Intraductal carcinoma of the breast: results of treatment with excisional biopsy and irradiation

Between 1976 and 1983, 40 women with intraductal carcinoma of the breast without invasion underwent excisional biopsy and irradiation as an alternative to mastectomy. The median age was 53 years (range, 28 to 77 years) and the median follow-up time since initiation of radiation was 44 months (range, 14 to 97 months). Twenty-seven patients presented with a palpable mass; in 13 patients the tumor was detected only by mammography. A limited axillary dissection was performed in 13 patients, and all lymph nodes removed were negative. Treatment was administered to the breast and adjacent chest wall to a dose of 4,600 to 5,000 rad, with 26 patients also receiving a boost dose of 1,000 to 2,000 rad to the site of the primary. Four patients have developed a recurrence in the treated breast, at 17, 19, 35, and 63 months after the beginning of radiation therapy. The 5-year actuarial rate of local recurrence is 10%. Three of the recurrences were in those four patients who presented with a nipple discharge and a central primary. In two cases, the recurrence consisted of only intraductal carcinoma; in the other two, both intraductal and invasive cancer were found. All four patients with recurrence underwent mastectomy and are well without evidence of distant metastases at 1, 12, 15, and 15 months since mastectomy. Cosmetic results were excellent. No patient has developed distant metastases. Since the number of patients treated is small and the period of follow-up is short, one must be cautious in the interpretation of these results. Nonetheless, the treatment of intraductal carcinoma of the breast by excision and irradiation appears to give acceptable local control and excellent survival when suitable precautions of patient selection and evaluation are taken.     

Factors determining cosmetic results after periareolar excisional biopsy of benign breast lesions

Objective To assess the factors that determine cosmetic results after periareolar excisional biopsy for the management of Breast Imaging- Reporting and Data System （BI-RADS） 3 and 4 breast lesions. Methods Potential risk factors for adverse cosmetic results of incision after periareolar excisional biopsy were evaluated in 74 patients （7 people had bilateral breast operations） undergoing a single biopsy after suspicion of a malignant lesion that subsequently proved to be benign. The overall cosmetic result was evaluated using a modification of the European Organisation for Research and Treatment of Comcer （EORTC） cosmetic indices individually scored 6 months after the breast excisional biopsy. To evaluate the factors affecting cosmetic outcome of incision, an analysis of variance was undertaken using the Kruskal-Wallis test for continuous variables and the chi-squared and Fisher exact tests for categorical variables. Based on cosmetic outcome of incision as dependent variables, and patient＇ s age, incision location, scar color respectively as independent variables, multivariate analysis was performed with logistic regression for screening the factors. Results Out of 81 operated breasts, the cosmetic result of incision was rated as excellent （0 score） in 19 （23.46%）, good （1 score） in38 （46.91%）, fair （2 scores） in 14 （17.28%）, and poor （3 scores） in 10 （12.34%）. Univariate analysis shows that age, incision location and scar color affected cosmetic result. Older patients, with no scar or white scar, and the inferior or lateral periareolar incision had better cosmetic outcomes of incision. Patients more than 45 years had better cosmetic outcomes of incision than those less than 31 years （P = 0. 0231 ）. Patients with the inferior or lateral periareolar incision obtained better cosmetic outcomes than those with the superior or medial incision. Patients with no scar obtained better cosmetic outcomes than those with white scar or red scar. Conclusions The cosmetic outcomes after periareolar excisional biopsy of benign breast lesions are excellent or good in most of cases. Age, incision location and scar color all affect cosmetic results of incision.     

Primary breast lymphoma: results of a controlled clinical trial

OBJECTIVES: To assess the efficacy and toxicity of the most employed therapeutic approaches in the treatment of primary breast lymphoma (PBL). METHODS: Ninety-six patients with PBL in the early stage (I or II) were enrolled to receive radiotherapy (45 Gy); chemotherapy (six cycles of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP), every 21 days), or combined therapy. RESULTS: Complete response was achieved in 20 of 30 patients treated with radiotherapy, 19 of 32 who were treated with chemotherapy and 30 of 34 in the combined arm (p<0.01). Actuarial curves at 10 years showed that event-free survival was 50, 57 and 83%, respectively (p<0.01). Actuarial curves for overall survival were 50, 50 and 76% (p<0.01), respectively. The most common site of relapse was the central nervous system. Acute toxicity was mild. Until now, no second neoplasm or acute leukemia has been observed. CONCLUSIONS: In our study combined therapy is the best treatment in this special setting of patients; with improvement in event-free survival and overall survival without acute or severe late side effects. Prophylaxis to the central nervous system will be considered in the initial treatment to improve outcome.     

An evaluation of excisional biopsy for tongue carcinoma

An evaluation of excisional biopsy for tongue carcinoma (T1, T2) as a surgical treatment was performed. Forty-seven patients who received excisional biopsy among 394 patients with tongue carcinoma (T1, T2) treated in National Cancer Center Hospital during 24 years were examined. These patients were divided into following three groups: group a) patients treated with excisional biopsy only, group b) those treated with excisional biopsy and cryosurgery, group c) those treated with excisional biopsy and radiotherapy. We examined local control rate of these groups, degree of differentiation in histopathological examination, and median cancer free surgical margin. From these we obtained following results: 1) There was no significance in local control rate among these three groups (group a 77%, group b 84%, group c 45%) 2) There were no local recurrences in the patients with cancer free margin of 5 mm or more except when the histopathology showed perineural invasion, lymphatic vessel invasion, and/or deep invasion to the muscle. 3) Even if we had cancer positive surgical margin with excisional biopsy, we could obtain high local control rate (75%) with additional cryosurgery. We conclude that excisional biopsy for tongue carcinoma (T1, T2) is a good method for primary therapy.     

Sentinel-node biopsy for axillary staging in breast cancer: results from a large prospective German multi-institutional trial.

PURPOSE: To analyse the reliability of sentinel-node biopsy (SNB) in a multicentre setting and define conditions for the routine use of the procedure. MATERIAL AND METHODS: SNB with consecutive axillary clearing was performed in 1124 breast cancer patients. The detection rate of a sentinel lymph node and its dependence on the choice of lymphography technique, patient selection, and technical procedure were analysed. The diagnostic performance of the sentinel-node method was compared to clinical, ultrasound-guided and histological staging. In order to study training effects all learning periods were included. RESULTS: Twenty-two institutions with a total of 89 surgeons participated in the trial. The detection rate (overall: 85.2%) was found to be related to the applied lymphography technique, the experience of the institution and various technical factors of the procedure itself. The false-negative rate (FNR, overall: 8.2%) was independent of patient selection and technical features. The FNR did not depend on experience in the application of the method, but seemed related to surgical accuracy to detect sentinel nodes. Compared to conventional staging procedures (palpation, ultrasound) SNB yielded highly reproducible results for the prediction of the axillary status even in a multicentre setting involving surgeons with different training status. CONCLUSION: SNB is suited as standard of care procedure. Measures of quality control appear more important than learning periods to minimize the FNR.     

Morbidity after sentinel lymph node biopsy in primary breast cancer: results from a randomized controlled trial.

PURPOSE: Axillary lymph node dissection (ALND) as part of surgical treatment for patients with breast cancer is associated with significant morbidity. Sentinel lymph node biopsy (SLNB) is a newly developed method of staging the axilla and has the potential to avoid an ALND in lymph node-negative patients, thereby minimizing morbidity. The aim of this study was to investigate physical and psychological morbidity after SLNB in the treatment of early breast cancer in a randomized controlled trial. PATIENTS AND METHODS: Between November 1999 and February 2003, 298 patients with early breast cancer (tumors 3 cm or less on ultrasound examination) who were clinically node negative were randomly allocated to undergo ALND (control group) or SLNB followed by ALND if subsequently found to be lymph node positive (study group). A detailed assessment of physical and psychological morbidity was performed during a 1-year period postoperatively. RESULTS: A significant reduction in postoperative arm swelling, rate of seroma formation, numbness, loss of sensitivity to light touch and pinprick was observed in the study group. Although shoulder mobility was less impaired on average in the study group, this was significant only for abduction at 1 month and flexion at 3 months. Scores reflecting quality of life and psychological morbidity were significantly better in the study group in the immediate postoperative period, with fewer long-term differences. CONCLUSION: SLNB in patients undergoing surgery for breast cancer results in a significant reduction in physical and psychological morbidity.     

Electronic support groups for breast carcinoma: a clinical trial of effectiveness

BACKGROUND: A recent Pew Charitable Trust study found that 52,000,000 individuals used the Internet to obtain health/medical information. Clinical trials of face-to-face breast carcinoma support groups show evidence of 1) improvement in quality of life, 2) reduction of psychologic symptoms, 3) improvement in coping responses, and 4) a reduction in pain. To the authors' knowledge, a few studies published to date have investigated Internet-delivered electronic support groups (ESGs) for cancer. The most sophisticated is the Comprehensive Health Enhancement Support System (CHESS) program, which provides integrated information, referral, and a newsgroup-based social support program. However, to the authors' knowledge, no studies published to date have examined the impact of a breast carcinoma ESG in a clinical trial. METHODS: Sixty-seven women completed the initial baseline questionnaires, 32 of whom accepted the authors' invitation and began the groups. With regard to geographic location, 49% lived in rural/small towns, 41% lived in medium-sized cities, and 10% lived in large cities. Diagnostic stages of disease were: Stage I, 22%; Stage II, 56%; Stage III, 12%; and other forms, 10%. There were 4 intervention groups, of which 8 participants led by trained Wellness Community (TWC) (a national agency) leaders met for 1.5 hours once a week for 16 weeks. Student t tests for paired outcome data were computed using baseline and postgroup scores. RESULTS: The results of the current study indicated that breast carcinoma patients significantly reduced depression (Center for Epidemiologic Studies-Depression [CES-D] scale) and Reactions to Pain. They also demonstrated a trend toward increases on The Posttraumatic Growth Inventory (PTGI) in two subscales: New Possibilities and Spirituality. Counterintuitively, breast carcinoma patients appeared to demonstrate an increase in emotional suppression. Postinterview results indicated that approximately 67% of patients found the group to be beneficial. Those who withdrew from the groups (20%) demonstrated low scores in their ability to contain anxiety and appeared to be more likely to suppress their thoughts and feelings regarding their illness. CONCLUSIONS: The findings of the current study are encouraging, particularly because it was conducted through TWC, a national agency willing to make this type of intervention readily available at no cost. A limitation of the current study was the lack of randomization and a control group comparison. Although the authors were not able to demonstrate effectiveness without the addition of a control condition, the analysis of pregroup and postgroup outcomes suggests that a randomized trial is worthwhile. Women with a devastating disease will join and commit themselves to an online support group. In addition, because a large percentage of these women were from rural locations, this type of intervention may hold promise for those who have limited access to support groups.     

Oral vinorelbine in metastatic breast cancer: a review of current clinical trial results

Background

Oral chemotherapy is one of the options for the treatment of endocrine non-responsive metastatic breast cancer.

Patients and methods

A search of the online PubMed database was undertaken to identify clinical trials evaluating oral vinorelbine in metastatic breast cancer. All the clinically relevant data have been analysed in this article.

Results

A total of 31 studies including more than 1000 patients have been included into this analysis. Oral vinorelbine either as a single-agent or in combination has shown consistent efficacy results (response rates between 27% and 85% in first-line). The all-oral combination of oral vinorelbine and capecitabine has shown comparable efficacy to a taxane-based combination in a randomised phase II study. Importantly, activity has also been observed in the subset of patients previously treated with anthracyclines and taxanes. For HER2-positive patients, oral vinorelbine in combination with trastuzumab is among the most active options. Oral vinorelbine presents a manageable tolerance profile. Neutropenia is the most common adverse event and alopecia is not frequently observed. Anti-emetic prophylaxis is recommended.

Conclusion

Taken together, these data indicate that oral vinorelbine is a highly effective and well tolerated agent which can be used in first-line and subsequent metastatic breast cancer settings. Moreover, this compound may offer the specific advantages of oral chemotherapy, as fewer and shorter hospital visits, delayed use of central venous access devices and maintained social activities.     

Radiotherapy after breast-conserving surgery in small breast carcinoma: Long-term results of a randomized trial

Background:Breast-conserving surgery followed by radiotherapy isa widely accepted form of treatment in patients with breast cancer of limitedextent. Many attempts have been made to identify subgroups of patients whomight avoid radiotherapy. Patients and methods:Between 1987 and 1989, 579 women withcarcinoma of the breast were randomly assigned to quadrantectomy, axillarydissection and radiotherapy (299) and to quadrantectomy with axillarydissection without radiotherapy (280). Eligible patients were women with abreast carcinoma less than 2.5 cm in maximum diameter up to 70 years of age.Primary endpoints were intra-breast tumour reappearance (IBTR) and all-causemortality. Results:The number of IBTRs was significantly higher in patientstreated with surgery alone (59 cases out of 273; 10-year crude cumulativeincidence of 23.5%) than in patients treated with surgery plusradiotherapy (16 cases out of 294; 10-year crude cumulative incidence of5.8%). The difference in IBTR frequency between the two treatmentsappeared to be particularly high in women up to 45 years of age, tending todecrease with increasing age up to no apparent difference in women older than65 years. Overall survival curves for the two groups, did not differsignificantly (P = 0.326). However, a limited survival advantagewas evident after radiotherapy for node-positive women. Conclusions:After breast-conserving surgery radiotherapy appearsindicated in all patients up to 55 years of age, in patients with positiveaxillary nodes, and in patients with extensive intraductal component athistology. The data suggest that radiotherapy may be avoided in patients olderthan 65, and may be optional in women aged 56–65 years with negativenodes.     

The impact of sharing results of a randomized breast cancer clinical trial with study participants

Background There has been growing interest in providing clinical trial participants with study results yet only limited information exists regarding the process and impact of sharing results. We sought to evaluate patient perceptions of how results had been shared from a large randomized cooperative group trial, and the impact of learning results. Patients and methods A subset of women who participated in NCCTG 9831 (A Phase III Trial of Adjuvant Chemotherapy with or without Trastuzumab for Women with HER2-positive Breast Cancer) were mailed surveys after the preliminary study results were released to the public and mailed to participants. Results One hundred and 67 of 228 surveys sent (73%) were returned; 61% reported receiving trastuzumab on study; 4% reported recurrent disease. Ninety-five percent of participants were glad they received results; 81% were satisfied with how results were shared; 23% were more anxious after learning the results. Sixty-nine percent correctly interpreted the results. Logistic regression revealed that satisfaction with the process of receiving results was associated with satisfaction with treatment (P = 0.04), and increased anxiety was associated with dissatisfaction with treatment (0.02), incorrect interpretation of results (0.04), and not having received trastuzumab (P < 0.0001). Conclusion Sharing results directly with study participants is met with overwhelmingly favorable responses from patients, although some may not initially understand the findings. The potential for increased anxiety should be considered, and psychosocial support may be required by some. A plan to share results should be routinely and prospectively considered in the design of cancer clinical trials.     

乳腺钙化活检标本的病理取材的块状定位法

目的：介绍一种新颖的切割线标记及／或金属标记的乳腺钙化活检标本的块状定位法,以增加病理医生在切片取材时的精确程度。方法：回顾分析钙化病灶BI—RADS分级达IV级以上5例患者6侧乳房的活检方法和标本块状定位法。首先对于钙化灶进行开放式手术活检。钙化灶的上下、内外及深浅三维定位参照内外侧斜位和头足位钼靶片所示的钙化位置及标尺刻度;切下标本之后,进行块状定位：将标本平行地或放射状地两次到三次切割和／或配合金属标记将标本分割成块;接着标本摄x片,确定钙化灶被完整切除;最后会同病理科医生将块状定位下的可疑组织进行准确的取材和病理检查,从而完成诊断。结果：标本x片显示钙化灶均被完整切取;通过切割线和金属标记的方式完成了标本x片中的块状定位及对应的标本大体观中的块状定位;病理科医生可以准确地根据标本x片所示的可疑位置在标本中精确取材到对应组织。结论：乳腺钙化活检标本的块状定位可以增加标本切片取材时的精确程度。     

乳腺钙化活检标本的病理取材的块状定位法

目的:介绍一种新颖的切割线标记及/或金属标记的乳腺钙化活检标本的块状定位法,以增加病理医生在切片取材时的精确程度.方法:回顾分析钙化病灶BI-RADS分级达IV级以上5例患者6侧乳房的活检方法和标本块状定位法.首先对于钙化灶进行开放式手术活检.钙化灶的上下、内外及深浅三维定位参照内外侧斜位和头足位钼靶片所示的钙化位置及标尺刻度;切下标本之后,进行块状定位:将标本平行地或放射状地两次到三次切割和/或配合金属标记将标本分割成块;接着标本摄X片,确定钙化灶被完整切除;最后会同病理科医生将块状定位下的可疑组织进行准确的取材和病理检查,从而完成诊断.结果:标本X片显示钙化灶均被完整切取;通过切割线和金属标记的方式完成了标本X片中的块状定位及对应的标本大体观中的块状定位;病理科医生可以准确地根据标本X片所示的可疑位置在标本中精确取材到对应组织.结论:乳腺钙化活检标本的块状定位可以增加标本切片取材时的精确程度.     

Endoscopic ultrasound guided biopsy performed routinely in lung cancer staging spares futile thoracotomies: preliminary results from a randomised clinical trial

BACKGROUND: Up to 45% of operations with curative intent for non-small-cell lung cancer (NSCLC) can be regarded as futile, apparently because the stage of the disease is more advanced than expected preoperatively. During the past decade several studies have evaluated the usefulness of endoscopic ultrasound guided fine needle aspiration biopsy (EUS-FNA) in lung cancer staging with promising results. However, no randomised trials have been performed, in which a staging strategy with EUS-FNA performed in all patients is compared with a conventional workup. METHODS: Before surgery (i.e. mediastinoscopy and subsequent thoracotomy) 104 patients from one hospital were randomly assigned to either a conventional workup (CWU), including EUS-FNA only for selected patients, or a strategy where all patients were offered EUS-FNA (routine EUS-FNA) in addition to CWU. Patients were followed up for a median period of 1.3 years (range 0.2-2.4 years). Thoracotomy was regarded as futile if the patient had an explorative thoracotomy without tumour resection or if a resected patient had recurrent disease or died from lung cancer during follow-up. Analysis was by intention to treat. RESULTS: Fifty-three patients were randomly assigned to routine EUS-FNA and 51 patients to CWU. EUS-FNA was performed in 50 patients (94%) in the routine EUS-FNA group and in 14 patients (27%) in the CWU group. In the routine EUS-FNA group five patients (9%) had a futile thoracotomy, compared with 13 (25%) in the CWU group, p = 0.03. CONCLUSION: Addition of routine-EUS-FNA to standard workup in routine clinical practice improved selection of surgically curable patients with NSCLC.     

Management of anastrozole-induced bone loss in breast cancer patients with oral risedronate: results from the ARBI prospective clinical trial

Introduction

The aim of this multicenter, phase III, prospective open label clinical trial was to investigate the effect of risedronate (R) on bone mineral density (BMD) in postmenopausal, early breast cancer (BC) patients scheduled to receive anastrozole (A).

Methods

Pre-treatment BMD of 213 patients with hormone receptor-positive BC was evaluated at lumbar spine (LS) and hip (HP). Patients were categorized according to their baseline BMD T-score as being at low, moderate and high risk of osteoporosis. Low risk patients received anastrozole only (A), moderate risk were randomized to anastrozole +/- risedronate (A+/-R) administration and high risk patients received anastrozole + risedronate (A+R). Anastrozole was given at a dosage of 1 mg/day while oral risedronate was given at 35 mg/week. BMD was then assessed at 12 and 24 months. All patients received daily supplements of calcium (1000 mg/day) and vitamin D (400 IU/day).

Results

At 24 months, in the moderate risk group, treatment with A+R resulted in a significant increase in BMD at LS and HP compared to treatment with A only (5.7% v -1.5%, Wilcoxon test P = 0.006, and 1.6% v -3.9% Wilcoxon test P = 0.037, respectively), while no significant difference was found at 12 months; 24.3% of the patients moved to normal BMD region. In the high risk group, a significant increase for LS was detected both at 12 and 24 months (6.3% and 6.6%, P < 0.001) but not for HP; BMD in 14% of patients improved to the osteopenic region. In the low risk group, a significant decrease of BMD was detected at 12 months for LS and HP (-5.3% P < 0.001 and -2.4% P < 0.001, respectively,); at 24 months, a significant decrease of BMD was detected only for LS (-2.5%, P < 0.001). However, 22% of patients became osteopenic and only 4% became osteoporotic.

Conclusions

The addition of oral risedronate in post-menopausal breast cancer patients receiving anastrozole has a favorable effect on BMD. Patients with pre-treatment osteopenic to osteoporotic status should be treated with a combination of both therapies in order to avoid bone loss induced by aromatase inhibition. Patients with normal BMD before starting treatment with anastrozole have a very low risk to develop osteoporosis.

Trial registration

ClinicalTrials.gov Identifier NCT00809484.     

Clinical breast examination: preliminary results from a cluster randomized controlled trial in India

A cluster randomized controlled trial was initiated in the Trivandrum district (Kerala, India) on January 1, 2006, to evaluate whether three rounds of triennial clinical breast examination (CBE) can reduce the incidence rate of advanced disease incidence and breast cancer mortality. A total of 275 clusters that included 115,652 healthy women, aged 30-69 years, were randomly allocated to intervention (CBE; 133 clusters; 55,844 women) or control (no screening; 142 clusters; 59,808 women) groups. Performance characteristics (sensitivity, specificity, false-positive rate, and positive predictive value) of CBE were evaluated. An intention-to-treat analysis was performed for comparison of incidence rates between the intervention and control groups. Preliminary results for incidence are based on follow-up until May 31, 2009, when the first round of screening was completed. Of the 50,366 women who underwent CBE, 30 breast cancers were detected among 2880 women with suspicious findings in CBE screening that warranted further investigations. Sensitivity, specificity, false-positive rate, and positive predictive value of CBE were 51.7% (95% confidence interval [CI] = 38.2% to 65.0%), 94.3% (95% CI = 94.1% to 94.5%), 5.7% (95% CI = 5.5% to 5.9%), and 1.0% (95% CI = 0.7% to 1.5%), respectively. The age-standardized incidence rates for early-stage (stage IIA or lower) breast cancer were 18.8 and 8.1 per 100,000 women and for advanced-stage (stage IIB or higher) breast cancer were 19.6 and 21.7 per 100,000 women, in the intervention and control groups, respectively.