Anaphylactic reactions to isosulfan blue dye during sentinel lymph node biopsy for breast cancer.

BACKGROUND: Sentinel lymph node biopsy (SLNB) is an alternative to axillary dissection for many breast cancer patients. Cases of anaphylactic reaction to the isosulfan blue dye used during SLNB have recently been reported. No study on the incidence of serious anaphylactic reactions during SLNB for breast cancer has been reported. METHODS: We reviewed 639 consecutive SLNBs for breast cancer performed at our institution. Sentinel lymph node biopsy was performed using both isosulfan blue dye and technetium-99m sulfur colloid. Cases of anaphylaxis were reviewed in detail. RESULTS: Overall, 1.1% of patients had severe anaphylactic reactions to isosulfan blue requiring vigorous resuscitation. No deaths or permanent disability occurred. In patients with anaphylaxis, hospital stay was prolonged by a mean of 1.6 days. In 1 patient, the anaphylactic reaction required termination of the operation. CONCLUSIONS: Prompt recognition and aggressive treatment of anaphylactic reactions to isosulfan blue are critical to prevent an adverse outcome. Lymphatic mapping with blue dye should be performed in a setting where personnel are trained to recognize and treat anaphylaxis.

Breast conservation therapy as a treatment option for the elderly. The M. D. Anderson experience.

BACKGROUND: Although almost half of all incidents of breast carcinoma occur in women age > or = 65 years, not enough is known about appropriate care for patients in this age group. The objective of the current study was to evaluate the role of breast conservation therapy in the management of breast carcinoma in women age > or = 65 years. METHODS: From 1970 to 1994, 1325 patients with carcinoma of the breast were treated with breast conservation therapy (segmental mastectomy and radiation therapy with or without axillary lymph node dissection) at The University of Texas M. D. Anderson Cancer Center. From this patient group, the authors identified 184 elderly women (> or = 65 years) with Stage 0-III disease at the time of diagnosis. RESULTS: The median patient age was 70 years (range, 65-88 years). The distribution of disease by stage among the women was Stage 0 disease in 12 patients (7%), Stage I disease in 107 patients (58%), Stage II disease in 63 patients (34%), and Stage III disease in 2 patients (1%). Comorbid conditions that may have influenced treatment planning were reported in 91 patients (50%). An axillary lymph node dissection was performed in 135 patients (73%), with positive axillary lymph nodes found in 30 patients (22%). Adjuvant chemotherapy was given to 10 patients (5%), and tamoxifen therapy was given to 63 patients (34%). Complications from treatment were reported in 24 patients (13%). With a median follow-up of 7.3 years (range, 0.25-23.5 years), 9 patients developed locoregional disease recurrence (5%), 10 patients developed contralateral breast carcinoma (5%), and 21 patients developed distant metastasis (11%). At last follow-up, 113 patients (61%) were alive, 15 patients (8%) were dead of disease, and 56 patients (30%) were dead of other causes. The 5-year and 10-year disease specific survival rates were 96% and 91%, respectively. CONCLUSIONS: Breast conservation therapy with segmental mastectomy and postoperative radiation therapy with or without axillary lymph node dissection provides excellent local control and disease free survival in elderly women with breast carcinoma. This treatment should be considered as the standard of care for elderly patients without severe comorbid disease.

Adverse prognostic significance of infraclavicular lymph nodes detected by ultrasonography in patients with locally advanced breast cancer.

BACKGROUND: Ultrasonography is increasingly used to evaluate the nodal status of breast cancer patients and specialized positioning permits assessment of the infraclavicular fossa. However, the incidence and significance of infraclavicular (level III) adenopathy detected sonographically in locally advanced breast cancer (LABC) has not been defined. METHODS: The study population consisted of 146 LABC patients registered in a prospective trial of induction chemotherapy between 1991 and 1996. All patients underwent ultrasound imaging before and after chemotherapy. Median follow-up was 32 months. RESULTS: Forty-two of 146 patients (29%) had suspicious infraclavicular adenopathy; all 42 had additional positive axillary lymph nodes by ultrasound. Disease-free and overall survival for the patients with suspicious infraclavicular adenopathy was significantly worse compared with patients without this feature; disease-free survival 50% versus 68% (P = 0.112); overall survival 58% versus 83% (P = 0.026). CONCLUSIONS: Nearly one third of LABC patients will have infraclavicular lymph node involvement by ultrasound imaging; this finding is a significant adverse prognostic feature, and we recommend that infraclavicular nodal evaluation become a routine component of the sonographic workup of breast cancer patients, particularly if lower axillary lymph nodes appear involved.

Feasibility of breast preservation in the treatment of occult primary carcinoma presenting with axillary metastases.

BACKGROUND: The objective of the study was to compare the treatment outcomes in patients with occult primary carcinoma with axillary lymph node metastasis who were treated with mastectomy or with intent to preserve the breast. METHODS: From 1951 to 1998, 479 female patients were registered with axillary lymph node metastasis from an unknown primary. After clinical workup, including mammography, 45 patients retained this diagnosis and received treatment for T0 N1-2 M0 carcinoma of the breast. Clinical and pathological data were collected retrospectively, and survival was calculated from the date of initial diagnosis using the Kaplan-Meier method. Median follow-up time was 7 years. RESULTS: Median age was 54 years (range, 32-79). Clinical nodal status was N1 in 71% and N2 in 29% of the patients. Surgical treatment was mastectomy in 29% and an intent to preserve the breast in 71% of the patients. Locoregional radiotherapy was used in 71% and systemic chemoendocrine therapy was used in 73% of the patients. Of the 13 mastectomy patients, only one had a primary tumor discovered in the specimen. Two patients (4%) were ultimately diagnosed with lung cancer and neuroendocrine tumor. No significant difference was detected between mastectomy and breast preservation in locoregional recurrence (15% versus 13%), distant metastases (31% versus 22%), or 5-year survival (75% vs. 79%). Regardless of surgical therapy, the most important determinant of survival was the number of positive nodes. Five-year overall survival was 87% with 1-3 positive nodes compared with 42% with > or =4 positive nodes (P < .0001). CONCLUSIONS: Occult primary carcinoma with axillary metastases can be treated with preservation of the breast without a negative impact on local control or survival.

Educational review: role of the surgeon in hereditary breast cancer.

Up to 10% of the breast cancers detected in the United States are related to an inherited germline mutation, usually in the BRCA1 or BRCA2 genes, and the majority of these patients will at some point require surgical evaluation and/or treatment. Women who harbor a genetic predisposition for breast cancer face an increased risk for early onset disease, bilateral tumors, and other non-breast malignancies, such as ovarian cancer. These issues raise questions regarding the appropriate surveillance regimen, and the potential efficacy of risk reduction strategies that should be considered. Once a breast cancer diagnosis has been established, the prognosis appears to be similar to stage-controlled sporadic breast cancer, despite an increased prevalence of adverse primary tumor features. However, the role of breast conservation therapy for these patients and the optimal means of addressing the substantially increased risk for contralateral tumors is not yet defined. The reported literature in this area, including a discussion of the value of genetic counseling and genetic testing, is reviewed.

Radiofrequency ablation of solid tumors.

Radiofrequency ablation of solid tumors is produced by frictional heating caused when ions in the tissue attempt to follow the changing directions of a high-frequency alternating current. The radiofrequency probe is typically placed under ultrasound guidance, and the ablation is performed with real-time ultrasound monitoring. Radiofrequency ablation has been demonstrated to be effective in the treatment of unresectable hepatic tumors, and promising results have also been obtained in tumors of the lung, bone, brain, kidney, prostate gland, and pancreas. Most recently, radiofrequency ablation has been tested in the treatment of invasive breast tumors. A preliminary study reported that intraoperative radiofrequency ablation causes invasive breast cancer cell death in patients with locally advanced breast cancer. An ongoing study is investigating the use of radiofrequency ablation for the treatment of breast tumors 2 cm or less in diameter.

Utility of breast sentinel lymph node biopsy using day-before-surgery injection of high-dose 99mTc-labeled sulfur colloid.

BACKGROUND: In sentinel lymph node (SLN) biopsy for breast cancer, many centers use same-day preoperative injection of technetium 99mTc-labeled sulfur colloid and intraoperative injection of blue dye for localization of SLNs. Same-day sulfur colloid injections can be problematic because of the variability in sulfur colloid migration times, which can lead to ineffective use of operating room time, and low SLN-to-background radioactivity ratios. We examined the utility of day-before-surgery injections of high dose 99mTc-labeled sulfur colloid injections. METHODS: The day before surgery, high-dose 99mTc-labeled sulfur colloid was injected peritumorally, and a lymphoscintigram was obtained. Intraoperatively, after injection of blue dye, a gamma probe was used to localize SLNs. Nodes that were stained blue or were highly radioactive were considered SLNs and were removed. RESULTS: Lymphoscintigraphy demonstrated drainage in 107 patients (91%). Transcutaneous localization of the SLN was possible in 104 patients (89%). In three patients, all of whom had no drainage demonstrated on lymphoscintigraphy, no SLN was identified at surgery (97.5% success rate for SLN identification). A mean of 2.3 SLNs per patient were identified. Twenty-five patients (21%) had at least one histologically positive SLN. In 23 of these patients, the positive SLN was the SLN with the most radioactivity, and in the remaining two patients, the positive SLN was both blue-stained and hot. CONCLUSION: Day-before-surgery injection of high-dose 99mTc-labeled sulfur colloid results in high rates of transcutaneous and intraoperative identification of SLNs. The delay between injection and surgery did not appear to promote significant passage of sulfur colloid to second-echelon nodes.

Surgical conservation planning after neoadjuvant chemotherapy for stage II and operable stage III breast carcinoma.

BACKGROUND: This study was performed to investigate the extent of tumor downstaging achieved in women with operable breast cancer treated with neoadjuvant chemotherapy and breast-conservation surgery, develop recommendations for effective surgical planning, and report local-regional recurrence rates with this approach. METHODS: One hundred nine patients with stage II or III (T3N1) breast cancer were treated in three prospective trials utilizing four cycles of 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC, n = 72) or paclitaxel (n = 37) followed by segmental resection (n = 109) and axillary node dissection (n = 94). Postoperatively, patients received 4 additional cycles of FAC followed by irradiation of the breast. The median follow-up was 53 months. RESULTS: The median tumor size was 4 cm (range 1.1 to 9 cm) at presentation and only 1 cm (range 0 to 4.5 cm) after four cycles of chemotherapy. The primary tumor could not be palpated after chemotherapy in 55% of 104 patients presenting with a palpable mass and therefore required needle localization or ultrasound guidance for surgical resection. Of the 34 patients clinically deemed to have no residual carcinoma in the breast after chemotherapy and before surgery, only 50% of these patients were found to have no residual carcinoma on pathologic examination after surgery. Patients with primary tumors < or =2 cm were significantly more likely than patients with larger tumors to have complete eradication of the primary tumor prior to surgery (P <0.001). The 5-year local-regional recurrence rate was 5%. CONCLUSIONS: Tumor downstaging is marked in patients with operable breast cancer and requires close monitoring during chemotherapy. We recommend placement of metallic tumor markers when the primary tumor is < or =2 cm to facilitate adequate resection and pathologic processing. Resection of the tumor bed remains necessary in women deemed to have a complete clinical response to ensure low rates of recurrence.

Presentation, management and outcome of axillary recurrence from breast cancer.

BACKGROUND: The impact of axillary node dissection on breast cancer survival is unclear. Limited axillary surgery has been proposed but may increase regional recurrence rates. Optimal management for axillary recurrence is poorly understood. METHODS: Axillary recurrences were initial treatment failure sites in 44 of 4,255 breast cancer patients (1%) seen at M.D. Anderson Cancer Center, 1982 to 1992. RESULTS: Twenty-one patients (48%) had early stage disease (0, I, II) at diagnosis. With 70.8 months median follow-up, complete control of axillary recurrence was achieved in 31 patients (71%). Distant metastases developed in 50% and were more likely with uncontrolled axillary recurrences. Failure to receive multimodality therapy and failure to undergo surgery for the recurrence correlated with resistant axillary disease. CONCLUSIONS: Axillary recurrence from breast cancer is uncommon but may follow any stage of disease. One half of affected patients develop distant metastases. Durable disease control is best achieved with multimodality therapy including a surgery component.

Ductal carcinoma-in-situ: long-term results of breast-conserving therapy.

BACKGROUND: The role of breast-conserving therapy (BCT) in the management of ductal carcinoma-in-situ (DCIS) is controversial because of reported high recurrence rates. We reviewed our experience to determine whether the rate and pattern of locoregional recurrence after BCT were similar in patients with DCIS and patients with early-stage (T1) invasive breast tumors and whether local recurrence affected survival. METHODS: Between 1973 and 1994, 87 patients with DCIS alone, 22 patients with DCIS with microinvasion (DCIS-M), and 646 patients with invasive breast cancer 2 cm or smaller in diameter were treated with BCT (wide local excision with radiotherapy) at The University of Texas M. D. Anderson Cancer Center. Survival was calculated by the Kaplan-Meier method. The median follow-up times were 11 years for patients with DCIS alone, 12 years for patients with DCIS-M, and 8 years for patients with invasive breast cancer. RESULTS: Eleven (13%) of 87 patients with DCIS and 5 (23%) of 22 patients with DCIS-M had developed locoregional recurrences at follow-up. Two patients with DCIS with locoregional recurrence died of breast cancer. Of the 646 patients with invasive breast cancer, 56 (9%) had a locoregional recurrence, and 16 (2%) died of breast cancer. The median time to locoregional recurrence was significantly longer in patients with DCIS or DCIS-M (9-10 years) than patients with invasive tumors (5 years). CONCLUSIONS: DCIS is a favorable disease with an excellent long-term survival. The locoregional recurrence rate in patients with DCIS treated with BCT is similar to that in patients with early-stage invasive breast cancer treated with BCT, but time to locoregional recurrence is significantly longer in patients with DCIS. In patients with DCIS treated with BCT, intense surveillance for locoregional recurrence needs to be maintained for the patient's lifetime.

Sentinel lymph node biopsy is accurate after neoadjuvant chemotherapy for breast cancer.

PURPOSE: Sentinel lymph node (SLN) biopsy has proved to be an accurate method for detecting nodal micrometastases in previously untreated patients with early-stage breast cancer. We investigated the accuracy of this technique for patients with more advanced breast cancer after neoadjuvant chemotherapy. PATIENTS AND METHODS: Patients with stage II or III breast cancer who had undergone doxorubicin-based neoadjuvant chemotherapy before breast surgery were eligible. Intraoperative lymphatic mapping was performed with peritumoral injections of blue dye alone or in combination with technetium-labeled sulfur colloid. All patients were offered axillary lymph node dissection. Negative sentinel and axillary nodes were subjected to additional processing with serial step sectioning and immunohistochemical staining with an anticytokeratin antibody to detect micrometastases. RESULTS: Fifty-one patients underwent SLN biopsy after neoadjuvant chemotherapy from 1994 to 1999. The SLN identification rate improved from 64.7% to 94.1%. Twenty-two (51.2%) of the 43 successfully mapped patients had positive SLNs, and in 10 of those 22 patients (45.5%), the SLN was the only positive node. Three patients had false-negative SLN biopsy; that is, the sentinel node was negative, but at least one nonsentinel node contained metastases. Additional processing revealed occult micrometastases in four patients (three in sentinel nodes and one in a nonsentinel node). CONCLUSION: SLN biopsy is accurate after neoadjuvant chemotherapy. The SLN identification improved with experience. False-negative findings occurred at a low rate throughout the series. This technique is a potential way to guide the axillary treatment of patients who are clinically node negative after neoadjuvant chemotherapy.

Prophylactic mastectomy.

The Society of Surgical Oncology has developed a position statement54 that lists conditions warranting consideration of prophylactic mastectomy (Table 4). It must be stressed that there are no absolute indications for prophylactic mastectomy. The data are limited about the efficacy of prophylactic mastectomy in humans, but recent studies suggest that it results in up to 90% reduction in the risk for breast cancer. Total mastectomy is technically a more definitive procedure, although reported series have had a predominance of patients undergoing subcutaneous, nipple-sparing procedures. Prophylactic mastectomy may improve longevity in BRCA mutation carriers, but this must be balanced against the impact on quality of life. The benefits of prophylactic mastectomy relative to chemoprevention are unclear because there are no prospective randomized studies comparing these two strategies. Contralateral prophylactic mastectomy in patients with a unilateral cancer is unlikely to improve survival, but this approach may be considered for high-risk or difficult-to-observe patients, to facilitate breast reconstruction, and for the psychologic benefits. Patients considering prophylactic mastectomy should be well informed of risk-reduction alternatives and the limitations in the efficacy and cosmetic results of the procedure.

The correlation of axillary ultrasonography with histologic breast cancer downstaging after induction chemotherapy.

BACKGROUND: The goal of this study was to examine the role of ultrasonography in detecting axillary lymph node metastases in stage II breast cancer patients after induction chemotherapy (IC). METHODS: Of 172 consecutive patients with T1-3, N0-1, M0 breast cancer registered in a prospective IC trial, a subset of 130 evaluable patients were chosen, with (1) both physical and ultrasonographic examinations of the axilla before and after IC; (2) exactly four cycles of IC; (3) no presurgical radiation therapy; and (4) an axillary lymph node dissection. RESULTS: Before IC, 32 patients (25%) were negative for axillary involvement by both physical and ultrasonographic examinations. After IC, this number increased to 64 (49%). Of these, 31 (48%) were positive by pathology examination. In most cases, however, the residual tumor was minimal. CONCLUSIONS: Stage II breast cancer patients who were or became node negative by both ultrasonographic and physical examinations after IC had a 48% incidence of nodal metastases. Because the residual tumor was minimal, irradiation may be sufficient for adequate local control of the axilla.

Role of specimen radiography in patients treated with skin-sparing mastectomy for ductal carcinoma in situ of the breast.

BACKGROUND: Specimen radiography is an important part of breast conservation surgery for ductal carcinoma in situ (DCIS). The objective of this study was to determine whether mastectomy specimen radiography could help in obtaining negative resection margins in patients with DCIS undergoing skin-sparing mastectomy (SSM) with immediate breast reconstruction (IBR). METHODS: Of 95 patients treated at our institution with SSM and IBR for DCIS, 35 had specimen radiography. The mastectomy specimen was first examined grossly and then inked, serially sectioned, and sent for radiographic assessment. Tissue slices containing calcifications were identified for pathologic evaluation. Additional tissue was excised if tumor was found near the inked margins or if calcifications were found near the radiographic margins. RESULTS: Of the 35 patients who had specimen radiography, the radiographic margins were free of calcifications in 30 patients (86%); of these patients, the margins on the final histologic examination were free of tumor in 27 and within 1 mm in 3. The other five patients (14%) had calcifications close to the radiographic margin; four underwent an intraoperative re-excision, but the margin for one of those four patients was still positive on final histologic examination. Margins were found to be negative by both mastectomy specimen radiography and histology in 77% of the patients. Of the 95 patients with DCIS, three patients (3%), none of whom had specimen radiography, developed local recurrences. One of these was successfully re-treated, one died as a result of synchronous distant metastases, and one was lost to follow-up. At a median follow-up time of 3.7 years, 93 patients (98%) were alive and free of disease. CONCLUSIONS: Intraoperative radiography of mastectomy specimens may be useful for assessing margin status and for identifying the location of microcalcifications within tissue slices.

Prognostic implications of pathological lymph node status after preoperative chemotherapy for operable T3N0M0 breast cancer.

BACKGROUND: Although preoperative chemotherapy has become the standard of care for inoperable locally advanced breast cancer, its role for downstaging resectable primary tumors is still evolving. The purpose of this study was to determine whether the prognostic information from an axillary node dissection in patients with clinical T3N0 breast cancer was altered by preoperative chemotherapy compared with surgery de novo. METHODS: Between 1976 and 1994, 91 patients with clinically node-negative operable T3 breast cancer received doxorubicin-based combination chemotherapy on protocol at one institution. Fifty-three patients received both preoperative and postoperative chemotherapy (PreopCT), and 38 received postoperative chemotherapy only (PostopCT). All patients underwent axillary lymph node dissection as part of their definitive surgical treatment. There were no differences between the PreopCT and PostopCT groups in median age (51 vs. 49 years), median tumor size at presentation (6 cm vs. 6 cm), tumor grade, or estrogen receptor status (estrogen receptor negative 38% vs. 32%). The median follow-up time was 7 years. RESULTS: Patients in the PreopCT group had fewer histologically positive lymph nodes (median, 0 vs. 3, P < .01), and a lower incidence of extranodal extension (19% vs. 42%, P = .02). By univariate analysis, the number of pathologically positive lymph nodes (P < .01) and extranodal extension (P < .01) were predictors of disease-specific survival in PreopCT patients. Multivariate analysis showed that extranodal extension was the only independent prognostic factor in PreopCT patients (P < .01). Overall, PreopCT and PostopCT patients had similar 5-year disease-free survival rates (66% vs. 57%); however, PreopCT patients had worse disease-free (P = .01) and disease-specific survival (P = .04) when survival was compared after adjustment for the number of positive lymph nodes. Furthermore, PreopCT patients with 4-9 positive lymph nodes had a lower 5-year disease-free survival rate than PostopCT patients with 4-9 positive nodes (17 vs. 48%, P = .04). CONCLUSIONS: Axillary lymph node status remains prognostic after chemotherapy. Pathologically positive lymph nodes after preoperative chemotherapy are associated with a worse prognosis than the same nodal status before chemotherapy.

The feasibility of minimally invasive surgery for stage IIA, IIB, and IIIA breast carcinoma patients after tumor downstaging with induction chemotherapy.

BACKGROUND: Induction chemotherapy (IC) has become the standard of care for locally advanced breast carcinoma, frequently downstaging both the primary tumor and the axilla, and making patients eligible for less invasive surgical procedures. The usefulness of IC in earlier stage operable breast carcinoma is now being considered. METHODS: This study involved a subset of 129 patients from a series of 174 with T2-3, N0-1, M0 or T1, N1, M0 breast carcinoma (Stage IIA, IIB, or IIIA ) who were registered in a prospective IC trial using paclitaxel or a combination of fluorouracil, doxorubicin, and cyclophosphamide (FAC). The subset included patients who had received no preoperative radiation therapy but had completed 3-5 cycles of induction chemotherapy and had undergone a Level I-II axillary lymph node dissection. The objective was to evaluate the effectiveness of induction chemotherapy with paclitaxel or FAC in downstaging the primary tumor and axillary metastases in these early stage breast carcinoma patients. RESULTS: The median initial tumor size was 4 cm (range, 0.6-10.0); after IC, tumor size was downstaged to 1.6 cm (range, 0.0-7.0) (P < 0.0001). Clinical response to IC was complete in 24% of patients and partial in 36%. Primary tumor shrinkage was similar with paclitaxel and FAC. Among patients clinically classified as N1, 34% became histologically negative and 38% had only 1-3 positive lymph nodes after induction chemotherapy. CONCLUSIONS: IC with paclitaxel or FAC resulted in effective downstaging of primary tumors and axillary metastases in patients with Stage IIA, IIB, and IIIA breast carcinoma. However, a significant proportion of patients still had residual but low volume microscopic disease; such disease status may allow minimally invasive surgical approaches to locoregional therapy.

Randomized trial of high-dose chemotherapy and blood cell autografts for high-risk primary breast carcinoma.

BACKGROUND: Uncontrolled studies have reported encouraging outcomes for patients with high-risk primary breast cancer treated with high-dose chemotherapy and autologous hematopoietic stem cell support. We conducted a prospective randomized trial to compare standard-dose chemotherapy with the same therapy followed by high-dose chemotherapy. PATIENTS AND METHODS: Patients with 10 or more positive axillary lymph nodes after primary breast surgery or patients with four or more positive lymph nodes after four cycles of primary (neoadjuvant) chemotherapy were eligible. All patients were to receive eight cycles of 5-fluorouracil, doxorubicin (Adriamycin), and cyclophosphamide (FAC). Patients were stratified by stage and randomly assigned to receive two cycles of high-dose cyclophosphamide, etoposide, and cisplatin with autologous hematopoietic stem cell support or no additional chemotherapy. Tamoxifen was planned for postmenopausal patients with estrogen receptor-positive tumors and chest wall radiotherapy was planned for all. All P values are from two-sided tests. RESULTS: Seventy-eight patients (48 after primary surgery and 30 after primary chemotherapy) were registered. Thirty-nine patients were randomly assigned to FAC and 39 to FAC followed by high-dose chemotherapy. After a median follow-up of 6.5 years, there have been 41 relapses. In intention-to-treat analyses, estimated 3-year relapse-free survival rates were 62% and 48% for FAC and FAC/high-dose chemotherapy, respectively (P =.35), and 3-year survival rates were 77% and 58%, respectively (P =.23). Overall, there was greater and more frequent morbidity associated with high-dose chemotherapy than with FAC; there was one septic death associated with high-dose chemotherapy. CONCLUSIONS: No relapse-free or overall survival advantage was associated with the use of high-dose chemotherapy, and morbidity was increased with its use. Thus, high-dose chemotherapy is not indicated outside a clinical trial.

Feasibility of immediate breast reconstruction for locally advanced breast cancer.

BACKGROUND: Immediate breast reconstruction (IBR) has been considered contraindicated for patients with locally advanced breast cancer (LABC). Our goal was to determine whether IBR resulted in delayed postoperative chemotherapy, increased postoperative complications, or increased risk of recurrent disease. METHODS: A prospective database of 540 modified radical mastectomies performed with IBR between 1990 and 1993 identified 50 patients with LABC. Postoperative management and outcome were compared to that of 72 patients undergoing modified radical mastectomy without IBR treated on a standardized LABC protocol using preoperative chemotherapy, postoperative chemotherapy, and radiotherapy during the same time period. RESULTS: Results were evaluated by chi2 analysis. The median ages for the patients with IBR versus those not undergoing IBR were 44 and 46 years, respectively. The stage distribution for the IBR patients versus patients not undergoing IBR was as follows: IIB, 46% versus 17%; IIIA, 44% versus 39%; and IIIB, 10% versus 44%. The types of IBR were transverse rectus abdominis myocutaneous (TRAM) flap (68%), latissimus dorsi flap (2%), and implants (30%). Chemotherapy was given to all IBR patients: 24% preoperatively and 96% postoperatively. Radiotherapy was used in 40%. Four postoperative complications (8%) necessitated prolongation of hospitalization, including two patients requiring surgical debridement for partial flap loss; there were no complete flap losses. The incidences of major and minor wound complications in the group not undergoing IBR were 7% and 4%, respectively. Of the 15 patients receiving implant reconstruction, 7 (47%) required subsequent implant removal because of contractures or infections. The median interval between surgery and postoperative chemotherapy was 35 days for the IBR patients and 21 days for the patients not undergoing IBR. This difference was marginally significant (P =.05). With a median follow-up of 58.4 months, no significant differences in local or distant relapse rates were detected. CONCLUSIONS: IBR can be performed with low morbidity in patients with LABC. Use of autogenous tissue is preferable because of poor results with implants. IBR is associated with somewhat longer intervals to resumption of postoperative chemotherapy, but this does not appear to be clinically significant-the local and distant relapse rates are similar for LABC patients undergoing modified radical mastectomy with or without IBR.