Correlation of SUV on Early Interim PET with Recurrence-Free Survival and Overall Survival in Primary Operable HER2-Positive Breast Cancer (the TBCRC026 Trial)

Maeve A. Hennessy, Jeffrey P. Leal, Chiung Yu Huang, Lilja B. Solnes, Rita Denbow, Vandana G. Abramson, Lisa A. Carey, Minetta C. Liu, Mothaffar Rimawi, Jennifer Specht, Anna Maria Storniolo, Vicente Valero, Christos Vaklavas, Eric P. Winer, Ian E. Krop, Antonio C. Wolff, Ashley Cimino-Mathews, Richard L. Wahl, Vered Stearns, Roisin M. Connolly

Research output: Contribution to journalArticlepeer-review

3 Scopus citations


Predictive biomarkers of response to human epidermal growth factor receptor 2 (HER2)–directed therapy are essential to inform treatment decisions. The TBCRC026 trial reported that early declines in tumor SUVs corrected for lean body mass (SULmax) on 18F-FDG PET/CT predicted a pathologic complete response (pCR) to HER2 therapy with neoadjuvant trastuzumab and pertuzumab (HP) without chemotherapy in estrogen receptor (ER)–negative, HER2-positive breast cancer. We hypothesized that 18F-FDG PET/CT SULmax parameters would predict recurrence-free survival (RFS) and overall survival (OS). Methods: Patients with stage II/III ER-negative, HER2-positive breast cancer received neoadjuvant HP (n 5 88). pCR after HP alone was 22% (18/83), additional nonstudy neoadjuvant therapy was administered in 28% (25/88), and the majority received adjuvant therapy per physician discretion. 18F-FDG PET/CT was performed at baseline and at cycle 1, day 15 (C1D15). RFS and OS were summarized using the Kaplan–Meier method and compared between subgroups using logrank tests. Associations between 18F-FDG PET/CT ($40% decline in SULmax between baseline and C1D15, or C1D15 SULmax # 3) and pCR were evaluated using Cox regressions, where likelihood ratio CIs were reported because of the small numbers of events. Results: Median follow-up was 53.7 mo (83/88 evaluable), with 6 deaths and 14 RFS events. Estimated RFS and OS at 3 y was 84% (95% CI, 76%–92%) and 92% (95% CI, 87%–98%), respectively. A C1D15 SULmax of 3 or less was associated with improved RFS (hazard ratio [HR], 0.36; 95% CI, 0.11–1.05; P 5 0.06) and OS (HR, 0.14; 95% CI, 0.01–0.85; P 5 0.03), the latter statistically significant. The association of an SULmax decline of at least 40% (achieved in 59%) with RFS and OS did not reach statistical significance. pCR was associated with improved RFS (HR, 0.25; 95% CI, 0.01–1.24; P 5 0.10) but did not reach statistical significance. Conclusion: For the first time, we report a potential association between a C1D15 SULmax of 3 or less on 18F-FDG PET/CT and RFS and OS outcomes in patients with ER-negative, HER2-positive breast cancer receiving neoadjuvant HP alone. If confirmed in future studies, this imaging-based biomarker may facilitate early individualization of therapy.

Original languageEnglish
Pages (from-to)1690-1696
Number of pages7
JournalJournal of Nuclear Medicine
Issue number11
StatePublished - Nov 1 2023


  • biomarkers
  • breast cancer
  • HER2-positive
  • neoadjuvant


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