Search

Background: Breast cancer related lymphedema (BCRL) represents a dreaded complication of breast cancer treatment that can lead to morbidity, diminished quality of life, and psychosocial harm and is associated with increased costs. Increasingly, data has supported the concept of prospective BCRL surveillance coupled with early intervention to mitigate these effects. Methods: We performed a systematic review of the literature searching for published randomized and prospective data evaluating prospective BCRL surveillance with early intervention. Results: We identified 12 studies (2,907 patients) including 4 randomized trials (1,203 patients) and 8 prospective studies (1,704 patients). Randomized data consistently demonstrate that early intervention reduces rates of progression to chronic BCRL with multiple paradigms and diagnostic modalities utilized; the strongest data in the review comes from the randomized PREVENT trial which demonstrated early detection with bioimpedance spectroscopy (BIS), coupled with a compression garment applied for 12 hours a day over 4 weeks, significantly reduced the rate of chronic BCRL compared to tape measurement. Conclusions: Current data support the role of prospective BCRL surveillance with early detection and intervention to reduce rates of chronic BCRL. Breast cancer patients at risk for BCRL should undergo prospective surveillance as part of survivorship. Given the level 1 data demonstrating that BIS is superior to conventional tape measure, it should be included as the standard BCRL diagnostic modality unless an equally effective modality is employed. Citation Format: Pat Whitworth, Frank Vicini, Stephanie Valente, Kirstyn Brownson, Beth Dupree, Manpreet Kohli, Laura Lawson, Chirag Shah. Reducing Rates of Chronic Breast Cancer Related Lymphedema with Screening & Early Intervention: An Update of Recent Data [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P5-08-15.

Background Breast-conserving surgery is a critical step in treatment with the goal of removing all cancer cells while minimizing the removal of healthy tissue. 15% to 25% of lumpectomy patients have positive margins and require a second surgery to achieve negative margins and reduce the risk of local recurrences. These positive margins are poorly predictive (35% PPV) of cancer left in the cavity, so most second surgeries find no residual cancer. Better detection tools are needed to guide in real-time the removal of cancer missed during the initial lumpectomy to reduce the number of second operations. The pegulicianine imaging agent is injected intravenously before surgery and its fluorescence signal is activated by proteases in tumor cells and cells at the tumor margin. The LUM Imaging System visualizes activated pegulicianine in the lumpectomy cavity via a hand-held detector and proprietary tumor detection software. This system was previously tested in multiple single-site studies and a prospective multi-site study that enrolled 234 patients and showed good ability to detect residual cancer in the lumpectomy cavity. Trial Design and Specific Aims: The current prospective, multi-center, randomized, blinded study was designed to show the clinical efficacy, system accuracy, and safety of the LUM Imaging System. It aims to demonstrate guided removal of residual cancer in the lumpectomy missed during the initial procedure and potentially reduce the rates of positive margins. This study is powered by an event-driven design that requires 70 truth-standard positive events. It is expected that approximately 390 women at fourteen medical centers across the US will be enrolled to achieve the number of events. Pegulicianine is injected 2-6 hours prior to the lumpectomy procedure. Surgeons perform standard of care (SOC) lumpectomy followed by blinded intraoperative imaging of the lumpectomy cavity with the LUM Imaging System in regions where SOC shaves will be taken. The patient is then randomized. If the random assignment is to the device arm, the surgeon is directed to excise margins that have positive LUM signal. Pathologists are blinded to the source of tissue removed (SOC vs. LUM) when conducting the pathology assessment. The amount of additional tissue volume resected is also evaluated. Patient reported outcome data is collected as a quality-of-life survey before and after the subject’s lumpectomy.Eligibility Criteria: This study seeks to enroll women with primary invasive breast cancer (IBC), ductal carcinoma in situ (DCIS) or a combination of IBC/DCIS undergoing a lumpectomy for their breast malignancy. Patients must not have a history of allergic reaction to polyethylene glycol, contrast agents, or have received neoadjuvant therapy to treat their current breast cancer. Use of blue dyes before imaging with the LUM System are not allowed. Additional detailed eligibility criteria are listed in the protocol. Accrual and Study Progress To date, 350 subjects have participated in this trial. This study is funded in part by the National Cancer Institute (5R44CA211013). This trial is registered as NCT03686215. Citation Format: Jorge Ferrer, David Carr, Peter Blumencranz, Irene Wapnir, Donna Dyess, Shelly Hwang, Nayana Dekhne, Daleela Dodge, Beth-Ann Lesnikoski, Kelly Hunt, Patricia Clark, Stephanie Valente, Marie Catherine Lee, Lynne Clark, Brian Schlossberg, Sean Madden, Alejandra Rodriguez, Kate Smith, Manna Chang, Barbara Smith. Pivotal study of the Lum imaging system for assisting intraoperative detection of residual cancer in the tumor bed of female patients with breast cancer: The INCITE trial [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT2-12-03.

Introduction:Inflammatory breast cancer (IBC) is a rare and aggressive malignancy with a 5-year relapse free survival (RFS) previously reported to be approximately 40%. Standard treatment is tri-modality therapy consisting of neoadjuvant chemotherapy, surgery, and post-mastectomy radiation therapy. Certain systemic therapy recommendations for IBC are based on historical standards (such as use of anthracyclines for HER2+ breast cancer) that may no longer be favored in the real-world setting. Similarly, modified radical mastectomy without reconstruction has traditionally been the operation of choice for patients with IBC due to fears of margin positivity, risk of local recurrence, and the need for timely radiation. Studies have shown that reconstruction in breast cancer patients is associated with improved quality of life. Recognizing this benefit, the role of reconstruction in the setting of IBC is evolving. The purpose of this study is to characterize response to modern neoadjuvant chemotherapy, utilization of reconstruction, and survival outcomes for patients with IBC treated at our institution.Methods:A review of the Cleveland Clinic tumor registry was performed to identify patients with IBC between 2006-2019 who completed all 3 treatment modalities. Patient demographics, disease characteristics, treatment details, recurrence details, and date of last follow-up/death were recorded. Estimates of local and distal recurrence and RFS were created using Kaplan-Meier estimates. Results:A total of 68 patients with IBC were identified. Median duration of follow-up was 1.83 years (0.85-6.82) and median age was 55. Cases included 19 ER-/HER2-, 17 ER-/HER2+, 21 ER+/HER2-, and 11 ER+/HER2+. Pathologic complete response (pCR) was achieved in 27.9% of all patients with results by subtype as follows: ER-/HER2- 21.6%, ER-/HER2+ 41.2%, ER+/HER2- 19.0% and ER+/HER2+ 18.2%. The most common chemotherapy received by patients was AC-Taxol (52.9%). For HER2+ patients, 50% received AC-Taxol and 50% received non-anthracycline based chemotherapy. RFS was similar for ER+/HER2-, ER+/HER2+ and ER-/HER2+ patients, while ER-/HER2- patients had numerically worse RFS (58-65% vs 28% at 5 years) although this was not statistically significant (p=0.06). RFS was significantly better in patients who achieved pCR compared to those who had partial or no response to chemotherapy, regardless of biologic subtype (p=0.038).17 patients (24.3%) had immediate reconstruction (IR), 7 (10.0%) had delayed reconstruction (DR, >1 year after initial treatment) and46 patients (65.7%) had no reconstruction (NR). The 5 year RFS for IR and NR was similar (52% vs 47%, respectively, p=0.5) although surgical complication rates were higher in the IR group (35.3% vs 6.3%, respectively, p= 0.012).Conclusion:With modern approach to treatment, patients with ER+/HER2+ breast cancer have encouraging survival outcomes compared to historical standards. Patients with ER-/HER2- IBC continue to have poor outcomes and are a group of patients in need of better systemic therapy options. In this cohort, patients who underwent IR did not see an appreciable difference in RFS compared to their non-reconstructed counterparts. Patients should have consultation with plastic surgery as initial surgical management is being discussed if reconstruction is desired. These data may be helpful in counseling patients on anticipated complications of surgery with reconstruction. Citation Format: Jennifer Tran, Stephanie Valente, Chao Tu, Megan Kruse. Management trends and outcomes assessment for inflammatory breast cancer [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P1-24-07.

Purpose Breast cancer-related lymphedema (BCRL) represents a significant concern for patients following breast cancer treatment, and assessment for BCRL represents a key component of survivorship efforts. Growing data has demonstrated the benefits of early detection and treatment of BCRL. Traditional diagnostic modalities are less able to detect reversible subclinical BCRL while newer techniques such as bioimpedance spectroscopy (BIS) have shown the ability to detect subclinical BCRL, allowing for early intervention and low rates of chronic BCRL with level I evidence. We present updated clinical practice guidelines for BIS utilization to assess for BCRL. Methods and Results Review of the literature identified a randomized controlled trial and other published data which form the basis for the recommendations made. The final results of the PREVENT trial, with 3-year follow-up, demonstrated an absolute reduction of 11.3% and relative reduction of 59% in chronic BCRL (through utilization of compression garment therapy) with BIS as compared to tape measurement. This is in keeping with real-world data demonstrating the effectiveness of BIS in a prospective surveillance model. For optimal outcomes patients should receive an initial pre-treatment measurement and subsequently be followed at a minimum quarterly for first 3 years then biannually for years 4–5, then annually as appropriate, consistent with previous guidelines; the target for intervention has been changed from a change in L-Dex of 10 to 6.5. The lack of pre-operative measure does not preclude inclusion in the prospective surveillance model of care. Conclusion The updated clinical practice guidelines present a standardized approach for a prospective model of care using BIS for BCRL assessment and supported by evidence from a randomized controlled trial as well as real-world data.

Background: Standard surgical techniques result in positive lumpectomy margins 20-40% of the time. These positive margins require surgical re-excision which places significant burden on the healthcare system and patients. The LUM Imaging System consists of a fluorescence-based imaging agent, a hand-held wide-field detector (LUM Imaging Device) used to image the surgical cavity walls intraoperatively in real-time after the resection of the main lumpectomy specimen, and a proprietary tumor detection algorithm that highlights regions in the tumor bed suspected to contain residual cancer. This imaging system was previously tested in a single-site clinical study. The current study is evaluating the imaging system in a multi-study, large patient cohort. Trial Design / Methods This trial (NCT03321929) is a non-randomized, open-label, multi-site trial designed to further refine the tumor detection algorithm utilized by the LUM Imaging System. This is a prospective, interventional feasibility study and is a pilot arm to a pivotal study which will evaluate the safety and efficacy of the LUM Imaging System. Up to 250 adult female breast cancer patients undergoing lumpectomies are being enrolled at sixteen medical centers across the US. LUM015, a fluorescence-based imaging agent, is injected prior to the subject’s lumpectomy procedure. Surgeons perform their standard of care lumpectomy followed by intraoperative imaging of the lumpectomy cavity with the LUM Imaging System. Specific Aims The primary objective is to assess performance characteristics of the LUM Imaging System and to refine the tumor detection algorithm. A secondary objective is to develop and refine the process of implementing the LUM Imaging System into institution-specific workflows during lumpectomies. Eligibility Criteria This study seeks to enroll women, over the age of 18 and with histologically or cytologically confirmed primary invasive breast cancer (IBC), ductal carcinoma in situ (DCIS) or a combination of IBC/DCIS undergoing a lumpectomy for their breast malignancy. In addition to be willing to follow study procedures, participating in an informed consent discussion, signing an informed consent form, and having baseline lab and screening values within protocol limits, enrolled subjects must meet the following key exclusion criteria: have no history of allergic reaction to polyethylene glycol, no history of allergic reaction to intravenous contrast agents, have not undergone any systemic therapies to treat their cancer, and will not be administered methylene blue or other dye for sentinel lymph node detection during their lumpectomy. Additional detailed eligibility criteria are listed in the protocol. Statistical Methods For categorical variables, summary tabulations of the number and percentage of patients within each category (with a category for missing data) of the parameter will be presented. For continuous variables, the number of patients, mean, median, standard deviation, minimum, and maximum values will be presented. The secondary objective will be met by evaluating a robust training and proficiency protocol for all enrolling institutions. Accrual To date, 208 subjects have participated in this LUM Imaging System trial. Contact Information Jorge Ferrer: jmferrer@lumicell.com Kate Smith: kate@lumicell.com Citation Format: Kate Smith, Jorge Ferrer, David Carr, Peter Blumencranz, Daleela Dodge, Nayana Dekhne, Irene Wapnir, Kelly Hunt, Linsey Gold, Stephanie Valente, Peter Beitsch, Donna Dyess, Shelly Hwang, Lynne Clark, Beth-Ann Lesnikoski, Anees Chagpar, Stephen Karp, Brian Schlossberg, Livia Gjylameti, Barbara Smith. Expansion into multiple institutions for training in the use of the LUM Imaging System for intraoperative detection of residual cancer in the tumor bed of female subjects with breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT3-06-02.

Purpose: This study aimed to delineate postoperative complications following lumpectomy and mastectomy in women with pregnancy associated breast cancer (PABC).Methods: This is a single institution retrospective study of 74 patients with PABC treated with lumpectomy (n=28) or mastectomy (n=46). Patient demographics, presentation, tumor characteristics, staging, genetic testing, and postoperative complications were recorded. Results: PABC was diagnosed in 74 patients; 28 (37.8%) were diagnosed with PABC during pregnancy (PABC-P) and 46 patients (62.2%) were diagnosed with postpartum PABC within the first 12 months after delivery (PABC-PP). The overall clinical stage distribution at diagnosis was: Stage 0, 6.9%; I, 18.1%; II, 47.2%; III, 22.2%; and IV, 5.6%, with no significant difference between PABC-P and PABC-PP (p=0.18). There was no significant difference in the rate of lumpectomy (25.0% vs 23.9%, p=0.92), mastectomy (75.0% vs 76.1%, p=0.92), sentinel lymph node biopsy (39.3% vs 52.2%, p=0.28), axillary dissection (14.3% vs 4.3%, p=0.19), or rate of immediate reconstruction (42.9% vs 65.7%, p = 0.094) performed in patients with PABC-P and PABC-PP, respectively. Contralateral prophylactic surgery was performed in 43.2% of patients (39.3% PABC-P vs 47.5% PABC-PP, p=0.59). Most (79.9%) patients did not experience any postoperative complications, regardless of whether they underwent lumpectomy or mastectomy (83.3% vs 78.6%, p=0.99) or if they had PABC-P or PABC-PP (89.3% vs 73.9%, p=0.11). There was a statistically significant difference in the rate of complications between PABC-P patients undergoing mastectomy with immediate reconstruction (n=0/9, 0%) as compared to the PABC-PP patients (n=9, 39%; p=0.035). Seroma was the most commonly observed complication after both lumpectomy and mastectomy (n=3 vs n=5, p=0.39). Conclusions: There was no increased risk of postoperative complications in women with PABC treated with lumpectomy as compared to mastectomy. There is an increased risk of postoperative complications in patients with PABC-PP treated with mastectomy and immediate reconstruction.

Trabalho de projecto de mestrado, Tradução, Universidade de Lisboa, Faculdade de Letras, 2010 Nível de preservação: critical, Criado em: 2010-05-05 15:23:43, Criado por: super:ULB53, Alterado em: 2010-05-05 16:37:55, Modificado por: super:ULB53 Made available in DSpace on 2010-07-27T17:17:04Z (GMT). No. of bitstreams: 2 22253_ulfl071273_tm.pdf: 57159776 bytes, checksum: b90f42c7f92a3672361a3040bd00e4a0 (MD5) 22253.xml: 9794 bytes, checksum: 4647d20f452289d99ae72904c9d16d69 (MD5) Previous issue date: 2009