Current Patterns of Care in Breast Cancer: Use of Adjuvant Trastuzumab Neil Love, MD September 17, 2005 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 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 CI CO CI CO No 100% 94% 100% 96% 100%
95% Yes 0% 6% 0% 4% 0% 5% CI = Clinical Investigators CO = Community Oncologists Source: Breast Cancer Update Patterns of Care Study; Vol2(1): February 2005. Clinical Use of Adjuvant Trastuzumab Would you recommend adjuvant trastuzumab to a 65-year-old woman with an ER-negative, HER2positive 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 Trastuzumab Have you ever utilized adjuvant trastuzumab in a nonprotocol setting? CI CO No 57% 82% Yes 43% 18%
2 patients 3 patients For those answering yes, in how many patients? Median CI = Clinical Investigators CO = Community Oncologists Source: Breast Cancer Update Patterns of Care Study; Vol2(1): February 2005. 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. Current Patterns of Care: Case A 1.2-cm IDC, ER/PR/HER2-positive, 3 positive nodes 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% Source: Breast Cancer Update Patterns of Care Study; Vol2(2): August 2005. 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% 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%
Source: Breast Cancer Update Patterns of Care Study; Vol2(2): August 2005. 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 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% Source: Breast Cancer Update Patterns of Care Study; Vol2(2): August 2005. 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 16% Source: Breast Cancer Update Patterns of Care Study; Vol2(2): August 2005. 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 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 Oak Lawn, Illinois
76 yo woman: 3.5-cm, ER/PR-negative, HER2-positive, nodenegative 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: NCI SBIR Grant R43CA103264-01A1 Richard Margolese, MD Ms L, a participant in NSABP-B-35 Sandra Franco, MD Ms F, a participant
in NSABP-B-38 Cynthia Frankel, RN Ms R, a participant in NSABP-B-38 Ms M, a participant in NSABP-B-31 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
