TBCRC 008: Early change in 18 fluorodeoxyglucose (FDG) uptake on positron emission tomography (PET) predicts response to preoperative systemic therapy (PST) in HER2 negative …

Epigenetic modifiers, including the histone deacetylase inhibitor vorinostat, may sensitize tumors to chemotherapy and enhance outcomes. We conducted a multicenter randomized phase II neoadjuvant trial of carboplatin and nanoparticle albumin-bound paclitaxel (CP) with vorinostat or placebo in women with stage II/III, HER2-negative breast cancer, in which we also examined whether change in maximum standardized uptake values corrected for lean body mass (SULmax) on FDG-PET predicted pathologic complete response (pCR) in breast and axillary lymph nodes. Methods: Participants were randomly assigned to 12 weeks of preoperative carboplatin (AUC 2 weekly) and nab-paclitaxel (100 mg/m 2 weekly) with vorinostat (400 mg oral daily, days 1-3 of every 7-day period) or placebo. All patients underwent FDG-PET and research biopsy pretreatment and on C1D15. The primary endpoint was the pCR rate …