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Clinical studies have shown equivalent survival rates between breast-conserving surgery (BCS) and mastectomy in early breast cancer; however, rates for BCS remain low. The purpose of this study was to determine (a) the prevalence of BCS in a regional medical center, (b) clinicopathologic factors associated with BCS, and (c) patient perceptions of the treatment decision-making process.We retrospectively reviewed 251 consecutive breast cancer cases during January 1990-December 1991; 77 patients were ineligible for BCS because of unfavorable pathology. We then interviewed 118 of the 160 women available for interview.BCS was performed in 31 of the eligible patients (18%). Multivariate analysis revealed that tumor size10 mm (p = 0.03) was the only significant predictive variable for BCS. Patient interviews revealed that 93% said their surgeon was the primary source of information regarding treatment options. Among 69% of the women whose surgeons reportedly recommended a particular option, 89% recommended mastectomy with 93% compliance, and 11% recommended BCS with 89% compliance. The BCS group more often obtained a second opinion (p = 0.04) and 60% said they made the decision themselves compared with only 37% of the mastectomy group (p = 0.05).Limiting BCS to women whose tumor size is10 mm is too restrictive; this excludes a large number of women who are clinically eligible for BCS. The surgical decision-making process for early-stage breast cancer is very much surgeon-driven, with a high degree of patient compliance.

Eradication of breast cancer by wide local excision alone is not possible unless the clinical margins of excision exceeds 5 cm or a segmental mastectomy is performed, though recurrences may still occur after a segmental mastectomy. With inadequate excision radiotherapy to the breast is essential, but will not prevent local recurrence. In a prospective trial (1981 to 1990) to assess the value of radiotherapy to the breast when adjuvant therapy was administered, 418 patients treated by wide local excision and adjuvant chemotherapy (tamoxifen if oestrogen receptor-positive and CMF chemotherapy if oestrogen receptor-negative) were randomized to have loco-regional radiotherapy to the breast or not. At a minimum 5-year follow-up, the local recurrence rate in patients receiving radiotherapy was 13% compared to 35% in those not so treated. Local recurrence was strictly related to microscopic clearance in millimetres irrespective of clinical wide local excision, nodal, or menopausal status. Where, histologically, local excision was incomplete and patients received radiotherapy, the local recurrence rate was 17%. The criteria for wide local excision need to be strictly defined and histologically proven if post-operative radiotherapy is to achieve its effective function, that is the prevention of local recurrence. Radiotherapy cannot compensate for inadequate surgery.

Purpose The purpose of the study was to evaluate the effect of preoperative magnetic resonance imaging (MRI) on survival outcomes for breast cancer. Methods A total of 954 patients who had T1-2 breast cancer and received breast-conserving therapy (BCT) between 2007 and 2010 were enrolled. We divided the patients according to whether they received preoperative MRI or not. Survival outcomes, including locoregional recurrence-free survival (LRRFS), recurrence-free survival (RFS), and overall survival (OS), were analyzed. Results Preoperative MRI was performed in 743 of 954 patients. Clinicopathological features were not significantly different between patients with and without preoperative MRI. In the univariate analyses, larger tumors were marginally associated with poor LRRFS compared to smaller tumors (hazard ratio [HR], 3.22; p=0.053). Tumor size, histologic grade, estrogen receptor (ER), progesterone receptor (PR), hormonal therapy, and adjuvant chemotherapy status were associated with RFS. Larger tumor size, higher histologic grade, lack of ER and PR expression, and no hormonal therapy were associated with decreased OS. Tumor size was associated with LRRFS in the multivariate analyses (HR, 4.19; p=0.048). However, preoperative MRI was not significantly associated with LRRFS, RFS, or OS in either univariate or multivariate analyses. Conclusion Preoperative MRI did not influence survival outcomes in T1-2 breast cancer patients who underwent BCT. Routine use of preoperative MRI in T1-2 breast cancer may not translate into longer RFS and OS.

PURPOSE The objective of this study was to investigate the influence of radiotherapy on the cosmetic outcome after immediate breast reconstruction using an absorbable mesh in breast cancer. METHODS From July 2008 to July 2009, 35 breast cancer patients who received immediate breast reconstruction with absorbable mesh insertion at the time of breast conserving surgery followed by radiotherapy were retrospectively studied. RESULTS In 91% of cases there was an excellent or good cosmetic outcome before the initiation of radiotherapy, and in 8.6% the outcome was fair at this point. However, 6 months after surgery and irradiation, the rate of excellent to good cosmetic outcomes had decreased to 60% and fair outcomes had increased to 25.7%. Contrary to the decreased rate of good cosmetic outcomes from 65.7% to 42.9% at 1 year after operation, the rate of fair to poor outcomes considerably increased from 8.6% to 57.1%. The significant factors affecting cosmetic outcomes were pathology, specimen volume, and the estimated percentage of breast volume excised (EPBVE). Chemotherapy affected the cosmetic outcome at borderline significance level. Age, breast volume tumor site, insertion of drain, radiation dose, and time elapsed between surgery and radiotherapy were not significantly associated with the cosmetic outcome. CONCLUSION Applying an absorbable mesh for the immediate reconstruction of the breast should be carefully considered in patients with an EPBVE of over 30% who are scheduled to be irradiated.

Purpose Breast-conserving surgery (BCS) with radiotherapy has become a standard treatment for early stage breast cancer, since the installation of NSABP B-06. One of the serious problems in BCS is that of local recurrence. There are many risk factors for local recurrence, such as large tumor size, multiple tumors, axillary lymph node involvement, young age, high nuclear grade, and so on. The aim of this study is to identify patients with a higher risk of local recurrence of breast cancer. Methods Between January 2002 and December 2006, 447 patients with breast cancer, and who had undergone BCS with immediate breast reconstruction, were enrolled in the study. The follow-up period was 5 years from the time of operation and we analyzed local recurrence, disease-free survival (DFS), and overall survival (OS). The analysis included various clinicopathological factors such as age, chemotherapy, radiotherapy, hormone therapy, pathologic characteristics, and margin status. Statistical analysis was performed with log-rank test and Kaplan-Meier method. The p-value

Breast conservative treatment (BCT) can be advantageous compared with skin-sparing (SSM) or nipple-sparing mastectomy for many patients affected by unicentric ductal carcinoma in situ (DCIS), Paget’s disease, invasive lobular carcinoma (ILC) and invasive ductal carcinoma (IDC) up to 2-3 cm as diameter and without extension to skin (T1; part of T2 in larger breast), and more recently T2 up to 5 cm previously treated by neoadjuvant chemotherapy with positive effect on tumor size reduction. Partial or segmental mastectomy, i.e. quadrantectomy, should include 1.5–3cm excision of normal tissue around the tumour, including the ductal tree, and the removal of a portion of overlying skin and underlying fascia when indicated. Contrary to what happens in Europe and in Italy, lumpectomy is largely preferred in the United States because of the higher cosmetic result without the help of plastic remodelling. Quadrantectomy associated to axillary dissection with radiation therapy (QUART) or without it (QUAD), likely shows three advantages: 1) preservation of healthy breast with satisfying cosmetic appearance if reshaped by the plastic surgeon; 2) preservation of vascular supply and innervation of the nipple-areola complex except of central quadrantectomy; 3) maintenance of some average symmetry improvable with the reshaping reduction of the contralateral breast. Unfortunately many breast surgeons use to perform more lumpectomies rather than ask for plastic surgery aid in order to reshape a quadrantectomy. Disadvantages are given by the radiation effects on soft tissues and the long-term higher rate of local recurrences compared to mastectomy. May radiation be avoided in patients with DCIS? There are no extra-benefit for survival or distant metastases compared to excision alone; patients with high-grade DCIS lesions and positive margins benefited most from the addition of radiotherapy (Viani, 2007). Even if many trials suggest significant reduction of absolute local recurrence after radiation, many unicentric DCIS are conventionally treated by local excision alone. The unsolved problem remains how to identify subgroups of patients with DCIS with different rates of local recurrence incidence (Silverstein, 2006). Annual risk for in-breast recurrence is rated 1.97 per 100 patients even in the most favourable subgroup with clear margins and minimal amount of comedonecrosis without radiation (Fisher, 1995). At least clear margins of 1 cm for tumour size of 1 cm are obtained, regardless of nuclear grade, comedonecrosis, or

Clinical trials at our institution and all over the world have proven that conservative surgery for small breast cancers is effective and safe. The aim of the procedures is to avoid, whenever possible, a useless mutilation to patients and to offer a good aesthetic outcome. In our view, the segmental mastectomy should be a locally “radical” procedure by means of a “wide” excision unlike the simple biopsy performed in the so called “tumorectomy.” For this reason about 15% of the patients present a poor cosmetic result worth improving by means of a plastic surgery procedure. Such unsatisfying cosmetic results are usually due to the extent of the excision compared with the size of the breast, the location of the cancer, and the effects of radiotherapy. Because it is our experience that delayed reconstructive procedures are limited by the effects of RT, it is preferable to achieve the best shape at the time of the primary surgical procedure (ie, to perform an immediate reconstruction). It is our philosophy that major reconstruction (ie, transfer of latissimus dorsi or rectus abdominis flaps) should be avoided whenever possible as a primary procedure. Indeed, it is unclear why a total mastectomy and a primary reconstruction should not be performed in these patients instead of having the double problem of facing the morbidity and the scars subsequent to the transfer of distant tissue and of leaving behind a good portion of potentially diseased breast tissue. A number of techniques suitable for the immediate repair of segmental mastectomy defects have been studied. They vary depending on the breast site involved and consist in rotation or advancement of dermoglandular flaps based on an inferior or superior pedicle. In selected cases, a custom-made segmental prosthesis has been used, as well as a latissimus dorsi flap.

Current problems in the pathological assessment and subclassification of ductal carcinoma in situ of the breast are reviewed, both in its pure form and in association with invasive disease. The different clinical significance of these 2 types of presentations is emphasized, with particular reference to breast-conserving surgery. Adherence to the variably defined concept of extensive intraductal component may not be necessary if completeness of excision of intraductal disease can be demonstrated. A uniform approach is presented for the examination of surgical margins around intraductal carcinoma, regardless of the presence of invasion, using radiological-pathological correlation of sliced specimens.

Background. A delay in administration of radiation therapy has been suggested to increase the risk of local recurrence after breast-conserving surgery. Methods. The data were retrospectively reviewed from 552 patients in whom treatment consisted of total mastectomy (n = 467) or segmental mastectomy (n=85), irradiation, and combination chemotherapy. Of these, 463 patients received radiation therapy first, and 89 received chemotherapy first. The pattern of failures was compared between the subgroups according to the order of administration chemotherapy and irradiation and its effect on the local control of disease. Results. The median follow-up time of the local mastectomy subgroup was 133 months; of the segmental mastectomy subgroup, it was 39 months

A 44-year-old woman presented for sentinel node biopsy and segmental mastectomy. After anesthetic induction, a laryngeal mask airway was placed, and ventilation was satisfactory. Three minutes after isosulfan blue dye injection, ventilation became difficult. The laryngeal mask airway was removed, and an endotracheal tube was easily placed. Twenty minutes later, she became hypotensive and unresponsive to phenylephrine, ephedrine, and vasopressin. With erythema and swelling in her arm and chest, low-dose epinephrine was titrated until her mean arterial blood pressure stabilized. Serum tryptase was increased to 27.2 μg/L (normal 0.4-10.9 μg/L).

Breast conservation therapy, consisting of lumpectomy or segmental mastectomy with negative margins followed by breast irradiation, has become a standard and safe alternative to mastectomy in selected patients with early-stage breast cancer. As the inclusion criteria for breast conservation therapy have continued to evolve to include lower quadrant tumors, very large breasts, and central tumors, the potential for significant disfigurement after breast conservation therapy has increased. Bilateral reduction mammaplasty in conjunction with tumor-directed partial mastectomy is a surgical approach that can benefit these patients by creating symmetric, aesthetically pleasing breasts in a single-stage operation.

PURPOSE: Accelerated partial breast irradiation (APBI) has gained popularity as an alternative to adjuvant whole breast irradiation; however, owing to limitations of delivery devices for brachyther- apy, APBI has not been a suitable option for all the patients. This report evaluates APBI using the strut-adjusted volume implant (SAVI) single-entry catheter to deliver brachytherapy for breast cancer in the setting of an augmented breast. METHODS AND MATERIALS: The patient previously had placed bilateral subpectoral saline implants; stereotactic core biopsy revealed estrogen receptor- and progesterone receptor-positive ductal carcinoma in situ of intermediate nuclear grade. The patient underwent needle-localized segmental mastectomy of her left breast; pathologic specimen revealed no residual malignancy. An SAVI 8-1 device was placed within the segmental resection cavity. Treatment consisted of 3.4 Gy delivered twice a day for 5 days for a total dose of 34 Gy. Treatments were delivered with a high-dose-rate 192 Ir remote afterloader. RESULTS: Conformance of the device to the lumpectomy cavity was excellent at 99.2%. Dosi- metric values of percentage of the planning target volume for evaluation receiving 90% of the prescribed dose, percentage of the planning target volume for evaluation receiving 95% of the prescribed dose, volume receiving 150% of the prescribed dose, and volume receiving 200% of the prescribed dose were 97.1%, 94.6%, 22.7 cc, and 11.6 cc, respectively. Maximum skin dose was 115% of the prescribed dose. The patient tolerated treatment well with excellent cosmetic results, and limited acute and late toxicity at 8 weeks and 6 months, respectively. CONCLUSIONS: Breast augmentation should not be an exclusion criterion for the option of APBI. The SAVI single-entry catheter is another option to successfully complete APBI using brachytherapy for breast cancer in the setting of an augmented breast. 2011 American Brachy

If a surgical intervention is needed, early stage breast cancer may lead to three basic surgery choices: breast-sparing surgery followed by radiation therapy, mastectomy, mastectomy with breast reconstruction surgery. Breast-sparing surgery (breast conservation therapy (BCT)) removes the breast tumor and a margin of surrounding normal tissues. It is also known by other names: lumpectomy, partial mastectomy, segmental mastectomy, and quadrantectomy. Radiation therapy follows lumpectomy to eliminate any microscopic cancer cells in the remaining breast tissue. The purpose of BCT is to give women the same cure rate they would have if they were treated with a mastectomy but to leave the breast intact, with an appearance and texture as close as possible to what they had before treatment. Trials for breast conservative therapy with patients affected by breast cancer (I and II) have demonstrated conclusively that BCT produces disease control and survival rates at least equivalent to those of mastectomy, and possibly better in the long run for patients with stage II [1]. BCT is combined to radiation therapy. While BCT removes the tissue that contain the tumor with a negative margin, radiotherapy insure that residual microscopic disease are controlled. Contra-indications to BCT are generally for patients with high probability of recurrence, high probability of normal tissue damage from irradiation. While cosmesis after BCT might be generally satisfactory, the quality of the result is very sensitive to the location and extent of the tumor. Further, the breast is a very deformable structure with a complicated anatomy that is patient specific. The mechanical properties of glandular, fatty and cancerous tissue are quite different, and vary from one patient to another. The Cooper’s ligament also plays a key role in the outcome. Strong asymmetry in the location or large tumor size are prone to anesthetic BCT result. Surgical results are also depending on the time scale. Beside the short time scale modeling that might be caught by the mechanical model, one can expect that inflammation, postsurgical radiotherapy, and healing dynamic can change significantly in the long time scale of the cosmetic outcome. In other words biology plays a role as well.

The 20th century is marked by significant advances regarding the management of breast cancer. A clear trend towards less aggressive surgical operation was constantly noted. Modified radical mastectomy gradually replaced radical mastectomy during the second half of the 20th century, while during the last two decades breast-conservation therapy became the treatment of choice for the treatment of breast cancer. This type of therapy includes segmental mastectomy (either quadrantectomy or lumpectomy) with axillary lymph node dissection, followed by postoperative irradiation. Other significant advances during the 20th century include the introduction of systemic therapy (chemotherapy, hormonal therapy) and radiation therapy. Better patient follow-up, statistical analysis, development of staging systems and the introduction of frozen section, the development and wide use of mammography (including screening mammography), breast reconstruction following mastectomy and the development of newer diagnostic methods [including breast magnetic resonance imaging and the advanced breast biopsy instrumentation (ABBI)] are other advances that contributed to a better management of breast cancer patients. Sentinel lymph node biopsy has been introduced during the 1990 s in an attempt to reduce morbidity due to axillary lymph node dissection. Despite these advances, breast cancer remains a significant problem and represents a field of active and intense research.

Failure after breast conserving surgery (BCS) and total breast irradiation usually occurs at the site of the original tumor. This has caused an increased interest in accelerated partial breast irradiation (APBI), because if radiation is delivered directly to the tumor bed there should be better local control. Patients greater than age 50 with core biopsy confirmed invasive ductal carcinoma were enrolled. They had preoperative ultrasound defining margins of less than 3.5 cm. Intraoperative ultrasound was also performed in an effort to ensure good surgical margins. After excision of the tumor, intraoperative radiotherapy (IORT) with the Intrabeam System was delivered to the tumor bed. The procedure has been performed on 67 patients. Sixty-one patients had it with the original surgery, while 6 had the procedure after re-exploration of the segmental mastectomy site. Because of the final pathology (surgical margins, tumor biology, and nodal status) 4 patients later had total mastectomy and 11 received total breast irradiation. When total breast irradiation is done the IORT serves as the radiation boost. The cosmetic results have been good to excellent, and there have been no serious surgical or radiation complications. To date there have been no local failures. IORT with the Intrabeam System is feasible, user friendly, versatile, with few complications, good cosmetic results, and great patient acceptance. It is practical and excellent for breast IORT in the community setting.

Interest in the presence and management of synchronous multiple ipsilateral breast cancer has been reported since the early 1920s. The demonstration of multiple foci of breast cancer has been reported in 9-75% of breast cancer related specimens. The large difference in reported incidence is multifactorial and related to the definitions applied, mode of detection and pathological assessment. However, randomised clinical trials comparing total mastectomy and segmental mastectomy with or without radiation over many years have shown no difference in distant disease-free survival or overall survival in patients with synchronous multiple ipsilateral breast cancer compared with unifocal breast cancer. This review examines the current definitions, incidence, pathological assessment, staging and surgical options of synchronous multiple ipsilateral breast cancer.

The aim of this study was to determine if patients who underwent partial-breast irradiation followed by segmental mastectomies had fewer mammographic changes on the first post-treatment mammogram than those who underwent segmental mastectomies followed by whole-breast irradiation.Subjects enrolled in a study of partial-breast irradiation therapy after segmental mastectomy (intraoperative radiation therapy) plus a random sample of patients who underwent segmental mastectomies followed by conventional whole-breast radiation therapy were identified through the institution's breast cancer database from March 2003 through February 2006. A radiologist specializing in breast imaging reviewed and recorded each patient's pretreatment mammogram for breast density and tumor location and the first post-treatment mammogram, obtained within the first year of treatment, for three common types of mammographic change seen after breast surgery and radiation treatment (breast edema, skin thickening, and surgical scarring), which when severe make it difficult to use mammography for continuing follow-up of the conserved breast. The extent of mammographic change was noted by the radiologist as minimal, moderate, or marked. The data were entered into a database, and statistical analysis was conducted using logistic regression models and chi(2) tests. The effect of breast density on mammographic change was also assessed.The severity of edema was lower with decreasing breast density (P.006). There was no apparent effect of breast density on the severity of skin thickening. The extent of surgical scarring decreased as breast density increased (P.026). Analysis of the data from the cumulative logistic regression models demonstrated that even after controlling for breast density, patients who underwent whole-breast radiation therapy had significantly more edema (P = .003), skin thickening (P = .003), and surgical scarring than those who underwent intraoperative radiation therapy (P.001).Patients have a higher probability of having fewer post-treatment mammographic changes after partial-breast irradiation followed by segmental mastectomy than after breast conservation surgery followed by whole-breast irradiation.

A 52-year-old postmenopausal woman presented because of a progressive dyspnea, non-productive cough and right side chest pain that worsened with deep inspiration. She had a history of breast carcinoma 2 years earlier and subsequent left segmental mastectomy, axillary dissection, adjuvant chemotherapy and local radiotherapy (RT). One year later she underwent to a T-8 balloon vertebroplasty and local RT for symptomatic bone metastases. Afterward, her disease remained well controlled by treatment with trastuzumab and systemic chemotherapy. Physical examination revealed shortness of breath and …

Growing concern exists regarding the impact of breast cancer and its treatment on patients’ quality of life. Sequelae of modified radical mastectomy or segmental mastectomy with axillary lymph node dissection may include pain, shoulder dysfunction, and lymphedema. A rehabilitation team consisting of a physiatrist, a physical therapist, and an occupational therapist can comprehensively and appropriately assess physical disabilities and prescribe an individual treatment plan. Early mobilization of the affected arm with supervision by the therapist can accelerate return of range of motion, decrease pain, and reduce emotional trauma without increasing the risk of postsurgical complications. Restoration of function of the patient’s extremity produces a sense of recovery and control in the patient’s life. Lymphedema can be managed with complex decongestive therapy performed by a physical therapist under the physiatrist’s supervision. The rehabilitation team can assist the patient in correcting self-care and mobility deficits and transitioning from an inpatient to an outpatient setting. The physical and emotional recovery course is proportional to the extent of the surgery. Early intervention by the rehabilitation team can minimize long-term disability, thereby improving quality of life.

Mastectomy rates have been assumed to be a function of physician recommendations, although they correlate with patient involvement in decision making. The influence of age on the decision-making process and treatment choice is poorly described. All women with ductal carcinoma in situ (DCIS) and a random sample with invasive breast cancer were identified from two Surveillance Epidemiology and End Results (SEER) program registries and surveyed 6 months postoperatively. Women older than 79 years with noninvasive or localized invasive breast cancer diagnosed in 2002 were included. Women with breast-conserving therapy (BCT) contraindications were excluded. Women were questioned about involvement in surgical decision-making, inquiring if this decision was patient-based, surgeon-based, or shared. Knowledge and concerns were assessed. The response rate was 77.0%. There were 1,259 patients who met the study eligibility criteria and age data was available for 1,131. Median patient age was 59.9 years. The frequency of patient-based decisions did not vary with age (p = 0.20), but older women had less knowledge for decision making. The mastectomy rate overall was 19.7%, with no differences in mastectomy choice by age (p = 0.18). In logistic regression for the likelihood of undergoing mastectomy, patient involvement (p

Purpose/Objective(s): Currently, no biological molecular targets exist for women diagnosed with triple negative breast cancer (TNBC). In an in vitro murine breast cancer model, we have shown that radiation therapy (RT) combined with carboplatin potentiates immunogenic tumor cell death, thereby contributing to a pro-immunogenic milieu (Golden et al., Oncoimmunology 2014). Thus, we hypothesized that this regimen may not only radio-sensitize, but also trigger an adaptive anti-tumor immune response. We are conducting a phase I-II IRB-approved trial [clinicaltrials. gov NCT01289353] to test the feasibility and clinical efficacy of this combination in terms of rates of local control, distant recurrence, and overall survival. Materials/Methods: Women with Stage I e II (pT1-T2, pN0) TNBC are eligible after segmental mastectomy and axillary lymph node assessment. Weekly carboplatin (AUCZ2.0) is delivered x6 weeks with RT to the whole breast being delivered during weeks 2-4, via a 3D-CRT or IMRT technique in the prone position. The whole breast receives 40.5 Gy in 15 fractions (Monday-Friday). The tumor bed receives an additional 3 Gy boost, delivered on 2 consecutive Sundays (beginning of the 2 and 3weeks of RT). Consequently, a total of 46.5 Gy is delivered to the tumor bed in 17 fractions over 19 days. Adverse effects of treatment are assessed weekly during treatment, and once at 45-60 days, thereafter, using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Results: A total of 33 patients have accrued so far. Acute toxicities are displayed below and never exceeded grade 3. Twenty patients received adjuvant chemotherapy. With a median follow-up of 25.9 months, 97% (32/33) of all women remain alive and without recurrent disease. One patient died with possible distant recurrence occurring at 5.6 months from beginning treatment. Conclusion: Adjuvant concurrent carboplatin and prone accelerated radiation therapy appears to be a safe and effective treatment for women diagnosed with early stage TNBC. Since approximately 50% of TNBC carriers recur within 2 years from treatment, it is encouraging that 97% of the patients in the trial have not experienced a recurrence.

BACKGROUND. The objectives of this study were to determine the locoregional recurrence (LRR) rate and to evaluate the correlation between surgical resection volume (RV) and LRR in patients with breast cancer who underwent segmental mastectomy after achieving a pathologic complete response (pCR) on neoadjuvant chemotherapy. METHODS. The authors reviewed the outcomes of all 109 patients who underwent segmental mastectomy after the complete eradication of invasive disease by neoadjuvant chemotherapy at their institution between 1987 and 2002. LRRs were recorded, and RVs after segmental mastectomy were calculated and categorized as small, medium, or large. RESULTS. At a median follow-up of 6.6 years, 3 patients (2.7%) developed LRR. In 2 of those patients, the recurrence was located in the ipsilateral breast; in the other patient, the recurrence was located in the supraclavicular lymph nodes with synchronous distant metastases. The median RV was 73.12 cm3 (range, 2.82–451.51 cm3). Large RVs (>125 cm3) were less common than small RVs (up to 70 cm3) or medium RVs (between 70 cm3 and 125 cm3; P = .009 and P

Este fue un estudio comparativo prospectivo de 104 pacientes con cáncer de seno, a quienes se ofreció la elección entre dos tratamientos quirúrgicos conservadores: cuadrantectomía con mastopexia tipo donut (Grupo CMD, n=39) o cuadrantectomía estándar (Grupo CE, n=75). Los grupos fueron similares en tamaño radiológico del tumor, localización del tumor en el seno, tamaño histológico, y la distribución por estadios pT. En el grupo CMD, la incisión de piel fue tres veces más grande que en el grupo CE, pero con ella se obtuvo al final, una cicatriz alrededor del complejo areola-pezón, sin complicaciones posoperatorias posteriores. El volumen promedio del espécimen quirúrgico y los márgenes de sección, fueron mayores en el grupo CMD comparados con el grupo CE. Se obtuvieron márgenes libres de tumor con mayor frecuencia en el grupo CMD que en el grupo CE, pero la diferencia no fue significativa. Estos datos indican fuertemente que la técnica CMD puede ser más eficiente que la técnica CE, en términos de precisión en la resección del tejido mamario. This is a prospective comparative study comprising 104 patients with breast cancer to which two modalities of conservative therapy were offered: quadrantectomy with mastopexy doughnut type (group QMD, n = 39) or standard quadrantectomy (group QS, n = 75). The two groups had similar tumor size, location of the tumor, histology size and PT distribution. In the QMD group the skin incision was three times greater than in the QS group, but a good healing around the areola-nipple complex was achieved without postoperative complications. Both the size of the surgical specimen and the free margins were greater in the QMD group. Free section margins were more frequently achieved in the QMD group, but the difference was not significant. Our date strongly indicate that the QMD technique can be more efficient that the QS in terms of precision of mammary tissue resection.

The current trial tests a regimen of conformal hypo-fractionated radiotherapy (5 fractions) directed to the original tumor bed with margins in a selected subset of post- menopausal women with breast cancer with a very low risk for local recurrence elsewhere in the breast. We are currently reporting the feasibility results and DVN analysis of the first 29 patients accrued. After planning CT is conducted in the prone position the breast tissue and tumor bed are contoured on a 3D planning system and a 2 cm margin added to determine the PTV. A plan is generated to treat the PTV to 90% of the prescription dose. Six Gy per fraction are delivered to the 95 isodose surface in 5 fractions over ten days weeks to a total dose of 30 Gy. All patients appeared to tolerate treatment very well. DVH varied based on the position of the original tumor bed and the size of the breast. In most cases it was possible to successfully plan and treat a quadrant of the breast with parallel opposed tangent fields without exceeding 50% of the dose to 50% of the breast volume. We continue accrual as planned, to a total of 99 patients.

Background Significant morbidity such as pain, paresthesia, and arm stiffness has often been associated with axillary dissection for breast cancer. We report our experience of 30 patients with stage I and II invasive ductal carcinoma of the breast who underwent laparoscopic-assisted axillary dissection together with segmental mastectomy. Methods Tumours were situated in the upper or lower lateral quadrants only. In all cases, initial exposure for axillary dissection was performed through the breast periareolar incision. A 10-mm 30° laparoscope was introduced through the breast incision to gain entry to the axilla. A separate stab incision in the lower aspect of the axilla was used for introduction of the 5-mm Harmonic shears (Ethicon Endo-Surgery, Inc, Cincinnati, OH). A grasping forceps was introduced through the main incision alongside the endoscope. Subsequent axillary dissection was performed laparoscopically, and the axillary content was removed through the breast incision. Results Average yield of lymph nodes was 15 (range 7 to 25). There were no intraoperative complications. Immediately postsurgery, all patients were able to fully mobilize the upper limb, facilitated by absence of an axillary scar. Patients also reported minimal pain, paresthesia, with no stiffness or frozen shoulder. Conclusion Laparoscopic-assisted axillary dissection offers a safe and improved approach to the axilla, which can be incorporated into breast cancer surgery.

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The surgical management of breast cancer has evolved gradually over the past century from the exclusive use of radical mastectomy to the current practice of segmental mastectomy and radiation therapy. This less aggressive surgical approach in the management of breast cancer extended to treatment of the axilla. The latter led to the recent introduction and subsequent acceptance of lymphatic mapping and sentinel node biopsy as an alternative strategy to the routine use of formal levels I and II axillary dissection in clinically node-negative patients.

Background: Mastectomy is often recommended to women with early breast cancer who have large tumours or where the breast volume requiring resection to achieve adequate tumour clearance is too great to allow for a satisfactory cosmetic result after breast conservation surgery. The use of a latissimus dorsi muscular flap (latissimus dorsi miniflap (LDMF)) to replace the volume loss after major breast sector resection is an option where the tumour to breast volume ratio is large. The present study describes the technique and evaluates the experience of the LDMF at Royal Adelaide Hospital, Adelaide, Australia. Methods: Between August 1997 and April 2002, 18 women aged 37–64 years underwent wide local excision for primary breast cancer with LDMF reconstruction. Tumour characteristics, breast specimen weight and postoperative sequelae were assessed. Quality of life measurements and objective assessments of aesthetic outcome were evaluated. Results: Tumour diameter ranged from 13 to 80 mm (median 30 mm). Nine patients had multifocal or extensive intraductal component positive tumours. The weight of the resected specimens ranged from 75 to 395 g (median 130 g). There were no major postoperative complications, with a range of inpatient stay of 3–10 days. Seromas were aspirated in 14 patients but did not delay adjuvant treatment. Quality of Life results showed high patient satisfaction in all but one patient. A satisfactory cosmetic result was achieved in all but one patient who subsequently required mastectomy. Conclusion: The LDMF procedure allows breast conservation to be achieved in women with large tumour to breast volume ratios, with satisfactory resection margins and good cosmetic and functional results. In the present experience standard oncological adjuvant treatment is not compromised.

Purpose: To present the results of a process survey on breast-conserving therapy (BCT) in Japan from 1995 to 1997. Methods and Materials: From September 1998 to December 1999, data on the treatment process of 865 randomly selected BCT patients were collected by extramural audits. Results: For primary surgery, wide excision or tumorectomy was performed in 372 patients (43.0%), and quadrantectomy or segmental mastectomy was performed in 493 patients (57%). The extent of axillary dissection was equal or beyond Level II in 590 patients (68.2%). Systemic chemotherapy was administered to 103 of 160 node-positive patients (64.4%) and 180 of 569 node-negative patients (31.6%). Tamoxifen was administered to 234 of 323 hormone receptor-positive patients (72.5%) and 68 of 130 hormone receptor-negative patients (52.3%). Photon energy of 10 MV was administered for whole breast irradiation in 38 patients (4.4%) without bolus. Conclusions: The extent of surgical resection for BCT was large in Japan. Pathologic assessment and the technique of radiation therapy were apparently suboptimal in some cases. Information on prognostic/predictive factors was not fully utilized to individualize systemic adjuvant therapy. Establishment and widespread use of guidelines for BCT for in Japan are desirable. Repeated surveys will demonstrate how such guidelines affect clinical practices.

Purpose : The aim of this study was to assess impairments, disabilities and health related Quality of Life (QOL) after treatment of breast cancer and to analyse the relationship between treatment modalities, impairments, disabilities and health related QOL.Method : Fifty-five patients who underwent a modified radical mastectomy or a segmental mastectomy with axillary lymph node dissection were retrospectively assessed with a mean follow up of 2.7 years after treatment. Impairments were assessed by means of measuring active shoulder range of motion, grip strength, arm volume and pain. Disabilities were assessed by means of the Shoulder Disability Questionnaire (SDQ) and health related QOL was assessed by means of the RAND 36-item Health Survey (RAND-36).Setting : University Hospital Groningen (The Netherlands).Results : Pain (60%) and reduction of grip-strength (40%) were the most frequent impairments found. The prevalence of impaired range of motion and oedema was 9 - 16% respectively 15%. Mean group score of the SDQ was 33.7 (sd: 32.1) and mean scores of the RAND-36 differed significantly for physical functioning, vitality and health perception to that of a female norm group. Radiotherapy and chemotherapy were significant factors in the prediction of impaired range of motion. Pain and restricted range of motion explained 61% respectively 12% of the variance in disability (SDQ). In the prediction of health related QOL, pain, grip strength and arm volume were significant factors respectively in six, three and two domains.Conclusions : Pain is the most frequent assessed impairment after breast cancer treatment with strong relationship to perceived disability and health related QOL. Disability is mild and health related QOL (RAND-36) differed in three of the nine domains with a female norm group.

57-year-old woman presented witha palpable abnormality in the upperouter right breast. Findings onmammography showed a 1.4-cm well-circum-scribed round mass in the right breast at the 10-o’clock position (Fig. 1A). On sonography, themass had internal echoes and gently lobulatedborders with some through-transmission (Fig.1B). Sonographically guided core biopsy (Fig.1C) revealed atypical papillary proliferationsuggesting intracystic papillary carcinoma. Thepatient underwent right segmental mastectomy.The histopathologic diagnosis was intracysticpapillary carcinoma (Fig. 1D). Intracystic papillary carcinoma of the breast isa rare malignant tumor, constituting 1–2% of allbreast carcinomas [1]. Intracystic papillary carci-noma, which may be unifocal or multifocal, has apropensity to occur in postmenopausal women.Women with intracystic papillary carcinoma mayhave no symptoms, a palpable mass, or maypresent with bloody nipple discharge. On mammography, intracystic papillarycarcinoma is often seen as a round or oval cir-cumscribed mass, most frequently in the ret-roareolar region [2, 3]. Sonography usuallyreveals a cystic mass, with or without septa-tions, with solid papillary masses projectinginto the cyst lumen [2, 3]. Although most pap-illary carcinomas are cystic masses, some maybe mixed in composition with predominantlysolid components. In some patients, such asthis one, a cyst is not seen on sonography, andthe term “solid papillary carcinoma” may beappropriate. Sonography may be useful forshowing wall thickening and adjacentanechoic and hyperechoic areas that may rep-resent hemorrhage resulting from rupturedcapillaries within the cyst wall or hemorrhagicinfarction of the tumor cells [4].Fine-needle aspiration and core needle bi-opsy may be unable to distinguish between insitu and invasive papillary lesions because thecenter of the lesion is often targeted, and in-vasion is often identified at the periphery ofthe tumor. Therefore, in general, excision issuggested when papillary lesions are sus-pected or diagnosed at fine-needle aspirationor core needle biopsy. At pathologic exami-nation, intracystic papillary carcinoma isusually a well-circumscribed mass with acystic component containing a nodular or apapillary inner surface. The most commonhistologic feature is arborization of the fi-brovascular stroma. A monotonous cell pop-ulation, the presence of mitoses, and thelack of myoepithelial cells confirm the diag-nosis of intracystic papillary carcinoma. Intracystic papillary carcinoma has a slowgrowth rate and an excellent prognosis. The10-year survival rate has been reported to be100% [5]. Segmental mastectomy is usuallyperformed, and axillary lymph node sampling(axillary lymph node dissection or sentinellymph node mapping) is suggested in patientsin whom invasion is likely.

The wire-guided excision of nonpalpable breast cancer often results in tumor resections with inadequate margins. This prospective, randomized trial was undertaken to investigate whether intraoperative ultrasound (US) guidance enables a better margin clearance than the wire-guided technique in the breast-conserving treatment of nonpalpable breast cancers.Patients with a preoperative histological diagnosis of nonpalpable breast cancer that could be visualized both with US and mammography were included. Patients were randomized to undergo either a wire-guided or a US-guided excision. Adequate margins were defined asor=1 mm.Of 49 included patients, 23 were assigned to undergo wire-guided excision and 26 to undergo US-guided excision. One patient crossed over to US-guided excision after inadvertent wire displacement. Mean tumor diameter, specimen weight, and operating time were similar in both groups. The excision was adequate in 24 (89%) of 27 US-guided excisions and 12 (55%) of 22 wire-guide excisions (P =.007).US-guided excision seems to be superior to wire-guided excision with respect to margin clearance of mammographically detected and US-visible nonpalpable breast cancers. Patients do not have to undergo the unpleasant wire placement before surgery.

Since 1997, the hydrophilic polyacrylamide gel (PAAG), an injectable alloplastic biomaterial, imported from the Ukraine has been used for augmentation mammaplasty in China. There were twelve patients with various complications visiting our hospitals after breast augmentation with injected hydrophilic polyacrylamide gel by other clinics, even though such procedures are not performed in our clinical practices. The complications included four cases of PAAG-induced multiple induration and lumps, and one with lactation, three cases of hematoma, two cases of inflammation (infection), and persistent mastodymia, unsatisfactory contour results and abnormal skin sensations in each case. All patients have been treated by removing the injected gel and giving antibiotics. Other procedures included replacement by silicon breast prostheses, mammotomy, and segmental mastectomy. We suggest that the injectable hydrophilic polyacrylamide gel be contraindications for breast augmentation in any young female who is not married, or without a child, with a tendency to hemorrhage, and with little mammary tissue. Some considerations to prevent and manage these complications are discussed.

combination in terms of rates of local control, distant recurrence, and overall survival. Materials/Methods: Women with stage I II (pT1-T2, pN0) TNBC are eligible after segmental mastectomy and axillary lymph node assessment. Weekly carboplatin (AUC Z 2.0) is delivered x 6 weeks with RT to the whole breast, delivered during weeks 2-4 via a 3D-CRT or an IMRT technique in the prone position. The whole breast receives 40.5 Gy in 15 fractions (Monday-Friday). The tumor bed receives an additional 3 Gy boost, delivered on 2 consecutive Sundays (beginning on the 2nd and 3rd weeks of RT). Consequently, a total of 46.5 Gy is delivered to the tumor bed in 17 fractions over 19 days. Adverse effects of treatment are assessed weekly during treatment, and once at 45-60 days, thereafter, using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Results: A total of 27 patients have accrued so far. The median age was 56 years (range: 27-82). Reported acute skin toxicities are displayed (see Table). With a median follow-up of 26 months all of the women remain alive and without recurrent disease. Conclusions: Adjuvant concurrent carboplatin and prone accelerated radiation therapy appears to be a safe and effective treatment for women diagnosed with early stage TNBC. Since approximately 50% of TNBC carriers recur within 2 years from treatment, it is encouraging that none of the patients in the trial have experience a recurrence. The trial remains open for patient accrual. Author Disclosure: E.B. Golden: None. R.E. Vatner: None. M. FentonKerimian: None. Y. Novik: None. R. Oratz: None. J. Speyer: None. S.C. Formenti: None.

For well-selected elderly women who undergo segmental mastectomy for early-stage, estrogen receptor-positive breast cancer, hormonal therapy alone is emerging as an acceptable adjuvant therapy option since the initial publication of Cancer and Leukemia Group B 9343 study in 2004 and update in 2013. The rate of adoption of adjuvant hormonal therapy alone in lieu of radiation therapy (RT) and its associated patterns of care is not known in the United States and was the subject of this study.We used the National Cancer Data Base to identify women aged ≥70 diagnosed with T1N0/T1Nx invasive breast cancer who underwent segmental mastectomy between 1998 and 2011. Because hormone receptor status was not specifically and reliably coded, only those who received hormonal therapy were included in this analysis. Univariate and multivariable exploratory analyses of factors associated with the use of RT were performed using SPSS, version 17.0.Of the 182,115 patients who met inclusion criteria, 97,530 (53.6%) patients underwent hormonal therapy and were included in the analysis. The RT utilization rate in this subset decreased with time from 84.9% in 1998 to 75.1% in 2011 (P.001). Multivariable analysis revealed that the factors associated with decreased use of RT include (in order of association): older age, later year of diagnosis, greater comorbidity score, low grade, lack of insurance, treatment at academic facility, race, rural location, lower median income, and distance from facility.This study assesses the patterns of care associated with the omission of RT in elderly women with early-stage breast cancer who received adjuvant hormonal therapy. Since the publication of major clinical trials, this strategy has been increasingly adopted. The strongest predictors of using this strategy included advanced patient age, high comorbidity score, and low-grade disease.

Purpose The purpose of our study was to evaluate the underestimation rate of atypical ductal hyperplasia (ADH) on vacuum-assisted breast biopsy (VABB), and to examine the correlation between residual microcalcifications and the underestimation rate of ADH. Methods A retrospective study was performed on 27 women (mean age, 49.2±9.2 years) who underwent additional excision for ADH via VABB for microcalcifications observed by using mammography. The mammographic findings, histopathologic diagnosis of all VABB and surgical specimens, and association of malignancy with residual microcalcifications were evaluated. The underestimation rate of ADH was also calculated. Results Of the 27 women with microcalcifications, nine were upgraded to ductal carcinoma in situ (DCIS); thus, the underestimation rate was 33.3% (9/27). There was no difference in age (p=0.40) and extent of microcalcifications (p=0.10) when comparing benign and malignant cases. Six of 17 patients (35.3%) with remaining calcifications after VABB were upgraded to DCIS, and three of 10 patients (30%) with no residual calcifications after VABB were upgraded (p=1.00). Conclusion The underestimation rate of ADH on VABB was 33.3%. Furthermore, 30% of patients with no remaining calcifications were upgraded to DCIS. Therefore, we conclude that all ADH cases diagnosed via VABB should be excised regardless of the presence of residual microcalcifications.

Purpose Several accelerated partial breast irradiation (APBI) techniques are being investigated in patients with early-stage breast cancer. The present study evaluated the feasibility, early toxicity, initial efficacy, and cosmetic outcomes of accelerated partial breast intensity-modulated radiotherapy (IMRT) for Chinese female patients with early-stage breast cancer after breast-conserving surgery. Methods A total of 38 patients met the inclusion criteria and an accelerated partial breast intensity-modulated radiotherapy (APBI-IMRT) plan was designed for each patient. The prescription dose was 34 Gy in 10 fractions, 3.4 Gy per fraction, twice a day, in intervals of more than 6 hours. Results Of the 38 patients, six patients did not meet the planning criteria. The remaining 32 patients received APBI-IMRT with a mean target volume conformity index of 0.67 and a dose homogeneity index of 1.06. The median follow-up time was 53 months and no local recurrence or distant metastasis was detected. The most common acute toxicities observed within 3 months after radiotherapy were erythema, breast edema, pigmentation, and pain in the irradiated location, among which 43.8%, 12.5%, 31.3%, and 28.1% were grade 1 toxicities, respectively. The most common late toxicities occurring after 3 months until the end of the follow-up period were breast edema, pigmentation, pain in the irradiated location, and subcutaneous fibrosis, among which 6.2%, 28.1%, 21.9%, and 37.5% were grade 1 toxicities, respectively. Thirty-one patients (96.8%) had fine or excellent cosmetic outcomes, and only one patient had a poor cosmetic outcome. Conclusion It is feasible for Chinese females to receive APBI-IMRT after breast conserving surgery. The radiotherapeutic toxicity is acceptable, and both the initial efficacy and cosmetic outcomes are good.

We aimed to determine predictive factors affecting cosmetic results after breast conserving management in breast cancer. Data on 96 patients with 97 breast cancer cases, who had been admitted to Uludag University M.A. Radiotherapy Center between October 1995 and December 1998 and managed with breast-conserving treatment, were analysed to determine the factors affecting cosmetic outcome. Possible factors affecting cosmesis were grouped as patient-related, tumor-related and treatment-related. Mann–Whitney U test was used in univariate analyses whereas logistic regression was used in multivariate analyses. Median follow-up time was 29.5 months ranging between 11 and 53 months and median age at admission was 50 (range 22–84). Cosmetic results were grouped in five categories; excellent; good; fair; poor and, very poor, using criteria, such as presence of fibrosis, telangiectasia, shape of breast, asymmetry, status of areola, pigmentation. Treated breasts were scored by the patients, three radiation oncologists and a breast surgeon independently. In the analysis performed using scores given by the patients, cases with scores 3 and above (unsatisfactory) were compared with cases with scores below 3 (satisfactory). Eighty-two patients (84%) considered cosmetic result as satisfactory (excellent/good) whereas 15 patients (16%) considered unsatisfactory (fair/poor/very poor). In univariate analysis using Mann–Whitney U test, type of surgery ( P =0.0655) was the statistically significant factors affecting cosmetic results. In multivariate analysis using logistic regression, tumor quadrant ( P =0.0060) and elapsed radiation therapy days ( P =0.0090) were the most significant factors. Median values were taken into consideration for the scores given by the physicians and cases with scores 3 and above (unsatisfactory) were compared with cases with scores below 3 (satisfactory). Eighty-two cases were evaluated as satisfactory (84%) whereas 15 cases were unsatisfactory (16%). In this set of data, patient age ( P =0.0144), menopausal status ( P =0.0111), institution which surgery was performed ( P =0.0045), type of surgery ( P =0.0044), placement of metallic clips ( P =0.0083) and skin fibrosis ( P =0.038) were found to be significant in univariate analysis using Mann-Whitney U test. In multivariate analysis using logistic regression, institution where surgery took place ( P =0.0015), menopausal status ( P =0.0087) and telangiectasia ( P =0.0657) were the most significant factors.

PURPOSE: To determine outcomes in local-regional control, disease-free survival, and overall survival in patients with locally advanced breast cancer (LABC) who present with ipsilateral supraclavicular metastases and who are treated with combined-modality therapy. PATIENTS AND METHODS: Seventy patients with regional stage IV LABC, which is defined by our institution as LABC with ipsilateral supraclavicular adenopathy without evidence of distant disease, received treatment on three prospective trials of neoadjuvant chemotherapy. All patients received neoadjuvant chemotherapy with cyclophosphamide, doxorubicin, and fluorouracil, or cyclophosphamide, doxorubicin, vincristine, and prednisone. Patients then received local therapy that consisted of either total mastectomy and axillary lymph node dissection (ALND) or segmental mastectomy and ALND before or after irradiation. Patients with no response to neoadjuvant chemotherapy were treated with surgery and/or radiotherapy. After completion of local therapy, chemotherapy was continued for four to 15 cycles, followed by radiotherapy. Patients older than 50 years who had estrogen receptor–positive tumors received tamoxifen for 5 years. RESULTS: Median follow-up was 11.6 years (range, 4.8 to 22.6 years). Disease-free survival rates at 5 and 10 years were 34% and 32%, respectively. The median disease-free survival was 1.9 years. Overall survival rates at 5 and 10 years were 41% and 31%, respectively. The median overall survival was 3.5 years. The overall response rate (partial and complete responses) to induction chemotherapy was 89%. No treatment-related deaths occurred. CONCLUSION: Patients with ipsilateral supraclavicular metastases but no other evidence of distant metastases warrant therapy administered with curative intent, ie, combined-modality therapy consisting of chemotherapy, surgery, and radiotherapy. Patients with ipsilateral supraclavicular metastases should be included in the stage IIIB category of the tumor-node-metastasis classification because their clinical course and prognosis are similar to those of patients with stage IIIB LABC.

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.

It takes 25,000 years for light from the Double Helix Nebula to reach Earth. Astronomers gazing on its spiral arms know that the place where it seems to be located is actually a place where it has already been. Fortunately for patients with cancer, whose lives are measured in shorter segments of the space-time continuum, progress in oncology occurs at a pace much quicker than that of transgalactic signaling. Nevertheless, waiting for the light to come into view can still require patience and time, and it just might be that the place in which we now find ourselves is a place we have seen before. We were led to our most recent viewpoint by Dr Bernard Fisher, whose National Surgical Adjuvant Breast and Bowel Project (NSABP) has performed landmark studies advancing treatment of breast cancer for more than five decades. Dr Fisher can be credited for much of the direction and clarity of this research effort; few organizations have been fortunate enough to have a single visionary at the helm for so long. Dr Fisher’s many accomplishments include the promotion of the scientific process and the randomized clinical trial to obtain answers to questions directly affecting clinical care. Outcomes of the NSABP trials have been evaluated as puzzle pieces, filling in a picture and contributing to his understanding of cancer biology. He has always been one of the first to advocate for redirection of scientific inquiry on the basis of this changing picture. Like the old axiom he once quoted—“that which is logical is apt not to be true, and that which is true often seems illogical”—he has made it clear that scientific reality is not always readily intuitive. At the scientific core of Dr Fisher’s work is his self-described alternative hypothesis, known to most of us as the systemic or Fisher hypothesis of breast cancer. In this model, breast cancer is considered a systemic disease at time of diagnosis, a condition requiring treatment of the entire patient rather than just the source organ. Ultimate manifestation of systemic (metastatic) disease is the result of tumor and patient heterogeneity and the complex interactions between them. This theory diverges dramatically from the Halsted hypothesis, the established paradigm of the preceding 100 or so years, named for the surgeon who performed the first radical mastectomy in 1882. Halsted and his disciples saw breast cancer as a disease spreading in an orderly and typically contiguous manner: from breast to lymph nodes and only then to distant metastatic sites. This concept supported the use of extensive local surgery (ie, radical mastectomy) to remove all contiguous regional disease; this was expected to yield the greatest cure rates. The Fisher hypothesis was formulated after the integration of years of laboratory and clinical investigations. The degree to which this paradigm shift was original and dramatic cannot be overstated. The NSABP B-04 study challenged Halstedian philosophy by comparing radical mastectomy (the standard treatment of the day) with simple mastectomy and regional irradiation and with simple mastectomy alone (ie, no treatment to the axillary lymph nodes). The lack of difference in disease-free and overall survival between the arms despite differences in regional recurrence exposed a major chink in the Halstedian armor. As Dr Fisher himself stated, “the B-04 findings supported our alternative hypothesis and corroborated our previous contention that variations in the treatment of locoregional disease were unlikely to affect survival.” The firm commitment of the NSABP to the model that local therapy and local disease control cannot affect survival outcomes (given the presumed presence of occult systemic disease) is evident in the design of the subsequent B-06 trial, which established breast conservation as a standard approach to early-stage breast cancer. This trial compared total mastectomy with segmental mastectomy with or without breast irradiation. Interestingly, according to the guidelines of that protocol, disease recurrence in the breast after breast-conserving surgery was treated with mastectomy and considered merely a “cosmetic failure;” recurrence in the breast was not even scored as an event affecting disease-free survival. Furthermore, for patients in the B-06 study experiencing ipsilateral breast tumor recurrence (IBTR), the protocol specified that other than salvage mastectomy, “no other therapy will be permitted without evidence of tumor elsewhere. This includes radiation therapy, systemic therapy such as chemotherapy, hormonal therapy, and castration.” Local recurrences were not considered potential sources of subsequent metastatic spread. There is now, however, a sizable body of evidence, much of it originating from within the NSABP itself, suggesting a need to reevaluate the Fisher hypothesis and consider bringing Halsted back into view. Data in this issue of Journal of Clinical Oncology reported by Anderson et al, taken together with numerous other analyses, reveal a constellation of provocative observations. A sampling of these include: ● Lumpectomy followed by breast irradiation, as compared with lumpectomy alone, was associated with a marginally significant decrease in deaths due to breast cancer (P .04),” as reported in the 20-year follow-up of the NSABP B-06 trial. ● The risk of distant disease for patients treated on the NSABP B-06 trial was 3.41 times greater in patients who developed IBTR than in patients who did not. JOURNAL OF CLINICAL ONCOLOGY E D I T O R I A L VOLUME 27 NUMBER 15 MAY 2

The role of adjuvant radiotherapy for sarcoma of the breast, based on local extension of disease and patterns of failure, remains undefined because of the rarity of the disease presentation.Fifty-nine cases of soft tissue sarcoma of the breast were retrospectively reviewed. Cystosarcoma phylloides was excluded from analysis. Surgical intervention consisted of segmental resection (n = 16) or mastectomy (n = 38); five patients underwent excisional biopsy. Adjuvant radiotherapy was administered in four patients following segmental resection and in 13 patients after mastectomy. Doses totaled 50 Gy in the majority of patients, and conventional criteria and radiotherapy techniques for adjuvant breast irradiation were used.None of the dissected axillary nodes contained metastatic tumor on pathologic review. Patterns of failure were evaluated. Tumor size (P0.03) and surgical margins (P0.002) were predictive of local failure (LF). Due to limited patient numbers, no statistical significance was identified with any treatment modality. Following mastectomy alone, LF occurred in 13 patients (34%) versus the 13% rate of LF with mastectomy and radiotherapy (P = NS). Distant metastases developed concurrently with the two local failures in the group that underwent mastectomy and radiation. After segmental mastectomy, LF occurred in 3 cases (25%) concurrent with distant metastases: no LF were noted after segmental mastectomy and radiation (P = 0.27). For all treatment groups, local recurrences were characterized as multiple and involved the chest wall. Local failure occurred in 60% of patients with positive surgical margins who did not receive adjuvant irradiation. Irrespective of surgical margins, over 75% of local recurrences developed among patients treated by surgery alone.The role of radiotherapy for breast sarcoma remains undefined due to the rarity of this disease presentation. This retrospective review failed to demonstrate a statistical benefit for the administration of adjuvant irradiation in sarcoma of the breast, probably because of limited patient numbers. Because large tumor size and positive surgical margins incur a higher risk for LF, radiotherapy is probably indicated in these cases. Axillary dissection obligates the radiotherapist to treat the axilla in order to include all tissues in the surgical bed, and should be avoided to reduce potential treatment related morbidity. Established therapeutic principles and techniques used for both soft tissue sarcoma and breast cancer should continue to be applied.

The operative treatment of primary breast cancer has changed. The radical mastectomy has been replaced by the modified radical mastectomy. Increasingly breast-conserving operations are being accepted as the standard of care. The logical culmination of the retreat from radical mastectomy is tumor extirpation without open surgical procedures. The biological rationale for this is the same rationale that resulted in the abandonment of en bloc tumor resection in favor of breast preservation. Recent& technology permits highly accurate tissue sampling of non-palpable mammographically imaged densities. An unanticipated observation associated with the use of stereotactic core biopsy was the complete removal of tumors up to 1.2 centimeters in diameter.