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PubMed1999

Family history of breast cancer and local recurrence after breast-conserving therapy. The Dutch Study Group on Local Recurrence after Breast Conservation (BORST).

The impact of a family history of breast cancer on the local recurrence (LR) risk after breast-conserving therapy (BCT) was performed within the framework of a large, multicentre matched case-control study of risk factors for LR after BCT (BORST study). Family history was assessed for 218 breast cancer patients with LR (cases) and 480 patients without LR (controls). Detailed histological tumour features were determined by review of the primary tumour. The risk of LR for patients with a positive family history was similar to or less than that of non-familial patients (unadjusted odds ratio (ORunadj) 0.66 (95% confidence interval (CI) 0.40-1.08)). Familial patients were older than non-familial patients (P = 0.07) and their tumours had a lower histological grade (P = 0.07). A second primary tumour occurred significantly more often in familial patients (P = 0.02). Adjustment for these factors did not essentially alter the results (ORadj 0.71 (0.38-1.32)). Separate analyses according to age at onset (younger and older than 50 years) and time to LR/site of LR produced similar results. The sole presence of a positive family history of breast cancer does not appear to be a risk factor for local recurrence after BCT. Whilst this might be different for genetically predisposed patients, a positive family history does not appear to be a contra-indication for BCT.

Breast Neoplasms↗
PubMed1997

Menstrual cycle and timing of breast surgery in premenopausal node-positive breast cancer: results of the International Breast Cancer Study Group (IBCSG) Trial VI.

PURPOSE: It has been postulated that breast cancer surgery performed during the follicular phase of the menstrual cycle is associated with poorer outcome. PATIENTS AND METHODS: We tested this hypothesis by evaluating disease-free survival (DFS) for 1033 premenopausal patients who received definitive surgery either during the follicular phase (n = 358) or the luteal phase (n = 675). All patients were enrolled in a randomized trial conducted between July 1986 and April 1993. All had node positive breast cancer and randomization was stratified by estrogen receptor (ER) status. All patients received at least three cycles of adjuvant cyclophosphamide, methotrexate, and 5-fluorouracil (CMF). The median follow-up was 60 months. RESULTS: Patients who underwent definitive surgery for breast cancer in the follicular phase had a slightly worse disease-free survival than those operated on during the luteal phase (five-year DFS percentage: 53% versus 58%; hazard ratio, 1.13; 95% confidence interval (CI), 0.94-1.38; P = 0.20). The effect was significantly greater for the subpopulation of 300 patients with ER-negative primaries (P = 0.02 interaction effect; five-year DFS percentages 42% vs. 59%; hazard ratio 1.60; 95% CI, 1.12-2.25; P = 0.008). The effect of timing of surgery diminished for analyses based on lesser surgical procedures, e.g., excisional biopsies. In particular, no effect of timing was observed for fine needle aspiration procedures. CONCLUSIONS: Surgical procedures which are more extensive than a fine needle aspiration biopsy might be associated with worse prognosis if conducted during the follicular phase of the menstrual cycle. This phenomenon was seen predominantly for high risk breast cancer with low levels or no estrogen receptors in the primary tumor.

Breast Neoplasms↗
PubMed2005

CYP17 genetic polymorphism, breast cancer, and breast cancer risk factors: Australian Breast Cancer Family Study.

INTRODUCTION: Because CYP17 can influence the degree of exposure of breast tissues to oestrogen, the interaction between polymorphisms in this gene and hormonal risk factors is of particular interest. We attempted to replicate the findings of studies assessing such interactions with the -34T-->C polymorphism. METHODS: Risk factor and CYP17 genotyping data were derived from a large Australian population-based case-control-family study of 1,284 breast cancer cases and 679 controls. Crude and adjusted odds ratio (OR) estimates and 95% confidence intervals (CIs) were calculated by unconditional logistic regression analyses. RESULTS: We found no associations between the CYP17 genotype and breast cancer overall. Premenopausal controls with A2/A2 genotype had a later age at menarche (P < 0.01). The only associations near statistical significance were that postmenopausal women with A1/A1 (wild-type) genotype had an increased risk of breast cancer if they had ever used hormone replacement therapy (OR 2.40, 95% CI 1.0 to 5.7; P = 0.05) and if they had menopause after age 47 years (OR 2.59, 95% CI 1.0 to 7.0; P = 0.06). We found no associations in common with any other studies, and no evidence for interactions. CONCLUSION: We observed no evidence of effect modification of reproductive risk factors by CYP17 genotype, although the experiment did not have sufficient statistical power to detect small main effects and modest effects in subgroups. Associations found only in subgroup analyses based on relatively small numbers require cautious interpretation without confirmation by other studies. This emphasizes the need for replication in multiple and large population-based studies to provide convincing evidence for gene-environment interactions.

Adult↗
PubMed2006

Investigation of factors related to periods to ipsilateral breast tumor recurrence after breast-conserving surgery and measures for preventing recurrence in early breast cancer.

BACKGROUND: The most important issue in breast-conserving surgery is avoidance of ipsilateral breast tumor recurrence (IBTR). We have investigated the factors related to the period between surgery and recurrence and the measures taken. SUBJECT AND METHODS: From April 1989 to December 2004, 888 cases (excluding cases who underwent neoadjuvant chemotherapy) of breast-conserving surgery were performed. IBTR occurred in 56 of these cases. We investigated the timing of these recurrences. Furthermore, the rate of recurrence before and after 1999 when postoperative adjuvant therapy (such as CEF and Taxanes) was started as standard treatment was investigated. RESULTS: The mean period to recurrence in the 56 patients that experienced IBTR was 41.3 months; early recurrence within two years occurred in 21 (37.5%) patients. On the other hand, recurrence from the fifth year onwards post-surgery occurred in 11 patients (19.6%). Of the factors related to the timing of recurrence, a significant difference was seen in tumor proliferative activity, ER (estrogen receptor) status, lymphatic invasion (ly), and whether the lesion was inside or outside the mammary gland tissue. Furthermore, patients experiencing an early recurrence including inflammatory type breast recurrence had a complicated course with distant metastases and their prognosis was poor. Therefore, there was delayed onset of recurrence in the ER positive and ly negative patients with decreased tumor proliferation. With regard to the timing of operation in relation to adjuvant therapy, there was an increase in the conservation rate for the patients in the later phase of the study (1999 onwards), and the number of significantly large and surgical margin positive patients that were at risk of a recurrence was high. However, early recurrence was significantly low, and standard therapy was found to inhibit recurrence. CONCLUSIONS: Although tumor proliferative activity, ER status and ly caused differences in timing of recurrence, standard adjuvant therapy, particularly chemotherapy for early recurrence, was effective in inhibiting recurrence.

Adult↗
PubMed1979

Circulating breast tumour antigen-sensitive T lymphocytes in early breast cancer and high risk benign breast disease.

Levels of circulating T lymphocytes sensitized to breast tumour associated antigens (BTA) were correlated with pathological tumour stage or benign histopathology in preoperative studies of 180 patients by the antigen-stimulated active rosette-forming T cell (AgARFC) assay. Incubation of lymphocytes with allogeneic BTA extracts produced increased AgARFC compared with incubation without BTA. Significant levels of BTA-sensitive T cells were found in 78 per cent of breast cancer patients compared with 23 per cent of patients with benign disease (P less than 0.0005, by X2). Over 93 per cent of stage I cancer patients responded to BTA, compared with 69 per cent of stage II patients (P less than 0.025) and 59 per cent of stages III-IV patients (P less than 0.005). Twenty-nine per cent of 42 patients with fibrocystic disease were positive to BTA in contrast to 8 per cent of 25 patients with fibroadenomas. This was a 3.6-fold higher incidence of BTA-sensitive T cells associated with fibrocystic disease than with fibroadenomas, which was in agreement with the increased breast cancer risk rate associated with fibrocystic disease. These findings suggest that the AgARFC assay may detect early malignant change in fibrocystic disease. The AgARFC assay was found to reliably detect early invasive carcinoma.

Adenocarcinoma↗
PubMed1985

The relationship of cyst type to risk factors for breast cancer and the subsequent development of breast cancer in patients with breast cystic disease.

The frequency of epithelial hyperplasia and papillary apocrine change in patients with palpable breast cysts lined by either apocrine or flattened epithelium has been compared. Hyperplasia of any degree, severe hyperplasia with or without atypia and papillary apocrine change were all seen significantly more frequently in patients with clinically palpable apocrine cysts. Twelve patients were identified with breast cancer with a history of cyst aspiration, in whom all cysts aspirated could be classified as apocrine or flattened on the basis of cytology or electrolyte composition of cyst fluid. Eleven patients had single or multiple apocrine cysts and one had a single flattened cyst. This represents a significantly increased preponderance of apocrine cysts as compared with that normally seen in patients with cystic disease. The mastectomy specimens of those 11 patients with a history of apocrine cyst aspiration more frequently contained hyperplastic changes and non-invasive carcinoma than age- and menopausal-matched controls who did not have a history of cystic disease. This study suggests that patients who develop cysts lined by apocrine epithelium may be at a greater risk of subsequent breast cancer than those with flattened epithelial cysts.

Breast↗
PubMed2006

Impact of concurrent proliferative high-risk lesions on the risk of ipsilateral breast carcinoma recurrence and contralateral breast carcinoma development in patients with ductal carcinoma in situ treated with breast-conserving therapy.

BACKGROUND: The purpose of the study was to determine the risk of ipsilateral breast carcinoma recurrence (IBCR) and contralateral breast carcinoma (CBC) development in patients with a concurrent diagnosis of ductal carcinoma in situ (DCIS) with atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), or lobular carcinoma in situ (LCIS). METHODS: Records of all 307 patients with DCIS treated with breast-conserving treatment (BCT) from 1968 to 1998 were analyzed. Initial pathology reports and all slides available were re-reviewed for evidence of ADH, ALH, or LCIS. Actuarial local recurrence rates were calculated. RESULTS: Fifty-five cases of DCIS were associated with ADH, 11 with ALH or LCIS, and 14 with both ADH and ALH or LCIS. Overall, IBCR occurred in 14% and no significant difference in the IBCR rate was identified for patients with proliferative lesions compared with patients without these lesions (P = 0.38). Development of CBC in patients with concurrent DCIS and ADH was 4.4 times (95% confidence interval [CI], 1.44-13.63) that in patients with DCIS alone (P < 0.01). The 15-year cumulative rate of CBC development was 22.7% in patients with ALH or LCIS compared with 6.5% in patients without these lesions (P = 0.30) and 19% in patients with ADH compared with 4.1% in patients with DCIS alone (P < 0.01). CONCLUSION: The risk of CBC development is higher with concurrent ADH than in patients with DCIS alone, and these patients may therefore be appropriate candidates for additional chemoprevention strategies. Concurrent ADH, ALH, or LCIS with DCIS is not a contraindication to BCT.

Breast Neoplasms↗
PubMed2004

Aberrations of breast cancer susceptibility genes occur early in sporadic breast tumors and in acquisition of breast epithelial immortalization.

In the search for early deletion targets in sporadic breast cancer, the analysis of TP53, BRCA1, BRCA2, and ATM revealed loss of heterozygosity (LOH) in tumor cells at 1 or more genes in 18 of 24 cases examined. Notably, in more than 60% of such tumors, LOH was detectable in morphologically normal terminal ductal lobular units (TDLUs) adjacent to carcinoma (LOHint). At BRCA2 and ATM, LOHint was most frequent, particularly in TDLUs of women <or= 50 years old (7 of 10). In a novel preneoplastic model system, declining expression levels observed with increasing passage in culture supported the postulate that during the acquisition of continuous growth, elimination of these genes at an early stage confers a distinct selective advantage. The intimate role of these genes in DNA repair and their early deletion has implications for the possible transforming effects of DNA-damaging agents on unexcised breast tissue harboring LOHint within breast cancer patients.

Adult↗
PubMed1998

Do women who undergo further investigation for breast screening suffer adverse psychological consequences? A multi-centre follow-up study comparing different breast screening result groups five months after their last breast screening appointment.

BACKGROUND: In 1995-1996 about 53500 women aged 50-64 attending for routine breast screening were called back for further investigation after an initial mammogram. Even when women were found to be clear after further investigation, significant adverse psychological consequences (PCs) can remain one month later. This follow-up study investigates whether residual emotional effects persisted five months after women received a clear result. METHODS: Women who had previously completed a questionnaire one month after their last breast screening appointment, at which they had a clear result, were invited to complete a further postal questionnaire four months later (five months after their last appointment). We compare women who received a clear result after assessment without fine needle aspiration cytology (FNAC), after assessment with FNAC, after a benign biopsy, and those who had been placed on early recall, with those who received a clear result after mammography (reference group). RESULTS: The response rate was 76 per cent (215/284). All groups of women who went on for further investigation suffered significantly greater adverse psychological consequences (PCs) at five months than women who were given a clear result after mammography. Compared with 10 per cent (5/52) of women who received a clear result after a basic mammogram, adverse psychological consequences were experienced by 59 per cent (27/46, p<0.00001) of the women who were placed on six month early recall, 61 per cent (14/23, p<0.0001) of women who had benign surgical biopsy, 44 per cent (18/41, p<0.0001) of women who received a clear result after assessment (with FNAC), and 45 per cent (23/51, p<0.0001) of women who received a clear result after assessment (without FNAC). Whereas all groups who had gone on for further investigations had experienced a significant decrease in PCs between one month and five months, those who were placed on six month early recall showed no significant difference in PCs between these two time periods. Other factors relating to adverse experiences as a result of breast screening are reported. CONCLUSION: Despite receiving a clear final result, women who undergo further investigation suffer significantly greater adverse psychological consequences five months after their last screening appointment than women who receive a clear result after mammography.

Adaptation, Psychological↗
PubMed1986

Edinburgh breast education campaign on breast cancer and breast self-examination: was it worth while?

A health education campaign was carried out at the start of a large trial of screening for breast cancer in Edinburgh. After preliminary studies the campaign concentrated on talks to small groups of women by specially trained health visitors. Over a year, 12,000 women attended. Systematic evaluation after 12 months showed that selected women who heard the talks were more knowledgeable about breast cancer, and a random sample of women in Edinburgh had a small but significant improvement in knowledge compared with women in Aberdeen. However, the random sample did not report an increase in the practice of breast self-examination (BSE) and there was no increase in workload for general practitioners. It is suggested that BSE is more likely to be accepted if combined with a physical examination.

Adult↗
PubMed2004

Randomized, controlled trial investigating short-term health-related quality of life with doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in patients with metastatic breast cancer: European Organization for Research and Treatment of Cancer Breast Cancer Group, Investigational Drug Branch for Breast Cancer and the New Drug Development Group Study.

PURPOSE: To compare health-related quality of life (HRQOL) in patients with metastatic breast cancer receiving the combination of doxorubicin and paclitaxel (AT) or doxorubicin and cyclophosphamide (AC) as first-line chemotherapy treatment. PATIENTS AND METHODS: Eligible patients (n = 275) with anthracycline-naive measurable metastatic breast cancer were randomly assigned to AT (doxorubicin 60 mg/m(2) as an intravenous bolus plus paclitaxel 175 mg/m(2) as a 3-hour infusion) or AC (doxorubicin 60 mg/m(2) plus cyclophosphamide 600 mg/m(2)) every 3 weeks for a maximum of six cycles. Dose escalation of paclitaxel (200 mg/m(2)) and cyclophosphamide (750 mg/m(2)) was planned at cycle 2 to reach equivalent myelosuppression in the two groups. HRQOL was assessed with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 and the EORTC Breast Module at baseline and the start of cycles 2, 4, and 6, and 3 months after the last cycle. RESULTS: Seventy-nine percent of the patients (n = 219) completed a baseline measure. However, there were no statistically significant differences in HRQOL between the two treatment groups. In both groups, selected aspects of HRQOL were impaired over time, with increased fatigue, although some clinically significant improvements in emotional functioning were seen, as well as a reduction in pain over time. Overall, global quality of life was maintained in both treatment groups. CONCLUSION: This information is important when advising women patients of the expected HRQOL consequences of treatment regimens and should help clinicians and their patients make informed treatment decisions.

Adult↗
PubMed2003

Factors associated with ipsilateral breast failure and distant metastases in patients with invasive breast carcinoma treated with breast-conserving therapy. A clinicopathologic study of 607 neoplasms from 583 patients.

All slides from 607 consecutive invasive breast carcinomas from 583 patients were reviewed. Margin distance, composite width of invasive carcinoma, and number of ducts with intraductal carcinoma within the one-half low-power field (LPF) adjacent to the final margin were recorded. Final margin groups were positive (carcinoma at margin), near (< or = 1/2 LPF of margin), and negative (> 1/2 LPF). There were 39 ipsilateral breast failures (IBFs), and 63 patients (10.8%) developed distant metastases (DMs). Decreasing margin distance and increasing amounts of carcinoma near the margin were associated with IBF and DM. The 5-tiered composite factor of margin distance and amount of carcinoma near margin (negative margins, near least amount, near intermediate amount, near greatest amount, and positive margins) resulted in 12-year IBF rates of 9%, 6%, 18%, 24%, and 30%, respectively (P < .001). The composite factor, margin amount of carcinoma near margin, and invasive carcinoma/initial excision specimen dimension ratio were the most precise parameters assessing excision adequacy and, ultimately, IBF risk. The amount of carcinoma near the margin and volume of excised parenchyma related directly to the amount of residual carcinoma in the adjacent breast parenchyma.

Adult↗
PubMed1999

Local recurrence after breast conservation therapy for early stage breast carcinoma: detection, treatment, and outcome in 266 patients. Dutch Study Group on Local Recurrence after Breast Conservation (BORST).

BACKGROUND: Controversy exists concerning the roles of mammography and physical examination in the detection of local recurrence after conservation therapy for breast carcinoma. In addition, the prognostic factors for and optimal treatment of patients with local recurrence are uncertain. METHODS: At eight radiotherapy institutes, two cancer institutes, and one surgical clinic in the Netherlands, regular follow-up of patients who underwent breast conservation therapy between 1980 and 1992 identified 266 patients with local recurrence in the breast. These patients exhibited no clinical signs of distant metastases at the time of diagnosis of the local recurrence. Data on the method of detection were available for 189 patients (72%). Local recurrence was diagnosed by mammography alone in 47 cases (25%). Of all patients, 85% underwent salvage mastectomy, 8% underwent local excision, 4% received systemic treatment only, and 3% remained untreated. Specimens of the primary tumor were available for review from 238 of the 266 patients (89%). RESULTS: Local recurrences detected by mammography alone were smaller than those detected by physical examination (P = 0.04). At 5 years from the date of salvage treatment, the overall survival rate for all 266 patients was 61% (95% confidence interval [CI], 55-67%), and the distant recurrence free survival rate was 47% (95% CI, 40-53%). For the 25 patients with noninvasive recurrence, these figures were 95% and 94%, respectively. Skin involvement, the extent of recurrence (< or = 10 mm vs. >10 mm), and both lymph node status and histologic grade of the primary disease were strong predictors for distant metastases in patients with invasive recurrence. CONCLUSIONS: Patients with invasive local recurrence more than 1 cm in size are at a substantial risk for distant disease. The better distant disease free survival for patients with recurrence measuring 1 cm or less may indicate that early detection can improve the treatment outcome. Recurrence with skin involvement should be considered generalized disease.

Adult↗
PubMed1998

Quality of life of early-stage breast cancer patients treated with radical mastectomy or breast-conserving procedures: results of EORTC Trial 10801. The European Organization for Research and Treatment of Cancer (EORTC), Breast Cancer Co-operative Group (BCCG).

In 1980 the EORTC-BCCG initiated a multicentre randomised clinical trial comparing modified radical mastectomy (MRM) with breast-conserving therapy (BCT) in stage I and II breast cancer. The main endpoint of the trial was survival. A brief quality of life (QoL) questionnaire consisting of two multi-item scales (body image and fear of recurrence) and two single items (satisfaction with treatment and cosmetic result) was included in the trial. A cosmetic evaluation of the breast after conservative surgery was also performed. This report concentrates on the results of the QoL study and the cosmetic evaluation. Multitrait scaling analysis was employed to verify the hypothesised scale structure of the questionnaire. Treatment comparison of the QoL scores at 2 years post-treatment was performed using a stratified Wilcoxon rank sum test. Both patients' and doctors' ratings of the cosmetic result were documented on the clinical follow-up form. A multivariate analysis was performed to identify which factors influenced the cosmetic outcome. In total, 127 patients in the MRM arm and 151 in the BCT arm completed a QoL questionnaire at approximately 2 years after randomisation (months 25-36). The Cronbach's alpha coefficients were 0.79 and 0.73 for the body image and fear of recurrence scales, respectively. Significant benefit in body image and satisfaction with treatment was observed in the BCT patients. No significant difference was observed in fear of recurrence between the two groups. Ratings of cosmetic results decreased with time, in line with clinical observations of long-term side-effects of radiotherapy. Wide excision appeared to be the most important predictive factor for poor cosmetic result. In this multicentre randomised study, BCT helped to maintain the patients' body image, resulted in higher satisfaction with treatment and yielded no significant difference from MRM with respect to fear of recurrence.

Adult↗
PubMed1998

An assessment of the influence of clinical breast examination reports on the interpretation of mammograms in a breast screening program. Ontario Breast Screening Program Radiologists Research Group.

The population-based Ontario Breast Screening Program (OBSP) provides two-yearly screening by both nurse examiner clinical breast examination (CBE) and two-view mammography to women aged 50 to 69. CBE alone accounts for about 5% of cancer detection. The purpose of this study was to determine whether CBE information affects radiologists' interpretation of mammography. Interpretation was defined by 1) radiologists' referral rates for diagnostic evaluation and 2) radiologists' accuracy in distinguishing cancer from non-cancer on mammograms. Mammograms were obtained from women randomly selected from those screened in the OBSP between 1990 and 1992. Selection was stratified by whether or not the nurse examiner had independently referred for diagnostic evaluation. Additional women diagnosed with breast cancer were selected to increase the precision of the receiver-operating characteristic (ROC) curve. Each participating OBSP radiologist read a set of mammograms twice, approximately three weeks apart. The first reading was based on mammograms alone. At the second reading, the CBE report was included on the reporting form. Among 620 women referred by the nurse, radiologist referral rate increased from 37.7% to 40.8% (p = 0.079) when CBE information was available. Among the 637 not referred by the nurse, radiologist referral rate decreased from 29.8% to 25.6% (p = 0.005). There was little effect on the sensitivity and specificity of radiologist referral and the areas under the two ROC curves (with and without CBE information) were not significantly different (p = 0.571). Although there was some effect of CBE information on radiologists' pattern of referral, there was no effect on accuracy of cancer detection.

Breast Neoplasms↗
PubMed2000

Management of the axilla in operable breast cancer treated by breast conservation: a randomized clinical trial. Edinburgh Breast Unit.

BACKGROUND: In the treatment of operable breast cancer by breast conservation, the extent of axillary dissection, the need for radiotherapy to the axilla and the morbidity associated with these procedures have not been assessed adequately. METHODS: Patients with operable breast cancer were randomized to have level III axillary node clearance (232 patients) or axillary node sample (234 patients). Radiotherapy to the axilla was given selectively. Radiotherapy was not given to those who had an axillary clearance. In the early part of the study all patients who had node sample were treated by radiotherapy (54 patients); subsequently this was modified to include only those who were node positive. The morbidity to the shoulder and arm was assessed before and after operation by measuring upper limb volume and circumference, and combined glenohumeral and scapular movement and muscle power. RESULTS: Comparing the two surgical policies, no difference was found in local (axillary clearance 14 versus sample 15), axillary (eight versus seven) or distant (29 versus 29) recurrence. There was no statistically significant difference in 5-year survival rate (clearance 82.1 versus sample 88.6 per cent). Morbidity was least in those who had a node sample and no radiotherapy to the axilla. Radiotherapy to the axilla in patients who had a node sample resulted in a significant reduction in range of movement of the shoulder, e.g. mean(s.e.) 2.2(0.6) cm reduction in lateral rotation at 3 years. Surgical axillary clearance was associated with significant lymphoedema of the upper limb, e.g. 4.1(0.7) per cent increase in arm volume at 3 years. CONCLUSION: A selective policy for the management of the axilla is associated with no increase in axillary recurrence or mortality rate compared with routine axillary node clearance. Patients who are node negative after axillary sample can avoid radiotherapy or axillary clearance.

Aged↗
PubMed2001

Primary chemotherapy for operable breast cancer: incidence and prognostic significance of ipsilateral breast tumor recurrence after breast-conserving surgery.

PURPOSE: To determine the incidence and the prognostic value of ipsilateral breast tumor recurrence (IBTR) in patients treated with primary chemotherapy and breast-conserving surgery. PATIENTS AND METHODS: Between January 1985 and December 1994, 257 patients with invasive T1 to T3 breast carcinoma were treated with primary chemotherapy, lumpectomy, and radiation therapy. The median follow-up time was 93 months. To evaluate the role of IBTR in metastase-free survival, a Cox regression multivariate analysis was performed using IBTR as a time-dependent covariate. RESULTS: The IBTR rates were 16% (+/- 2.4%) at 5 years and 21.5% (+/- 3.2%) at 10 years. Multivariate analysis showed that the probability of local control was decreased by the following independent factors: age < or = 40 years, excision margin < or = 2 mm, S-phase fraction more than 4%, and clinical tumor size more than 2 cm at the time of surgery. In patients with excision margins of more than 2 mm, the IBTR rates were 12.7% at 5 years and 17% at 10 years. Nodal status, age < or = 40 years, and negative estrogen receptor status were predictors of distant disease in the Cox multivariate model with fixed covariates. The contribution of IBTR was highly significant (relative risk = 5.34) when added to the model, whereas age < or = 40 years was no longer significant. After IBTR, 31.4% (+/- 7.0%) of patients developed metastases at 2 years and 59.7% (+/- 8.1%) at 5 years. Skin involvement, size at initial surgery, and estrogen receptor status were predictors of metastases after IBTR. CONCLUSION: IBTR is a strong predictor for distant metastases. There are implications for conservative surgery after downstaging of the tumor and therapy at the time of IBTR.

Adult↗