was found in 25, and invasive carcinoma was found in 11 (100% sensitivity, 88.8% specificity). IGCNBB demonstrated carcinoma in situ in 84 patients; WLEBB confirmed carcinoma in situ in 54 and invasive carcinoma in 30 (65.4% sensitivity, 97.7% specificity). IGCNBB demonstrated invasive carcinoma in 178 patients. Three were lost to follow-up. On WLEBB, 173 of the remaining 175 had invasive carcinoma; the other 2 patients had carcinoma in situ (80.8% sensitivity, 99.8% specificity). CONCLUSIONS: An IGCNBB that demonstrates atypical hyperplasia or carcinoma in situ requires WLEBB to define the extent of breast pathology. Mammographic surveillance for a patient with a benign IGCNBB is supported by nearly 100% specificity. An IGCNBB diagnosis of invasive carcinoma is also associated with nearly 100% specificity; therefore, these patients can have definitive surgical therapy, including axillary dissection or mastectomy, without waiting for the pathologic results of a WLEBB. Based on the authors' findings, IGCNBB can safely replace WLEBB in evaluating patients with nonpalpable breast abnormalities.

A core breast biopsy diagnosis of invasive carcinoma allows for definitive surgical treatment planning.

BACKGROUND: We reviewed our image-guided core needle breast biopsy (IGCNBB) experience with patients diagnosed with invasive carcinoma (IC) to determine the accuracy of a core biopsy diagnosis of invasion and our ability to perform a single definitive cancer operation. METHODS: All IGCNBBs between July 1993 and July 1997 were reviewed to identify patients diagnosed with IC. Data included initial surgical treatment, surgical pathology, and subsequent surgical treatment. RESULTS: Of the 1,676 biopsies, invasive carcinoma was diagnosed in 208 with follow-up in 204 cases. Invasive carcinoma diagnosis was confirmed in 202 of 204 cases (99%). One hundred ninety-two patients had surgical treatment. Of these 192 patients, 173 (90%) could have achieved definitive surgical treatment with a single operation. CONCLUSIONS: An IGCNBB diagnosis of IC is accurate and allows for definitive breast cancer therapy. The potential impact on patient management is that a single operation can usually accomplish what traditionally has required at least two surgical procedures.

Accelerated hyperfractionation radiation therapy after lumpectomy and axillary lymph node dissection in patients with stage I or II breast cancer: pilot study.

PURPOSE: To prospectively assess tolerance to accelerated hyperfractionation radiation therapy in patients undergoing breast-conservation therapy and to exclude, with 90% confidence, a 20% or greater risk of an acute toxic reaction of at least grade 3 (severe). MATERIALS AND METHODS: Thirty-seven patients (aged 33-80 years) with evaluatable cases received 48 Gy in twice-daily 1.6-Gy fractions to the breast and regional lymph nodes (if three or more lymph nodes were involved) and a boost of 9.6 Gy in twice-daily 1.6-Gy fractions. Acute and late effects were scored by using the Radiation Therapy Oncology Group and European Organization for the Research and Treatment of Cancer radiation morbidity criteria. RESULTS: One patient developed a grade 3 acute skin toxic reaction and another grade 3 (continuous) acute edema. There have been no grade 4 (life-threatening) acute toxic reactions, local recurrences, or cancer- or treatment-related deaths. CONCLUSION: This breast-conservation accelerated hyperfractionation radiation therapy schedule is tolerable. Additional follow-up is necessary to determine long-term morbidity and cosmesis, and further study in a larger patient group is necessary to confirm efficacy.

Phase III double-blind evaluation of an aloe vera gel as a prophylactic agent for radiation-induced skin toxicity.

PURPOSE: Considerable pilot data and clinical experience suggested that an aloe vera gel might help to prevent radiation therapy-induced dermatitis. METHODS AND MATERIALS: Two Phase III randomized trials were conducted. The first one was double blinded, utilized a placebo gel, and involved 194 women receiving breast or chest wall irradiation. The second trial randomized 108 such patients to aloe vera gel vs. no treatment. Skin dermatitis was scored weekly during both trials both by patients and by health care providers. RESULTS: Skin dermatitis scores were virtually identical on both treatment arms during both of the trials. The only toxicity from the gel was rare contact dermatitis. CONCLUSIONS: This dose and schedule of an aloe vera gel does not protect against radiation therapy-induced dermatitis.

Disseminated epidemic Kaposi's sarcoma treated with radiation and chemotherapy.

When a 40-year-old patient with end-stage acquired immunodeficiency syndrome (AIDS) had bloating and abdominal pain, a large epidemic Kaposi's sarcoma (EKS) lesion was found obstructing the pylorus. Treatment consisted of single-agent chemotherapy for the disseminated lesions and external beam irradiation to the obstructing lesion. Within days of radiation therapy, symptoms began to resolve, and by completion of therapy, the patient was virtually asymptomatic. Although EKS is common in homosexual men infected with the AIDS virus, these patients usually succumb to overwhelming opportunistic infections. Nevertheless, palliative courses of radiation, which can produce a complete response in 50% to 100% of treated KS lesions, can substantially improve the quality of life in these patients.

Mammographically detected, clinically occult ductal carcinoma in situ treated with breast-conserving surgery and definitive breast irradiation.

PURPOSE: Ductal carcinoma in situ (DCIS) is increasingly detected as a nonpalpable lesion on mammographic screening performed for the early detection of breast cancer. Because of the growing incidence of mammographically detected DCIS, the present study was undertaken to determine the outcome of treatment of nonpalpable, mammographically detected intraductal carcinoma of the breast using breast-conserving surgery and definitive breast irradiation. MATERIALS AND METHODS: An analysis was performed of 110 women who presented with unilateral, nonpalpable, mammographically detected intraductal carcinoma of the breast and who were treated with breast-conserving surgery and definitive breast irradiation at 10 institutions in Europe and the United States. In all patients, complete gross excision of the primary tumor was performed, and breast irradiation was delivered with definitive intent. When performed, pathologic axillary lymph node staging was node negative (n=29). The median follow-up time was 9.3 years. RESULTS: The 10-year actuarial overall survival rate was 93%, and the 10-year actuarial cause-specific survival rate was 96%. The 10-year actuarial rate of freedom from distant metastases was 96%. There were 15 local recurrences in the treated breast. The actuarial rate of local failure was 7% at 5 years and 14% at 10 years. The histology of the local recurrence was intraductal carcinoma in 9 cases and invasive ductal carcinoma (with or without associated intraductal carcinoma) in 6 cases. The median time to local recurrence was 5.0 years (mean, 5.4; range, 2.1-15.2). With a median follow-up time of 4.4 years after salvage treatment, 14 of the 15 patients with local recurrence were alive without evidence of disease at the time of last follow-up examination. The crude incidence of local recurrence was 7% (3/42) when the final pathology margin of tumor excision was negative, 29% (5/17) when the margin was close or positive, and 14% (7/51) when the margin was unknown. There was no difference in the rate of local recurrence based on pathologic characteristics of the primary tumor. DISCUSSION: Results from the present study demonstrate high rates of overall survival, cause-specific survival, and freedom from distant metastases at 10 years following the treatment of nonpalpable, mammographically detected DCIS of the breast using breast-conserving surgery and definitive breast irradiation. Local recurrences within the treated breast were detected early and were treated with salvage for cure. These results support the initial treatment of nonpalpable, mammographically detected DCIS of the breast using breast-conserving surgery and definitive breast irradiation. Improvements in patient selection have the potential to reduce the risk of local recurrence.

Brachytherapy or electron beam boost in conservation therapy of carcinoma of the breast: a nonrandomized comparison.

PURPOSE: The results of breast-conservation therapy using breast irradiation and a boost to the tumor excision site with either electron beam or interstitial 192Ir implant are reviewed. METHODS AND MATERIALS: A total of 701 patients with histologically confirmed Stage T1 and T2 carcinoma of the breast were treated with wide local tumor excision or quadrantectomy and breast irradiation. The breast was treated with tangential fields using 4 or 6 MV photons to deliver 48 to 50 Gy in 1.8 to 2 Gy daily dose, in five weekly fractions. In 80 patients the regional lymphatics were irradiated. In 342 patients with Stage T1 and 107 with Stage T2 tumors, boost to the primary tumor excision site was delivered with 9 MeV and, more frequently, with 12 MeV electrons. In 91 patients with Stage T1 and 38 patients with Stage T2 tumors an interstitial 192Ir implant was performed. Tumor control, disease-free survival, cosmesis, and morbidity of therapy are reviewed. Minimum follow-up is 4 years (median 5.6 years; maximum, 24 years). RESULTS: The overall local tumor recurrence rates were 5% in the T1 and 11% in the T2 tumor groups. There was no significant difference in the breast relapse rate in patients treated with either electron beam or interstitial 192Ir boost. Regional lymph node recurrences were 1% in patients with T1 and 5% with T2 tumors. Distant metastases were recorded in 5% of the T1 and 23% of the T2 groups. The 10-year actuarial disease-free survival rates were 87% for patients with T1 and 75% with T2 tumors. Disease-free survival was exactly the same in patients receiving either electron beam or interstitial 192Ir boost. Cosmesis was rated as excellent/good in 84% of patients with T1 tumors treated with electron beam and 81% of patients treated with interstitial implant, and 74 and 79% respectively, in patients with T2 tumors. CONCLUSIONS: Breast-conservation therapy is an effective treatment for patients with T1 and T2 carcinoma of the breast. There is no difference in local tumor control, disease-free survival, cosmesis, or morbidity in patients treated with either electron beam or interstitial 192Ir implant boost. Clinical trials in progress will further elucidate this controversial subject.

Factors influencing cosmetic results after conservation therapy for breast cancer.

PURPOSE: Host, tumor, and treatment-related factors influencing cosmetic outcome are analyzed for patients receiving breast conservation treatment. METHODS AND MATERIALS: Four-hundred and fifty-eight patients with evaluable records for cosmesis evaluation, a subset of 701 patients treated for invasive breast cancer with conservation technique between 1969 and 1990, were prospectively analyzed. In 243 patients, cosmetic evaluation was not adequately recorded. Cosmesis evaluation was carried out from 3.7 months to 22.3 years, median of 4.4 years. By pathologic stage, tumors were 62% T1N0, 14% T1N1, 15%, T2N0, and 9% T2N1. The majority of patients were treated with 4-6 MV photons. Cosmetic evaluation was rated by both patient and physician every 4-6 months. A logistic regression analysis was completed using a stepwise logistic regression. P-values of 0.05 or less were considered significant. Excellent cosmetic scores were used in all statistical analyses unless otherwise specified. RESULTS: At most recent follow-up, 87% of patients and 81% of physicians scored their cosmetic outcome as excellent or good. Eighty-two percent of physician and patient evaluations agreed with excellent-good vs. fair-poor rating categories. Analysis demonstrated a lower proportion of excellent cosmetic scores when related to patient age > 60 years (p = 0.001), postmenopausal status (p = 0.02), black race (p = 0.0034), and T2 tumor size (p = 0.05). Surgical factors of importance were: volume of resection > 100 cm3 (p = 0.0001), scar orientation compliance with the National Surgical Adjuvant Breast Project (NSABP) guidelines (p = 0.0034), and > 20 cm2 skin resected (p = 0.0452). Extent of axillary surgery did not significantly affect breast cosmesis. Radiation factors affecting cosmesis included treatment volume (tangential breast fields only vs. three or more fields) (p = 0.034), whole breast dose in excess of 50 Gy (p = 0.0243), and total dose to tumor site > 65 Gy (p = 0.06), as well as optimum dose distribution with compensating filters (p = 0.002). Daily fraction size of 1.8 Gy vs. 2.0 Gy, boost vs. no boost, type of boost (brachytherapy vs. electrons), total radiation dose, and use of bolus were not significant factors. Use of concomitant chemotherapy with irradiation impaired excellent cosmetic outcome (p = 0.02). Use of sequential chemotherapy or adjuvant tamoxifen did not appear to diminish excellent cosmetic outcomes (p = 0.31). Logistic regression for excellent cosmetic outcome analysis was completed for age, tumor size, menopausal status, race, type of surgery, volume of breast tissue resected, scar orientations, whole breast radiation dose, total radiation dose, number of radiation fields treated, and use of adjuvant chemotherapy. Significant independent factors for excellent cosmetic outcome were: volume of tissue resected (p = 0.0001), type of surgery (p = 0.0001), breast radiation dose (p = 0.005), race (p = 0.002), and age (p = 0.007). CONCLUSIONS: Satisfactory cosmesis was recorded in 81% of patients. Impaired cosmetic results are more likely with improper orientation of tylectomy and axillary incisions, larger volume of breast resection, radiation dose to the entire breast in excess of 50.0 Gy, and concurrent administration of chemotherapy. Careful selection of treatment procedures for specific patients/tumors and refinement in surgical/irradiation techniques will enhance the cosmetic results in breast conservation therapy.

Noninvasive carcinoma of the breast: the rationale for various treatment options.

As a result of the increasing utilization of screening mammography, the incidence of noninvasive breast cancers has been steadily climbing. This phenomenon has inspired questions about the biological behavior and natural history of this disease and has sparked a controversy about which patients should be treated by local excision alone or local excision followed by breast irradiation and which patients require a mastectomy for disease-free survival. New data have been published within the past year shedding some light on these issues, but questions remain.

Breast conservation therapy for intraductal carcinoma of the breast.

PURPOSE: Between 1979 and 1987, 76 women with 77 ductal carcinomas in-situ of the breast were evaluated by The Radiation Oncology Center after breast conservation surgery. METHODS AND MATERIALS: Seventy breasts (91%) had tylectomy and irradiation and seven breasts (9%) had tylectomy alone. Median follow-up was 4.0 years, with a range of 2-10 years. Fifty patients (65%) had occult lesions discovered by mammography with a median mammographic size of 0.9 cm. The twenty-six patients with presenting symptoms had a median clinical tumor size of 1.95 cm. All patients had local excision of the primary tumor. Of 15 patients who had axillary dissections, one had nodal metastasis. Seventy breasts were irradiated. Seven patients refused radiotherapy. RESULTS: Overall 5-year actuarial survival was 99%; 5-year actuarial disease-free survival was 89%; the 5-year actuarial intramammary tumor control rate for irradiated patients was 93% vs. 57% for patients not irradiated (p < 0.001). Comedocarcinoma had a 5-year actuarial tumor control rate of 75%, 88% in the irradiated group as compared to 98% for all other histologic subtypes of ductal carcinoma in situ (p < 0.03). All six patients with local failure were successfully salvaged by further surgery. Multivariate analysis revealed significant factors in local control to be (a) radiotherapy, (b) comedocarcinoma histology, and (c) menopausal status. CONCLUSIONS: Although the number of patients treated is small, and follow-up time is limited, these early results support the contention that the treatment of ductal carcinoma in situ by excision and irradiation is an acceptable alternative to mastectomy. We urge caution in treating patients with the comedocarcinoma subtype and counsel these patients to have more treatment than excision alone.

Is breast preservation possible in women with large, locally advanced breast cancers?

Breast conservation therapy is an accepted treatment option for early stage breast carcinoma, but is rarely considered appropriate for locally advanced nonmetastatic lesions. Mastectomy specimens of 46/50 patients treated at the Ochsner Clinic and the Mallinckrodt Institute of Radiology with neoadjuvant chemotherapy prior to mastectomy +/- irradiation were evaluated by a single pathologist to assess tumor response to chemotherapy. Forty percent of this group would potentially have been eligible for breast conservation therapy, using a residual tumor size of < or = 4 cm with negative surgical margins as the criteria. Patients most likely to qualify for breast conservation therapy were those with T3N0-1 lesions (67%). Least likely were patients with skin involvement at diagnosis 4/33 (12%). Tumors with an extensive intraductal component at biopsy often had residual islands of intraductal carcinoma occupying the original tumor volume, even when the invasive component was absent or much reduced. A prospective trial will be required to determine whether or not acceptable local control rates can be obtained after breast conservation therapy for that subset of patients with a favorable response to induction chemotherapy.