Routine Use of a Standardized Mastectomy Diagram by Surgeons Improves Accuracy and Timeliness of the Final Pathological Report.

BACKGROUND: Accurate and timely assessment of pathology specimens is critical for patient care and oncologic management. This study aimed to determine whether a standardized mastectomy diagram would facilitate communication among surgeons and pathologists and improve pathologic processing. METHODS: A prospective quality improvement study was conducted over a continuous 12-month period. During the first 6 months, usual pathologic processing of mastectomy specimens was performed per standard department protocol. In the second 6 months, a standardized mastectomy diagram was completed at the time of surgery, noting the location and preoperative pathologic diagnosis of all benign and malignant lesions. An analysis of covariance was used to compare the number of breast lesions identified and the number of days between specimen receipt and the date of the final pathology report between each group. RESULTS: Time from specimen receipt to final pathologic report decreased from a mean (± SE) of 8.3 ± 0.7 days in the usual processing group to 6.1 ± 0.6 days with the use of the standardized mastectomy diagram, for a between-group difference of 2.1 days (95% confidence interval [CI] 0.3-4.0; p = 0.02). The number of lesions identified increased from 1.8 ± 0.2 to 2.6 ± 0.2, for a between-group difference of 0.8 (95% CI 0.1-1.5; p = 0.02). CONCLUSION: A standardized mastectomy diagram completed at the time of surgery improves the quality of pathologic processing. The diagram, which serves as a mastectomy lesion map, assists lesion localization, enhances accuracy, and reduces time to final pathology report.

ACR Appropriateness Criteria® Imaging of Deep Inferior Epigastric Arteries for Surgical Planning (Breast Reconstruction Surgery): 2022 Update.

Breast cancer is the most common malignancy in women in the United States, with surgical options including lumpectomy and mastectomy followed by breast reconstruction. Deep inferior epigastric perforator (DIEP) flap is a muscle-sparing perforator free flap breast reconstruction technique, which uses the deep inferior epigastric artery (DIEA) perforators to create a vascular pedicle. Multiple perforators are identified by preoperative imaging, which are typically ranked based on size, location, and intramuscular course. The goal of preoperative imaging is to aid the surgical team in preoperative planning given the variability of the DIEA perforator branches anatomy between patients. The objective of this document is to review the imaging modalities that can be used preoperatively to identify the optimal perforator and thereby reduce intraoperative complications, reduce postoperative complications, and improve clinical outcomes. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision process support the systematic analysis of the medical literature from peer reviewed journals. Established methodology principles such as Grading of Recommendations Assessment, Development, and Evaluation or GRADE are adapted to evaluate the evidence. The RAND/UCLA Appropriateness Method User Manual provides the methodology to determine the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances in which peer reviewed literature is lacking or equivocal, experts may be the primary evidentiary source available to formulate a recommendation.

ACR Appropriateness Criteria® Imaging After Mastectomy and Breast Reconstruction.

Mastectomy may be performed to treat breast cancer or as a prophylactic approach in women with a high risk of developing breast cancer. In addition, mastectomies may be performed with or without reconstruction. Reconstruction approaches differ and may be autologous, involving a transfer of tissue (skin, subcutaneous fat, and muscle) from other parts of the body to the chest wall. Reconstruction may also involve implants. Implant reconstruction may occur as a single procedure or as multistep procedures with initial use of an adjustable tissue expander allowing the mastectomy tissues to be stretched without compromising blood supply. Ultimately, a full-volume implant will be placed. Reconstructions with a combination of autologous and implant reconstruction may also be performed. Other techniques such as autologous fat grafting may be used to refine both implant and flap-based reconstruction. This review of imaging in the setting of mastectomy with or without reconstruction summarizes the literature and makes recommendations based on available evidence. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

Long-Term Update of NRG Oncology RTOG 0319: A Phase 1 and 2 Trial to Evaluate 3-Dimensional Conformal Radiation Therapy Confined to the Region of the Lumpectomy Cavity for Stage I and II Breast Carcinoma.

PURPOSE: NRG Oncology RTOG 0319 was the first cooperative group trial in the United States to evaluate 3-dimensional conformal radiation therapy (3D-CRT) accelerated partial breast irradiation (APBI). This report updates secondary endpoints of toxicity and efficacy. METHODS AND MATERIALS: Patients with stage I or II invasive breast cancer (tumor size ≤3 cm, ≤3 positive lymph nodes, negative margins) were eligible for 3D-CRT APBI: 38.5 Gy in 10 twice-daily fractions. Patient characteristics and treatment details have previously been reported. Adverse events were graded with CTCAE v3.0 (National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0). This analysis updates the rates of ipsilateral breast recurrence (IBR), contralateral breast recurrence, ipsilateral node recurrence (INR), metastatic sites (distant metastases [DM]), mastectomy, disease-free survival, mastectomy-free survival, and overall survival. RESULTS: Of 58 enrolled patients, 52 were eligible, with a median age of 61 years; 94% had stage I cancer and 83% had estrogen receptor positive disease. The median follow-up period was 8 years (minimum-maximum, 1.7-9.0 years). The 7-year estimate of isolated IBR (no DM) was 5.9%. The 7-year estimates of all IBRs, INR, mastectomy rate, and DM were 7.7%, 5.8%, 7.7%, and 7.7%, respectively. All 4 IBRs were invasive, of which 3 had a component within the planning target volume. The patterns of failure were as follows: 3 IBRs, 1 INR, 2 DM, 1 INR plus DM, and 1 IBR plus INR plus DM. The 7-year estimates of mastectomy-free survival, disease-free survival, and overall survival were 71.2%, 71.2%, and 78.8%, respectively. Thirteen patients died: 3 of breast cancer and 10 of other causes. Grade 3 (G3) treatment-related adverse events were reported by 4 patients (7.7%). No G3 pain or pulmonary or cardiac toxicities were reported. CONCLUSIONS: This phase 1 and 2 trial of 3D-CRT APBI continues to show durable tumor control and minimal G3 toxicity, comparable to other APBI techniques. Mature phase 3 results will determine the appropriateness and limitations of this noninvasive APBI technique.

Late toxicity and patient self-assessment of breast appearance/satisfaction on RTOG 0319: a phase 2 trial of 3-dimensional conformal radiation therapy-accelerated partial breast irradiation following lumpectomy for stages I and II breast cancer.

PURPOSE: Late toxicities and cosmetic analyses of patients treated with accelerated partial breast irradiation (APBI) on RTOG 0319 are presented. METHODS AND MATERIALS: Patients with stages I to II breast cancer ≤3 cm, negative margins, and ≤3 positive nodes were eligible. Patients received three-dimensional conformal external beam radiation therapy (3D-CRT; 38.5 Gy in 10 fractions twice daily over 5 days). Toxicity and cosmesis were assessed by the patient (P), the radiation oncologist (RO), and the surgical oncologist (SO) at 3, 6, and 12 months from the completion of treatment and then annually. National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0, was used to grade toxicity. RESULTS: Fifty-two patients were evaluable. Median follow-up was 5.3 years (range, 1.7-6.4 years). Eighty-two percent of patients rated their cosmesis as good/excellent at 1 year, with rates of 64% at 3 years. At 3 years, 31 patients were satisfied with the treatment, 5 were not satisfied but would choose 3D-CRT again, and none would choose standard radiation therapy. The worst adverse event (AE) per patient reported as definitely, probably, or possibly related to radiation therapy was 36.5% grade 1, 50% grade 2, and 5.8% grade 3 events. Grade 3 AEs were all skin or musculoskeletal-related. Treatment-related factors were evaluated to potentially establish an association with observed toxicity. Surgical bed volume, target volume, the number of beams used, and the use of bolus were not associated with late cosmesis. CONCLUSIONS: Most patients enrolled in RTOG 0319 were satisfied with their treatment, and all would choose to have the 3D-CRT APBI again.

Initial efficacy results of RTOG 0319: three-dimensional conformal radiation therapy (3D-CRT) confined to the region of the lumpectomy cavity for stage I/ II breast carcinoma.

PURPOSE: This prospective study (Radiation Therapy Oncology Group 0319) examines the use of three-dimensional conformal external beam radiotherapy (3D-CRT) to deliver accelerated partial breast irradiation (APBI). Initial data on efficacy and toxicity are presented. METHODS AND MATERIALS: Patients with Stage I or II breast cancer with lesions < or =3 cm, negative margins and with < or =3 positive nodes were eligible. The 3D-CRT was 38.5 Gy in 3.85 Gy/fraction delivered 2x/day. Ipsilateral breast, ipsilateral nodal, contralateral breast, and distant failure (IBF, INF, CBF, DF) were estimated using the cumulative incidence method. Mastectomy-free, disease-free, and overall survival (MFS, DFS, OS) were recorded. The National Cancer Institute Common Terminology Criteria for Adverse Events, version 3, was used to grade acute and late toxicity. RESULTS: Fifty-eight patients were entered and 52 patients are eligible and evaluable for efficacy. The median age of patients was 61 years with the following characteristics: 46% tumor size <1 cm; 87% invasive ductal histology; 94% American Joint Committee on Cancer Stage I; 65% postmenopausal; 83% no chemotherapy; and 71% with no hormone therapy. Median follow-up is 4.5 years (1.7-4.8). Four-year estimates (95% CI) of efficacy are: IBF 6% (0-12%) [4% within field (0-9%)]; INF 2% (0-6%); CBF 0%; DF 8% (0-15%); MFS 90% (78-96%); DFS 84% (71-92%); and OS 96% (85-99%). Only two (4%) Grade 3 toxicities were observed. CONCLUSIONS: Initial efficacy and toxicity using 3D-CRT to deliver APBI appears comparable to other experiences with similar follow-up. However, additional patients, further follow-up, and mature Phase III data are needed to evaluate the extent of application, limitations, and value of this particular form of APBI.

A phase I/II trial to evaluate three-dimensional conformal radiation therapy confined to the region of the lumpectomy cavity for Stage I/II breast carcinoma: initial report of feasibility and reproducibility of Radiation Therapy Oncology Group (RTOG) Study 0319.

BACKGROUND: This prospective study (Radiation Therapy Oncology Group Study 0319) examines the use of three-dimensional conformal external beam radiation therapy to deliver accelerated partial breast irradiation. Reproducibility, as measured by technical feasibility, was the primary end point with the goal of demonstrating whether the technique is widely applicable in a multicenter setting before a Phase III trial is undertaken. METHODS AND MATERIALS: This study was designed such that if fewer than 5 cases out of the first 42 patients evaluable were scored as unacceptable, the treatment would be considered reproducible. Patients received 38.5 Gy in 3.85 Gy/fraction delivered twice daily. The clinical target volume included the lumpectomy cavity plus a 10-15-mm margin bounded by 5 mm within the skin surface and the lung-chest wall interface. The planning target volume (PTV) included the clinical target volume plus a 10-mm margin. Treatment plans were judged as follows: (1) No variations (total coverage), 95% isodose surface covers 100% of the PTV and all specified critical normal tissue dose-volume histogram (DVH) limits met. (2) Minor variation (marginal coverage), 95% isodose surface covers between > or = 95% and <100% of the PTV. No portion of PTV receives <93% of prescription (isocenter) dose. All specified critical normal tissue DVH limits fall within 5% of the guidelines. (3) Major variation (miss), 95% isodose surface covers <95% of the PTV. Portion of PTV receives <93% of prescription isocenter dose. Any critical normal tissue DVH limit exceeds 5% of the specified value. RESULTS: A total of 58 patients were enrolled on this study between 8/15/03 and 4/30/04, 5 of whom were ineligible or did not receive protocol treatment. Two additional patients were excluded, one because the on-study form was not submitted, and the other because no treatment planning material was submitted. This primary end point analysis is based on the first 42 (out of 51) evaluable patients, which were accrued from 17 different institutions (31 centers were credentialed for case enrollment, but because of rapid accrual, not all centers were able to submit cases before trial closure). These 42 patients had the following characteristics: median age was 61 years; 48% had a maximum tumor dimension of <1 cm; 86% had invasive ductal carcinoma; 64% were postmenopausal; the location of tumor was upper outer for 40% and upper central for 21%; 79% had no chemotherapy, and 64% had no hormonal therapy. There were 4 cases with major variations (all 4 related to normal tissue DVHs exceeding 5% of the specified limit). A total of 32 cases with minor variations in treatment plans were detected (16 related to normal tissue DVHs exceeding the specified limits [by < or = 5%], 6 related to suboptimal coverage of the PTV, and 10 related to both). There were 6 cases with no variations. Of the 51 total evaluable patients, 1 additional major variation was noted (PTV receiving <93% of the prescription dose). An additional 5 cases with minor variations in treatment plans were detected (3 related to normal tissue DVHs exceeding the specified limits [by < or = 5%], 1 related to suboptimal coverage of the PTV, and 1 related to both). There were 3 more cases with no variations. CONCLUSION: Accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy was shown in this preliminary analysis of the first 42 evaluable patients to be technically feasible and reproducible in a multi-institutional trial using exceptionally strict dosimetric criteria.

Use of pathologic factors to assist in establishing adequacy of excision before radiotherapy in patients treated with breast-conserving therapy.

BACKGROUND: We reviewed our experience in patients with early-stage breast carcinoma treated with breast-conserving therapy (BCT) to identify pathologic factors useful in defining the adequacy of excision before radiotherapy (RT). METHODS AND MATERIALS: All slides from 607 consecutively treated cases of Stage I-II breast carcinoma were reviewed by one pathologist. Numerous pathologic factors were evaluated for their association with ipsilateral breast failure (IBF). Margin distance was classified as negative, near (<0.50 low-power field), or positive. The amount of carcinoma near the final margin was measured as the width of invasive carcinoma and number of ducts with carcinoma in situ near the margin and divided into three groups: near-least, near-intermediate, and near-greatest amount. The median follow-up was 8.5 years. RESULTS: Patients with negative, near-least, near-intermediate, and near-greatest amount of carcinoma near the margin, and positive final margins had a 12-year IBF rate of 9%, 6%, 18%, 24%, and 30%, respectively. On multivariate analysis, only the amount of carcinoma near the margin was independently associated with IBF (p <0.001). To help explain these observations, 441 initial and reexcision specimens were examined. The amount of carcinoma near the initial margin and the invasive carcinoma/specimen maximal dimension ratio were significantly associated with greater amounts of residual carcinoma in adjacent breast parenchyma. CONCLUSION: The amount of carcinoma near the margin, in addition to margin status, appears to be directly related to an increased risk of IBF in patients treated with BCT. Pathologic factors that incorporate the amount of excised breast parenchyma and amount of carcinoma near the margin may be useful to clinicians in deciding whether a patient has undergone adequate excision for BCT.

Changes in management techniques and patterns of disease recurrence over time in patients with breast carcinoma treated with breast-conserving therapy at a single institution.

BACKGROUND: The authors reviewed changes in the initial clinical presentation, management techniques, and patterns of disease recurrence over time (1981-1996) in patients with breast carcinoma treated with breast-conserving therapy (BCT) at a single institution. The goals of the current study were to determine the frequency and use of optimal local and systemic therapy techniques and to evaluate the impact of these changes on treatment efficacy. METHODS: Six hundred seven patients with American Joint Committee on Cancer Stage I or II invasive breast carcinomas treated with BCT at William Beaumont Hospital (Royal Oak, MI) constituted the study population. All patients received at least an excisional biopsy of the primary tumor, an axillary lymph node staging procedure, and postoperative radiotherapy (RT) (a median tumor bed dose of 61 Gray [Gy] was administered). All sides were reviewed by one pathologist. Numerous clinicopathologic and treatment-related factors were analyzed to monitor changes that occurred over time. Changes in patterns of disease recurrence and treatment efficacy over time also were analyzed. RESULTS: Over the time period analyzed, changes at initial presentation included an increase in the mean age at diagnosis (age 56.1 years vs. 61.4 years; P < 0.001), a decrease in the number of patients with clinically palpable tumors (78% vs. 36%; P < 0.001), a decrease in the mean tumor size (2.2 cm vs. 1.6 cm; P < 0.001), but no change in the percentage of patients with negative lymph nodes (79% vs. 78%; P = 0.83). No differences over time were observed in mean tumor grade (2.0 vs. 1.9; P = 0.2) or the presence of angiolymphatic invasion (27% vs. 26%; P = 0.25). Changes in surgical management and pathologic assessment included the more frequent use of reexcision (46% vs. 81%; P < 0.001), larger mean total volumes of breast tissue specimens excised (115 cm3 vs. 189 cm3; P = 0.001), a larger percentage of patients with final negative surgical margins (74% vs. 97%; P < 0.001), and a small increase in the mean number of lymph nodes excised (13.8 lymph nodes vs. 14.1 lymph nodes; P = 0.01). The only other significant change in the pathologic management of patients over time included a doubling in the mean number of slides examined (10.6 slides vs. 21.1 slides; P < 0.001). Changes in adjuvant local and systemic therapy included an increase in the percentage of patients treated with > 60 Gy to the tumor bed (66% vs. 95%; P < 0.001), a doubling in the mean number of days from the last surgery to the start of RT (24 days vs. 50 days; P < 0.001), and a decrease in the use of regional lymph node RT (24% vs. 8%; P < 0.001). The use of adjuvant tamoxifen increased from 10% to 61% (P < 0.001). Finally, improvements were observed in the 5-year and 12-year actuarial rates of local disease recurrence (8% vs. 1% and 21% vs. 9%, respectively; P = 0.001) and distant metastases (12% vs. 4% and 22% vs. 9%, respectively; P = 0.006). No changes in the mean number of years to ipsilateral (6.5 years vs. 6.4 years; P = 0.59) or distant disease recurrence (4.6 years vs. 3.8 years; P = 0.73) were observed. CONCLUSIONS: The impact of screening mammography and substantial changes in surgical, pathologic, RT, and systemic therapy recommendations were observed over time in the study population. These changes were associated with improvements in 5-year and 12-year local and distant control rates and suggested that improvements in outcome can be realized through adherence to best practice guidelines and continuous monitoring of treatment outcome data.

Lobular carcinoma in situ and invasive cancer: the contralateral breast controversy.

We determined if the risk of relapse is increased in patients with the concomitant diagnosis of lobular carcinoma in situ (LCIS) and an invasive cancer, suggesting the need for a more aggressive surgical approach. A retrospective chart review was conducted from the University of Michigan's Cancer Registry of patients with LCIS and a simultaneous invasive cancer and patients with invasive cancer only diagnosed between 1981 and 1997. The two groups were compared statistically with the following variables: age at diagnosis, tumor stage, histopathologic type of cancer, type of surgery, first line of treatment, relapse status with dates, site of relapse, and vital status. Statistically significant differences were found in the distribution of age (mean p = 0.0484 and median p = 0.0216), and histopathologic type of cancer (p < 0.0001). No significant difference was noted in the overall survival between the two groups (p = 0.511). There was also a significant difference in the relapse-free survival curves between the groups (p = 0.032). The risk of relapse was almost double (1.92) for the cancer-only patients relative to patients with LCIS as a histologic component of cancer. There was no significant increase in contralateral or ipsilateral breast recurrence for patients with LCIS and an invasive cancer compared to an invasive cancer alone. This lends support to the use of breast conservation therapy for invasive cancer patients with a histologic component of LCIS. The significant difference in the types of cancer may support the theory of genetic progression of LCIS to cancer, but clearly further data are required to prove this hypothesis.

Mammographic screening of TRAM flap breast reconstructions for detection of nonpalpable recurrent cancer.

PURPOSE: To evaluate findings from routine mammographic screenings in patients with transverse rectus abdominis musculocutaneous (TRAM) flap reconstructions. MATERIALS AND METHODS: During a 25-month study period, 214 consecutive screening mammograms in 113 asymptomatic women (mean age, 51 years) with TRAM flap reconstructions were obtained. Mastectomies were performed for cancer in 106 (94%) of the 113 women and for prophylaxis in seven (6%). Prospectively, a Breast Imaging Reporting and Data System (BI-RADS) assessment category 1-5 was assigned to each mammogram. Surgical, medical, pathologic, and radiographic records were retrospectively reviewed. CIs were determined by the normal approximation to the binomial distribution. RESULTS: Seven (3%) of 214 examinations were BI-RADS category 4 or 5. Six (86%) of seven patients underwent biopsy. Two (33%) of these six biopsies demonstrated invasive ductal carcinoma. Cancer detection rate for mammography was 1.9% (two of 106) (95% CI: 0.33%, 7.32%) for women with reconstruction for breast cancer during the 2-year period. One (6%) of 16 BI-RADS category 3 examinations later proved to be invasive ductal carcinoma at follow-up. No interval cancer was discovered in 171 cases of BI-RADS category 1 or 2 examinations with 1-year follow-up. No cancers occurred in women who underwent prophylactic mastectomy. A biopsy positive predictive value of 33% (95% CI: 6%, 76%) was observed. CONCLUSION: Screening mammography of TRAM flap-reconstructed breasts enables detection of nonpalpable cancer before clinical examination.