Partial Breast Irradiation: Market Assessment

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June 2007

Project Objectives

To understand the market dynamics in partial breast irradiation and the competitive advantages/disadvantages between SenoRx’s Multi-Lumen Radiation Balloon and other products including Cytyc’s MammoSite®.

Assess the decision-making process by determining who is involved and what influences the choice of whole versus partial breast irradiation, as well as the use of accelerated partial breast irradiation
Validate estimated partial breast irradiation market size
Identify competing products or therapies likely to impact the use of partial breast irradiation, and specifically accelerated partial breast radiation, in the next 1-3 years
Forecast trends in the next 1-3 years for accelerated partial breast irradiation
Understand the strengths and weaknesses of specific accelerated PBI therapies including SenoRx’s Multi-Lumen Radiation Balloon, Cytyc’s MammoSite®, and Xoft’s Axxent® Electronic Brachytherapy System
Evaluate the potential use of SenoRx’s Multi-Lumen Radiation Balloon and facilitators/barriers to its uptake in the next 1-3 years
Explore anecdotal evidence that SenoRx’s Multi-Lumen Radiation Balloon has better clinical outcomes and reimbursement than Cytyc’s MammoSite

Companies and Products Mentioned in This Report

	Company	Product
SENO	SenoRx	Multi-Lumen Radiation Balloon
CYTC	Cytyc	MammoSite®
	Xoft	Axxent® Electronic Brachytherapy System
		3D conformal radiation

Key Findings

Trends in breast cancer care: More women are choosing breast conservation therapy; however, the use of breast MRI is causing a slight increase in the number of mastectomies. In the past 12 months, the number of patients receiving partial breast irradiation has either stayed the same or increased, but many think this number will increase over the next 12 months.
Accelerated partial breast irradiation (APBI): The overall trend in use has either remained the same or increased in the past 12 months, but is expected to increase over the next 12 months. Use will be affected by the results of the RTOG/NSABP trial when they are released in a few years.
Cytyc’s Mammosite®: Used by all providers; strengths include ease of use with simple dosimetry; weaknesses include limited use with irregular cavity.
SenoRx’s Multi-Lumen Radiation Balloon: Not used by any panelists yet; strengths include better conformity to irregular cavity and flexible dosing due to multiple lumens; weaknesses include more complex and time-consuming treatment planning.
Reimbursement: Experience with reimbursement ranges from “very good” to not being covered because it is still considered experimental. Reimbursement for SenoRx’s Multi-Lumen Radiation Balloon may be higher due to more dwell positions and complexity in planning.

Inclusion Criteria and Panelist Demographics

Inclusion Criteria

10 board-certified radiation oncologists
Based in U.S
2-30 years of practice
Treating a high volume of breast cancer patients with partial and whole breast irradiation
Familiarity with Cytyc’s MammoSite
Prior use of Cytyc’s MammoSite (8 out of 10 participants)

anonymous panelist information

ID	Hospital or Lab	State	# Breast Cancer Pts/wk	Setting
1	East Carolina University	NC	5	Academic Hospital
2	Alexian Brothers Medical Center	IL	10	Private Practice
3	Forrest General Hospital	MS	12	Community Hospital
4	University of Pittsburgh Medical Center	PA	10-15	Academic Hospital
8	Massachusetts General Hospital	MA	30	Academic Hospital
10	Christiana Care Health System	DE	30-40	Private Practice
11	Auburn Medical Center	WA	20	Community Hospital
12	New Jersey Medical School	NJ	3	Academic Hospital
13	Hollywood Medical Center	FL	23	Free standing oncology center
14	Arnot Ogden Medical Center	NY	30	Community Hospital

Primary Question Index

Question	Page number(s)
Q1: Trends in breast cancer care During the past twelve months, what trends have you observed among eligible women with regard to selecting breast conserving therapy versus mastectomy? What changes, if any, do you expect over the next twelve months? Three years from now?	6
Q2: Decision-making process What factors influence your decision to perform partial versus whole breast irradiation? How do you then decide whether to use accelerated PBI? Are there other providers involved in this decision process? If yes, please identify them.	7
Q3: Current procedures for APBI Which form(s) of APBI do you currently recommend? What are your key considerations when selecting the therapy for each patient? What are the main characteristics of the patients who receive each type of APBI (e.g., demographics, type and stage of cancer, etc)?	9
Q4: Cytyc’s MammoSite® Please describe your clinical experience using Cytyc’s MammoSite. In your answer, please address the strengths and weaknesses of the product. How do you use this product in patients receiving chemotherapy? Please describe the average regimen for a patient (i.e., number of treatments over number of days)?	11
Q5: SenoRx’s Multi-Lumen Radiation Balloon Please describe your familiarity with SenoRx’s Multi-Lumen Radiation Balloon. What do you foresee as the strengths of this product? The weaknesses? How might you envision using this product with patients? Have you heard any anecdotal discussions regarding the product and its potential applications?	12
Q6: Xoft’s Axxent® Electronic Brachytherapy System Please describe your familiarity with Xoft’s Axxent Electronic Brachytherapy System. What do you foresee as the strengths of this product? The weaknesses? How might you envision using this product with patients? Have you heard any anecdotal discussions regarding the product and its potential applications?	14
Q7: Comparison of ABPI therapies When considering the use of Cytyc’s MammoSite, SenoRx’s Multi-Lumen Radiation Balloon, or Xoft’s Axxent Electronic Brachytherapy System, how might you choose one over the others? Have you heard any specific information related to superior clinical outcomes with any of these products? What do you think are the advantages and disadvantages of SenoRx’s Multi-Lumen Radiation Balloon over the other two products?	15
Q8: Features of ABPI therapies Please comment on the following specific features of APBI therapies: • Skin spacing – Please explain the importance of skin spacing in APBI and how it relates to any of the APBI therapies? • Lumens – Are there significant advantages/disadvantages of the dual-lumen delivery method of MammoSite versus the multi-lumen delivery method of SenoRx’s and Xoft’s products? • Vacuum - Is the vacuum feature of SenoRx’s product useful? Why or why not? Do you think it provides a significant advantage for SenoRx over MammoSite?	16
Q9: Barriers and facilitators Please describe any adverse events, side effects, and negative patient reactions to Cytyc’s MammoSite, SenoRx’s Multi-Lumen Radiation Balloon, and Xoft’s Axxent Electronic Brachytherapy System. What do you consider to be the greatest barriers to the use of these therapies? What would help facilitate greater use of these therapies?	17
Q10: Adoption of SenoRx’s therapy What clinical or product information would you need to see in order to increase your future use of SenoRx’s Multi-Lumen Radiation Balloon method? What do you perceive as the challenges for the adoption of this product in the marketplace after an anticipated full launch in 2008?	18
Q11: Reimbursement What has been your experience with reimbursement for APBI therapies? Do you anticipate any differences in reimbursement between dual-lumen and multi-lumen catheters?	19
Q12: Competition Are you aware of any other products, procedures, or therapies for APBI that are on the market or launching soon? Are there any therapies or technologies outside of partial breast irradiation that might be used in the future potentially making APBI less relevant?	20
Appendix	22

Transcript

Accelerated Partial Breast Irradiation Panel Discussion

June 2007

Introduction

Welcome to this discussion among radiation oncologists in which we will discuss options for breast irradiation therapy. Our primary goals are to understand current practice patterns regarding the use of accelerated partial breast irradiation (APBI), and to compare product options for APBI. MedPanel discussions are enhanced when you, as a panelist, not only respond to the posted questions, but also reply to comments made by our moderator and your fellow panelists. We look forward to a lively and interactive discussion. Please note: In your participation on this panel, Panel Intelligence expects and requires that you comply with the terms of the Consultant Confidentiality Agreement to which you previously agreed. If you have any questions about the terms of that agreement, please review them through the link provided on your Panel Intelligence home page after you've logged in.

Instant survey please complete.

1.	How many newly invasive breast cancer patients do you see per year?
2.	What percent of these patients are diagnosed at an early stage?
3.	How many patients with carcinoma in situ (CIS) do you see per year?
4.	Of your patients with CIS or early stage invasive breast cancer, what percent are eligible for breast conserving therapy?
5.	What percent of your patients eligible for breast conserving therapy choose to have it?
6.	What percent of your patients having breast conserving therapy complete radiation therapy?
7.	Of you patients receiving radiation therapy, what percent receive partial breast radiation?
8.	Of your patients receiving partial breast radiation, what percent receive accelerated partial breast radiation?

Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8

Panelist 1	100	50	25	95	95	99	5	75
Panelist 4	150	80	25	90	90	95	20	100
Panelist 14	100	60	25	90	90	99	10	50
Panelist 3	40	50	8	75	35	90	20	100
Panelist 10	75	70	50	90	95	95	15	100
Panelist 8	600	60	200	95	90	100	30	98
Panelist 11	100	90	50	50	70	95	30	100
Panelist 2	80	60	20	95	90	95	20	100

Q1: Trends in breast cancer care

During the past twelve months, what trends have you observed among eligible women with regard to selecting breast conserving therapy versus mastectomy? What changes, if any, do you expect over the next twelve months? Three years from now?

Panelist 4: More women who opt for breast conserving therapy desire accelerated breast radiation and would continue to see increase usage of APBI

Panelist 2: More and more patients continue to select breast conservation therapy over mastectomy, and

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