Trends in BREAST HEALTH

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1 Trends in BREAST HEALTH VOL. 1 MAR IN THIS ISSUE APBI: The Results Are In 1 Advances in Breast Cancer Detection 3 Meeting Highlights 1 Advocacy Issues 2 Case Study 4 Literature Corner 4 Editor s Bios 6 R TRENDS EDITORS Pamela Benitez, MD Dr. Benitez is a general surgeon focusing exclusively on diseases of the breast and breast cancer at William Beaumont Hospital in Royal Oak, Michigan Martin Keisch, MD Dr. Keisch is a board-certifi ed radiation oncologist at University of Miami Hospital and President of Cancer HealthCare Associates (CHCA) APBI: The Results Are In PY CHEN, MD Over the past two decades, more and more scientifi c medical evidence has proven the effi cacy of breast conservation therapy (BCT) in the treatment of earlystage breast cancer. These clinical trials, including phase III studies, have provided strong objective evidence that BCT is equivalent to mastectomy. In such The original single-lumen trials, the standard form of irradiation is that which is MammoSite FDA cleared in 2002 delivered to the whole breast requiring over 6 weeks to deliver. To shorten the treatment time, centers have been investigating the use of accelerated partial breast irradiation (APBI) in more rapid treatment schemes, and comparing the outcomes to those of standard whole breast tangential beam irradiation delivered in six and a half weeks. Accelerated partial breast irradiation (APBI) is the delivery of larger doses per fraction of radiation therapy to the lumpectomy cavity (plus a 1-2 cm margin) using brachytherapy or external beam continued on page 2 k HOLOGIC SPONSORED MEETINGSk Miami Breast Cancer Conference Miami, FL March 9-12, 2011 ABS Winter School West Palm Beach, FL March 11-12, 2011 ABS Annual Meeting San Diego, CA April 14-16, 2011 ASBS Annual Meeting Washington, DC April 27 - May 1,

2 I am very excited to introduce you to our new quarterly newsletter, which has been developed to keep you informed about MammoSite and emerging technologies in breast cancer screening, diagnosis and therapy. We hope this newsletter will provide valuable information that will help you deliver the best patient care possible. As you know, Hologic is a company focused solely on women s health issues, including breast cancer, and continued from page 1 APBI: The Results Are In PY CHEN, MD irradiation techniques, after breast conserving surgery. One major advantage is the time compression, from the 6 to 7 weeks required for whole breast radiotherapy with boost down to 4 to 5 days for partial breast radiotherapy. The rationale for APBI includes the time reduction with its greater convenience, and this may also improve the utilization of breast conserving therapy, known to be underutilized. It potentially reduces the toxicities of therapy as the volume of treatment is dramatically smaller. Such reduction in morbidity should lead to improvement in the quality of life of patients. As well, APBI may eliminate the scheduling problems of integrating systemic therapies by concisely delivering the radiotherapy initially. One means of APBI delivery is via a balloon brachytherapy device known as the MammoSite RTS applicator which underwent initial clinical investigations in 1999 through 2001 with FDA clearance of the device in May, Once approved, the manufacturer initiated a registry trial that same year for continued accumulation of patient and treatment-related data. The American Society of Breast Surgeons assumed management of this trial in November Eighty-seven institutions with over 300 investigators participated in the trial which closed accrual in August This trial represents the largest published population of patients treated with APBI, a total of 1440 patients (1449 cases). With a median followup of 54 months, the 5-year results have been updated and published by Vicini et al in The 5 year actuarial rate of local breast control is 96.2 % with 91% of patients having a good to excellent cosmetic outcome at 60 months. Side effects have been few and minor with symptomatic breast seromas seen in 13% of cases and benign fat necrosis in 2.3%. These results apply equally for those patients with invasive ductal carcinoma as well as ductal carcinoma in situ. Thus, the ASBS Registry Trial is the largest published collection of patients treated with APBI with the fi rst FDA cleared balloon catheter device, namely the MammoSite RTS. This trial has substantiated the treatment effi cacy as well as good/excellent cosmetic outcome in patient so treated at the 5 year analysis point; these results are comparable to those published of other forms of APBI with similar follow-up. every Hologic employee is committed to delivering world class products and services j ADVOCACY ISSUESi to physicians and the patients they serve. I want to personally thank you for your dedication to this fi eld and hope you enjoy this newsletter. Carter Houghton Senior VP, President of IBS After experiencing years of declining reimbursement, the national Medicare rates for ABPI increased for catheter placement and radiation delivery by approximately 8% compared to 2010 rates. The national Medicare averages are as follows: Catheter Implant on date separate from partial mastectomy* CPT Code 19296** Physician Fee Offi ce $ Physician Fee Hospital / ASC $ Facility Fee $4, ASC Fee $2, Hologic continues to provide reimbursement support through a fi eld team of managed care experts to assist with policy and coverage. Contact your sales representative for assistance. In addition, Hologic also provides a Reimbursement Hotline to assist you with any coding questions, pre-certifi cation and denied claims. The Hologic Reimbursement Hotline can be accessed by phone or and is available Monday Friday, 8:30am 5:30pm Eastern. Phone: Hologic@thepinnaclehealthgroup.com 2

3 Trends in BREAST HEALTH Advances in Breast Cancer Detection Hologic, Inc. announced that the Company s Selenia Dimensions three-dimensional (3-D) digital mammography tomosynthesis system received FDA approval on February 11, Example of tissue Superimposition Mimics Pathology Benign Superimposed Parenchyma Breast tomosynthesis is a three-dimensional imaging technology that involves acquiring images of a stationary compressed breast at multiple angles during a short scan. The individual images are then reconstructed into a series of thin high-resolution slices that can be displayed individually or in a dynamic ciné mode. Mammography systems using conventional 2D imaging have limitations caused by overlapping tissue in the breast that may hide lesions or cause benign areas to appear suspicious. Clinical trials using Hologic s Selenia Dimensions system in combomode showed measurable improvement in clinical performance over conventional mammography based on ROC analysis. These trials also showed signifi cant gains in specifi city the confi dence to rule out cancer without recalling the patient for further study and improved sensitivity the proportion of mammograms with cancer which were correctly diagnosed. The combination of measurable improvements in accuracy and detection, improved sensitivity, makes combo mode imaging with the Selenia Dimensions superior to conventional digital mammography.* 2D image - Selenia Dimensions Mammogram Tissue Superimposition Can Hide Pathology 3D image - Selenia Dimensions Tomosynthesis *The Hologic Selenia Dimensions clinical studies presented to the FDA as part of Hologic s PMA submission that compared Hologic s Selenia Dimensions combo-mode to Hologic s 2D FFDM Lesion not seen on mammogram 3

4 Trends in BREAST HEALTH q CASE STUDY r Case Study: The patient is a 49 year old woman with a new mammographic fi nding of a cluster of microcalcifi cations in the lateral aspect of the right breast. Ultimately a 12 mm pure ductal carcinoma in situ was resected with the closest margin at 2mm. The sentinal node was biopsied as the lesion was high grade, and was benign. Accelerated partial breast radiation was recommended and a multilumen MammoSite ML balloon was placed. As can be seen in the fi gures, both the skin and chest wall were less than 1.0 centimeters from the balloon surface (image 1). Inverse planning was employed to dose limit both these structures to less than 125% of the prescription dose. The dose volume histogram shows successful coverage of the target (PTV) with protection of the chest wall and skin (image 2). The patient s treatment was delivered successfully, and the peak skin reaction occurred at 2 weeks, consisting of mild erythema (grade 1) Image 1: Skin spacing Images courtesy of Dr. Keisch, University of Miami Hospital and Aventura Hospital Image 2: Dose Volume Histogram Images courtesy of Dr. Keisch, University of Miami Hospital and Aventura Hospital Per the MammoSite ML instructions for use: Do not deliver radiation if the minimum distance from the balloon surface to the skin surface is less than 5 mm, or if the distance from the balloon to the skin surface is less than 5 mm over a continuous length greater than 1 cm on the surface of the skin unless the maximum skin dose is less than or equal to 145% of the prescription dose. T LITERATURE CORNER ARTICLES OF INTEREST U 1. Int J Radiat Oncol Biol Phys Aug 21. [Epub ahead of print] Outcomes After Accelerated Partial Breast Irradiation in Patients with ASTRO Consensus Statement Cautionary Features. McHaffi e DR, Patel RR, Adkison JB, Das RK, Geye HM, Cannon GM. Department of Human Oncology, University of Wisconsin School of Medicine and Public Health, Madison, WI. Abstract PURPOSE: To evaluate outcomes among women with American Society for Radiation Oncology (ASTRO) consensus statement cautionary features treated with brachytherapy-based accelerated partial breast irradiation (APBI). METHODS AND MATERIALS: Between March 2001 and June 2006, 322 consecutive patients were treated with high-dose-rate (HDR) APBI at the University of Wisconsin. A total of 136 patients were identifi ed who met the ASTRO cautionary criteria. Thirty-eight (27.9%) patients possessed multiple cautionary factors. All patients received 32 to 34 Gy in 8 to 10 twice-daily fractions using multicatheter (93.4%) or MammoSite balloon (6.6%) brachytherapy. RESULTS: With a median follow-up of 60 months, there were 5 ipsilateral breast tumor recurrences (IBTR), three local, and two loco-regional. The 5-year actuarial rate of IBTR was 4.8% +/- 4.1%. The 5-year disease-free survival was 89.6%, with a cause-specifi c survival and overall survival of 97.6% and 95.3%, respectively. There were no IBTRs among 32 patients with ductal carcinoma in situ (DCIS) vs. 6.1% for patients with invasive carcinoma (p = 0.24). Among 104 patients with Stage I or II invasive carcinoma, the IBTR rate for patients considered cautionary because of age alone was 0% vs. 12.7% in those deemed cautionary due to histopathologic factors (p = 0.018). continued on following page 4

5 continued from previous page Literature Corner Articles of Interest CONCLUSIONS: Overall, we observed few local recurrences among patients with cautionary features. Women with DCIS and patients 50 to 59 years of age with Stage I/II disease who otherwise meet the criteria for suitability appear to be at a low risk of IBTR. Patients with tumor-related cautionary features will benefi t from careful patient selection. 2. Int J Radiat Oncol Biol Phys May 24. [Epub ahead of print] Limitations of the American Society of Therapeutic Radiology and Oncology Consensus Panel Guidelines on the Use of Accelerated Partial Breast Irradiation. Vicini F, Arthur D, Wazer D, Chen P, Mitchell C, Wallace M, Kestin L, Ye H. Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI. Abstract PURPOSE: We applied the American Society of Therapeutic Radiology and Oncology (ASTRO) Consensus Panel (CP) guidelines for the use of accelerated partial breast irradiation (APBI) to patients treated with this technique to determine the ability of the guidelines to differentiate patients with signifi cantly different clinical outcomes. METHODS AND MATERIALS: A total of 199 patients treated with APBI and 199 with whole-breast irradiation (WBI) (matched for tumor size, nodal status, age, margins, receptor status, and tamoxifen use) were stratifi ed into the three ASTRO CP levels of suitability ( suitable, cautionary, and unsuitable ) to assess rates of ipsilateral breast tumor recurrence (IBTR), regional nodal failure, distant metastases, disease-free survival, cause-specific survival, and overall survival based on CP category. Median follow-up was 11.1 years. RESULTS: Analysis of the APBI and WBI patient groups, either separately or together (n = 398), did not demonstrate statistically signifi cant differences in 10-year actuarial rates of IBTR when stratifi ed by the three ASTRO groups. Regional nodal failure and distant metastasis were generally progressively worse when comparing the suitable to cautionary to unsuitable CP groups. However, when analyzing multiple clinical, pathologic, or treatment-related variables, only patient age was associated with IBTR using WBI (p = 0.002). CONCLUSIONS: The ASTRO CP suitable group predicted for a low risk of IBTR; however, the cautionary and unsuitable groups had an equally low risk of IBTR, supporting the need for continued refi nement of patient selection criteria as additional outcome data become available and for the continued accrual of patients to Phase III trials. 3. Ann Surg Oncol Oct;17 Suppl 3: Epub 2010 Sep 19. Five-year outcome of patients classified in the unsuitable category using the American Society of Therapeutic Radiology and Oncology (ASTRO) Consensus Panel guidelines for the application of accelerated partial breast irradiation: an analysis of patients treated on the American Society of Breast Surgeons MammoSite Registry trial. Beitsch P, Vicini F, Keisch M, Haffty B, Shaitelman S, Lyden M. Surgery, Dallas Breast Center, Dallas, TX, USA. Beitsch@aol.com Abstract PURPOSE: We applied the ASTRO Consensus Panel (CP) guidelines for the application of accelerated partial breast irradiation (APBI) to patients treated with this technique on the ASBS MammoSite registry trial to determine potential differences in outcome of patients classifi ed in the unsuitable category. METHODS: Of 1,449 cases treated with APBI on the registry trial, 176 fi t the criteria for the unsuitable category: 130 cases were <50 years of age, 13 had positive margins, 38 had positive nodes, 6 had tumors >3 cm, and 9 had an EIC >3 cm. Rates of ipsilateral breast tumor recurrence (IBTR) and regional nodal failure (RNF) were assessed. Median follow-up was 53.6 months. RESULTS: The 5-year actuarial rate of IBTR for unsuitable cases was 5.25% (RNF rate was 0.63%). By comparison, the 5-year actuarial IBTR rates for various subsets of patients were: all 1,449 cases, 3.89% (p = ); all 1,449 cases excluding unsuitable cases [n =1,273] (3.6%, p =0.1683); invasive only cases [n = 1,255] (3.86%, p = ); and invasive only cases excluding unsuitable invasive cases [n =1,105] (3.89%, p = ). On univariate analysis for variables potentially associated with IBTR in all 1,255 cases with invasive cancer (including age, tumor size, nodal status, overall stage, margin status, ER status, presence of an EIC, and ASTRO unsuitable category), only negative ER (-) status was associated with the 5-year rate of IBTR (p = 0002). No other variable (including unsuitable CP designation) was associated with IBTR. CONCLUSIONS: The ASTRO CP guideline designation of unsuitable did not differentiate a subset of patients with a signifi cantly worse rate of IBTR when treated with the MammoSite breast brachytherapy catheter to deliver APBI. PMID: [PubMed - indexed for MEDLINE] 5

6 ) TRENDS EDITORS _ Trends in Breast Health is a newsletter for health professionals dedicated to serving the breast cancer community. It is our mission to provide you with informative and relevant topics of interest to aid you in your respective clinical setting. Martin Keisch, MD President of Cancer HealthCare Associates Radiation Oncologist University of Miami Hospital and Aventura Hospital Martin E. Keisch, MD, a board-certifi ed radiation oncologist at University of Miami Hospital, is President of Cancer HealthCare Associates (CHCA). Dr. Keisch has extensive expertise in breast, prostate and GYN brachytherapy. He has authored many publications on Accelrated Partial Breast Irradiaion. He was the Principal Investigator of the initial MammoSite Trial. He currently serves as an investigator in the Mammosite Multicenter DCIS trial and the Mammosite Registry trial for the American Society of Breast Surgeons. He graduated with honors from Tufts University School of Medicine in Boston, MA, in Dr. Keisch completed a residency in radiation oncology in 1992 at the Mallinckrodt Institute of Radiology at Washington University Medical Center in St. Louis, MO, where he served as chief resident in radiation oncology. In addition, he was an American Cancer Society research fellow. Prior to joining University of Miami Hospital, Dr. Keisch worked as a radiation oncologist at Mount Sinai Medical Center Miami Beach, FL, as well as Medical Director of Radiation oncology at Sharp Healthcare in San Diego, CA (3/13) Hologic All rights reserved. Printed in USA. Specifi cations are subject to change without prior notice. Hologic and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/ or its subsidiaries in the United States and/or other countries. MISC rev. 001 Pamela Benitez, MD Breast Surgeon William Beaumont Hospital Dr. Pamela Benitez is a graduate of Albany Medical College, did her surgical residency at the University of Michigan Hospitals. She comes to us from William Beaumont Hospital in Royal Oak, Michigan, where she is a general surgeon with a busy practice focusing exclusively on diseases of the breast and breast cancer. She is also highly active in research and medical education. Her recent publications are on the cosmetic outcomes and toxicities with interstitial catheter brachytherapy partial breast irradiation (PBI), infections with breast surgery, surgical considerations with PBI, and non-invasive breast cancer (DCIS) and MammoSite PBI. Her most recent work has appeared in Cancer and The American Journal of Surgery. In April of 2006, Dr. Benitez presented the data of the DCIS MammoSite Trial at the Annual Meeting of the American Society of Breast Surgeons which was subsequently published in the American Journal of Surgery. The 5-year results of the Initial Clinical Trial of MammoSite Balloon Catheter Partial Breast Irradiation were presented by Dr. Benitez at the Annual Meeting of the ASBS 2007 and published in The American Journal of Surgery in October