Current Patterns of Care in Breast Cancer: Use of Adjuvant Trastuzumab

Neil Love, MD

September 17, 2005

Current Patterns of Care Current Patterns of Care in Breast Cancer:in Breast Cancer:

Use of Adjuvant TrastuzumabUse of Adjuvant Trastuzumab

Recent Trends in Adjuvant Systemic Recent Trends in Adjuvant Systemic Therapy of Early Breast CancerTherapy 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

35 years old 65 years old 75 years old

CI CO CI CO CI CO

No 100% 94% 100% 96% 100% 95%

Yes 0% 6% 0% 4% 0% 5%

Trastuzumab in the Adjuvant SettingTrastuzumab in the Adjuvant Setting

1.2-centimeter, Grade II tumor ER-negative, HER2-positive 3 positive nodes

Would you utilize adjuvant trastuzumab off protocol?

CI = Clinical Investigators

CO = Community Oncologists

Source: Breast Cancer Update Patterns of Care Study; Vol2(1): February 2005.

Clinical Use of Adjuvant TrastuzumabClinical 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%

CI = Clinical Investigators

CO = Community Oncologists

Source: Breast Cancer Update Patterns of Care Study; Vol2(1): February 2005.

Use of Adjuvant TrastuzumabUse 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

CI = Clinical Investigators

CO = Community Oncologists

Source: Breast Cancer Update Patterns of Care Study; Vol2(1): February 2005.

Breast Cancer Survivors’ Perspectives Breast Cancer Survivors’ Perspectives on Adjuvant Trastuzumabon 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.

35yo 55yo 75yo 85yo

Trastuzumab 88% 88% 56% 36%

6 months

1 year

2 years

5%

90%

5%

5%

95%

—

14%

86%

—

22%

78%

—

Concurrent

Sequential

73%

27%

73%

27%

64%

36%

50%

50%

Current Patterns of Care: Case A — 1.2-cm Current Patterns of Care: Case A — 1.2-cm IDC, ER/PR/HER2-positive, 3 positive nodesIDC, ER/PR/HER2-positive, 3 positive nodes

Source: Breast Cancer Update Patterns of Care Study; Vol2(2): August 2005.

35yo 55yo 75yo 85yo

10+ nodes, 1.2 cm 96% 96% 84% 52%

3+ nodes, 1.2 cm 96% 96% 72% 32%

1+ node, 1.2 cm 96% 96% 68% 32%

Node-neg, 2.4 cm 92% 92% 64% 28%

Node-neg, 1.2 cm 80% 76% 56% 28%

Current Patterns of Care: Case B — Current Patterns of Care: Case B — ER/PR-negative, HER2-positive, Grade II IDC:ER/PR-negative, HER2-positive, Grade II IDC:

Would You Recommend Trastuzumab?Would You Recommend Trastuzumab?

Source: Breast Cancer Update Patterns of Care Study; Vol2(2): August 2005.

Time since completion of AC T

6 mo 1 yr 2 yr 4 yr

Node-neg 56% 32% 4% —

3+ nodes 80% 60% 16% 4%

10+ nodes 84% 72% 44% 28%

Current Patterns of Care: Case C — a 55 yo Current Patterns of Care: Case C — a 55 yo with a 2.4-cm, Grade II, ER/PR-negative, with a 2.4-cm, Grade II, ER/PR-negative,

HER2-positive IDCHER2-positive IDC

Would you start delayed trastuzumab?Would you start delayed trastuzumab?

Source: Breast Cancer Update Patterns of Care Study; Vol2(2): August 2005.

Sources of Information about Sources of Information about ASCO Adjuvant Trastuzumab TrialsASCO 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 16%

Source: Breast Cancer Update Patterns of Care Study; Vol2(2): August 2005.

Case of Dr Barbara Fallon Case of Dr Barbara Fallon New Britton, ConnecticutNew Britton, Connecticut

42 yo woman: ER/PR-negative, HER2-positive IDC, 5 positive nodes

Enrolled on NSABP-B-31 — randomized to AC 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?

Case of Dr Gary Steinecker Case of Dr Gary Steinecker Oak Lawn, IllinoisOak Lawn, Illinois

76 yo woman: 3.5-cm, ER/PR-negative, HER2-positive, node-negative IDC (2/2005)

CALGB 49909: randomized to A/C paclitaxel 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?

Use of Media to Assist with Informed Consent:Use of Media to Assist with Informed Consent: NCI SBIR Grant R43CA103264-01A1 NCI SBIR Grant R43CA103264-01A1

Sandra Franco, MDRichard Margolese, MD

Ms M, a participant in NSABP-B-31

Ms R, a participant in NSABP-B-38

Ms F, a participant in NSABP-B-38

Ms L, a participant in NSABP-B-35

Cynthia Frankel, RN

AgendaAgenda

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