Abstract P1-18-23: Evaluating the potential utility of presenting breast cancer clinical investigator estimates for numeric treatment benefit and recommendations for the use of two anti-HER2 adjuvant therapies: HER RISK
Authors: Love Neil , Hurvitz Sara A , Rugo Hope S , Hart Lowell , Kelly Gloria , Miller Kirsten , Cruse Trenton , Paley Douglas , Moss Jonathan , Ziel Kathryn 
Published: March 2020

Abstract
Background: The recent introductions of pertuzumab (P) and neratinib (N) have made counseling patients with HER2-positive breast cancer (BC) regarding the potential benefits of various adjuvant systemic regimens more complex and challenging. The HER RISK initiative was conceived as a novel means to support adjuvant therapy decision-making by providing input from BC clinical investigators (CIs). Methods: 30 CIs were recruited to provide numeric estimates of the potential benefit in 5-year disease-free survival (DFS) of various adjuvant therapeutic regimens and postadjuvant N for 24 HER2-positive BC scenarios along with their likely treatment recommendations. 50 community-based oncologists (CBOs) were then recruited and asked to provide the same estimates for 4 of the scenarios evaluated. They were then shown the responses from the CIs and asked to provide their perspectives on this information and its potential value as an educational resource. A modest honorarium was provided to CI and CBO participants. Results: There was a clear relationship between projected benefit of adding P or N and use of these agents in the 4 situations evaluated (Table). More than two thirds of CIs believe P improves DFS in cases with 2 positive nodes, and most generally recommend its inclusion in adjuvant therapy. However, for the 2 node-negative cases, CIs perceived the benefit of adding P to be minimal or absent and generally did not recommend this treatment. The numeric estimates and practice patterns of the CBOs were similar to those of the CIs, but P was perceived to be somewhat more beneficial by CBOs and was used more frequently in the node-negative scenarios. In terms of the decision to recommend postadjuvant N, CI responses strongly correlated with ER and nodal status. Almost all stated that N would provide benefit for a patient with ER-positive disease and 2 positive nodes and indicated that they would generally recommend N in that setting. CIs’ perceived benefit of N in the node-negative cases was minimal or absent, with few recommending it even for the ER-positive scenarios. N is commonly recommended by CBOs in the node-positive scenario — similar to the CIs — but more of these clinicians perceive a benefit to N in the node-negative cases and recommend its use. When asked whether they obtained clinical value from reviewing these types of estimates, 48 CBOs (96%) found the information useful and 34 (68%) stated that having access to it was likely to affect their practices. 45 CBOs (90%) would share the 5-year DFS estimates and treatment recommendations from the CIs with interested patients if available in an online format. Conclusions: The numeric estimates and practice patterns of CIs and CBOs were generally similar for the scenarios presented, but both P and N were perceived to be somewhat more beneficial and were used more frequently by CBOs than CIs in node-negative cases. Even in node-positive cases, CIs and CBOs estimated the benefit of P and N to be modest but in many cases sufficient to warrant their use. For both groups, there was a clear relationship between the estimated benefit of therapy and its use. CBOs found value in the graphical presentation of the CI estimates and practice patterns and would use them as part of patient counseling. The next phase of this ongoing project will evaluate whether integrating this information into shared decision-making is feasible and beneficial for CBOs.
Case scenarioUse of pertuzumab (P)CI (N = 30)CBO (N = 50)Median 5-year DFS estimate w/chemo/TIncr Ben = 0Incr Ben &gt; 0Median 5-year DFS estimate w/chemo/TIncr Ben = 0Incr Ben &gt; 0(%)(No.)(No.)(%)(No.)(No.)ER-, 2+ nodes8212980248MED: 3%MED: 5%(1 uses P)(26 use P)(2 use P)(45 use P)ER+, 2+ nodes8562480446MED: 2%MED: 5%(3 use P)(21 use P)(3 use P)(40 use P)ER-, N-, 1.6-2.0-cm tumor941812901139MED: 1%MED: 3%(0 use P)(2 use P)(0 use P)(11 use P)ER+, N-, 1.6-2.0-cm tumor95246901238MED: 1%MED: 3%(0 use P)(2 use P)(0 use P)(13 use P)Use of neratinib (N) after chemo/TER-, 2+ nodes821515801931MED: 3%MED: 3%(0 use N)(4 use N)(2 use N)(14 use N)ER+, 2+ nodes8532780248MED: 3%MED: 3%(0 use N)(18 use N)(0 use N)(35 use N)ER-, N-, 1.6-2.0-cm tumor94264902030MED: 2%MED: 2%(0 use N)(1 uses N)(0 use N)(4 use N)ER+, N-, 1.6-2.0-cm tumor951713901139MED: 2%MED: 3%(0 use N)(1 uses N)(1 uses N)(16 use N)CI = clinical investigator; CBO = community-based oncologist; DFS = disease-free survival; chemo/T = chemotherapy/trastuzumab; Incr Ben = incremental benefit (pertuzumab added to chemo/T, neratinib after adjuvant chemo/T); MED = median estimated incremental benefit; N- = node-negative
Citation Format: Neil Love, Sara A Hurvitz, Hope S Rugo, Lowell Hart, Gloria Kelly, Kirsten Miller, Trenton Cruse, Douglas Paley, Jonathan Moss, Kathryn Ziel. Evaluating the potential utility of presenting breast cancer clinical investigator estimates for numeric treatment benefit and recommendations for the use of two anti-HER2 adjuvant therapies: HER RISK [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-18-23.