1. Current Patterns of Care in Breast Cancer: Use of Adjuvant Trastuzumab
Neil Love, MD
September 17, 2005

2. Recent Trends in Adjuvant Systemic Therapy of Early Breast Cancer
Chemotherapy
Taxanes
Dose-dense chemotherapy
Use of computer models like Adjuvant!
Oncotype DX™ assay
Endocrine therapy
Aromatase inhibitors
Biologic therapy
Trastuzumab

3. Trastuzumab in the Adjuvant Setting
1.2-centimeter, Grade II tumor
ER-negative, HER2-positive
3 positive nodes
Would you utilize adjuvant trastuzumab off protocol?
35 years old
65 years old
75 years old CI CO No
100%
94%
96%
95%
Yes 0% 6% 4% 5%
Figure 63
CI = Clinical Investigators
CO = Community Oncologists
Source: Breast Cancer Update Patterns of Care Study;
Vol2(1): February 2005.

4. Clinical Use of Adjuvant Trastuzumab
Would you recommend adjuvant trastuzumab to a 65-year-old woman with an ER-negative, HER2-positive tumor with 10 positive nodes? CI CO No
73%
82%
Yes
27%
18%
Figure 64
CI = Clinical Investigators
CO = Community Oncologists
Source: Breast Cancer Update Patterns of Care Study;
Vol2(1): February 2005.

5. Use of Adjuvant Trastuzumab
Have you ever utilized adjuvant trastuzumab in a nonprotocol setting? CI CO No
57%
82%
Yes
43%
18%
For those answering “yes,” in how many patients?
Median
2 patients
3 patients
Figure 65
CI = Clinical Investigators
CO = Community Oncologists
Source: Breast Cancer Update Patterns of Care Study;
Vol2(1): February 2005.

6. Breast Cancer Survivors’ Perspectives on Adjuvant Trastuzumab
Case scenario: 40-year-old woman with ER/PR/HER2-positive IDC and 6 positive nodes
New York
Miami
Houston
Would want trastuzumab off protocol
15%
35%
48%
Would participate in a randomized adjuvant trastuzumab trial
21%
44%
40%
Source: Love NL et at. San Antonio Breast Cancer Symposium, 2003.
Abstract 142.

7. Current Patterns of Care: Case A — 1
Current Patterns of Care: Case A — 1.2-cm IDC, ER/PR/HER2-positive, 3 positive nodes
35yo
55yo
75yo
85yo
Trastuzumab
88%
56%
36%
6 months
1 year
2 years 5%
90%
95% —
14%
86%
22%
78%
Concurrent
Sequential
73%
27%
64%
50%
Source: Breast Cancer Update Patterns of Care Study;
Vol2(2): August 2005.

8. Current Patterns of Care: Case B — ER/PR-negative, HER2-positive, Grade II IDC: Would You Recommend Trastuzumab?
35yo
55yo
75yo
85yo
10+ nodes, 1.2 cm
96%
84%
52%
3+ nodes, 1.2 cm
72%
32%
1+ node, 1.2 cm
68%
Node-neg, 2.4 cm
92%
64%
28%
Node-neg, 1.2 cm
80%
76%
56%
Source: Breast Cancer Update Patterns of Care Study;
Vol2(2): August 2005.

9. Time since completion of AC g T
Current Patterns of Care: Case C — a 55 yo with a 2.4-cm, Grade II, ER/PR-negative, HER2-positive IDC Would you start delayed trastuzumab?
Time since completion of AC g T
6 mo
1 yr
2 yr
4 yr
Node-neg
56%
32% 4% —
3+ nodes
80%
60%
16%
10+ nodes
84%
72%
44%
28%
Source: Breast Cancer Update Patterns of Care Study;
Vol2(2): August 2005.

10. Sources of Information about ASCO Adjuvant Trastuzumab Trials
Attended ASCO
36%
Meetings (CME, tumor board, ASCO review, etc)
56%
Medical/scientific journals
44%
Breast Cancer Update audio series
40%
Lay press/news media
16%
Other
Source: Breast Cancer Update Patterns of Care Study;
Vol2(2): August 2005.

11. Case of Dr Barbara Fallon New Britton, Connecticut
42 yo woman: ER/PR-negative, HER2-positive IDC, 5 positive nodes
Enrolled on NSABP-B-31 — randomized to AC g T
Patient is now 28 months since start of adjuvant chemotherapy
• Should trastuzumab be administered at this time?
• If she presented today, what would you recommend?

12. Case of Dr Gary Steinecker Oak Lawn, Illinois
76 yo woman: 3.5-cm, ER/PR-negative, HER2-positive, node-negative IDC (2/2005)
CALGB 49909: randomized to A/C g paclitaxel g trastuzumab
Significant toxicity with chemotherapy (colitis)
Post AC MUGA: drop from 66% to 50% — not eligible for trastuzumab as per protocol
Repeat MUGA : EF 71%; 2D Echo: EF 45%
• Should trastuzumab be administered at this time?
• If she presented today, what would you recommend?

13. Use of Media to Assist with Informed Consent: NCI SBIR Grant R43CA103264-01A1
Richard Margolese, MD
Sandra Franco, MD
Cynthia Frankel, RN
Ms L, a participant in NSABP-B-35
Ms F, a participant in NSABP-B-38
Ms R, a participant in NSABP-B-38
Ms M, a participant in NSABP-B-31

14. Agenda 12:00 PM Dr Wolmark: Introduction
12:05 PM Dr Love: Current patterns of care in the community
12:15 PM Dr Romond: Combined analysis: NSABP-B-31/NCCTG-N9831
12:35 PM Dr Slamon: BCIRG 006: Background, design, initial results
12:55 PM Dr Leyland-Jones: First results of the HERA trial
1:15 PM Dr Kaufman: NCCTG-N9831: Sequential versus concurrent trastuzumab and chemotherapy
1:35 PM Dr Geyer: NSABP-B-31 cardiac toxicity data
2:00 PM Close