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Old 05-18-2014, 01:59 PM   #1
'lizbeth
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Post Comparison of recurrent and nonrecurrent breast cancer patients undergoing AE37 pepti

Comparison of recurrent and nonrecurrent breast cancer patients undergoing AE37 peptide vaccine therapy.



Abstract No:
613
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2014 ASCO Annual Meeting!


Session: Breast Cancer - HER2/ER
Type: General Poster Session
Time: Monday June 2, 8:00 AM to 11:45 AM
Location: S Hall A2
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Author(s): Erika J Schneble, Sonia A. Perez, John S. Berry, Alfred F Trappey, Tim Vreeland, Diane F. Hale, Alan K. Sears, Guy T. Clifton, Eric von Hofe, Alexandros Ardavanis, Nathan M. Shumway, Sathibalan Ponniah, Michael Papamichail, George Earl Peoples, Elizabeth Ann Mittendorf; San Antonio Military Medical Center, San Antonio, TX; Cancer Immunology and Immunotherapy Center, Saint Savas Cancer Hospital, Athens, Greece; Antigen Express, Worcester, MA; Department of Clinical Oncology, Cancer Immunology Immunotherapy Center, Saint Savas Cancer Hospital, Athens, Greece; Cancer Vaccine Development Program, United States Military Cancer Institute, USUHS, Bethesda, MD; The University of Texas MD Anderson Cancer Center, Houston, TX
Abstract Disclosures

Abstract:

Background: We are conducting a Phase II clinical trial of the HER2 peptide vaccine AE37 (MHC Class II binding) for the prevention of breast cancer recurrence in disease-free, node-positive or high-risk node-negative patients (pts). In this analysis, we compare disease features and immunologic responses (IR) between vaccinated recurrent (vR) pts and vaccinated non-recurrent (vNR) pts. Methods: After completion of standard of care therapy, pts with any level of HER2 expression (IHC1-3+) who were randomized to the vaccine group received AE37+GM-CSF in 6 monthly intradermal inoculations during the primary vaccine series (PVS) followed by four boosters every 6 months. Ex vivo IR was measured by T-cell proliferation using thymidine incorporation and expressed in mean counts per minute (cpm) ±SEM at R0 and as the average of multiple time points after the PVS and throughout the booster series (R). In vivo IR was measured by delayed type hypersensitivity (DTH) immediately before (R0) and after the PVS (R6). Data was compared using student’s t-test and Fisher’s exact as appropriate. Results: Of 298 enrolled and randomized pts, 153 have been vaccinated. For this analysis, 5 patients were excluded for second malignancies leaving 14 vR and 134 vNR available for analysis. Demographics between vaccinated pts were compared with vR exhibiting a higher percentage of node positive (85.7% v 61.9%, p=0.07) disease. vR pts displayed significantly weaker proliferation than nVR pts (R0: 912±254 v 1954±350, p=0.02; R: 4463±764 v 6803±391, p=0.01). DTH between vR and vNR revealed a significantly lower initial DTH response (R0: 1.09±0.78 v 2.80±0.71mm, p<0.05), but similar post PVS DTH (R6: 33.3±9.1 v 28.9±2.0mm, p=0.68). Conclusions: Comparison of vR and vNR pts demonstrates that vR have more advanced disease as well as a consistently weaker intrinsic anti-HER2 immunity as measured in vivo and ex vivo at baseline. The factors responsible for the diminished endogenous immune response and reduced amplification in these pts will require further studies in larger patient populations. Of particular interest would be the response in HER2 non-overexpressing and triple negative pts, both of which appear to derive a greater benefit from AE37. Clinical trial information: NCT00524277.
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