Abstract PS2-07-12: Gut microbiome composition predicts pathologic complete response in patients with early-stage HER2-positive breast cancer receiving neoadjuvant HER2-targeted therapy +/- immunotherapy with pembrolizumab
Abstract
The gut microbiome has been shown to influence response to immune checkpoint inhibitors (ICI). This study aimed to investigate the association between gut microbiome profiles and clinical outcomes in patients with early-stage HER2-positive (HER2+) breast cancer receiving neoadjuvant HER2-targeted therapy +/- immunotherapy with pembrolizumab (K) as part of the randomized phase II neoHIP trial.
Patients with stage II-III HER2+ breast cancer were randomized to 3 treatment arms: Arm A consisted of paclitaxel (T), trastuzumab (H), and pertuzumab (P), THP; Arm B of THP-K; and Arm C of TH-K. Fecal samples were collected at baseline, cycle 3 day 1, surgery, and at 30 and 60 days post-surgery and were analyzed using deep shotgun metagenomics sequencing. Pre-operative fecal samples were analyzed according to pathologic complete response (pCR) and onset of diarrhea during the neoadjuvant period. Comparisons were adjusted to control for false discovery rates (q-value).
99 fecal samples (Arm A: n=32; Arm B: n=48; Arm C: n=19) from 27 patients were included in the analysis. Bacterial diversity by Jaccard analysis was significantly different across all time points for all arms (all p<0.05; q<0.05). In the THP and THP-K arms, Jaccard analysis demonstrated differences in gut microbiome diversity in patients who achieved pCR versus non-pCR (p=0.009; q=0.009). In patients treated with THP who achieved pCR, multiple species were in greater abundance including GGB9237 SGB14179 (log fold change…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 48 participants or records.
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